Page 1

1.1 GORD,

ULCERS, IRRITABLE BOWEL

1.1 GORD, ULCERS, IRRITABLE BOWEL

ALIMENTARY SYSTEM

2MO

H2 blocker. Nizatidine 150mg. Pale/dark yellow ACIDEX Pinewood cap. coded 3144. 30, A12.95. S Duodenal and benign gastric ulcer. 2O Prevention of duodenal ulcer recurrence. Reflux suppressant/antacid. Na+ alginate 500mg, P 300mg in the evening for four or if + ++ Na bicarbonate 267mg, Ca carbonate 160mg/ necessary eight weeks. Alternatively, 150mg 10ml. Susp. 200ml, A2.93; 500ml, A3.82. morning and evening. Prophylaxis, 150mg in the S Gastric reflux, oesophagitis, hiatus evening for up to 1 year. hernia, heartburn incl. heartburn of pregnancy, Q Not recommended. similar gastric disorders. B Impaired renal or hepatic function. P 10-20ml after meals and at night. Pregnancy, lactation. Q Under 6 years, not recommended. 6-12 years, 5-10ml after meals and at bedtime. Over 12 A Urticaria, somnolence, sweating, raised liver enzymes, hepatitis, jaundice, years, same as adult. thrombocytopenic purpura. Hypersensitivity B Na+ restricted diet. reactions. A Constipation, flatulence, stomach cramps, belching.

BISODOL

ALUDROX

Ocean

McNeil Healthcare 2 K

2O Antacid. Alum. (hydrox.). Gel. 200ml, A1.56; 500ml, A2.19. S Hyperacidity, peptic ulceration, dyspepsia. P 5-10ml four times daily between meals and at bedtime. Q Infants, not recommended; others, in proportion to dosage for 70kg adult. D Hypophosphataemia.

Antacid. Heavy mag. carb. 18mg, light mag. carb. 345mg, Na+ bicarb. 532mg per 5ml. Powder. 50g, A1.91; 100g, A2.97. S Relief of indigestion, dyspepsia, heartburn, acidity and flatulence. P 1 x 5ml spoonful in water after meals or as required. Q Not recommended.

2K

ALSO BISODOL TABLETS Sodium bicarb. 64mg, Ca++ carb. 522mg, light mag. carb. 68mg. White tab. 30, A1.45; 100, A3.34. ANDREWS ANTACID TABLETS GSK P 2 as required. Q Not recommended. 2K B Renal impairment. Antacid. Ca++ carb. 600mg, Mg++ carb. 125mg. C Tetracyclines, iron salts, vits. and digoxin White tab. 30, A1.38. (take 2 hrs. apart). S Stomach upsets due to hyperacidity and heartburn. BUSCOPAN Boehringer Ing.

2K

ALSO ANDREWS FRUIT FLAVOUR Ca++ carb. 600mg, Mg++ carb. 125mg. Lemon tab. 30, A1.60; 60, A3.05. P 1-2 as required. Max. 12 in 24 hours. Q Under 12 years, not recommended. C Caution: Tetracyclines.

2MO Anticholinergic. Hyoscine butylbromide 10mg. White sug-ctd tab. 56, A3.03. S Spasm of GI and genito-urinary tract. P 2 four times daily. Q Under 6 years, not recommended. 6-12 years, 1 three times daily.

Treatment and prophylaxis of NSAID-associated benign gastric/duodenal ulcers. ZES. Benign peptic lesions, including reflux oesophagitis (RO), unresponsive to H2 receptor antagonists. Eradication and prevention of H. pylori associated ulcers in combination with appropriate antibiotic therapy. P GORD: 30mg once daily, for 4 weeks; double duration if not fully healed. Long term management: 15-30mg once daily. Duodenal/ benign gastric ulcer: 30mg once daily; duodenal ulcers, 4 weeks; gastric ulcers, 8 weeks. NSAIDassociated ulcers: 15-30mg once daily for 4 or 8 weeks; if not fully healed a further 4 weeks treatment can be given. Longer course or higher dose may be used if severe or in at risk patients. Prophylaxis of NSAID-associated ulcers: 15mg or 30mg once daily. ZES: Initially 60mg once daily. Individually adjust and continue as long as necessary. Eradication of Hp: 30mg twice daily for 1 week in combination with appropriate antibiotic therapy, see SPC. If daily dose q 120mg admin. in 2 divided doses. Swallow cap. whole, before food. Severe hepatic impairment: 15-30mg. Max. 30mg daily. R 15-30mg. Max. 30mg daily. Q Not recommended. D Pregnancy, lactation (no data). B Exclude possibility of malignant gastric tumour. Severe hepatic dysfunction. Risk of GI infections. Treatment q 1 year: Unless considered essential; if visual disturbances occur consult ophthalmologist. Contains sucrose. C Avoid: Ketoconazole, itraconazole. Caution: Oral contraceptives, phenytoin, carbamazepine, theophylline, warfarin, CYP2C19 and CYP3A4 inhibitors, drugs with a narrow therapeutic index. Tacrolimus (monitor). Antacids and sucralfate (take 1 hr apart). A GI disorders, eczema, urticaria, itching, headache, dizziness, fatigue.

BYSEC

Helsinn Birex

2MO

PPI. Omeprazole 10mg, 20mg. Yellow and white or white resp. gastro-resistant cap. marked 10mg or 20mg. 10mg-28, A8.44; 20mg-28, A13.41. ANTEPSIN ALSO BUSCOPAN INJECTION Hyoscine S Duodenal ulcer, relapse of reflux 2M butylbromide 20mg/ml. 1ml amp. 10, A2.37. oesophagitis (RO), NSAID related gastric and Cytoprotectant. Sucralfate 1g. White oblong S Acute spasm, as in renal or biliary colic; duodenal ulcers (treatment and prevention in scored tab. marked ANTEPSIN one side, WY/39 on in radiology for differential diagnosis of patients with history). Benign gastric ulcers, reverse. 50, A7.16. obstruction and to reduce spasm and pain in Zollinger-Ellison syndrome (ZES). The eradication 2M pyelography and in other diagnostic procedures of H. pylori associated peptic ulcers in combination ALSO ANTEPSIN SUSPENSION Sucralfate 1g/5ml. where spasm may be a problem, e.g. gastrowith appropriate antibacterial therapeutic Susp. 250ml, A7.16. duodenal endoscopy. regimens. S Duodenal and gastric ulcer, chronic P 20mg IM or IV repeated after half an P Swallow cap. whole with sufficient gastritis. Prophylaxis of GI haemorrhage from hour if required. fluid. RO: 20mg once daily for 4-8 weeks. stress ulceration in seriously ill patients. Q Not recommended. Maintenance: 10mg-20mg once daily. Duodenal P 2-4g twice daily on rising and at D Myasthenia gravis, megacolon, narrow ulcers: 20mg once daily for 2-4 weeks. bedtime. Alternatively 1-2g four times daily taken angle glaucoma. Maintenance: 10mg once daily. Benign gastric 1 hour before meals. Max. daily dose 8g. B Tachycardia, cardiac insufficiency or ulcers: 20mg once daily for 4-8 weeks. All 3 Prophylaxis in stress ulceration, 1g six times daily. failure, cardiac surgery, intestinal or urinary outlet conditions, increase to 40mg once daily if Tabs. may be dispersed in water. obstruction, pyrexia. Pregnancy (only if benefit necessary. ZES: Initially, 60mg once daily. Adjust Q Not recommended. outweighs risk), lactation. individually. Above 80mg daily should be divided B Pregnancy, lactation. Renal dysfunction. C Caution: TCAs, antihistamines, and given twice daily. No time limit. NSAID quinidine, amantadine, phenothiazines, Separate admin. from any drug if bio-availability related gastric and duodenal ulcers: 20mg daily for butyrophenones and disopyramide, dopamine critical. 4-8 weeks. Maintenance: 20mg daily. Hp antagonists, b-adrenergic agents. C Tetracyclines, phenytoin, cimetidine, Eradication: 20mg with amoxicillin 1000mg, digoxin. clarithromycin 500mg, or 20mg with BYLANS Ergha A Constipation, diarrhoea, nausea, gastric clarithromycin 250mg, metronidazole 400-500mg; discomfort, indigestion, dry mouth, rash, pruritus, 2 M O all twice daily for 1 week. Impaired hepatic back pain, dizziness, sleeplessness, vertigo, function: Max. 20mg daily. PPI. Lansoprazole 15mg, 30mg. Cap. with white drowsiness. Q Over 2 years, severe RO only. 10-20kg: cap marked L and white body marked with 15 or 10mg/day; over 20kg: 20mg/day. Duration for 4-8 30 resp. 15mg-28, A6.95; 30mg-28, A13.61. AXID Clonmel S GORD. Duodenal/benign gastric ulcer. weeks; max.12 weeks. Under 2 years, not

2NO Chugai

2

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Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


ALIMENTARY SYSTEM recommended. B Exclude possibility of malignancy. Confirm RO endoscopically. Risk of GI infections. Severe hepatic dysfunction (monitor liver enzymes). Combination treatment, caution patients with renal/hepatic dysfunction. Treatment q 1 year: Review regularly. Severely ill patients, monitor visual/auditory senses. Contains sucrose. Pregnancy, lactation (only if benefit outweighs risk). Driving or using machines. C Contra: St. John’s wort, atazanavir, clarithromycin in patients with hepatic impairment. Warfarin, phenytoin, ciclosporin (monitor). Ketoconazole, itraconazole, benzodiazepines (e.g. diazepam, triazolam, flurazepam), digoxin, vitamin B12. A Somnolence, insomnia, vertigo, headache, GI disorders.

GORD,

ULCERS, IRRITABLE BOWEL

B See section 8.1. C Contra: Ergot vasoconstrictors, cisapride, pimozide and terfenadine; substrates of CYP3A4 (unless clearly indicated). Caution: Astemizole and other macrolides, quinidine, disopyramid, drugs with potential to prolong QT, cyclosporin, tacrolimus, sirolimus, digoxin, theophylline, warfarin, zidovudine, inducers / strong inhibitors of CYP3A4. HMG Co-A reductase inhibitors. A Oral monilia, headache, smell alteration, GI disorders. Elevated BUN.

1.1

Pregnancy unless considered essential.

GAVISCON

Reckitt Benckiser

2K Reflux suppressant. Na+ alginate 250mg, Na+ hydrogen carbonate 133.5mg, Ca+ carbonate 80mg. Off-white chewable tabs. 2 flavours (peppermint and lemon). 16-A2.37; 32-A3.96.

2KO

ALSO GAVISCON ADVANCE Na+ alginate 1000mg, K+ bicarb. 200mg per 10ml. Sugar-free, aniseed A COLOFAC Solvay flavour liquid. 500ml, 7.12. S Gastro-oesophageal reflux such as acid 2MO regurgitation, heartburn and indigestion. Antispasmodic. Mebeverine (HCl) 135mg. White P 2-4 tabs. after meals and at bedtime. sug-ctd tab. 100, A9.68. Q Under 12 years, not recommended. S Management of Irritable Bowel 2KO Syndrome ALSO GAVISCON ADVANCE TABLETS Na+ alginate P 1 tab. three times daily 20 mins. before 500mg, K+ bicarb. 100mg. Cream, circular tab. with CIMELDINE Clonmel meals. peppermint flavour, marked with sword and circle 2MO Q Over 10 years, as for adults. Under 10 on one side and GA 500 on reverse. 60, A4.05. H2 blocker. Cimetidine 200mg, 400mg and 800mg. years, not recommended. P 5-10ml or 1-2 tabs after meal or at Pale green film-ctd tab. coded 274, oblong filmCOLPERMIN McNeil Healthcare bedtime. ctd tab. coded 275 and oval film-ctd tab. coded Q Under 12 years, not generally 276 resp. All marked with logo one side. 200mg2K recommended, except on medical advice. 120, A11.04; 400mg-60, A10.51; 800mg-30, Antispasmodic-carminative. Peppermint oil 0.2ml. 2K A11.04. In sust.-release matrix in light blue/dark blue entALSO GAVISCON ADVANCE ORAL SUSPENSION S Benign ulceration of oesophagus, ctd cap. with blue band. 20, A4.91; 100, A13.76. Na+ alginate 100mg, K+ hydrogen carb. 20mg per stomach upper intestinal tract (incl. post-operative S Relief of symptoms of irritable bowel 1ml. Off-white viscous susp. in sachets. 20, A5.30. stomal area) and the Zollinger-Ellison syndrome, syndrome. conditions benefitting from reduced gastric acid P 1 or 2 three times daily 30 mins. before P One to two 5ml measuring spoons after meals and at bedtime excretion. Long term maintenance of benign meals for up to 3 months. Q Over 12 years: As per adults. Under 12 peptic ulcer disease under regular surveillance. Q Not recommended. years: On medical advice. P Duodenal ulcer, 400mg twice daily or D Hypersensitivity to menthol. 2K 800mg at bedtime for min. four weeks; B Capsules should not be broken or ALSO GAVISCON LIQUID GAVISCON LIQUID maintenance, 400mg at bedtime or twice daily. chewed. Other indications, see SPC. C Do not take antacids at the same time. PEPPERMINT Na+ alginate 500mg, Na+ hydrogen carbonate 267mg, Ca+ carbonate 160mg. Oral Q Over 2 years, 25-30mg/kg body weight A Heartburn, skin rash, headache. suspension. 2 flavours (peppermint and aniseed). daily in divided doses. CYTOTEC Pharmacia 300ml-A4.53, 600ml-A6.05. B Exclude malignant disease before and P 10-20 ml after meals and before during treatment. Impaired renal function. 2NO retiring. Monitor patients on long term therapy. Prostaglandin analogue. Misoprostol 200mcg. Q Under 12 years, not recommended. Pregnancy, lactation. Patients with a history of White/off-white hexagonal tab. marked SEARLE 2KO peptic ulcer, particularly the elderly, being treated 1461. 60, A15.96; 112, A29.78. with NSAIDs should be observed regularly. ALSO GAVISCON SUSPENSION Na+ alginate S Treatment of duodenal, gastric and C Oral anticoagulants, phenytoin, 500mg, Na+ bicarb. 267mg, Ca++ carb. 160mg/ NSAID-induced ulceration. Prophylaxis of NSAIDtheophylline. 10ml. Pink, oral suspension. 500ml, A3.27. induced ulceration. A Diarrhoea, dizziness, rash, tiredness. P 10-20ml after meals and at night. P 4 daily in two or four divided doses Gynaecomastia, occasional reversible liver damage, with meals and at bedtime for 4-8 weeks. Q Half adult dose. confusion. Leucopenia, incl. agranulocytosis, 2OY Prophylaxis, one, two, three or four times daily pancytopenia, aplastic anaemia, sinus bradycardia, during NSAID use. ALSO GAVISCON INFANT Alginic acid 225mg, tachycardia, heart block, anaphylaxis, Q Not recommended. mag. alginate 87.5mg per dose Powder. 15 dual hypersensitivity, masculitis, alopecia. Very rarely D Pregnancy. Women planning pregnancy. sachets (30 doses), A3.03. interstitial nephritis with occasional increase in Lactation. Allergy to prostaglandins. S Helps to prevent gastric regurgitation in plasma creatinine, acute pancreatitis, B Cerebrovascular, coronary artery or infants where competence of the cardiac sphincter thrombocytopenia, headache, myalgia, arthralgia. severe peripheral vascular disease. Pre-menopausal has not been fully established. The indications for women should use contraception. use are gastric regurgitation, gastro-oesophageal CLOROM Rowex A Diarrhoea, abdominal pain, GI upset, reflux and reflux associated with hiatus hernia in menstrual problems, vaginal bleeding, rash, 2NO infants and young children. dizziness. Macrolide. Clarithromycin 250mg, 500mg. White, Q Breast fed infants: under 4.5kg 1 dose; oblong, convex, film-ctd tab. scored on both faces. over 4.5kg 2 doses. Add 5ml boiled cooled water FYBOGEL MEBEVERINE A A 250mg-14, 10.75; 500mg-14, 18.20. to powder, mix, add further 10ml water, give Reckitt Benckiser after each feed. Bottle fed infants: under 4.5kg 1 S Eradication of H. pylori (Hp) in patients 2OY with Hp associated ulcers in combination with dose in 115ml feed; over 4.5kg 2 doses in 225ml appropriate antibacterial and ulcer healing agents. Antispasmodic/bulking agent. Mebeverine (HCl) feed. Young children, 2 doses prepared as for P 500mg twice daily in combination with 135mg, ispaghula husk 3.5g. Orange flavoured breast fed infants, to be taken after each meal. A A amoxicillin 1000mg twice daily and omeprazole D Gaviscon Infant: Diarrhoea, excessive efferves. grans. Sachets-10, 2.92; 60, 17.54. 20mg twice daily during 7 days. water loss, renal impairment. S Irritable bowel syndrome. Q 12 years and under with weight Q P 1 sachet morning and evening in water B Highly restricted salt diet (contains K+ and Na+); hypercalcaemia, nephrocalcinosis, renal 30kg, not suitable. 30 mins. before meals. An additional sachet may calculi (contains Ca++). Renal insufficiency. Tabs. D Severe hepatic/renal impairment. be taken before the midday meal. contain aspartame. Advance oral suspension Hypokalemic patients (risk of prolongation of QT- Q Not recommended. time). Hypersensitivity to other macrolides, D Intestinal obstruction and colonic atony. contains methyl hydroxybenzoate and propyl Severe renal or cardiovascular conditions. hydroxybenzoate. lincosamide and azalide antibacterial agents. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

3


1.1 GORD,

ULCERS, IRRITABLE BOWEL

GERTAC

Gerard

ALIMENTARY SYSTEM

KLACID FORTE

Abbott Caution: CYP2C19 and CYP3A4 inhibitors and

2MO

2NO

H2 blocker. Ranitidine (HCl) 150mg white-beige film-ctd tab. marked G one side and 00/30 on reverse. 300mg white-beige cap.-shaped film-ctd tab. marked G one side and 0031 on reverse. 150mg-60, A22.41; 300mg-30, A20.67. S Treatment of duodenal and gastric ulcer; prophylaxis of duodenal ulcer, reflux oesophagitis (RO). Treatment of Zollinger-Ellison’s syndrome (ZES). P Duodenal and gastric ulcer, 150mg twice daily or 300mg at bedtime. For duodenal ulcer dosage may be increased to 300mg twice daily for up to 4 weeks. Prophylaxis of duodenal ulcer, 150mg at bedtime. RO, 300mg daily or 150mg twice daily for 4-8 weeks or if necessary up to 12 weeks. ZES, see SPC. Q Not recommended. B Exclude malignant disease before treatment. Impaired renal function. Pregnancy, lactation. A Headache, dizziness. Rarely hepatitis, thrombocytopenia, leucopenia, hypersensitivity, confusion, breast symptoms.

Macrolide. Clarithromycin 500mg. Yellow oval film-ctd tab. marked with logo. 14, A12.13. S Eradication of H. pylori in patients with duodenal ulcer, in conjunction with anti-secretory agent. P Triple therapy vs H. pylori, 500mg twice daily with amoxycillin 1g twice daily and a PPI (at the approved daily dose) for 7-10 days. Dual therapy vs H. pylori eradication, 500mg three times daily for 14 days with an acid suppressant. Q Not recommended. B Renal or hepatic impairment. Pregnancy, lactation. C Theophylline, oral anticoagulants, carbamazepine, digoxin, terfenadine, drugs metabolised by P450. A Nausea, vomiting, abdominal pain and diarrhoea, headache, rash. Transient CNS effects.

substrates (e.g. theophylline, carbamazepine). Digoxin, tacrolimus, phenytoin, warfarin. Antacids and sucralfate (take 1 hr apart). A GI disorders, eczema, urticaria, itching, rash, headache, dizziness, fatigue.

LANZOL

Rowex

2MO

PPI. Lansoprazole 15mg, 30mg. Opaque, yellow and white gelatine caps. resp. 15mg-28, A12.42; 30mg-7, A6.17; 30mg-28, A24.68. S Duodenal and gastric ulcer. Reflux oesophagitis (RO), long-term prophylaxis of RO. Eradication of H. pylori (Hp) in combination with antibiotic therapy and prevention of relapse. Zollinger-Ellison syndrome (ZES). NSAID-associated benign gastric and duodenal ulcers (maintenance and treatment). GORD. P Ulcers and RO: 30mg once daily swallowed whole with liquid into empty stomach; duodenal ulcers, 2 weeks; gastric ulcers and RO, 4 LANZIOP Teva weeks; double duration if not fully healed. NSAID2MO associated ulcers: 30mg once daily for 4 or 8 PPI. Lansoprazole 15mg, 30mg. White/redweeks; longer course or higher dose may be used brownish and white gel caps., resp. 15mg-28, if severe. Prophylaxis of RO and NSAID-associated A13.60; 30mg-28, A27.12. ulcers: 15mg once daily; may be increased up to IMOGAS McNeil Healthcare S Duodenal and gastric ulcer. Reflux 30mg daily. Eradication of Hp: 30mg twice daily in 2K oesophagitis (RO), long-term prophylaxis of RO. combination with recommended antibiotics. ZES: Deflatulent. Simeticone 240mg. Egg-shaped Zollinger-Ellison syndrome (ZES). Initially 60mg once daily. Individually adjust and transparent soft cap. 10, A2.55. P Ulcers and RO: 30mg once daily continue as long as necessary. Max. 180mg, if daily S Symptomatic treatment of abdominal swallowed whole with liquid into empty stomach; dose q 120mg admin. in 2 divided doses. GORD: distension (flatulence) in adults from the age of duodenal ulcers, 2 weeks; gastric ulcers and RO, 4 15-30mg once daily for up to 4 weeks. If 15 years. weeks; double duration if not fully healed. symptoms persist after 4 weeks on 30mg further P 1 cap. at the end of each main meal Prophylaxis of RO: 15mg once daily; may be examination recommended. Impaired renal with a glass of water. Duration: Restricted to 10 increased up to 30mg daily. ZES: Initially 60mg function/ mildly impaired hepatic function: Max. days. once daily. Individually adjust and continue as 30mg daily. Moderately impaired hepatic function: B If symptoms persist or worsen, or long as necessary. Max. 180mg, if daily dose q Max. 15mg daily. prolonged constipation occurs, patient should seek 120mg admin. in 2 divided doses. Impaired renal R 15-30mg. Max. 30mg daily. medical advice. Not recommended for infant colic. function/ mildly impaired hepatic function: Max. Q Not recommended. A Nausea, constipation, hypersensitivity 30mg daily. Moderately impaired hepatic function: D Severely impaired hepatic function. reactions. Max. 15mg daily. Pregnancy, lactation (no data). R 15-30mg. Max. 30mg daily. B Exclude possibility of malignant gastric INFACOL Ocean Q Not recommended. tumour. Caution: Hepatic dysfunction. Risk of GI 2 D Severely impaired hepatic function. infections. Treatment q 1 year: Review regularly, Deflatulent. Activated dimethicone (as Pregnancy, lactation (no data). if visual disturbances occur consult simethicone) 40mg/ml. Emulsion. 50ml, A2.96. B Exclude possibility of malignant gastric ophthalmologist. Contains sucrose. Driving or S Relief of griping pain, colic or wind for tumour. Caution: Hepatic dysfunction. Risk of GI using machines. swallowed air. infections. Treatment q 1 year: Review regularly, C Avoid: Ketoconazole, itraconazole. P Not applicable. if visual disturbances occur consult Caution: CYP2C19 inhibitors, CYP3A4 inhibitors Q Infants, 20mg (0.5ml) before each feed ophthalmologist. Gastro-duodenal ulcers, consider and substrates, digoxin, tacrolimus, phenytoin, increasing to 40mg (1ml) if necessary. A H. pylori infection as an etiological factor. warfarin. Antacids and sucralfate (take one hour progressive improvement in symptoms may occur Contains sucrose. Driving/using machines. apart). over several days. C Avoid: Ketoconazole, itraconazole. A GI disorders, eczema, urticaria, itching, headache, dizziness, fatigue.

LANZOPRAZOLE BENTLEY

MIMS Ireland current policy for drug inclusion The current editorial policy in MIMS Ireland is to include only medicines with Product Authorisations (PA number) or unlicensed products that are GMS reimbursed. Consequently, all products that do not belong to either of these categories are not listed in the present publication. This decision has been taken in order to preserve conciseness and consistency of MIMS Ireland. 4

Bentley

2MO PPI. Lansoprazole 15mg, 30mg. White opaque caps marked L on cap and strength on body, with gastro-resistant micropellets. 15mg-28, A9.90; 30mg-28, A19.67. S Duodenal/benign gastric ulcers, reflux oesophagitis (RO, maintenance and treatment), gastrooesophageal reflux disease (GORD), NSAID related gastric/duodenal ulcers (maintenance and treatment), Zollinger-Ellison syndrome (ZES). In combination with antibacterial regimens for eradication of H. pylori (Hp) associated peptic ulcers. P Admin. all treatments once daily in the morning, except Hp eradication (twice daily morning and evening). Swallow whole with liquid at least 30 mins before food. Ulcers: 30mg daily;

2

5

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b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


ALIMENTARY SYSTEM duodenal, 2 weeks; gastric, 4 weeks. RO: 30mg daily for 4 weeks. Maintenance, 15mg daily as necessary. For ulcers and RO, double duration if not fully healed. GORD: 15 or 30mg daily, up to 4 weeks. NSAID-related ulcers: 30mg daily for 4 weeks or 8 weeks if not fully healed (consider longer course or higher dose if severe or in at risk patients). Prophylaxis: 15mg daily; increase to 30mg daily if fails. ZES: Initially 60mg daily. Individually adjust up to 180mg and continue as long as necessary. Doses q120mg daily should be divided in two. Eradication of Hp: 30mg twice daily for 7 days in combination with one of the following: Clarithromycin 250-500mg twice daily and amoxicillin 1g twice daily or clarithromycin 250mg twice daily and metronidazole 400-500mg twice daily. Moderate or severe hepatic impairment: Use half dose. R Max. 30mg daily. Q Not recommended. B Exclude possibility of malignant gastric tumour. Teatment q1 year (assess risk/benefit). Contains sucrose. Pregnancy, lactation (not recommended). C Contra: Atazanavir. Avoid ketoconazole, itraconazole. Caution: Digoxin, CYP3A4 substrates, theophylline, tacrolimus, fluvoxamine, CYP2C19 and CYP3A4 inducers (e.g. rifampicin, St John’s wort), antacids, sucralfate (1 hr apart). A Headache, dizziness, GI disorders, rash, urticaria, itching, fatigue. Increase in liver enzyme levels.

GORD,

ULCERS, IRRITABLE BOWEL

1.1

cyclosporin, clarithromycin, ketoconazole or itraconazole, digoxin, vit. B12. A Drowsiness, somnolence, sleep disturbances, vertigo and headaches, GI disorders.

PPI. Omeprazole 10mg, 20mg, 40mg. Light pink, pink and red-brown tabs resp. All oblong, film-ctd marked with tab. strength and containing ent-ctd pellets. Dispersible in water. 10mg-28, A8.74; 20mg-28, A16.45; 40mg-14, A16.43. LOSAMEL Clonmel S Treatment of oesophageal reflux (OR) disease, incl. reflux oesophagitis (RO). Treatment 2MO PPI. Omeprazole 20mg. Light grey gastro-resistant of duodenal and benign gastric ulcers. Healing and prophylaxis of NSAID-associated benign A tab. (tabs. must not be broken). 30, 28.12. gastric ulcers and duodenal ulcers. H. pylori S Treatment of duodenal ulcer, benign gastric ulcers, reflux oesophagitis, Zollinger-Ellison eradication in peptic ulcer disease. Relief of syndrome, treatment of NSAID-related gastric and associated dyspeptic symptoms. Prophylaxis of acid aspiration. Zollinger-Ellison syndrome (ZES). duodenal ulcers, gastro-oesophageal reflux P OR: 20mg once daily for 4 weeks. In disease, in combination with appropriate those unhealed after initial course, healing usually antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with occurs during a further 4-8 weeks treatment. Refractory RO, 40mg daily for 8 weeks. H. pylori associated peptic ulcers. Maintenance of severe RO, 20mg daily increasing P Duodenal ulcer: 20mg once daily; to 40mg once daily if relapse. Acid reflux disease: healing usually occurs within 2-4 weeks. Benign Long term management, 10mg once daily, gastric ulcers and RO: 20mg once daily; healing increasing to 20mg if symptoms return. Duodenal usually occurs within 4-8 weeks. Maintenance and gastric ulcer: 20mg daily usually for 4-8 treatment of reflux oesophagitis: 10-20mg daily. Zollinger-Ellison syndrome: See SmPC. NSAID weeks. Increase to 40mg once daily if severe. ulceration: 20mg once daily; healing usually occurs Maintenance, 10mg once daily increasing to 20mg within 4-8 weeks; maintenance 20mg once daily. once daily if symptoms return. NSAID ulceration: Gastro-oesophageal reflux disease: 10-20mg daily. For healing and prophylaxis 20mg once daily. Hp Healing usually occurs within 2-4 weeks. H. pylori eradication: Triple therapy, Losec 20mg with eradication regimens in peptic ulcer disease: 20mg clarithromycin 250mg and metronidazole 400mg twice daily in association with the following or amoxycillin 1g and clarithromycin 500mg all regimens amoxicillin 1000mg and clarithromycin twice a day for 1 week. Dual therapy, Losec 20mg 500mg both twice daily for one week or with oral amoxycillin 1g both twice daily for 2 clarithromycin 250mg and metronidazole 400weeks. Alternatively, Losec 40mg once daily with 500mg both twice daily for one week. Tabs. clarithromycin 500mg three times daily for 2 LOPRAZ Teva should be swallowed whole before a meal. weeks. Acid aspiration: 40mg on evening before 2MO Q Severe RO resistant to other therapeutic surgery followed by 40mg 2- 6 hrs prior to PPI. Omeprazole 10mg, 20mg, 40mg. Opaque measures: 10mg (10-20 kg) or 20mg (q20 kg) once surgery. ZES: Initially 60mg, adjusting at 20-120mg yellow caps. containing gastro-resistant granules. daily. daily. Doses above 80mg, twice daily. 10mg-28, A13.10; 20mg-28, A24.61; 40mg-14, B Avoid use during pregnancy and Q Treatment of refractory RO, 10mg (10A24.65. lactation. Severe liver disease. In gastric ulcer 20kg) or 20mg (q20kg) once daily for 4-12 weeks. S Duodenal ulcer, benign gastric ulcers, exclude malignancy before treatment. With 2N reflux oesophagitis (RO, maintenance and prolonged treatment, patients should be reviewed ALSO LOSEC INFUSION Omeprazole 40mg (as treatment), GORD, Zollinger-Ellison syndrome periodically by a consultant. omeprazole Na+ 42.6mg). Powder in vial. 40mg-5, (ZES), NSAID related gastric and duodenal ulcers C Diazepam, phenytoin, warfarin, A43.48. (maintenance and treatment). In combination with ketoconazole, itraconazole, digoxin, P Where oral medication inappropriate, antibacterial regimens for eradication of H. pylori clarithromycin, roxithromycin, erythromycin, 40mg once daily as IV inf. over 20-30 mins. Acid associated peptic ulcers. hexabarbital, citalopram, imipramine, aspiration: 40mg as IV inf. one hour before P Swallow tab. whole with sufficient fluid clomipramine, disulfiram, cyclosporin, vitamin B12. surgery. Only reconstitute powder in 100ml saline before meal. Duodenal ulcers: 20mg once daily A Headache, vertigo, drowsiness, sleep or 100ml dextrose (5%) for inf. during 2-4 weeks. Gastric ulcers: 20mg daily during disturbances, GI upset, paraesthesia, changes in Q Not recommended. 4-(6)-8 weeks. RO: 20mg daily during 4-8 weeks; liver function, hypersensitivity (skin rash). B Pregnancy and lactation. Severe liver maintenance, 10-20mg daily. All three conditions, Leucopenia and thrombocytopenia have been disease. In gastric ulcer exclude malignancy before increase to 40mg once daily if necessary. GORD: reported. treatment. With prolonged treatment, review 10-20mg daily during 2-4 weeks. ZES: Initially, patients periodically. 60mg daily. Adjust individually. Above 80mg daily, LOSEC MUPS AstraZeneca C Contra: Atazanavir. Ketoconazole, admin. in two divided doses. No time limit. NSAID 2MO itraconazole, clarithromycin, tacrolimus. diazepam, related gastric and duodenal ulcers: 20mg daily during 4-8 weeks. Maintenance: 20mg daily. CHANGE OF ADDRESS Eradication: 20mg with amoxicillin 1000mg and clarithromycin 500mg, or 20mg with Doctors are requested to notify the publisher clarithromycin 250mg and metronidazole 400immediately of any change of address.Write to: 500mg, all 2 times daily during 1 week. Impaired hepatic function: Max. 20mg daily. Q Over 2 years, severe RO only. 10-20kg: Circulation Department, 10mg/day; over 20kg: 20mg/day. Duration: 4-8 MIMS Ireland weeks; max.12 weeks. Under 2 years, not 24-26 Upper Ormond Quay, recommended. B Exclude possibility of malignancy. Renal Dublin 7. dysfunction, severe hepatic impairment (monitor liver function). Long-term treatment. Contains or fax: (01) 8176365 sucrose. Pregnancy, lactation (only if benefit or e-mail: subscribe@mims.ie outweighs risk). C Clarithromycin (do not use if hepatic giving new address, old address and, if possible label from impairment), St. John’s wort (avoid). Caution: Diazepam, some other benzodiazepines, warfarin, a previously posted issue. phenytoin, other CYP2C substrates, disulfiram, AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

5


1.1 GORD,

ULCERS, IRRITABLE BOWEL

phenytoin, warfarin and other vitamin K antagonists. A Headache, GI upset.

ALIMENTARY SYSTEM

2

ALSO MAALOX PLUS TABLETS Alum. hydrox. 200mg, mag. hydrox. 200mg, simethicone 25mg. Yellow/white tab. marked MAALOX on one side LOSEPINE Pinewood and RORER on reverse. 20, A2.84; 50, A5.25. S Heartburn, indigestion, flatulence and 2MO dysepsia. PPI. Omeprazole 10mg, 20mg. Oval red-brown P 1-2 tabs. four times a day (after meals gastro-resistant tab. 10mg-28, A14.50; 20mg-28, and at bedtime) or as required. A27.38. Q Not recommended. S Duodenal ulcer, benign gastric ulcers, reflux oesophagitis (maintenance and treatment), D Severely debilitated patients. Kidney GORD, Zollinger-Ellison syndrome (ZES), history of failure. Pregnancy (unless essential). ulcer following use of anti-inflammatory products, B Advance renal disease, low phosphate diet e.g. malnutrition. NSAID related gastric and duodenal ulcers (maintenance and treatment). In combination with C Caution: Tetracyclines, digoxin and vitamins. antibacterial regimens for eradication of H.pylori associated peptic ulcers. Amdipharm P Swallow tab. whole with sufficient fluid MAXOLON before meal or on empty stomach. Duodenal 2MO ulcers: 20mg once daily during 2-4 weeks. Antidopaminergic. Metoclopramide Maintenance: 10mg daily. Gastric ulcers: 20mg monohydrochlor. 10mg. White to off-white scored daily during 4-(6)-8 weeks. RO: 20mg daily during tab. marked MAXOLON. 84, A6.36. 4-8 weeks. Maintenance: 10-20mg daily. All three 2MO conditions, increase to 40mg once daily if ALSO MAXOLON SYRUP Metoclopramide (HCl) necessary. GORD: 10-20mg daily during 2-4 weeks. 5mg/5ml. 100ml, A1.60; 200ml, A3.20. ZES: Initially, 60mg daily. Adjust individually. 2NO Above 80mg daily, admin. in two divided doses. ALSO MAXOLON INJECTION Metoclopramide No time limit. NSAID related gastric and duodenal (HCl) 5mg/2ml. Amp 12 x 5mg, A3.46. ulcers: 20mg daily during 4-8 weeks. Maintenance: S Adults over 20 years: Disorders of the GI 20mg daily. Eradication: 20mg with amoxicillin tract associated with delayed gastric emptying 1000mg and clarithromycin 500mg, or 20mg with (e.g. reflux oesophagitis, hiatus hernia, postclarithromycin 250mg and metronidazole 400vagotomy syndrome). Diagnostic procedures (e.g. 500mg, all 2 times daily during 1 week. Impaired barium studies and duodenal intubations). To hepatic function: Max. 20mg daily. counteract gastric stasis associated with attacks of Q Over 2 years, severe RO only. 10-20kg: migraine and assist absorption of orally 10mg/day; over 20kg: 20mg/day. Duration: 4-8 administered analgesics for that condition. Under weeks; max.12 weeks. Under 2 years, not 20 years: As an aid to GI intubation. recommended. P 10mg three times daily. Q60kg, see B Exclude possibility of malignancy. below. Diagnostic indications: Single 10-20mg Increased risk of GI infections. Hepatic dysfunction dose, 5-10 min before examination. (monitor transaminase levels). Contains lactose. Q Medical indications: 15-19 years q60kg, Pregnancy, lactation. 10mg three times daily; 30-59kg, 5mg three times C Caution: Ketoconazole or itraconazole, daily; 9-14 years r30kg, 5mg three times daily; 5diazepam, R-warfarin and phenytoin, digoxin, 9 years 20-29kg, 2.5mg three times daily; 3-5 years erythromycin and roxitromycin. 15-19kg, 2mg two to three times daily; 1-3 year A Dizziness, somnolence, insomnia, 10-14kg, 1mg two to three times daily; Q1year vertigo, sense of malaise and headache, GI Q10kg, 1mg twice daily. Diagnostic indications: 5disorders. 10 min before examination. 15-19 years, 10mg; 9-

faintly cream circular biconvex film-ctd tabs. 10, 20, A6.43.

A3.67;

2K ALSO MOTILIUM FASTMELTS Domperidone 10mg. White or off-white circular orodispersible tab. 10, A3.99; 20, A7.00. S Post-prandial symptoms of fullness, nausea, epigastric bloating and belching occasionally accompanied by epigastric discomfort and heartburn. P Up to 10mg 3 times daily and at night for 2 weeks max. Q Under 16 years, not recommended. Over 16 years, as per adults. D Prolactin-releasing pituitary tumour (prolactinoma). GI haemorrhage, mechanical obstruction or perforation. Hepatic and/or renal impairment. Pregnancy, lactation. B Contains aspartame. C Strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, erythromycin). A Raised serum prolactin.

MOTILIUM RX

McNeil Healthcare

2OY Antidopaminergic. Domperidone 10mg. White film-ctd tab. marked M/10 on one side and JANSSEN on reverse. 100, A 6.04. S Disorders of GI tract associated with delayed gastric emptying and oesophageal reflux. P 10mg orally, 3 times daily, 15-30 mins before meals and if necessary before retiring. Q Under 1 year, under specialist supervision.

2MO ALSO MOTILIUM SUSPENSION Domperidone 1mg per ml. Oral susp. 200ml, A2.08. S Epigastric sense of fullness, upper abdominal discomfort and regurgitation of gastric contents in adults. P 10ml-20ml 3-4 times per day before meals. Max. 80ml. Reevaluate after 4 weeks.

2MO

ALSO MOTILIUM SUPPOSITORIES Domperidone 10mg, 30mg, 60mg. 10mg-6, A1.80; 30mg-6, A1.81; 60mg-6, A7.31. S Epigastric sense of fullness, upper abdominal discomfort and regurgitation of gastric 14 years, 5mg; 5-9 years, 2.5mg; 3-5 years, 2mg; contents in adults. MAALOX sanofi-aventis Q3 years, 1mg. P 1 (60mg) suppos. twice daily. Reevaluate 2O D Phaeochromocytoma. Epilepsy. GI after 4 weeks. Antacid. Alum. hydrox. gel 225mg, mag. hydrox. haemorrhage, mechanical obstruction or D Pregnancy (unless essential), lactation. 200mg/5ml. Susp. 500ml, A5.00. perforation. Pregnancy, lactation (unless essential). Patients with prolactin releasing pituitary tumours, GI haemorrhage, mechanical obstruction or S Dyspepsia. perforation. Hepatic impairment. P 5-10ml (1-2 spoonfuls) taken 20-60 mins. B Not for use in the immediate postB Severe renal insufficiency, especially if after meals and at night. operative period (up to 3-4 days) following 2 pyloroplasty or gut anastomosis. Assess risk/benefit: prolonged use. C Anticholinergics, CYP3A4 inhibitors, Significant hepatic or renal impairment, ALSO MAALOX NO. 2 TABLETS Dried alum. antacids or antisecretory agents, phenothiazines or Parkinson’s disease. If vomiting persists, reassess hydrox. gel 400mg, mag. hydrox. 400mg. White other neuroleptics, dopaminergic agonists. patient to exclude underlying disorder (e.g. tab. marked WHR both sides with odour of A Raised serum prolactin. cerebral irritation). Caution: History of atopy peppermint. 40, A3.45. (including asthma) or porphyria. May occur: S Dyspepsia. NEXIUM AstraZeneca P 1-2 four times daily chewed 20-60 mins. Neuroleptic malignant syndrome, elevation of serum prolactin levels. Rare hereditary problems of 2 M O after meals and at bedtime. Max. 8 in 24 hrs. not galactose intolerance, Lapp lactose deficiency of more than 2 weeks unless indicated by physician. PPI. Esomeprazole (magnesium trihydrate) 20mg, glucose-galactose malabsorption. Q Not recommended. 40mg. Pink oblong film-ctd tabs. marked 20mg or C Anticholinergics, phenothiazines, CNS 2 40mg one side and symbol on reverse. 20mg-28, drugs (MAOIs, sympathomimetics), serotonergic A26.72; 40mg-28, A41.23. ALSO MAALOX PLUS SUSP Alum. hydrox. gel drugs, alcohol. 225mg, mag. hydrox. 200mg, simethicone 25mg/ S Treatment of erosive reflux oesophagitis A Extrapyramidal reactions. A 5ml. Susp. 355ml, 5.00. (RO); long-term management of patients with healed oesophagitis to prevent relapse; S Heartburn, indigestion, flatulence and MOTILIUM McNeil Healthcare symptomatic treatment of gastroesophageal reflux dysepsia. 2K disease (GORD). Healing of H. pylori (Hp) P 1-2 x 5ml spoonfuls four times a day Antidopaminergic. Domperidone 10mg. White to associated duodenal ulcer. Prevention of Hp (after meals and at bedtime) or as required.

6

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


1.1 GORD,

ULCERS, IRRITABLE BOWEL

associated peptic ulcer relapse. Patients requiring continued NSAID therapy: Healing of gastric ulcers associated with NSAID therapy, and prevention of gastric and duodenal ulcers associated with NSAID therapy in at risk patients. Treatment of Zollinger Ellison Syndrome (ZES). Prolonged treatment after IV induced prevention of rebleeding of peptic ulcers. P Erosive RO: Treatment, 40mg once daily for 4 weeks; additional 4 weeks for patients not healed. Prevention of relapse, 20mg once daily. GORD without oesophagitis: 20mg once daily until symptom resolution; maintenance 20mg once daily when required. In adults, an on demand regimen taking 20mg once daily, when needed, can be used. Healing/ prevention of Hp associated ulcers: 20mg with 1g amoxycillin and 500mg clarithromycin, all twice daily for 7 days. NSAID induced ulcers: Treatment, 20mg once daily for 4-8 weeks; prevention, 20mg once daily. ZES: 40mg twice daily. Usual range 80-160mg daily. Doses q 80mg daily, divide and admin. twice-daily. After IV induced prevention of rebleeding of peptic ulcers: 40 mg once daily for 4 weeks. Severe renal impairment: Max. 20mg once daily. Q Over 12 years, RO and GORD only, as per adults. Under 12 years, not recommended.

2JM ALSO NEXIUM I.V. 40MG Esomeprazole (sodium) 42.5mg (equiv. esomeprazole 40mg). Powder in vial for soln. for inj. or inf. 40mg-1, A7.98. S GORD in patients with esophagitis and/ or severe symptoms of reflux as an alternative to oral therapy. Healing of gastric ulcers associated with NSAID therapy. Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk. Prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers. P IV inj. over 3 mins. or IV inf. over 1030mins. RO: 40mg once daily. Symptomatic treatment for reflux disease/healing and prevention of NSAID-associated ulcers: All 20mg once daily. Transfer to oral as soon as possible. Prevention of rebleeding after endoscopy: 80mg as bolus inf. over 30 min, followed by IV inf. of 8mg/h over 72 hrs, then by oral acid-suppression therapy. Severe liver impairment: GORD, max. 20mg daily; rebleeding prevention, 4mg/h for 71.5 hours may be sufficient. Q Not recommended. D Hypersensitivity to other substituted benzimidazoles. Lactation. B In gastric ulcer exclude malignancy before treatment. Long term treatment (monitor). Severe hepatic/renal insuffiency. Slightly increased risk of GI infections (Salmonella, Campylobacter). Pregnancy. Contains lactose. C Contra: Nelfinavir. Not recommended: Atazanavir. Caution: Ketoconazole, itraconazole, CYP2C19 substrates (diazepam, phenytoin, citalopram, imipramine, clomipramine), warfarin or other coumarine derivatives, cisapride. A Headache, GI disorders.

ALIMENTARY SYSTEM

(ZES), NSAID related gastric and duodenal ulcers (maintenance and treatment). In combination with antibacterial regimens for eradication of H. pylori associated peptic ulcers. P Swallow tab. whole with sufficient fluid before meal. Duodenal ulcers: 20mg once daily during 2-4 weeks. Gastric ulcers: 20mg daily during 4-(6)-8 weeks. RO: 20mg daily during 4-8 weeks; maintenance, 10-20mg daily. All three conditions, increase to 40mg once daily if necessary. GORD: 10-20mg daily during 2-4 weeks. ZES: Initially, 60mg daily. Adjust individually. Above 80mg daily, admin. in two divided doses. No time limit. NSAID related ulcers: 20mg daily during 4-8 weeks. Maintenance: 20mg daily. Eradication: 20mg with amoxicillin 1000mg and clarithromycin 500mg, or 20mg with clarithromycin 250mg and metronidazole 400-500mg, all 2 times daily during 1 week. Impaired hepatic function: Max. 20mg daily. Q Over 2 years, severe RO only. 10-20kg: 10mg/day; over 20kg: 20mg/day. Duration: 4-8 weeks; max.12 weeks. Under 2 years, not recommended. B Exclude possibility of malignancy. Severe hepatic impairment (monitor liver function). Longterm treatment (q1 year). Contains sucrose. Pregnancy, lactation (only if benefit outweighs risk). C Contra: Atazanavir, clarithromycin (in hepatic impairment). Avoid St. John’s wort, ketoconazole itraconazole. Caution: Diazepam, some other benzodiazepines, warfarin, phenytoin, other CYP2C substrates, disulfiram, cyclosporin, tacrolimus, clarithromycin, digoxin, vit. B12. A Drowsiness, dizziness, somnolence, sleep disturbances, headaches, GI disorders.

500mg twice daily or amoxicillin 1g twice daily + metronidazole 400-500mg twice daily. Gastric/ duodenal ulcers: 40mg daily. ZES: Initially 80mg daily. Doses q80 mg daily, divide dose and give twice daily. May be temporarily increased to q160mg (no longer than required for adequate acid control); maintain as long as required. Impaired liver function: Max 40mg every other day. R Max 40mg daily except for H.pylori eradication (as per adults for 1 week). Q Not recommended. D Severe hepatic insufficiency (combination therapy for H. pylori eradication). For prescribing information, see pantoprazole Drug Presc. Notes. B Contains maltitol.

PANTIUM

2MO

Clonmel

2MO PPI. Pantoprazole 20mg. Yellow oval gastroresistant tab. 20mg-28, A12.27. S Mild reflux disease and associated symptoms; long-term management and prevention of relapse in reflux oesophagitis (RO); prevention of gastroduodenal ulcers induced by non-selective NSAID in patients at risk with need for continuous NSAID treatment. P Mild reflux disease: 20mg daily. Control recurrent symptoms with 20mg once daily ondemand regimen if required; if symptoms not controlled adequately consider switch to continuous therapy. RO: 20mg daily; increase to 40mg daily if relapse occurs. Carefully analyse risk/ benefit for treatment q1 year. NSAID-induced ulcers: 20mg daily. Impaired liver function: Max 20mg daily . Q Under 12 years, not recommended. Over 12 years: Mild reflux disease, RO: As per adults.

2MO

ALSO PANTIUM 40MG Pantoprazole 40mg. Yellow oval gastro-resistant tab. 40mg-28, A22.73. S Combination therapy with 2 suitable antibiotics for eradication of H. pylori and prevention of relapse of peptic ulcers in patients OMEPRAZOLE BENTLEY Bentley with H. pylori associated ulcers; duodenal ulcers; 2MO gastric ulcers; moderate or severe forms of RO; PPI. Omeprazole 10mg, 20mg, 40mg. Opaque red/ long-term treatment of Zollinger-Ellison syndrome (ZES) and other disorders accompanied by orange, blue/orange, blue/orange caps. marked pathological gastric acid hypersecretion. O10, O20, O40 resp. containing gastro-resistant P RO: 40mg daily; may be doubled. H. granules. 10mg-28, A11.05; 20mg-28, A17.99; A pylori eradication: 40mg twice daily in 40mg-14, 18.84. combination with either amoxicillin 1g twice daily S Duodenal ulcer, benign gastric ulcers, + clarithromycin 500mg twice daily or reflux oesophagitis (RO, maintenance and clarithromycin 250-500mg + metronidazole 400treatment), GORD, Zollinger-Ellison syndrome

8

PANTOFLUX

Actavis

2MO PPI Pantoprazole 20mg. Elliptical biconvex light yellow gastro-resistant tab. 28, A13.08. S Treatment of mild reflux disease and associated symptoms; long-term management and prevention of relapse in reflux oesophagitis (RO); prevention of gastroduodenal ulcers induced by non-selective NSAID in patients at risk with a need for continuous NSAID treatment. P Mild reflux disease: 20mg daily; control recurrent symptoms with 20mg once daily ondemand regimen if required; consider switching to continuous therapy if symptoms not controlled adequately. RO: 20mg daily; increase to 40mg daily if relapse occurs. NSAID-induced ulcers: 20mg daily. Severe liver impairment: Max 20mg daily. Q Under 12 years, not recommended. Over 12 years: Mild reflux disease, RO: As per adults. ALSO PANTOFLUX 40MG Pantoprazole 40mg. Elliptical biconvex dark yellow gastro-resistant tab. 28, A24.17. S Symptomatic improvement and healing of GI diseases requiring a reduction in acid secretion: Duodenal ulcer, gastric ulcer, moderate and severe RO, Zollinger-Ellison-Syndrome (ZES) and other pathological hypersecretory conditions, eradication of Helicobacter pylori (in combination with antibiotics in patients with duodenal ulcer or gastric ulcer). P RO: 40mg daily. Duodenal/gastric ulcer: 40mg daily. ZES: Initially 80mg daily. Doses q80 mg daily, divide dose and give twice daily. May be temporarily increased to q160mg (no longer than required for adequate acid control). H. pylori eradication: 40mg twice daily in combination with either amoxicillin 1g twice daily + clarithromycin 500mg twice daily or clarithromycin 500mg + metronidazole 500mg twice daily or amoxicillin 1g twice daily + metronidazole 500mg twice daily. Impaired renal function: Max 40mg daily. Severe hepatic impairment: Max 40mg every other day. R Max 40mg daily except for H.pylori eradication (as per adults for 1 week). Q Under 12 years, not recommended. Over 12 years: RO: As per adults. D Moderate to severe liver or renal insufficiency (40mg tab. in combination therapy to eradicate H. pylori). For prescribing information, see pantoprazole Drug Presc. Notes.

PANTOPRAZOLE NICHE

Niche

2MO PPI. Pantoprazole 20mg. Light brownish yellow, oval, slightly biconvex gastro-resistant tab. 28,

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


ALIMENTARY SYSTEM A11.46.

S Mild reflux disease and associated symptoms. Long-term management and prevention of relapse in reflux oesophagitis (RO). Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with need for continuous NSAID treatment. P Mild reflux disease: 20mg daily; control recurrent symptoms with 20mg once daily ondemand regimen if required; consider switching to continuous therapy if symptoms not controlled adequately. RO (long-term, prevention of relapse): 20mg daily; increase to 40mg daily if relapse occurs. NSAID-induced gastroduodenal ulcers: 20mg daily. Impaired renal function: Max 40mg daily. Severe hepatic impairment: Max 20mg daily. R Max 40mg daily. Q Not recommended.

2MO ALSO PANTOPRAZOLE NICHE 40MG Pantoprazole 40mg. Light brownish yellow, oval, slightly biconvex gastro-resistant tab. 28, A21.22. S Relief of symptoms and short-term treatment of GI diseases which require a reduction in acid secretion: Duodenal ulcer, gastric ulcer, moderate and severe RO, eradication of H. pylori in combination with antibiotic therapy in patients with peptic ulcer, Zollinger-Ellison syndrome and other hypersecretory conditions. P Moderate to severe RO/ duodenal/ gastric ulcer: 40mg daily. H. pylori eradication: 40mg twice daily in combination with either amoxicillin 1g twice daily + clarithromycin 500mg twice daily or clarithromycin 250-500mg + metronidazole 400-500mg twice daily or amoxicillin 1g twice daily + metronidazole 400500mg twice daily. ZES: Initially 80mg daily. Doses q80 mg daily, divide dose and give twice daily. May be temporarily increased to q160mg (no longer than required for adequate acid control). Impaired renal function: Max 40mg daily. Severe hepatic impairment: Max 40mg every other day. R Max 40mg daily except for H.pylori eradication (as per adults for 1 week). Q Not recommended. B For prescribing information, see pantoprazole Drug Presc. Notes. Contains sorbitol.

GORD,

ULCERS, IRRITABLE BOWEL

prevention of relapse in reflux oesophagitis (RO). Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment. P Mild reflux disease: 20mg daily; control recurrent symptoms with 20mg once daily ondemand regimen if required; consider switching to continuous therapy if symptoms not controlled adequately. RO (long-term, prevention of relapse): 20mg daily; increase to 40mg daily if relapse occurs. NSAID-induced gastroduodenal ulcers: 20mg daily. Severe hepatic impairment: Max 20mg daily. Q Under 12 years, not recommended.

2MO ALSO PANTOPRAZOLE RANBAXY 40MG Pantoprazole 40mg. Yellow enteric-ctd oval shaped, biconvex tab. marked P 40 on one side. 28, A15.14. S Moderate and severe reflux oesophagitis. Duodenal ulcer. Gastric ulcer. Zollinger-Ellison syndrome (ZES) and other pathological hypersecretory conditions. P Moderate to severe RO/ duodenal/ gastric ulcer: 40mg daily; may be doubled. ZES: Initially 80mg daily. Doses q80 mg daily, divide dose and give twice daily. May be temporarily increased to q160mg (no longer than required for adequate acid control). Impaired renal function: Max 40mg daily. Severe hepatic impairment: Max 20mg daily or 40mg every other day. Elderly: Max 40mg daily. R Max 40mg daily. Q Under 12 years, not recommended. B For prescribing information, see pantoprazole Drug Presc. Notes.

PANTOPRAZOLE TEVA

Teva

2MO

PPI inhibitor. Pantoprazole 20mg (as Na+ sesquihydrate). Light brownish-yellow, oval, slightly biconvex gastro-resistant tab. 20mg-28, A12.27. S Treatment of mild reflux disease and associated symptoms. Long-term management and prevention of relapse in reflux oesophagitis (RO). Prevention of gastroduodenal ulcers induced by non-selective NSAIDs. P Mild reflux disease: 20mg daily. RO: PANTOPRAZOLE RANBAXY 20mg daily. Increase to 40mg daily if relapse Ranbaxy occurs. NSAID-induced ulcers: 20mg daily. Hepatic 2MO impairment: Max 20mg daily. Q Not recommended. PPI. Pantoprazole 20mg. Yellow enteric-ctd oval 2MO shaped, biconvex tab. marked P 20 on one side. 28, A8.18. ALSO PANTOPRAZOLE TEVA 40MG Pantoprazole 40mg (as Na+ sesquihydrate). Light brownishS Treatment of mild reflux disease and associated symptoms. Long-term management and yellow, oval, slightly biconvex gastro-resistant tab.

1.1

40mg-28, A22.72. S Relief of symptoms and short-term treatment of Gl diseases requiring reduction in acid secretion: Duodenal ulcer, gastric ulcer, moderate and severe RO, Zollinger-Ellison Syndrome (ZES) and other hypersecretory conditions. P Duodenal gastric ulcer, moderate and severe RO: 40mg daily. ZES: Initially 80mg daily; doses q80 mg daily, divide dose and give twice daily; may be temporarily increased to q160mg. Hepatic impairment: 40mg every other day. Renal impairment: Max 40mg daily. R Max 40mg daily. Q Not recommended. B For prescribing information, see pantoprazole Drug Presc. Notes. Contains sorbitol.

PANTUP

Rowex

2MO PPI. Pantoprazole 20mg. Yellow oval ctd tabs. imprinted 20 in black. 20mg-28, A10.82. S Mild reflux disease and associated symptoms; long-term management and prevention of relapse in reflux oesophagitis (RO); prevention of gastroduodenal ulcers induced by non-selective NSAID in patients at risk with need for continuous NSAID treatment. P Mild reflux disease: 20mg daily; control reoccurring symptoms with 20mg once daily ondemand if required; consider switch to continuous therapy if symptoms not controlled adequately. RO: 20mg daily; increase to 40mg daily if relapse occurs. NSAID-induced gastroduodenal ulcers: 20mg daily. Severe hepatic impairment: Max 20mg daily. Q Not recommended.

2MO ALSO PANTUP 40MG Pantoprazole 40mg. Yellow oval ctd tabs. imprinted 40 in black. 40mg-28, A20.04. S Duodenal ulcers; gastric ulcers; moderate or severe RO; Zollinger-Ellison syndrome (ZES) and other disorders involving pathological hypersecretion. P Duodenal /gastric ulcer, RO: 40mg daily; dose may be doubled. ZES: Initially 80mg daily. Doses q80 mg daily, divide dose and give twice daily. May be temporarily increased to q160mg (no longer than required for adequate acid control). Impaired renal function: Maximum 40mg. Severe hepatic impairment: Maximum 40mg every other day. R Maximum 40mg daily. Q Not recommended. D Moderate to severe liver or renal insufficiency (40mg tab. in combination with antibiotic therapy). For prescribing information,

Drug Prescribing Notes ● PANTOPRAZOLE Special Precautions Exclude malignancy of gastric ulcer or a malignant disease of the oesophagus prior to treatment ● May reduce the absorption of vitamin B12 ● Severe liver impairment: Monitor liver enzymes regularly, discontinue if levels increase ● Regular surveillance in long term treatment (especially when exceeding a treatment period of 1 year) ● May lead to a slightly increased risk of GI infections, such as Salmonella and Campylobacter ● Patients who do not respond after 4 weeks should be investigated ● Restrict use of 20mg tablets for NSAID induced gastroduodenal ulcers to patients requiring continuous NSAID treatment and at increased risk of GI complications (>65 years, history of gastric or duodenal ulcer, upper GI bleeding). Pregnancy: Clinical experience in pregnant women is limited. In animal reproduction studies, signs of slight fetotoxicity were observed at doses above 5 mg/kg. Lactation: There is no information on the excretion of pantoprazole into human breast milk. Should only be used when the benefit to the mother is considered greater than the potential risk to the foetus/baby. Drug Interactions Contraindicated: Atazanavir. Caution: Drugs with pH-dependent bioavailability (e.g. ketoconazole, itraconazole), coumarin anticoagulants (monitor prothrombin time/INR after initiation, termination or during irregular use of pantoprazole). Side-Effects Headache, upper abdominal pain, diarrhoea, constipation, flatulence. Revised November 2009

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

9


1.1 GORD,

ULCERS, IRRITABLE BOWEL

ALIMENTARY SYSTEM

400mg-60, A11.02. S Benign ulceration of oesophagus, stomach, upper intestinal tract (incl. post-operative PARIET Janssen-Cilag stomal area) and the Zollinger-Ellison syndrome. Conditions benefitting from reduced gastric acid 2MO PPI. Rabeprazole (Na+) 10mg, 20mg. Pink tab. and excretion. Long term maintenance of benign peptic ulcer disease under regular surveillance. yellow tab. resp. Both ent-ctd. 10mg-28, A17.58; P Duodenal ulcer, 400mg twice daily or 20mg-28, A27.56. 800mg at bedtime for min. four weeks; S Active duodenal ulcer, active benign maintenance, 400mg at bedtime or twice daily. gastric ulcer and symtomatic erosive or ulcerative Other indications, see SPC. Impaired renal gastro-oesophageal reflux disease (GORD). Long function; Reduce dosage. Daily dosage, do not term maintenance of patients with GORD. exceed 2400mg. Symptomatic treatment of moderate to very Q Over 2 years, 25-30mg/kg body weight severe GORD. Zollinger-Ellison Syndrome (ZES). In daily in divided doses. combination with appropriate antibacterial B Exclude malignant disease before and regimens for the eradication of Helicobacter pylori during treatment. Impaired renal function. in patients with peptic ulcer disease. Monitor patients on long term therapy. P Swallow tab. whole in the morning Caution:Driving/operating machinery, patients at before eating. Active duodenal or benign gastric risk of falling blood cell counts. Contains lactose. ulcer, 20mg once daily for 4-6 weeks. Erosive or Pregnancy, lactation. ulcerative GORD, 20mg once daily for 4-8 weeks. C Oral anticoagulants, phenytoin, Maintenance, 10-20mg once daily. Symptomatic theophylline. GORD, 10mg once daily in patients without oesophagitis; once symptoms resolved, subsequent A Diarrhoea, dizziness, rash, tiredness. control can be achieved by 10mg once daily taken Gynaecomastia, occasional reversible liver damage, when needed. ZES, initially 60mg once a day; may confusional states, mood/behavioural changes, insomnia. Leucopenia. Very rarely interstitial be titrated up to 120mg/day (120mg dose in two divided dose). Eradication of H. Pylori, 20mg twice nephritis with occasional increase in plasma creatinine, acute pancreatitis, thrombocytopenia, daily for 7 days in combination with headache, myalgia, arthralgia. clarithromycin 500mg twice daily and amoxycillin 1g twice daily. PROTIUM Nycomed Q Not recommended. 2MO D Pregnancy, lactation. PPI. Pantoprazole 20mg. Yellow, oval biconvex B Exclude malignancy, severe hepatic film-ctd tab. with P20 in brown ink on one side. impairment, long-term treatment. 28, A8.66. C Caution: Ketoconazole, itraconazole. A Headache, GI upset, Infection, insomnia, S Treatment of mild reflux disease and associated symptoms (e.g. heartburn, acid dizziness, cough, pharyngitis, rhinitis, pain/back regurgitation, pain on swallowing). Long-term pain, asthenia, flu-like syndrome. management and prevention of relapse in reflux PEPCID MSD oesophagitis (RO). Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti2MO H2 blocker. Famotidine 20mg beige film-ctd square inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment. tab. marked MSD 963; 40mg brown film-ctd P Mild reflux disease: 20mg daily; control square tab. marked MSD 964. 20mg-28, A16.24. recurrent symptoms with 20mg once daily onA 40mg-28, 30.85. demand regimen if required; consider switching to S Duodenal and benign gastric ulcers. continuous therapy if symptoms not controlled Prevention of relapse of duodenal ulceration. adequately. RO (long-term, prevention of relapse): Zollinger-Ellison syndrome. Prevention and 20mg daily; increase to 40mg daily if relapse treatment of gastro-oesophageal reflux disease. occurs. NSAID-induced gastroduodenal ulcers: P Benign gastric and duodenal ulcer: 20mg daily. Severe hepatic impairment: Max 20mg 40mg at night for 4-8 weeks. Prophylaxis of daily. duodenal ulcer relapse: 20mg at night. ZollingerQ Under 12 years, not recommended. Ellison syndrome: Initially 20mg every 6 hours, 2MO adjust as necessary; max. 800mg daily. GastroALSO PROTIUM 40MG Pantoprazole 40mg. oesophageal reflux disease: 20mg twice daily for 6-12 weeks; with associated erosion or ulceration, Yellow, oval biconvex enteric-ctd tab. marked P40 on one side. 28, A16.03. 40mg twice daily for 6-12 weeks. S Moderate and severe reflux Q Not recommended. oesophagitis. Duodenal ulcer. Gastric ulcer. D Lactation. Zollinger-Ellison syndrome (ZES) and other B Impaired renal function, gastric pathological hypersecretory conditions. Eradication carcinoma. Pregnancy. of H. pylori, in combination with two antibiotics in A Headache, dizziness, CNS disturbances, patients with duodenal ulcer or gastric ulcer. constipation, diarrhoea, dry mouth, nausea, P Moderate to severe RO: 40mg daily. abdominal discomfort, rash, anorexia, fatigue, Duodenal/gastric ulcer: 40mg daily, may be arthralgia, muscle cramps, liver enzyme doubled. ZES: Initially 80mg daily. Doses q80 mg abnormalities, cholestatic jaundice, anaphylaxis, daily, divide dose and give twice daily. May be angioedema. Rarely toxic epidermal necrolysis, A-V temporarily increased to q160mg (no longer than block. required for adequate acid control). H. pylori eradication: 40mg twice daily in combination with PINAMET Pinewood either amoxicillin 1g twice daily + clarithromycin 2MO 500mg twice daily or clarithromycin 250mg + H2 blocker. Cimetidine 400mg. Pale, green, oblong metronidazole 400mg twice daily. Impaired renal function: Max 40mg daily. Severe hepatic bi-convex film-ctd tabs marked 2Y1 on one side. see pantoprazole Drug Presc. Notes. B Contains Ponceau 4R aluminium lake.

10

impairment: Max 40mg every other day. R Max 40mg daily. Q Under 12 years, not recommended.

2N ALSO PROTIUM IV Pantoprazole 40mg (Na+). Powder in vial. 5, A39.21. S Duodenal ulcer. Gastric ulcer. Moderate and severe RO. ZES and other pathological hypersecretory conditions. P Reconstitute with 10ml saline for admin. by inj.; alternatively mix with 100ml saline or 5% glucose sln, for inf. Switch to tab. as soon as oral therapy possible. Moderate to severe RO/ duodenal/gastric ulcer: 40mg daily. ZES: Initially 80mg daily. Doses q80 mg daily, divide dose and give twice daily. May be temporarily increased to q160mg (no longer than required for adequate acid control). For rapid acid control, 2 x 80mg initially. Severe hepatic impairment: 20mg max. Q Under 18 years, not recommended. B For prescribing information, see pantoprazole Drug Presc. Notes. Use IV only if oral application not appropriate.

RANITIC

Rowex

2MO H2 blocker. Ranitidine (HCl) 150mg, 300mg. Both: White film-ctd tab. scored one side. 300mg: Oblong. 150mg-60, A21.73; 300mg-30, A20.56. S Duodenal ulcer, benign gastric ulcer, reflux oesophagitis (RO), post operative ulcer, Zollinger-Ellison’s syndrome (ZES) and other conditions where reduction of gastric acid is likely to be beneficial. P Duodenal and gastric ulcer: 150mg twice daily or 300mg at bedtime. Duodenal, may be increased to 300mg twice daily for up to 4 weeks. RO: 150mg twice daily or 300mg at bedtime for 8 or if necessary up to 12 weeks; moderate to severe oesophagitis, increase to 150mg 4 times daily or 300mg twice daily. ZES, see SPC. Q Peptic ulcer, 2mg/kg or 4mg/kg twice daily; max. 300mg daily.

2K ALSO RANITIC 75MG Ranitidine (HCl) 75mg. Filmctd tab. 7, A2.85; 14, A4.76; 28, A8.56. S Short term symptomatic relief of acid indigestion and heartburn. P 1 swallowed whole with water. Repeat if symptoms return. Max. 2 tabs. in 24 hrs. If symptoms persist more than 2 weeks consult doctor. Q Under 16 years, not recommended. B Exclude malignant disease before treatment. History of acute porphyria. GI ulcers, severe renal/hepatic impairment, dyspepsia related weight loss, middle aged or older patients with dyspepsia symptoms, patients under regular medical control or taking medication; consult doctor before use. Contains lactose. Pregnancy, lactation. C High doses of sucralfate (take 2 hrs apart). NSAIDs (monitor, especially elderly or if history of peptic ulcer).

RANOPINE

Pinewood

2MO H2 blocker. Ranitidine (HCl) 150mg white to offwhite round film-ctd tab. marked RAN 150; 300mg white to off-white cap. shaped film-ctd tab. marked RAN 300. 150mg-60, A19.50; 300mg-30, A18.48. S Benign gastric and duodenal ulcers.

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


1.1 GORD,

ULCERS, IRRITABLE BOWEL

ALIMENTARY SYSTEM

Q Under 8 years, not recommended; 8-12 years, 1 three times daily. D Paralytic ileus. Intestinal obstruction, PPI. Omeprazole 10mg, 20mg, 40mg. Hard gastro- faecal impact, total atony of colon. Pregnancy, resistant cap. containing dull yellowish brown lactation. granules.10mg: light brown marked OME10. 20mg: B Adequate fluid intake should be White, marked OME20. 40mg: White cap, light maintained. brown body, marked OME40. 10mg-28, A12.38; C Anti-hypertensives. 20mg-28, A21.23; 40mg-14, A23.28. A Nausea. S Duodenal ulcers, benign gastric ulcers, reflux oesophagitis (RO, treatment and ULCID Astellas maintenance), symptomatic treatment of 2MO gastrooesophageal reflux disease (GORD), PPI. Omeprazole 20mg. White gelatine cap. Zollinger-Ellison syndrome (ZES), NSAID-related containing white or almost white granules. 7, gastric and duodenal ulcers (treatment and A6.35; 28, A15.22. maintenance), in combination with appropriate S Benign gastric and duodenal ulcer. antibacterial therapeutic regimens to eradicate H. Reflux Oesophagitis (RO), treatment and pylori in patients with H. pylori associated peptic maintenance. NSAID related ulcers, treatment, ulcers. Children q1 year and q10kg: Reflux prophylaxis and maintenance. Zollinger Ellison Oesophagitis, symptomatic treatment of heartburn Syndrome (ZES). Hp eradication in peptic ulcer and acid regurgitation in gastro-oesophageal disease. reflux disease. Children over 4 years: In P Duodenal ulcer: 20mg once daily, combination with antibiotics in treatment of treatment 2-4 weeks. Gastric ulcer: 20mg once duodenal ulcer caused by H. pylori. daily, treatment 4-8 weeks. RO, NSAID related P Duodenal ulcers: 20mg daily for 2-4 ulcers: 20mg once daily, treatment 4-8 weeks; weeks; maintenance, 10mg. Benign gastric ulcers: prophylaxis, maintenance 20mg once daily. ZES: 20mg once daily for 4-8 weeks. RO: 20mg daily for Initially, 60mg once daily; divide dose twice daily RAZOLAGER Gerard 4-8 weeks. 40mg may be used in refractory RO. when above 80mg; no time limit on duration. Hp Maintenance: 10-20mg. ZES: Initially 60mg daily. 2MO eradication: 20mg with amoxicillin 1000mg + Divide doses q80mg in twice daily doses. NSAIDclarithromycin 500mg or 20mg with clarithromycin PPI. Lansoprazole 15mg, 30mg. Opaque, yellow related ulcers: 20mg daily for 4-8 weeks. 250mg + metronidazole 400-500mg; all twice daily and white gel. caps. resp. 15mg-28, A12.85; 30mgMaintenance: 20mg. GORD: 10-20mg daily for 2-4 A for 1 week. Impaired hepatic function: Max. daily 28, 23.35. weeks; if no improvement after 2 weeks, perform dose, 20mg. Take cap. preferably in the morning S Duodenal and gastric ulcer. Reflux further examinations. H. pylori eradication: 20mg before breakfast. oesophagitis (RO), long-term prophylaxis of RO. for 1 week in combination with amoxicillin Q Above 2 years, refractory RO: 10mg (10Eradication of H. pylori (Hp) in combination with 1000mg + clarithromycin 500mg twice daily; 20kg) or 20mg (q20kg) once daily. Use alternative antibiotic therapy and prevention of relapse. alternatively, in combination with clarithromycin product for 10mg dosage. Duration usually 4-8 Zollinger-Ellison syndrome (ZES). NSAID-associated 250mg + metronidazole 400-500mg twice daily. weeks, max. 12 weeks. Under 2 years, not benign gastric and duodenal ulcers (maintenance Impaired hepatic function: 20mg daily max. indicated. and treatment). GORD. Q See SPC. B Peptic ulcer disease (determine H. pylori P Ulcers and RO: 30mg once daily B Peptic ulcer disease: Determine H. pylori status, exclude possibility of malignancy). Confirm swallowed whole with liquid into empty stomach; status if relevant. Exclude malignancy before diagnosis of RO endoscopically. Elderly, hepatic/ duodenal ulcers, 2 weeks; gastric ulcers and RO, 4 treatment. Confirm RO diagnosis endoscopically. renal dysfunction (caution, especially in high doses weeks; double duration if not fully healed. NSAIDMay lead to slightly increased risk of GI infections. and during combination therapy). Severely associated ulcers: 30mg once daily for 4 or 8 Hepatic impairment, check liver enzymes impaired hepatic function (check liver enzyme weeks; longer course or higher dose may be used periodically. NSAID-related ulcers: Restrict values periodically). NSAID-related ulcers (consider if severe or in at risk patients. Prophylaxis of RO treatment to at risk patients; consider stopping stopping intake of causative agent before and NSAID-associated ulcers: 15mg once daily; may NSAID. Long term use q 1year: Review risk/ treatment). Pregnancy, lactation. be increased up to 30mg daily. Eradication of Hp: benefit assessment. Combination treatment, C Diazepam (or other benzodiazepines), 30mg twice daily in combination with caution in patients with renal/hepatic dysfunction. phenytoin, warfarin, hexobarbital, citalopram, recommended antibiotics. ZES: Initially 60mg once Monitor visual and auditory senses in severely ill imipramine, clomipramine, disulfiram, cyclosporin, daily. Individually adjust and continue as long as patients. Pregnancy, lactation. Contains lactose. clarithromycin, roxithromycin, erythromycin, necessary. Max. 180mg, if daily dose q 120mg C Contra: Atazanavir, St John’s wort. ketoconazole, itraconozole, digoxin or vit.B12. admin. in 2 divided doses. GORD: 15-30mg once Caution: CYP2C substrates (e.g. diazepam, A GI disorders, nervous system disorders daily for up to 4 weeks. If symptoms persist after 4 triazolam, flurazepam, phenytoin, warfarin, (drowsiness, somnolence, sleep disturbances, weeks on 30mg further examination hexabarbital, citalopram imipramine, vertigo, headaches). recommended. Impaired renal function/ mildly clomipramine), disulfiram, ciclosporin (monitor impaired hepatic function: Max. 30mg daily. plasma levels), clarithromycin, ketoconazole, ZANTAC GSK Moderately impaired hepatic function: Max. 15mg itraconazole, digoxin, vitamin B12. daily. 2MO A Somnolence, sleep disturbances R 15-30mg. Max. 30mg daily. H2 blocker. Ranitidine (HCl) 150mg, 300mg. White (insomnia), vertigo, headaches, drowsiness, GI Q Not recommended. round or capsule-shaped film-ctd tab. marked disorders. D Severely impaired hepatic function. GXE2 or GXEC3 resp. 150mg-60, A13.45; 300mgPregnancy, lactation (no data). SPASMONAL FORTE Norgine 30, A12.41. B Exclude possibility of malignant gastric 2MO 2MO tumour. Caution: Hepatic dysfunction. Risk of GI ALSO ZANTAC EFFERVESCENT Ranitidine (HCl) Antispasmodic. Alverine citrate 120mg. Grey/blue infections. Treatment q 1 year: Review regularly, 150mg. White to pale yellow tab. 2 x 15, A18.78. cap. marked SP120. 60, A15.41. if visual disturbances occur consult 2MO S Irritable bowel syndrome. Painful ophthalmologist. Contains sucrose. ALSO ZANTAC SYRUP Ranitidine (HCl) 150mg/ diverticular disease of the colon. C Avoid: Ketoconazole, itraconazole. 10ml, ethanol 7.5%. Sugar-free syrup. 300ml, P One, 1-3 times daily. Caution: CYP2C19 and CYP3A4 inhibitors and A26.36. Q Not recommended. substrates (e.g. theophylline, carbamazepine). 2 M O 2N Digoxin, tacrolimus, phenytoin, warfarin. Antacids ALSO SPASMONAL Alverine citrate 60mg blue/ ALSO ZANTAC INJECTION Ranitidine (HCl) 50mg/ and sucralfate (take 1 hr apart). grey cap. marked SP60. 100, A12.84. 2ml. Amp. 5, A4.38. A GI disorders, eczema, urticaria, itching, headache, dizziness, fatigue. P 1-2 one to three times daily. S Duodenal, benign gastric and postPost-operative ulcer. Zollinger-Ellison syndrome, reflux oesophagitis and other conditions where reduction in gastric acid secretion is likely to be beneficial. P Duodenal and gastric ulcer: 150mg twice daily in the morning and evening or as a single bedtime dose of 300mg for 4-8 weeks. RO: 150mg twice daily or 300mg at bedtime for up to 8 weeks, extended to a max. of 12 weeks if necessary. Moderate to severe oesophagitis, 150mg four times daily up to max. 12 weeks. Other conditions, see SPC. Q Peptic ulcer, 2-4mg/kg twice daily. Max. daily dose 300mg in divided doses. B Exclude malignancy disease before and during treatment, impaired renal function. Monitor patients taking NSAIDs concomitantly, the elderly and those with a history of peptic ulcer. History of acute intermittent porphyria, avoid. Pregnancy, lactation. A Headache, dizziness, mental confusion, blood dyscrasias, skin rash and musculo-skeletal symptoms. Hepatitis, breast symptoms. Rarely hypersensitivity reactions, bradycardia and AV block. Transient changes in the results of liver function tests, acute pancreatitis.

12

ROMEP

Rowex

2MO

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


ALIMENTARY SYSTEM operative ulceration. Reflux oesophagitis, Zollinger-Ellison syndrome, prophylaxis of NSAID associated duodenal ulcer, other conditions where reduction of gastric acid is beneficial. P Duodenal and gastric ulcer: 150mg twice daily or 300mg at bedtime for four to eight weeks; maintenance, 150mg at bedtime. Prophylaxis of NSAID associated duodenal ulcer: 150mg twice daily. Other conditions, see SPC. Q Treatment of peptic ulcer disease 2mg/ kg or 4mg/kg twice daily; max. 300mg daily. B Exclude malignant disease before treatment. Impaired renal function. Pregnancy, lactation. A Headache, dizziness. Rarely hepatitis, thrombocytopenia, leucopenia, hypersensitivity, confusion, breast symptoms.

GORD,

ULCERS, IRRITABLE BOWEL

PPI. Lansoprazole 15mg, 30mg. Opaque, hard gastro-resistant caps.15mg, yellow; 30mg, white. 15mg-28, A10.59; 30mg-28, A19.17. S Healing of confirmed duodenal and gastric ulcer. Treatment and prophylaxis of reflux oesophagitis (RO). Treatment and prophylaxis of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAIDtreatment. Eradication of H. pylori (Hp) in combination with antibiotics and prevention of relapse. Zollinger-Ellison Syndrome (ZES). Symptomatic gastro-oesophageal reflux disease (GORD). P Ulcers and RO: 30mg once daily on empty stomach; duodenal ulcers, 2 weeks; gastric ulcers and RO, 4 weeks; double duration if not fully healed. NSAID-related ulcers: 30mg once daily for 4 or 8 weeks; use longer course or higher dose ZOLEPANT Pinewood if required. Prophylaxis of RO and NSAID-related ulcers: 15mg once daily; may be increased up to 2MO 30mg daily. Eradication of Hp: 30mg twice daily PPI. Pantoprazole 20mg. Light brownish yellow, with antibiotics. ZES: Initially 60mg once daily; oval, slightly biconvex tab. 28, A10.82. adjust and continue for as long as necessary. Max. S Mild reflux disease and associated 180mg daily. Take daily dose q120mg in two symptoms. Long-term management and divided doses. GORD: 15mg or 30mg once daily prevention of relapse in reflux oesophagitis (RO). (rapid relief). Moderate hepatic impairment: Max. Prevention of gastroduodenal ulcers induced by 15mg daily. non-selective non-steroidal anti-inflammatory Q Not recommended. drugs (NSAIDs) in patients at risk with need for D Severe hepatic impairment. Pregnancy, continuous NSAID treatment. P Mild reflux disease: 20mg daily; control lactation (no data). B Hepatic/renal dysfunction, elderly. recurrent symptoms with 20mg once daily ondemand regimen if required; consider switching to Exclude malignant gastric tumour. Long-term treatment (q1 year); review regularly. Driving/ continuous therapy if symptoms not controlled adequately. RO (long-term, prevention of relapse): using machines. C Avoid ketoconazole, itraconazole. 20mg daily; increase to 40mg daily if relapse Antacids, sucralfate (1 hr apart). Caution: CYP2C19 occurs. NSAID-induced gastroduodenal ulcers: /CYP3A4 substrates (eg. tacrolimus, 20mg daily. Impaired renal function: Max 40mg carbamazepine, phenytoin) and inhibitors, digoxin, daily. Hepatic impairment: Max 20mg daily. warfarin, theophylline, antibiotics. R Max 40mg daiy. A GI disorders, dyspepsia, headache, Q Not recommended. dizziness, eczema, urticaria, itching, fatigue. 2MO

1.1

duodenal ulcers, consider H. pylori infection as an etiological factor. Very rarely cases of colitis have been reported. Pregnancy (not recommended), lactation. C Contraindicated: Atazanavir. Avoid: Ketoconazole, itraconazole. Caution: Digoxin, drugs that are metabolised by CYP3A4 (incl. theophylline, tacrolimus), fuvoxamine, rifampicin, St John’s wort. Antacids and sucralfate (take 1 hour apart). A Headache, dizziness, GI disorders, increase in liver enzyme levels, urticaria, itching, rash, fatigue.

ZOTROLE

Pinewood

2MO

PPI. Lansoprazole 15mg, 30mg. White/redbrownish and white gel caps., resp. 15mg-28, A12.96; 30mg-28, A23.31. S Duodenal and gastric ulcer. Reflux oesophagitis (RO), long-term prophylaxis of RO. H. pylori eradication. Treatment and prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers. Symptomatic gastro-oesophageal reflux disease. Zollinger-Ellison syndrome (ZES). P Ulcers and RO: 30mg once daily swallowed whole with liquid into empty stomach; duodenal ulcers, 2 weeks; gastric ulcers and RO, 4 weeks; double duration if not fully healed. Prophylaxis of RO: 15mg once daily; may be increased up to 30mg daily. Eradication of H. pylori: 30mg twice daily for 7 days in combination with either clarithromycin 250-500mg twice daily + amoxicillin 1g twice daily or clarithromycin 250mg twice daily + metronidazole 400-500mg twice daily. NSAID associated ulcers: 30mg once daily for 4 weeks, may be continued for another 4 weeks if not fully healed. Prophylaxis of NSAID associated ulcers: 15mg once daily. If fails, use 30mg once daily. Symptomatic gastro-oesophageal reflux: 15mg or 30mg once daily; adjust dose individually. ALSO ZOLEPANT 40MG Pantoprazole 40mg. Light ZOTON FASTAB Wyeth If symptoms not relieved in 4 weeks, increase to brownish yellow, oval, slightly biconvex tab. 28, 30mg daily. ZES: Initially 60mg once daily. 2 M O A20.04. Individually adjust and continue as long as PPI. Lansoprazole 15mg, 30mg. Oro-dispersible S Relief of symptoms and short-term necessary. Max. 180mg, if daily dose q 120mg treatment of GI diseases which require a reduction white-yellowish tabs. speckled with orange-dark admin. in 2 divided doses. Impaired renal function/ brown gastro-resistant microgranules debossed in acid secretion: Duodenal ulcer, gastric ulcer, mildly impaired hepatic function: Max. 30mg daily. A with 15 or 30 resp. 15mg-28, 18.26; 30mg-7, moderate and severe RO, eradication of H. pylori Moderately impaired hepatic function: Max. 15mg A9.08 (hospital only pack); 14, A19.78; 28, in combination with antibiotic therapy in patients daily. A36.29. with peptic ulcer, Zollinger-Ellison syndrome and R 15-30mg. Max. 30mg daily. S Duodenal and gastric ulcer. Treatment other hypersecretory conditions. Q Not recommended. and prophylaxis of reflux oesophagitis (RO). P Moderate to severe RO/ duodenal/ D Pregnancy, lactation (no data). Eradication of H. pylori concurrently given with gastric ulcer: 40mg daily. H. pylori eradication: appropriate antibiotics. Treatment and prophylaxis B Exclude possibility of malignant gastric 40mg twice daily in combination with either tumour. Caution: Hepatic dysfunction. Risk of GI of NSAID-associated benign gastric and duodenal amoxicillin 1g twice daily + clarithromycin 500mg infections. Treatment q 1 year: Review regularly, ulcers in patients requiring continued therapy. twice daily or clarithromycin 250-500mg + assess benefit against risks; if visual disturbances Symptomatic GORD. Zollinger-Ellison syndrome metronidazole 400-500mg twice daily or occur consult ophthalmologist. Gastro-duodenal (ZES). amoxicillin 1g twice daily + metronidazole 400ulcers, consider H. pylori infection as an etiological P Duodenal ulcer: 30mg once daily for 2 500mg twice daily. ZES: Initially 80mg daily. Doses factor. Contains sucrose. Driving/using machines. If or 4 weeks. Gastric ulcer/RO: 30mg once daily for q80 mg daily, divide dose and give twice daily. used in combination with antibiotics H. pylori 4 or 8 weeks. Prophylaxis of RO: 15-30mg once May be temporarily increased to q160mg (no eradication, follow antibiotics instructions. Colitis daily. ZES: 60mg once daily. See SPC. Hp longer than required for adequate acid control). may rarely occur. Restrict treatment to high risk eradication regimens: 30mg twice daily in Impaired renal function: Max 40mg daily. H.pylori combination with clarithromycin 250-500mg twice patients for the prevention of peptic ulceration in triple therapy not suitable. Severe hepatic daily and either amoxycillin 1g twice daily or patients needing continuous NSAIDs. impairment: Max 40mg every other day; H.pylori metronidazole 400-500mg twice daily for 7-14 C Avoid: Ketoconazole, itraconazole. triple therapy not suitable. days. NSAID-associated ulcers: Treatment, 15-30mg Caution: CYP2C19 and CYP3A4 inhibitors and R Max 40mg daily except for H. pylori once daily for 4 or 8 weeks. Prophylaxis, 15-30mg substrates (e.g. theophylline, carbamazepine). eradication (as per adults for 1 week). once daily. Digoxin, tacrolimus. Antacids and sucralfate (take Q Not recommended. R Max. 30mg daily. 1 hr apart). B For prescribing information, see Q Not recommended. A GI disorders, increase in liver enzymes pantoprazole Drug Presc. Notes. Contains sorbitol. B Exclude possibility of malignant gastric levels, urticaria, itching, rash, headache, dizziness, tumour. Hepatic dysfunction. Risk of GI infections. fatigue. ZOMEL Clonmel Treatment q 1 year: Review regularly. Contains 2MO lactose. Driving or using machines. Gastro1.2 CONSTIPATION AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

13


1.2 CONSTIPATION

ALIMENTARY SYSTEM 1 tab. night before and 1x5mg suppos. following

BABYLAX

Dr. Mann morning. Under 4 years, constipation: 1x5mg

2K

suppos.

Faecal softner/lubricant. Glycerol 1.8g, benzalkonium Cl 0.36g. 3.6g soln. in rectal applicator. 3, A5.48. S Constipation in adults, elderly and children of any age. P 1-2 applicators. Q Under 3 months, v-1 applicator; 3 months-6 years, 1 applicator; over 6 years, 1-2 applicators. B For single use only.

ALSO DULCO-LAX PERLES Sodium picosulfate 2.5mg. Small, pearl-shaped, soft gelatin caps. 50, A4.28. S Constipation. Bowel clearance before surgery, childbirth or radiological examinations. P 2-4 at night. Q Over 10 years, as for adults. 4 to10 years, 1-2 at night. Under 4 years, not recommended.

CELEVAC

2K

2

Amdipharm ALSO DULCO-LAX LIQUID Sodium picosulph. 5mg/

5ml. Liquid. 100ml, A2.76; 300ml, A7.78. S Constipation. Bowel clearance before surgery, childbirth or radiological examinations. P 5-10ml at night. Q Under 4 years, 250mcg/Kg BW; 410years, 2.5-5ml. Both at night. D Ileus, intestinal obstruction, acute surgical abdominal conditions like acute appendicitis, acute IBDs, and severe dehydration. B Children under 10 years (medical advice CODALAX Mundipharma required). Pregnancy, lactation (not recommended). 2MO C Diuretics or adreno-corticosteroids Faecal softner/stimulant. Poloxamer ’188’ 200mg, (increased risk of electrolyte imbalance). Broad dantron 25mg per 5ml. Liquid. 300ml, A4.33. spectrum antibiotics (reduced laxative action). 2MO A Abdominal discomfort (incl. pain and ALSO CODALAX FORTE Poloxamer ’188’ 1g, cramps), diarrhoea. danthron 75mg per 5ml. Liquid. 300ml, A14.50. S Treatment or prophylaxis of analgesic DUPHALAC Solvay induced constipation in terminally ill. 2O P 5-10ml at night. Osmotic. Lactulose 3.35g/5ml. Soln. 300ml, A1.14; Q 2.5-5ml at night. 1L, A3.44. 2MO S Constipation. Hepatic encephalopathy. ALSO CODALAX CAPSULES Poloxamer ’188’ P Constipation: Initially 15ml twice daily. 200mg, danthron 25mg. Light brown/orange cap. Encephalopathy: Initially 30-50ml 3 times daily; marked CX. 60, A13.33. adjust dose to produce 2 or 3 soft stools daily and P 1-2 at night. an acidic faecal pH. Q 1 at night. Q Constipation, 1 month-1 year: 2.5ml; 1-2 2MO years: 2.5-5ml; 2-5 years, 5ml; 5-10 years, 10ml. All ALSO CODALAX FORTE CAPSULES Poloxamer twice daily. ’188’ 500mg, danthron 35.5mg. Light brown/green D Galactosaemia. GI obstruction. cap. marked CXF. 60, A14.49. B Contains lactose. P 1-2 at night. C Avoid enteric coated mesalazine (5Q Not recommended. ASA). D Intestinal obstruction, acute painful A Flatulence. conditions of abdomen. Infants in nappies. FLEET De Witt Pregnancy. B Incontinence. 2 A Colouring of urine and perianal skin. Osmotic. Sodium acid phos. 21.4g, Na+ phos. 9.4g. 133ml single dose enema. 1, 84c. DULCO-LAX Boehringer Ing. SM S Constipation. Pre- and post-operatively 2K in obstetrics and prior to proctoscopy, sigmoidoscopy or X-ray. Stimulant. Bisacodyl 5mg. Yellow ent-ctd tab. 10, A1.21; 20, A2.01; 40, A3.89; 60, A4.64. P 1 enema once daily. S Evacuation of colon in constipation and Q Under 3 years not recommended; over 3 years, in proportion according to body weight. in preparation for radiological investigations. D Conditions where the absorbtive 2K ALSO DULCO-LAX SUPPOSITORIES Bisacodyl 5mg capacity of the colon is increased, CHF. B Restricted Na+ intake. and 10mg. Suppos. 5mg-5, A1.49; 10mg-10, A2.75; 20, A5.10. FYBOGEL CITRUS Reckitt Benckiser S Evacuation of colon in constipation and 2O in preparation for radiological investigations. Bulking agent. Ispaghula husk 3.5g. Citrus P Constipation: 1-2 tabs. at night or flavoured sugar-free and gluten-free grans. 1x10mg suppos. in morning. Diagnostic and Sachets-30, A2.48; 60, A4.96. preoperative preparation: 2-4 tabs. night before 2K and 1x10mg suppos. following morning. Q Over 10 years, same as adult. 4-10 years: ALSO FYBOGEL ORANGE Ispaghula husk 3.5g. Orange flavoured grans. Sachets-10, A1.97. Constipation: 1 tab. at night or 1x5mg suppos. in morning. Diagnostic and preoperative preparation: S Patients requiring a high-fibre regimen.

2

Bulking agent. Methylcellulose 500mg. Pink tab. 112, A3.58. S Constipation. Patients requiring a high fibre diet. P 3-6 night and morning with at least 300ml liquid. Q 6-12 years, half adult dose. B Pregnancy, adequate fluid intake.

14

P 1 sachet or 2 level 5ml spoonfuls in water morning and evening after meals. Q Under 12 years, only on medical advice. 6-12 years, v-1 level 5ml spoonful of the granules, depending on age and size, morning and evening. D Intestinal obstruction, colonic atony.

KLEAN-PREP

Helsinn Birex

2 Electrolytes/osmotic. PEG 3350 59g, anhydrous sod. sulph. 5.685g, sod. bicarb. 1.685g, KCl 0.7425g, aspartame 0.0494g, flavouring 0.378g. Sachets-4, A6.19; 4+container, A6.71. S GI lavage, preparation prior to diagnostic examination or surgery particularly for the large bowel. Short term laxative in constipation. P Orally 200-250ml every 10mins. for laxative until 1L of reconstituted soln. is consumed; for GI lavage until 4L reconstituted soln. consumed or rectal effluent is clear. Q Not recommended. D GI obstruction or perforation, ileus, gastric retention, acute intestinal or gastric ulceration, toxic colitis or megacolon. Body weight below 20kg. B UC, proctitis. A Bloating, abdominal cramps, vomiting, urticaria, allergic reactions.

LAXIDO ORANGE

Galen

2MO Laxative. Macrogol 3350 13.125g, NaCl 350.7mg, NaHCO3 178.5mg, KCl 46.6mg. Free flowing white powder for oral solution in a single-dose sachet. 30, A7.68. S Chronic constipation. Also effective in resolving faecal impaction. P Chronic constipation: Dissolve each sachet in 125ml water. 1-3 sachets daily in divided doses, according to individual response. Can be adjusted down to 1 or 2 sachets daily for extended use. Faecal impaction: 8 sachets daily within a 6 hour period. Dissolve each sachet as above or dissolve 8 sachets in 1 litre of water (store reconstituted solution covered at 2oC-8oC for up to 6 hours). Do not exceed 3 days. Impaired cardiovascular function, no more than 2 sachets to be taken in any 1 hour. Q Under 12 years, not recommended. Over 12 years, as per adults. D Intestinal obstruction or perforation caused by functional or structural disorder of the gut wall, ileus and in patients with severe inflammatory conditions of the intestinal tract. Pregnancy and lactation (unless clearly necessary). B Confirm faecal impaction diagnosis by appropriate physical or radiological examination of the rectum and abdomen. Stop immediately if symptoms indicating shifts of fluids/electrolytes develop (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure); measure electrolytes and treat any abnormality appropriately. Contains glucose and sulphur dioxide. C No other medicines to be taken orally for 1 hour before and for 1 hour after admin. A Abdominal distension and pain, borborygmi, nausea, mild diarrhoea.

LAXOSE

Pinewood

2O Osmotic. Lactulose 3.3g/5ml. 300ml, A1.87; 500ml, A3.87; 1L, A5.70.

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Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


ALIMENTARY SYSTEM S Constipation. Hepatic encephalopathy. P Constipation: initially 15ml twice daily. Encephalopathy: initially 30-50ml three times daily adjusting to produce 2 to 3 soft stools daily. Q Constipation, 2-5 years, 5ml; 6-10 years, 10ml. Both twice daily. D Galactosaemia. GI obstruction.

Iso-osmotic laxative. Macrogol 3350 (polyethylene glycol 3350) 13.125g, NaCl 350.7mg, NaHCO3 178.5mg, KCl 46.6mg (on reconstitution: Na+ 65mmol/l, Cl- 53mmol/l, K+ 5.4mmol/l, HCO317mmol/l. Powder. Sachets: 20, A7.63; 30, A10.64. S Chronic constipation. Faecal impaction. P Constipation: 1-3 sachets daily in divided doses. Impaction: 8 sachets daily within a MESTINON Meda 6 hour period for up to 3 days. Impaired cardiovascular function: No more than 2 sachets in 2MO Anticholinesterase. Pyridostigmine bromide 60mg. any one hour. Reconstitute each sachet in 125ml water. White quarter-scored tab. marked ICN. 200, Q Under 12 years, not recommended. A53.85. 2MO S Paralytic ileus. ALSO MOVICOL PAEDIATRIC PLAIN Macrogol P 1-4 as required. 3350 (polyethylene glycol 3350) 6.563g, NaCl Q 15-60mg as required. 175.4mg, NaHCO3 89.3mg, KCl 25.1mg (on D Intestinal or urinary obstruction. reconstitution: Na+ 65mmol/l, Cl- 53mmol/l, K+ B Bronchial asthma, cardiac disease, 5.4mmol/l, HCO3- 17mmol/l). Powder. Sachets: 30, vagotonia, epilepsy, Parkinsonism. A7.14. C Depolarising muscle relaxants, S Chronic constipation. Faecal impaction. cyclopropane, halothane. Prevention of recurrence of faecal impaction. A Nausea, salivation, diarrhoea, colic. Q Chronic constipation/ prevention MICOLETTE Pinewood reimpaction: Under 2 years, not recommended. 2-6 years, Initially 1 sachet daily; 7-11 years, 2 sachets 2 daily adjusted every second day. Duration at least Faecal softener/lubricant. Sodium lauryl 6-12 months; max. 4 sachets a day. Faecal sulphoacetate 45mg, Na+ citrate 450mg, glycerol impaction: Under 5 years, not recommended. 5-11 625mg. Micro-enema. 12 x 5ml, A7.21. S Constipation. Bowel clearance pre- and years, initially 4 sachets a day. See SPC for full dosing recommendations. 12 years and older, use post-operatively or before rectal examination. Movicol. Reconstitute each sachet in 62.5ml P 1-2 enemas inserted to full length of (approx. t glassful) water. nozzle. Q Under 3 years, not recommended. Over D GI obstruction or perforation, ileus, severe inflammatory condition of intestinal tract 3 years, same as adults, insert nozzle to half (eg. Crohn’s disease, UC, toxic megacolon). length only. B Monitor for symptoms indicating shifts D Inflammatory or ulcerative bowel of fluid/electrolytes. Children with cardiovascular disease, acute GI conditions. or renal impairment; not recommended. MICROLAX McNeil Healthcare Pregnancy, lactation (only if essential). A Abdominal distension, nausea.

CONSTIPATION 1.2 particularly narrow therapeutic index or short half-life drugs, within one hour of admin. A Nausea, vomiting, bloating, abdominal pain, anal irritation, sleep disturbance, allergic reaction, hunger, hypophosphatemia, dizziness, headache, rigors.

NORMACOL

Norgine

2O Bulking agent. Sterculia 62%. White coated grans. Sachets-60 x 7g, A5.52; 500g, A6.57. S Constipation (incl. pregnancy and lactation). Management of colostomies and ileostomies. P 1-2 sachets or 1-2 heaped 5ml spoonfuls once or twice daily after meals taken unchewed with a drink. Q Under 6 years, not recommended; 6-12 years, half adult dose.

2 ALSO NORMACOL PLUS Sterculia 62%, frangula 8%. Brown coated grans. 200g, A4.53; 500g, A9.32. S Constipation. Initiation and maintenance of bowel action after rectal surgery or haemorrhoidectomy. P 1-2 heaped 5ml spoonfuls once or twice daily after meals swallowed unchewed with a drink. Q Under 6 years, not recommended; 6-12 years, in proportion to adult dose.

PICOLAX

Ferring

2

Stimulant/osmotic laxative. Na+ picosulph. 10mg, magnesium oxide 3.5g, citric acid 12.0g. Powder. Sachets-1 x 2, A6.29. S Bowel clearance before radiography, endoscopy or surgical procedures. 2K P 1 sachet reconstituted in water and Faecal softener/lubricant. Sodium citrate 450mg, MOVIPREP Norgine taken before 8h00 on day prior to procedure, repeat 6-8 hours later. Na+ lauryl sulphoacetate 45mg, sorbic acid 5mg 2N Q Not recommended. per 5ml. Disposable enema. 50, A27.21. Laxative. Sachet A: Macrogol 3350 100g, sodium D CHF, gastric retention, GI ulceration, S Constipation, evacuation of the colon prior to surgical and diagnostic procedures and in sulphate anhydrous 7.5g, NaCl 2.691g, KCl 1.015g. toxic colitis/megacolon, ileus, nausea and Sachet B: Ascorbic acid 4.7g, sodium ascorbate vomiting, acute surgical abdominal conditions, GI obstetrics prior to delivery. 5.9g. Free flowing powder. Sachet A: White to obstruction/perforation. Severe renal impairment. P 1 enema as required yellow. Sachet B: White to light brown. 4 sachets Impaired consciousness, general weakness. Patients Q Under 3 years, insert half nozzle only; (2 x sachet A and B), A13.26. with a tendency to aspiration or regurgitation or over 3 years, same as adult. S Bowel cleansing prior to bowel impaired swallowing reflex. B IBD. Acute GI conditions. endoscopy or radiology. B Recent GI surgery. Caution: Renal MIL-PAR Seven Seas P One sachet A and one sachet B impairment, heart disease or IBD. Patients at risk dissolved together in 1L of water to be drunk over of hypokalaemia. Monitor for signs of 2 period of 1-2 hrs the evening before day of hyponatraemia (correct promptly). Elderly, Osmotic/faecal softner. Magnesium hydroxide procedure. Repeat with a second litre of product, debilitated patients and at risk patients (those 300mg, liquid paraffin 1.25ml per 5ml. Oral susp. either the evening before or the morning of day with increased risk for underlying renal 200ml, A2.73; 500ml, A4.20. of procedure, at least 1hr before procedure. impairment, electrolyte disturbance, acute MI, S Temporary relief of occasional Q Under 18 years, not recommended. unstable angina); maintain adequate hydration constipation. D GI obstruction or perforation, disorders and monitor baseline and post treatment P 15-30mls before breakfast or at of gastric emptying (e.g. gastroparesis), ileus, toxic electrolytes. Advise low residue diet before and bedtime. megacolon complicating inflammatory conditions 250ml/hour water/other clear fluid intake during Q 2-7 years: 5-10ml; over 7 years: 7.5-15ml. of the intestinal tract eg. Crohn’s disease and treatment. Use for 24 hour max. Pregnancy, Taken at bedtime. ulcerative colitis, unconsciousness. caution. D Children Q 2 years old. B Diarrhoea expected outcome. Caution: C Absorption of concomitant oral B Caution: Swallowing difficulties. Not for Fragile, poor health, serious clinical impairment medication may be modified. Bulk-forming use if symptoms of appendicitis, intestinal (cardiac impairment NYHA grade III), laxatives. Caution: Drugs associated with obstruction, IBD, abdominal pain of unknown dehydratation (correct before use), severe acute hypokalaemia, NSAIDS or drugs known to induce origin. Contains Mg++ salts. Consult doctor if inflammatory disease. Impaired consciousness, SIADH (e.g. TCAs, SSRIs, antipsychotics, needed every day, persistent abdominal pain/ impaired gag reflex, tendency to aspiration of carbamazepine). symptoms. Consult doctor before use if taking regurgitation: Closely monitor, especially if medication, suffer from kidney disease or under nasogastric admin. Poor health, ccQ30ml/min, risk REGULAN P & GP doctor’s care. Prolonged use. of electrolyte imbalance: Baseline and post2O treatment electrolyte renal function test needed. MOVICOL Norgine Pregnancy, lactation (only if essential). Bulking agent. Ispaghula husk 3.4g flavoured, 2MO C Do not take oral medication, sugar-, gluten-free powder or 3.6g flavoured, AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

15


1.3 DIARRHOEA

ALIMENTARY SYSTEM

sugar-, gluten-free powder. Sachets. 30, A2.16. S Constipation. To increase daily fiber intake. P 1 sachet in water one to three times daily. Q 6-12 years, v-1 level teaspoonful in water one to three times daily. Over 12 years, as per adults. D Intestinal obstruction, faecal impaction, colonic atony . B Supervise treatment in the elderly or debilitated and patients with intestinal narrowing or decreased motility (GI obstruction risk). Contains phenylalanine, sunset yellow. A Temporary increase in flatulence and abdominal distension.

RELISTOR

Wyeth

2O Peripheral opioid receptor antagonist. Methylnaltrexone bromide 12mg/0.6ml (20mg/ml). Sterile, clear, colourless to pale-yellow sln for inj. in vial. 0.6ml-1; 0.6ml-7. Prices on request. S Opioid-induced constipation in advanced illness patients receiving palliative care when response to usual laxative therapy not sufficient. P 1 single dose every other day as a subcutaneous inj. May be given at longer intervals, if needed. 2 consecutive doses 24 hrs apart may be given only when there has been no response to the dose on the preceding day. Recommended dose: 8mg (0.4ml) (patients weighing 38-61kg) or 12mg (0.6ml) (patients weighing 62-114kg). See SPC. Q Not recommended. D Known or suspected mechanical gastrointestinal obstruction or acute surgical abdomen. Pregnancy (unless clearly necessary). B Not recommended: Severe hepatic impairment or end-stage renal impairment requiring dialysis. Not indicated for non-opioid induced constipation. Can result in the rapid onset of a bowel movement (within 30-60 min). Use only for a limited period. Caution: Patients with colostomy, peritoneal catheter, active diverticular disease or faecal impaction (no data). Lactation. A Dizziness, GI disturbances, injection site reactions.

SENOKOT

Reckitt Benckiser

2 Stimulant laxative. Sennoside B (as total sennosides) 7.5mg. Brown tab. marked with tab name and a sword. 20, A2.62; 60, A5.46; 100, A7.26; 500, A18.77.

2 ALSO SENOKOT SYRUP Sennoside B (as total sennosides) 15mg/10ml. 150ml, A5.19. S Occasional constipation. P 2-4 tabs. or 10-20ml syrup at bedtime. If no bowel action after 3 days, consult doctor. Q Under 12 years, not to be given except on medical advice. If admin. to children necessary: 2-6 years, 2.5-5ml syrup in 24 hrs; over 6 years, half adult dose. Both in the morning. Under 2 years, not recommended. D Undiagnosed acute or persistent abdominal symptoms.

TOILAX

Orion

2 Bisacodyl 10mg/5ml. 5, A3.73; 50, A29.76. S Constipation, evacuation of colon.

16

P Constipation: 1-2 tabs. in the evening or 1 enema. Surgical preparation: 4 tabs. in two divided doses on the day prior to examination. Use enema on morning of examination. Q Constipation: Over 2years, 1-2 tabs. (0.3mg/kg body weight) or 1 enema; under 2years, v enema. Children insert half nozzle only. D Inflammatory or ulcerative conditions of large bowel.

inhibition or peristalsis is to be avoided. B Severe acute UC. Pregnancy. Defective hepatic function. A Rashes.

IMODIUM PLUS

McNeil Healthcare

2K

Antipropulsive antidiarrheals. Loperamide (HCl) 2mg, simeticone equiv. to polydimethylsiloxane 125mg. White, capsule-shaped tab. 12, A6.05. 1.3 DIARRHOEA S Acute diarrhoea associated with gasDIORALYTE sanofi-aventis related abdominal discomfort incl. bloating, cramping or flatulence. 2O P 2 tabs. initially, followed by 1 tab. after Electrolytes. Sodium chlor. 0.47g, K+ chlor. 0.30g, every loose stool. Max R 4 tabs. in 1 day. disodium hydrogen citrate 0.53g, glucose 3.56g. Duration R 2 days. Powder in sachet (plain, flavoured). 20, A4.68. Q 12-18 years: 1 tab. initially, followed by S Oral correction of fluid and electrolyte 1 tab. after every loose stool. Max R 4 tabs. in 1 loss and management of watery diarrhoea. day. Duration R 2 days. Under 12 years, P 20-40ml/kg daily. (Approx. 1-2 sachets contraindicated. after every loose motion). Reconstitute 1 sachet D Children Q 12 years. Acute dysentery, with 200ml fresh drinking water. acute UC, pseudomembranous colitis associated Q Children: As per adults except with broad spectrum antibiotics. Bacterial reconstitute 1 sachet after every loose motion. enterocolitis caused by invasive organisms. When Infants: 1 to 1v times the usual feed vol or 150ml/ inhibition of peristalsis is to be avoided due to risk kg daily. Infants under 12 months: Only under of significant sequelae incl. ileus, megacolon, toxic medical advice. megacolon. Discontinue if constipation, subileus, B Only reconstitute with water at volume abdominal distension develop. Pregnancy (unless stated. Severe renal/hepatic impairment or other clinically justified), lactation. conditions where normal electrolyte balance is B Fluid and electrolyte depletion may distributed. If nausea and vomiting present, drink occur. No improvement within 48 hours, small but frequent amounts at first. If no discontinue and consult physician. AIDS patients, improvement within 24-36 hr consult physician. stop therapy at sign of abdominal distension. Toxic megacolon in AIDS patients with infectious ELECTROLADE Eastern colitis treated with loperamide HCI has been 2 reported rarely. Hepatic insufficiency (caution); hepatic dysfunction (monitor); severe hepatic Electrolytes. Sodium chlor. 236mg, K+ chlor. dysfunction (use under medical supervision). 300mg, Na+ bicarb. 500mg, glucose 4g. Powder Driving using machines, if dizziness occurs. (flavoured) in sachets. 6, A1.39; 20, A4.43. S Dehydration associated with diarrhoea. A Nausea, taste perversion. P 1-2 sachets after every loose motion, LOMOTIL Goldshield max. 16 in 24 hours. Reconstitute 1 sachet in 200ml water. 2MO Q Under 2 years, 1-1v times normal feed Opiate/anticholinergic. Diphenoxylate (HCl) 2.5mg, volume; over 2 years, 1 sachet after every loose atropine sulph. 25mcg. White tab. marked SEARLE. motion, max. 12 in 24 hours. 100, A11.52; 500, A57.56, 1000, A115.09. D Renal impairment. S Diarrhoea. P 4 initially then 2 every six hours until IMODIUM McNeil Healthcare control. Q Under 4 years, not recommended; 4-8 2MO years, 1 three times daily; 9-12years, 1 four times Opiate. Loperamide (HCl) 2mg. Dark green/grey daily; 13-16years, 2 three times daily. A cap. 60, 5.11. D Intestinal obstruction. Acute ulcerative S As an adjunct in the management of colitis. Pseudo-membranous colitis. Jaundice. diarrhoea. B Hepatic dysfunction. Concurrent admin. P Adults and children 9-12 years, 2-4mg of narcotics or sedatives. Pregnancy, lactation. initial dose, followed by 2mg 3 times daily. Max. Correct severe dehydration and electrolyte daily dose 10mg. Q 4-8 years, total max. 4mg.Under 4 years, imbalance before initiating therapy. C CNS depressants. MAOIs. not recommended. A CNS disturbances, allergic reactions, 2MO gastrointestinal upset. Anticholinergic effects. ALSO IMODIUM ORAL SOLUTION Loperamide (HCl) 1mg/5ml. Slightly viscous soln. 100ml, A2.21. QUESTRAN BMS S Adjunct in the management of 2MO diarrhoea. Symptomatic control of diarrhoea Ion-exchange resin. Cholestyramine 4g. Powder in associated with chronic bowel disorders. sachet. 50, A24.32. P 2-4mg (10-20ml) initially followed by 2mg (10ml) three times daily. Max. daily dose S Relief of diarrhoea associated with ileal 10mg. Chronic bowel disorders. initially 4-8mg resection, Crohn’s disease, radiation, vagotomy daily in two divided doses and adjust according to and diabetic vagal neuropathy. Pruritus associated response with partial biliary obstruction. Q Under 4 years, not recommended; 4-8 P Diarrhoea, 12-24g daily in divided doses; years, max. daily dose of 4mg in divided doses; 9- max. 36g daily. Pruritus, 4-8g daily. 12 years, as adult dose. Q Under 6 years, not recommended; over D Use in children under 4 years or when 6 years, in proportion to dose for 70kg adult.

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Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


ALIMENTARY SYSTEM D Complete biliary obstruction. B On long term, suppl. diet with vitamins A, D and K. Pregnancy, lactation. Contain sucrose. C Digitalis, antibiotics, diuretics. Take all drugs 1 hour before or 4-6 hours after Questran. A Constipation.

ANO-RECTAL CONDITIONS, A Systemic corticosteroid effects.

ASACOLON

COLITIS

COLIFOAM

1.4 Meda

Tillotts 0 N O

2MO

Salicylate. Mesalazine 400mg, 800mg. Red-brown resin-coated oblong tabs. 400mg-100, A27.29; 1.4 ANO-RECTAL CONDITIONS, COLITIS 800mg-90, A63.04. S Treatment of mild acute ulcerative ANUGESIC-HC Parke-Davis colitis. Maintenance of remission of ulcerative colitis. Maintenance of surgically-induced remission 0NO of Crohn’s disease. Soothing/antiseptic/steroid. Pramoxine (HCl) 1%, hydrocortisone (acetate) 0.5%, zinc oxide 12.33%, P UC: Induction of remission, 2.4g daily in Peru balsam 1.8%, benzyl benzoate 1.2%, bismuth divided doses increasing to 4g if required; oxide 0.87%, resorcinol 0.87%. Cream. 30g, A7.17. maintenance, 1.2-2.4g daily in divided doses. Crohn’s disease: Maintenance of remission, 2.4g 0NO daily in divided doses. ALSO ANUGESIC-HC SUPPS Pramoxine (HCl) Q Not recommended. 27mg, hydrocortisone (acetate) 5mg, bismuth 2MO subgallate 59mg, zinc oxide 296mg, Peru balsam ALSO ASACOLON SUPPS Mesalazine 500mg 20, 49mg, benzyl benzoate 33mg, bismuth oxide A14.42. 24mg. Buff coloured suppository. 12, A3.05. S Proctitis and proctosigmoiditis. Adjunct S Severe and acute discomfort or pain to oral therapy in severe generalised ulcerative associated with internal and external colitis affecting the rectum and rectosigmoid haemorrhoids, proctitis, cryptitis, anal fissures, colon. pruritus ani and perianal sinuses. Also indicated post-operatively in ano-rectal surgical procedures. P 1 inserted up to three times daily after P 1 suppos. or application of cream night defecation depending on the severity of the disease and reducing dose as condition improves. and morning and after defaecation. In severe cases insert 1 morning and evening as an Q Not recommended. D Tuberculous, fungal and viral infections. adjunct to oral therapy. Q Not recommended. B Avoid prolonged use. Pregnancy. A Systemic corticosteroid effects. Transient D Hypersensitivity to salicylates. Severe renal impairment. Lactation. burning on application. B GI tract obstruction. Renal impairment ANUSOL McNeil Healthcare and raised blood urea or proteinuria. Elderly. Pregnancy. 2 Soothing/antiseptic/astringent. Bismuth subgallate C Lactulose. Products that decrease stool pH. 59mg, bismuth oxide 24mg, Peru balsam 49mg, A Gl disturbances, headache, blood zinc oxide 296mg/2.8g. Suppos. 12, A3.62; 24, dyscrasias, hepatic and renal reactions, A6.29. pancreatitis. 2K

Steroid. Hydrocortisone acetate 10%. Mucoadherent foam in aerosol. 20g (approx. 14 applications) plus applicator, A8.44. S Ulcerative colitis, proctosigmoiditis, granular proctitis. P 1 applicatorful inserted into the rectum once or twice daily for 2-3 weeks and every second day thereafter. Q Not recommended. D Obstruction, abscess, perforation, peritonitis, fresh intestinal anastomoses and extensive fistulae. Tuberculous, fungal or viral infections. B Severe ulcerative disease. Avoid prolonged use. Pregnancy. A Systemic corticosteroid effects.

DIPENTUM

UCB

2MO Salicylate. Olsalazine Na+ 500mg yellow scored tab. 250mg beige cap. 500mg-60, A33.25; 250mg112, A31.04. S Treatment of mild-moderate acute ulcerative colitis and maintenance of remission. P Initially 1g daily I divided doses increasing to max. 3g daily, maintenance dose 500mg twice daily. Must be taken with food. Q Not recommended. D Hypersensitivity to salicylates, severe renal impairment. Pregnancy. A GI upset, headache, arthralgia, rash.

ENTOCORT CR

AstraZeneca

0MO

Corticosteroid. Budesonide 3mg. Grey/pink cap. marked with strength and CIR containing controlled-release ent-ctd granules. 100, A96.68. S Induction of remission in mild to moderate Crohn’s disease affecting the ileum and/ ALSO ANUSOL CREAM Zinc oxide 10.75%, BUDENOFALK Dr Falk or the ascending colon. bismuth oxide 2.14%, Peru balsam 1.8%. Cream. 0NO P 3 caps. once daily in the morning, for 23g, A3.50. Glucocorticoid. Budesonide 3mg. Hard, pink, up to 8 weeks, taken before meals. 2K A gastro-resistant cap. 100, 93.50. Q Not recommended. ALSO ANUSOL OINTMENT Zinc oxide 10.75%, B Caution: Bacterial, fungal or viral S Induction of remission in patients with bismuth oxide 0.87%, Peru balsam 1.87%, bismuth mild to moderate active Crohn’s disease affecting infections, hypertension, diabetes mellitus, subgallate 2.25%. Oint. 25g, A3.50. osteoporosis, peptic ulcer, glaucoma, cataracts, the ileum and/or the ascending colon. S Haemorrhoids, pruritus ani- and other family history of diabetes or glaucoma, chicken Symptomatic relief of chronic diarrhoea due to ano-rectal conditions. pox, measles, surgery, liver dysfunction. Withdraw collagenous colitis. P 1 suppos. or application of cream or oint. night and morning and after defaecation. P 1 cap. 3 times daily about half an hour gradually. Pregnancy, lactation. C Cholestryamine, ketoconazole. Avoid Q Not recommended. before meals, swallowed with plenty of fluid. grapefruit juice. Max. duration: 8 weeks. ANUSOL HC McNeil Healthcare Q Not recommended (insufficient A Cushingoid features, hypokalaemia, behavioural changes, blurred vision, palpitations, experience). 0N dyspepsia, skin reactions (urticaria, exanthema), D Hepatic cirrhosis with signs of portal Steroid/antiseptic/astringent. Hydrocortisone muscle cramps, menstrual disorders. hypertension. Pregnancy, lactation. (acetate) 10mg, benzyl benzoate 33mg, bismuth B Increased susceptibility to infections. subgallate 59mg, bismuth oxide 24mg, resorcinol HUMIRA Abbott Caution: Tuberculosis, hypertension, diabetes 24mg, Peru balsam 49mg, zinc oxide 29mg. A mellitus, osteoporosis, peptic ulcer, glaucoma, 2NT Suppos. 12, 4.06. cataracts, family history of diabetes or of 0NO Tumour necrosis factor (TNF) antagonist. glaucoma, exposure to chickenpox or measles, live Adalimumab 40mg. Soln for inj in 0.8-ml pre-filled ALSO ANUSOL HC OINTMENT Hydrocortisone (acetate) 0.25%, benzyl benzoate 1.25%, bismuth vaccines, severe liver dysfunction. Withdraw pen or pre-filled syringe (2 per pack). Price subgallate 2.25%, bismuth oxide 0.87%, resorcinol gradually. available on request. C CYP3A4 inhibitors. Caution: CYP3A4 0.87%, Peru balsam 1.87%, zinc oxide 10.75%. S Severe, active Crohn’s disease in patients inductors or substrates, steroid-binding resins and who have not responded despite full and 15g, A5.10. S Haemorrhoids and inflammation of ano- antacids (take 2 hours apart), cardiac glycosides, adequate course of therapy with corticosteroid saluretics. rectal area. and/or immunosuppressants; or who are intolerant A Depression, irritability, euphoria, P 1 suppos. or application of oint. night to or have medical contraindications for such glaucoma, cataract, hypertension, thrombosis, and morning and after defaecation. therapies. Induction treatment, admin. in vasculitis, duodenal ulcer, pancreatitis, skin Q Not recommended. combination with corticosteroids; if corticosteroids D Tuberculous, fungal and viral infections. disorders, systemic steroid effects, increased risk inappropriate then admin. as monotherapy. B Avoid prolonged use. Pregnancy. P 80mg at week 0, followed by 40mg at infections, metabolism and nutrition disorders. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

17


1.4 ANO-RECTAL

CONDITIONS, COLITIS

week 2; and then 40mg once fortnightly via SC injection. If need for more rapid response to therapy: 160mg at week 0, 80mg at week 2, can be used (higher risk of adverse events during induction). Q Under 18 years, not recommended. D Active tuberculosis, other severe infections (sepsis), uncontrolled / opportunistic infections. Moderate to severe HF. Pregnancy, lactation. B Monitor for infections, incl. tuberculosis, before, during and after treatment; discontinue if serious. Do not initiate if active, chronic or localised infection unless controlled. Pre-existing or recent-onset CNS demyelinating disorders, mild HF (caution), COPD, heavy smokers. Use adequate contraception, avoid breastfeeding and pregnancy for 5 months after last treatment. Malignancies incl. lymphoma, demyelinating disease, HBV reactivation, pancytopenia reported. C Increased antibody formation and Humira clearance when admin. without methotrexate. Live vaccines, anakinra (not recommended), immunosupressants (caution). A Inj. site reaction, upper and lower respiratory infections, viral/bacterial infections, candidiasis, dizziness, headache, neurological sensation disorders. Cough, nasopharyngeal pain, diarrhoea, abdominal pain, stomatitis and mouth ulceration, nausea, hepatic enzymes increased, rash, pruritus, dermatitis, eczema, hair loss, musculoskeletal pain, pyrexia, fatigue.

ALIMENTARY SYSTEM

ALSO PENTASA SUPPOSITORIES Mesalazine 1g. Suppos. 28, A50.24. S Treatment of ulcerative proctitis. P Acute, 1 rectally twice daily for two to four weeks. Maintenance, 1-2 daily. Q Under 2 years, contraindicated. Over 2 years, 20-30mg/kg body weight daily divided into several doses when possible.

Ferring

2MO PENTASA RECTAL SUSPENSION. Salicylate. Mesalazine 1g. Enema. 7 x 100ml, A24.79. S Management of active ulcerative colitis. P 1 at bedtime for 2-3 weeks. Q Under 2 years, contraindicated. Over 2 years, reduced dose according to body weight.

2MO

18

PREDSOL

UCB

0NO

Steroid. Prednisolone (as disodium phos.) 20mg. Enema. 7 x 100ml, A6.09. S Ulcerative colitis. Crohn’s disease. ALSO PENTASA PR 500MG TABLETS Mesalazine P 1 at night for 2-4weeks. 500mg. White grey to pale brown prolongedQ Not recommended. release scored tab. marked with tab. strength and D Tuberculosis, bacterial, fungal and viral PENTASA. 100, A41.13. infections. S Ulcerative colitis and Crohn’s disease. B Avoid prolonged use. Severe disease. P Acute treatment (colitis/Crohn’s): Up to Pregnancy, lactation. 4g daily in 2 or 3 divided doses. MaintenanceC Rifampicin, rifabutin, carbamazepine, colitis: 2g once daily; Maintenance-Crohn’s: Initially phenobarbitone, phenytoin, primidone, 1.5g daily in 2 or 3 divided doses. aminoglutethimide, hypoglycaemics, Q Under 2 years, not recommended. Over antihypertensives, diuretics, coumarin, salicylates. 2 years, acute treatment, 20-30mg/kg body weight A Systemic corticosteroid effects. daily in two or three divided doses.

2MO

PREPARATION H

2MO

ALSO PENTASA SACHET Mesalazine 1g, 2g. White-grey to white-brown prolonged-release grans. in sachet. 1g-50, A46.55. 2g-60, A97.92. S Mild to moderate ulcerative colitis. P Acute, up to 4g daily divided into 2 to 4 doses, placed on the tongue and washed down with water or orange juice (must not be chewed). Maintenance, 2g once daily. Q Under 12 years, contraindicated. D Pregnancy/ lactation (except if benefit outweighs risk). Rectal Suspension/Suppositories/ MEZAVANT XL Shire Tabs: Children Q2 years, active peptic ulcer, 2MO coagulopathy, severe liver and/or renal impairment. Sachets: Children Q12 years. Salicylate. Mesalazine 1200mg. Red-brown, B Caution: Hepatic, renal impairment, ellipsoidal, film-ctd, gastro-resistant prolonged haemorrhagic diathesis, active peptic ulcer, allergy release tab, debossed with S476 on one side. 60, A71.47. to sulphasalazine. Monitor: Renal and liver function, differential blood counts. May occur: S Induction and maintenance of clinical Renal dysfunction (nephrotoxicity risk increased by and endoscopic remission of mild to moderate, concomitant NSAIDs and azathioprine), cardiac active ulcerative colitis. P Induction of remission: 2.4 to 4.8g once hypersensitivity reactions (myo- and pericarditis), blood dyscrasias (perform blood test if suspected). daily with food. 4.8g/day recommended for C Caution: Known nephrotoxic agents patients not responding to lower doses (evaluate (incl. NSAIDs and azathioprine), 6-mercaptopurine. treatment after 8 weeks). Maintenance: 2.4g/day. A Headache, diarrhoea, abdominal pain, Q Under 18 years, not recommended. nausea, vomiting, rash. D Severe renal impairment (GFR Q30ml/ 2 min/1.73m ) and/or severe hepatic impairment. PERINAL SPRAY Dermal B Serious blood dyscrasias may occur; 2MO discontinue and perform haematological investigations. Risk of hypersensitivity reactions: Steroid/local anaesthetic. Hydrocortisone 0.2%, Conditions predisposing to myo- or pericarditis, lignocaine (HCl) 1%. Soln. in a metered dose chronic lung function impairment (especially pump spray. 30ml, A7.26. asthma). Caution: Mild to moderate renal S Anal and perianal pain and pruritus impairment, hepatic impairment, allergy to such as associated with haemorrhoids. sulphasalazine. Renal impairment may occur. P Spray twice over affected area, up to Pregnancy (caution at high doses), lactation (if three times daily. benefit outweighs risk). Q Not recommended. C Caution: Known nephrotoxic agents D Bacterial, viral or fungal infections. (incl. NSAIDs and azathioprine), thiopurine B Avoid prolonged use. Pregnancy. methyltransferase, coumarin-type anticoagulants A Systemic corticosteroid effects. e.g. warfarin (closely monitor). A Headache, flatulence, nausea. PREDFOAM Forest

PENTASA RANGE

D Peritonitis, fistulae, obstruction, perforation, infections. B Avoid prolonged use. Pregnancy.

0NO Steroid. Prednisolone (as metasulphobenzoate Na+) white mucoadherent foam in aerosol. 20mg per metered dose. 25g (14 dose) plus disposable applicators, A9.76. S Proctitis, ulcerative colitis. P 1 metered dose inserted rectally once or twice daily for 2 weeks, continue for a further 2 weeks if good response. Q Not recommended.

Wyeth Healthcare

2 Soothing/antiseptic. Alcohol soluble extract of live yeast cells 1%, shark liver oil 3%. Rectal ointment. 25g, A3.64. S Haemorrhoids. P Application of oint. morning and night and after defaecation. Q Not recommended.

PROCTOFOAM HC

Meda

0MO Steroid/local anaesthetic. Hydrocortisone acetate 1%, pramoxine (HCl) 1%. Mucoadherent foam in aerosol. 21.2g plus applicator, A5.63. S Haemorrhoids, proctitis, cryptitis, fissures. P 1 applicatorful in the rectum 2 or 3 times daily and after defaecation. Perianally, apply as needed. Q Not recommended. D Tuberculous, fungal or viral infections. B Avoid prolonged use. Pregnancy. A Systemic corticosteroid effects.

PROCTOSEDYL

sanofi-aventis

0NO Steroid/local anaesthetic/antibiotic. Hydrocortisone 5mg, cinchocaine (HCl) 5mg, framycetin sulph. 10mg, esculin 10mg. Suppos. 12, A3.44.

0NO ALSO PROCTOSEDYL OINTMENT Hydrocortisone 0.5%, cinchocaine (HCl) 0.5%, framycetin sulph. 1%, esculin 1%. 30g, A7.62. S Haemorrhoids, anal fissure, inflammation, pruritus. V 1 suppos. and/or application of oint. morning and night and after defaecation. D Tuberculous, fungal and viral infections. B Avoid prolonged use. Pregnancy. A Systemic corticosteroid effects.

RECTOGESIC

Clonmel

2MO Nitrate. Glyceryl trinitrate 4mg/g. Ointment. 30g, A44.02. S Relief of pain associated with chronic anal fissure. P 375mg (measured using dosing line on carton) applied intra-anally every 12 hours. Continue until pain abates, up to max. 8 weeks. Q Under 18 years, not recommended.

2

5

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c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


ALIMENTARY SYSTEM

ANO-RECTAL CONDITIONS,

D Previous idiosyncratic reactions to other organic nitrates. Postural hypotension, hypotension or uncorrected hypovolaemia; increased intracranial pressure or inadequate cerebral circulation; migraine or recurrent headache; aortic or mitral stenosis, hypertrophic obstructive cardiomyopathy; constrictive pericarditis or pericardial tamponade; marked anaemia or closed-angle glaucoma. B Severe hepatic or renal disease. Avoid excessive hypotension. Monitor for hypotension/ tachycardia in patients with acute MI or CHF. If bleeding associated with haemorrhoids increases, stop treatment. Contains propylene glycol, lanolin. If anal pain persists exclude other causes. Pregnancy, lactation; not recommended. Driving or using machines. C Contra: Sildenafil citrate, tadalafil, vardenafil, NO donors e.g. isosorbide dinitrate and amyl or butyl-nitrite. Caution: Other vasodilators, Ca++ channel blockers, ACE inhibitors, b-blockers, diuretics, anti-hypertensives, TCAs, major tranquillisers, alcohol, dihydroergotamine, acetylsalicylic acid, NSAIDs. A Headache, dizziness, nausea.

REMICADE 2N

Soothing/antiseptic/astringent. Bismuth subgallate 2%, zinc oxide 8%, menthol 1%. Cream. 26g, A3.40. S Haemorrhoids, anal irritation. P Apply three times daily and after defaecation. For internal haemorrhoids use cannula nozzle. Q Not recommended.

SALAZOPYRIN

1.4

recurrance, 1 suppos. three times daily. Q Under 10 years, not recommended.

2MO ALSO SALOFALK ENEMA Mesalazine 4g. 7, A49.46. S Ulcerative colitis. P 1 daily before retiring. Q Under 10 years, not recommended.

2MO ALSO SALOFALK GRANULES Mesalazine 500mg,

Pharmacia 1000mg. 500mg-100, A41.55; 1000mg-50, A41.55.

S Acute episodes and maintenance of remission of ulcerative colitis. P Acute treatment: 3 sachets of Salofalk 500mg or 1000mg once daily preferably in the morning; alternatively 1 sachet of Salofalk 500mg 2MO or 1000mg 3 times daily (equiv. 1.5-3g daily) as ALSO SALAZOPYRIN EN-TABS Sulphasalazine required; usual duration 8-12 weeks. Maintenance: 500mg. Orange/yellow ent-ctd oval tab. marked 1 sachet of Salofalk 500mg 3 times daily. Swallow KPh one side and 102 on reverse. 112, A13.27. S Ulcerative Colitis. Active Crohn’s Disease. without chewing, with plenty of liquid. Q Under 6 years, not recommended. Over P Attack, 2-4 tabs. four times daily in 6 years and adolescents, acute treatment: 30conjunction with steroids. Maintenance, 4 tabs. a 50mg/kg/day once daily preferably in the morning day. or in 3 divided doses; maintenance: 15-30mg/kg/ Q Under 2 years, not recommended. day in 2 divided doses. Usually: Up to 40kg, half Others: Attack or relapse, 40-60mg/kg body adult dose; above 40kg, normal adult dose. Schering-Plough weight daily. Maintenance, 20-30mg/kg daily. 2MO

2MO

Salicylate-sulphonamide. Sulphasalazine 500mg. Orange/yellow round tab. marked kPh on one side and 101 on the other. 112, A9.41.

2MO

Monoclonal antibody. Infliximab 100mg. Powder for conc. for soln. in vial. 1, A690.43. S Severe active Crohn’s disease, fistulising Crohn’s disease and moderate/severe active ulcerative colitis where conventional therapy (eg. corticosteroids, immunosuppressants, 6-MP or AZA) is inappropriate or ineffective. P Crohn’s/UC: 5mg/kg IV inf. over 2 hrs, repeat after 2 and 6 weeks. Repeat inf. every 8 weeks; alternatively re-admin. inf. if symptoms recur. Discontinue use if no response following initial inf. after 2 doses in severe active and after 3 doses in fistulising active and UC. Crohn’s re admin.: Within 16 weeks following last inf. Q Crohn’s in 6-17 year olds: 5mg/kg IV inf. over 2 hrs, repeat after 2 and 6 weeks. Follow with inf. every 8 weeks. D TB (must be screened for active/ inactive), severe infections eg. sepsis, abscesses. Moderate/severe HF. Women should use adequate contraception and should not breastfeed during treatment and within 6 months of last dose. B Monitor for acute inf. reactions during/ within a few hours of inf. If necessary interrupt immediately. Ensure emergency equip. and treatment available. Monitor patients retreated after a long period. Caution: Chronic infection or recurrent infections. Discontinue if patient develops symptoms of lupus-like syndrome, antinuclear antibodies or serious infection. Elderly, hepatic impairment, mild heart failure. Increased risk of malignancies (caution with heavy smokers, history of malignancy). UC patients: Regularly screen for dysplasia. Crohn’s: Rare cases of hepatosplenic T-cell lymphoma reported. Paediatric Crohn’s: If possible, bring up to date with all vaccinations before initiating Remicade therapy. C Anakinra, live vaccines (not recommended). A Viral infection, serum sickness-like reactions, headache, vertigo, flushing, RTIs, dyspnoea, sinusitis, GI disorders, dyspepsia, skin/SC tissue disorders, fatigue, chest pain, fever, elevated hepatic transaminases, inf. reactions.

ROWATANAL

2

COLITIS

ALSO SALAZOPYRIN SUSPENSION Sulphasalazine 250mg/5ml. Orange-lemon flavoured susp. 500ml, A18.50. P 20-40ml four times daily for 2-3 weeks. Maintenance, 10ml 3-4 times daily. Interval between doses should not exceed 8 hrs. Q Under 2 years, not recommended. Others: Attack or relapse, 40-60mg/kg body weight daily. Maintenance, 20-30mg/kg daily.

2MO ALSO SALAZOPYRIN SUPPOSITORIES Sulphasalazine 500mg. Orange/yellow Suppos. 10, A3.43. P 2 morning and night after defaecation. Reduce after 3 weeks if improvement allows. Q Under 2 years, not recommended. Others, reduce dose in proportion to body weight. Oral and rectal may be used simultaneously. D Jaundice, porphyria. Pregnancy (unless essential). B Hepatic/renal dysfunction, blood dyscrasias; great caution. Regular blood checks and liver function tests during first 3 months. G6PD deficiency (risk of haemolytic anaemia). Lactation. C Folic-acid antagonists, hypoglycaemics. A Nausea, headache, rash, fever, loss of appetite. Blood dyscrasias, reversible oligospermia.

SALOFALK

ALSO SALOFALK RECTAL FOAM Mesalazine 1g per actuation. 14 actuations with applicators, A37.24. S Active, mild ulcerative colitis of the sigmoid colon and rectum. P Two admin. once a day at bedtime. Q Under 12 years, not recommended. D Hypersensitivity to salicylates, severe impairment of hepatic and renal function, preexisting gastric or duodenal ulcer, haemorrhagic diathesis. Pregnancy (unless benefit outweighs risk), lactation. B Monitor blood parameters and urinary status. Impaired renal function (not recommended). Caution: Impaired hepatic function, pulmonary disease (asthma), history of adverse drug reactions to preparations containing sulphasalazine. Acute intolerability reactions (discontinue). Contains aspartame. Foam contains propylene glycol and cetostearyl alcohol. C Caution: Coumarin anticoagulants, glucocorticoids, sulphonylureas, methotrexate, probenecid/sulphinpyrazone, spironolactone/ frusemide, rifampicin, azathioprine or 6mercaptopurine. A Abdominal distention (Rectal Foam).

SCHERIPROCT

Bayer Schering

0MO

Dr Falk Steroid/local anaesthetic. Prednisolone caproate

2MO Salicylate. Mesalazine 250mg. Yellow ent-ctd tab. 100, A20.78. S Management of ulcerative colitis and treatment of Crohn’s disease in patients adversely responsive to sulphasalazine. P Acute inflammation, 2 three times daily. In severe cases, dosage may be doubled for max. 8-12 weeks. Maintenance 2 three times daily. Q Under 10 years, not recommended.

2MO

ALSO SALOFALK SUPPOSITORIES Mesalazine 250mg. 30, A21.98. S Ulcerative colitis. P Acute inflammation, 2 suppos. three times daily. Severe cases, dosage may be doubled. Rowa Long term treatment and prevention of

equiv. prednisolone 0.15% and cinchocaine (HCl) 0.5%. Oint. 30g, A5.13. S Internal or external haemorrhoids, anal fissures and proctitis. V Apply twice daily; for faster relief, up to four times on day 1.

0MO ALSO SCHERIPROCT SUPPOSITORIES Prednisolone caproate equiv. prednisolone 1mg, cinchocaine (HCl) 1mg. 12, A2.43. V 1 once daily; if severe, two to three times daily on day 1. D Tuberculous, fungal and viral infections. B Avoid prolonged use. Pregnancy. A Systemic corticosteroid effects.

ULTRAPROCT

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

Bayer Schering

19


1.5 GALLSTONES,

ALIMENTARY SYSTEM

PANCREATIC DISORDERS

White scored tabs. marked with logo one side and coded 344, 345 or 346 on reverse. 12.5mg-56, 25mg-56, A8.69; 50mg-56, A14.80. S Congestive heart failure when diuretic (frusemide 40-80mg or equiv.) is insufficient to control symptoms. P Initially 6.25mg or 12.5mg. Usual maintenance 25mg twice daily. Max. 150mg daily. Q Not recommended. D Aortic stenosis. See SPC. URSOFALK Dr Falk B Initiate under close supervision. With renal impairment, collagen vascular disease, 2MO Bile acid. Ursodeoxycholic acid 250mg. White cap. immunosuppressant therapy, monitor white cell count and urinary protein. 100, A53.02. C K+sparing diuretics, K+suppl., NSAIDs, S Dissolution of cholesterol gallstones in 1.5 GALLSTONES, PANCREATIC vasodilators, clonidine, allopurinol, procainamide, functioning gallbladders. Primary biliary cirrhosis probenecid, immunosuppressants, lithium. DISORDERS (PBC) stages I-III. A Rash, loss of taste, neutropenia, P Usually 10-12mg/kg daily taken in the thrombocytopenia, proteinuria, hypotension, ANTOX Pharma Nord evening i.e. usually 750mg daily in the evening. angioedema. Anaemia, elevated blood urea and Y Q Not recommended. D Radio-opaque calcified gallstones. Non- creatinine, elevated serum potassium and acidosis, Oral nutritional. L-Methionine 480mg, vit. C tachycardia, pruritis, flushing, vesicular or bullous functioning gallbladder. Pregnancy or women 120mg, vit. E 35mg, selenium 50mcg. Yellow oval who may become pregnant. Inflammation of small rash and photosensitivity, elevation of liver tab. 180, A79.46. enzymes in a few patients, rare cases of intestine or colon, extra hepatic cholestasis, S Chronic pancreatitis. hepatocellular injury and cholestatic jaundice. hepatitis or cirrhosis. P Up to 6 daily. Gastric irritation and abdominal pain may occur, B LFT’s prior to and during therapy. Not Q Under 16 years, at discretion of paraesthesias of the hands, serum sickness, cough, recommended for gallstones above 15mm. diam. physician. Under 5 years, not recommended. bronchospasm and lymphadenopathy. or of non-cholesterol origin. Monitor progress D Suspected or proven schizophrenia. radiologically. Secondary calcification of Renal insufficiency. Parenteral use. Pregnancy, ADENOCOR sanofi-aventis cholesterol stones may occur (related to length of lactation. 2N treatment). B Use under medical supervision. Not C Alum. hydroxide, cholestyramine or Purine nucleoside. Adenosine 6mg/2ml of 0.9% suitable as sole source of nutrition. colestipol which bind and prevent absorption. Na+ Cl sterile soln. Vial. 6 x 2ml, A31.07. CREON 10000 Solvay A Mild transient diarrhoea. S Supraventricular arrhythmias, tachycardia where there is doubt as to the 2MO 2.1 C ONGESTIVE HEART FAILURE, diagnosis. Pancreatic enzyme. Pancreatin 150mg equiv. to P Admin. by rapid IV bolus inj. when TACHYCARDIA , POST -MI lipase 10,000, amylase 8,000, protease 600 PhEur facilities exist for cardiac monitoring. Initially 3mg units. Brown/clear cap. containing gastro-resistant ACCUPRO Pfizer over 2 seconds. If necessary second dose of 6mg granules. 100, A19.33. should be given if there is no elimination of the 2MO 2MO ACE inhibitor. Quinapril 5mg, 10mg, 20mg, 40mg. supraventricular tachycardia within 1-2 mins. A ALSO CREON 25000 Pancreatin 300mg equiv. to third dose of 12mg may be given. See SPC. lipase 25,000, amylase 18,000, protease 1000 PhEur 5mg, 10mg, 20mg: Elliptical, triangular or round Q Not recommended. units. Orange/clear cap. containing gastro-resistant resp., brown film-ctd tabs. All marked with tab. D 2nd or 3rd degree AV block and sick strength. 40mg: Reddish-brown, oval biconvex granules. 50, A23.09. sinus syndrome (except in patients with film-ctd tab. with debossing 40 on one side and 2MO functioning artificial pace maker), asthma. A PD 535 on reverse. 5mg-28, 8.38; 10mg-28, ALSO CREON 40000 Pancreatin 400mg equiv. to B Atrial fibrillation/flutter, prolonged QT A9.57; 20mg-28, A9.81; 40mg-28, A10.05. lipase 40,000, amylase 25,000, protease 1,600 S Adjunct to diuretics or cardiac glycosides interval. PhEur units. Brown/clear cap. containing gastroC Dipyridamole, xanthines, drugs tending in congestive heart failure. resistant granules. 100-A56.92. to impair cardiac conduction. P Initiate treatment under close medical S Pancreatic exocrine insufficiency. supervision with 5mg single dose increasing up to A Facial flush, dyspnoea, bronchospasm, V Initially 1 or 2 with meals. Adjust thoracic constriction, nausea. Rarely discomfort, 40mg daily given in one or two doses. Usual according to response. sweating, palpitations, hyperventilation, head maintenance, 10-20mg daily with concomitant 2MO pressure, apprehension, blurred vision, burning therapy. Treatment of severe or unstable CHF ALSO CREON FOR CHILDREN 5000 Pancreatin sensation, bradycardia, asystole, chest pain, should be initiated in hospital. 60.36mg equiv. lipase 5,000, amylase 3,600, headache, dizziness. Q 6-12 years, not recommended. protease 200 PhEur units. Round, light brown D Subaortic stenosis, history of ACE inh. gastro-resistant granules. 20g, A27.57. AMOLIN Ergha Q Initially 5000 lipase units with each feed related angioneurotic oedema. Pregnancy, 3MO or meal. Adjust according to response. Max. daily lactation. Cardioselective b-blocker. Atenolol 25mg, B Hypoglycaemia, neutropenia/ dose: 10,000 lipase units/kg/day. agranulocytosis, anaphylactoid reactions. Caution: 50mg,100mg. White film-ctd tabs. marked C23, D Hypersensitivity to porcine proteins. C24 and C25 resp. 25mg-30, A1.56; 50mg-30, Hepatic impairment, alcoholic cyrrhosis. Renal Early stages of acute pancreatitis. A2.36; 100mg-30, A3.10. insufficiency; monitor renal function before and B Monitor abdominal symptoms S Cardiac dysrhythmias. Early intervention during therapy. Contains lactose. (especially if doseq10,000 units lipase/kg/day). C Avoid tetracyclines. Caution: b-blockers, of myocardial infarction. Pregnancy, lactation (only if clearly necessary). P 50-100mg daily. methyldopa, diuretics, lithium, agents increasing A GI disorders, skin and SC tissue allergic Q Not recommended. serum K+, antidiabetics, surgery/anaesthesia. or hypersensitivity reactions. D See 2.4, b-blockers Drug Presc. Notes. A Pharyngitis, insomnia, hyperkalaemia, ROWACHOL Rowa paraesthesia, dyspnoea, abdominal pains, back ARYTHMOL Abbott pain, myalgia, asthenia. 2O

0MO

Steroid/local anaesthetic/antihistamine. Fluocortolone pivalate 0.092%, fluocortolone hexanoate 0.095%, cinchocaine (HCl) 0.5%. Oint. 30g, A5.30. S Internal or external haemorrhoids, anal fissures and proctitis. P Apply twice daily; for faster relief, up to four times on day 1. D Tuberculous, fungal and viral infections. 1st trimester of pregnancy. B Avoid prolonged use. Pregnancy, lactation. A Systemic corticosteroid effects.

Essential oils. Menthol 32mg, menthone 6mg, essential oils a-b-pinenes 17mg, camphene 5mg, cineole 2mg, borneol 5mg. Green ent-ctd oval gelatin cap. 50, A4.76.

20

S Hepato-biliary disorders incl. the dissolution of radiolucent gallstones in the functioning gallbladder. P 1-2 caps three times daily before meals. Q 6 to 14 years: 1 cap three times daily before meals. Under 6 years, not recommended. D Pregnancy, lactation. B Oral contraceptives. Oral anticoagulants. C Oral contraceptives. Oral anticoagulants.

ACEOMEL

Clonmel

2MO ACE inhibitor. Captopril 12.5mg, 25mg, 50mg.

A7.73;

2MO Class I antiarrhythmic. Propafenone (HCl) 150mg, 300mg. White film-ctd tabs. 150mg-90, A23.19; 300mg-60, A23.19.

2

5

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c

s

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d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM

CONGESTIVE

HEART FAILURE, TACHYCARDIA, POST-MI

2.1

Uncoated tabs debossed with strength on 1 side. Light yellow biconvex cap-shaped tab. (10mg); light peach biconvex cap-shaped tab. (20mg). Cardioselective b-blocker. Atenolol 25mg, 50mg, 10mg-28, A7.87; 20mg-28, A9.32. 100mg. White, white, orange film-ctd tabs. S Symptomatic cardiac insufficiency. Shortmarked AT/25, AT/50, AT/100, resp. All marked term treatment (6 weeks) of haemodynamically with maker’s symbol. 25mg-28, A2.49; 50mg-28, stable patients in the 24 hours following acute MI. A3.77; 100mg-28, A5.38. P Heart failure: Initially 2.5mg once a day S Cardiac arrhythmias. Long-term under medical supervision. Increase to highest prophylaxis after recovery from acute MI. Angina dose tolerated, up to max 35mg once a day by pectoris. Essential hypertension. increments of not more than 10mg, at intervals r P Arrythmias: 50-100mg daily. Prophylaxis 2 weeks. Acute MI: Do not start if systolic BP after recovery from MI: 100mg daily. Hypertension: Q100mmHg. Initially (3 days after infarct), 5mg 50mg daily increasing to 100mg daily if required. orally, followed by 5mg after 24 hours, 10mg after Allow time to achieve full effects (1-2 weeks) 48 hours and 10mg/day thereafter. Low systolic BP before determining need to increase to 100mg (R120mmHg) at start of treatment or within first daily. Angina: 100mg daily as a single dose or as 3 days of infarct: Initially, 2.5mg orally. 50mg twice daily. Maintenance, 10mg once a day. Reassess after 6 Q Not recommended. weeks. If hypotension occurs (systolic BP ATACAND AstraZeneca D See 2.4, b-blockers Drug Presc. Notes. R100mmHg), 5mg with temporary decrease to 2MO 2.5mg if necessary; withdraw if prolonged. Renal ATENOMEL Clonmel impairment, ccQ10ml/min, initially 2.5mg; Angiotensin II antagonist. Candesartan cilexetil 3 M O 2mg, 4mg, 8mg, 16mg. White, white, light pink 10QccQ30ml/min, initially 2.5-5mg; 31QccQ80ml/ Cardioselective b-blocker. Atenolol 25mg, 50mg, and pink tabs. resp. 4, 8 and 16mg tabs scored. min, initially 5-10mg/day. 2mg-14, A7.89; 4mg-28, A14.42; 8mg-28, A18.33; 100mg. White tab. marked C23, C24, C25. 50 and Q Not recommended. 100mg scored. 25mg-30, A2.60; 50mg-30, A3.94; 16mg-28, A24.74. D History of angioedema associated with S Treatment of heart failure and impaired 100mg-30, A5.01. prior ACE inhibitor treatment, hereditary or S Cardiac arrhythmias, early intervention left ventricle systolic function as add-on therapy to idiopathic angioedema, pregnancy, lactation. in acute MI. ACE inhibitors or when ACE inhibitors are not B Caution: Acute MI (renal dysfunction, P 50-100mg daily. tolerated. do not use), mitral stenosis and LV outflow Q Not recommended. P Initially 4mg once daily. Titration to obstruction, aortal stenosis, hypertrophic D See 2.4, b-blockers Drug Presc. Notes. target dose 32mg once daily done by doubling myocardiopathy, bilateral renal artery stenosis or dose at intervals of min. 2 weeks. artery stenosis in a single kidney (strict supervision BELLISIN Ranbaxy Q Under 18 years, not recommended. with low doses; careful dose adjustment), preD Severe hepatic impairment, cholestasis. 2MO existing renal impairment (monitor blood K+ and Pregnancy, lactation. ACE inhibitor. Lisinopril (as dihydrate)10mg, 20mg. creatinine concentrations), major surgery, B Correct volume/salt depletion before starting therapy. Severe or end-stage renal PRESCRIBING NOTES HEART FAILURE (HF) impairment, renal artery stenosis, aortic or mitral HF is diagnosed in patients with known/suspected cardiac disorder who present with dyspnoea, fatigue, stenosis, obstructive hypertrophic cardiomyopathy. oedema. Primary hyperaldosteronism (not recommended). HF arises from primary myocardial disease, such as dilated cardiomyopathy, but it occurs most frequently Monitor serum K+ and renal function. Contain secondary to coronary artery disease. Valvular heart disease and arrhythmias, e.g. uncontrolled atrial lactose. fibrillation, are other common causes of HF. HF is graded either as mild, moderate or severe or using the + + C Caution: K sparing diuretics, K suppl., New York Heart Association reference grades I, II, III, IV. When investigating HF an echocardiogram is the heparin, lithium, antihypertensives, indomethacin. most useful tool. An ECG is seldom normal but not diagnostically abnormal in impaired hearts while a A Hypotension, hyperkalaemia, renal chest x-ray is not usually helpful in diagnosing the aetiology but may show an enlarged heart and changes impairment, increases in creatinine, urea and K+. in the lung fields. Other investigations should include baseline blood tests, such as full blood count (to S Ventricular and supraventricular extrasystoles and tachycardias, tachyarrhythmias. P Adjust to individual requirements. Q Not recommended. D Manifest HF, sick sinus syndrome, complete heart block, cardiac shock, severe bradycardia, 3 months post-MI, marked hypotension, electrolyte imbalance, severe obstructive pulmonary disease, myasthenia gravis, known hypersensitivity. B Initiate under cardiological surveillance. C Other anti-arrhythmic agents, bblockers, digitalis, local anaesthetics, TCAs, disipramine, cyclosporin, digoxin, cimetidine, quinidine, phenobarbital, rifampicin, oral anticoagulants. A Nausea, blurred vision, vertigo, proarrythmic events, GI disorders.

ATECOR

Rowex

3MO Cardioselective b -blocker. Atenolol 25mg, 50mg, 100mg. White scored film-ctd tabs. 25mg-30, A2.67; 50mg-30, A4.04; 100, A12.84; 100mg-30, A5.77; 100, A18.67. S Cardiac arrhythmias. Early intervention of acute MI. P 50-100mg twice daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

ATENI

Gerard

3MO Cardioselective b-blocker. Atenolol 50mg, 100mg white tabs. Both marked AT and strength one side, G on reverse. 50mg-28, A4.16; 100mg-28, A5.38. S Long-term prophylaxis from MI. P Myocardial infarction: Early intervention; 50mg orally 15 min after IV inf. followed by 50mg orally 12 hr after IV inf. then 100mg orally 12 hr later. Late intervention; 100mg daily. See SPC. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

ATENOGEN

Antigen

3MO

exclude anaemia), urea and electrolytes, creatinine and blood glucose. Drug Treatment Lifestyle advice on diet, weight loss and salt restriction should be advised and tightly implemented in more severe cases of HF. Fluid restriction is often necessary in advanced HF. Exercise should be encouraged to improve efficiency of the circulation. Bed rest is indicated only in people with acute right or left ventricular failure and even then for a limited period of time only. Alcohol intake should be minimal. ACE inhibitors produce clinical benefit in all stages of HF improving both quality and life expectancy. They are recommended in all cases of symptomatic HF and in case of asymptomatic LV dysfunction. ACE inhibitors can restore the potassium loss caused by moderate doses of loop diuretics. Trials have shown that ACE inhibitors have a protective effect against myocardial infarction, unstable angina, and cardiac death in patients with either symptomatic or asymptomatic HF. Diuretics: Thiazide and loop diuretics have a synergistic effect and can be used in combination in more severe cases of HF. Both classes can cause hypokalaemia so electrolyte monitoring is essential. There are many combination products which include a loop diuretic and a potassium-sparing diuretic, e.g. coamilofruse (frusemide and amiloride). Spironolactone produces a more powerful diuresis than amiloride, but has a higher side effect profile. Beta-blockers should be considered in all patients with NYHA class II to IV with reduced LVEF on standard treatment including diuretics and ACE inhibitors. They are also recommended, in addition to ACEinhibitors, in patients with LV systolic dysfunction (even if asymptomatic) following an AMI. Only bisoprolol, carvedilol, metoprolol succinate and nebivolol can be recommended. Nebivolol has recently been approved in elderly patients > 70 years with mild and moderate CHF in addition to standard therapies. Aldosterone receptor antagonists are recommended in addition to ACE inhibitors, beta-blockers and diuretics in patients with advanced HF (NYHA III/IV), or in combination with ACE inhibitors and betablockers in patients with a recent MI, LV systolic dysfunction and signs of HF or diabetes. Angiotensin II receptor blockers (ARBs) have similar efficacy as ACE inhibitors and can be used as an alternative in patients intolerant to ACE inhibitors. ARBs can also be used in combination with ACE inhibitors in CHF patients who remain symptomatic. Other drugs used in the management of HF include digoxin (especially useful in atrial fibrillation) and hydralazine and nitrates in combination (when ACE inhibitors and ARBs are not tolerated). References available on request. Revision date: January 2006.

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

21


2.1 CONGESTIVE

HEART FAILURE, TACHYCARDIA, POST-MI

function prior to and during treatment. Caution: Impaired liver function, volume- and saltdepletion, anaesthesia. May occur rarely: Agranulocytosis and bone marrow depression, reduction in red cell count, Hb content and platelet count, hyperkalaemia. Avoid haemodialysis using high flux membranes and LDL apheresis with dextran sulphate. C Caution: Diuretics or other antihypertensives, K+ sparing diuretics, K+ supplements, antidiabetics, NSAIDs, lithium, allopurinol, immunosuppressants and other substances that may change the blood picture. A Hypersensitivity reactions, eosinophilia, raised antinuclear antibodies titres, sleep disorders, depressed mood, anxiety, dizziness, disturbances of balance, nervousness, restlessness, tremor, confusion, loss of appetite, paraesthesiae, BELLRAMIL Ranbaxy conjunctivitis, symptomatic hypotension, syncope, MI or cerebrovascular accident possibly secondary 2MO to severe hypotension, chest pain, palpitations, ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Size 4 rhythm disturbances, angina pectoris, vasculitis, hard cap. with resp. yellow, orange, maroon or dry tickling cough, rhinitis, sinusitis, bronchitis, blue cap /white body, imprinted with R on cap bronchospasm, GI disorders, cutaneous and and strength on body. Contain white to off-white mucosal reactions, muscle cramps, muscle and joint granular powder. 2.5mg-30, A5.50; 5mg-30, pains, impaired renal function, impotence, A7.10; 10mg-30, A9.60. decreased libido, taste change/reduction/loss, fever S To reduce risk of MI, stroke, cardiovascular death or need for revascularisation headache, fatigue, malaise, increases in blood urea, nitrogen and serum creatinine, decreased procedures in patients of 55 years or more with serum Na+, increased serum K+. clinical evidence of cardiovascular disease (previous MI, unstable angina or multivessel CABG BETALOC AstraZeneca or multivessel PTCA), stroke or peripheral vascular 3MO disease or with one or more of the following clinical findings: Hypertension (systolic Cardioselective b-blocker. Metoprolol tartrate BPq160mmHg or diastolic BPq90mmHg); high 50mg white tab. scored and marked A/BB; 100mg total cholesterol q5.2mmol/L); low HDL white tab. scored and marked A/ME. 50mg-100, A2.11; 100mg-100, A3.91. (Q0.9mmol/L); current smoker; known microalbuminuria; clinical evidence of previous S Cardiac arrhythmias. vascular disease. Congestive HF as adjunctive P 50mg two or three times daily; max. therapy to diuretics with or without glycosides. 300mg daily. Reduces mortality when given to patients Q Not recommended. surviving acute MI with clinical evidence of HF. 3N P Reducing risk of MI, stroke or ALSO BETALOC INJECTION Metoprolol tartrate cardiovascular death and/or need for 1mg/ml. 5ml amp. 5, A3.03. revascularisation procedures: Initially, 2.5mg once S Maintenance therapy in myocardial daily. Double dose after 1 week, after 3 further infarction. Supraventricular arrhythmias. weeks increase to 10mg. Maintenance: 10mg once D See 2.4, b-blockers Drug Presc. Notes. daily. Congestive HF: Patients stabilised on diuretic therapy, 1.25mg once daily. If needed, double BIOCARD Niche dose at 1-2 week intervals. If daily dose q2.5mg 3MO required, take as a single dose or as 2 divided a/b blocker. Carvedilol 3.125mg, 6.25mg, 12.5mg, doses. Max daily dose: 10mg. Post MI: Initiate in 25mg. Round bevel edged tabs. (3.125mg), scored hospital between day 3 and day 10 following MI. on one side (25mg). Oval tab., marked S2 on one Starting dose, 2.5mg twice daily during 2 days. side (6.25mg scored) or S3 on one side (12.5mg May be increased to 5mg twice a day after 1-3 scored). All slightly biconvex, white. 3.125mg-28, days interval. If initial 2.5mg not tolerated, 1.25mg A 5.09; 6.25mg-28, A6.23; 12.5mg-28, A7.45; twice a day should be given for 2 days before 25mg-28, A8.32. increasing to 2.5mg and 5mg twice daily. If dose S Symptomatic CHF (NYHA Class II and III) cannot be increased to 2.5mg twice daily, as adjunct to standard therapy. withdraw treatment. Max daily dose 10mg. P Titrate dose individually and monitore Maintenance: 2.5mg-5mg twice daily. Renal during up-titration. Initially, 3.125mg twice daily impairment: ccQ30ml/min, initially 1.25mg once for 2 weeks. If tolerated, titrate at min. 2 week daily, max 5mg once daily; ccQ10ml/min, 1.25mg intervals to 6.25mg twice daily, then to 12.5mg once daily, maintenance 2.5mg once a day max. twice daily, then 25mg twice daily. Max. 25mg Hepatic impairment: Initially, 1.25mg under close twice daily in patients under 85kg, or 50mg twice medical supervision. daily in patients over 85kg. R Caution Q Under 18 years, not recommended. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. D History of angioneurotic oedema, NYHA class IV decompensated HF requiring IV haemodynamically relevant renal artery stenosis inotropic support, liver dysfunction. (bilateral or unilateral in single kidney). Aortic or mitral valve stenosis or outflow obstruction. BISOP Rowex Hypotensive or haemodynamically unstable 3MO patients. Pregnancy, lactation. B Renal impairment risk; assess renal Cardioselective b-blocker. Bisoprolol fumarate

anaesthesia, diabetes. May occur: Systemic hypotension, angioedema (withdraw immediately), anaphylactoid reactions in haemodialysis patients or during desensitisation treatment, acute renal insufficiency in patients with HF (usually reversible), hepatic insufficiency, neutropenia/ agranulocytosis, cough. C Not recommended: Lithium. Caution: Diuretics, K+ sparing diuretics, K+ supplements, salt substitutes containing K+, NSAIDs (incl. acetylsalicylic acid r 3g/day), other antihypertensives, certain anaesthetics, tricyclic antidepressants and antipsychotic agents, sympathicomimetics, anti-diabetics. A Dizziness, headache, orthostatic effects (incl. hypotension), diarrhoea, vomiting, renal dysfunction, impotence.

22

CIRCULATORY SYSTEM 1.25mg, 2.5mg, 3.75mg, 5mg, 7.5mg, 10mg. Round film-ctd tablet encoded BIS and strength on one side. White (2.5mg), yellow-white with a score (3.75mg), yellow with a cross score (5mg), yellow with a score (7.5mg), apricot with a cross score (10mg). 1.25mg-28, A5.58; 2.5mg-28, A5.17; 3.75mg-28, A6.38; 5mg-28, A5.34;7.5mg-28, A7.74;10mg-28, A6.01. S Stable chronic HF with reduced systolic LV function in addition to ACE inhibitors and diuretics, and optionally cardiac glycosides. P Should be taken with liquid (not chewed), in the morning. Requires titration, monitoring vital signs closely, increasing dose if well tolerated: 10mg (max) once daily for maintenance. If max dose not well tolerated, consider gradual dose reduction. Lower dose or consider gradual discontinuation if transient worsening of HF, hypotension, bradycardia occur. Q Not recommended. D Acute HF or during episodes of HF decompensation requiring IV inotropic therapy. Cardiogenic shock. AV block of 2nd or 3rd degree (without a pacemaker). Sick sinus syndrome. Sinoatrial block. Bradycardia (Q 60 beats/min) before start of therapy. Hypotension (systolic BP Q 100mmHg). Severe bronchial asthma or severe COPD. Late stages of peripheral arterial occlusive disease and Raynaud’s syndrome. Untreated phaeochromocytoma. Metabolic acidosis. Pregnancy (unless necessary), lactation. B Regular monitoring required. Withdraw gradually. Caution: Bronchospasm, diabetes mellitus with large fluctuations in blood glucose (hypoglycaemia symptoms can be masked), strict fasting, ongoing desensitisation therapy, AV block of 1st degree, Prinzmetal’s angina, peripheral arterial occlusive disease, general anaesthesia. In bronchial asthma or other COPD, bronchodilating therapy should be given concomitantly. Psoriasis: Assess risk/benefit. Phaeochromocytoma: Do not admin. until after a-receptor blockade. Symptoms of thyrotoxicosis may be masked. Contains lactose. Driving/operating machinery ability (at start of treatment, with alcohol). C Contra: Floctafenin, sultopride. Not recommended: Ca++ antagonists (verapamil type and diltiazem type), class I antiarrhythmics, centrally acting antihypertensives. Caution: Ca++ (dihydropyridine type (e.g. felodipine, amlodipine), class-III antiarrhythmics (e.g. amiodarone), topical b-blocking agents (e.g. eye drops for glaucoma treatment), parasympathomimetics, insulin and oral antidiabetics, anaesthetic agents, digitalis glycosides, NSAIDs, b-sympathomimetics that

Anti-Doping Information

s This medicinal product contains substance(s) prohibited for use in specific sports only (as listed in WADA Prohibited List 2010). Athletes requesting to use this product in these specific sports are required to apply for a TUE.

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM

CONGESTIVE

HEART FAILURE, TACHYCARDIA, POST-MI

P CHF: Initially, 1.25mg once daily; may be doubled at intervals of 1-2 weeks. Dose r2.5mg may be taken as single dose or two divided doses. Max. 10mg daily. Post MI: Start treatment in hospital between day 3 and 10 post MI. Initially, 2.5mg twice a day, increased to 5mg twice a day after 2 days. If 2.5mg not tolerated, start with 1.25mg twice a day for 2 days; withdraw treatment if cannot be increased. Maintenance: 2.5-5mg twice a day. Prevention of cardiovascular BLOPRESS Takeda events: Initially 2.5mg once daily. If tolerated, double after 1 week and after another 3 weeks 2MO up to 10mg daily (usual maintenance dose). Angiotensin II antagonist. Candesartan cilexetil Q Not recommended. 2mg, 4mg, 8mg, 16mg, 32mg. 2mg: Round white tab. 4mg: Round white tab. with single score line D History of angioneurotic oedema relating to previous ACE inhibitor treatment. on both sides. 8mg: Round pale pink tab. with single score line on both sides. 16mg: Round light Pregnancy, lactation. Use in children. pink tab. with one convex side embossed with 16 B Aortic stenosis, outflow obstruction (not recommended). Assess renal function prior to and and one scored flat side. 32mg: Round light pink during treatment. Impaired renal/liver function; tab. with convex sides, debossed 32 on one side reduce dose and monitor closely. Haemodialysis and scored on the other. 2mg-7, A1.81; 2mg-28, using high-flux membranes (avoid). Correct A7.26; 4mg-7, A3.30. 4mg-28, A13.20; 8mg-28, volume/salt depletion before initiating therapy. 15.81; 16mg-28, A19.22; 32mg-28, A24.63. Collagen vascular disease; monitor white blood S Heart failure and left ventricle systolic cell counts and protein levels in urine. dysfunction (LVEF R40%) as add-on therapy to Hyperkalaemia, angioneurotic oedema have been ACE-inhibitors or when ACE-inhibitors not reported rarely. Surgery/anaesthesia. Driving or tolerated. operating machines. P Initially 4mg once daily. Titrate up to C Caution: Antidiabetics, NSAIDs. 32mg once daily by doubling dose at intervals of A Nausea, dizziness and headache, GI at least 2 weeks. disturbances, cough, skin/mucosal reactions. Q Safety and efficacy not established. D Pregnancy, lactation. Severe hepatic BYZESTRA Ergha impairment and/or cholestasis. 2MO B Not recommended: Primary hyperaldosteronism. Caution: Haemodynamically Lisinopril dihydrate 2.5mg, 5mg, 10mg, 20mg. relevant aortic mitral valve stenosis, obstructive White tabs marked LSN followed by strength. hypertrophic cardiomyopathy, severe CHF, 2.5mg-28, A3.13; 5mg-28, A4.41; 10mg-28, A5.44; underlying renal disease (incl. renal artery 20mg-28, A6.25. stenosis), haemodialysis (carefully titrate with S Heart failure (HF) as additive therapy to thorough monitoring of BP), anaesthesia and non-K+-sparing diuretics and where appropriate, surgery. Monitor renal function, serum K+ and digitalis. Acute MI in haemodynamically stable patients (SBPq100mmHg) without significant creatinine levels (HF, elderly, renal impairment, renal dysfunction as suppl. to standard therapy. concomitant ACE inhibitor). Hypotension may P HF: 2.5mg in the morning; titrated in occur. Contains lactose. increments of 2.5mg at intervals of 2-4 weeks; C Possible interaction with NSAIDs. Antihypertensive effect may be enhanced by other maintenance, 5-20mg once daily; max. 35mg daily. + + MI: Initiate within 24 hrs of symptom onset in antihypertensives. K -sparing diuretics, K haemodynamically stable patients. Initially, 5mg supplements, salt substitutes containing K+, or daily, then 5mg after 24 hrs, 10mg after 48 hrs other medicinal products that may increase K+ and thereafter 10mg once daily. Continue for 6 levels, lithium. weeks. Min. maintenance dose, 5mg daily. A Hyperkalaemia, hypotension, renal Moderate renal impairment: As per elderly. impairment. R Initially, 2.5mg in the morning; BREVIBLOC Baxter maintenance usually 5-10mg daily; max. 20mg daily. 3N Q Not recommended. Cardioselective b-blocker. Esmolol (HCl) 10mg/ml, D Angioneurotic oedema, severe renal 250mg/ml. Soln. 10mg/ml vial-5 x 10ml, A40.08; impairment, aortic or mitral valve stenosis, 250mg/ml amp.-1 x 10ml, A89.55. hypertrophic cardiomyopathy, haemodynamically D See 2.4, b-blockers Drug Presc. Notes. unstable patients after acute MI, SBPR100mmHg. Lactation, pregnancy. Permanent haemodialysis, BYTRITE Helsinn Birex cardiogenic shock. 2MO B Initiate therapy/adjust dose in hospital ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, in: High risk for severe acute hypotension, e.g. vol/ 10mg. Opaque hard gelatin caps. Yellow, light salt depletion, pre-existing hypotension, orange, pink and blue cap with white bodies renovascular hypertension, renal artery stenosis, printed 93 and 7209, 7210, 7211, 7212 resp. unstable cardiac failure, renal impairment, high1.25mg-28, A2.48; 2.5mg-28, A3.53; 5mg-28, dose vasodilator therapy, patients r70 years, A4.94; 10mg-28, A6.73. cerebrovascular disease, malignant hypertension. Discontinue or reduce diuretic therapy for 2-3 days S Congestive heart failure (CHF), as before treatment and start with 2.5mg daily. adjunctive therapy to diuretics with or without Primary hyperaldesteronism (not recommended). cardiac glycosides. Acute MI. Patients with Hypertrophic cardiomyopathy, surgery; caution. increased cardiovascular risk of MI, stroke or C Caution: K+-sparing and other diuretics, cardiovascular death taking standard therapy or K+ suppls, NaCl, antihypertensives, analgesics, antitype 2 diabetic patients at risk. activate both b and a-adrenoreceptors (e.g. noradrenaline, adrenaline), antihypertensives, tricyclic antidepressants, barbiturates, phenothiszines. Mefloquine, MAOIs (except MAOB inhibitors). A Bradycardia, worsening of heart failure, dizziness, headache, GI complaints, feeling of coldness or numbness in extremities, hypotension, asthenia, fatigue.

2.1

inflammatory agents, lithium, alcohol, anaesthetics/ narcotics/ hypnotics, sympathomimetics, oral antidiabetics, antacids, NSAIDs. A Hypotension, headache, tiredness, dry cough, sore throat, bronchitis, nausea, rash, angioneurotic oedema, hyperkalaemia.

CAPOTEN

BMS

2MO ACE inhibitor. Captopril 12.5mg, 25mg, 50mg. Mottled white cap. shaped scored tab. marked SQUIBB 450, mottled white quarter scored square tab. coded 452 and SQUIBB, mottled white oval tab. coded 482 and SQUIBB. 12.5mg-56, A7.99; 25mg-56, A9.10; 84, A24.72; 50mg-56, A15.52; 84, A42.12. S Congestive heart failure when diuretic (frusemide 40-80mg daily or equiv.) is insufficient to control symptoms. Post MI with left ventricular dysfunction. P CHF: initially 6.25mg; usual maintenance, 25-50mg twice daily. Max. 150mg daily. See SPC. Post MI: initially 6.25mg. Titrate slowly to 150mg daily in divided doses. Initiate therapy 3 days after MI. Q Contact manufacturer. D Aortic stenosis. Renal impairment. Pregnancy, lactation. See SPC. B Initiate therapy under close supervision, continue diuretics and if appropriate, digitalis concurrently. With renal impairment, collagen vascular disease, immunosuppressant therapy or leukopenic drugs, monitor white cell count and urinary protein. Contains lactose. C K+sparing diuretics or K+suppl., NSAIDs, vasodilators, clonidine, allopurinol, procainamide, probenecid, immunosuppressants. A Rash, loss of taste, cough. Rarely neutropenia, agranulocytosis, proteinuria.

CAPTOR

Rowex

2MO ACE inhibitor. Captopril 12.5mg, 25mg, 50mg. White tabs. scored one side (12.5mg); white tabs. cloverleaf form with facet and quarter scored both sides (25mg, 50mg). 12.5mg-60, A8.54; 100, A14.25; 25mg-60, A9.73; 100-A16.22; 50mg-60, A16.60; 100, A27.67. S Chronic heart failure with reduction of systolic ventricular function, in combination with diuretics and, if appropriate, digitalis and bblockers. MI: Clinically stable patients within 1st 24 hours of an infarction; long term prevention in clinically stable patients with asymptomatic left ventricular dysfunction. Macroproteinuric diabetic nephropathy in patients with type I diabetes. P HF: Initially 6.25mg-12.5mg twice or three times daily; titrate by at least two week intervals to maintenance 75-150mg/day; max.150mg daily. Post-MI: Short term, initiate therapy with 6.25mg as soon as possible in patients with stable haemodynamics; 12 hrs later 12.5mg; next days 100mg/day in two admins. for 4 weeks. Chronic, initiate therapy 3-16 days after MI with 6.25mg followed by 12.5mg 3 times daily for 2 days and then 25mg 3 times daily; long-term treatment, 75-150mg daily in two or three doses. Renal impairment: See SPC. R Initially 6.25mg twice daily. Q Initially 0.3mg/kg, or 0.15mg/kg in infants or renal dysfunction. Generally 3 times a day. D Angioneurotic oedema. Pregnancy,

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

23


2.1 CONGESTIVE

HEART FAILURE, TACHYCARDIA, POST-MI

lactation. B Renal impairment, renal artery stenosis, LV valvular and outflow tract obstruction, collagen vascular disease, patients at risk for hyperkalaemia, diabetes, hepatic impairment, anaesthesia. Neutropenia/ agranulocytosis, proteinuria. Contains lactose. C K+sparing diuretics, K+suppl., diuretics, other anti hypertensive agents, lithium, TCAs, allopurinol, procainamide, cytostatic or immunossupressive drugs, NSAIDs, sympathomimetics, antidiabetics. A Pruritus, rash, alopecia, dry cough, loss of taste, dizziness, sleep disorders, GI disorders.

CARDICOR

Daiichi Sankyo/Merck Serono

3MO Cardioselective b-blocker. Bisoprolol fumarate 1.25mg, 2.5mg, 3.75mg, 5mg, 7.5mg, 10mg. White, white, off white, white-yellow, light yellow, light orange film ctd tabs. 1.25mg round, all others heart shaped and scored. 1.25mg-28, A 3.58; 2.5mg-28, A3.31; 3.75mg-28, A4.09; 5mg-28, A4.28; 7.5mg-28, A4.95; 10mg-28, A5.48. S Stable chronic HF with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides. P Patients should be stable when initiating treatment. If tolerated, titrate gradually to 10mg once daily max. Initially 1.25mg once daily for 1 week, 2.5mg once daily for a further week, 3.75mg once daily for a further week, 5mg once daily for the following 4 weeks, 7.5mg once daily for the following 4 weeks, 10mg once daily for maintenance therapy. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. Acute HF or during episodes of HF decompensation requiring IV inotropic therapy. B Require exp. in management of chronic HF. Observe patient for 4 hours after start of treatment.

CIBACEN

Meda

2MO ACE inhibitor. Benazepril (HCl) 5mg cap-shaped pale yellow film-ctd tab scored both sides and marked CG one side and LV on reverse. 10mg dark yellow film-ctd tab marked CG one side and HO on reverse. 5mg-28, A9.33; 10mg-28, A12.44. S Adjunctive therapy in patients with congestive heart failure. P Initially 2.5mg once daily. Titrate to max. 20mg once daily at 2-4 week intervals. Q Not recommended. D Pregnancy, lactation. History of angioedema. B Salt and/or volume depletion. Renal artery stenosis, renal impairment, surgery, anaethesia, CHF. C Other anithypertensives, K+suppl., K+sparing diuretics, lithium. A Headache, upper respiratory tract symptoms, dizziness, fatigue, musculoskelatal pain, cough, rhinitis, nausea, diarrhoea, rash.

Parkinson-White syndrome. Atrial flutter and fibrillation where other drugs cannot be used. All types of paroxysmal tachyarrhythmias where other drugs cannot be used. Prevention of ventricular arrhythmias in high-risk patients following MI or in patients with clinical signs of CHF and/or LVEF Q 40% receiving appropriate cardiac failure treatment incl. ACE-inhibitors (under hospital/ specialist supervision). P 200mg three times daily for 1 week then 200mg twice daily for 1 week. Maintain on min. effective dose, usually 200mg daily. R Use minimum dose; monitor regularly. D Sinus bradycardia, sino-atrial heart block. Evidence or history of thyroid dysfunction. Pregnancy (except exceptional circumstances), lactation. B In patients with severe conduction disturbances (high grade AV block, bifascicular or trifascicular block) or sinus node disease, only use in conjunction with a pacemaker. Severe bradycardia and conduction disturbances may occur at too high doses (discontinue). May occur: Marked heart rate reduction (elderly); 2nd or 3rd degree A-V block, sino-atrial block, or bifascicular block (discontinue); onset of new arrhythmias / worsening of treated arrhythmias (sometimes fatal), hyperthyroidism (withdraw); peripheral sensorimotor neuropathy and/or myopathy; hypothyroidism or hyperthyroidism (monitor usTSH before starting treatment). Monitor: Liver function, pulmonary function (particularly if pulmonary toxicity suspected). If blurred or decreased vision occurs, perform complete ophthalmologic examination. Caution: long-term therapy. Instruct patients to avoid sun exposure. Contains lactose and iodine. C Contra: Drugs which prolong QT interval. Not recommended: b-blockers, diltiazem, verapamil, stimulant laxatives, fluoroquinolones. Caution: Oral anticoagulants, digoxin, phenytoin, diuretics, systemic corticosteroids, tetracosactride, intravenous amphotericin, general anaesthesia, high dose oxygen therapy, flecainide, drugs metabolised by CYP3A4 (fentanyl, ciclosporin, simvastatin, atorvastatin and lovastatin, tacrolimus, sildenafil, midazolam, triazolam, dihydroergotamine, ergotamine). Avoid grapefruit juice. Advise patients to moderate alcohol levels. A Bradycardia, hypothyroidism, hyperthyroidism, corneal microdeposits, GI disorders, increased serum transaminases, acute liver disorders, extrapyramidal tremor, nightmares, sleep disorders, pulmonary toxicity, photosensitivity, pigmentation on light exposed skin.

COVERSYL ARGININE

Mitral valve stenosis, obstruction in the outflow of the left ventricle. Renal impairment. Dialysis with highflux membranes. Kidney transplantation, no data. Angioedema reported rarely (discontinue if occurs). Patients at risk of hyperkalaemia. Contains lactose. Surgery, anaesthesia. C Diuretics, K+ sparing diuretics, K+containing salt substitutes, K+ supplements, lithium, NSAIDs, other antihypertensives and vasodilators, antidiabetics, TCAs, antipsychotics, anesthetics, sympathomimetics. A Headache, dizziness, vertigo, paresthaesia, vision disturbance, tinnitus, hypotension, cough, dyspnoea, GI disorders, rash, pruritus, muscle cramps, asthenia.

COZAAR

MSD

2MO Angiotensin II antagonist. Losartan (K+) 12.5mg, 50mg, 100mg. Blue oval-shaped film-ctd tab. marked 11, white film-ctd scored tab. marked 952. 12.5mg-28, A9.60; 50mg-28, A18.32; 100mg-28, A30.80.

2MO

ALSO COZAAR ORAL SUSPENSION Losartan K+, 2.5mg/ml (reconstituted susp.). White to off-white powder and cloudy, colorless solvent for oral susp. 500mg/200ml, A50. S Chronic HF (patients r 60 years), when treatment with ACE inhibitors not suitable due to incompatibility (esp. cough) or contraindication. Patients with HF stabilised with an ACE inhibitor should not be switched to losartan. Patients should have LV ejection fraction R40% and be clinically stable and on established treatment regimen for chronic HF. P Initially 12.5mg once daily. Titrate at weekly intervals to maintenance of 50mg once daily. Q Not recommended. D Severe hepatic impairment. Pregnancy. B History of angiooedema (closely monitor). Volume depletion may cause symptomatic hypotension. Monitor K+ and cc. Hepatic impairment, renal impairment, renal artery stenosis, primary aldosteronism (not recommended), aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. No sufficient therapeutic experience: HF with concomitant severe renal impairment, severe HF, HF and symptomatic life threatening cardiac arrhythmias. Lactation (not recommended). Tabs contain lactose. C Rifampicin, fluconazole, NSAID, K+ sparing diuretics, K+ suppl. or salts, lithium. A Dizziness, vertigo, hypotension, Servier asthenia/fatigue, hyperkalaemia, hypoglycaemia.

2MO

ACE inhibitor. Perindopril arginine 5mg. Lightgreen, rod-shaped scored film-ctd tab with a symbol. 5mg-30, A14.12. S Symptomatic heart failure. P Initially 2.5mg in the morning (under medical supervision). If tolerated, can increase to 5mg after 2 weeks. Severe HF: Initiate under careful supervision. Renal insufficiency, 2.5mg according to creatinine clearance. CORDARONE X sanofi-aventis Q Not recommended. 2MO D ACE inhibitor hypersensitivity. History of Class III antiarrhythmic. Amiodarone (HCl) 100mg, angioneurotic oedema (previous ACE treatment), 200mg. Round, white tab. with breakline one side, hereditary or idiopathic angioedema. Pregnancy, imprinted 100 or 200 on the other. 100mg-28, lactation. A6.03; 200mg-28, A9.87. B Symptomatic hypotension may occur in S Tachyarrhythmias associated with Wolff- patients with salt or volume depletion. Caution:

24

CIRCULATORY SYSTEM

COZATAN

Clonmel

2MO Angiotensin II antagonist. Losartan (K+), 50mg, 100mg. Resp. round or oblong biconvex white film-ctd tab. with breaking notch on both sides. Can be divided into equal quarters or halves. 50mg-28, A9.54; 100mg-28, A16.03. S Cronic HF (r60 years), when treatment with ACE inhibitors not suitable due to incompatibility or contraindication. Patients with HF stabilised with an ACE inhibitor should not be switched to losartan. Patients should have a LV ejection fraction R40% and be stabilised under treatment of chronic HF. Reduction in stroke risk in hypertensive patients with LV hypertrophy documented by ECG.

2

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c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM

CONGESTIVE

P HF: Initially, 12.5mg once daily. Titrate at weekly intervals to 50mg once daily maintenance dose, as tolerated by patient. Stroke risk reduction: Initially, 50mg once daily. Based on BP response, add low dose of HCTZ and/or increase Cozatan to 100mg once daily. Intravascular volume depletion: Consider 25mg once daily initially. Hepatic impairment: Consider a lower dose. R As per adults. q75 years, consider initiating therapy with 25mg. D Severe hepatic impairment. Pregnancy, lactation. B History of angioedema (closely monitor). Volume depletion may cause symptomatic hypotension (correct prior to initiating or use lower starting dose). Monitor K+ and cc. Caution: Hepatic impairment, renal impairment, renal artery stenosis, primary aldosteronism (not recommended), ischaemic cardiovascular and cerebrovascular disease, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Monitor renal function regularly. No sufficient therapeutic experience: HF with concomitant severe renal impairment, severe HF (NYHA class IV), HF and symptomatic life threatening cardiac arrhythmias. Contains lactose. C Not recommended: K+ sparing diuretics, K+ supplements or salts, ACE inhibitors. Caution: Other antihypertensives, TCAs, antipsychotics, baclofen, amifostine, fluconazole, rifampicin, lithium, NSAIDs.

DIOVAN

Novartis

2MO Angiotensin II antagonist. Valsartan 40mg, 80mg, 160mg. Yellow, pale red, grey-orange film-ctd scored tabs. marked DO, D/V, and DX/DX resp. on one side and NVR on reverse. 40mg-28, A15.70; 80mg-28, A17.80; 160mg-28, A23.02. S Clinically stable patients with symptomatic heart failure (HF) or asymptomatic left ventricular systolic dysfunction after recent (12 hrs-10 days) MI. Symptomatic HF when ACE inhibitors could not be used, or as add-on therapy to ACE inhibitors when b-blockers could not be used. P HF: Initially 40mg twice daily; uptitration to 80mg and 160mg twice daily (max. dose) at min. 2 week intervals to highest dose tolerated. Post-MI: After 12hrs, initially 20mg twice daily; uptitration to target max. dose of 160mg twice daily. Use with ACE inhibitors in post-MI not recommended. Mild to moderate hepatic impairment without cholestasis: Max. 80mg daily. Q Under 18 years, not recommended. D Pregnancy, lactation. Severe hepatic impairment, biliary cirrhosis and cholestasis, severe renal impairment (cc Q10ml/min.), patients undergoing dialysis. Primary aldosteronism. B Correct volume/salt depletion before starting therapy. HF, recent MI; reduction in BP. Renal artery stenosis, kidney transplantation, hepatic impairment, obstructive hypertrophic cardiomyopathy, aortic and mitral valve stenosis. C Caution: K+suppl., K+ sparing diuretics, antihypertensives, lithium. A Postural dizziness, orthostatic hypotension, renal failure/impairment.

DOPACARD

Cephalon

0JN Catecholamine. Dopexamine (HCl) 50mg/5ml. Amp. Concentrate for sln for infusion. 10 x 5ml,

HEART FAILURE, TACHYCARDIA, POST-MI

2.1

A377.93. S Short term IV admin. to patients who require peripheral or renal vasodilation and inotropic therapy in the treatment of heart failure or cardiac surgery. P Admin. by IV inf. diluted before use. See SPC. Q Not recommended. D Aortic stenosis, cardiomyopathy, phaeochromocytoma, thrombocytopenia. Pregnancy, lactation. MAOI treatment. B Cardiogenic shock, myocardial infarction, angina, hypokalaemia, hyperglycaemia. Use in specialised units with facilities for patient surveillance and monitoring. Benign arrhythmias. C Sympathomimetics, b -blockers, MAOIs. See SPC. A Tachycardia. Nausea, vomiting, tremor.

necessary. Inj. rate should not exceed 50mg per min. Q Not recommended. D Sinus bradycardia, sino-atrial block, 2nd/ 3rd degree A-V block, Adams-Stokes syndrome. B Severe cardiotoxic reactions and fatalities have been reported. 1st sign of acute toxicity, determine serum drug level. Caution, patients with: Hypotension, severe myocardial insufficiency, diabetes, porphyria, impaired liver function. Discontinue if skin rash appears (only resume if mild rash and it has cleared). Contains propylene glycol, Na+, ethanol. Pregnancy, lactation. C Certain anticonvulsants, antidepressants, anticoagulants, Ca++ channel blockers, antifungals. Amiodarone, chloramphenicol, chlordiazepoxide, diazepam, disulfiram, oestrogens, H2-antagonists, halothane, isoniazid, methylphenidate, ELANTAN UCB omeprazole, phenylbutazone, salicylates, folic acid, rifampicin, sucralfate, theophylline, vigabatrin, St 2M John’s wort, antineoplastics, certain antacids, Nitrate. Isosorbide mononitrate 10mg, 20mg, ciprofloxacin, alcohol, phenothiazines. See SPC. 40mg. White scored tabs. marked E20 or E40. A Toxicity (signs are associated with A A 10mg-56, 4.43; 10mg-84, 6.64; 20mg-56, cardiovascular and CNS depression), inj. site A5.64; 20mg-84, A8.00; 40mg-56, A9.20; 40mgreactions, rash, haemopoietic complications, GI 84, A13.77. disorders, hypersensitivity, polyarthropathy, S As adjunctive therapy in chronic congestive heart failure not responding to cardiac interstitial nephritis, pneumonitis. glycosides or diuretics. EUCARDIC Roche P 40-80mg daily in two or three divided 3MO doses after meals; max. 120mg daily. Q Not recommended. a/b-blocker. Carvedilol 3.125mg, 6.25mg, 12.5mg, A Headache, flushes, dizziness. 25mg. Resp. pink, yellow, light brown or pale beige round scored tab. marked BM on one side ENAP Rowex and K1, F1, H3 or D5 on other side. 3.125mg-28, A3.67; 6.25mg-28, 4.36; 12.5mg-28, A4.78; 25mg2MO 28, A5.72. ACE inhibitor. Enalapril maleate 5mg, 10mg, S Adjunctive therapy for the treatment of 20mg. White, red and orange tabs marked EN 5, EN 10 and EN 20 resp. All scored, oblong. 5mg-30, symptomatic CHF to reduce morbidity and increase A6.34; 10mg-30, A8.89; 20mg-30, A10.57. patient well-being. P Dosage should be titrated to individual S Heart failure (HF). HF prevention in requirements and monitored during up-titration. asymptomatic left ventricular dysfunction. Initially, 3.125mg twice daily with food for 2 P Initially 2.5mg once daily increasing weeks. If tolerated, titrate at min. 2 week intervals gradually over 2-4 weeks to maintenance 20mg to 6.25mg twice daily, then to 12.5mg twice daily, daily given in single or two divided doses. Max, then 25mg twice daily. Max. 25mg twice daily in 40mg daily in two divided doses. Q Not recommended. patients under 85kg, or 50mg twice daily in D Angioedema. Pregnancy, lactation. patients over 85kg. B Kidney transplantation (avoid), renal Q Under 18 years, not recomennded. artery stenosis, aortic or mitral valve stenosis, D See 2.4, b-blockers Drug Presc. Notes. diabetes, collagen vascular disease, surgery, renal NYHA class IV decompensated HF requiring IV impairment, jaundice (discontinue if occurs). inotropic support, liver dysfunction. Contains Reduce dose of diuretic, if possible prior to lactose. therapy, as vol. depletion may cause symptomatic HYPOVASE Pfizer hypotension. Contains lactose. C Other anti-hypertensive agents, 2MO K+suppl., K+sparing and other diuretics, lithium, Selective a-blocker. Prazosin (HCl) 500mcg, 1mg. TCAs, antipsychotics, anaesthetics, White tab. marked Pfizer and white tab. scored sympathomimetics, antidiabetics, antacids, NSAIDs, and marked M6, resp. B.D. Starter pack (8 x alcohol, immunosuppressants, allopurinol, 500mcg plus 32 x 1mg), A4.49; 500mcg-56, A3.17; procainamide. 1mg-56, A4.07. A Blurred vision, dizziness, hypotension, S Congestive cardiac failure. headache, depression, cough, dyspnoea, asthenia, P Initially 500mcg two, three or four times nausea, GI disorders, rash, angioneurotic oedema, daily, increasing to 4mg in divided doses; serum creatinine increase, hyperkalaemia. maintenance 4-20mg daily in divided doses. Q Not recommended. EPANUTIN Parke-Davis D Sensitivity other quinazolines. CCF due 2NO to aortic and mitral valve stenosis, pulmonary Class I antiarrhythmic. Phenytoin Na+ 50mg/ml. embolism and restrictive pericardial disease. A Soln for inj. or inf. Amp. 5ml x 10, 48.30. B HF due to recent MI; insufficient data. Pregnancy, lactation. Initial low dose and gradual S Cardiac arrhythmias where 1st line titration is recommended. therapy is not effective, particularly digitalisC Other antihypertensives. Caution: PDE-5 induced. inhibitors. P Initially 3.5-5mg/kg IV repeated once if

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

25


2.1 CONGESTIVE

HEART FAILURE, TACHYCARDIA, POST-MI

change in dosage. Monitor periodically thereafter especially in patients at risk for hyperkalaemia (eg. elderly, renal insufficiency, diabetes). Impaired INDERAL AstraZeneca renal and hepatic function. Pregnancy. Contains lactose. 3MO C K+-sparing diuretics, K+-suppl., strong Non-cardioselective b-blocker. Propranolol (HCl) 10mg. Pink film-ctd tab. marked Inderal 10. 10mg- inhibitors of CYP3A4 eg. itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, 100, A1.20. telithromycin and nefazodone (all S Prevention of myocardial reinfarction. contraindicated). Strong CYP3A4 inducers, lithium, Cardiac dysrhythmias. cyclosporin and tacrolimus (avoid). Caution: Other P Reinfarction: 40mg four times daily for CYP3A4 inhibitors, NSAIDs, trimethoprim, ACE two or three days starting 5 to 21 days after infarction, then 80mg twice daily. Arrhythmias: 10- inhibitors or aII antagonists, a-1 blockers, TCAs, neuroleptics, amifostine, baclofene, 40mg three or four times daily. Q Arrhythmias, 0.25-0.5mg/kg body weight glucocorticoids, tetracosactide, digoxin, warfarin. A Hyperkalaemia, dizziness, hypotension, three or four times daily. diarrhoea, nausea, abnormal renal function. D See 2.4, b-blockers Drug Presc. Notes. Contains lactose. A Dizziness, blurred vision, dry mouth, nausea, impotence.

CIRCULATORY SYSTEM ALSO LANOXIN-PG ELIXIR Digoxin 50mcg/ml. 60ml, A5.36.

2NO

ALSO LANOXIN INJECTION Digoxin 0.25mg/ml. 2ml amp. 5, A3.72. S Digitalis therapy, particularly congestive heart failure. P Maintenance, 0.25-0.5mg daily. Elderly, 0.125-0.25mg daily; maintenance, 0.125-0.25mg daily. Q Maintenance, 10-20mcg/kg daily in single or divided doses. D Ventricular tachycardia. Hypertrophic obstructive cardiomyopathy. Elective electroconversion. Hypercalcaemia. B Acute myocardial infarction. AV block. Cation imbalance, severe pulmonary disease, elderly patients, renal insufficiency, thyroid ISOKET 0.1% UCB dysfunction. C Ca++ inj. or suppl., other cardiac 2 N INNOVACE MSD glycosides, K+depleting agents, quinidine, lithium, Nitrate. Isosorbide dinitrate 1mg/ml. Amps.-10 x 2MO antacids, antibiotics. 10ml, A59.11; Bottles-50ml, A29.33; 100ml, ACE inhibitor. Enalapril maleate 2.5mg, 5mg, A GI, visual and conduction disturbances. A40.50. 10mg, 20mg. 2.5mg: White, round, biconvex tabs. 2N marked MSD 14; 5/10/20mg: White, rust-red and LESTACE Actavis ALSO ISOKET 0.05% Isosorbide dinitrate 0.5mg/ peach rounded triangle-shaped tabs. scored on 2MO one side and marked MSD 712, MSD 713 and MSD ml. 50ml, A15.69. ACE inhibitor Lisinopril 2.5mg, 5mg, 10mg, 20mg. 714 resp. on the other. 2.5mg-28, A6.49; 5mg-28, S Unresponsive left ventricular failure secondary to acute myocardial infarction, Round tabs, can be divided in equal halves. 2.5mg: A3.56; 10mg-28, A4.99; 20mg-28, A 5.93. White, biconvex. 5mg: White, flat, scored both S Treatment of symptomatic heart failure. unresponsive LVF of various aetiology. P 2-10mg/hour adjusting according to sides. 10mg: Light pink, biconvex, scored one side. Prevention of symptomatic heart failure in response. Max. 20mg/hour. 20mg: Pink, biconvex, scored one side. 2.5mg-28, patients with asymptomatic left ventricular A5.06; 5mg-28, A7.18; 10mg-28, A8.84; 20mg-28, Q Not recommended. dysfunction. A10.16. D Uncompensated cardiac shock. Severe P Initially 2.5mg in conjunction with hypotension. Marked anaemia. Cerebral S Symptomatic HF. Short-term (6 weeks) diuretics and, where appropriate, digitalis or bhaemorrhage. treatment of haemodynamically stable patients blockers; titrate over 2-4 weeks to usual within 24 hours of acute MI. maintenance dose of 20mg in single or twice daily A Headache, flushes, dizziness. P HF: Initially 2.5mg once a day under dose. Max. 40mg daily in two divided doses. ISOPTIN Abbott medical supervision. Increase to highest tolerated Q Not recommended. dose, up to max 35mg once a day by increments 2MO D Angioedema. Pregnancy, lactation. of 10mg max and at intervals of 2 weeks B Reduce dose of diuretic, if possible, Class I Ca++ antagonist. Verapamil 40mg, 80mg, minimum. Acute MI: Do not start if systolic arterial before initiating therapy. Volume depletion may 120mg. White film-ctd tabs. 40mg-100, A2.12; pressure Q100mmHg. Initially (first 3 days postcause symptomatic hypotension. LV valvular and 80mg-100, A4.24; 120mg-100, A6.36. MI), 5mg orally, followed by 5mg after 24 hours, outflow tract obstruction, renal impairment, renal S Supraventricular tachycardia, atrial 10mg after 48 hours and 10mg/day thereafter. artery stenosis, surgery. Angioneurotic oedema fibrillation and atrial flutter. (discontinue promptly). Contains lactose. P 40-80mg three times daily or 120-240mg Patients with low systolic arterial pressure (R120mmHg) at start of treatment or within first C Other anti-hypertensive agents, lithium, twice daily. Higher dosage, see SPC. 3 days of infarct: 2.5mg orally. Maintenance, 10mg K+suppl., diuretics, antidiabetics, TCAs, NSAIDs, Q Not recommended. once daily. Reassess after 6 weeks. If hypotension sympathomimetics, alcohol, gold. 2NO occurs: 5mg with temporary decrease to 2.5mg if A Cough, nausea, blurred vision, dizziness, ALSO ISOPTIN INJECTION Verapamil 5mg/2ml necessary; withdraw if hypotension prolongs. hypotension, syncope, angina pectoris, amp. 5, A6.44. tachycardia, headache, depression, dyspnoea, GI S Acute angina pectoris. Tachyarrhythmias Renal impairment, ccQ10ml/min, initially 2.5mg; 10QccQ30ml/min, initially 2.5-5mg; 31QccQ80ml/ disorders, taste alteration, rash, hypersensitivity/ and hypertensive crisis. angioneurotic oedema, asthenia, fatigue. P 1 amp. slow i.v. if necessary a second or min, initially 5-10mg/day. Q Not recommended. third at 5-10 mins. interval. INSPRA Pfizer Q Neonates, 0.75-1mg. Infants, 0.75mg. 1- D History of angioedema associated with previous ACE inhibitor therapy. Hereditary or 5 years, 2-3mg; 6-14 years, 2.5-5mg. 5MO idiopathic angioedema. Pregnancy, lactation. Aldosterone antagonist. Eplerenone 25mg, 50mg. D Cardiogenic shock. 2nd or 3rd degree B Caution: Acute MI (do not use: Renal AV block. Severe bradycardia. Uncompensated Yellow film-ctd tab. marked Pfizer on one side, dysfunction, systolic BP R100mmHg, cardiogenic cardiac failure. Sick sinus syndrome. and NSR over strengh on reverse. 25mg-28, shock), mitral stenosis and left ventricle outflow B 1st degree AV block. Poor cardiac A56.00; 50mg-28, A56.00. obstruction (aortal stenosis, hypertrophic reserve should be controlled with digitalis and S In addition to standard therapy incl. bmyocardiopathy), bilateral renal artery stenosis or diuretics. Hepatic impairment. Acute phase of blockers, in stable patients with left ventricular stenosis of the artery in a single kidney (strict myocardial infarction. Bradycardia. dysfunction (LVEFR40%) and heart failure after supervision with low doses; careful dose C b-blockers, quinidine or digoxin. recent MI. adjustment), pre-existing renal impairment A Constipation, headache, flushes. P Maintenance dose, 50mg once daily. (monitor blood K+, creatinine), major surgery, Initially, 25mg once daily, titrated to 50mg once LANOXIN GSK anaesthesia, renal insufficiency, diabetes. May daily preferably within 4 weeks, taking into occur: Systemic hypotension, angioedema 2MO account K+ level (see SPC). Start within 3-14 days (withdraw immediately if occurs), anaphylactoid Cardiac glycoside. Digoxin 0.25mg. White scored after MI. reactions in haemodialysis patients or during A8.37. tab. marked WELLCOME X3A. 500, Q Not recommended. desensitisation treatment, acute renal insufficiency + 2 M O D Serum K q5mmol/L at initiation. in patients with HF (usually reversible), hepatic ALSO LANOXIN-PG Digoxin 62.5mcg. Blue tab. Moderate to severe renal insufficiency, severe insufficiency, neutropenia/agranulocytosis, cough. marked WELLCOME U3A. 500, A7.85. hepatic insufficiency. Lactation. C Not recommended: Lithium. Caution: + Diuretics, K+-sparing diuretics, K+ containing B Monitor serum K at initiation and with 2 M O

26

2

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Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM

CONGESTIVE

HEART FAILURE, TACHYCARDIA, POST-MI

2.1

sympathomimetics, lithium, antacids, NSAIDs, alcohol, anaesthetics, narcotics, hypnotics, oral hypoglycaemic agents, diuretics, NaCl. A Hypotension, dry cough, sore throat, bronchitis, dizziness, feeling weak, impaired vision, nausea, stomach pain, indigestion, rash, headache, tiredness, palpitations, renal failure.

losartan. Patients should have left ventricular ejection fraction R40% and be stabilised under treatment of chronic HF. P Initially 12.5mg once daily. Increase at weekly intervals to maintenance of 50mg once daily. Usually combine with a diuretic, digitalis and/or a b-blocker. Patients with intravascular volume depletion: 25mg once daily initially. LOAVEL sanofi-aventis Hepatic impairment: Consider lower dose. LEVOPHED Hospira 2 M O R Over 75 years, consider initiating therapy with 25mg. 0JN ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, Q Not recommended. 10mg. White, yellow, red and white oblong tabs. Sympathomimetic amine. Noradrenaline (as acid D Pregnancy, lactation. Severe hepatic with score line on both sides. 1.25mg-28, A2.57; tartrate) 1mg/ml. Amp. 6 x 2ml, A6.93. 2.5mg-28, A3.65; 5mg-28, A5.08; 10mg-28, A6.88. impairment. B History of angioedema (closely monitor). LISOPRESS Niche S Congestive heart failure; as adjunctive Volume depletion may cause symptomatic to diuretics with or without cardiac glycosides. 2MO hypotension. Monitor K+ and cc. Hepatic Post MI in patients with heart failure. Prevention ACE inhibitor. Lisinopril 2.5mg white scored tab. impairment, renal impairment, renal artery of MI, stroke or cardiovascular death in patients marked 2.5; 5mg white scored tab. marked 5; stenosis, primary aldosteronism (not with an increased cardiovascular risk who are 10mg white square tab. scored and marked 10; recommended), ischaemic cardiovascular and already taking standard therapy and in type 2 20mg white pentagonal tab. scored and marked diabetic patients with an increased cardiovascular cerebrovascular disease, aortic or mitral valve 20. 2.5mg-28, A4.63; 5mg-28, A7.11; 10mg-28, stenosis, obstructive hypertrophic cardiomyopathy. risk. A8.77; 20mg-28, A9.59. No sufficient therapeutic experience: HF with P CHF: Initially 1.25mg once daily, then S Adjunct to diuretics and where double dose at intervals of 1-2 weeks according to concomitant severe renal impairment, severe HF, appropriate digitalis in congestive heart failure. response; max. 10mg daily. Reduce dosage of any HF and symptomatic life threatening cardiac Acute MI in haemodynamically stable patients. diuretics first. Initiate therapy under close medical arrhythmias. Contains lactose. P CHF, initially 2.5mg once daily in the C Caution: Other antihypertensives, supervision. Post MI: Initiate in hospital between morning increasing gradually over 2-4 weeks to fluconazole, rifampicin, NSAIDs, lithium (monitor maintenance 5-20mg once daily. If possible reduce days 3-10 post-MI. Initially 2.5mg twice daily. After levels). Not recommended: Heparin, K+ sparing 2 days, increase to 5mg twice daily. If starting dose of any diuretic first. Initial therapy under diuretics, K+ supplements or salts. dose not tolerated, reduce to 1.25mg twice daily close medical supervision (in hospital for severe for 2 days. Then increase to 2.5mg twice daily. If unstable HF or high risk patients). Acute MI, LOTANOS Rowex necessary, increase to 5mg twice daily 2 days later. initially 5mg followed by 5mg after 24 hrs, 10mg 2MO Withdraw if dose cannot be increased to 2.5mg after 48 hrs and then 10mg once daily. Angiotensin II antagonist. Losartan K+ 50mg, twice daily. Usual maintenance dose 2.5- 5mg Q Not recommended. 100mg. White oblong tab. Resp. with 1 or 3 twice daily. Prevention of MI, stroke or D Pregnancy, lactation. Renal artery notches on each side and embossed with 3 or 5 on cardiovascular death: Initially 2.5mg once daily, stenosis, severe renal impairment, one side. 50mg-28, A11.73; 100mg-28, A19.71. the dose is gradually increased. Double the dose haemodynamically relevant aortic or mitral valve S Heart failure (HF), when treatment with after 1 week and after another 3 weeks increase stenosis, haemodynamically unstable patients after ACE inhibitors is no longer appropriate; patients to 10mg. Usual maintenance dose is 10mg. acute MI. with HF stable with an ACE inhibitor should not R Consider initial dose of 1.25mg daily. B Haemodialysis. Hypotension, unstable be switched to Lotanos. Titrate according to need for BP control. cardiac failure, renal impairment, renovascular P Initially 12.5mg once daily. Q Not recommended. hypertension, primary hyperaldosteronism, proteinuria, angioneurotic oedema, aortic stenosis, D History of angiooedema. Aortic stenosis Recommended titration: 7 days at 12.5mg daily, followed by 25mg daily for a further 7 days and or outflow obstruction. Renal artery stenosis, surgery/anaesthesia. C K+ sparing diuretics, K+ suppl., diuretics, hypotensive or haemodynamically unstable states. then increase to 50mg daily. D Pregnancy, lactation. Pregnancy, lactation. Na+, Cl, antihypertensive agents, analgesics, antiB Volume depletion may cause inflammatory agents, lithium, alcohol, B CHF, hepatic impairment, blood symptomatic hypotension. Caution: Hepatic anaesthetics, hypnotics, narcotics, dyscrasias. Renal impairment: Reduce dose and impairment (dose adjustment), renal impairment sympathomimetics, antacids. assess renal function prior to and during A Hypotension, dizziness, weakness, treatment. Caution: Patients with hyper stimulated (hyperkalaemia risk). May occur: Angioedema, changes in renal function. No data on use in impaired vision, syncope, tachycardia, palpitations, angiotension system. Electrolyte monitoring haemodynamically significant obstructive valvular arrhythmias, chest pain, angina. recommended. Haemodialysis (avoid in patients disease. Contains lactose. dialysed with high flux membranes). Malignant C Caution: Rifampicin, fluconazole, K+ LISPRIL Rowex hypertension: Initiate in hospital under close sparing diuretics, K+ supplements or salt supervision. Symotomatic hypotension, 2MO substitutes containing K+, indomethacin. agranulocytosis/bone marrow depression, ACE inhibitor. Lisinopril (dihydrate) 5mg, 10mg, hyperkalaemia have been reported rarely. Caution: A Dizziness, hypotension. 20mg. Slightly red scored tabs. 5mg-30, A8.13; Surgery and during anaesthesia. 10mg-30, A10.03; 20mg-30, A11.51. METOCOR Rowex C Antihypertensive agents, K+sparing S Congestive heart failure as adjunctive diuretics, K+suppl., lithium, sympathomimetics, 3MO therapy to non-potassium sparing diuretics. Acute antidiabetic agents, NSAIDs. Cardioselective b-blocker. Metoprolol tartrate MI. A Nausea, dizziness, headache, dry tickling 50mg, 100mg. White tabs. scored one side. 50mgP HF: Initially 2.5mg in the morning, cough. 100, A3.50; 100mg-100, A6.50. maintenance 5-20mg once daily. MI: Initially 5mg S Prevention of cardiac mortality then 5mg 24 hours later, maintenance 10mg. LOSARTAN TEVA Teva following myocardial infarction. Cardiac R Initially 2.5mg increasing to 5-10mg arrthythmias, especially supraventricular 2MO once daily. tachyarrhythmias. Angiotensin II antagonist. Losartan (K+) 50mg, Q Not recommended. P Reinfarction, initial therapy: See SPC. 100mg. White, oval, slightly arched film-ctd tabs, D History of angioneurotic oedema Maintenance: 200mg daily. Arrythmias: 50mg two debossed with strength on one side, scoreline on related to previous ACE-inhibitor treatment. or three times daily; max. 300mg daily. A A the other. 50mg-28, 12.45; 100mg-28, 20.94. Pregnancy, lactation. st Q Not recommended. S Chronic HF, when treatment with ACE B Renal impairment, hypotension (1 D See 2.4, b-blockers Drug Presc. Notes. dose), aortic stenosis, acute MI, multiple or high inhibitors not suitable due to incompatibility or dose diuretic therapy. contraindication. Patients with HF stabilised with METOP Gerard + C K suppl., antihypertensive agents, an ACE inhibitor should not be switched to supplements and salts, NSAIDs (incl. acetylsalicylic acid r 3g/day), other antihypertensives, injectable gold, certain anaesthetic drugs, TCAs, antipsychotic agents, sympathicomimetics, antidiabetics. A Dizziness, headache, cough, diarrhoea, vomiting, renal dysfunction, orthostatic effects (incl. hypotension).

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

27


2.1 CONGESTIVE

HEART FAILURE, TACHYCARDIA, POST-MI

3MO Cardioselective b-blocker. Metoprolol tartrate 50mg, 100mg. White tabs. Both marked ml and strength one side, G on reverse. 50mg-100, A3.50; 100mg-100, A6.51. S Prevention of cardiac mortality following myocardial infarction. Supraventricular arrhythmias. P Reinfarction, initial therapy: See SPC.: Maintenance: 200mg daily. Arrhythmias: 50mg two or three times daily; max. 300mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

NEBILET

A. Menarini

3MO Vasodilating cardioselective b-blocker. Nebivolol (as HCl) 5mg. White cross scored tab. 28, A12.94. S Stable mild and moderate chronic heart failure (CHF) in addition to standard therapies in elderly patients r70 years. P Patients receiving cardiovascular drug therapy should be stabilised during the 2 weeks prior to treatment. Initially, 1.25mg once daily. Titrated up through 2.5mg, 5mg and 10mg at 1-2 weekly intervals. Initiate and increase dose under close medical supervision. If necessary discontinue gradually (dose divided into halves weekly). Max. 10mg once daily. Q Children and adolescents, not recommended. D See 2.4, b-blockers Drug Presc. Notes. Liver insufficiency or liver function impairment.

NITROCINE

UCB

2N Nitrate. Glyceryl trinitrate 1mg/ml. Soln. in amps. and bottles. Amps.-10 x 10ml, A128.94; Bottles-1 x 50ml, A30.22. S Rapid control of hypertension and myocardial ischaemia during cardiac surgery. Reduction of BP and controls for hypotension during surgical procedures. Treatment of unresponsive CHF secondary to acute MI. Indicated for unstable angina. P Surgery: Starting dose 25mcg/min increased by increments of 25mcg/min at 5 min intervals until BP stabilised. 10 -200mcg/min sufficient; max. 400mcg/min. Perioperative myocardial ischaemia: 15 – 20mcg/min with increments of 10 -15mcg/min until stabilised. Unresponsive CHF: 20 -25mcg/min increased in steps of 20 -25mcg/min every 15 – 30mins until stabilised. Lowest dose: 10mcg/min. Unstable angina: Initial dose 10mcg/min with increments of 10mcg/min every 30 mins. D Anaemia, severe cerebral haemorrhage, head trauma, uncorrected hypovolaemia, severe hypotension. Pregnancy, lactation. B Monitor pulse and BP. Hypothyroidism, severe liver/renal disease, hypothermia, malnutrition. C b blockers, Ca++ antagonists, alcohol. PDE-5 inhibitors e.g. Sildenafil. Do not admin. within 48 hours after taking PDE-5 inhibitors. Neuroleptics, TCAs. A Headaches, nausea, hypotension, tachycardia, retching, sweating, apprehension, restlessness, muscle twitching, retrosternal discomfort, palpitations, dizziness, abdominal pain.

NORTENOLOL

Tillomed

3MO Cardioselective b-blocker. Atenolol 25mg,

28

CIRCULATORY SYSTEM

50mg,100mg. White, white, orange unscored filmctd tabs. marked A25, A50, A100 resp. 25mg-30, A2.70; 50mg-30, A4.10; 100mg-30, A5.98. S Cardiac dysrhythmias. Early intervention in acute MI. P 50-100mg daily. MI: 5-10mg atenolol IV followed by 50mg tab 15min later and another 50mg tab 12 hours after IV inj. Then 12 hours later, 100mg once daily. Renal impairment: See SPC. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

Based on cc (see SPC). R CAD: Initially 2mg once daily in 1st week, then 4mg once daily the next week, then up to 8mg once daily depending on renal function. Q Not recommended. D Angioedema, history of ACEI related angioedema. Pregnancy, lactation. B Symptomatic hypotension may occur. Correct salt depletion / hypovolaemia, if possible, prior to therapy. Monitor renal function and serum K+ before and during treatment. Caution: Severe HF impaired renal function, tendency for PENDREX Rowex electrolyte disturbance, mitral valve stenosis, obstruction in the outflow of the left ventricle, 2MO collagen vascular disease, anaesthesia (discontinue ACE inhibitor. Perindopril tert-butylamine 2mg one day prior to surgery), patients at risk of (1.67mg perindopril), 4mg (3.34mg perindopril). White, round, biconvex tablet debossed with 2 or hyperkalemia. May occur: Unstable angina pectoris (re-evaluate), jaundice, angioedema (promptly 4 on one side. 2mg-30, A8.53; 4mg-30, A12.07. discontinue), anaphylactoid reactions (interrupt S Symptomatic heart failure. during LDL aphaeresis or desensitisation). Contains P Use in combination with a non K+sparing diuretic and/or digoxin and/or a b-blocker. lactose. C Not recommended: Lithium, K+-sparing Initially 2mg, may be increased to 4mg by diuretics, K+ suppl, diuretics. Caution: increments of 2mg at intervals of no less than 2 Immunosuppressant, allopurinol or procainamide, weeks. Severe HF or high risk patients: Initiate oral antidiabetics, NSAIDs, vasodilators, certain under careful supervision. Renal impairment: See anaesthetics, TCAs, antipsychotics, SPC. sympathomimetics. Q Not recommended. A Headache, dizziness, vertigo, D History of angioedema associated with paresthaesia, vision disturbance, tinnitus, previous ACE inhibitor therapy. Hereditary or hypotension, cough, dyspnoea, GI disorders, rash, idiopathic angioedema. Pregnancy, lactation. B If unstable angina pectoris occurs in 1st pruritus, muscle cramps, asthenia. month, reappraise benefit/risk before continuing PERFAN Myogen treatment. Volume depletion, symptomatic HF 2N may cause symptomatic hypotension. Caution: Selective inhibitor of PDE-III. Enoximone 5mg/ml. Mitral valve stenosis, aortic stenosis, hypertrophic Amp. 10 x 20ml, A179.90. cardiomyopathy, collagen vascular disease, S Congestive heart failure. immunosuppressant therapy, treatment with P Dilute before admin. Loading: Initially allopurinol or procainamide, diabetes. Renal 0.5mg/kg at a rate not greater than 12.5mg/min. impairment: Adjust dosage according to cc and May be repeated after 30 mins. Maintenance: Inf. response to treatment. Anaphylactoid reactions 2.5-5mcg/kg/min. See SPC. may occur during dialysis with high flux Q Not recommended. membrane or low-density lipoproteins apheresis with dextran sulphate. Discontinue if angioedema D Lactation. occurs. May occur: Hepatic syndrome, neutropenia/ B Monitor platelet counts, BP, heart rate, ECG, hepatic and renal function. Congestive agranulocytosis, thrombocytopenia, anaemia, cardiac failure associated with blood platelet persistent non-productive cough, elevation in counts below 100,000/ml. Pregnancy. serum K+. Discontinue 1 day prior to surgery. + + C Avoid: Diuretics, K sparing diuretics, K - A Hypotension, chest pain, abnormal heart beat, breathlessness, headache, insomnia, + containing salt substitutes, K supplements, nausea, vomiting, diarrhoea, chills, fever. lithium. Caution: NSAIDs, other antihypertensives and vasodilators, antidiabetics, TCAs, PHYLLOCONTIN CONTINUS antipsychotics, anaesthetics, sympathomimetics, Mundipharma antacids. 2MO A Headache, dizziness, vertigo, paresthaesia, vision disturbance, tinnitus, Xanthine. Aminophylline 225mg. Pale yellow filmhypotension and related effects, cough, dyspnoea, ctd sust.-release tab. marked SA one side, Napp GI disturbances, rash, pruritus, asthenia. logo on reverse. 56, A3.91. S Cardiac asthma and left ventricular or PERCARNIL Actavis congestive cardiac failure. P Initially 1 tab. 12-hourly for one week, 2MO then maintenance 2 twice daily. ACE inhibitor. Perindopril (tert-butylamine salt) 4mg, 8mg. White tabs, PP marked on one side and Q Not recommended. strength on reverse. 4mg oblong with a break-line D Hypersensitivity to xanthine group of drugs. Pregnancy (only if essential), lactation. on both sides; 8mg circular. 4mg-30, A9.92; 8mgB Cardiac or liver disease, viral infection, 30, A16.29. S Symptomatic heart failure. Reduction of elderly; reduce dose. History of seizure (not risk of cardiac events in patients with a history of advised), insomnia. C Cimetidine, erythromycin, b-adrenergic MI or revascularisation. P HF: Initially 2mg in the morning; may be agonists, glucagon, ephedrine. increased by increments of 2mg at intervals of no A Nausea, gastric irritation, headache, CNS stimulation. less than 2 weeks to 4mg once daily if tolerated. CAD: Initially 4mg once daily; after two weeks PRINDACE Clonmel increase to 8mg once daily. Renal impairment:

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Prohibited in competition

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Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM

CONGESTIVE

HEART FAILURE, TACHYCARDIA, POST-MI

2.1

White marked R4. 2.5mg-28, A5.80; 5mg-28, A8.10; 10mg-28, A11.04. S High-risk patients with CVD or type 2 diabetes with at least one additional risk factor. Mild to moderate heart failure after acute stage of MI. P CVD/diabetes: Initially, 1.25-2.5mg once daily; may be increased by doubling with min. 3 week interval. Maintenance, 5mg daily; max, 10mg daily. HF after MI: Start at least 3 days after MI. Initially, 1.25-2.5mg twice a day with strict monitoring of BP and renal function; increase after min. 2 days to 2.5-5mg twice a day. Target dose, 5mg twice a day. Hypertension with HF: Initially 1.25mg once daily. On diuretics: Discontinue diuretic 2-3 days before therapy (or earlier if long-acting). If diuretic cannot be discontinued, initial dose 1.25mg. Renal impairment: cc Q50ml/min, initially 1.25mg once daily; max. 5mg once daily; cc Q20ml/min, initially 1.25mg every second day; max. 2.5mg once daily. Q Not recommended. RAMILO Rowex D Hypersensitivity to any ACE inhibitors. Angioneurotic oedema. Renal artery stenosis, 2MO kidney transplantation. Renal dysfunction or ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, hypotension in patients with acute MI. Primary 10mg. White, oblong, biplane with facet tabs. hyperaldosteronism. Pregnancy, lactation. marked R 1.25, R 2.5, R 5, and R 10 on one side. Both sides with breaking notch. 1.25mg-30, A4.39; B Mitral valve stenosis or outflow obstruction (caution). Jaundice (discontinue). 2.5mg-30, A6.21; 5mg-30, A8.65; 10mg-30, Haemodialysis using high-flux membranes (risk of A11.78. anaphylactoid reactions). Fluid/salt abnormalities, PRONESTYL BMS S Symptomatic heart failure, cardiac severe hypertension, elderly. If potential for 2MO failure following myocardial infarction (MI). symptomatic hypotension; monitor closely. Class I antiarrhythmic. Procainamide (HCl) 250mg. P CHF: Initially 1.25mg once daily Surgery/anaesthesia. Bone marrow depression, White scored tab. marked SQUIBB 754. 100, swallowed whole with plenty of fluid. May be hyperkalaemia, angioneurotic oedema have been A6.42. increased at intervals of 1-2 weeks to 1.25mg reported. Contains lactose. Driving/using machines. S Cardiac arrhythmias. twice daily, then 2.5mg twice daily. Target, 10mg C Caution: K+ sparing diuretics, K+ P 50mg per kg daily in divided doses daily. Uncomplicated cases, initially 1.25mg once supplements, diuretics, nitrates, other vasodilators, three to six hourly. daily, increased to 1.25mg twice daily on day 2-7, heparin, alcohol, allopurinol, procainamide, Q Not recommended. then to 2.5mg twice daily on week 2, and 5mg cytostatics or immunosuppressants, trimethoprim, 2NO twice daily on week 3. Maintenance, single or two antidiabetics, sympathomimetics, NSAIDs. Avoid divided doses. Post- MI: Initiate on day 3-10 after ALSO PRONESTYL INJECTION Procainamide (HCl) lithium. A MI in stable patient with 1.25-2.5mg twice daily; 100mg/ml. 10ml multidose vial. 1, 2.21. A Dizziness and headache, orthostatic P See SPC. increase after no less than 2 days to 2.5-5mg twice effects, diarrhoea, vomiting, cough, renal Q Not recommended. daily. Target, 5mg twice daily; later may be taken impairment. D AV block. SLE. as single daily dose. Max. 10mg daily. Concomitant B Elderly. Renal, hepatic or cardiac failure. diuretic treatment/ nephropathy: Initially 1.25mg RAMYTE Actavis Myasthenia gravis. Perform regular serological once daily. Renal impairment: See SPC. Impaired 2MO tests. Pregnancy. Contains: Na+ metabisulphite, hepatic function: Max. 2.5mg daily. ACE inhibitor Ramipril 2.5mg, 5mg, 10mg. Size 4 benzyl alcohol, Na+ (less than 1mmol/dose). Q Not recommended. hard cap. containing white powder, with light A GI disturbance, SLE, leucopenia, D Angioedema, history of angioedema grey body and resp. light green, green or dark agranulocytosis. with previous ACE inhibitor therapy. Pregnancy, green cap, marked R on cap and strength on lactation. body. 2.5mg-28, A5.76; 5mg-28, A8.02; 10mg-28, RAMIC Pinewood B If possible, discontinue diuretic A10.92. treatment 2-3 days before therapy initiation. 2MO S Reduces mortality in patients surviving Volume depletion may cause symptomatic ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Hard acute MI with clinical evidence of HF. caps. with light grey body and light green, green, hypotension. Caution: LV valvular and outflow P Initiate in hospital between day 3 and and dark green cap marked R on cap and strength tract obstruction, renal impairment, renal artery day 10 following AMI. Initially, 2.5mg twice daily on body. 2.5mg-28, A6.07; 5mg-28, A8.46; 10mg- stenosis, haemodialysis patients, surgery. for 2 days. Then increase to 5mg twice a day. Discontinue if jaundice occurs. Driving/ operating 28, A11.54. Withdraw treatment if dose cannot be increased machines. S Congestive heart failure (CHF), as to 2.5mg twice daily. Maintenance: 2.5mg-5mg C Lithium (not recommended). Caution: adjunctive therapy to diuretics with or without twice daily. Renal/hepatic impairment, see SPC. + suppl. or Other anti-hypertensive agents, K cardiac glycosides. Reduce mortality in patients R Caution. K+sparing diuretics, diuretics, TCAs, anaesthetics, surviving acute MI. D History of angioneurotic oedema antipsychotics, antidiabetics, NSAIDs, P CHF: Patients stabilised on diuretic relating to previous ACE inhibitor treatment. sympathomimetics. therapy, initially 1.25mg once daily; may be Pregnancy, lactation. Use in children. A Dizziness, headache, cough, orthostatic doubled at intervals of 1-2 weeks. Max. 10mg B Aortic stenosis or outlaw obstruction effects (incl. hypotension), diarrhoea, vomiting, (not recommended). Renal impairment risk daily. Patients previously on high dose diuretic (dosage reduction and/or discontinue); assess renal should have diuretic dose before starting. Post MI: renal dysfunction. function prior to and during treatment. Caution: Start treatment in hospital between day 3 and 10 RAMITACE Clonmel Impaired liver function, volume- and salt-depletion post acute MI. Initially, 2.5mg twice a day, 2 M O (symptomatic hypotension risk), anaesthesia, increased to 5mg twice a day after 2 days. If surgery. May occur rarely: Agranulocytosis and 2.5mg not tolerated, start with 1.25mg twice a ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Cap.bone marrow depression, reduction in red cell day for 2 days before increasing to 2.5mg and shaped, flat tabs. scored on one side. 2.5mg: count, haemoglobin content and platelet count, 5mg twice a day; withdraw if cannot be increased Yellow marked R2. 5mg: Pink marked R3. 10mg:

2MO

ACE inhibitor. Perindopril tert-butylamine 4mg. 30, A7.24. S Symptomatic heart failure. P Initially 2mg daily; may be increased after 2 weeks to 4mg once daily if tolerated. Renal impairment, see SPC. Q Under 18 years, not recommended. D Angioedema. Pregnancy, lactation. B Increased risk of symptomatic hypotension eg. salt depletion, hypovolaemia, diuretics; correct, if possible, prior to therapy. Monitor BP, renal function, serum K+ closely, before and during treatment. Hyperkalemia, increases in blood urea and plasma creatinine. Caution: Mitral valve stenosis, obstruction in the outflow of left ventricle, diabetes. LDL apheresis. Jaundice, angioedema (facial/ intestinal) reported rarely; discontinue promptly. Discontinue one day prior to surgery. Contains lactose. C Lithium, K+ supplements (not recommended), diuretics. Caution: NSAIDs, antihypertensives, vasodilators, antidiabetics, anaesthetics, TCAs, antipsychotics, sympathomimetics, injectable gold. A Hypotension, headache, dizziness, vertigo, paraesthesia, vision disturbance, tinnitus, cough, dyspnoea, GI disorders, dysgeusia, dyspepsia, rash, pruritus, muscle cramps, asthenia.

to 2.5mg twice a day. Maintenance: 2.5-5mg twice a day. Q Not recommended (contra). D History of angioneurotic oedema relating to previous ACE inhibitor treatment. Pregnancy, lactation. B Aortic stenosis, outflow obstruction (not recommended). Hypotension, agranulocytosis, bone marrow depression, hyperkalaemia, angioneurotic oedema may occur. Assess renal function prior to and during treatment. Impaired liver function (reduce dose), collagen vascular disease; monitor. Correct volume/salt depletion before initiating therapy. Surgery/ anaesthesia. Haemodialysis using high-flux membranes (avoid). Driving/ operating machines. C Caution: Antidiabetics, NSAIDs. A Nausea, dizziness, headache, GI disturbances, dry tickling cough, skin/mucosal reactions, sinusitis, bronchitis, conjunctivitis, hair loss.

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

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2.1 CONGESTIVE

HEART FAILURE, TACHYCARDIA, POST-MI

to cardiac arrhythmia. Cardiogenic shock. Cardiomyopathy or severe uncompensated HF. Children. Renal/hepatic impairment. Pregnancy, lactation. B 1st degree AV block. Cardiac failure should be controlled with glycosides.Caution: Hypokalaemia (check K+ levels regularly), renal/ hepatic insufficiency, narrow-angle glaucoma, Prostatic hypertrophy (risk of urinary retention). May occur: Hypotension (discontinue immediately), arrhythmias, hypoglycaemia (discontinue), aggravation of myasthenia gravis. C Contra: Other antiarrhythmics or other drugs liable to provoke ventricular arrhythmias (esp. torsades de pointes). Not recommended: PDE5 inhibitors, CYP3A inhibitors and inducers. Caution: Drugs associated with Torsades de Pointe risk (tricyclic and tetracyclic antidepressants, erythromycin (IV), astemizole, cisapride, pentamidine, pimoxide, sparfloxacin, terfenadine)., hypokalaemia inducing drugs (diuretics, amphotericin B, tetracosactide, gluco and REVATIO Pfizer mineralo- corticoids, stimulant laxatives), anticholinergics, roxithromycin. 2NT A Arrhythmias, intra&ndash@rdiac Phosphodiesterase type 5 inhibitor. Sildenafil (as citrate) 20mg. White, round, biconvex film-ctd tab. conduction abnormalities, anticholinergic effects marked PFIZER on one side and RVT 20 on reverse. (dysuria, acute urinary retention, diplopia, accommodation disorders, GI disorders, impotence, 90, A553.95. psychiatric disorders). S Pulmonary arterial hypertension classified as WHO functional class III, to improve SOTACOR BMS exercise capacity. 3MO P 1 three times a day, approx. 6-8 hours Non-cardioselective b-blocker. Sotalol (HCl) 80mg, apart. 160mg. Both white tabs. scored on one side and Q Under 18 years, not recommended. tab. strength marked on other side. 80mg-28, D Severe hepatic impairment; recent A1.60; 160mg-28, A3.16. stroke or MI, severe hypotension (BPQ90/ S Prevention of myocardial infarction. 50mmHg) at initiation; Retinitis pigmentosa; loss Cardiac arrhythmias. Angina. Hypertension. of vision in one eye because of non-arteritic P Reinfarction: 320mg once daily, starting anterior ischaemic optic neuropathy (NAION). 5-14 days after infarction. Arrhythmias: Initial dose Lactation, pregnancy (unless strictly necessary). 80mg either singly or as 2 divided doses. Allow 2-3 B Caution: Hypotension, fluid depletion, days between increments. Most respond to dose severe LV outflow obstruction, autonomic of 160-320mg admin. in 2 divided doses at 12 hr dysfunction; penis deformation, condition intervals. In renal impairment; cc q60ml/min: predisposing to priapism; bleeding disorders, Normal dose; cc 30-60ml/min: Half normal dose; cc peptic ulceration. Signs of pulmonary oedema; 10-30ml/min: Quarter normal dose; cc Q10ml/min: potential for veno-occlusive disease. Contains Avoid. lactose. Withdraw gradually. Q Not recommended. C Contra: Potent CYP3A4 inhibitors (eg. ketoconazole, itraconazole, ritonavir), nitric oxide D See 2.4, b-blockers Drug Presc. Notes. Prolonged QT interval, torsades de pointes, renal donors (eg. amyl nitrite), nitrates, nicorandil. failure. Caution: Other CYP3A4 inhibitors, CYP3A4 B Caution: Pre-existing arrhythmias, QT substrates/ inducers, a-blockers. Bosentan, interval q 550msec. Electrolyte disturbances esp. epoprostenol, iloprost, other PDE5 inhibitors (no hypokalaemia or hypomagnesaemia. Caution: Left data). A Headache, flushing, limb pain, myalgia, ventricular dysfunction, recent MI. See b-blockers Prescribing Notes. See 2.4, b-blockers Drug Presc. dyspepsia, diarrhoea, cough, epistaxis, insomnia, Notes. pyrexia, influenza, visual disturbances. hyperkalaemia, hyperkalaemia (hypertensive patients), angioneurotic oedema. Avoid haemodialysis using high flux polyacrylonitrile membranes and low-density lipoprotein apheresis with dextran sulphate. C Caution: Antidiabetics, NSAIDs. A Nausea, dizziness, headache, symptomatic hypotension, MI, cerebrovascular accident, chest pain, palpitations, rhythm disturbances, angina pectoris, impaired renal function, GI disorders, hypersensitivity reactions, cutaneous and mucosal reactions, vasculitis, muscle and joint pains, fever or eosinophilia, dry tickling cough, disturbances of balance, nervousness, restlessness, terror, sleep disorders, confusion, loss of appetite, depressed mood, feeling of anxiety, paraesthesiae, taste change/reduction/loss, muscle cramps, erectile impotence, reduced sexual desire, increased blood urea nitrogen and serum creatinine, deterioration of pre-existing proteinuria.

CIRCULATORY SYSTEM B Caution: Pre-existing arrhythmias, QT interval q 550msec. Electrolyte disturbances esp. hypokalaemia or hypomagnesaemia. Caution: Left ventricular dysfunction, recent MI. See 4.2 bblockers Drug Presc. Notes.

SUSCARD BUCCAL

Forest

2MO Nitrate. Glyceryl trinitrate 2mg, 3mg, 5mg. White sust.-release tabs. marked with tab. strength. 2mg100, A20.19; 3mg-100, A28.29; 5mg-100, A39.67. S Congestive heart failure. Place tab. high up between upper lip and gum and allow to disolve. P Initially 5mg three times daily. Q Not recommended. A Headache, flushes.

TAMBOCOR

Meda

2MO Class I antiarrhythmic. Flecainide acetate 50mg white tab. marked 3M, TR50; 100mg white scored tab. marked 3M, TR100. 50mg-60, A10.18;100mg60, A11.19. S AV nodal reciprocating tachycardia. Wolff-Parkinson-White syndrome. Paroxysmal atrial fibrillation and atrial flutter. Symptomatic life threatening or disabling sustained ventricular tachycardia. Premature ventricular contractions and/or non-sustained ventricular tachycardia not responding to other therapy. P Supraventricular arrhythmias: Initially 50mg twice daily; max. 300mg daily. Ventricular arrhythmias: Initially 100mg twice daily; max. 400mg daily. Reduce after 3-5 days to lowest dose required to maintain control. Q Under 18, not recommended.

2N

ALSO TAMBOCOR INJECTION Flecainide acetate 10mg/ml; amp. 5 x 15ml, A29.20. S Rapid control of ventricular tachyarrhythmias, AV nodal reciprocating tachycardia and Wolff-Parkinson White syndrome. D Cardiac failure, history of MI with asymptomatic ventricular arrhythmias, severe ischaemic heart disease, 2nd or 3rd degree AV block, sinus node disease in absence of pacemaker. B Correct electrolyte disturbances before admin. Pacemakers or temporary pacing electrodes. Renal or hepatic insufficiency; monitor plasma levels. Cardiac disease. Pregnancy. C Other antiarrhythmics, digoxin, bblockers, other cardiac depressants (verapamil), amiodarone, other Na+ channel blockers, fluoxetine, tricyclics, reboxetine, phenytoin, phenobarbital, carbamazepine, clozapine, diuretics, mizolastine, terfenadine, quinine, RYTHMODAN RETARD sanofi-aventis SOTOGER Gerard ritonavir, lopinavar, indinavir, cimetidine, bupropion. 2MO 3MO Class I antiarrhythmic. Disopyramide (as phos.) Non-cardioselective b-blocker. Sotalol (HCl) 80mg, A AV block, cardiac failure, chest pain, hypotension, MI, palpitation, nausea, abdominal 250mg. White prolonged-release circular film-ctd 160mg. White tabs. 80mg-28, A2.66; 160mg-28, pain, constipation, diarrhoea, flatulence, elevated A5.25. tab. marked 013 on one side and E on the other. liver enzymes, Hepatic dysfunction, dizziness, 56, A19.12. S Prophylaxis of and control of atrial visual disturbances, blood dyscrasias, dyspnoea, flutter and fibrilation. Suppression and prevention S Cardiac arrhythmias. depression, anxiety, insomnia, rashes, alopecia. of ventricular tachycardia. P 1 tab. twice daily (morning and P Initially 80mg once or twice daily; evening). TENORMIN AstraZeneca maintenance, 160 mg twice daily. Max 640mg Q Not recommended. 3MO daily. Dose titration under close medical D 2nd or 3rd degree AV block and sinus Cardioselective b-blocker. Atenolol 25mg, 50mg, supervision and ECG control. node disease in absence of pacemaker. Bundle 100mg. White, white, orange biconvex film-ctd branch block associated with 1st degree AV block. Q Not recommended. tabs. marked Tenormin 25, Tenormin 50, and Double block (left posterior or anterior hemiblock D See 2.4, b-blockers Drug Presc. Notes. Tenormin respectively. 100mg bisected on reverse. and RBBB). Pre-existing long QT. Severe sinus node Prolonged QT interval, torsades de pointes, renal 25mg-28, A1.97; 50mg-28, A2.54; 100mg-28, dysfunction. Severe heart failure, unless secondary failure.

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Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM

CONGESTIVE

HEART FAILURE, TACHYCARDIA, POST-MI

A3.23.

Pregnancy. B Treatment should be initiated and monitored by experienced physician. Women of childbearing potential should practice reliable contraception. Monitor ALT/AST levels prior to and at monthly intervals during treatment. C Cyclosporin A, glibenclamide, warfarin, THELIN Encysive simvastatin, ketoconazole, digoxin. A Headache, upper RTI, nasopharyngitis, 2JT Endothelin A receptor antagonist. Sitaxentan (Na+) oedema, flushing, hypotension, abnormal hepatic function. 100mg. Cap. shaped yellow-orange film-ctd tab. marked T-100. 28, A2538.05. TRANTALOL Pinewood S Pulmonary arterial hypertension 3MO classified as WHO functional class III, to improve Cardioselective b-blocker. Atenolol 25mg, 50mg, exercise capacity. 100mg. White tabs. 25mg: Circular, flat, scored on P 1 once daily. Response should be seen one side. 50mg and 100mg: Biconvex, film-ctd, by week 12, sometimes week 24. marked 1U1 and 2U1 resp. 25mg-30, A2.54; 50mgQ Under 18 years, not recommended. 30, A3.90; 100mg-30, A5.50. D Mild to severe hepatic impairment. S Cardiac arrhythmias. Early intervention Elevated liver AST or/and ALT prior to treatment in acute MI. Long-term prophylaxis after recovery (q 3xULN). Lactation. Pregnancy (unless clearly from MI. necessary). B Monitor for signs of pulmonary oedema P Arrhythmias: 50-100mg as single daily (consider veno-occlusive disease). Monitor AST/ALT dose. MI: 50mg 15 mins orally and 12 hrs after IV levels prior to treatment and at monthly intervals dose. Then 100mg orally 12 hrs later once daily. Renal failure: Reduce dose (see SPC). (see SPC if elevations). Check Hb levels prior to Q Not recommended. treatment, after 1 and 3 months, and every 3 D See 2.4, b-blockers Drug Presc. Notes. months thereafter. Contains lactose. B Caution: Patients with poor cardiac C Contra: Ciclosporin A. Caution: reserve. Will reduce heart rate. Contains lactose Epoprostenol, sildenafil, iloprost, vitamin K (50mg and 100mg). See 2.4, b-blockers Drug Presc. antagonists (e.g. warfarin, acenocoumarol and fenprocoumon), OATP inhibitors (e.g. some statins, Notes. C See 2.4, b-blockers Drug Presc. Notes. proteinase inhibitors, tuberculostatics), oral A Precipitation of atrioventricular block, contraceptives, nifedipine, CYP2C9 substrates. purpura, thrombocytopenia, impotence. See 2.4, bA Headache, insomnia, dizziness, peripheral oedema, nasal congestion, epistaxis, GI blockers Drug Presc. Notes. disorders, flushing, muscle cramp, fatigue, INR TRITACE sanofi-aventis increased, prothrombin prolonged. S Cardiac arrhythmias. Early intervention in acute MI. Angina pectoris. Hypertension. P 50-100mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

TRACLEER

2MO Actelion

2NT Endothelin receptor antagonist (ERA). Bosentan (monohydrate) 62.5mg, 125mg. Orange-white film-ctd tab. marked with strength. 62.5mg-56, A2538.00; 125mg-56, A2538.00. S Primary pulmonary arterial hypertension (PAH). PAH secondary to scleroderma without significant interstitial pulmonary disease. P Initially 62.5mg twice daily for 4 weeks increasing to maintenance 125-250mg twice daily morning and evening. Q Under 12 years, not recommended. D Moderate to severe hepatic impairment.

EDITORIAL INFORMATION The information published in the editorial listing in MIMS Ireland is based upon details supplied by the manufacturers.The Index lists preparations which are available on prescription in general practice.

ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, 10mg. White, yellow, red and white oblong tabs. with score line on both sides. 1.25mg-28, A2.59; 2.5mg-28, A3.66; 5mg-28, A5.10; 10mg-28, A6.94. S Adjunct to diuretics and where appropriate, digitalis in congestive heart failure. Post MI prevention of disease progression in patients with heart failure. Prevention of MI, stroke or cardiovascular death in patients with an increased cardiovascular risk who are already taking standard therapy and in type 2 diabetic patients with an increased cardiovascular risk. P CHF: initially 1.25mg once daily, then double dose at intervals of 1-2 weeks according to response; max. 10mg daily. Reduce dosage of any diuretics first. Initiate therapy under close medical supervision. Post MI: initiate in hospital between days 3-10 post-MI. Starting dose 2.5mg twice daily. After two days, increase to 5mg twice daily. If starting dose not tolerated, reduce to 1.25mg twice daily for two days. Then increase to 2.5mg twice daily. If necessary, increase to 5mg twice daily two days later. Withdraw if dose cannot be increased to 2.5mg twice daily. Usual maintenance dose 2.5- 5mg twice daily. Prevention of MI, stroke or cardiovascular death: the initial dose is 2.5mg once daily, the dose is gradually increased. It is recommended to double the dose after 1 week and after another three weeks increase to 10mg. Usual maintenance dose is 10mg. R No special dosage recommendations for elderly patients apart from general warning about patients with renal or hepatic insufficiency or CHF which may be common in elderly and concomitant use of diuretic drugs. Dose titrated according to

2.1

need for BP control. Q Not recommended. D History of angioneurotic oedema. Aortic stenosis, outflow obstruction. Pregnancy, lactation. Hypersensitivity to ramipril. B CHF, hepatic impairment, blood dyscrasias. Renal impairment: reduce dose and assess renal function prior to and during treatment. Haemodialysis (avoid in patients dialysed with high flux membranes). Use with caution in surgery and during anaesthesia. C Antihypertensive agents, K+sparing diuretics, K+suppl., lithium, antidiabetic agents, NSAIDs. A Nausea, vomiting, dizziness, fatigue, headache, abdominal pain, diarrhoea, cough. Liver dysfunction, renal impairment, hypersensitivity reactions. Rarely, symptomatic hypotension, angioneurotic oedema, syncope.

UNIPHYLLIN CONTINUS Mundipharma

2MO Xanthine. Theophylline 200mg white cap. -shaped scored sust.-release tab. marked U200; 300mg white cap.-shaped scored sust.-release tab. marked U300; 400mg white cap.-shaped scored sust.release tab. marked NAPP U400 one side, UNIPHYLLIN on reverse. 200mg-56, A4.17; 300mg56, A6.38; 400mg-56, A8.72. S Cardiac asthma, congestive cardiac failure. P Less than 70kg and elderly, 200mg 12 hourly for 1 week, then 300mg 12 hourly or 600mg at night. Over 70kg, 200-300mg 12 hourly for 1 week, then 400mg 12 hourly or 800mg at night. Q Not recommended. D Hypersensitivity to xanthine group of drugs. Lactation. B Other cardiac disease; liver disease. Peptic ulceration. Pregnancy. C Cimetidine, erythromycin. b-adrenergic agonists, glucagon, ephedrine, ciprofloxacin, fluvoxamine, interferon, steroids, diuretics. See SPC. A Nausea, gastric irritation, headache, CNS stimulants.

VASCACE

Roche

2MO ACE inhibitor. Cilazapril 0.5mg, 1mg, 2.5mg, 5mg. White, yellow, red or brown oval film-ctd scored tabs. marked CIL and strength. 0.5mg-28, A5.02; 1mg-28, A8.11; 2.5mg-28, A13.06; 5mg-28, A18.79. S Chronic heart failure usually as adjunctive therapy with digitalis and/or diuretics. P Initially 0.5mg once daily under close supervision. Adjust according to response. Maintenance usually 1-2.5mg once daily. Max. 5mg once daily. Q Not recommended. D Ascites, aortic stenosis, hypertrophic cardiomyopathy or outflow obstruction. Pregnancy, lactation. B Haemodialysis. Renal or hepatic impairment, CHF, salt or volume depletion, surgery, anaesthesia. C K+sparing diuretics, NSAIDs. A Headache, dizziness, fatigue, dyspepsia, nausea, rash, coughing. Rarely angioneurotic oedema and alterations in blood count.

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

31


2.1 CONGESTIVE

HEART FAILURE, TACHYCARDIA, POST-MI

CIRCULATORY SYSTEM

100, A5.16; 120mg-100, A10.59. S Superventricular tachycardia. P 40-120mg three times daily. Q Not recommended. D Cardiogenic shock. 2nd or 3rd degree AV block. Severe bradycardia. Uncompensated cardiac failure. Sick sinus syndrome. B 1st degree AV block. Poor cardiac reserve should be controlled with digitalis and diuretics. Hepatic impairment. Acute phase of MI. Bradycardia. C b-blockers, quinidine or digoxin. A Constipation, headache, flushes.

D Pregnancy, lactation. Renal artery stenosis, post kidney transplant. History of angioneurotic oedema. Aortic or mitral valve Platelet aggregation inhibitor. Iloprost 10mcg/ml stenosis, hypertrophic cardio-myopathy. Systolic BP (as iloprost trometamol). 2ml nebuliser sln in Q100mmHg before treatment initiation. amps. Price available on request. Permanent haemodialysis. Primary S Primary pulmonary hypertension, hyperaldosteronism. classified as NYHA functional class III, to improve B Diuretics (q80mg frusemide), exercise capacity and symptoms. hypovolaemia, hyponatraemia, hyperkalaemia. P 2.5mcg or 5mcg (as delivered at the Hypotension (first dose). Acute MI and cardiac mouthpiece of nebuliser) 6 to 9 times per day. Use failure (if unstable), renal impairment, high-dose with recommended nebulisers. vasodilator therapy. LDL-cholesterol apheresis. Q Under 18 years, no experience. Elderly. D Conditions increasing risk of C Diuretics incl. K+sparing, K+suppl., other haemorrhage (e.g. active peptic ulcers, trauma, VOLIBRIS GSK antihypertensives, analgesics/anti-inflammatories, intracranial haemorrhage). Severe CHD or unstable 2 T lithium, alcohol, anaesthetics, narcotics, hypnotics. angina, MI within last six months, decompensated Ambrisentan 5mg, 10mg. Resp. pale pink or deep Sympathomimetics, oral antidiabetic agents, cardiac failure if not under close medical insulin. pink, square or oval film-ctd tab. with GS on one supervision, severe arrhythmias, cerebrovascular A Hypotension, dizziness, fatigue, side and K2C or KE3 on the other. Prices on events (e.g. TIA, stroke) within last 3 months. arrhythmias. Proteinuria, dry cough, nausea request. Pulmonary hypertension due to venous occlusive (occasionally), abdominal pain, rash, headache. S Pulmonary arterial hypertension (PAH) disease. Congenital or acquired valvular defects WHO functional class II and III, to improve exercise with myocardial function disorders not related to ZESTAN Clonmel capacity. pulmonary hypertension. Pregnancy, lactation. 2MO P 5mg once daily. If well tolerated, may B Unstable pulmonary hypertension with ACE inhibitor. Lisinopril 2.5mg, 5mg white tabs. be increased to 10mg in WHO class III PAH advanced right HF (not recommended). Acute marked with strength and scored both sides; patients. Severe renal impairment: Initiate pulmonary infections (monitor). Systolic arterial 10mg, 20mg white tabs. marked with strength cautiously. hypotension Q85mmHg (not recommended). and quadrisected both sides. 2.5mg-28, A4.84; Q Under 18 years, not recommended. Hepatic dysfunction or renal failure requiring 5mg-28, A6.95; 10mg-28, A8.35; 20mg-28, A9.76. D Pregnancy. Women of child-bearing dialysis. Caution with discontinuation. S Adjunct to diuretics and where potential not using reliable contraception. C Caution: Vasodilatators and appropriate, digitalis, in congestive heart failure. Lactation. Severe hepatic impairment. AST and/or antihypertensive agents, anticoagulants or other Treatment of acute MI in haemodynamically stable ALT q3xULN. inhibitors of platelet aggregation. patients. B Safety not established in WHO A Vasodilatation, hypotension, syncope, P CHF, initially 2.5mg once daily functional class I PAH. Evaluate ALT and AST prior increased cough, headache, trismus. increasing in intervals of 2-4 weeks to to initiation and monitor during treatment; VERAMIL Orion discontinue if clinically significant elevations occur maintenance of 5-20mg once daily. If possible or elevations with symptoms of hepatic injury. Not reduce dose of any diuretics first. Initiate therapy 2MO under close medical supervision (in hospital for recommended: Clinically significant anaemia. Class I Ca++ antagonist. Verapamil chlor. 40mg, severe or unstable HF or high risk patients). Post Regularly measure Hb and/or haematocrit levels. 80g, 120mg. White film-ctd tabs. coded VL-40, VL- Peripheral oedema may occur (increased frequency MI, initially 5mg followed by 5mg after 24 hrs, 80 and VL-120. 40mg-100, A5.17; 80mg-100, 10mg after 48 hrs, and then 10mg once daily. and severity over 65 years). Monthly pregnancy A8.67; 120mg-100, A11.56. tests recommended. Contains soya, lactose, Allura Q Not recommended. S Supraventricular tachycardias and D Angioneurotic oedema, severe renal red AC. prevention of recurrence. impairment, haemodynamically unstable patients C Caution: Cyclosporine A, other PAH P 40-120mg three to four times daily. after MI, haemodynamically relevant aortic or treatments (e.g. prostanoids, PDE-5 inhibitors). Severe liver dysfunction: Use 1/3 dose. mitral valve stenosis or hypertrophic A Palpitation, anaemia, headache, upper D Severe left ventricular dysfunction. cardiomyopathy, systolic BP R 100 mmHg before respiratory congestion, sinusitis, nasopharyngitis, Severe hypotension, cardiogenic shock. 2nd or 3rd rhinitis, GI disorders, flushing, peripheral oedema, initiation of treatment, cardiogenic shock. degree AV block. Marked bradycardia. Sick sinus B Haemodialysis. Hypotension, syndrome. CHF incl. including uncompensated HF. fluid retention. renovascular hypertension, renal impairment, Lactation. ZESGER Gerard monitor renal function before and during B 1st degree AV block reported. treatment, severe CHF, primary Hypertrophic cardiomyopathy, elderly, attenuated 2 M O neuromuscular transmission. Mild to moderate HF ACE inhibitor. Lisinopril 2.5mg, 5mg, 10mg, 20mg. hyperaldosteronism, aortic stenosis, hypertrophic cardiomyopathy. Low-density apheresis/ Round, flat beveled edge, square biconvex and (control with digitalis and diuretics). Porphyria desensitisation therapy. (unsafe). Hepatic impairment (monitor during pentagonal biconvex tabs. debossed on one side C Diuretics, K+ sparing diuretics, K+ suppl., long-term therapy). Contains lactose. Pregnancy. with 2.5, 5, 10 and 20 resp. All white with A C Grapefruit juice, digitalis intoxication, IV breakline on other side. 2.5mg-28, 5.38; 5mg-28, Na+ Cl, lithium, anti-hypertensives, analgesics, anti-inflammatories, alcohol, anaesthetics, b-blockers (contra). Colchicine, cisapride (avoid). a/ A7.59; 10mg-28, A9.37; 20mg-28, A10.75. b-blockers, CYP3A4 inhibitors/substrates, S Heart failure as additive therapy to non- narcotics, hypnotics, sympathomimetics, oral antidiabetics, insulin, antacids, NSAIDs. antiarrhythmics, CCBs, cardiac glycosides, K+sparing diuretics, and digitalis (where A Hypotension, angioedema, dizziness, theophylline, imipramine, glyburide, doxorubicin, appropriate). Acute MI in haemodynamically weakness, impaired vision, renal dysfunction, dry paclitaxel, tamoxifen, cimetidine, statins, stable patients, in addition to usual standard cough, sore throat, hoarseness, bronchitis, GI almotriptan, halothane, dantrolene, Ca++ salts, therapy in MI, especially together with nitrates. disturbances, rash, headache, tiredness. alcohol, lithium, timolol eye drop, quinidine, P Initially 2.5mg in the morning. antihypertensives. Maintenance dose titrated by 2.5mg increments ZESTRIL AstraZeneca A Constipation, headache, dizziness, according to patient response. Time interval fatigue, rash, bradycardia, hypotension, cardiac 2MO between dose increases q2 weeks but preferably insufficiency, swelling of ankles. ACE inhibitor. Lisinopril 2.5mg, 5mg, 10mg, 20mg. 4 weeks; max. 35mg daily. Post MI: initially 5mg, then 5mg after 24hours, 10mg after 48 hours and White, pink, pink, red tabs. resp. marked with VERISOP Gerard thereafter 10mg once daily. Low systolic BP: heart shape, strength and ZESTRIL. 2.5mg-28, 2MO initially 2.5mg. Hypotension: max. daily dose 5mg, A3.23; 5mg-28, A4.56; 10mg-28, A5.63. 20mg-28, A6.46. with reduction to 2.5mg if necessary. If Class I Ca++ antagonist. Verapamil chlor. 40mg, S Adjunctive therapy in congestive heart hypotension persists on 2.5mg, discontinue. 80g, 120mg. White tabs. marked VL and strength one side, G on reverse. 40mg-100, A3.53; 80mgfailure with non-potassium sparing diuretics with Q Not recommended.

VENTAVIS

Bayer Schering

2NT

32

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM or without digitalis. Acute myocardial infarction. P CHF: Initially 2.5mg once daily increasing gradually to 5-20mg once daily, according to response. Reduce dose of any diuretic first. Acute MI: First dose is 5mg, followed by 5mg after 24 hours, 10mg after 48 hours and then 10mg once daily. Q Not recommended. D History of angioneurotic oedema. Not recommended: Lactation, pregnancy (contra 2nd3rd trim.). B Renal impairment; monitor renal function before and during treatment. Aortic stenosis, cor pulmonale, outflow tract obstruction. 1st dose hypotension. Anaphylactoid reactions (during haemodialysis using high flux membranes, LDL apheresis, desensitisation). C K+ sparing diuretics, K+ suppl., other antihypertensives, indomethacin, lithium, injectable gold. A Dizziness, headache, fatigue, diarrhoea, cough, rash, asthenia, angioedema, renal failure. Hypotension, palpitations, chest pain, impotence.

ANGINA 2.2 90, A3.03; 10mg-90, A3.85. P Initially 5mg eight hourly adjusted according to response, increasing to max. 20mg every 8 hrs. Q Not recommended. D Women of child-bearing potential, lactation. Cardiogenic shock, aortic stenosis. Acute angina attacks, unstable angina pectoris, during or within one month of MI. Adalat LA only: Hepatic impairment, history of GI obstruction, IBD, Crohn’s disease. B Poor cardiac reserve, HF, hepatic impairment, severe hypotension. Diabetes, dialysis. Severe GI narrowing. Elderly. Driving/using machines. Postural hypertension, syncope, tachycardia reported. C Contra: Rifampicin. Avoid grapefruit juice. Caution: Antihypertensive agents, cimetidine, quinidine, digoxin, phenytoin, diltiazem, cisapride, quinupristin/dalfopristin, CYP3A4 inhibitors. A Headache, vasodilatation, palpitation, nausea, dizziness, oedema. Lethargy, asthenia, constipation.

within 2-4 weeks, may be increased to max. 10mg once daily. May be used as monotherapy or in combination with other antianginal drugs. Q Under 12 years, not recommended. D Severe hypotension, shock, HF after acute MI (during 1st 28 days), obstruction of outflow tract of left ventricle (e.g. high grade aortic stenosis), unstable angina pectoris. Pregnancy (unless essential), lactation. B Low cardiac reserve, cardiac failure, hepatic impairment, elderly. Contains lactose. C Caution: CYP3A4 inhibitors/ inducers, other antihypertensives incl. b-blockers. A Ankle swelling. Headache, fatigue, dizziness, asthenia, palpitations, flushing, nausea, dyspepsia, abdominal pain.

AMLIST

Gerard

2MO

Ca antagonist. Amlodipine 5mg, 10mg (as amlodipine maleate). White round tab. 10mg with break score on both sides. 5mg-28, A9.20; 10mg28, A13.75. S Chronic stable and vasospastic angina ZOFENIL A. Menarini ADIZEM XL CAPSULES Mundipharma pectoris. 2MO P 5mg once daily with water. If no effect 2MO within 2-4 weeks, may be increased to max. 10mg Cardioprotective ACE inhibitor. Zofenopril 7.5mg. ++ A once daily. May be used as monotherapy or in White film-ctd. tab. 12, 2.91. Class III Ca antagonist. Diltiazem (HCl) 120mg combination with other antianginal drugs. S Post acute MI, with or without heart pink/blue cap.; 180mg pink/blue cap.; 240mg red/ Q Under 18 years, not recommended. failure if haemodynamically stable and not on blue cap.; 300mg maroon/blue cap. All cont.D Severe hypotension, shock, HF after antithrombolytic therapy. release caps. marked with DCR and strength. A A acute MI (during 1st 28 days), obstruction of P First and second day, 7.5mg 12 hourly, 120mg-28, 8.40; 180mg-28, 12.45; 240mg-28 A16.05; 300mg-28, A12.42. outflow tract of left ventricle (e.g. high grade third and fourth day, 15mg 12 hourly, increasing aortic stenosis), unstable angina pectoris. S Angina. on fifth day to 30mg 12 hourly. Pregnancy (unless essential), lactation. R Use with caution in those over 75 years. P Initially 240mg once daily adjusting according to response. Caps. should be swallowed B Low cardiac reserve, cardiac failure, Q Not recommended. hepatic impairment, elderly. Contains lactose. whole. D Angioneurotic oedema, severe hepatic R Initially 120mg once daily and carefully Driving or using machines. impairment, renal artery stenosis. Pregnancy, C Caution: CYP3A4 inhibitors/ inducers, lactation. Women of child-bearing potenial unless titrate as required. other antihypertensives incl. b-blockers. Q Not recommended. protected by effective contraception. A Ankle swelling. Headache, fatigue, 2 M O B Reduce dosage of diuretic if possible dizziness, asthenia, palpitations, flushing, nausea, before initiating therap. Volume depletion may ALSO ADIZEM SR CAPSULES Diltiazem (HCl) 90mg dyspepsia, abdominal pain. cause sympathetic hypotension, dialysis, white cap.; 120mg brown/white cap.; 180mg anaesthesia, renal or heptic impairment. brown/white cap. All cont. -release caps. marked AMLODE Rowex C Other anti-hypertensive agents, with strength. 90mg-56, A12.80; 120mg-56, A14.21; 180mg-56, A21.32. 2MO diuretics, lithium, K+sparing diuretics, K+suppl., NSAIDs. P Initially 90mg twice daily. Increase Ca++ antagonist. Amlodipine 5mg, 10mg (as A Dizziness, fatigue, headache, cough, gradually to 120mg or 180mg twice daily as amlodipine besilate). White oblong, bevelled tab. nausea, vomiting, rash, muscle cramp, weakness. required. scored on one side and marked with strength on R Start at lowest level of 90mg twice reverse. 5mg-28, A8.33; 10mg-28, A12.50. 2.2 ANGINA daily; carefully titrate as required. S Chronic stable and vasospastic angina Q Not recommended. pectoris. ADALAT LA Bayer Schering D Pregnancy, lactation. Sick sinus P 5mg once daily with water. If no 2MO syndrome, 2nd or 3rd degree AV block, marked sufficient effect within 2-4 weeks, may be ++ bradycardia, decompensated cardiac failure. increased to 10mg daily (as single dose). Class II Ca antagonist. Nifedipine 20mg, 30mg, 60mg. Pink modified-release tab. marked ADALAT B Mild bradycardia, prolonged PR interval. Q Under 18 years, not recommended. D Hypersensitivity to dihydropyridine 20, ADALAT 30 and ADALAT 60. 20mg-28, A9.21; Measure heart rate regularly in elderly and in patients with hepatic or renal impairment. derivatives. Severe hypotension, shock, HF after 30mg-28, A11.85; 60mg-28, A17.61. Diabetes. acute MI (during 1st 28 days), obstruction of S Chronic stable angina pectoris. C b-blockers, digoxin, cimetidine, outflow-tract of left ventricle (e.g. high grade P Initially 30mg once daily in the diazepam, antihypertensives, anaesthetics, aortic stenosis), unstable angina pectoris. morning. Increase if necessary up to max. 90mg dantrolene inf. Pregnancy (unless essential), lactation. once daily. Tabs. must be swallowed whole with A Anorexia, nausea, bradycardia, oedema, B Hepatic impairment, cardiac failure, low water. rash, flushing, fatigue, AV block. cardiac reserve, elderly. Q Not recommended. C Caution: CYP3A4 inhibitors/inducers. 2MO Pinewood Other antihypertensives (e.g. a/b blockers, ACEALSO ADALAT RETARD 10 Nifedipine 10mg. Pink- AMLID inhibitors, diuretics). 2MO grey tab. marked A10 one side, Bayer cross on A Ankle swelling, headache, facial reverse. 10mg-56, A9.72; 20mg-56, A11.87 Ca++ antagonist. Amlodipine 5mg, 10mg (as flushing, dizziness, fatigue, asthenia, palpitations, P Initially 10mg twelve hourly adjusting to amlodipine maleate). White round biconvex tab. abdominal pain, nausea, dyspepsia. response, increasing to 40mg every 12 hours. A 10mg tab. scored on both sides. 5mg-28, 9.19; Q Not recommended. 10mg-28, A13.70. AMLOTAN Clonmel 2MO S Chronic stable and vasospastic angina 2MO ALSO ADALAT Nifedipine 5mg, 10mg. Orange, pectoris. gelatin ovoid caps. containing yellow fluid. 5mgP 5mg once daily with water. If no effect Ca++ antagonist. Amlodipine 5mg, 10mg (as ++

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

33


2.2 ANGINA

CIRCULATORY SYSTEM

amlodipine mesilate monohydrate). White round biconvex tab embossed with 5 or 10 resp. 10mg tab. scored. 5mg-28, A7.34; 10mg-28, A10.97. S Chronic stable and vasospastic angina pectoris. P 5mg once daily with water. If no effect within 2-4 weeks, may be increased to max. 10mg once daily. Q Under 18 years, not recommended. D Severe hypotension, shock, HF after acute MI (during 1st 28 days), obstruction of outflow tract of left ventricle (e.g. high grade aortic stenosis), unstable angina pectoris. Pregnancy (unless essential), lactation. B Low cardiac reserve, cardiac failure, hepatic impairment, elderly. C Caution: CYP3A4 inhibitors/ inducers, other antihypertensives incl. b-blockers. A Ankle swelling. Headache, fatigue, dizziness, asthenia, palpitations, flushing, nausea, dyspepsia, abdominal pain.

ATENOGEN

Antigen

3MO Cardioselective b-blocker. Atenolol 25mg, 50mg, 100mg. White, white, orange film-ctd tabs. marked AT/25, AT/50, AT/100, resp. All marked with maker’s symbol. 25mg-28, A2.49; 50mg-28, A3.77; 100mg-28, A5.38. S Cardiac arrhythmias. Long-term prophylaxis after recovery from acute MI. Angina pectoris. Essential hypertension. P Arrythmias: 50-100mg daily. Prophylaxis after recovery from MI: 100mg daily. Hypertension: 50mg daily increasing to 100mg daily if required. Allow time to achieve full effects (1-2 weeks) before determining need to increase to 100mg daily. Angina: 100mg daily as a single dose or as 50mg twice daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

240mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

BETALOC

AstraZeneca

3MO Cardioselective b-blocker. Metoprolol tartrate. 50mg white tab. scored and marked A/BB one side; 100mg white tab. scored and marked A/ME one side. 50mg-100, A2.11; 100mg-100, A3.91. S Angina. P 50-100mg twice or three times daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

BISOCOR

Niche

3MO

Cardioselective b-blocker. Bisoprolol hemifumarate 5mg, 10mg. Pale-yellow scored tab. marked BI and 5, beige scored tab. marked BI and 10. 5mg-28, ATENOMEL Clonmel A5.28. 10mg-28, A5.99. S Chronic stable angina. AMOLIN Ergha 3 M O P Usually 10mg once daily. Max. 20mg Cardioselective b-blocker. Atenolol 25mg, 50mg, daily. 3MO 100mg. White tab. marked C23, C24, C25. 50 and Q Not recommended. Cardio-selective b-blocker. Atenolol 25mg, 50mg, 100mg scored. 25mg-30, A2.60; 50mg-30, A3.94; D See 2.4, b-blockers Drug Presc. Notes. 100mg. White film-ctd tabs. marked C23, C24 and 100mg-30, A5.01. Acute HF or during episodes of HF C25 resp. 25mg-30, A1.56; 50mg-30, A2.36; S Angina pectoris. decompensation requiring IV inotropic therapy. 100mg-30, A3.10. P 50-100mg daily. S Angina pectoris. Q Not recommended. BISOP Rowex P 50-100mg daily. D See 2.4, b-blockers Drug Presc. Notes. 3MO Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. BETA-ADALAT Bayer Schering Cardioselective b-blocker. Bisoprolol fumarate 5mg, 10mg. Resp. yellow or apricot, round film-ctd 3MO tablet with a cross score encoded BIS and strength ATECOR Rowex Cardioselective b-blocker/class II Ca++ antagonist. on one side. 5mg-28, A5.34;10mg-28, A6.01. 3MO Atenolol 50mg, slow release nifedipine 20mg. S Angina pectoris. Reddish-brown cap. marked with name and Bayer Cardioselective b-blocker. Atenolol 25mg, 50mg, P Should be taken with liquid (not cross. 28 (Cal/Pk), A11.87. 100mg. White scored film-ctd tabs. 25mg-30, chewed), in the morning. Initially 5mg; usual dose S Chronic stable angina pectoris, where b 10mg once daily; max 20mg/day. A2.67; 50mg-30, A4.04; 100, A12.84; 100mg-30, -blocker or calcium antagonist monotherapy is A5.77; 100, A18.67. Q Not recommended. inadequate. S Angina pectoris. D Acute HF or during episodes of HF P 1 every 12 hours. If necessary P 100mg once daily or 50mg twice daily. decompensation requiring IV inotropic therapy. prophylactic nitrate therapy or additional Q Not recommended. Cardiogenic shock. AV block of 2nd or 3rd degree nifedipine may be given. D See 2.4, b-blockers Drug Presc. Notes. (without a pacemaker). Sick sinus syndrome. Q Not recommended. Sinoatrial block. Bradycardia (Q 60 beats/min) ATENI Gerard D Women of child bearing potential. HF. before start of therapy. Hypotension (systolic BP 2nd or 3rd degree heart block. Cardiogenic shock, Q 100mmHg). Severe bronchial asthma or severe 3MO use in conjunction with other cardio-depressant COPD. Late stages of peripheral arterial occlusive Cardioselective b-blocker. Atenolol 50mg, 100mg drugs, severe bradycardia, acute angina attacks, disease and Raynaud’s syndrome. Untreated white tabs. Both marked AT and strength one unstable angina pectoris, severe aortic stenosis, phaeochromocytoma. Metabolic acidosis. side, G on reverse. 50mg-28, A4.16; 100mg-28, during or within one month of MI, wheezing, Pregnancy (unless necessary), lactation. A5.38. asthma, severe renal failure. Pregnancy, lactation. B Regular monitoring required. Withdraw S Angina pectoris. B Cardiac conduction defects or poor gradually. Caution: Bronchospasm, diabetes P 100mg once daily or 50mg twice daily. cardiac reserve. OAD. Renal or hepatic mellitus with large fluctuations in blood glucose Q Not recommended. impairment. Diabetes. Anaesthesia. Elderly. (hypoglycaemia symptoms can be masked), strict D See 2.4, b-blockers Drug Presc. Notes. C Antihypertensives, cimetidine, quinidine, fasting, ongoing desensitisation therapy, AV block rifampicin, digoxin, cardiodepressants, adrenergic- of 1st degree, Prinzmetal’s angina, peripheral neurone blocking drugs, non-cardio-selective barterial occlusive disease, general anaesthesia. In blockers, grapefruit juice. bronchial asthma or other COPD, bronchodilating A Flushing, headache, fatigue, dizziness, therapy should be given concomitantly. Psoriasis: dry eyes, skin rash, oedema, hypersensitivity type Assess risk/benefit. Phaeochromocytoma: Do not jaundice (rare), gingival hyperplasia, This medicinal product admin. until after a-receptor blockade. Symptoms gynaecomastia, impotence. Mood changes, MI, of thyrotoxicosis may be masked. Contains lactose. contains substance(s) ischaemic pain (discontinue). Driving/operating machinery ability (at start of prohibited for use in specific treatment, with alcohol). BETA-PROGRANE Tillomed C Contra: Floctafenin, sultopride. Not sports only (as listed in 3MO recommended: Ca++ antagonists (verapamil type WADA Prohibited List 2010). Non-cardioselective b-blocker. Propranolol (HCl) and diltiazem type), class I antiarrhythmics, Athletes requesting to use 80mg, 160mg. White hard prolonged.-release cap. centrally acting antihypertensives. Caution: Ca++ A 8.13; 80mg (HALF BETA-PROGRANE)- (dihydropyridine type (e.g. felodipine, this product in these specific 160mg-28, 28, A6.27. amlodipine), class-III antiarrhythmics (e.g. sports are required to apply S Angina. amiodarone), topical b-blocking agents (e.g. eye P 80mg every morning or evening; may drops for glaucoma treatment), for a TUE. be increased if necessary to 160mg daily up to parasympathomimetics, insulin and oral

Anti-Doping Information

s

34

2

5

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c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM antidiabetics, anaesthetic agents, digitalis glycosides, NSAIDs, b-sympathomimetics that activate both b and a-adrenoreceptors (e.g. noradrenaline, adrenaline), antihypertensives, tricyclic antidepressants, barbiturates, phenothiszines. Mefloquine, MAOIs (except MAOB inhibitors). A Bradycardia, worsening of heart failure, dizziness, headache, GI complaints, feeling of coldness or numbness in extremities, hypotension, asthenia, fatigue.

ANGINA 2.2 Q Not recommended.

2MO

ALSO DILZEM SR Diltiazem (HCl) 60mg, 90mg, 120mg. Prolonged release hard capsules marked with cap.strength. 60mg-56, A8.12; 90mg-56, A12.16; 120mg-56, A13.90. P Initially 90mg twice daily, increasing gradually to 180mg twice daily. R Initially 60mg twice daily increasing gradually. Q Not recommended. D Pregnancy, lactation, women of child BISOPINE Pinewood bearing potential. Sick sinus syndrome, 2nd or 3rd degree AV block, marked bradycardia, 3MO Cardioselective b-blocker. Bisoprolol hemifumarate decompensated cardiac failure. Atrial fibrillation/ flutter with WPW. Concomitant dantrolene 5mg, 10mg. Resp. pale yellow or beige mottled infusion. tabs. marked BI above breakline 5 or 10 below. B Mild bradycardia, prolonged PR interval, 5mg-28, A5.90; 10mg-28, A6.65. diabetes, red. LV function, monitor patients with S Chronic stable angina pectoris. hepatic dysfunction and renal impairment. P Usually 10mg once daily; max. 20mg C Antihypertensives, halogenated daily. Upon discontinutation, diminish slowly by anaesthetics, H2 agonists, digoxin. weekly halving dose. Severe renal impairment: A Oedema, headache, dizziness, asthenia, Max dose 10mg daily bradycardia, flushing, 1st degree heart block. R Lowest dose recommended. Regular monitoring during treatment initiation. ELANTAN LA UCB Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. 2MO Acute HF or during episodes of HF Nitrate. Isosorbide mononitrate 25mg brown/white decompensation requiring IV inotropic therapy. sust.-release cap., 50mg brown/flesh sust.-release Combinations with floctafenine and sultopride. cap. 25mg-28 (Cal/Pk), A7.63; 50mg-28 (Cal/Pk), B See 2.4, b-blockers Drug Presc. Notes. A13.12. Iodated contrast products. Driving/operating S Prophylaxis of angina pectoris. machinery. Contains lactose. P 25-50mg in the morning swallowed C See 2.4, b-blockers Drug Presc. Notes. whole. Anti-cholinesterastic drugs. Amifostine. NSAID. Q Not recommended. A See 2.4, b-blockers Drug Presc. Notes. 2MO Headache. ALSO ELANTAN Isosorbide mononitrate 10mg, 20mg, 40mg. White scored tabs. marked E10, E20 DILTAM RETARD Rowex or E40. 10mg-56, A4.43; 10mg-84, A6.64; 20mg2MO 56, A5.64; 20mg-84, A8.00; 40mg-56, A9.20; 40mg-84, A13.77. Class III Ca++ antagonist. Diltiazem (HCl) 90mg. A P Initial dosage for patients not already White sust.-release tab. 60, 12.38. receiving prophylactic nitrate therapy, 10mg twice S Angina pectoris incl. Prinzmetal’s daily, dose may be increased to 10mg three times angina. daily. Others, 40-80mg daily in two or three P Initially 60mg twice daily increasing to divided doses after meals. Max. 120mg daily. 90mg twice daily. Q Not recommended. R Initially 60mg twice daily increasing D Acute MI and cardiac shock. Severe gradually. hypotension. Q Not recommended. C Alcohol. D Pregnancy, lactation. Sick sinus A Headache, flushes, dizziness. syndrome, 2nd or 3rd degree AV block, marked bradycardia, decompensated cardiac failure. Gerard B Mild bradycardia, prolonged PR interval. EMCOLOL Measure heart rate regularly in elderly and in 3O patients with hepatic or renal impairment. Cardioprotective b-blocker. Bisoprolol fumarate Diabetes. 5mg and 10mg. Yellow and orange heart-shaped, C b-blockers, digoxin, cimetidine, scored film-ctd tabs. resp. 5mg-28, A5.93; 10mgdiazepam, antihypertensives, anaesthetics. 28, A6.65. A Anorexia, nausea, bradycardia, oedema, S Angina pectoris rash, flushing, fatigue, AV block, headache, GI P Usually 10mg once daily. Max. 20mg disturbance. daily. Q Not recommended. DILZEM XL Cephalon D See 2.4, b-blockers Drug Presc. Notes.

2MO Class III Ca++ antagonist. Diltiazem (HCl) 120mg, 180mg, 240mg. Prolonged release hard capsules marked with cap. strength and logo. 120mg-28, A8.39; 180mg-28, A12.44; 240mg-28, A16.06. S Angina pectoris, incl. Prinzmetal’s angina. Mild to moderate hypertension. P 180mg once daily increasing gradually, as necessary to 360mg once daily. R Initially 120mg once daily, increasing gradually.

function: Max. 10mg once daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. Acute HF or during episodes of HF decompensation requiring IV inotropic therapy.

ENTRYDIL

Orion

2MO Class III Ca++ antagonist. Diltiazem 60mg. White film-ctd scored caplet coded DL60. 100, A17.16. S Angina pectoris. P Usually 1 three times daily, increasing if necessary to up to 8 daily in divided doses. R Initially 1 twice daily. Q Not recommended.

2MO ALSO ENTRYDIL CR Diltiazem 90mg, 120mg. Modified release white scored film-ctd caplets marked DL 90 or DL 120. 90mg-100, A21.53; 120mg-100, A35.60. P Usually 90-120mg twice daily increasing to 180-240mg twice daily if necessary. Q Not recommended. D Pregnancy. Sick sinus syndrome, 2nd or 3rd degree AV block, marked bradycardia, decompensated cardiac failure. B Mild bradycardia, prolonged PR interval. Measure heart rate regularly in elderly and in patients with hepatic or renal impairment. C b -blockers, digitalis. A Anorexia, nausea, bradycardia, oedema, rash, flushing

EUCARDIC

Roche

3MO a/b-blocker. Carvedilol 12.5mg, 25mg. Resp. light brown or pale beige round scored tab. marked BM on one side and H3 or D5 on other side. 12.5mg-28, A4.78; 25mg-28, A5.72. S Long-term management of stable angina pectoris. P Initially, 12.5mg twice daily for first 2 days. then 25mg twice daily. If necessary titrate at 2 week interval up to 50mg twice daily. R Max. 50mg daily in divided doses. Q Under 18 years, not recomended. D See 2.4, b-blockers Drug Presc. Notes. NYHA class IV decompensated HF requiring IV inotropic support, liver dysfunction. Contains lactose.

GLYTRIN SPRAY

Pharmasol

2MO

Nitrate. Glyceryl trinitrate 0.4mg/metered dose. CFC-free spray. 200 dose unit, A3.89. S Treatment and prophylaxis of angina pectoris and treatment of variant angina. P 1-2 doses as required for relief of angina pain or for short-term prophylaxis before exercise. Max. 3 doses per angina attack. All by sublingual admin. Q Not recommended. D Hypotensive disorders incl. shock, severe anaemia, cerebral haemorrhage and brain trauma, EMCOR Daiichi Sankyo/Merck Serono mitral stenosis, angina caused by hypertrophic obstructive cardiomyopathy. 3MO C Alcohol. Cross tolerance to other Cardioselective b-blocker. Bisoprolol fumarate nitrates. 5mg, 10mg. Yellow and orange biconvex film-ctd A Headache, flushing, postural heart-shaped scored tabs. 5mg-28, A3.56; 10mghypotension, tachycardia and paradoxical A 28, 4.01. bradycardia. S Angina pectoris. P Usually 10mg once daily; max. 20mg IKOREL sanofi-aventis daily. In some 5mg/day may be adequate. Final 2MO stage impairment of renal function or liver

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

35


2.2 ANGINA

CIRCULATORY SYSTEM

Potassium channel opener. Nicorandil 10mg, 20mg. White scored tabs. marked IK10 or IK20. 10mg-60, A12.84; 20mg-60, A22.73. S Prevention and management of angina pectoris. P Initially: 10mg twice daily. Titrate according to response. Maintenance: 10-20mg twice daily; max. 40mg twice daily. Patients susceptible to headache, initially 5mg daily. Q Not recommended. D Cardiogenic shock with depleted blood volume, hypotension, LV failure with low filling pressure or acute pulmonary oedema and myocardial infarction. Pregnancy, lactation. C Antihypertensive drugs, TCADs. A Headache, flushing, nausea, dizziness, hypotension and tachycardia.

Q Not recommended. D Uncompensated cardiac shock. Severe hypotension. Marked anaemia. Cerebral haemorrhage. A Headache, flushes, dizziness.

ISOMEL SR 60 2MO

nausea, palpitations, fatigue, abdominal pain, somnolence.

ISTOLDE

Actavis

2MO Ca++ antagonist. Amlodipine 5mg, 10mg. White,

Clonmel uncoated, round, flat, tab. with score on one side,

Nitrate. Isosorbide mononitrate 60mg. Yellow oval film-ctd modified release tab. scored on both sides and marked IM60. 28, A9.95. S Prophylaxis of angina. P 1 daily in the morning, increasing if necessary to max. 2 once daily. Q Not recommended. D Severe cerebrovascular insufficiency, hypotension. Pregnancy, lactation. B Not indicated for acute angina attacks. IMDUR AstraZeneca C Alcohol, NA, acetylcholine, histamine, 2MO anti-hypertensives. Nitrate. Isosorbide mononitrate 60mg. Yellow oval A Headache, hypotension, dizziness, film-ctd sust.-release tab. scored and marked A/ID. nausea. 28, A6.36. ISOMONIT RETARD Rowex S Prophylaxis of angina. P 1 daily in the morning, increasing if 2MO necessary to max. 2 once daily. Nitrate. Isosorbide mononitrate 60mg. White Q Not recommended. scored prolonged release tab. 30, A10.79. D Acute myocardial infarction, anaemia, S Prophylaxis of angina. head trauma, cerebral haemorrhage, severe P 1 daily in the morning, increasing if hypotension, cerebrovascular insufficiency. necessary to max. 2 once daily. Pregnancy, lactation. Q Not recommended. B Closed angle glaucoma. Hypothyroidism, D Acute myocardial infarction with low malnutrition, severe renal or hepatic disease. filling pressure, circulatory failure, marked C Alcohol. anaemia, head trauma, cerebral haemorrhage, A Headache, dizziness, nausea, severe hypotension, hypovolaemia, severe hypotension, collapse. cerebrovascular insufficiency. B Closed angle glaucoma. Hypothyroidism, INDERAL LA AstraZeneca malnutrition, severe renal or hepatic disease. 3MO C Alcohol. Non-cardioselective b-antagonist. Propranolol (HCl) A Headache, dizziness, nausea, hypotension, collapse. 160mg. Lavender/pink hard prolong.-release cap. marked INDERAL LA. 28, A8.41.

embossed with AB5 or AB10 on the other. 5mg28, A8.54; 10mg-28, A12.71. S Chronic stable and vasospastic angina pectoris. P Initially 5mg once daily. If no effect within 2-4 weeks, may be increased to max. 10mg once daily. As monotherapy or in combination with anti-anginal medication. R Caution when increasing dose. Q Under 18 years, not recommended. D Severe hypotension. Shock (incl. cardiogenic). Heart failure after acute MI (first 28 days). High-grade aortic stenosis. Unstable angina pectoris. Pregnancy, lactation. B Caution: Cardiac failure, hypertensive crisis (safety and efficacy not established), dialysis, hepatic impairment, heart failure (increased incidence of pulmonary oedema in NYHA class III and IV). C Caution: CYP3A4 inhibitors/ inducers, other antihypertensives. A Headache, somnolence, dizziness, weakness, palpitations, GI disorders, ankle oedema, facial flushing with heat sensation.

METOCOR

Rowex

3MO Cardioselective b-blocker. Metoprolol tartrate 50mg, 100mg. White tabs. scored one side. 50mg100, A3.50; 100mg-100, A6.50. S Angina. P 50-100mg twice or three times daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

3MO

ISOPTIN

ALSO HALF-INDERAL LA Propranolol (HCl) 80mg. Lavender/pink hard prolong.-release cap. marked HALF-INDERAL LA. 28, A6.13. S Angina. P 80mg or 160mg daily. Max. 240mg daily. Q Not recommended.

2MO

3MO

Class I Ca++ antagonist. Verapamil (HCl) 40mg, 80mg, 120mg. White film-ctd tabs. 40mg-100, A2.12; 80mg-100, A4.24; 120mg-100, A6.36. S Angina. P 120mg three times daily. Q Not recommended. D Cardiogenic shock. 2nd or 3rd degree AV block. Severe bradycardia. Unconpensated cardiac failure. Sick sinus syndrome. B 1st degree AV block. Poor cardiac reserve should be controlled with digitalis and diuretics. Hepatic impairment. Acute phase of myocardial infarction. Bradycardia. C b-blockers, quinidine or digoxin. A Constipation, headache, flushes.

Cardioselective b-blocker. Metoprolol tartrate 50mg, 100mg. White tabs. Both marked ml and strength one side, G on reverse. 50mg-100, A3.50; 100mg-100, A6.51. S Angina. P 50mg twice daily or 100mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

3MO ALSO INDERAL TABLETS Propranolol (HCl) 10mg. Pink film-ctd tab. marked Inderal 10. 10mg-100, A1.20. S Angina pectoris. P Initially 40mg two or three times daily increasing as necessary at weekly intervals; usual dose 120-240mg daily. Q Up to 1mg/kg body weight three or four times daily. D See 2.4, b-blockers Drug Presc. Notes. Tabs contain lactose.

Abbott

METOP

Gerard

MYOSTIN

Teva

2MO

Ca++ antagonist. Amlodipine 5mg, 10mg (as amlodipine maleate). White, round, tab. scored on one side. 5mg-28, A8.28; 10mg-28, A12.38. S Chronic stable and vasospastic angina pectoris as monotherapy or in combination with ISTIN Pfizer other antianginal drugs. 2MO P 5mg once daily. If no sufficient effect within 2-4 weeks, may be increased to max. 10mg Ca++ antagonist. Amlodipine besylate 5mg, 10mg. ISOKET 0.1% UCB once daily. White emerald-shaped tabs. marked AML-5 or 2N Q Under 18 years, not recommended. AML-10 resp. and Pfizer on reverse. 5mg-28, A5.53; 10mg-28, A8.26. Nitrate. Isosorbide dinitrate 1mg/ml. Soln. Amps.D Severe hypotension, shock, HF after 10 x 10ml, A59.11; Bottles-50ml, A29.33; 100ml, acute MI (during 1st 28 days), obstruction of S Prophylaxis of angina pectoris A40.50. outflow-tract of left ventricle, unstable angina associated with myocardial ischaemia. 2N pectoris. Lactation, pregnancy (unless clearly P Initially 5mg daily increasing to max. necessary). 10mg. ALSO ISOKET 0.05% Isosorbide dinitrate 0.5mg/ A B Low cardiac reserve, hepatic Q Not recommended. ml. 50ml, 15.69. impairment, cardiac failure, elderly; caution. B Impaired liver function. Pregnancy, S Severe or unstable angina pectoris. Driving/using machines. P 2-10mg/hour adjusting according to lactation. C Caution: CYP3A4 inhibitors/inducers, response. Max. 20mg/hour. A Oedema, headache, flushing, dizziness,

36

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Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM

ANGINA 2.2

other antihypertensives incl. b-blockers. A Ankle swelling, headache, dizziness, fatigue, asthenia, palpitations, dyspnoea, abdominal pain, nausea, dyspepsia, flushing.

NIFED

Rowex

2MO Class II Ca antagonist. Nifedipine 10mg. Oblong brown caps. 100, A7.01. S Acute and chronic coronary insufficiency in particular angina pectoris. P 30-60mg daily in divided doses. R 15mg in divided doses. Q Not recommended. ++

2MO ALSO NIFED RETARD Nifedipine 10mg, 20mg. Pink film-ctd modified-release tabs. 10mg-60, A8.08; 20mg-100, A18.16. P Initially 10mg twelve hourly, increasing if necessary to 40mg twelve hourly. Q Not recommended. D Cardiogenic shock. unstable angina pectoris, advanced aortic stenosis, porphyria, acute MI. Women of child-bearing potential. Pregnancy, lactation. B Caution: Severe hypotension, poor cardiac reserve, diabetes, malignant hypertension, irreversible renal failure with hypovolaemia, risk of hypotensive crisis (medical supervision). 20mg Retard tab. contain lactose. C Not recommended: Rifampicin, antiepileptics. Caution: Cimetidine, erythromycin, nefazodone, azole antifungals, digoxin, diltiazem, cyclosporine, tacrolimus, vincristine, antidiabetics, qinidine, cisapride. Avoid grapefruit juice. A Headache, facial reddening, palpitations, dizziness, leg oedema.

sympathomimetics, prostaglandin synthetaseinhibiting drugs, anaesthetics, cimetidine. A Oedema, dizziness, headache, GI disturbance, purpura, impotence, fatigue.

ventricular (LV) failure until appropriate IV therapy. P Hold canister to mouth, spray under tongue and close mouth immediately. Acute attack: 1-2 doses; max. 3 per attack. ExerciseNITRO-DUR Schering-Plough induced angina: 1-2 doses before exertion. LV failure: 2 doses as quickly as possible in upright 2MO position, repeated as necessary. Nitrate. Glyceryl trinitrate 0.1mg/hour (20mg), Q Not recommended. 0.2mg/hour (40mg), 0.4mg/hour (80mg), 0.6mg/ hour (120mg). Transdermal patch. 0.1mg/hour-28, D Hypotensive shock, severe anaemia, cerebral haemorrhage and brain trauma, mitral A14.05; 0.2mg/hour-28, A18.36; 0.4mg/hour-28, stenosis, arterial hypoxaemia, uncorrected A20.32; 0.6mg/hour-28, A22.36. hypovolaemia and angina caused by hypertrophic S Prophylaxis of angina pectoris. obstructive cardiomyopathy. Pregnancy, lactation P Initially one 0.2mg/hour patch daily; (unless benefi outweighs risk). titration to higher or lower doses may be C Contra: Phosphodiesterase inhibitors for necessary. Patches are suitable for continuous or intermittent use. Patches may be applied for a 12 erectile dysfunction. A Headache, somnolence, dizziness, hour period then removed to provide a nitratetachycardia, hypotension, orthostatic hypotension. free interval, of 12 hours. Q Not recommended. NORTENOLOL Tillomed D Severe hypotension, increased 3MO intracranial pressure, myocardial insufficiency. B Acute myocardial infarction, CHF. Cardio-selective b-blocker. Atenolol 25mg, 50mg, Arterial hypoxemia due to anaemia. Closed angle 100mg. White, white, orange unscored film-ctd glaucoma. tabs. marked A25, A50, A100 resp. 25mg-30, A2.70; 50mg-30, A4.10; 100mg-30, A5.98. C Vasodilating agents, ACE inhibitors, alcohol, anti-hypertensive agents, b-blockers, S Angina pectoris. phenothiazines, Ca++ channel blocking agents. P 100mg daily or 50mg twice daily. Renal A Headache, dizziness, rash. impairment: See SPC. Q Not recommended. NITROCINE UCB D See 2.4, b-blockers Drug Presc. Notes.

2N

Nitrate. Glyceryl trinitrate 1mg/ml. Soln. in amps. and bottles. Amps.-10 x 10ml, A128.94; Bottles-1 x 50ml, A30.22. S Rapid control of hypertension and myocardial ischaemia during cardiac surgery. Reduction of BP and controls for hypotension NIFTEN AstraZeneca during surgical procedures. Treatment of unresponsive CHF secondary to acute MI. Indicated 3MO for unstable angina. Cardioselective b-blocker/Class II Ca++ antagonist. P Surgery: Starting dose 25mcg/min Atenolol 50mg, sust.-release nifedipine 20mg. increased by increments of 25mcg/min at 5 min Reddish brown cap. marked NIF-TEN. 28, A12.96. intervals until BP stabilised. 10 -200mcg/min S Angina inadequately controlled on sufficient; max. 400mcg/min. Perioperative monotherapy. myocardial ischaemia: 15 – 20mcg/min with P 1 twice daily, if necessary prophylactic increments of 10 -15mcg/min until stabilised. nitrate therapy or additional nifedipine may be Unresponsive CHF: 20 -25mcg/min increased in given. steps of 20 -25mcg/min every 15 – 30mins R Max. 1 twice daily. until stabilised. Lowest dose: 10mcg/min. Unstable Q Not recommended. angina: Initial dose 10mcg/min with increments of D Bradycardia, cardiogenic shock, hypotension, metabolic acidosis, severe peripheral 10mcg/min every 30 mins. arterial circulatory disturbances, 2nd or 3rd degree D Anaemia, severe cerebral haemorrhage, head trauma, uncorrected hypovolaemia, severe heart block, sick sinus syndrome, untreated phaeochromocytoma, uncontrolled HF, pregnancy, hypotension. Pregnancy, lactation. B Monitor pulse and BP. Hypothyroidism, lactation, severe aortic stenosis, marked renal severe liver/renal disease, hypothermia, impairment (ccQ 15 ml/min). malnutrition. B Controlled HF. Conduction defects or C b blockers, Ca++ antagonists, alcohol. poor cardiac reserve. Prinzmetal’s angina, 1st PDE-5 inhibitors e.g. Sildenafil. Do not admin. degree heart block. May aggravate less severe within 48 hours after taking PDE-5 inhibitors. peripheral arterial circulatory disturbances. May Neuroleptics, TCAs. modify tachycardia of hypoglycaemia. May mask A Headaches, nausea, hypotension, thyrotoxicosis. Will reduce heart rate. Do not tachycardia, retching, sweating, apprehension, discontinue abruptly in ischaemic heart disease. restlessness, muscle twitching, retrosternal History of anaphylactic reaction to allergens. discomfort, palpitations, dizziness, abdominal pain. Asthmatics, diabetes, clinically significant liver disease. Discontinue if ischaemic pain occurs. Use NITROLINGUAL SPRAY Merck Serono in men in in vitro fertilisation. 2MO C Contra: Ca++ channel blockers with Nitrate. Glyceryl trinitrate 0.4mg per metered negative inotropic effects (e.g. verapamil, dose. Pump spray. 200 dose, A5.07. diltiazem), rifampicin. Grapefruit juice, not recommended. Caution: Other dihydropyridines, S Treatment and prophylaxis of angina, digitalis glycosides, clonidine, class 1 incl. variant angina. Emergency treatment of antiarrhythmics (e.g. disopyramide), amiodarone, pulmonary oedema secondary to acute left

PROCORALAN

Servier

2NO Pure heart rate lowering agent. Ivabradine 5mg, 7.5mg (as ivabradine HCl). Salmon, film-ctd tabs. marked with strength on one side and symbol on reverse. 5mg oblong scored; 7.5mg triangular. 5mg-56, A56.00; 7.5mg-56, A56.00. S Chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm: In patients unable to tolerate or with a contra-indication to b-blockers; in combination with b-blockers in patients inadequately controlled with optimal b-blocker dose and with heart rate q 60bpm. P Initially, 5mg twice daily (morning and evening during meals). After three to four weeks, may be increased to 7.5mg twice daily. If heart rate decreases persistently Q 50bpm at rest or if symptoms of bradycardia occur, titrate dose downward possibly to 2.5mg twice daily. Discontinue if heart rate Q 50bpm or symptoms of bradycardia persist. R 75 years or more, consider initial dose of 2.5mg twice daily. Q Children and adolescents, not recommended. D Resting heart rate Q 60bpm before treatment, cardiogenic shock, acute MI, severe hypotension (Q 90/50mmHg), severe hepatic insufficiency, sick sinus syndrome, sino-atrial block, HF NYHA III-IV, pacemaker dependent, unstable angina, AV-block 3rd degree. Pregnancy, lactation. B Avoid: AV-block 2nd degree, atrial fibrillation or other cardiac arrhythmias interfering with sinus node function, immediately after a stroke, congenital QT syndrome. Caution: Severe renal insufficiency (ccQ15ml/min), moderate hepatic impairment, HF NYHA I-II, asymptomatic LV dysfunction, retinitis pigmentosa, mild to moderate hypotension. Monitor for occurrence of atrial fibrillation. Contains lactose. C Contra: Strong CYP3A4 inhibitors (azole

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

37


2.2 ANGINA

CIRCULATORY SYSTEM

10-30ml/min: Quarter normal dose; cc Q10ml/min: Avoid. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. Prolonged QT interval, torsades de pointes, renal SELECTOL sanofi-aventis failure. B Caution: Pre-existing arrhythmias, QT 3MO interval q 550msec. Electrolyte disturbances esp. Vasodilating cardioselective b-blocker. Celiprolol hypokalaemia or hypomagnesaemia. Caution: Left (HCl) 200mg, 400mg. 200mg yellow heart-shaped tab.; 400mg white heart-shaped tab. Both marked ventricular dysfunction, recent MI. See b-blockers Prescribing Notes. See 2.4, b-blockers Drug Presc. with logo one side and 200 or 400 on reverse. RANEXA A. Menarini 200mg-28 (Cal/Pk), A12.08; 400mg-28 (Cal/Pk), Notes. ;NO A15.11. SUSCARD BUCCAL Forest S Angina pectoris. Antianginal. Ranolazine 375mg, 500mg, 750mg. P 200mg once daily. In case of inadequate 2 M O Resp. pale blue, light orange or pale green ovalshaped prolonged-release tabs engraved with CVT response, increase to 400mg once daily taken one Nitrate. Glyceryl trinitrate 2mg, 3mg, 5mg. White hour before or two hours after meals. and strength on one side. 375mg-60, A53.37; sust.-release tabs. marked with tab. strength. 2mgQ Not recommended. 100, A20.19; 3mg-100, A28.29; 5mg-100, A39.67. 500mg-60, A53.37; 750mg-60, A53.37. D See 2.4, b-blockers Drug Presc. Notes.. S Add-on therapy for symptomatic S Treatment and prophylaxis of angina Acute HF or during episodes of HF treatment of patients with stable angina pectoris pectoris. decompensation requiring IV inotropic therapy. inadequately controlled or intolerant to first-line P Acute: initially 2mg as required. Chronic: antianginal therapies (b-blockers and/or Ca++ 2mg three times daily increasing strength and SOPROL Helsinn Birex frequency if necessary. Place tab. high up between antagonists). the upper lip and gum and allow to dissolve. P Initially 375mg twice daily. After 2-4 3MO Q Not recommended. weeks, titrate to 500mg twice daily. May be Cardioselective b-blocker. Bisoprolol fumarate A Headache, flushes. further titrated to 750mg max twice daily. Down- 5mg, 10mg. White film-ctd tabs. marked titration to 500mg or 375mg twice daily may be BISOPROLOL and tab. strength on one side. 5mgTENORMIN AstraZeneca required if adverse events occur. Moderate hepatic 28, A3.45;10mg-28, A3.86. impairment, mild to moderate renal impairment, 3MO S Angina pectoris. CHF, low weight, elderly: Caution during titration. P Usually 10mg once daily; max. 20mg Cardioselective b-blocker. Atenolol 25mg, 50mg, daily. 100mg. White, white, orange biconvex film-ctd Q Not recommended. Q Not recommended. tabs. marked Tenormin 25, Tenormin 50, and D Severe renal impairment (ccQ30 ml/ D See 2.4, b-blockers Drug Presc. Notes. Tenormin respectively. 100mg bisected on reverse. min). Moderate/severe hepatic impairment. Acute HF or during episodes of HF 25mg-28, A1.97; 50mg-28, A2.54; 100mg-28, Pregnancy (unless clearly necessary), lactation. A3.23. decompensation requiring IV inotropic therapy. B Caution when prescribing or uptitrating: C See 2.4, b-blockers Drug Presc. Notes. S Cardiac arrhythmias. Early intervention Patients at increased exposure risk (mild hepatic Avoid: Floctafenine, sultopride. Caution: in acute MI. Angina pectoris. Hypertension. impairment, mild to moderate renal impairment Rifampicin, baclofen, iodated contrast products, P 50-100mg daily. (cc, 30-80ml/min), elderly, low weight (R60 kg), mefloquine, corticosteroids. Q Not recommended. moderate to severe CHF (NYHA Class III窶的V)), if D See 2.4, b-blockers Drug Presc. Notes. SORMON Gerard several factors are combined monitor adverse TILDIEM LA Sanofi events frequently, reduce dose, discontinue 2MO treatment if needed; increased exposure risk in 2MO Nitrate. Isosorbide mononitrate 60mg. Yellow, patients lacking CYP2D6 activity; congenital or ++ elliptical, film-ctd tab. with breaklines, marked IM Class III Ca antagonist. Diltiazem (HCl) 200mg family history of long QT syndrome, known 60 on one side. 28, A10.24. pink/grey cap.; 300mg white/yellow cap.; acquired QT interval prolongation. Check renal containing immediate release and sust.-release S Prophylaxis of angina. function regularly. Contains lactose, E110, E102. pellets. 200mg-28, A11.87; 300mg-28, A12.95. P 1 daily in the morning, increasing if C Contra: Potent CYP3A4 inhibitors, Class necessary to max. 2 once daily. S Angina. Ia or Class III antiarrhythmics other than Q Not recommended. P Initially 1 x 300mg once daily, increasing amiodarone. Avoid Ranexa initiation: Inducers of D Acute myocardial infarction, anaemia, if necessary to 2 x 200mg once daily, or then 1 x CYP3A4. Careful titration (down titration may be head trauma, cerebral haemorrhage, severe 200mg plus 1 x 300mg daily. required): Moderately potent CYP3A4 inhibitors, P- hypotension, cerebrovascular insufficiency. R Initially 1 x 200mg daily increasing to 1 gp inhibitors. Caution: CYP2D6 inhibitors, CYP2B6 Pregnancy, lactation. x 300mg once daily. substrates, digoxin (monitor levels during initiation B Closed angle glaucoma. Hypothyroidism, Q Not recommended. and termination of Ranexa), drugs known to malnutrition, severe renal or hepatic disease. 2MO prolong the QTc interval such as certain C Alcohol. ALSO TILDIEM RETARD Diltiazem (HCl) 90mg, antihistamines, certain antiarrhythmics, A Headache, dizziness, nausea, 120mg. Off-white sust.-release tabs. 90mg-56, erythromycin and TCAs. hypotension, collapse. A13.66; 120mg-56, A15.19. A Dizziness, headache, GI disorders, P 90-120mg twice daily. Max. 480mg asthenia. SOTACOR BMS daily. Q Not recommended. 3MO RUSTIN Helsinn Birex Non-cardioselective b-blocker. Sotalol (HCl) 80mg, 2 M O 2MO ALSO TILDIEM Diltiazem (HCl) 60mg. Off-white 160mg. Both white tabs. scored on one side and tab. coded TILDIEM 60. 90, A15.48. Ca++ antagonist. Amlodipine 5mg, 10mg (as tab. strength marked on other side. 80mg-28, amlodipine besilate). White, round, slightly arched A1.60; 160mg-28, A3.16. P Usually 60mg three times daily, tabs. marked with AB 5 or AB 10 resp. 10mg tab. S Prevention of myocardial infarction. increasing if necessary to max. 480mg daily in is scored. 5mg-28, A4.40; 10mg-28, A6.58. Cardiac arrhythmias. Angina. Hypertension. divided doses. P Reinfarction: 320mg once daily, starting R Initially 60mg twice daily, increasing to S Prophylaxis of angina pectoris 5-14 days after infarction. Arrhythmias: Initial dose 90-120mg twice daily. associated with MI. 80mg either singly or as 2 divided doses. Allow 2-3 Q Not recommended. P 5mg once daily, may be increased to days between increments. Most respond to dose D Pregnancy. Sick sinus syndrome; 2nd or max. dose of 10mg daily depending on response. of 160-320mg admin. in 2 divided doses at 12 hr 3rd degree AV block; marked bradycardia. Q Not recommended. intervals. In renal impairment; cc q60ml/min: B Observe patients with mild bradycardia D Lactation, pregnancy (unless clearly Normal dose; cc 30-60ml/min: Half normal dose; cc or a prolonged PR interval. Measure heart rate necessary). antifungals, macrolide antibiotics, HIV protease inhibitors, nefazodone). Avoid: Ca++ channel blockers (verapamil, diltiazem), QT prolonging agents. Caution: Moderate CYP3A4 inhibitors, grapefruit juice, CYP3A4 inducers. A Transient luminous phenomena (phosphenes), blurred vision (discontinue if unexpected deterioration). Bradycardia, AV 1st degree block, ventricular extrasystoles. Headache, dizziness.

38

B Heart failure, hepatic impairment. A Somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, oedema, fatigue.

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Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM

OEDEMA 2.3 affecting chorioretinal tissue and cochleovestibular structures. P 1 three times daily with meals. Q Not recommended. B Closed angle glaucoma. Pregnancy, lactation. UCB C MAOIs.

regularly in the elderly and in patients with hepatic or renal impairment. C b -blockers, digitalis. A Bradycardia, 1st degree AV block, ankle oedema, nausea, headache, rash.

TRANDATE 3MO

a/b-blocker. Labetalol (HCl) 100mg, 200mg. Orange film-ctd tabs. marked with tab. name and strength. 100mg-50, A5.07; 56, A5.67; 250; A24.16; 200mg-50, A8.18; 56, A9.16; 250, A38.27. S Hypertension, incl. hypertension of pregnancy and for long term management of hypertension following acute myocardial infarction. Angina. P Initially 100mg twice daily with food increasing if necessary at fouteen day intervals. Max. 2.4g daily in three or four divided doses. Q Not recommended. B See 2.4, b-blockers Drug Presc. Notes. Liver damage. Contains sodium benzoate.

TRANSIDERM-NITRO

Novartis

2MO Nitrate. Glyceryl trinitrate 5mg, 10mg or 15mg per 24 hours. Transdermal patches. 5mg-28, A17.46; 10mg-28, A19.17; 15mg-30, A19.94. S Prophylaxis of angina pectoris, as monotherapy or in combination with other antianginal agents. Apply to non-hairy area of lateral chest wall, remove and replace with new patch using a different site daily. P Commence with 5mg patch, increasing to 10mg or 15mg, max. 2 x 10mg if necessary. A nitrate free interval of 8-12 hours (usually at night) during each 24 hour period is recommended. Q Not recommended. D Severe hypotension or hypovolaemia. Raised intracranial pressure. Myocardial insufficiency due to obstruction. B Recent myocardial infarction or acute HF. Arterial hypoxemia due to anaemia. Closed angle glaucoma. A Headache, rash, dizziness.

TRANTALOL

Pinewood

3MO Cardioselective b-blocker. Atenolol 25mg, 50mg, 100mg. White tabs. 25mg: Circular, flat, scored on one side. 50mg and 100mg: Biconvex, film-ctd, marked 1U1 and 2U1 resp. 25mg-30, A2.54; 50mg30, A3.90; 100mg-30, A5.50. S Angina pectoris. P 100mg once daily or 50mg twice daily. Renal failure: Reduce dose (see SPC). Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. B Caution: Patients with poor cardiac reserve. Will reduce heart rate. Contains lactose (50mg and 100mg). See 2.4, b-blockers Drug Presc. Notes. C See 2.4, b-blockers Drug Presc. Notes. A Precipitation of atrioventricular block, purpura, thrombocytopenia, impotence. See 2.4, bblockers Drug Presc. Notes.

VASTAREL

Servier

2MO Cellular anti-ischaemic. Trimetazidine (diHCl) 20mg. Red film-ctd tab. 90, A12.72. S All grades of angina and as an adjunct in the treatment of certain ischaemic disorders

P 40-120mg three times daily. Q Not recommended. D Cardiogenic shock. 2nd or 3rd degree AV block. Severe bradycardia. Uncompensated cardiac failure. Sick sinus syndrome. B 1st degree AV block. Poor cardiac reserve should be controlled with digitalis and diuretics. Hepatic impairment. Acute phase of MI. VERAMIL Orion Bradycardia. C b-blockers, quinidine or digoxin. 2MO A Constipation, headache, flushes. Class I Ca++ antagonist. Verapamil chlor. 40mg, 80mg, 120mg. White film-ctd tabs. coded VL-40, 2.3 OEDEMA VL-80 and VL-120. 40mg-100, A5.17; 80mg-100, A8.67; 120mg-100, A11.56. ALDACTIDE Pharmacia S Chronic angina pectoris, both stable and 5NO unstable. Vasospastic (Prinzmetal variant) angina. + P 120mg three to four times daily. Angina K sparing/thiazide. Spironolactone, hydroflumethiazide 25mg/25mg, 50mg/50mg. of effort, 80mg three times daily may be Circular, biconvex, buff coloured, film-ctd tab. sufficient. Severe liver dysfunction: Use 1/3 dose. with peppermint odour marked SEARLE 101 and D Severe left ventricular dysfunction. Severe hypotension, cardiogenic shock. 2nd or 3rd SEARLE 180 resp. 25mg-100, A18.00; 50mg-28, A9.53; 100, A34.02. degree AV block. Marked bradycardia. Sick sinus syndrome. CHF incl. including uncompensated HF. S Hypertension, control of oedema in congestive heart failure. Lactation. P Hypertension, 25-100mg spironolactone B 1st degree AV block reported. Hypertrophic cardiomyopathy, elderly, attenuated daily with breakfast. CHF, initially 100mg neuromuscular transmission. Mild to moderate HF spironolactone daily with food; then adjust range 25-100mg daily. Continue at least 2 weeks for (control with digitalis and diuretics). Porphyria adequate response. (unsafe). Hepatic impairment (monitor during Q 1.5-3mg/kg spironolactone daily in long-term therapy). Contains lactose. Pregnancy. C Grapefruit juice, digitalis intoxication, IV divided doses. b-blockers (contra). Colchicine, cisapride (avoid). a/ D Anuria, acute renal insufficiency, severe or progessive renal failure, hyperkalaemia, b-blockers, CYP3A4 inhibitors/substrates, precoma associated with severe liver disease, antiarrhythmics, CCBs, cardiac glycosides, Addison’s disease, significant hypercalcemia. theophylline, imipramine, glyburide, doxorubicin, Neonates and young infants. Lactation. paclitaxel, tamoxifen, cimetidine, statins, B Monitor serum electrolystes periodically. almotriptan, halothane, dantrolene, Ca++ salts, May induce hyper/hypokalaemia, hyponatremia, alcohol, lithium, timolol eye drop, quinidine, hyperlipidaemia, hyperglycaemia, increases in antihypertensives. blood urea, hyperuricaemia; caution in elderly, A Constipation, headache, dizziness, obstruction of the urinary tract, hepatic or renal fatigue, rash, bradycardia, hypotension, cardiac impairment, diabetes, gout. Pregnancy. insufficiency, swelling of ankles. C Contra: K+suppl, K+ sparing diuretics. VERAP Rowex Caution: Diuretics, glucocorticoids, ACTH, digoxin, drugs with pro-arrhythmic effects, 2MO antihypertensives, aldosterone blockers, Class I Ca++ antagonist. Verapamil (HCl) 120mg, carbenoxolone, anaesthesia, colestyramine, 240mg. Beige scored and green oblong scored colestipol, lithium, skeletal muscle relaxants, both sides; both film-ctd prolonged release tabs. NSAIDs, aspirin, indometacin, mefenamic acid, 120mg-30, A5.43; 240mg-30, A10.85. antipyrine, ammonium chloride orcolestyramine. S Angina. A Gynaecomastia, GI upset, drowsiness, P 120-240mg twice daily. rash, photosensitivity, blood dyscrasias. Q Not recommended. D Cardiovascular shock, recent cardiac ALDACTONE Pharmacia infarction with complications, grade II and III AV 5NO block, sinu-atrial blockage, sick sinus syndrome. K+sparing. Spironolactone 25mg, 50mg, 100mg. B Monitor BP at regular intervals Round, biconvex tabs. with peppermint odour particularly in 1st degree AV block, hypotension, marked SEARLE/39, SEARLE/916 or SEARLE/134 bradycardia, atrial fibrillation/flutter or resp. 25mg, 100mg: Buff coloured. 50mg: White. simultaneous pre-excitation syndrome. Impaired 25mg-100, A10.56; 50mg-100, A21.10; 100mg-28, hepatic function. Pregnancy, lactation. A11.82; 100, A42.19. C Anti-arrhythmic drugs, b-blockers, S Oedema associated wit CHF, inhalation anaesthetics, quinidine, digoxin, hypertension, hepatic cirrhosis, malignant ascites, lithium, carbamazepine, cimetidine, ranitidine, nephrotic syndrome, primary aldosteronism. grapefruit juice. P CHF: 100mg daily increasing if necessary A Constipation, dizziness, giddiness, to 200mg daily; maintenance, 75-200mg daily. nervousness, headaches, fatigue, flush, paresthesia. Hypertension: 50-100mg daily increasing if necessary at two weekly intervals up to 200mg VERISOP Gerard daily. All with food. Other conditions, see SPC. 2MO Q Initially 3mg/kg daily in divided doses. ++ Class I Ca antagonist. Verapamil chlor. 40mg, D Anuria, acute renal insufficiency, 80g, 120mg. White tabs. marked VL and strength progressive/ severe renal impairment, one side, G on reverse. 40mg-100, A3.53; 80mghyperkalaemia, precoma associated with severe 100, A5.16; 120mg-100, A10.59. liver disease. Lactation. B Monitor serum electrolytes periodically. S Angina.

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

39


2.3 OEDEMA

CIRCULATORY SYSTEM

maintenance, 2.5-5mg daily. D Severe electrolyte imbalance. Severe renal/hepatic impairment. Addison’s disease, established gout, ulcer or GI tract obstruction. B K+suppl. may be required (monitor electrolytes). Renal/hepatic impairment, obstruction of urinary tract, disorders altering electrolyte balance. May: Cause hyperuricaemia and aggravate gout; activate SLE. Diabetes. Pregnancy, lactation. Contains lactose. C Contra: Lithium. Cardiac glycosides, hypotensive agents (adjust dose). TCAs, hypoglycaemic agents, NSAIDs, probenecid, cholestyramine, other drugs known to cause photosensitivity. A Headache, dizziness, fatigue, postural ARELIX sanofi-aventis hypotension, GI disorders. Electrolyte disturbances (long term use). 5MO Loop diuretic. Piretanide 6mg. Yellowish-white, LEO Pharma oblong scored tab. marked with logo on one side CENTYL K 5MO and ARE on reverse. 20-A4.32. S Fluid retention. Thiazide/K+suppl. Bendroflumethiazide 2.5mg, K+ P Initially, 6mg daily, adjusted to max. Cl 573mg (7.7mmol K+) in slow -release wax core. 30mg. Green, sugar-ctd, oval, modified release tab. 250, A15.11. R Initially, 3mg daily. Q Not recommended. S Oedema (cardiac, renal or hepatic D Severe electrolyte imbalance, origin). hypovolaemia, hypotension, hypokalaemia, preP Initially 1-4 every morning; coma associated with hepatic cirrhosis, advanced maintenance, 1-2 daily. renal failure, digitalis intoxication. Pregnancy, Q Not applicable. lactation. D Precoma associated with hepatic B Impaired micturition or prostatic cirrhosis, Addison’s disease. Severe renal hypertrophy. Severely impaired renal function impairment. Hyperkalaemia. (monitor serum electrolytes). B Diabetes, renal impairment, obstruction C Aminoglycoside, cephalosporin, of urinary tract; caution. Obstruction of small corticosteroids, carbenoxolone, laxatives, antibowel, ulceration (discontinue if occurs). hypertensive agents, cardiac glycosides, nonPregnancy, lactation (only if essential). depolarising muscle relaxants, drugs used in C K+sparing diuretics, lithium. Caution: treatment of gout, lithium, NSAIDs. Cardiac glycosides, antihypertensives. A Rash, photosensitivity, myopia BURINEX LEO Pharma aggravation, blood dyscrasias, gout, fatigue. Acute pancreatitis, hyperuricaemia, GI upset, oliguria, 5MO dizziness, headache, muscle pain, thirst, dry Loop diuretic. Bumetanide 1mg, 5mg. White mouth. Vasculitis. scored tabs. 1mg marked 133 and lion logo; 5mg marked with tab. strength. Scoreline only to DIAMOX Goldshield facilitate swallowing; not to divide into equal 5MO doses. 1mg-28, A1.98; 5mg-28, A9.03. Carbonic anhydrase inhibitor. Acetazolamide S Oedema associated with congestive 250mg. White scored tab. marked LEDERLE 4395. heart failure, hepatic ascites and renal disease, 112, A15.56. incl. the nephrotic syndrome. 5NO P Usually 0.5-2mg as a single or divided dose, adjust according to patients response. ALSO DIAMOX PARENTERAL Acetazolamide Na+ Q Not recommended. 500mg. Powder in vial. 1, A20.40. D Precomatose states associated with liver S Congestive heart failure, drug-induced cirrhosis. Electrolyte depletion, anuria. oedema, pre-menstrual tension. B K+suppl. may be required. Renal or P Initially 250-375mg once daily in the hepatic impairment. Diabetes. Pregnancy, morning or on alternate days. Pre-menstrual lactation. Prostatic hypertrophy or impaired oedema, 125-375mg as a single daily dose micturition. Elderly. Use with nephrotoxic drugs. beginning 5-10days before menstruation. See SPC. C Lithium, digitalis, antihypertensives, Q Not recommended. aminoglycosides, cephaloridine. D Chronic closed angle glaucoma. Renal A Hypokalaemia, GI discomfort, rash, hyperchloraemic acidosis. Adrenal insufficiency. cramps, thrombocytopenia, gynaecomastia, Na+ or K+ depletion. ototoxicity, gout, leucopenia, hyperuricaemia, B Gout. Diabetes. Pregnancy. K+suppl. may hyperglycaemia, bone marrow depression, nausea, be required. Monitor fluid, electrolytes and blood. vomiting, dizziness, muscle tenderness. C Folic acid antagonists, hypoglycaemics, oral anticoagulants. CENTYL LEO Pharma A Flushing, thirst, headache, drowsiness, polyuria, paraesthesia, blood dyscrasias, 5MO Thiazide. Bendroflumethiazide 2.5mg, 5mg. White, excitement, rash. circular, flat, slightly bevelled tabs. 2.5mg-500, DYAZIDE Goldshield A21.25; 5mg-100, A6.38; 500, A31.88. S Oedema (cardiac, renal, hepatic origin). 5 M O K+sparing/thiazide. Triamterene 50mg, HCTZ 25mg. P Initially 2.5-10mg every morning; May induce hyperkalaemia, hyponatremia, increases in blood urea; caution in elderly, obstruction of the urinary tract, hepatic or renal impairment. Pregnancy. C Contra: K+suppl., K+sparing diuretics. Avoid carbenoxolone, lithium. Caution: antihypertensives, diuretics, digitalis, cardiac glycosides, NSAIDs, anaesthesia, ammonium chloride, colestyramine, digoxin, aspirin, indometacin, mefenamic acid, antipyrine. A GI upset, drowsiness, headache, confusion, leg cramps, skin disorders, alopecia. Gynaecomastia, menstrual irregularities, breast pain, impotence, change in libido. Malaise, drug fever, lethargy.

40

Peach scored tab. coded E93. 30, A2.86. S Mild to moderate hypertension. Oedema. P Hypertension: initially 1daily. If added to already established therapy with another antihypertensive drug, the dosage should be reduced and later adjusted if necessary. Oedema: starting and maintenance dose 1 daily. R As for adults Q Not recommended. D Hyperkalaemia. Severe or progressive renal failure. Terminal hepatic cirrhosis, Addison’s disease. B Hepatic or renal impairment. Urinary tract obstruction. Diabetes; acidosis. Gout. Concomitant cardiac glycosides. Pregnancy, lactation. C K+suppl. K+sparing diuretics, lithium, digitalis, antihypertensives, indomethacin, ACE inhibitors. A Nausea, diarrhoea, cramps, weakness, headache, dry mouth, rash, blood dyscrasias.

FRUCO

Teva

5MO Loop/K+sparing. Furosemide 40mg, amiloride (HCl) 5mg. Orange scored tab. marked FRU CO. 28, A2.78; 56, A5.43. S Congestive cardiac failure, nephrotic syndrome, corticosteroid therapy, oestrogen therapy. Ascites in association with cirrhosis. P 1-2 in the morning. Q Not recommended. D Precomatose states associated with liver cirrhosis. Progressive renal failure. Hyperkalaemia. B Hepatic or renal impairment. Elderly. Diabetes, acidosis. Prostatic hypertrophy or impaired micturition. Gout. Pregnancy, lactation. C K+suppl., K+sparing diuretics, lithium, digitalis, aminoglycosides, cephalosporins, antihypertensives, NSAIDs, ACE inhibitors, nonpolarising muscle relaxants, hypoglycaemics. A Malaise, GI upset, rash, blood dyscrasias.

FRUMIL

sanofi-aventis

5MO Loop/K+sparing. Furosemide 40mg, amiloride (HCl) 5mg. Orange scored tab. marked FRUMIL. 28, A1.85; 56, A3.62. S Oedema associated with cardiac failure, hepatic and renal disease. P 1-2 in the morning. R Use Frumil LS. Q Not recommended.

5MO ALSO FRUMIL LS Furosemide 20mg, amiloride (HCl) 2.5mg. Orange tab. marked LS. 28 (Cal/Pk), A3.88. P 1 in the morning. Q Not recommended. D Precomatose states associated with liver cirrhosis. Progressive renal failure. Hyperkalaemia. B Hepatic or renal impairment. Diabetes, acidosis. Prostatic hypertrophy or impaired micturition. Gout. Pregnancy, lactation. C K+suppl., K+sparing diuretics, lithium, digitalis, aminoglycosides, cephalosporins, antihypertensives, NSAIDs, ACE inhibitors. A Malaise, GI upset, rash, blood dyscrasias.

FRUSIDE

Pinewood

5MO Loop diuretic. Furosemide 40mg. White, flat, bevel-edged tabs., engraved 2B2 with double

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Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM breakline on reverse. 100, A3.12; 500, A11.50. S Fluid retention, oedema of cardiac, hepatic or renal origin, pulmonary oedema and mild or moderate hypertension. P Initially 40mg daily, adjust as required from 20mg on alternate days to 120mg daily. R Titrate dosage as required (slower elimination). Q 1-3 mg/kg body weight daily. D Hypokalaemia or other electrolyte deficiency, anuria, pre-coma associated with liver cirrhosis, digitalis intoxication. Hypersensitivity to sulphonamides. B Monitor fluid and electrolyte state to avoid inadequate K+ suppl., or excessive loss of fluid. Bone marrow depression (monitor haemopoietic status). Diabetes mellitus (may induce hyperglycaemia). Elderly, potential obstruction of the urinary tract, disorders rendering electrolyte balance precarious. Lactation (not recommended), pregnancy. C Cardiac glycosides, hypotensive agents, non-depolarising muscle relaxants, lithium (adjust dosage). Effects of antidiabetics, pressor amines, salicylates, theophylline may also be affected. Cephaloridine or aminoglycosides (risk of aggravated toxicity). NSAIDs may attenuate furosemide action. Reduce or stop furosemide before treatment with ACE inhibitors. Glucocorticoids, laxatives (risk of increased K+ loss). A Fluid and/or electrolyte imbalance, hypotension, reduced serum Ca++ levels, transient increase of serum cholesterol and triglyceride levels, hyperuricaemia, aggravation of pre-existing metabolic alkalosis. Nausea, gastric upset, malaise, rashes, photosensitivity, diarrhoea, headache, muscle cramps, tinnitus, gout, ototoxicity.

HYPERTENSION 2.4 cardiac glycosides, digitalis preparations, drugs inducing QT interval prolongation syndrome, phenytoin, metolazone, probenecid, methotrexate, antidiabetic drugs, BP increasing sympathomimetics, curare type muscle relaxants, theophylline, risperidone. A Increase in cholesterol. Thromboses, vasculitis. GI upset. Hearing disorders, tinnitus. Skin disorders. Severe anaphylactic /anaphylactoid reactions. Paraesthesiae. Blood and lymphatic system disorders. Inj. site reactions, fever.

resp., brown film-ctd tabs. All marked with tab. strength. 40mg: Reddish-brown, oval biconvex film-ctd tab. with debossing 40 on one side and PD 535 on reverse. 5mg-28, A8.38; 10mg-28, A9.57; 20mg-28, A9.81; 40mg-28, A10.05. S All grades of essential hypertension as monotherapy or in combination with diuretics. P Initially 10mg once daily adjusting according to response; usual maintenance, 2040mg daily as single or in two divided doses; max. 80mg daily. Initial dose with concurrent diuretics, 5mg once daily. METOPIRONE Novartis R Initially 5mg once daily. Q 6-12 years, not recommended. 2MO Aldosterone inhibitor. Metyrapone 250mg. Cream D Subaortic stenosis, history of ACE inh. related angioneurotic oedema. Pregnancy, cap. coded CIBA and LN. 50, A14.42. lactation. S With glucocorticoids to treat resistant B Hypoglycaemia, neutropenia/ oedema due to increased aldosterone secretion. agranulocytosis, anaphylactoid reactions. Caution: Diagnosis and management of Cushing’s Hepatic impairment, alcoholic cyrrhosis. Renal syndrome; see SPC. insufficiency; monitor renal function before and P Resistant oedema, 3g daily in divided during therapy. Contains lactose. doses. Cushing’s syndrome, see SPC. C Avoid tetracyclines. Caution: b-blockers, Q 15mg/kg every 4 hours; min. 250mg methyldopa, diuretics, lithium, agents increasing every 4 hours. serum K+, antidiabetics, surgery/anaesthesia. D Primary adrenocortical insufficiency. A Pharyngitis, insomnia, hyperkalaemia, Pregnancy, lactation. paraesthesia, dyspnoea, abdominal pains, back B Hypopituitarism. A Nausea, vomiting, hypotension, allergic pain, myalgia, asthenia. reactions, abdominal pain, sedation, dizziness, ACCURETIC Parke-Davis headache, hypoadrenalism, hirsutism.

MODURET 25

5MO MSD ACE inhibitor/thiazide diuretic. Quinapril 20mg,

HCTZ 12.5mg. Pink, triangular, biconvex, film-ctd tab. with a scoreline on 1 side, plain on reverse. 28 (Cal/Pk), A12.56. S Hypertension. P Initially 10/12.5mg, increasing to 20/ 12.5mg as necessary. R As low as possible. Q Not recommended. D Hereditary/idiopathic angioneurotic oedema, history of angioneurotic oedema relating to previous treatment with an ACE inhibitor, anuria, hyperkalaemia, subaortic stenosis, left ventricular outflow tract obstruction, renal insufficiency, hypersensitivity to quinapril, thiazides or any sulphonamide-derived drug. Pregnancy, lactation. B Renal or liver impairment, severe CHF, NATRILIX SR Servier renal artery stenosis, haemodialysis, diabetes, anaesthesia, hypotension, anaphylactoid reactions, 5MO hypoglycaemia and diabetes. History of allergy or Antihypertensive diuretic. Indapamide bronchial asthma. Monitor renal function. hemihydrate 1.5mg. White sust.-release coated C Tetracyclines, K+ sparing diuretics, K+ tab. 30, A3.25. suppl., lithium, corticosteroids, NSAIDs, S Hypertension. tubocurarine, ACTH, NA. P 1 daily. A Headache, dizziness, rhinitis, coughing, Q Not recommended. fatigue, myalgia, GI upset, chest pain, insomnia, D Severe renal failure, hepatic chest infections. Sensitivity reactions, angioedema. encephalopathy or severe hepatic failure, hypokalaemia. ACEOMEL Clonmel B Pregnancy, lactation. Monitor K+ and 2MO uric acid serum levels. Monitor blood glucose in diabetics. ACE inhibitor. Captopril 12.5mg, 25mg, 50mg. C Lithium, agents causing hypokalaemia, White scored tabs. marked with logo one side and baclofen. coded 344, 345 or 346 on reverse. 12.5mg-56, A Hypokalaemia, fatigue, orthostatic A7.73; 25mg-56, A8.69; 50mg-56, A14.80. hypotension, allergic manifestations. S Hypertension. P Initially 25mg daily and titrate according 2.4 HYPERTENSION to response at 2-4 week intervals. Usual max. 100mg in single or divided doses. Add a diuretic if ACCUPRO Pfizer required. Elderly and those patients already on 2MO diuretic therapy, initially 25mg once daily and ACE inhibitor. Quinapril 5mg, 10mg, 20mg, 40mg. titrate according to response. Renal impairment, 5mg, 10mg, 20mg: Elliptical, triangular or round initiate at a lower dose, 12.5mg daily and titrate

5MO

K+sparing/thiazide diuretic. Amiloride (HCl) 2.5mg, HCTZ 25mg. Off-white diamond-shaped scored tab. coded 923. 28, A2.17. S Hypertension. LASIX sanofi-aventis P 1 tab. once daily. In some cases a starting dose of half a tab. once daily. 5MO Q Not recommended. Loop diuretic. Furosemide 20mg, 40mg. White D Hyperkalaemia. Progressive or severe round tab. marked DL or DLI resp. on one side renal failure. Pregnancy, lactation. and Hoechst on the other. 20mg-60, A0.82; 40mg- B Diabetes, acidosis, gout, renal or hepatic 100, A1.99. impairment. S Fluid retention. Mild to moderate C K+suppl., K+sparing diuretics, digitalis, hypertension. lithium, antihypertensives. ACE inhibitors. P 20-80mg as single dose daily or on A Rash. photosensitivity, blood dyscrasias, alternate days. gout. Q 1-3mg/kg daily.

5N ALSO LASIX INJECTION Furosemide 20mg/2ml. 5, A1.49. P Initially 20-50mg as single dose IM or slow IV. See SPC. Q 0.5-1.5mg/kg daily. D Precomatose and comatose states associated with hepatic encephalopathy. Hypovolaemia, dehydration, anuria, renal failure, severe hypokalaemia, severe hyponatraemia. Pregnancy, lactation. B Hepatorenal syndrome. Hypotension. Premature infants (increased risk of persistence of patent ductus arteriosus). Hypoproteinaemia. Acute porphyria. Glucose intolerance. Gout. Diabetes. Prostatic hypertrophy or impaired micurition. Monitor electrolytes and creatinine. Tabs. contain lactose. C Lithium, cyclosporin, radio-contrast therapy, aminoglycosides, nephrotoxic antibiotics, cephalosporins, sucralfate, corticosteroids, corticotrophin, amphotericin B, ACE-inhibitors, chloral hydrate, antihypertensives, diuretics, other hypotensive agents, NSAIDs, carbamazepine, aminoglutethimide, carbenoxolone, liquorice, B2 sympathomimetics, laxatives, reboxetine, cisplatin,

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

41


2.4 HYPERTENSION

CIRCULATORY SYSTEM

Drug Prescribing Notes BETA-BLOCKERS Non-selective ȕ1 /ȕ2 antagonists: Pindolol, propranolol, sotalol, tertatolol, timolol Cardioselective ȕ1 antagonists: Atenolol, betaxolol, bisoprolol, celiprolol, esmolol, metoprolol, nebivolol Non selective with Į1-blocking activity: Carvedilol, labetalol Contraindications N Hypersensitivity to other ȕ-adrenergic receptor blocking agents N Bradycardia (heart rate at rest < 60 beats/minute before therapy) N Cardiogenic shock N Hypotension (systolic blood pressure < 90 mmHg) N Metabolic acidosis N Advanced stages of peripheral arterial occlusive disease N Second and third degree heart block (without a pacemaker) N Sick sinus syndrome, including sino-atrial block N Overt heart failure (uncontrolled) N Untreated phaeochromocytoma N Bronchial hyper-reactivity (e.g. bronchial asthma, history of bronchospasm) Special Precautions N First-degree heart block, because of the negative effect of ȕ-blockers on conduction time N Peripheral circulatory disorders (Raynaud's syndrome, intermittent claudication); possible aggravation N Prinzmetal's angina due to unopposed alpha-receptor mediated coronary artery vasoconstriction; ȕ-blockers may increase the number and duration of anginal attacks (contraindicated with non-selective ȕ-blockers) N Diabetics with highly unstable blood glucose concentrations (risk of severe hypoglycaemic episodes) N Prolonged fasting or great physical exertion (risk of severe hypoglycaemic episodes) N Impaired hepatic or renal function N History or family history of psoriasis N History of severe hypersensitivity reactions, hyposensitisation therapy (ȕ- blockers may increase susceptibility to allergens and risk of exaggerated anaphylactic reactions) N May mask the signs of hyperthyroidism N COPD (ȕ-blockers may aggravate airway constriction) N Discontinue gradually, i.e. over 1-2 weeks Pregnancy: ȕ-blockers reduce placental perfusion, which may result in intra-uterine foetal death, intra-uterine growth retardation, immature and premature deliveries. Additional adverse effects include hypoglycaemia in the neonate and bradycardia in the foetus and in the neonate. There is an increased risk of cardiac and pulmonary complications in the neonate in the post-natal period. As with all drugs, ȕ-blockers should not be given during pregnancy unless its use is essential. Lactation: Most ȕ-blockers, particularly lipophilic compounds, will pass into breast milk although to a variable extent. Breastfeeding is not recommended following their administration. Drug Interactions Not recommended: Clonidine (rebound hypertension can follow withdrawal of clonidine). Ca++ channel blockers with negative inotropic effects (e.g. verapamil, diltiazem) can lead to an exaggeration of these effects which may result in severe hypotension, bradycardia and cardiac failure (admin. IV at least 48 min apart). Class I antiarrhythmics such as disopyramide, quinidine, procainamide (may have potentiating effect on atrial-conduction time and induce negative inotropic effect), lignocaine (increased lignocaine level). Neurone blocking agents such as guanethidine, reserpine, TCAs, barbiturates, MAOIs (except MAO-B inhibitors), phenothiazines, or other centrally acting antihypertensives (additive effect on antihypertensive action). Caution: Hypoglycaemic therapy in diabetic patients (may prolong the hypoglycaemic response to insulin; prevent the appearance of signs of hypoglycaemia). Anaesthetics (avoid myocardial depressants, such as cyclopropane, trichloroethylene, chloroform, ether or related anaesthetic). Dihydropyridine Ca++ channel blockers e.g. amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine (concomitant use may increase the risk of hypotension). Digitalis glycosides (may increase atrioventricular conduction time). Sympathomimetics e.g. adrenaline (may counteract the effect of ȕ-blockers). Ergotamine, dihydroergotamine or related compounds (vasospastic reactions reported). Prostaglandin synthetase inhibiting drugs e.g. ibuprofen and indomethacin (may decrease the hypotensive effects). Cimetidine, hydralazine, alcohol (may increase plasma levels of hepatically metabolised ȕ-blockers). Chlorpromazine (increase in plasma levels of both drugs). Class-III antiarrhythmics e.g. amiodarone (Class III agents, as well as Class I, and other drugs prolonging the QT-interval should not be given together with sotalol). Side-Effects Bradycardia, HFdeterioration, hypotension, peripheral vasoconstriction (e.g. Raynaud's phenomenon, exacerbation of intermittent claudication). Dizziness, confusion, mood changes, psychoses, hallucinations, sleep disturbances, nightmares. Hypoglycaemia, GI disorders, fatigue, rashes, exacerbation of psoriasis, alopecia, visual disturbances, dry eyes, bronchospasm, paraesthesia, exacerbation of myasthenia gravis.

42

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5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM

HYPERTENSION 2.4

according to response. Q Contact manufacturer. D Aortic stenosis. See SPC. B With renal impairment, collagen vascular disease, immunosuppressant therapy, monitor white cell count and urinary protein. Anaesthesia. C K+sparing diuretics, K+suppl., NSAIDs, vasodilators, clonidine, allopurinol, procainamide, probenecid, immunosuppressants, lithium. A Rash, loss of taste, neutropenia, thrombocytopenia, proteinuria, hypotension, angioedema. Anaemia, elevated blood urea and creatinine, elevated serum potassium and acidosis, tachycardia, pruritis, flushing, vesicular or bullous rash and photosensitivity, elevation of liver enzymes has been noted in a few patients, rare cases of hepatocellular injury and cholestatic jaundice. Gastric irritation and abdominal pain may occur, paraesthesias of the hands, serum sickness, cough, bronchospasm and lymphadenopathy.

ACERYCAL

anaesthetics. Diuretics, sympathomimetics, gold, bblockers, vasodilatators. A Somnolence, dizziness, headache, paresthaesia, vertigo, visual disturbances, tinnitus, palpitations, flushing, hypotension, GI disturbances, pruritus, rash, muscle cramps, oedema, peripheral oedema, fatigue, asthenia, dry cough.

C Contra: Rifampicin. Avoid grapefruit juice. Caution: Antihypertensive agents, cimetidine, quinidine, digoxin, phenytoin, diltiazem, cisapride, quinupristin/dalfopristin, CYP3A4 inhibitors. A Headache, vasodilatation, palpitation, nausea, dizziness, oedema. Lethargy, asthenia, constipation.

ADALAT LA

ADIZEM XL CAPSULES

Bayer Schering

2MO

Class II Ca antagonist. Nifedipine 20mg, 30mg, 60mg. Pink modified-release tab. marked ADALAT 20, ADALAT 30 and ADALAT 60. 20mg-28, A9.21; 30mg-28, A11.85; 60mg-28, A17.61. S Mild to moderate hypertension. P Initially 20mg once daily in the morning. Increase if necessary up to max. 90mg once daily. Tabs. must be swallowed whole with water. Q Not recommended.

Class III Ca antagonist. Diltiazem (HCl) 120mg pink/blue cap.; 180mg pink/blue cap.; 240mg red/ blue cap.; 300mg maroon/blue cap. All cont.release caps. marked with DCR and strength. 120mg-28, A8.40; 180mg-28, A12.45; 240mg-28 A16.05; 300mg-28, A12.42. S Mild to moderate hypertension. P Initially 240mg once daily adjusting according to response. Caps. should be swallowed whole. R Initially 120mg once daily; carefully titrate as required. Q Not recommended.

++

2MO

Servier ALSO ADALAT RETARD Nifedipine 10mg, 20mg.

2MO ACE inhibitor / Ca++ antagonist. Perindopril arginine / amlodipine, 5mg/5mg, 5mg/10mg, 10mg/5mg and 10mg/10mg. White tab. engraved with strength on 1 side and Servier logo on the other. 5/5mg, rod-shaped; 5/10mg, square-shaped; 10/5mg, triangular-shaped; 10/10mg, round. 5/ 5mg-30, A25.66; 5/10mg-30, A31.13; 10/5mg-30, A34.41; 10/10mg-30, A39.88. S Substitution therapy for treatment of essential hypertension and/or stable coronary artery disease, in patients already controlled with perindopril and amlodipine given concurrently at same dose level. P 1 tab./day as single dose, preferably the morning before a meal. Not suitable for initial therapy. Q Not recommended. D Hypersensitivity to ACE inhibitors and dihydropyridines. History of angioedema associated with previous ACE inhibitor therapy. Hereditary or idiopathic angioedema. Severe hypotension. Shock, including cardiogenic shock. Obstruction of the outflow-tract of the left ventricle (e.g. high grade aortic stenosis). Unstable angina pectoris (excluding Prinzmetal’s angina). HF after acute MI (during first 28 days). Pregnancy, lactation. B May rarely occur: Hypersensitivity, angioedema (discontinue if occurs) or anaphylactoid reactions during LDL-apheresis and desensitisation, neutropenia, agranulocytosis, thrombocytopenia, anaemia, hepatic failure, symptomatic hypotension (in patients with salt or volume depletion), hyperkaliemia. Caution: Aortic and mitral valve stenosis, hypertrophic cardiomyopathy, heart failure, collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, hepatic impairment. Renal impairment: Adjust dosage according to individual dose titration with the monocomponents. Discontinue 1 day prior to surgery. Closely monitor glycaemic control in diabetic patients. Contains lactose. C Not recommended: K+-sparing diuretics, K+ supplements, K+-containing salt substitutes, lithium, estramustine, dantrolene. Caution: NSAIDs, antidiabetics (insulin, hypoglycaemic sulphonamides), CYP3A4 inducers / inhibitors, baclofen, corticosteroids, tetracosactide, alphablockers, amifostine, TCAs, antipsychotics,

Mundipharma

2MO

Pink tab. marked A10 and 1U on one side resp. and Bayer cross on reverse. 10mg-56, A9.72; 20mg-56, A11.87. P Initially 10mg twelve hourly adjusting to response, increasing to 40mg every 12 hours. Q Not recommended.

++

2MO

ALSO ADIZEM SR CAPSULES Diltiazem (HCl) 90mg white cap.; 120mg brown/white cap.; 180mg brown/white cap. All cont. -release caps. marked with strength. 90mg-56, A12.80; 120mg-56, 2MO A14.21; 180mg-56, A21.32. ALSO ADALAT Nifedipine 5mg, 10mg. Orange, P Initially 90mg twice daily. Increase gelatin ovoid caps. containing yellow fluid. 5mggradually to 120mg or 180mg twice daily as 90, A3.03; 10mg-90, A3.85. required. P Initially 5mg eight hourly adjusted R Start at lowest level of 90mg twice according to response, increasing to max. 20mg daily; carefully titrate as required. every 8 hrs. Q Not recommended. Q Not recommended. D Pregnancy, lactation. Sick sinus D Women of child-bearing potential, syndrome, 2nd or 3rd degree AV block, marked lactation, cardiogenic shock, aortic stenosis. Acute bradycardia, decompensated cardiac failure. angina attacks, unstable angina pectoris, during or B Mild bradycardia, prolonged PR interval. within one month of MI. Adalat LA only: Hepatic Measure heart rate regularly in elderly and in impairment, history of GI obstruction, IBD, Crohn’s patients with hepatic or renal impairment. disease. Diabetes. B Poor cardiac reserve, HF, hepatic C b-blockers, digoxin, cimetidine, impairment, severe hypotension. Diabetes, dialysis. diazepam, antihypertensives, anaesthetics, Severe GI narrowing. Elderly. Driving/using dantrolene inf. machines. Postural hypertension, syncope, A Anorexia, nausea, bradycardia, oedema, tachycardia reported. rash, flushing, fatigue, AV block. Beta-blockers Unless otherwise specified, beta-blockers are prohibited in-competition only in the following sports: Aeronautic (FAI) Automobile (FIA) Billiards and Snooker (WCBS) Bobsleigh (FIBT) Boules (CMSB) Bridge (FMB) Curling (WCF) Golf (IGF) Gymnastics (FIG) Motorcycling (FIM) Modern Pentathlon (UIPM) for disciplines involving shooting Ninepin and Tenpin Bowling (FIQ) Powerboating (UIM) Sailing, (ISAF) match race helms only Skiing/Snowboarding (FIS) in ski jumping, freestyle aerials/halfpipe and snow board halfpipe/big air Wresting (FILA) Beta-blockers are prohibited in and out of competition in the following sports: Archery (FITA) Shooting (ISSF, IPC)

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

43


2.4 HYPERTENSION AMLID

CIRCULATORY SYSTEM Pinewood

AMLOTAN

Clonmel

2MO

2MO

Ca++ antagonist. Amlodipine 5mg, 10mg (as amlodipine maleate). White round biconvex tab. 10mg tab. scored on both sides. 5mg-28, A9.19; 10mg-28, A13.70. S Essential hypertension. P 5mg once daily with water. If no effect within 2-4 weeks, may be increased to max. 10mg once daily. Q Under 12 years, not recommended. D Severe hypotension, shock, HF after acute MI (during 1st 28 days), obstruction of outflow tract of left ventricle (e.g. high grade aortic stenosis), unstable angina pectoris. Pregnancy (unless essential), lactation. B Low cardiac reserve, cardiac failure, hepatic impairment, elderly. Contains lactose. C Caution: CYP3A4 inhibitors/ inducers, other antihypertensives incl. b-blockers. A Ankle swelling. Headache, fatigue, dizziness, asthenia, palpitations, flushing, nausea, dyspepsia, abdominal pain.

Ca++ antagonist. Amlodipine 5mg, 10mg (as amlodipine mesilate monohydrate). White round biconvex tabs embossed with 5 or 10 resp. 10mg tab. scored. 5mg-28, A7.34; 10mg-28, A10.97. S Essential hypertension. P 5mg once daily with water. If no effect within 2-4 weeks, may be increased to max. 10mg once daily. Q Under 18 years, not recommended. D Severe hypotension, shock, HF after acute MI (during 1st 28 days), obstruction of outflow tract of left ventricle (e.g. high grade aortic stenosis), unstable angina pectoris. Pregnancy (unless essential), lactation. B Low cardiac reserve, cardiac failure, hepatic impairment, elderly. C Caution: CYP3A4 inhibitors/ inducers, other antihypertensives incl. b-blockers. A Ankle swelling. Headache, fatigue, dizziness, asthenia, palpitations, flushing, nausea, dyspepsia, abdominal pain.

AMLIST

AMOLIN

Gerard

Ergha

2MO

3MO

Ca++ antagonist. Amlodipine 5mg, 10mg (as amlodipine maleate). White round tab. 10mg with break score on both sides. 5mg-28, A9.20; 10mg28, A13.75. S Essential hypertension. P 5mg once daily with water. If no effect within 2-4 weeks, may be increased to max. 10mg once daily. Q Under 18 years, not recommended. D Severe hypotension, shock, HF after acute MI (during 1st 28 days), obstruction of outflow tract of left ventricle (e.g. high grade aortic stenosis), unstable angina pectoris. Pregnancy (unless essential), lactation. B Low cardiac reserve, cardiac failure, hepatic impairment, elderly. Contains lactose. Driving or using machines. C Caution: CYP3A4 inhibitors/ inducers, other antihypertensives incl. b-blockers. A Ankle swelling. Headache, fatigue, dizziness, asthenia, palpitations, flushing, nausea, dyspepsia, abdominal pain.

Cardio-selective b-blocker. Atenolol 25mg, 50mg, 100mg. White film-ctd tabs. marked C23, C24 and C25 resp. 25mg-30, A1.56; 50mg-30, A2.36; 100mg-30, A3.10. S Hypertension. P 50-100mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

Angiotensin II antagonist. Irbesartan 75mg, 150mg, 300mg. White oval tabs. marked with heart symbol and 2771, 2772 or 2773. 75mg-28, A16.49; 150mg-28, A18.33; 300mg-28, A24.74. S Essential hypertension. P Initially 150mg once daily. Usual maintenance dose 150mg once daily. Increase if necessary to 300mg once daily or add other hypertensive agents. Haemodialysis: Consider 75mg starting dose. R Over 75 years, consider starting dose of 75mg once daily. Q Not recommended. D Pregnancy. B Renovascular hypertension, renal impairment, hyperkalaemia, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy, primary aldosteronism. If inadvertently taken during pregnancy, check skull and renal function with echography. Lactation not recommended (esp. newborn or preterm infants). Contains lactose. C K+sparing diuretics, K+suppl., lithium. A Headache, musculo-skeletal trauma, flushing.

ARELIX

sanofi-aventis

5MO

Loop diuretic. Piretanide 6mg. Yellowish-white, oblong scored tab. marked with logo on one side and ARE on reverse. 20-A4.32. S Mild to moderate hypertension. P Initially, 6mg daily for 2-4 weeks; may be increased if necessary at 2-4 week intervals to max. 18mg daily. R Initially, 3mg daily. APRESOLINE Novartis Q Not recommended. D Severe electrolyte imbalance, 2MO hypovolaemia, hypotension, hypokalaemia, preVasodilator. Hydralazine (HCl) 20mg. 2ml amp. 5, coma associated with hepatic cirrhosis, advanced A1.87. renal failure, digitalis intoxication. Pregnancy, S Hypertensive emergencies, including pre-eclampsia and toxaemia of pregnancy, and in lactation. B Impaired micturition or prostatic hypertension with renal complications. hypertrophy. Severely impaired renal function P Parenteral: Initially 5-10mg by slow IV inj; if necessary repeat inj. after 20-30min (monitor (monitor serum electrolytes). C Aminoglycoside, cephalosporin, BP and heart rate throughout). Satisfactory corticosteroids, carbenoxolone, laxatives, antiresponse defined as fall in diastolic BP to 90/ hypertensive agents, cardiac glycosides, non100mmHg. May also be given by continuous IV inf, beginning with 200-300mcg/min. Maintenance depolarising muscle relaxants, drugs used in treatment of gout, lithium, NSAIDs. AMLODE Rowex flow rates 50-150mcg/min. Q Not recommended. ATACAND AstraZeneca 2MO D Severe tachycardia and HF with high Ca++ antagonist. Amlodipine 5mg, 10mg (as 2MO cardiac output, myocardial insufficiency due to amlodipine besilate). White oblong, bevelled tab. mechanical obstruction, idiopathic SLE and related Angiotensin II antagonist. Candesartan cilexetil scored on one side and marked with strength on disease, dissecting aortic aneurysm, cor pulmonale. 2mg, 4mg, 8mg, 16mg. White, white, light pink other. 5mg-28, A8.33; 10mg-28, A12.50. and pink tabs. resp. 4mg, 8mg and 16mg scored. First half of pregnancy. S Essential hypertension. B Moderate to severe renal impairment or P 5mg once daily with water. If no hepatic dysfunction (adjust dose). Coronary or sufficient effect within 2-4 weeks, may be cerebrovascular disease. Lactation. Cardiac failure. increased to 10mg daily (as single dose). Reported: Peripheral neuritis; reduction in Hb, red Q Under 18 years, not recommended. cell counts (discontinue if occurs); SLE like D Hypersensitivity to dihydropyridine syndrome with prolonged treatment (determine This medicinal product derivatives. Severe hypotension, shock, HF after ANF and urine analyses approx. every 6 months). acute MI (during 1st 28 days), obstruction of contains substance(s) Driving/using machines. outflow-tract of left ventricle (e.g. high grade C Caution: TCAs, MAOIs, alcohol, major prohibited for use in specific aortic stenosis), unstable angina pectoris. tranquilisers, CNS depressants, anaesthetics, Pregnancy (unless essential), lactation. sports only (as listed in diuretics, antihypertensives, diazoxide, certain bB Hepatic impairment, cardiac failure, low WADA Prohibited List 2010). blockers (propranolol). cardiac reserve, elderly. A Tachycardia, hypotension, angina, Athletes requesting to use C Caution: CYP3A4 inhibitors/inducers. headache, flushes, arthralgia, myalgia, GI Other antihypertensives (e.g. a/b blockers, ACEthis product in these specific disturbances. inhibitors, diuretics). sports are required to apply A Ankle swelling, headache, facial APROVEL sanofi-aventis/BMS flushing, dizziness, fatigue, asthenia, palpitations, for a TUE. 2MO abdominal pain, nausea, dyspepsia.

Anti-Doping Information

s

44

2

5

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c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM 2mg-14, A7.89; 4mg-28, A14.42; 8mg-28, A18.33; 16mg-28, A24.74. S Hypertension. P Initially 8mg once daily. May be increased to 16mg once daily. Effect within 4 weeks. Max. 32mg once daily. Renal impairment/ vol. depletion: Initially 4mg daily. Mild/moderate hepatic impairment: Initially 2mg daily. Q Under 18 years, not recommended. D Severe hepatic impairment, cholestasis. Pregnancy, lactation. B Correct volume/salt depletion before starting therapy. Severe or end-stage renal impairment, renal artery stenosis, aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy. Primary hyperaldosteronism (not recommended). Monitor serum K+ in patients with HF or renal impairment. Contain lactose. C Caution: K+sparing diuretics, K+suppl., heparin, lithium, antihypertensives, indomethacin. A Dizziness/vertigo, headache, respiratory infection.

Cardioselective b-blocker/thiazide diuretic. Atenolol 50mg, chlorthalidone 12.5mg; atenolol 100mg, chlorthalidone 25mg. Both white tabs marked AC and strength one side, G on reverse. 50/ 12.5mg-28, A4.60; 100/ 25mg-28, A6.52. S Hypertension. P 1 tab daily. Q Not recommended. D 2o or 3o AV block, severe bradycardia, hypotension, uncontrolled HF, cardiogenic shock, hypokalaemia, hepatic/renal/addison’s disease. Severe peripheral arterial circulatory disturbances, metabolic acidosis, sick sinus syndrome, untreated phaeochromoctyoma. Pregnancy, lactation (only if essential). B Reduction in diastolic BP. Ischaemic heart disease: Withdraw gradually. Caution: CHF, asthma, obstructive airways disease. Poor cardiac reserve. Renal impairment, thyrotoxicosis/ hypoglycaemia, anaesthesia, hypokalaemia, pulse rate, serum uric acid, Prinzmetal’s angina, allergens, psoriasis. Driving/using machines. C Halogenated anaesthetics, class 1 antiATACAND PLUS AstraZeneca arrhythmics, NA or adrenaline. Adrenergic blockers, Ca++ channel blockers, hypoglycaemics, 5MO cardiac glycosides, non-depolarising muscle Angiotensin II antagonist/thiazide diuretic. relaxants. Clonidine, lithium, dihydropyridines, Candesartan cilexetil 16mg, HCTZ 12.5mg. Peach sympathomimetics, CYP450 inhibitors, alcohol, A scored tab. 28, 24.74. hydralazine. Prostaglandin synthetase inhibitors. S Essential hypertension where A Blood dyscrasias, electrolyte monotherapy is not sufficient. disturbances, hyperuricaemia, impaired glucose P 1 once daily. tolerance, hyponatraemia, confusion, mood Q Not recommended. changes, sleep disturbance, dizziness, headache, D Severe hepatic or renal impairment, paraesthesia, ocular changes, bronchospasm, GI refractory hypokalaemia and hypercalcaemia. disturbances, alopecia, rash, muscular fatigue, Gout. Pregnancy, lactation. impotence, fatigue. B Renal artery stenosis, intravascular volume depletion, renal impairment/kidney ATENI Gerard transplantation, hepatic impairment, aortic or mitral valve stenosis, primary hyperaldosteronism, 3 M O metabolic and endocrine effects. Cardioselective b-blocker. Atenolol 50mg, 100mg C K+sparing diuretics, K+suppl., lithium, white tabs. Both marked AT and strength one side, G on reverse. 50mg-28, A4.16; 100mg-28, NSAIDs, cholestyramine, anticholinergics, alcohol, A5.38. barbiturates, anaesthetics. A Headache, back pain, dizziness, S Hypertension. respiratory infection, influenza like symptoms, P 50mg once daily increasing to 100mg if sinusitis, bronchitis, UTI, nausea, tachycardia, required. fatigue, abdominal pain, pharyngitis. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

HYPERTENSION 2.4 100mg-30, A5.01. S Hypertension. P 50-100mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

BELLISIN

Ranbaxy

2MO

ACE inhibitor. Lisinopril (as dihydrate) 10mg, 20mg. Uncoated tabs debossed with strength on 1 side. Light yellow biconvex cap-shaped tab. (10mg); light peach biconvex cap-shaped tab. (20mg). 10mg-28, A7.87; 20mg-28, A9.32. S Hypertension. Renal disease in hypertensive patients with Type 2 diabetes and incipient nephropathy. P Hypertension: Initially, 10mg. Highly activated reninangiotensin-aldosterone system: 2.5-5mg initially. Maintenance, 20mg (single dose); if desired therapeutic effect not obtained within 2 to 4 weeks, may be increased to 80mg/day max. Patients on diuretics: If possible, withdraw diuretic 2 to 3 days before starting; if not possible, start with 5mg/day and monitor serum K+ and renal function. Renal complication of diabetes mellitus: 10mg once a day; may be increased to 20mg once a day if necessary. Renal impairment, ccQ10ml/ min, initially 2.5mg; 10QccQ30ml/min, initially 2.55mg; 31QccQ80ml/min, initially 5-10mg/day. Q Not recommended. D History of angioedema associated with prior ACE inhibitor treatment, hereditary or idiopathic angioedema, pregnancy, lactation. B Caution: Acute MI (renal dysfunction, do not use), mitral stenosis and LV outflow obstruction, aortal stenosis, hypertrophic myocardiopathy, bilateral renal artery stenosis or artery stenosis in a single kidney (strict supervision with low doses; careful dose adjustment), preexisting renal impairment (monitor blood K+ and creatinine concentrations), major surgery, anaesthesia, diabetes. May occur: Systemic hypotension, angioedema (withdraw immediately), anaphylactoid reactions in haemodialysis patients or during desensitisation treatment, acute renal insufficiency in patients with HF (usually reversible), hepatic insufficiency, neutropenia/ agranulocytosis, cough. ATECOR Rowex C Not recommended: Lithium. Caution: ATENOGEN Antigen 3MO Diuretics, K+ sparing diuretics, K+ supplements, 3MO Cardioselective b-blocker. Atenolol 25mg, 50mg, salt substitutes containing K+, NSAIDs (incl. 100mg. White scored film-ctd tabs. 25mg-30, Cardioselective b-blocker. Atenolol 25mg, 50mg, acetylsalicylic acid r 3g/day), other A2.67; 50mg-30, A4.04; 100, A12.84; 100mg-30, 100mg. White, white, orange film-ctd tabs. antihypertensives, certain anaesthetics, tricyclic A5.77; 100, A18.67. marked AT/25, AT/50, AT/100, resp. All marked antidepressants and antipsychotic agents, A S Hypertension. with maker’s symbol. 25mg-28, 2.49; 50mg-28, sympathicomimetics, anti-diabetics. P 50mg once daily increasing to 100mg if A3.77; 100mg-28, A5.38. A Dizziness, headache, orthostatic effects required. (incl. hypotension), diarrhoea, vomiting, renal S Cardiac arrhythmias. Long-term Q Not recommended. dysfunction, impotence. prophylaxis after recovery from acute MI. Angina D See 2.4, b-blockers Drug Presc. Notes. pectoris. Essential hypertension. Ranbaxy P Arrythmias: 50-100mg daily. Prophylaxis BELLRAMIL ATECOR CT Rowex after recovery from MI: 100mg daily. Hypertension: 2MO 5MO 50mg daily increasing to 100mg daily if required. ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Size 4 Allow time to achieve full effects (1-2 weeks) Cardioselective b-blocker/ thiazide diuretic. hard cap. with resp. yellow, orange, maroon or before determining need to increase to 100mg Atenolol 50mg, chlorthalidone 12.5mg; atenolol blue cap /white body, imprinted with R on cap daily. Angina: 100mg daily as a single dose or as 100mg, chlorthalidone 25mg. Both white film-ctd and strength on body. Contain white to off-white 50mg twice daily. tabs. scored one side. 50/12.5-30, A4.85; 100/ granular powder. 2.5mg-30, A5.50; 5mg-30, Q Not recommended. 25mg-30, A6.97. A7.10; 10mg-30, A9.60. D See 2.4, b-blockers Drug Presc. Notes. S Hypertension. S Mild to moderate hypertension. P 1 daily. P Initially 1.25mg once daily. Increase dose ATENOMEL Clonmel Q Not recommended. incrementally at intervals of 1-2 weeks up to max D See 2.4, b-blockers Drug Presc. Notes. 3MO 10mg once daily. Maintenance: 2.5-5mg. If Cardioselective b-blocker. Atenolol 25mg, 50mg, response unsatisfactory at 10mg, combination ATENETIC Gerard 100mg. White tab. marked C23, C24, C25. 50 and treatment recommended. In diuretic treated 5MO 100mg scored. 25mg-30, A2.60; 50mg-30, A3.94; patients, discontinue diuretic 2-3 days before AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

45


2.4 HYPERTENSION

CIRCULATORY SYSTEM rhinitis gastro-intestinal disorders, arthritis, back pain, skeletal pain, haematuria, UTIs, chest pain, fatigue, flu-like symptoms, peripheral oedema, pain.

C Antihypertensives, cimetidine, quinidine, rifampicin, digoxin, cardiodepressants, adrenergic neurone blocking drugs, non-cardio selective b blockers, grapefruit juice. A Flushing, headache, fatigue, dizziness, BENETOR PLUS Daiichi Sankyo dry eyes, skin rash, oedema, hypersensitivity type jaundice (rare), gingival hyperplasia, 5MO gynaecomastia, impotence. Mood changes, MI, Angiotensin II antagonist/thiazide diuretic. Olmesartan medoxomil/HCTZ, 20mg/12.5mg, 20mg/ ischaemic pain (discontinue). 25mg. Round film-ctd tab. 20mg/12.5mg, reddishBETA-PROGRANE Tillomed yellow; 20mg/25mg, pinkish embossed with C22, 3MO C24 resp. 28, A17.82. S Essential hypertension in patients whose Non-cardioselective b-blocker. Propranolol (HCl) blood pressure is not adequately controlled on 80mg, 160mg. White hard prolonged.-release cap. olmesartan medoxomil alone. 160mg-28, A8.13; 80mg (HALF BETA-PROGRANE)P Initially, 20mg/12.5mg once daily. If BP 28, A6.27. not adequately controlled 20mg/25mg once daily S Hypertension, adjuct in thyrotoxicosis, (max. daily dose). prophylaxis of upper GI bleeding in patients with Q 18 years and under, not recommended. portal hypertension and oesophageal varices. D Severe renal/hepatic impairment. P Hypertension: Initially 160mg daily Cholestasis and biliary obstructive disorders. taken morning or evening; may be increased if Refractory hypokalaemia, hypercalcaemia, necessary in 80mg increments. All other hyponatraemia and symptomatic hyperuricaemia. indications: 80mg every morning or evening; may Pregnancy, lactation. be increased if necessary to 160mg daily up to B Intravascular volume depletion (risk of 240mg daily. Portal hypertension: Target 25% reduction in resting heart rate; max. dose 320mg symptomatic hypotension). Impaired renal once daily. function (monitor serum K+, uric acid and Q Not recommended. creatinine levels). Caution: Renovascular D See 2.4, b-blockers Drug Presc. Notes. hypertension, hyperkalaemia, diabetes, aortic or mitral value stenosis, obstructive hypertrophic BETALOC AstraZeneca cardiomyopathy, ischaemic heart or cerebrovascular disease. Not recommended: Recent 3 M O kidney transplant, hepatic impairment, primary Cardioselective b-blocker. Metoprolol tartrate aldosteronism. Monitor serum electrolytes 50mg white tab. scored and marked A/BB; 100mg regularly. white tab. scored and marked A/ME. 50mg-100, C Not recommended: K+ suppl., K+ sparing A2.11; 100mg-100, A3.91. diuretics, lithium. Caution: Amifostine, alcohol, S Hypertension. Adjunct in thyrotoxicosis. barbiturates, narcotics, antidepressants, NSAIDs, P Hypertension, initially 100mg daily, other antihypertensives, baclofen, Ca++ salts, increasing if required to 400mg daily in one or cholestyramine/colestipol resins, digitalis two divided doses. Thyrotoxicosis, 50mg four times glycosides, class Ia and III antiarrhythmics, some daily. antipsychotics, non-depolarizing skeletal muscle Q Not recommended. relaxants, anticholinergics, antidiabetics, bD See 2.4, b-blockers Drug Presc. Notes. BENETOR Daiichi Sankyo blockers, diazoxide, pressor amines, probenecid, 2MO Niche sulfinpyrazone, allopurinol, amantadine, cytotoxic BIOCARD Angiotensin II antagonist. Olmesartan medoxomil agents, salicylates, methyldopa, cyclosporine, 3MO 10mg, 20mg, 40mg. White, film-ctd tabs. with C13, tetracyclines. a/b blocker. Carvedilol 3.125mg, 6.25mg, 12.5mg, C14 and C15 resp. embossed on one side. 10mg, A Dizziness, fatigue, bronchitis, cough, 25mg. Round bevel edged tabs. (3.125mg), scored 20mg: circular; 40mg: oval. 10mg-28, A14.74; pharyngitis, rhinitis, GI disorders, arthritis, on one side (25mg). Oval tab., marked S2 on one 20mg-28, A17.70; 40mg-28, A22.29. haematuria, UTI, pain, fatigue, flu-like symptoms, side (6.25mg scored) or S3 on one side (12.5mg S Essential hypertension. peripheral oedema. scored). All slightly biconvex, white. 3.125mg-28, P Initially, 10mg once daily. Optimal dose, A5.09; 6.25mg-28, A6.23; 12.5mg-28, A7.45; 20mg once daily. Max.: 40mg, daily. Mild to BETA-ADALAT Bayer Schering 25mg-28, A8.32. moderate renal impairment: Max., 20mg once 3MO S Hypertension daily. P Initially, 12.5mg once daily for 2 days. Cardioselective b-blocker/class II Ca++ antagonist. R Max., 20mg once daily. Thereafter, 25mg once daily. Max. 50mg once Q 18 years and under, not recommended. Atenolol 50mg, slow-release nifedipine 20mg. D Pregnancy, lactation. Biliary obstruction. Reddish-brown cap. marked with name and Bayer daily or in divided doses. Dose titration at 2-week intervals. A 11.87. cross. 28 (Cal/Pk), B Hepatic impairment and severe renal Q Under 18 years, not recommended. S Hypertension, where b-blocker or impairment: Not recommended (limited D See 2.4, b-blockers Drug Presc. Notes. calcium antagonist monotherapy is inadequate. experience). Intravascular volume depletion, renovascular hypertension, kidney transplantation, P 1 daily, increasing to 1 every 12 hours if NYHA class IV decompensated HF requiring IV inotropic support, liver dysfunction. necessary. hyperkalaemia, lithium, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy, R Max. 1 daily. BISOCOR Niche Q Not recommended. primary aldosteronism, ethnic differences, other 3MO D Women of child bearing potential. HF. conditions stimulating renin-angiotensin2nd or 3rd degree heart block. Cardiogenic shock, Cardioselective b-blocker. Bisoprolol hemifumarate aldosterone system, ischaemic heart disease or 5mg, 10mg. Pale-yellow scored tab. marked BI and ischaemic cerebrovascular disease. use in conjunction with other cardio-depressant 5, beige scored tab. marked BI and 10. 5mg-28, C K+ suppl., K+ sparing diuretics and drugs, severe bradycardia, acute angina attacks, A5.28. 10mg-28, A5.99. lithium (not recommended). NSAIDs and unstable angina pectoris, severe aortic stenosis, angiotensin II antagonists (monitor renal function during or within one month of MI, wheezing, S Hypertension. at beginning of treatment and ensure regular asthma, severe renal failure. Pregnancy, lactation. P 5-20mg once daily. Usually 10mg once hydration). Well tolerated additive reduction in BP B Cardiac conduction defects or poor daily. with HCTZ. Q Not recommended. cardiac reserve. OAD. Renal or hepatic A Dizziness, bronchitis, cough, pharyngitis, impairment. Diabetes. Anaesthesia. Elderly. D See 2.4, b-blockers Drug Presc. Notes.

initiating. Patients with congestive HF, start treatment at 1.25mg under close medical supervision in hospital. R Caution Q Not recommended. D History of angioneurotic oedema, haemodynamically relevant renal artery stenosis (bilateral or unilateral in single kidney). Aortic or mitral valve stenosis or outflow obstruction. Hypotensive or haemodynamically unstable patients. Pregnancy, lactation. B Renal impairment risk; assess renal function prior to and during treatment. Caution: Impaired liver function, volume- and saltdepletion, anaesthesia. May occur rarely: Agranulocytosis and bone marrow depression, reduction in red cell count, Hb content and platelet count, hyperkalaemia. Avoid haemodialysis using high flux membranes and LDL apheresis with dextran sulphate. C Caution: Diuretics or other antihypertensives, K+ sparing diuretics, K+ supplements, antidiabetics, NSAIDs, lithium, allopurinol, immunosuppressants and other substances that may change the blood picture. A Hypersensitivity reactions, eosinophilia, raised antinuclear antibodies titres, sleep disorders, depressed mood, anxiety, dizziness, disturbances of balance, nervousness, restlessness, tremor, confusion, loss of appetite, paraesthesiae, conjunctivitis, symptomatic hypotension, syncope, MI or cerebrovascular accident possibly secondary to severe hypotension, chest pain, palpitations, rhythm disturbances, angina pectoris, vasculitis, dry tickling cough, rhinitis, sinusitis, bronchitis, bronchospasm, GI disorders, cutaneous and mucosal reactions, muscle cramps, muscle and joint pains, impaired renal function, impotence, decreased libido, taste change/reduction/loss, fever headache, fatigue, malaise, increases in blood urea, nitrogen and serum creatinine, decreased serum Na+, increased serum K+.

46

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


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MIMS Ireland


2.4 HYPERTENSION

CIRCULATORY SYSTEM

D See 2.4, b-blockers Drug Presc. Notes. Acute HF or during episodes of HF decompensation requiring IV inotropic therapy. BISOP Rowex Combinations with floctafenine and sultopride. B See 2.4, b-blockers Drug Presc. Notes. 3MO Iodated contrast products. Driving/operating Cardioselective b-blocker. Bisoprolol fumarate 5mg, 10mg. Resp. yellow or apricot, round film-ctd machinery. Contains lactose. tablet with a cross score encoded BIS and strength C See 2.4, b-blockers Drug Presc. Notes. Anti-cholinesterastic drugs. Amifostine. NSAID. on one side. 5mg-28, A5.34;10mg-28, A6.01. A See 2.4, b-blockers Drug Presc. Notes. S Hypertension. Headache. P Should be taken with liquid (not chewed), in the morning. Initially 5mg; usual dose BLOPRESS Takeda 10mg once daily; max 20mg/day. 2MO Q Not recommended. D Acute HF or during episodes of HF Angiotensin II antagonist. Candesartan cilexetil decompensation requiring IV inotropic therapy. 2mg, 4mg, 8mg, 16mg, 32mg. 2mg: Round white nd rd Cardiogenic shock. AV block of 2 or 3 degree tab. 4mg: Round white tab. with single score line on both sides. 8mg: Round pale pink tab. with (without a pacemaker). Sick sinus syndrome. single score line on both sides. 16mg: Round light Sinoatrial block. Bradycardia (Q 60 beats/min) pink tab. with one convex side embossed with 16 before start of therapy. Hypotension (systolic BP and one scored flat side. 32mg: Round light pink Q 100mmHg). Severe bronchial asthma or severe tab. with convex sides, debossed 32 on one side COPD. Late stages of peripheral arterial occlusive and scored on the other. 2mg-7, A1.81; 2mg-28, disease and Raynaudâ&#x20AC;&#x2122;s syndrome. Untreated A7.26; 4mg-7, A3.30. 4mg-28, A13.20; 8mg-28, phaeochromocytoma. Metabolic acidosis. Pregnancy (unless necessary), lactation. 15.81; 16mg-28, A19.22; 32mg-28, A24.63. B Regular monitoring required. Withdraw S Essential Hypertension. gradually. Caution: Bronchospasm, diabetes P Initially 8mg once daily. Usual mellitus with large fluctuations in blood glucose maintenance dose: 8mg, may be increased to (hypoglycaemia symptoms can be masked), strict 16mg. If blood pressur not sufficiently controlled fasting, ongoing desensitisation therapy, AV block after 4 weeks, may be increased to 32mg. Renal of 1st degree, Prinzmetalâ&#x20AC;&#x2122;s angina, peripheral impairment (incl. haemodialysis) and intravascular arterial occlusive disease, general anaesthesia. In volume depletion: 4mg initially. Moderate hepatic bronchial asthma or other COPD, bronchodilating impairment: 2mg initially. therapy should be given concomitantly. Psoriasis: Q Safety and efficacy not established. Assess risk/benefit. Phaeochromocytoma: Do not D Pregnancy, lactation. Severe hepatic admin. until after a-receptor blockade. Symptoms impairment and/or cholestasis. of thyrotoxicosis may be masked. Contains lactose. B Not recommended: Primary Driving/operating machinery ability (at start of hyperaldosteronism. Caution: Haemodynamically treatment, with alcohol). relevant aortic mitral valve stenosis, obstructive C Contra: Floctafenin, sultopride. Not hypertrophic cardiomyopathy, severe CHF, recommended: Ca++ antagonists (verapamil type underlying renal disease (incl. renal artery and diltiazem type), class I antiarrhythmics, stenosis), haemodialysis (carefully titrate with centrally acting antihypertensives. Caution: Ca++ thorough monitoring of BP), anaesthesia and (dihydropyridine type (e.g. felodipine, surgery. Monitor renal function, serum K+ and creatinine levels (HF, elderly, renal impairment, amlodipine), class-III antiarrhythmics (e.g. concomitant ACE inhibitor). Hypotension may amiodarone), topical b-blocking agents (e.g. eye occur. Contains lactose. drops for glaucoma treatment), C Possible interaction with NSAIDs. parasympathomimetics, insulin and oral Antihypertensive effect may be enhanced by other antidiabetics, anaesthetic agents, digitalis antihypertensives. K+ -sparing diuretics, K+ glycosides, NSAIDs, b-sympathomimetics that supplements, salt substitutes containing K+, or activate both b and a-adrenoreceptors (e.g. other medicinal products that may increase K+ noradrenaline, adrenaline), antihypertensives, levels, lithium. tricyclic antidepressants, barbiturates, phenothiszines. Mefloquine, MAOIs (except MAO- A Respiratory infection, dizziness/vertigo, headache. B inhibitors). A Bradycardia, worsening of heart failure, BLOPRESS PLUS Takeda dizziness, headache, GI complaints, feeling of coldness or numbness in extremities, hypotension, 5 M O asthenia, fatigue. Angiotensin II antagonist/thiazide diuretic. Candesartan cilexetil/HCTZ 8mg/12.5mg, 16mg/ BISOPINE Pinewood 12.5mg, 32mg/12.5mg, 32mg/25mg. Resp. white, 3MO light pink, light yellow or light pink scored oval Cardioselective b-blocker. Bisoprolol hemifumarate tabs marked with strength and C (8mg/12.5mg, 5mg, 10mg. Resp. pale yellow or beige mottled 16mg/12.5mg), C1 (32mg/12.5mg) or C2 (32mg/ tabs. marked BI above breakline 5 or 10 below. 25mg). 8mg/12.5mg-28, A15.81; 16mg/12.5mg-28, A19.22; 32mg/12.5mg-28, A24.63; 32mg/25mg-28, 5mg-28, A5.90; 10mg-28, A6.65. A24.63. S Hypertension. P 5-20mg once daily, usually 10mg once S Essential Hypertension, where daily. Upon discontinuation, diminish slowly by monotherapy with candesartan cilexetil or HCTZ is weekly halving dose. Severe renal impairment: not sufficient. Max dose 10mg daily. P 1 tab. once daily. Titrate candesartan R Lowest dose recommended. Regular dose before switching to Blopress Plus (esp. in monitoring during initiation of treatment. renal impairment and volume depleted patients). Q Not recommended. When clinically appropriate direct switch from Acute HF or during episodes of HF decompensation requiring IV inotropic therapy.

48

monotherapy to Blopress Plus may be considered. Mild-moderate renal impairment: Initially 4mg candesartan. Mild to moderate hepatic impairment: Initially, 2mg candesartan. Q Safety and efficacy not established. D Pregnancy, lactation. Severe hepatic impairment and/or cholestasis. Severe renal impairment. Refractory hypokalaemia and hypercalcaemia. Gout. B Not recommended: Primary aldosteronism. Renal impairment: Monitor K+, creatinine and uric acid levels. Recent kidney transplant (no data). Caution: Renal artery stenosis, impaired hepatic function, progressive liver disease, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Correct intravascular volume and/or Na+ depletion before treatment. Hypotension may occur during anaesthesia and surgery. Monitor serum electrolytes. Discontinue before parathyroid function tests. May impair glucose tolerance. Hypersensitivity reactions to HCTZ may occur (particularly if history of allergy or bronchial asthma). Exacerbation or activation of SLE reported with thiazides. Contains lactose. C Caution: Skeletal muscle relaxants, drugs associated with K+ loss and hypokalaemia (e.g. other kaliuretic diuretics, laxatives, amphotericin, carbenoxolone, penicillin G Na+, salicylic acid derivates), Ca++ supplements, Vitamin D, bblockers, diazoxide, anticholinergics , amantadine, cytotoxic drugs, steroids, adrenocorticotropic hormone (ACTH), antidiabetics (incl. insulin), pressor amines, iodinated contrast media, lithium, K+ -sparing diuretics, K+ supplements, salt substitutes containing K+, or other medicinal products that may increase K+ levels. Possible interaction with NSAIDs. Antihypertensive effect may be enhanced by other antihypertensives. Absorption of HCTZ reduced by colestipol or cholestyramine. A Dizziness/vertigo, hyperglycaemia, hyperuricaemia, electrolyte imbalance (incl. hyponatraemia and hypokalaemia), glycosuria, weakness, increases in cholesterol and triglycerides.

BYTRITE

Helsinn Birex

2MO ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, 10mg. Opaque hard gelatin caps. Yellow, light orange, pink and blue cap with white bodies printed 93 and 7209, 7210, 7211, 7212 resp. 1.25mg-28, A2.48; 2.5mg-28, A3.53; 5mg-28, A4.94; 10mg-28, A6.73. S Hypertension. P Initially, 2.5mg once a day; should be increased at intervals of 1-2 weeks, up to max. 10mg once a day. Consider combination treatment if 10mg not effective. Diuretic treated patients: Discontinue diuretic 2-3 days prior to therapy. If diuretic cannot be discontinued, start with 1.25mg. Renal impairment: See SPC. Q Not recommended. D History of angioneurotic oedema relating to previous ACE inhibitor treatment. Pregnancy, lactation. Use in children. B Aortic stenosis, outflow obstruction (not recommended). Assess renal function prior to and during treatment. Impaired renal/liver function; reduce dose and monitor closely. Haemodialysis using high-flux membranes (avoid). Correct volume/salt depletion before initiating therapy. Collagen vascular disease; monitor white blood cell counts and protein levels in urine.

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM

HYPERTENSION 2.4

SPC. B With renal impairment, collagen vascular disease, immunosuppressant therapy, or leukopenic drugs monitor white cell count and urinary protein. Anaesthesia. Contains lactose. C K+sparing diuretics or K+suppl., NSAIDs, vasodilators, clonidine, allopurinol, procainamide, BYZESTRA Ergha probenecid, immunosuppressants. A Rash, loss of taste, cough. Rarely 2MO neutropenia, agranulocytosis, proteinuria. Lisinopril dihydrate 2.5mg, 5mg, 10mg, 20mg. White tabs marked LSN followed by strength. CAPOZIDE BMS 2.5mg-28, A3.13; 5mg-28, A4.41; 10mg-28, A5.44; 5MO 20mg-28, A6.25. ACE inhibitor/thiazide diuretic. Captopril 50mg, S Arterial hypertension alone or concomitantly with other antihypertensive agents. HCTZ 25mg. White scored tab. marked SQUIBB Renal disease in hypertensive patients with type 2 390. 28, A7.29. 5MO diabetes mellitus and incipient nephropathy. P Arterial hypertension: Initially, 5-10mg ALSO HALF CAPOZIDE Captopril 25mg, HCTZ in the morning; titrate at minimum 3 week 12.5mg. White scored tab. marked SQUIBB 536. intervals; maintenance, 20mg once daily; max. 28, A5.15. 80mg once daily. Renal complications of diabetes S Mild to moderate hypertension in mellitus: 10mg once daily; may be increased to patients who have been stabilised on captopril 20mg once daily to achieve BPQ90mmHg. and a thiazide diuretic. Moderate renal impairment: As per elderly. P 1 daily. R Initially, 2.5mg in the morning; maintenance usually 5-10mg daily; max. 20mg daily. Q Not recommended. D Angioneurotic oedema, severe renal impairment, aortic or mitral valve stenosis, hypertrophic cardiomyopathy, haemodynamically unstable patients after acute MI, SBPR100mmHg. Lactation, pregnancy. Permanent haemodialysis, cardiogenic shock. B Initiate therapy/adjust dose in hospital in: High risk for severe acute hypotension, e.g. vol/ salt depletion, pre-existing hypotension, renovascular hypertension, renal artery stenosis, unstable cardiac failure, renal impairment, highdose vasodilator therapy, patients r70 years, cerebrovascular disease, malignant hypertension. Discontinue or reduce diuretic therapy for 2-3 days before treatment and start with 2.5mg daily. Primary hyperaldesteronism (not recommended). Hypertrophic cardiomyopathy, surgery; caution. C Caution: K+-sparing and other diuretics, K+ suppls, NaCl, antihypertensives, analgesics, antiinflammatory agents, lithium, alcohol, anaesthetics/ narcotics/ hypnotics, sympathomimetics, oral antidiabetics, antacids, NSAIDs. A Hypotension, headache, tiredness, dry cough, sore throat, bronchitis, nausea, rash, angioneurotic oedema, hyperkalaemia. Hyperkalaemia, angioneurotic oedema have been reported rarely. Surgery/anaesthesia. Driving or operating machines. C Caution: Antidiabetics, NSAIDs. A Nausea, dizziness and headache, GI disturbances, cough, skin/mucosal reactions.

CAPOTEN

Q Not recommended. D Aortic stenosis. Pregnancy, lactation. See SPC. B With renal impairment, collagen vascular disease, immunosuppressant therapy, or leukopenic drugs monitor white cell count and urinary protein. Anaesthesia. Diabetes. Hepatic impairment. Gout. C Lithium, sulphonamide-derived drugs, NSAIDs, allopurinol, procainamide, probenecid, immunosuppressants, vasodilators, clonidine, K+sparing diuretics, K+suppl., antihypertensives. A Rash, loss of taste, cough. Rarely neutropenia, agranulocytosis, proteinuria.

CAPTOR

Rowex

2MO ACE inhibitor. Captopril 12.5mg, 25mg, 50mg. White tabs. scored one side (6.25mg, 12.5mg); white tabs. cloverleaf form with facet and quarter scored both sides (25mg, 50mg). 12.5mg-60, A8.54; 100, A14.25; 25mg-60, A9.73; 100-A16.22; 50mg-60, A16.60; 100, A27.67. S Hypertension.

BMS

2MO ACE inhibitor. Captopril 12.5mg, 25mg, 50mg. Mottled white scored tab. marked S, mottled white quarter scored square tab. coded 452 and SQUIBB, mottled white oval tab. coded 482 and SQUIBB. 12.5mg-56, A4.79; 25mg-56, A5.46; 84, A24.72; 50mg-56, A9.31; 84, A42.12. S Hypertension. P Initially 25mg or 50mg once daily. Add a diuretic if required after 2-4 weeks. Usual max. 100mg daily in single or divided doses. Elderly and those patients already on diuretic therapy, initially 25mg once daily and titrate according to response. Renally impaired, initiate at a lower dose e.g. 12.5mg once daily and titrate according to response. Q Contact manufacturer. D Aortic stenosis. Pregnancy, lactation. See AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

49


2.4 HYPERTENSION

CIRCULATORY SYSTEM

P Initially, 25-50mg daily in two divided doses; may be increased with intervals of at least 2 weeks, to 100-150mg/day in two divided doses. With diuretics, once-daily dosing regimen may be appropriate. Renal impairment, initiate at a lower dose (see SPC). R Initially 6.25mg twice daily. Q Initially 0.3mg/kg, or 0.15mg/kg in infants or renal dysfunction. Generally 3 times a day. D Angioneurotic oedema. Pregnancy, lactation. B Renal impairment, renal artery stenosis, LV valvular and outflow tract obstruction, collagen vascular disease, patients at risk for hyperkalaemia, diabetes, hepatic impairment, anaesthesia. Neutropenia/ agranulocytosis, proteinuria. Contains lactose. C K+sparing diuretics, K+suppl., diuretics, other anti hypertensive agents, lithium, TCAs, allopurinol, procainamide, cytostatic or immunossupressive drugs, NSAIDs, sympathomimetics, antidiabetics. A Pruritus, rash, alopecia, dry cough, loss of taste, dizziness, sleep disorders, GI disorders.

ALSO CARDURA Doxazosin mesylate (equiv. doxazosin) 1mg, 2mg. White round and oblong biconvex tabs. marked CN1 and CN2 resp. with Pfizer logo on reverse. 2mg tab. scored. 1mg-28 (Cal/Pk), A4.93; 2mg-28, A6.57. P Initially 1mg once daily; may be increased to 2mg once daily, then 4mg, 8mg, up to max. 16mg daily. Titration interval, 1-2 weeks. Usual recommended dose, 2-4mg once daily. Q Under 12 years, not recommended. D Lactation. Cardura XL: History of GI or oesophageal obstruction, decreased lumen diameter of GI tract. B Pregnancy. Renal/hepatic impairment, LV failure, elderly. Driving/using machines. Postural hypotension (warn patients), cataract surgery. Cardura tabs contain lactose. C Caution: PDE-5 inhibitors. A Vertigo, nausea, asthenia, oedema, fatigue, malaise, dizziness, headache, postural dizziness, somnolence, syncope, rhinitis. Most common reactions with Cardura XL of postural type.

2NO

CARSEM XL

5MO

CAPTOR-HCT

2MO

Rowex

Teva

Selective a-blocker. Doxazosin (as mesilate), 4mg. 5MO White, round biconvex film-ctd prolonged-release ACE inhibitor/thiazide diuretic. Captopril 50mg, tab. with DL bossing on one side. 28, A12.82. HCTZ 25mg. Off-white scored tab. 30, A13.00. S Essential hypertension: Not for 1st-line 5MO treatment, may be used as monotherapy in ALSO CAPTOR-HCT 25/12.5 Captopril 25mg, HCTZ patients who fail to respond/have A contraindications to other agents; as 2nd or 3rd 12.5mg. Off-white scored tab. 30, 9.18. S Hypertension not adequately controlled line treatment in combination with other by captopril alone or HCT alone. antihypertensives. P Maintenance, 50/25mg once daily in the P 4mg once daily. May be increased to morning. Renal impairment, salt/vol. depletion, 8mg once daily. diabetes: 25/12.5mg once daily. Q Not recommended. R 25/12.5mg once daily. D Benign hyperplasia and concomitant Q Not recommended. congestion of upper urinary tract, chronic UTIs, D Angioneurotic oedema. Severe renal or bladder stones. Overflow bladder, anuria, hepatic impairment. Pregnancy, lactation. progressive renal impairment. History of B Renal impairment, renal artery stenosis, oesophageal or GI obstruction, decreased GI tract LV valvular and outflow tract obstruction, collagen lumen diameter. Lactation. Pregnancy (unless vascular disease, patients at risk for clearly needed). hyperkalaemia, diabetes, hepatic impairment, B Severe hepatic impairment, not anaesthesia. Electrolyte imbalance, gout, recommended. Monitor for postural effects when neutropenia/ agranulocytosis, proteinuria. Contains initiating therapy. Caution: Acute heart disease, lactose. mild-moderate hepatic impairment, Diabetic C K+sparing diuretics, K+suppl., diuretics, Autonomic Neuropathy, cataract surgery. Not for vasodilators, lithium, TCAs, allopurinol, use as single agent in patients with 1 or more procainamide, cytostatic or immunossupressive additional cardiovascular disease risk factors. May drugs, NSAIDs, sympathomimetics, antidiabetics. influence plasma renin activity and urinary Amphotericin B (parenteral), carbenoxolone, excretion of vanillylmandelic acid. Driving/ corticosteroids, ACTH or stimulant laxatives, Ca++ operating machinery. salts, cardiac glycosides, cholestyramine resin and C Not recommended: Tadalafil. Caution: colestipol, nondepolarising muscle relaxants, drugs Sildenafil, vardenafil, other antihypertensives, nonassociated with torsades de pointes. steroidal antirheumatics, estrogens, A Pruritus, rash, alopecia, dry cough, loss sympathomimetics, medicinal products which may of taste, dizziness, sleep disorders, GI disorders. influence hepatic metabolism (e.g. cimetidine). A Apathia, muscle cramps, fatigue, CARDURA XL Pfizer malaise, headache, somnolence, accomodation disturbances, palpitations, chest pain, giddiness, 2MO dizziness, oedema, orthostatic dysregulation, Selective a-blocker. Doxazosin 4mg, 8mg. White dyspnoea, rhinitis, GI disorders, frequent desire to prolonged-release round biconvex tabs. with hole micturate, increased micturation, delayed in one side, marked CXL4 or CXL8. 4mg-28 (Cal/ ejaculation, asthenia. Pk), A9.05; 8mg-28 (Cal/Pk), A37.54. S All grades of hypertension as Boehringer Ing. monotherapy or with thiazide diuretic, b-blocking CATAPRES 2MO drugs, Ca++ antagonists or ACE inhibitors. P Initially 4mg once daily. If necessary, Central a-agonist. Clonidine (HCl) 100mcg, may be increased to 8mg once daily (max. dose). 300mcg. White round tabs marked O1C/O1C and Q Under 12 years, not recommended. O3C/O3C resp. on one side and maker’s symbol on 2MO reverse. 100mcg-100, A7.89; 300mcg-100, A18.37.

50

ALSO CATAPRES INJECTION Clonidine 150mcg/ml. Sln for inj. in 1ml amp. 5, A1.69. S Hypertension that has failed to respond adequately to other anti-hypertensives. P 50-100mcg three times daily increasing gradually. Optimal dose 300-1200mcg/day in divided doses. Q Not recommended. D Severe bradyarrhythmia resulting from either sick sinus syndrome or AV block of 2nd or 3rd degree. Pregnancy, lactation. B Depression, Raynaud’s disease, other peripheral vascular occlusive disease, cerebrovascular or coronary insufficiency, mild to moderate bradyarrhythmia, polyneuropathy, constipation, HF, renal insufficiency. Withdraw gradually. Contains lactose. C TCAs, a blockers, b other hypertensives, CNS depressants, NSAIDs, digitalis glycosides. A Sedation, dry mouth, drowsiness.

CENTYL

LEO Pharma

Thiazide. Bendroflumethiazide 2.5mg, 5mg. White, circular, flat, slightly bevelled tabs. 2.5mg-500, A21.25; 5mg-100, A6.38; 500, A31.88. S Hypertension, alone or in combination with other antihypertensives. P 2.5-5mg once daily. D Severe electrolyte imbalance. Severe renal/hepatic impairment. Addison’s disease, established gout, ulcer or GI tract obstruction. B K+suppl. may be required (monitor electrolytes). Renal/hepatic impairment, obstruction of urinary tract, disorders altering electrolyte balance. May: Cause hyperuricaemia and aggravate gout; activate SLE. Diabetes. Pregnancy, lactation. Contains lactose. C Contra: Lithium. Cardiac glycosides, hypotensive agents (adjust dose). TCAs, hypoglycaemic agents, NSAIDs, probenecid, cholestyramine, other drugs known to cause photosensitivity. A Headache, dizziness, fatigue, postural hypotension, GI disorders. Electrolyte disturbances (long term use).

CENTYL K

LEO Pharma

5MO Thiazide/K+suppl. Bendroflumethiazide 2.5mg, K+ Cl 573mg (7.7mmol K+) in slow -release wax core. Green, sugar-ctd, oval, modified release tab. 250, A31.10. S Hypertension alone or in combination with other antihypertensives. P 1-2 every morning. Q Not applicable. D Precoma associated with hepatic cirrhosis, Addison’s disease. Severe renal impairment. Hyperkalaemia. B Diabetes, renal impairment, obstruction of urinary tract; caution. Obstruction of small bowel, ulceration (discontinue if occurs). Pregnancy, lactation (only if essential). C K+sparing diuretics, lithium. Caution: Cardiac glycosides, antihypertensives. A Rash, photosensitivity, myopia aggravation, blood dyscrasias, gout, fatigue. Acute pancreatitis, hyperuricaemia, GI upset, oliguria, dizziness, headache, muscle pain, thirst, dry mouth. Vasculitis.

CIBACEN

Meda

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM HCTZ 12.5mg. Yellow, ovaloid, beveled edge, filmctd tablet, debossed with NVR on one side and CTI on the reverse. 28, A32.24. P 1 daily, with fluid. Start with lower strength (320mg/12.5mg) and continue for at least 4-8 weeks before starting treatment with 320mg/ 25mg strength. Max. effect within 4-8 weeks. If no relevant additional effect, consider dose reduction and treatment with an additional or alternative antihypertensive. Q Under 18 years, not recommended. D Severe hepatic/renal impairment, anuria, biliary cirrhosis, cholestasis, dialysis, refractory hypokalaemia, hyponatraemia, hypercalcaemia, symptomatic hyperuricaemia. Pregnancy, lactation. B Vol. depletion and serum electrolyte changes (monitor); correct vol./ Na+ depletion before starting therapy. Not recommended: Renal artery stenosis, primary hyperaldosteronism, severe chronic HF. Caution: Aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy, renal transplantation, hypersensitivity to other Ang II receptor blocking agents, allergy, asthma. Mild hepatic impairment without cholestasis, use 80/ 12.5 tab. only. May activate or exacerbate systemic lupus erythematosus. Altered glucose tolerance, CO-BETALOC Pharmacia raised serum levels of cholesterol, triglyceride, uric acid. 5MO C Drugs that increase/decrease serum K+ Cardioselective b-blocker/thiazide diuretic. levels, digitalis glycosides, drugs inducing torsades Metoprolol tartrate 100mg, HCTZ 12.5mg. White de pointes, antiarrhythmics, other scored tab. marked A/MH. 28, A8.96. antihypertensives, lithium, vit. D or Ca++ salts, S Mild to moderate hypertension. antidiabetics, b-blockers, diazoxide, drugs for the P 1-2 daily in single or divided doses. treatment of gout (allopurinol, probenecid, Q Not recommended. sulfinpyrazone), anticholinergics, pressor amines, D See SPC. amantadine, anionic exchange resins, cytotoxics, CO-DIOVAN Novartis NSAIDs, curare derivatives, cyclosporin, tetracyclines, alcohol, anaesthetics, sedatives, 5MO methyldopa. Angiotensin II antagonist/thiazide. Valsartan 80mg, A Diarrhoea, fatigue, nasopharyngitis. HCTZ 12.5mg. Light orange ovaloid film-ctd tab. marked HGH on one side and CG on reverse. 28, COAPROVEL sanofi-aventis/BMS A17.80. 5MO S Hypertension where monotherapy Angiotensin II antagonist/thiazide. Irbesartan/HCTZ proves inadequate. 150mg/12.5mg; 300mg/12.5mg; 300mg/25mg. P 1 daily. Mild to moderate hepatic Peach, peach, pink tabs marked 2875, 2876, 2788 impairment without cholestasis: Max. valsartan resp. All: Biconvex, oval, film-ctd marked with a 80mg daily. heart on reverse. 150/12.5mg-28, A18.33; 300/ Q Under 18 years, not recommended. 12.5mg-28, A24.74; 300/25mg-28, A24.71. 5MO S Essential hypertension in those ALSO CO-DIOVAN 160MG/12.5MG Valsartan inadequately controlled by either agent alone. 160mg, HCTZ 12.5mg. Dark red, ovaloid film-ctd. P 1 x 150/12.5mg tab. once daily where tab. Imprinted HHH on one side and CG on the irbesartan 150mg or HCTZ taken alone do not other. 28 (2x14): A23.87. control BP. Alternatively, 1 x 300mg/12.5 tab. once P 1 daily. daily where irbesartan 300mg taken alone or Q Under 18 years, not recommended. CoAprovel 150mg/12.5mg do not control BP. 1 x 5MO 300mg/25mg once daily may be admin. in patients ALSO CO-DIOVAN 160MG/25MG Valsartan 160mg, insufficiently controlled by CoAprovel 300mg/ HCTZ 25mg. Brown, ovaloid tab. marked with HXH 12.5mg. Max: 300mg/25mg once daily. on one side and NVR on reverse. 28, A24.33. Q Under 18 years, not recommended. P 1 daily. Start with 160mg/12.5mg for D Severe renal impairment. Refractory min. 4-8 weeks. hypokalaemia, hypercalcaemia. Severe hepatic Q Under 18 years, not recommended. impairment, biliary cirrhosis, cholestasis. 5MO Pregnancy. ALSO CO-DIOVAN 320MG/12.5MG Valsartan B Correct volume/salt depletion before 320mg, HCTZ 12.5mg. Pink, ovaloid, beveled edge, initiating therapy. Renal impairment: Monitor K+, film-ctd tab., debossed with NVR on one side and creatinine and uric acid serum levels regularly. HIL on the reverse. 28, A29.13. Kidney transplantation, no data. Caution: Hepatic P 1 daily with fluid. When clinically impairment; renal artery stenosis; aortic or mitral appropriate direct change from monotherapy to stenosis, or obstructive hypertrophic the fixed dose combination may be considered. cardiomyopathy; diabetics; severe CHF, ischemic Max. effect within 4-8 weeks cardiopathy or ischemic CVD. Primary Q Under 18 years, not recommended. aldosteronism, not recommended. Hyperuricaemia/ 5MO gout; hypercalcaemia; hypomagnaesemia; ALSO CO-DIOVAN 320MG/25MG Valsartan 320mg, hypersensitivity reactions, may occur. Monitor

2MO

ACE inhibitor. Benazepril (HCl) 5mg cap-shaped pale yellow film-ctd tab scored both sides and marked CG one side and LV on reverse. 10mg dark yellow film-ctd tab marked CG one side and HO on reverse. 5mg-28, A9.33; 10mg-28, A12.44. S Hypertension. P Initially 10mg once daily. Patients with severe renal impairment or HF, initially 5mg once daily. Maintenance, 10mg once daily; max. 40mg daily. Discontinue diuretic therapy for at least 3 days before commencing therapy. R Initially 5mg once daily. Titrate to 10mg once daily. Q Not recommended. D Pregnancy, lactation. History of angioedema. B Salt and/or volume depletion. Renal artery stenosis, renal impairment, surgery, anaethesia, CHF. C Other anithypertensives, K+suppl., K+sparing diuretics, lithium. A Headache, upper respiratory tract symptoms, dizziness, fatigue, musculoskelatal pain, cough, rhinitis, nausea, diarrhoea, rash.

HYPERTENSION 2.4 serum electrolytes regularly. May exacerbate or activate SLE. If inadvertently taken during pregnancy, skull and renal function should be checked with echography. Lactation not recommended (esp. newborn or preterm infants). Contains lactose. C Lithium, not recommended. Caution: Other antihypertensives, K+ sparing diuretics, K+ suppl., salt substitutes containing K+, digitalis glycosides, antiarrhythmics, NSAIDs, alcohol, antidiabetics, colestyramine, colestipol, corticosteroids, ACTH, muscle relaxants, antigout medicines, Ca++ suppl. or Ca++ sparing medicines, anticholinergics, amantadine, cytotoxic medicines. A Dizziness, nausea, vomiting, abnormal urination, fatigue. Increases in BUN, creatinine and creatinine kinase.

COVERSYL ARGININE

Servier

2MO ACE inhibitor. Perindopril arginine 5mg, 10mg. 5mg: Light green, rod-shaped scored film-ctd tab with a symbol. 10mg: Green, round, biconvex, film-ctd tab with heart on one side and symbol on reverse. 5mg-30, A14.12; 10mg-30, A22.59. S Essential hypertension as monotherapy or in combination with thiazide diuretics. P Initially, 5mg daily as single dose. After 4 weeks, increase to 10mg once daily if required. Discontinue diuretic 3 days beforehand. If not possible, commence with 2.5mg. Renal insufficiency, 2.5mg according to creatinine clearance. R Initially, 2.5mg once daily; increase to 5mg after 4 weeks, then 10mg if necessary. Q Not recommended. D ACE inhibitor hypersensitivity. History of angioneurotic oedema (previous ACE treatment), hereditary or idiopathic angioedema. Pregnancy, lactation. B Symptomatic hypotension may occur in patients with salt or volume depletion. Caution: Mitral valve stenosis, obstruction in the outflow of the left ventricle. Renal impairment. Dialysis with highflux membranes. Kidney transplantation, no data. Angioedema reported rarely (discontinue if occurs). Patients at risk of hyperkalaemia. Contains lactose. Surgery, anaesthesia. C Diuretics, K+ sparing diuretics, K+containing salt substitutes, K+ supplements, lithium, NSAIDs, other antihypertensives and vasodilators, antidiabetics, TCAs, antipsychotics, anesthetics, sympathomimetics. A Headache, dizziness, vertigo, paresthaesia, vision disturbance, tinnitus, hypotension, cough, dyspnoea, GI disorders, rash, pruritus, muscle cramps, asthenia.

COVERSYL ARGININE PLUS

Servier

5MO ACE inhibitor/antihypertensive diuretic. Perindopril arginine/indapamide, 5mg/1.25mg; 10mg/2.5mg White rod-shaped or round (resp.) tab. 5/1.25mg30, A19.67; 10/2.5mg-30, A31.47. S Essential hypertension. 5mg/1.25mg: When BP inadequately controlled on perindopril alone. 10mg/2.5mg: Substitution therapy, in patients already controlled with perindopril and indapamide given concurrently at the same dose level. P 1 daily preferably in the morning before a meal. Q Not recommended. D History of angioedema (Quincke’s

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

51


2.4 HYPERTENSION

CIRCULATORY SYSTEM

R As per adults. q75 years, consider initiating therapy with 25mg. Q Not recommended: Q 6 years, GFR Q30ml/min/1.73m2, hepatic impairment. Hypertension: 25mg once daily in patients q20Q50kg; exceptionally, can be increased to 50mg once daily maximum. Patients q50kg, 50mg once daily; exceptionally can be adjusted to 100mg once daily maximum. Doses q1.4mg/kg (or q100mg) daily not studied in paediatric patients. COZAAR COMP MSD D Severe hepatic impairment. Pregnancy, lactation. 5MO B History of angioedema (closely monitor). Angiotensin II antagonist/thiazide. Losartan (K+)/ HCTZ 50mg/12.5mg, 100mg/12.5mg, 100mg/25mg. Volume depletion may cause symptomatic or use Resp. yellow, white and yellow oval film-ctd tabs. hypotension (correct prior to initiating lower starting dose). Monitor K+ and cc. Caution: marked 717, 745 and 747 50/12.5mg-28, A18.32; Hepatic impairment, renal impairment, renal 100mg/12.5mg-28, A26.36; 100/25mg-28, A31.77. artery stenosis, primary aldosteronism (not S Hypertension; not usually appropriate recommended), ischaemic cardiovascular and for initial therapy. cerebrovascular disease, aortic or mitral valve P Start with 50mg/12.5mg once daily. If stenosis, obstructive hypertrophic cardiomyopathy. no response use 100mg/12.5mg or 100mg/25mg Monitor renal function regularly. No sufficient once daily (max. dose). therapeutic experience: HF with concomitant Q Not recommended. severe renal impairment, severe HF (NYHA class D Therapy resistant hypokalaemia or IV), HF and symptomatic life threatening cardiac hypercalcaemia. Severe hepatic impairment; cholestasis, biliary obstructive disorders. Refractory arrhythmias. Contains lactose. + C Not recommended: K sparing diuretics, hyponatraemia. Symtomatic hyperuricaemia/gout. K+ supplements or salts, ACE inhibitors. Caution: Severe renal impairment. Anuria. Pregnancy. Other antihypertensives, TCAs, antipsychotics, Lactation. B Not recommended: Hepatic impairment, baclofen, amifostine, fluconazole, rifampicin, lithium, NSAIDs. severe renal impairment. Caution: Renal disease and renal transplant recipients. Haemodynamically A Hypertension: Dizziness, vertigo. Patients with LV hypertrophy: dizziness, vertigo, significant obstructive valvular disease, asthenia/fatigue. Type 2 diabetes with renal cardiomyopathy. May occur: SLE, gout, disease: Dizziness, hypotension, asthenia/fatigue, angioedema, symptomatic hypotension, increased hypoglycaemia, hyperkalaemia. triglycerides, cholesterol and serum calcium, impaired glucose tolerance. Monitor serum DILTAM RETARD Rowex electrolytes. Contains lactose. 2MO + + sparing diuretics, K suppl. or salts, C K COZAAR MSD barbiturates, narcotics, alcohol, antidiabetics, other Class III Ca++ antagonist. Diltiazem (HCl) 90mg. 2MO White sust.-release tab. 60, A12.38. antihypertensives, colestyramine and colestipol Angiotensin II antagonist. Losartan (K+) 12.5mg, S Mild to moderate hypertension. resins, corticosteroids, pressor amines, muscle 50mg, 100mg. White film-ctd scored tab. marked P Initially 1 daily increasing to 2 daily if relaxants, lithium, NSAIDs (indometacin), 952, white film-ctd teardrop-shaped tab. marked required. rifampicin, fluconazole. 960. 12.5mg-28, A9.60; 50mg-28, A18.32; 100mg- A Insomnia, headache, dizziness, cough, Q Not recommended. 28, A30.80. D Pregnancy, lactation. Sick sinus upper respiratory infection, nasal congestion, 2MO sinusitis, sinus disorder, GI disorders, muscle cramp, syndrome, 2nd or 3rd degree AV block, marked ALSO COZAAR ORAL SUSPENSION Losartan K+, bradycardia, decompensated cardiac failure. back pain, leg pain, myalgia, asthenia, fatigue, 2.5mg/ml (reconstituted susp.). White to off-white chest pain, hyperkalaemia, mild reduction of B Mild bradycardia, prolonged PR interval. powder and cloudy, colorless solvent for oral susp. haematocrit and haemoglobin. Measure heart rate regularly in elderly and in 500mg/200ml, A50. patients with hepatic or renal impairment. S Essential hypertension in adults, children COZATAN Clonmel Diabetes. and adolescents 6-18 years. Reduction in risk of C b-blockers, digoxin, cimetidine, 2MO stroke in hypertensive adults with LV hypertrophy. diazepam, antihypertensives, anaesthetics. + Renal disease in adults with hypertension and type Angiotensin II antagonist. Losartan (K ), 50mg, A Anorexia, nausea, bradycardia, oedema, 100mg. Resp. round or oblong biconvex white 2 diabetes mellitus with proteinuria r 0.5g/day as rash, flushing, fatigue, AV block, headache, GI film-ctd tab. with breaking notch on both sides. part of antihypertensive treatment. disturbance. Can be divided into equal quarters or halves. P 50mg once daily. If necessary, increase 50mg-28, A9.54; 100mg-28, A16.03. to max. 100mg once daily (morning). May be DILZEM XL Cephalon S Essential hypertension. Renal disease in admin. with other antihypertensives (e.g. 2MO patients with hypertension and type 2 diabetes hydrochlorothiazide) Class III Ca++ antagonist. Diltiazem (HCl) 120mg, Q Under 6 years, not recommended. Over with proteinuria r0.5g/day as part of 180mg, 240mg. Prolonged release hard capsules antihypertensive treatment. 6 years: 20-50kg: 25mg once daily; may be P Hypertension: 50mg once daily; maximal marked with cap. strength and logo. 120mg-28, exceptionally increased to 50mg. q50kg: may be A8.39; 180mg-28, A12.44; 240mg-28, A16.06. effect attained 3-6 weeks after initiation of exceptionally increased to 100mg. Not therapy. May be increased to 100mg once daily (in S Angina pectoris, incl. Prinzmetalâ&#x20AC;&#x2122;s recommended: Hepatic impairment, glomerular 2 angina. Mild to moderate hypertension. the morning). Renal disease in diabetics: Initially filtration rate Q 30ml/min/1.73 m . 50mg once daily. May be increased to 100mg once P 180mg once daily increasing gradually, D Severe hepatic impairment. Pregnancy. daily based on BP response from one month after as necessary to 360mg once daily. B History of angiooedema (closely R Initially 120mg once daily, increasing initiation of therapy onwards. May be monitor). Volume depletion may cause + administered with other antihypertensives as well gradually. symptomatic hypotension. Monitor K and cc. Q Not recommended. as with insulin and other commonly used Hepatic impairment, renal impairment, renal 2MO hypoglycaemics. Intravascular volume depletion: artery stenosis, primary aldosteronism (not ALSO DILZEM SR Diltiazem (HCl) 60mg, 90mg, Consider 25mg once daily initially. Hepatic recommended), aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. No 120mg. Prolonged release hard capsules marked impairment: Consider lower dose.

oedema) with previous ACE inhibitor therapy. Hereditary/idiopathic angioedema. Hepatic encephalopathy. Severe and moderate hepatic impairment. Hypokalaemia. Severe and moderate renal impairment . Dialysis patients. Untreated decompensated heart failure. Pregnancy, lactation. B Not recommended: Renal artery stenosis, single functioning kidney. Monitor WBC counts: Collagen vascular disease, immunosuppressant / allopurinol / procainamide therapy. May occur: Angioedema, anaphylactoid reactions during desensitisation / LDL apheresis / dialysis with high flux membranes, photosensitivity, increased gout attacks, hepatic syndrome. Monitor for clinicals signs of water depletion, monitor electrolytes. Caution: Na+ depletion (hypotension risk), elderly, atherosclerosis, severe cardiac insufficiency, diabetes, surgery (discontinue 1 day before), aortic stenosis, long Q-T interval. Risk of arterial hypotension and/or renal insufficiency. Contains lactose. C Not recommended: Lithium, K+ salts, K+sparing diuretics, antidiabetics, Caution: Baclofen, NSAIDs, TCAs, neuroleptics, corticosteroids, tetracosactide, other antihypertensives, allopurinol, cytostatic or immunosuppressive agents, systemic corticosteroids, procainamide, anaesthetics, diuretics, injectable gold, torsades de pointes inducing drugs, amphotericin B (by IV), glucocorticoids and mineralocorticoids (systemic route), tetracosactide, stimulant laxatives, cardiac glycosides, iodinated contrast media, Ca++, ciclosporin. A Paraesthesia, headache, dizziness, vertigo, vision disturbance, tinnitus, hypotension, dry cough, dyspnoea, GI disorders, rash, pruritus, maculopapular eruptions, muscle cramps, asthenia.

52

sufficient therapeutic experience: HF with concomitant severe renal impairment, severe HF, HF and symptomatic life threatening cardiac arrhythmias. Lactation (not recommended). Tabs contain lactose. C Rifampicin, fluconazole, NSAID, K+ sparing diuretics, K+ suppl. or salts, lithium. A Dizziness, vertigo, hypotension, asthenia/fatigue, hyperkalaemia, hypoglycaemia.

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM with cap.strength. 60mg-56, A8.12; 90mg-56, A12.16; 120mg-56, A13.90. P Initially 90mg twice daily, increasing gradually to 180mg twice daily. R Initially 60mg twice daily increasing gradually. Q Not recommended. D Pregnancy, lactation, women of child bearing potential. Sick sinus syndrome, 2nd or 3rd degree AV block, marked bradycardia, decompensated cardiac failure. Atrial fibrillation/ flutter with WPW. Concomitant dantrolene infusion. B Mild bradycardia, prolonged PR interval, diabetes, red. LV function, monitor patients with hepatic dysfunction and renal impairment. C Antihypertensives, halogenated anaesthetics, H2 agonists, digoxin. A Oedema, headache, dizziness, asthenia, bradycardia, flushing, 1st degree heart block.

HYPERTENSION 2.4 A Palpitation, tachycardia, vertigo, GI disorders, asthenia, chest/ back pain, peripheral oedema, myalgia, dizziness, headache, cough, pruritus, urinary incontinence, postural Rowex hypotension.

A Dizziness, rhinitis, GI disorders, headache, fatigue, malaise, oedema, somnolence, asthenia, dry mouth.

DOXANE XL 2MO

Selective a-blocker. Doxazosin (as mesilate) 4mg. Prolonged release tab. White, round, biconvex tab. embossed DL. 28, A12.66. S Essential hypertension. P Initially 4mg once daily swallowed whole with water; may be increased to max. 8mg once daily. Taken as monotherapy or in combination with thiazide diuretics, badrenoceptor blocking agents, Ca++ antagonists or an ACE-inhibitor. Q Not recommended. D Benign hyperplasia and concomitant congestion of the upper urinary tract, chronic UTIs or bladder stones. Overflow bladder, anuria or progressive renal insufficiency. History of DIOVAN Novartis oesophageal or GI obstruction or decreased lumen 2MO diameter of the GI tract or patients at increased Angiotensin II antagonist. Valsartan 80mg, 160mg, risk for such obstruction. Pregnancy (only if 320mg. Pale red, grey-orange and dark grey-violet benefit outweighs risk), lactation. B Not considered appropriate as first line film-ctd scored tabs. marked D/V, DX/DX and DC/ treatment in hypertension. Monitor on initiation DC resp. on one side and NVR on reverse. 80mg28, A17.80; 160mg-28, A23.02. 320mg-28, A29.13. (risk of postural effects). Caution: Acute heart disease; minor/moderate hepatic impairment, S Hypertension. diabetic autonomic neuropathy. Severe hepatic P Usually 80mg once daily, increasing if impairment, not recommended. Driving/ using necessary to 320mg (max) once daily. Mild to moderate hepatic impairment without cholestasis: machines. C Caution: NSAIDs, oestrogens, Max. 80mg daily. sympathomimetics, PDE-5 inhibitors. Q Under 18 years, not recommended. A Apathia, muscle cramps, fatigue, D Pregnancy, lactation. Severe hepatic impairment, biliary cirrhosis and cholestasis, severe malaise, headache, somnolence, accommodation disturbances, palpitations, chest pain, giddiness, renal impairment (cc Q10ml/min.), patients dizziness, oedema, orthostatic dysregulation, undergoing dialysis. Primary aldosteronism. dyspnoea, rhinitis, constipation, dyspepsia, B Correct volume/salt depletion before increased micturation (or desire to), delayed starting therapy. HF, recent MI; reduction in BP. ejaculation, asthenia. Renal artery stenosis, kidney transplantation, hepatic impairment, obstructive hypertrophic DOXATAN Clonmel cardiomyopathy, aortic and mitral valve stenosis. C Caution: K+suppl., K+ sparing diuretics, 2MO antihypertensives, lithium. Selective a-blocker. Doxazosin mesilate (equiv. doxazosin) 1mg white tab. marked D1; 2mg, 4mg DOXACAR XL Gerard white oblong scored tabs. marked D2 or D4. 1mg28, A7.92; 2mg-28, A10.54; 4mg-28, A13.06. 2MO S Essential hypertension. Selective a-blocker. Doxazosin (as mesilate) 4mg. P Initial dose 1mg once daily. If necessary, Prolonged release tab. White, round, biconvex the dosage may be increased to 8mg once daily tab. embossed DL. 28, A14.03. according to response. Max. 16mg daily. S Essential hypertension. Q Not recommended. P Initially 4mg once daily swallowed whole with water; may be increased to max. 8mg 2 M O ALSO DOXATAN XL PROLONGED RELEASE once daily. Taken as monotherapy or in Doxazosin (as mesilate) 4mg. Prolonged release combination with thiazide diuretics, b++ adrenoceptor blocking agents, Ca antagonists or tab. White, round, biconvex tabs. marked with DL. A13.79. 28, an ACE-inhibitor. Q Not recommended. S Hypertension. As monotherapy or in D History of GI or oesophageal combination with thiazide diuretics, bobstruction (or risk of). BPH with urinary outflow adrenoceptor blocking agents, Ca++ antagonists or ACE inhibitors. obstruction, chronic UTIs or bladder stones. P Initially 4mg once daily swallowed Pregnancy (only if benefit outweighs risk), whole with water; may be increased to max. 8mg lactation. once daily. B Abnormally short transport time through GI tract may cause incomplete absorption. Q Under 12 years, not recommended. D History of GI or oesophageal Monitor on initiation (risk of postural effects). obstruction, or any degree of decreased lumen Caution: Acute heart disease; minor/moderate diameter of the GI tract. Pregnancy (only if hepatic impairment. Severe hepatic impairment, benefit outweighs risk), lactation. not recommended. Driving or operating B Caution: Impaired hepatic function. machinery. Introduction and adjustment. Initial dose: Excessive C Caution: Sildenafil or other PDE-5 hypotensive effect may occur. Driving or operating inhibitors. NSAIDs, oestrogens, symathomimetics, machinery. vanillylmandelic acid.

DOXEL

Pinewood

2MO Selective a-blocker. Doxazosin (as mesilate) 4mg. Prolonged release tab. White, round, biconvex tab. marked DL. 28, A13.36. S Hypertension. As monotherapy or in combination with thiazide diuretic, b-blocker, Ca++ antagonist or ACE inhibitor. P Initially 4mg once daily swallowed whole with water; may be increased to max. 8mg once daily. Q Under 12 years, not recommended. D History of GI or oesophageal obstruction, or any degree of decreased lumen diameter of the GI tract. Pregnancy (only if benefit outweighs risk), lactation. B Acute heart diseases. Not recommended: Severe hepatic insufficiency. Caution: Mildmoderate hepatic insufficiency. Postural hypotension may occur particularly at start of therapy; driving / using machines. Pregnancy (only if benefit outweighs risk). Patients undergoing cataract surgery. C Caution: PDE-5 inhibitors. A Delayed ejaculation, apathia, muscle cramps, fatigue, malaise, headache, somnolence, accommodation disturbances, palpitations, chest pain, giddiness, dizziness, oedema, dyspnoea, rhinitis, constipation, dyspepsia, increased micturation or desire to, asthenia.

EMCOLOL

Gerard

3MO Cardioprotective b-blocker. Bisoprolol fumarate 5mg and 10mg. Yellow and orange heart-shaped, scored film-ctd tabs. resp. 5mg-28, A5.93; 10mg28, A6.65. S Hypertension P 5-20mg once daily. Usually 10mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

EMCOR

Daiichi Sankyo/Merck Serono

3MO Cardioselective b-blocker. Bisoprolol fumarate 5mg, 10mg. Yellow and orange biconvex film-ctd heart-shaped scored tabs. 5mg-28, A3.56; 10mg28, A4.01. S Hypertension. P Usually 10mg once daily; max. 20mg daily. In some 5mg/day may be adequate. Final stage impairment of renal function or liver function: Max. 10mg once daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. Acute HF or during episodes of HF decompensation requiring IV inotropic therapy.

ENAP

Rowex

2MO ACE inhibitor. Enalapril maleate 5mg, 10mg, 20mg. White, red and orange tabs marked EN 5, EN 10 and EN 20 resp. All scored, oblong. 5mg-30, A7.55; 10mg-30, A10.58; 20mg-30, A12.57. S Hypertension. P Initially 5-20mg once daily. Maintenance usually 20mg; max. 40mg daily. Q Not recommended; see SPC.

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

53


2.4 HYPERTENSION

CIRCULATORY SYSTEM

   

     

          

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54

side. 5mg/80mg-28, A20.21; 5mg/160mg-28, A26.08; 10mg/160mg-28, A26.88. S Essential hypertension where BP not controlled on amlodipine or valsartan monotherapy. P 1 daily. Use 10mg/160mg if not controlled with valsartan 160mg, or amlodipine 10mg or Exforge 5/160mg. Individual dose titration with components recommended. Q Under 18 years, not recommended. D Severe hepatic impairment, biliary cirrhosis or cholestasis. Severe renal impairment (GFR Q30ml/min/1.73m2), dialysis. Primary hyperaldosteronism. Pregnancy, lactation. B Moderate renal impairment, monitor K+ levels and creatinine. Caution: Vol/salt depletion (risk for hypotension), elderly, HF, aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy, hepatic impairment, biliary obstructive disorders. ENTRYDIL Orion Mild to moderate hepatic impairment without cholestasis, max. valsartan 80mg. 2MO C Lithium, drugs increasing K+ levels Class III Ca++ antagonist. Diltiazem 60mg. White (avoid). Caution: CYP3A4 inhibitors/ inducers, film-ctd scored caplet coded DL60. 100, A17.16. NSAIDS. Avoid alcohol. S Hypertension. A Headache, nasopharyngitis, influenza, P 30-120mg three times daily, usually oedema, fatigue, flushing, asthenia, hot flush. 60mg three times daily. Q Not recommended.

D Angioedema. Pregnancy, lactation. B Kidney transplantation (avoid), renal artery stenosis, aortic or mitral valve stenosis, diabetes, collagen vascular disease, surgery, renal impairment, jaundice (discontinue if occurs). Reduce dose of diuretic, if possible prior to therapy, as vol. depletion may cause symptomatic hypotension. Contains lactose. C Other anti-hypertensive agents, K+suppl., K+sparing and other diuretics, lithium, TCAs, antipsychotics, anaesthetics, sympathomimetics, antidiabetics, antacids, NSAIDs, alcohol, immunosuppressants, allopurinol, procainamide. A Blurred vision, dizziness, hypotension, headache, depression, cough, dyspnoea, asthenia, nausea, GI disorders, rash, angioneurotic oedema, serum creatinine increase, hyperkalaemia.

FLOLAN

2MO ALSO ENTRYDIL CR Diltiazem 90mg, 120mg. Modified release white scored film-ctd caplets marked DL 90 or DL 120. 90mg-100, A21.53; 120mg-100, A35.60. P 120mg once or twice daily, increasing to 180mg twice daily if necessary. Q Not recommended. D Pregnancy. Sick sinus syndrome; 2nd or 3rd degree AV block; marked bradycardia, decompensated cardiac failure. B Observe patients with mild bradycardia or a prolonged PR interval. Measure heart rate regularly in the elderly and in patients with hepatic or renal impairment. C b -blockers, digitalis. A Bradycardia, 1st degree AV block, ankle oedema, nausea, headache, rash.

GSK

2NO

Prostaglandin. Epoprostenol 0.5mg, 1.5mg (as Na+ salt). Powder and solvent for soln for inf. 0.5mg, A122.96; 1.5mg, A198.88. S Long-term IV treatment of primary and secondary pulmonary hypertension in the scleroderma spectrum of diseases due to intrinsic precapillary pulmonary vascular disease in NYHA functional Class III and Class IV patients. P Short-term dose-ranging, initiate at 2ng/ kg/min and increase by increments of 2ng/kg/min every 15 mins or longer until max. haemodynamic benefit or dose-limiting effects. Long-term continuous inf., initiate at 4ng/kg/min less than max. tolerated inf. rate (MTiR) determined during short-term dose ranging. If MTiR Q 5ng/kg/min, start long-term inf. at one-half MTiR. Decrease gradually in 2ng/kg/min decrements every 15 mins EUCARDIC Roche or longer until dose-limiting effects resolve. Avoid 3MO abrupt withdrawal. Infusion rate: See SPC. R Caution. a/b-blocker. Carvedilol 3.125mg, 6.25mg, 12.5mg, Q Limited data. 25mg. Resp. pink, yellow, light brown or pale D CHF arising from severe LV dysfunction. beige round scored tab. marked BM on one side Do not use chronically in patients who develop and K1, F1, H3 or D5 on other side. 3.125mg-28, A3.67; 6.25mg-28, 4.36; 12.5mg-28, A4.78; 25mgpulmonary oedema during dose-ranging. B Monitor BP and heart rate during 28, A5.72. admin. Pregnancy and lactation (only if essential). S Hypertension. P Initially, 12.5mg once daily for two days C Caution: Anticoagulants, other vasodilators, NSAIDs. then 25mg once daily. If necessary titrate at two A Facial flushing, headache, GI disorders, week intervals to max. 50mg once daily or in jaw pain, dry mouth, lassitude, inf. site reaction, divided doses. chest pain, decreased platelet count, tachycardia, Q Under 18 years, not recomennded. bradycardia, anxiety, agitation. D See 2.4, b-blockers Drug Presc. Notes. NYHA class IV decompensated HF requiring IV GOPTEN Abbott inotropic support, liver dysfunction. Contains lactose. 2MO ACE inhibitor. Trandolapril 0.5mg red/yellow cap. EXFORGE Novartis 1mg red/orange cap. 2mg red/red cap. 0.5mg-14, 2MO A1.83; 1mg-28, A4.49; 2mg-28, A5.30 . Ca++ antagonist/AII antagonist. Amlodipine (as S All grades of essential hypertension. amlodipine besylate) / valsartan 5mg/80mg, 5mg/ May be used alone or in combination with other 160mg, 10mg/160mg. Film-ctd tab, imprinted with antihypertensive drugs. NVR on one side. 5mg/80mg: Dark yellow, round P Initially 1mg daily as single dose, with bevelled edges, with NV on other side. 5mg/ adjusting according to response. Max. 4mg daily 160mg: Dark yellow, oval with ECE on other side. as single dose. If used with diuretic, discontinue 10mg/160mg: Light yellow, oval with UIC on other diuretic for 3 days before starting therapy with

2

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Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM 0.5mg daily, then titrate according to response. Renal or hepatic impairment, start therapy with 0.5mg then adjust according to response. Q Not recommended. D Pregnancy, women of child bearing potential, lactation, known hypersensitivity, angioneurotic oedema associated with ACE inhibitor. B Renal impairment, haemodialysis, neutropenia, hypotension. C K+suppl. or K+sparing diuretics, antidepressants, anaesthetics, lithium. A Hypotension, angioedema, rash, headache, dizziness, cough, palpitations, GI upset, malaise, nausea.

ACE inhibitor. Enalapril maleate 2.5mg, 5mg, 10mg, 20mg. 2.5mg: White, round, biconvex tabs. marked MSD 14; 5/10/20mg: White, rust-red and peach rounded triangle-shaped tabs. scored on one side and marked MSD 712, MSD 713 and MSD 714 resp. on the other. 2.5mg-28, A6.49; 5mg-28, A3.56; 10mg-28, A4.99; 20mg-28, A 5.93. S Hypertension. P Initially 5-10mg once daily. Usual maintenance dose, 20mg daily; max. 40mg daily. Q Not recommended; see SPC. D Angioedema. Pregnancy, lactation. B Reduce dose of diuretic, if possible, before initiating therapy. Volume depletion may cause symptomatic hypotension. LV valvular and outflow tract obstruction, renal impairment, renal HYPOVASE Pfizer artery stenosis, surgery. Angioneurotic oedema (discontinue promptly). Contains lactose. 2MO C Other anti-hypertensive agents, lithium, Selective a-blocker. Prazosin (HCl) 500mcg, 1mg. + K suppl., diuretics, antidiabetics, TCAs, NSAIDs, White tab. marked Pfizer and white tab. scored sympathomimetics, alcohol, gold. and marked M6, resp. B.D. Starter pack (8 x 500mcg plus 32 x 1mg), A4.49; 500mcg-56, A3.17; A Cough, nausea, blurred vision, dizziness, hypotension, syncope, angina pectoris, 1mg-56, A4.07. tachycardia, headache, depression, dyspnoea, GI S Hypertension. disorders, taste alteration, rash, hypersensitivity/ P 500mcg on first evening, then 500mcg two or three times daily for 3-7 days, followed by angioneurotic oedema, asthenia, fatigue. 1mg two or three times daily for 3-7 days. INNOZIDE MSD Thereafter, increase gradually as required. Max. 5MO 20mg daily. Q Not recommended. ACE inhibitor/thiazide diuretic. Enalapril maleate D Sensitivity other quinazolines. 20mg, HCTZ 12.5mg. Yellow fluted scored tab. B Pregnancy, lactation. Initial low dose marked MSD 718 on reverse. 28, A16.72. and gradual titration is recommended. S Hypertension. C Other antihypertensives. Caution: PDE-5 P Usually 1 once daily. Max: 2 tabs. daily. inhibitors. Q Not recommended. A Depression, nervousness, dizziness, D Anuria, aortic/renal artery stenosis, drowsiness, headache, faintness, syncope, loss of hypertrophic cardiomyopathy, hyperkalaemia. conciousness, blurred vision, vertigo, palpitations, Hereditary or idiopathic angioedema, history of dyspnoea, nasal congestion, GI disorders, rash, angioneurotic oedema. Hypersensitivity to other urinary frequency, oedema, lack of energy, sulphonamide-derived drugs. Acute hypertension. weakness. CHF (no data). Moderate/severe renal impairment. Pregnancy, lactation. INDERAL LA AstraZeneca B Volume depletion may cause symptomatic hypotension. Haemodialysis, renal or 3MO hepatic impairment, surgery/anaesthesia, diabetes. Non-cardioselective b-blocker. Propranolol (HCl) Anaphylactoid reactions during LDL apheresis, 160mg. Lavender/pink hard prolong.-release cap. hypersensitivity/angioneurotic oedema reported marked INDERAL LA 28, A8.41. rarely. Contains lactose. 3MO C Lithium, antidiabetics, tubocurarine, ALSO HALF-INDERAL LA Propranolol (HCl) 80mg. K+suppl. or K+sparing diuretics, allopurinol, Lavender/pink hard prolong.-release cap. marked cytostatic or immunosuppressive agents, A HALF-INDERAL LA. 28, 6.13. S Hypertension. Adjunct in thyrotoxicosis. procainamide, ganglionic or b-blockers, P Hypertension: 160mg daily increasing if cholestyramine, colestipol, NSAIDs, corticosteroids, ACTH, narcotic drugs/antispsychotics, alcohol, necessary in 80mg increments until adequate ciclosporin, antacids, sympathomimetics, pressor response is achieved. Thyrotoxicosis: 80mg or amines, gold. 160mg daily. Max. 240mg daily. A Dizziness, fatigue. Muscle cramps, Q Not recommended. nausea, asthenia, orthostatic effects including 3MO hypotension, headache, cough, impotence. ALSO INDERAL TABLETS Propranolol (HCl) 10mg. Pink film-ctd tab. marked Inderal 10. 10mg-100, ISOPTIN Abbott A1.20. 2MO S As above and phaeochromocytoma. P Hypertension: initially 80mg twice daily Class I Ca++ antagonist. Verapamil (HCl) 40mg, increasing if necesary at weekly intervals to 16080mg, 120mg. White film-ctd. tabs. 40mg-100, 320mg daily. Phaeochromocytoma: 60mg daily A2.12; 80mg-100, A4.24; 120mg-100, A6.36. with a-blocker for 3 days preoperatively or 30mg 2NO daily in inoperable cases. ALSO ISOPTIN INJECTION Verapamil 5mg/2ml. Q 0.25-0.5mg/kg body weight three or Amp. 5 x 2ml, A6.44. four times daily. S Mild to moderate hypertension. D See 2.4, b-blockers Drug Presc. Notes. P 80-160mg three times daily. Tabs contain lactose. Q Up to 10mg/kg body weight daily in divided doses. INNOVACE MSD D Cardiogenic shock. 2nd or 3rd degree 2MO AV block. Severe bradycardia. Uncompensated

HYPERTENSION 2.4 cardiac failure. Sick sinus syndrome. B 1st degree AV block. Poor cardiac reserve should be controlled with digitalis and diuretics. Hepatic impairment. Acute phase of myocardial infarction. Bradycardia. C b-blockers, quinidine or digoxin. A Constipation, headache, flushes.

ISOPTIN SR

Abbott

2MO Class I Ca++ antagonist. Verapamil 240mg. Light green oblong film-ctd sust.-release tab. 28, A12.67. S Mild to moderate hypertension. P 1 daily. R v in the morning increasing by v at weekly intervals according to response. Q Not recommended. D See Isoptin.

ISTIN

Pfizer

2MO Ca++ antagonist. Amlodipine besylate 5mg, 10mg. White emerald-shaped tabs. marked AML-5 or AML-10 resp. and Pfizer on reverse. 5mg-28, A5.53; 10mg-28, A8.26. S Hypertension. P Initially 5mg daily, increasing to max. 10mg. Q Not recommended. B Impaired liver function. Pregnancy, lactation. A Oedema, headache, flushing, dizziness, nausea, palpitations, fatigue, abdominal pain, somnolence.

ISTOLDE

Actavis

2MO Ca++ antagonist. Amlodipine 5mg, 10mg. White, uncoated, round, flat, tab. with score on one side, embossed with AB5 or AB10 on the other. 5mg28, A8.54; 10mg-28, A12.71. S Essential hypertension. P Initially 5mg once daily. If no effect within 2-4 weeks, may be increased to max. 10mg once daily. R Caution when increasing dose. Q Under 18 years, not recommended. D Severe hypotension. Shock (incl. cardiogenic). Heart failure after acute MI (first 28 days). High-grade aortic stenosis. Unstable angina pectoris. Pregnancy, lactation. B Caution: Cardiac failure, hypertensive crisis (safety and efficacy not established), dialysis, hepatic impairment, heart failure (increased incidence of pulmonary oedema in NYHA class III and IV). C Caution: CYP3A4 inhibitors/ inducers, other antihypertensives. A Headache, somnolence, dizziness, weakness, palpitations, GI disorders, ankle oedema, facial flushing with heat sensation.

KAMIREN

Niche

2MO Selective a-blocker. Doxazosin (as mesilate) 4mg. Prolonged release tab. White, round, biconvex tab. 28, A12.27. S Hypertension. As monotherapy or in combination with thiazide diuretics, badrenoceptor blocking agents, Ca++ antagonists or ACE inhibitors. P Initially 4mg once daily swallowed whole with water; may be increased to max. 8mg

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

55


2.4 HYPERTENSION

CIRCULATORY SYSTEM

once daily. Q Under 12 years, not recommended. D History of GI or oesophageal obstruction, or any degree of decreased lumen diameter of the GI tract. Pregnancy (only if benefit outweighs risk), lactation. B Caution: Impaired hepatic function. Introduction and adjustment. Initial dose: Excessive hypotensive effect may occur. Driving or operating machinery. Contains lactose. C Caution: PDE-5 inhibitors. A Palpitation, tachycardia, vertigo, GI disorders, asthenia, chest pain, peripheral oedema, back pain, myalgia, dizziness, headache, coughing, bronchitis, pruritus, urinary incontinence, cystitis, postural hypotension.

R Caution. Q Under 18 years, not recommended. D LV outflow tract obstruction. Untreated CHF. Unstable angina pectoris. Within 1 month of MI. Severe renal/hepatic impairment. Women of child-bearing potential (unless effective contraception used). Pregnancy, lactation. B Caution: Sick-sinus syndrome, angina pectoris, mild to moderate renal/hepatic dysfunction. Isolated cases of MI cases observed. Contains lactose. C Contra: Strong CYP3A4 inhibitors, ciclosporin, grapefruit juice. Caution: CYP3A4 inducers, CYP3A4 substrates (digoxin, cimetidine, terfenadine, astemizole, class III antiarrhythmic drugs), b-blockers. Avoid alcohol.

2MO

ACE inhibitor Lisinopril 2.5mg, 5mg, 10mg, 20mg. Round tabs, can be divided in equal halves. 2.5mg: White, biconvex. 5mg: White, flat, scored both sides. 10mg: Light pink, biconvex, scored one side. 20mg: Pink, biconvex, scored one side. 2.5mg-28, A5.06; 5mg-28, A7.18; 10mg-28, A8.84; 20mg-28, A10.16. S Hypertension. P Initially, 10mg. Patients with highly activated reninangiotensin-aldosterone system: 2.5-5mg initially. Maintenance, 20mg (single dose); if desired therapeutic effect not obtained within 2-4 weeks, may be increased to 80mg/day max. Patients on diuretics: If possible, withdraw diuretic 2-3 days before starting treatment; if not possible, start with 5mg/day, monitor serum K+ and renal LERCARIL Recordati KONVERGE A. Menarini / Daiichi Sankyo function. Renal impairment, ccQ10ml/min, initially 2.5mg; 10QccQ30ml/min, initially 2.5-5mg; 2MO 2MO ++ ++ 31QccQ80ml/min, initially 5-10mg/day. ACE inhibitor/Ca antagonist. Enalapril maleate/ Angiotensin II antagonist/ Ca antagonist. Q Not recommended. lercanidipine hydochoride 10mg/10mg, 20mg/ Olmesartan medoxomil / amlodipine (as besilate), D History of angioedema associated with 10mg. Resp. white and yellow biconvex, round 20mg/5mg, 40mg/5mg, 40mg/10mg. Round, filmcoated tablets. Resp. white, cream or brownish-red film-ctd tabs. 10mg/10mg-28, A16.08; 20mg/10mg- previous ACE inhibitor therapy. Hereditary or idiopathic angioedema. Pregnancy, lactation. A debossed with C73, C75 or C77 on one side. 20mg/ 28, 18.30. B Caution: Acute MI (do not use: Renal S Essential hypertension not adequately 5mg-28, A20.20; 40mg/5mg-28, A24.42; 40mg/ dysfunction, systolic BP R100mmHg, cardiogenic controlled by lercanidipine 10mg alone. Not for 10mg-28, A25.73. shock), mitral stenosis and left ventricle outflow initial treatment of hypertension. S Essential hypertension if BP not P Individual dose titration recommended. obstruction (aortal stenosis, hypertrophic adequately controlled on olmesartan medoxomil myocardiopathy), bilateral renal artery stenosis or Direct switch from monotherapy may be or amlodipine monotherapy. stenosis of the artery in a single kidney (strict P 1 tab. per day. Use 20mg/5mg tab. if BP considered. 1 tab. once a day at least 15 min supervision with low doses; careful dose before meals, preferably in the morning. not adequately controlled by 20mg olmesartan adjustment), pre-existing renal impairment R Adjust dose based on renal function. medoxomil or 5mg amlodipine alone. Use 40mg/ (monitor blood K+, creatinine), major surgery, Q Under 18 years, not recommended. 5mg tab. if 20mg/5mg tab. not adequately anaesthesia, renal insufficiency, diabetes. May D LV outflow obstruction, incl. aortic controlling BP; if BP still not adequately stenosis. Untreated CHF. Unstable angina pectoris. occur: Systemic hypotension, angioedema controlled, use 40mg/10mg tablets. Titration of (withdraw immediately if occurs), anaphylactoid Within 1 month of MI. Severe renal impairment, individual components recommended before reactions in haemodialysis patients or during incl. patients undergoing haemodialysis. Severe switching to fixed combination. R Monitor BP closely if max. daily dose of hepatic impairment. History of angioedema caused desensitisation treatment, acute renal insufficiency by previous therapy with ACE-inhibitor. Hereditary in patients with HF (usually reversible), hepatic 40mg olmesartan medoxomil required. insufficiency, neutropenia/agranulocytosis, cough. or idiopathic angioedema. Pregnancy, lactation. Q Under 18 years, not recommended. C Not recommended: Lithium. Caution: B Adjust diuretic dose in HF patients as D Severe hepatic insufficiency, biliary Diuretics, K+-sparing diuretics, K+ containing symptomatic hypotension may occur. Caution: obstruction. Cardiogenic shock. Acute MI (within supplements and salts, NSAIDs (incl. acetylsalicylic Sick-sinus syndrome, left ventricular dysfunction, first 4 weeks). Unstable angina pectoris. acid r 3g/day), other antihypertensives, injectable ischaemic heart disease, mild to moderate renal Pregnancy, lactation. impairment, bilateral renal artery stenosis or single gold, certain anaesthetic drugs, TCAs, B Correct volume and/or Na+ depletion antipsychotic agents, sympathicomimetics, antiartery stenosis, hepatic dysfunction, diabetes, before treatment. Not recommended: primary diabetics. surgery/anaesthesia. Not recommended after aldosteronism. Caution: Severe CHF, underlying A Dizziness, headache, cough, diarrhoea, recent renal transplantation. May occur: renal disease incl. renal artery stenosis, impaired vomiting, renal dysfunction, orthostatic effects Neutropenia/agranulocytosis, thrombocytopenia renal function, moderate hepatic impairment, (incl. hypotension). and anaemia, hypersensitivity/angioneurotic aortic or mitral valve stenosis, obstructive oedema, anaphylactoid reactions during LDLhypertrophic cardiomyopathy. May occur: LISOPRESS Niche apheresis with dextran sulphate, hyperkalaemia. Hyperkalaemia, pulmonary oedema (NYHA III and C Contra: Strong CYP3A4 inhibitors, 2MO IV heart failure patients), MI, stroke. No data: cyclosporine, grapefruit juice. Not recommended: ACE inhibitor. Lisinopril 2.5mg, 5mg white scored Recent kidney transplant, end-stage renal K+-sparing diuretics, K+ supplements, lithium, tabs. marked 2.5 or 5; 10mg white square tab. impairment. estramustine, CYP3A4 substrates, digoxin. Caution: scored one side and marked 10; 20mg white C Not recommended: K+ supplements, Antidiabetics, thiazides, loop diuretics, NSAIDs, pentagonal tab scored and marked 20. 2.5mg-28, salts containing K+, K+ sparing diuretics, heparin, baclofen, amifostine, TCAs, neuroleptics, A4.63; 5mg-28, A7.11; 10mg-28, A8.77; 20mg-28, ACE inhibitors, lithium. Caution: Other anaesthetics, narcotics, corticosteroids, A9.59. antihypertensives, NSAIDs, CYP3A4 inhibitors/ tetracosactide, other antihypertensives, allopurinol, S Arterial hypertension. inducers. cytostatic or immunosuppressive agents, systemic P Initially 5mg in the morning increasing A Dizziness, headache, oedema, fatigue. corticosteroids or procainamide, antacids, to maintenance 10-20mg daily. A lower dose symphthomimetics, acetylsalicylic, injectable gold, 2.5mg in the morning in renal dysfunction, HF, LECALPIN Actavis midazolam, cimetidine, simvastatin. Avoid alcohol. patients who do not tolerate discontinuation of 2MO A Dizziness, vertigo, cough, diuretics, volume and/or salt depletion, severe or hypersensitivity, angioedema, depression, Ca++ antagonist. Lercanidipine (HCl), 10mg, 20mg. renovascular hypertension, elderly. dizziness, headache, blurred vision, myocardial Resp. yellow or pink, round, biconvex, film-ctd Q Not recommended. infarction, arrhythmia, angina pectoris, tab., scored on one side, marked L on the other. D Pregnancy, lactation. Renal artery tachycardia, hypotension, syncope, cerebrovascular stenosis, severe renal impairment, 10mg-28, A8.22; 20mg-28, A13.42. accident, cough, dyspnoea, nausea, diarrhoea, S Mild to moderate essential haemodynamically relevant aortic or mitral valve abdominal pain, dysgeusia, rash, asthenia, fatigue, stenosis, haemodynamically unstable patients after hypertension. P 10mg once a day at least 15 min before chest pain, increased blood K+, increased blood acute MI. creatinine. meals; may be increased to 20mg depending on B Haemodialysis. Hypotension, unstable response. Titrate gradually. Renal/hepatic cardiac failure, renal impairment, renovascular LESTACE Actavis hypertension, primary hyperaldosteronism, insufficiency: Caution when increasing to 20mg.

56

2

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Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM

HYPERTENSION 2.4

proteinuria, angioneurotic oedema, aortic stenosis, surgery/anaesthesia. C K+ sparing diuretics, K+ suppl., diuretics, Na+, Cl, antihypertensive agents, analgesics, antiinflammatory agents, lithium, alcohol, anaesthetics, hypnotics, narcotics, sympathomimetics, antacids. A Hypotension, dizziness, weakness, impaired vision, syncope, tachycardia, palpitations, arrhythmias, chest pain, angina.

LISPRIL

Rowex

2MO ACE inhibitor. Lisinopril (dihydrate) 5mg, 10mg, 20mg. Slightly red scored tabs. 5mg-30, A8.13; 10mg-30, A10.03; 20mg-30, A11.51. S All grades of essential and renovascular hypertension. P Initially 5mg in the morning, maintenance 10-20mg once daily. R Initially 2.5mg increasing to 5-10mg daily. Q Not recommended. D History of angioneurotic oedema related to previous ACE-inhibitor treatment. Pregnancy, lactation. B Renal impairment, hypotension (1st dose), aortic stenosis, acute MI, multiple or high dose diuretic therapy. C K+ suppl., antihypertensive agents, sympathomimetics, lithium, antacids, NSAIDs, alcohol, anaesthetics, narcotics, hypnotics, oral hypoglycaemic agents, diuretics, NaCl. A Hypotension, dry cough, sore throat, bronchitis, dizziness, feeling weak, impaired vision, nausea, stomach pain, indigestion, rash, headache, tiredness, palpitations, renal failure.

LISPRILHYDROCHLOROTHIAZIDE

Rowex

5MO ACE inhibitor/thiazide diuretic. Lisinopril and HCTZ 10mg/12.5mg, 20mg/12.5mg. Pink, round, biconvex tab. scored on one side. 10mg-30, A10.03; 20mg30, A11.52. S Essential hypertension where BP is not adequately controlled on lisinopril alone (or HCTZ alone). P Once daily, usually after titration with individual components. Max. 40mg/25mg. Q Not recommended. D Angioneurotic oedema relating to previous treatment with ACE inhibitor, hereditary/ idiopathic angioneurotic oedema. Severe liver and renal insufficiency (cc Q30ml/min). Stenosis of renal arteries. Pregnancy, lactation. B Electrolyte/fluid imbalance, ischaemic heart disease or cerebrovascular disease. Aortic stenosis, mitral stenosis or hypertrophic cardiomyopathy. Renal insufficiency (cc 30-80ml/ min); require titration of individual components. Hepatic disease, surgery/anaesthesia. Risk of angioedema. C K+ sparing diuretics, K+ suppl. and salt substitutes. Lithium, antidiabetics, NSAIDs, allopurino, cyclosporin, lovastatin, probenecid, trimethoprim, cardiac glycosides, sotalol, corticosteroids, colestyramin, TCADs, torsades de pointes-inducing drugs. A Dizziness, headache, fatigue, dry and persistent cough, hypotension.

LOAVEL

in patients not adequately controlled with monotherapies (1) in elderly hypertensive patients (2) in diabetic hypertensive patients (3) Presentation. Two strengths: tablets containing enalapril maleate 10 mg/lercanidipine hydrochloride 10 mg and enalapril maleate 20 mg/lercanidipine hydrochloride 10 mg. Indications. Treatment of essential hypertension in patients whose blood pressure is not adequately controlled by single component. Not for use as initial treatment of hypertension. Dosage. If blood pressure is not controlled by lercanidipine 10 mg alone, titrate up to 20 mg alone or switch to fixed combination Lercaril 10 mg/10 mg. If blood pressure not controlled by enalapril 20 mg alone titrate up to higher dose of enalapril monotherapy or switch to Lercaril 20 mg/10 mg. Individual dose titration with components can be recommended. Recommended dose for both strengths: one tablet every morning 15 minutes before meal (avoid grapefruit). Not recommended for children. Contraindications. Hypersensitivity to enalapril, lercanidipine, ACE inhibitors, strong inhibitors of CYP3A4, dihyropyridine calcium channel blockers; 2nd/3rd trimester; left ventricular outflow obstruction, untreated congestive heart failure, unstable angina, within one month of myocardial infarction; severe renal/hepatic impairment; hereditary or idiopathic angioedema; hereditary problems with galactose intolerance. Precautions and Warnings. In symptomatic hypotension careful monitoring required. More likely with volume depletion and heart failure. In sick-sinus syndrome and left ventricular dysfunction and ischaemic heart disease particular caution recommended. In mild to moderate renal impairment routine monitoring of serum potassium and creatinine recommended. In renovascular hypertension there is a risk of hypotension or renal failure with ACE-inhibitor therapy. In hepatic dysfunction antihypertensive effects may be potentiated. Cholestatic jaundice and hepatic necrosis has been observed with ACE-inhibitor therapy. Anaphylactoid reactions in concomitant use with insect venom desensitisation and LDL-apheresis are rare. In diabetes close monitoring of blood sugar needed for the first month. Alcohol should be avoided. Interactions. Possible potentiation with other hypotensives. Combination with potassium sparing diuretics, potassium supplements and lithium not recommended. Antihypertensive effect may be altered by NSAIDs, baclofen, cyclosporin, amifostine, tricyclic antidepressants, neuroleptics, anaesthetics, narcotics, nitrates, antacids, sympathomimetics and corticosteroids. Pregnancy and lactation. Not recommended. Side effects. For Lercaril 10 mg/10 mg; common: dizziness, vertigo, cough. Uncommon: abdominal pain, nausea, headache, hypersensitivity, rash, palpitations, tachycardia, circulatory collapse, hypotension, dry throat, polyuria, pollakiuria, erectile dysfunction, fatigue, asthenia, lowered haemoglobin. For Lercaril 20 mg/10 mg; common: headache, dizziness, flushing, cough, peripheral oedema. Uncommon: angioedema, thrombocytopenia, hypertriglyceridaemia, anxiety, palpitations, hypotension, pharyngolaryngeal pain, abdominal pain, constipation, dyspepsia, nausea, tongue disorder, erythema, rash, arthralgia, nocturia, fatigue, asthenia, feeling hot, increased ALT and AST. Pack size. 28 tabs. Legal category. POM. MAH. Recordati Ireland Limited. Raheens East, Ringaskiddy Co. Cork, Ireland. MAN. PA1404/002/001- 002. Date of First Authorisation/Renewal of the Authorisation. Date of First Authorisation: 22nd August 2008.For full prescribing information please see summary of product characteristics. References 1. Hair P.I., Scott L.I., Perry C.M.: Fixed-dose combination lercanidipine/enalapril. Drugs, 2007; 67 (1): 95-106 2. Puig J.G., Calvo C., Luurila O. et al.: Lercanidipine, enalapril and their combination in the treatment of elderly hypertensive patients: placebocontrolled, randomized, crossover study with four ABPM. J Human Hypertens, 2007; 21 (12): 917-924 3. Agrawal R., Marx A., Haller H.: Efficacy and safety of lercanidipine versus hydrochlorothiazide as add-on to enalapril in diabetic populations with uncontrolled hypertension. J Hypertens, 2006; 24 (1): 185-192 RILER0901017

sanofi-aventis

2MO AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

57


2.4 HYPERTENSION

CIRCULATORY SYSTEM P 50mg once daily. If necessary, increase to 50mg twice daily (1 tablet in the morning, 1 in the evening) or 100mg once daily (in the morning). May be administered with other antihypertensive agents, especially diuretics. Patients with intravascular volume depletion: 25mg once daily initially. Hepatic impairment: Consider lower dose. R Over 75 years, consider initiating therapy with 25mg. Q Not recommended. D Pregnancy, lactation. Severe hepatic impairment. B History of angioedema (closely monitor). Volume depletion may cause symptomatic hypotension. Monitor K+ and cc. Hepatic impairment, renal impairment, renal artery stenosis, primary aldosteronism (not recommended), ischaemic cardiovascular and cerebrovascular disease, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Contains lactose. C Caution: Other antihypertensives, fluconazole, rifampicin, NSAIDs, lithium (monitor levels). Not recommended: Heparin, K+ sparing diuretics, K+ supplements or salts. A Hypertension: Dizziness, vertigo. Hypertensive patients with left ventricular hypertrophy: Dizziness, vertigo, asthenia/fatigue. Hypertension and type 2 diabetes with renal disease: Dizziness, hypotension, asthenia/fatigue, hypoglycaemia, hyperkalaemia.

hypercalcaemia. Severe hepatic impairment; cholestasis and biliary obstructive disorders. Refractory hyponatraemia. Symptomatic hyperuricaemia/gout. Severe renal impairment. Anuria. Pregnancy, lactation. B History of angiooedema (closely monitor). Monitor K+ and cc. Caution: Mildmoderate hepatic impairment, renal artery stenosis, coronary heart disease, cerebrovascular disease, heart failure, aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy. Not recommended: Haemodialysis patients, primary aldosteronism. May occur: Impaired glucose tolerance, symptomatic hypotension, exacerbation or activation of SLE, gout, increased cholesterol and triglyceride levels, serum Ca++ elevation. Contains lactose. C Not recommended: K+ sparing diuretics, K+ supplements or salt substitutes containing K+. Caution: Rifampicin, fluconazole, lithium, NSAIDs, TCAs, antipsychotics, baclofene, amifostine, barbiturates, narcotics, alcohol, antidepressants, antidiabetics, other antihypertensives, colestyramine and colestipol resins, corticosteroids, ACTH, pressor amines, muscle relaxants, probenecid, sulfinpyrazone, allopurinol, anticholingergics, cytotoxics, salicylates, methyldopa, cyclosporine, digitalis glycosides, class Ia and class III antiarrythmics, some antipsychotics, bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidine, terfenadine, vincamine IV, calcium, carbamazepine, iodine contrast media, parenteral amphotericin B, Rowex stimulant laxatives. May interfere with parathyroid LONITEN Pharmacia LOTANOS function tests. 2MO 2MO A Insomnia, headache, dizziness, cough, Angiotensin II antagonist. Losartan K+ 50mg, Vasodilator. Minoxidil 5mg. White tab. marked upper respiratory infection, nasal congestion, with tab. strength one side, scored and marked U 100mg. White oblong tab. Resp. with 1 or 3 notches on each side and embossed with 3 or 5 on sinusitis, sinus disorder, GI disorders, muscle cramp, above and below score on reverse. 60, A15.11. back/leg/chest pain, myalgia, asthenia/fatigue, S Severe hypertension that is symptomatic one side. 50mg-28, A11.73; 100mg-28, A19.71. hyperkalaemia, mild reduction of haematocrit and S Hypertension. or associated with target organ damage. P Hypertension: 50mg once daily. Maximal haemoglobin, cephalagia. Hypertension not controlled adequately by a antihypertensive effect attained after 3-6 weeks. If combination of a diuretic and a sympathetic LOW CENTYL K LEO Pharma necessary, increase to 100mg once daily. May be suppressant. Hypertension not manageable with 5MO administered with other antihypertensive agents. max. therapeutic doses of a diuretic plus two Thiazide/K+suppl. Bendrofluazide 1.25mg, K+ Cl Patients with intravascular volume depletion: other antihypertensives. 573mg (7.7mmol K+). Yellow, sug-ctd, oval, 25mg once daily initially. Hepatic impairment: P Initially 5mg daily in single or divided modified release tab. 250, A17.62. Consider a lower dose. doses, increase at three day intervals, if necessary S Hypertension alone or in combination to 20mg daily and then to 40mg daily; usual max. D Pregnancy, lactation. B Volume depletion may cause with other antihypertensives. 50mg daily. P 1 daily. R Initially 2.5mg daily, then as per adults. symptomatic hypotension. Caution: Hepatic impairment (dose adjustment), renal impairment Q Not recommended. Q Initially 0.2mg/kg body weight daily in (hyperkalaemia risk). May occur: Angioedema, D Precoma associated with hepatic single or divided doses increase, at three day cirrhosis, Addisonâ&#x20AC;&#x2122;s disease. Severe renal intervals, by 0.1-0.2mg/kg body weight daily. Max. changes in renal function. No data on use in haemodynamically significant obstructive valvular impairment. Hyperkalaemia. 1mg/kg body weight daily. disease. Contains lactose. B Diabetes, renal impairment, obstruction D Phaeochromocytoma. Lactation. C Caution: Rifampicin, fluconazole, K+ of urinary tract; caution. Obstruction of small B MI. Diuretics and sympathetic sparing diuretics, K+ supplements or salt bowel, ulceration (discontinue if occurs). suppressants must be given concurrently. Renal + substitutes containing K , indomethacin. Pregnancy, lactation (only if essential). impairment. Multiple reports of pericarditis. A Dizziness. Patients with left ventricular C K+ sparing diuretics, lithium. Caution: Pericardial effusion and tamponade have been Cardiac glycosides, antihypertensives. reported. Thrombocytopenia and leukopenia have hypertrophy: Dizziness, vertigo, asthenia/fatigue. A Rash, photosensitivity, myopia been rarely reported. Pregnancy. LOTANOS COMP Rowex aggravation, blood dyscrasias, gout, fatigue. Acute C Sympathetic-blocking agents e.g. pancreatitis, hyperuricaemia, GI upset, oliguria, guanethidine or bethanidine may produce 5MO dizziness, headache, muscle pain, thirst, dry excessive blood pressure reduction and/or Angiotensin II antagonist/thiazide. Losartan K+/ mouth. Vasculitis. orthostasis. HCTZ 50/12.5mg, 100/25mg. Light yellow, round, A Hypertrichosis, oedema, tachycardia. biconvex film-ctd tab. 50/12.5mg-28, A12.46; 100/ METOCOR Rowex 25mg-28, A23.83. LOSARTAN TEVA Teva 3MO S Essential hypertension when BP not 2MO adequately controlled on losartan or HCTZ alone. Cardioselective b-blocker. Metoprolol tartrate 50mg, 100mg. White tabs. scored one side. 50mgAngiotensin II antagonist. Losartan (K+) 50mg, P Start with 50mg/12.5mg once daily. If 100, A3.50; 100mg-100, A6.50. 100mg. White, oval, slightly arched film-ctd tabs, no response use 100mg/12.5mg or 100mg/25mg debossed with strength on one side, scoreline on S Hypertension. Adjunct in thyrotoxicosis. once daily (max. dose). the other. 50mg-28, A12.45; 100mg-28, A20.94. P Hypertension: initially 100mg daily Q Not recommended. increasing to 400mg daily in single or divided S Essential hypertension. D Therapy resistant hypokalaemia or

ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, 10mg. White, yellow, red and white oblong tabs. with score line on both sides. 1.25mg-28, A2.57; 2.5mg-28, A3.65; 5mg-28, A5.08; 10mg-28, A6.88. S All grades of hypertension. P Patients not on diuretics: Initially 2.5mg once daily, increasing incrementally at intervals of 1-2 weeks to 5mg. Max. 10mg once daily. R Consider initial dose of 1.25mg daily. Titrate according to need for BP control. Q Not recommended. D History of angiooedema. Aortic stenosis or outflow obstruction. Renal artery stenosis, hypotensive or haemodynamically unstable states. Pregnancy, lactation. B CHF, hepatic impairment, blood dyscrasias. Renal impairment: Reduce dose and assess renal function prior to and during treatment. Caution: Patients with hyper stimulated angiotension system. Electrolyte monitoring recommended. Haemodialysis (avoid in patients dialysed with high flux membranes). Malignant hypertension: Initiate in hospital under close supervision. Symotomatic hypotension, agranulocytosis/bone marrow depression, hyperkalaemia have been reported rarely. Caution: Surgery and during anaesthesia. C Antihypertensive agents, K+sparing diuretics, K+suppl., lithium, sympathomimetics, antidiabetic agents, NSAIDs. A Nausea, dizziness, headache, dry tickling cough.

58

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5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM diabetes, history of hypersensitivity or bronchial asthma. Correct volume/ Na+ depletion before starting therapy. Monitor serum electolytes. May occur: Raised cholesterol and triglyceride levels, METOP Gerard hyperuricaemia or frank gout, exacerbation or activation of SLE, photosensitivity reactions 3MO (discontinue, protect from the sun / artificial UVA) Cardioselective b-blocker. Metoprolol tartrate Less effective in black patients. Contains lactose, 50mg, 100mg. White tabs. Both marked ml and A strength one side, G on reverse. 50mg-100, 3.50; sorbitol. C Drugs affecting serum K+ levels, digitalis 100mg-100, A6.51. S Hypertension. Adjunct in thyrotoxicosis. glycosides, drugs inducing torsades de pointes, antiarrhythmics, other antihypertensives, lithium, P Initially 100mg daily increasing to Ca++ salts, antidiabetics, b-blockers, diazoxide, 400mg daily in single or divided doses. drugs for treatment of gout (allopurinol, Thyrotoxicosis: 50mg four times daily. probenecid, sulfinpyrazone), anticholinergics, Q Not recommended. pressor amines, amantadine, anionic exchange D See 2.4, b-blockers Drug Presc. Notes. resins, cytotoxics, NSAIDs, curare derivatives, MICARDIS Boehringer Ing. cyclosporin, tetracyclines, alcohol, anaesthetics, sedatives, methyldopa, barbiturates, narcotics, 2MO antidepressants. Angiotensin II antagonist. Telmisartan 20mg, A Dizziness. 40mg, 80mg. White tabs. marked 50H, 51H, 52H resp. on one side and company symbol on other. MYOSTIN Teva 20mg: Round. 40mg, 80mg: Oblong. 20mg-28, 2MO A19.16; 40mg-28, A19.16; 80mg-28, A23.14. Ca++ antagonist. Amlodipine 5mg, 10mg (as S Treatment of essential hypertension. amlodipine maleate). White, round, tab. scored on P Usually 40mg once daily. Range 2080mg once daily. Severe renal impairment: Initially one side. 5mg-28, A8.28; 10mg-28, A12.38. S Essential hypertension. 20mg daily. May be used with thiazide diuretic. P 5mg once daily. If no sufficient effect Q Not recommended. within 2-4 weeks, may be increased to max. 10mg D Biliary obstructive disorders, severe once daily. hepatic impairment. Pregnancy, lactation. Q Under 18 years, not recommended. B Mild moderate hepatic impairment, D Severe hypotension, shock, HF after renovascular hypertension, renal impairment, acute MI (during 1st 28 days), obstruction of kidney transplant, intravascular volume depletion (correct prior to admin.), RAA stimulation, primary outflow-tract of left ventricle, unstable angina pectoris. Lactation, pregnancy (unless clearly aldosteronism, aortic and mitral valve stenosis, necessary). obstructive cardiomyopathy. May cause B Low cardiac reserve, hepatic + hyperkalaemia (monitor serum K in at risk impairment, cardiac failure, elderly; caution. patients). Contains sorbitol. Apparently less Driving/using machines. effective in black patients than other racial C Caution: CYP3A4 inhibitors/inducers, groups, ischaemic cardiopathy or CVD. other antihypertensives incl. b-blockers. C Not recommended: K+ sparing diuretics A Ankle swelling, headache, dizziness, or K+ supplements, lithium. Caution: NSAIDs, fatigue, asthenia, palpitations, dyspnoea, diuretics, heparin, immunosuppressors, abdominal pain, nausea, dyspepsia, flushing. trimethoprim. Concomitant use to be taken into account: Other antihypertensives, baclofen, NAPAMIDE PR Niche amifostine alcohol, barbiturates, narcotics or antidepressants, systemic corticosteroids. 5MO Antihypertensive diuretic. Indapamide 1.5mg. MICARDISPLUS Boehringer Ing. White, round, film-ctd prolonged release tab. 30, A4.05. 5MO S Essential hypertension. Angiotensin II antagonist/thiazide diuretic. P 1 daily. Telmisartan/HCTZ 40mg/12.5mg, 80mg/12.5mg, D Severe renal failure. Hepatic 80mg/25mg. Resp. red and white, red and white, encephalopathy or severe liver impairment. yellow and white tabs. with company logo and Hypokalaemia. coded H4, H8 and H9. 40/12.5mg-28, A19.16; 80/ B Impaired liver function. Monitor plasma A A 12.5mg-28, 23.14; 80/25mg-28, 28.45. Na+ before treatment and regularly thereafter. S Treatment of essential hypertension Monitor plasma K+ particularly in at risk patients. where monotherapy proves inadequate. P 40/12.5mg, 80/12.5mg or 80/25mg daily. May cause decrease in urinary calcium excretion. Monitor blood glucose in diabetics. Monitor uric Q Not recommended. acid; risk of gout in hyperuricaemic patients. Renal D Cholestasis and biliary obstructive insufficiency. Pregnancy, lactation, avoid. disorders, severe hepatic or renal impairment, C Not recommended: Lithium. Caution: refractory hypokalaemia, hypercalcaemia. Torsades de pointes-inducing drugs, NSAIDs, ACE Hypersensitivity to sulphonamide derivatives. inhibitors, other agents causing hypokalaemia, Pregnancy, lactation. baclofen, digitalis preparations. Combinations to B Not recommended: Primary be taken into consideration: K+ sparing diuretics, aldosteronism. Caution: Hepatic impairment, metformin, iodinated contrast media, imipramineprogressive liver disease, mild to moderate renal like antidepressants, neuroleptics, Ca++ salts, impairment (monitor renal function), renal artery cyclosporin, tacrolimus, corticosteroids, stenosis (renovascular hypertension risk), renal tetracosactide. transplantation, RAA system stimulation (severe CHF, renal disease), aortic or mitral valve stenosis, NATRILIX SR Servier obstructive hypertrophic cardiomyopathy, doses. Thyrotoxicosis: 50mg four times daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

HYPERTENSION 2.4 5MO Antihypertensive diuretic. Indapamide hemihydrate 1.5mg. White sust.-release coated tab. 30, A3.25. S Hypertension. P 1 daily. Q Not recommended. D Severe renal failure, hepatic encephalopathy or severe hepatic failure, hypokalaemia. B Pregnancy, lactation. Monitor K+ and uric acid serum levels. Monitor blood glucose in diabetics. C Lithium, agents causing hypokalaemia, baclofen. A Hypokalaemia, fatigue, orthostatic hypotension, allergic manifestations.

NEBILET

A. Menarini

3MO Vasodilating cardioselective b-blocker. Nebivolol (as HCl) 5mg. White cross scored tab. 28, A12.94. S Essential hypertension. P 5mg daily, preferably at same time of day. As monotherapy or with other antihypertensive agents. Renal insufficiency: Initially, 2.5mg daily; may be increased to 5mg. R Initially 2.5mg daily. May be increased to 5mg. q 75 years; caution. Q Children and adolescents, not recommended. D See 2.4, b-blockers Drug Presc. Notes. Liver insufficiency or liver function impairment.

NEBILET PLUS

A. Menarini

5MO Vasodilating cardioselective b-blocker/ Thiazide. Nebivolol/ HCTZ 5mg/12.5mg; 5mg/25mg. Resp. pink or violet, round, slightly biconvex film-ctd tab. embossed with strength on one side and a score line on the other. 5/12.5mg-28, A12.94; 5/ 25mg-28, A12.94. S Essential hypertension. Fixed dose combinations indicated in patients whose BP adequately controlled on nebivolol and HCTZ separately. P 1 tab. daily, preferably at same time of day. R Over 75 years, caution. Q Not recommended. D Hypersensitivity to sulphonamidederivatives. Liver insufficiency or liver function impairment. Anuria, severe renal insufficiency. Refractory hypokalaemia, hypercalcaemia, hyponatraemia, symptomatic hyperuricaemia. Pregnancy, lactation. See also: 2.4 b-blockers Drug Presc. Notes. B Caution: Renal impairment, diabetes mellitus. May occur: Increases in cholesterol and triglycerides, hyperuricaemia and/or gout, electrolyte imbalances, SLE exacerbation or activation , photosensitivity reactions, decreases in serum protein bound iodine levels. Contains lactose. See also: 2.4 b-blockers Drug Presc. Notes. C Not recommended: Lithium, products associated with K+ loss and hypokalaemia. Caution: NSAIDs, Ca++ salts, some antipsychotics, bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidine, sparfloxacin, terfenadine, vincamine IV, non-depolarizing skeletal muscle relaxants (e.g. tubocurarine), metformin, other b-blockers, diazoxide, pressor amines, probenecid, sulfinpyrazone and allopurinol, amantadine, salicylates, cyclosporine,

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

59


2.4 HYPERTENSION

CIRCULATORY SYSTEM

(monitor serum K+ and creatinine levels), aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy, ischaemic heart or NIVADIL Astellas cerebrovascular disease, elderly. Hyperkalaemia may occur; monitor serum K+ in at risk patients. 2MO NIFED Rowex Class II Ca++ antagonist. Nilvadipine 8mg, 16mg. Not recommended: Severe renal impairment 2MO Caps. containing sust.-release pellets coded Nv8 or (ccQ20ml/min), recent kidney transplant, severe hepatic impairment, primary aldosteronism. ++ Nv16. 8mg-28, A11.40; 16mg-28, A16.18. Class II Ca antagonist. Nifedipine 10mg. Oblong Contains lactose. brown caps. 100, A7.01. S Hypertension. C Not recommended: K+ suppl., K+ sparing P Initially 8mg increasing to max. 16mg S Mild to moderate hypertension. diuretics, lithium. Caution: NSAIDs, angiotensin II daily if necessary. P 30-60mg daily in divided doses. antagonists, other antihypertensives. Q Not recommended. R 15mg in divided doses. A Dizziness, bronchitis, cough, pharyngitis, D Cardiovascular shock, aortic stenosis. Q Not recommended. rhinitis, GI disorders, arthritis, back pain, skeletal Severe renal insufficiency (cc Q 30ml/min.). 2MO pain, haematuria, UTI, chest pain, fatigue, flu-like ALSO NIFED RETARD Nifedipine 10mg, 20mg. Pink Pregnancy, lactation. symptoms, peripheral oedema, pain, increased B Hepatic impairment, severe HF. film-ctd modified release tabs. 10mg-60, A8.08; C H2 antagonists, tricyclic antidepressants, creatine phosphokinase, hypertriglyceridaemia, 20mg-100, A18.16. hyperuricaemia, liver enzyme elevations. P Initially 10mg twelve hourly, increasing cyclosporin, anticonvulsants. A Headache, flushes, oedema, dizziness, if necessary to 40mg twelve hourly. OMESAR PLUS A. Menarini fatigue, nausea, GI fullness. Q Not recommended. 5MO D Cardiogenic shock. unstable angina Tillomed Angiotensin II antagonist/thiazide diuretic. pectoris, advanced aortic stenosis, porphyria, acute NORTENOLOL Olmesartan medoxomil/HCTZ, 20mg/12.5mg, 20mg/ MI. Women of child-bearing potential. Pregnancy, 3 M O 25mg. Round film-ctd tab. 20mg/12.5mg, reddishlactation. Cardio-selective b-blocker. Atenolol 25mg, 50mg, yellow; 20mg/25mg, pinkish embossed with C22, B Caution: Severe hypotension, poor 100mg. White, white, orange unscored film-ctd C24 resp. 28, A17.83. cardiac reserve, diabetes, malignant hypertension, tabs. marked A25, A50, A100 resp. 25mg-30, S Essential hypertension in patients whose irreversible renal failure with hypovolaemia, risk of A2.70; 50mg-30, A4.10; 100mg-30, A5.98. blood pressure is not adequately controlled on hypotensive crisis (medical supervision). 20mg S Hypertension. Retard tab. contain lactose. P 100mg daily; some patients 50mg daily. olmesartan medoxomil alone. P Initially, 20mg/12.5mg once daily. If BP C Not recommended: Rifampicin, antiClinical effect seen after 1-2 weeks. Renal not adequately controlled 20mg/25mg once daily epileptics. Caution: Cimetidine, erythromycin, impairment: See SPC. (max. daily dose). Moderate hepatic impairment: nefazodone, azole antifungals, digoxin, diltiazem, Q Not recommended. cyclosporine, tacrolimus, vincristine, antidiabetics, Initially 10mg once daily, max 20mg once daily; D See 2.4, b-blockers Drug Presc. Notes. qinidine, cisapride. Avoid grapefruit juice. Monitor BP and renal function. A Headache, facial reddening, ODRIK Abbott Q Under 18 years, not recommended. palpitations, dizziness, leg oedema. D Severe renal impairment. Severe hepatic 2MO ACE inhibitor. Trandolapril 0.5mg, 1mg, 2mg. Red/ impairment, cholestasis and biliary obstructive NIFTEN AstraZeneca yellow, red/orange and red/red caps. marked with disorders. Refractory hypokalaemia, hypercalcaemia, hyponatraemia and symptomatic 3MO cap. name, logo and strength. 0.5mg-28, A 3.66; hyperuricaemia. Pregnancy, lactation. ++ Cardioselective b-blocker/Class II Ca antagonist. 1mg-28, A4.49; 2mg-28, A5.30. B Caution: Intravascular volume depletion Atenolol 50mg, sust.-release nifedipine 20mg. S All grades of hypertension. (risk of symptomatic hypotension), bilateral renal Reddish brown cap. marked NIF-TEN. 28, A12.96. P Starting dose, 1mg once daily, adjust artery stenosis or stenosis of the artery to a single dosage incrementally at intervals of 2-4 weeks S Hypertension uncontrolled on functioning kidney, mild-moderate renal according to response to a max. of 4mg as a monotherapy. impairment (monitor serum K+, uric acid and single daily dose. P 1 daily, increasing to 1 twice daily if creatinine levels), hyperkalaemia, diabetes, aortic Q Not recommended. necessary. or mitral valve stenosis, obstructive hypertrophic D History of ACE induced angioneurotic R Max. 1 daily. cardiomyopathy, ischaemic heart or oedema. Pregnancy, lactation. Q Not recommended. cerebrovascular disease, mild-moderate hepatic B Renal or hepatic impairment. D Bradycardia, cardiogenic shock, impairment. Hypersensitivity reactions to hypotension, metabolic acidosis, severe peripheral Anaesthesia. Blood dyscrasias. hydrochlorothiazide may occur (more likely if arterial circulatory disturbances, 2nd or 3rd degree A Cough, headache, asthenia, dizziness. history of allergy or bronchial asthma). Nausea, hypotension. Allergic hypersensitivity heart block, sick sinus syndrome, untreated Exacerbation or activation of systemic lupus phaeochromocytoma, uncontrolled HF, pregnancy, reactions. Rarely angioneurotic oedema. erythematosus reported with thiazide diuretics. lactation, severe aortic stenosis, marked renal OMESAR A. Menarini Not recommended: Recent kidney transplant, impairment (ccQ 15 ml/min). primary aldosteronism. Monitor serum electrolytes 2MO B Controlled HF. Conduction defects or regularly. Contains lactose. poor cardiac reserve. Prinzmetalâ&#x20AC;&#x2122;s angina, 1st Angiotensin II antagonist. Olmesartan medoxomil C Not recommended: K+ suppl., K+ sparing degree heart block. May aggravate less severe 10mg, 20mg, 40mg. White film-ctd tabs. with C13, diuretics, lithium. Caution: Amifostine, alcohol, peripheral arterial circulatory disturbances. May C14, C15 resp. embossed on one side. 10mg-28, barbiturates, narcotics, antidepressants, NSAIDs, A14.74; 20mg-28, A17.70; 40mg-28, A22.29. modify tachycardia of hypoglycaemia. May mask other antihypertensives, baclofen, Ca++ salts, thyrotoxicosis. Will reduce heart rate. Do not S Essential hypertension. discontinue abruptly in ischaemic heart disease. P Optimal dose, 20mg once daily. Initially, cholestyramine/colestipol resins, digitalis glycosides, class Ia and III antiarrhythmics, some History of anaphylactic reaction to allergens. 10mg once daily. Max.: 40mg daily. Take at same Asthmatics, diabetes, clinically significant liver time each day. Effect present within 2 weeks and antipsychotics, non-depolarizing skeletal muscle relaxants, anticholinergics, antidiabetics, bdisease. Discontinue if ischaemic pain occurs. Use max. by about 8 weeks. Mild to moderate renal blockers, diazoxide, pressor amines, probenecid, impairment: Max 20mg once daily. Moderate in men in in vitro fertilisation. sulfinpyrazone, allopurinol, amantadine, cytotoxic hepatic impairment: Max 20mg once daily. C Contra: Ca++ channel blockers with agents, salicylates, methyldopa, cyclosporine, Q 18 years and under, not suitable negative inotropic effects (e.g. verapamil, tetracyclines. (limited experience). diltiazem), rifampicin. Grapefruit juice, not D Pregnancy, lactation. Biliary obstruction. A Dizziness, fatigue. See SPC. recommended. Caution: Other dihydropyridines, B Intravascular volume depletion (risk of digitalis glycosides, clonidine, class 1 Rowex symptomatic hypotension). Caution: bilateral renal PENDREX antiarrhythmics (e.g. disopyramide), amiodarone, artery stenosis or stenosis of the artery to a single 2 M O sympathomimetics, prostaglandin synthetasefunctioning kidney, impaired renal function inhibiting drugs, anaesthetics, cimetidine. ACE inhibitor. Perindopril tert-butylamine 2mg, iodine products (high doses), cytotoxic agents, barbiturates, narcotics, anionic exchange resins. See also: 2.4 b-blockers Drug Presc. Notes. A See SPC.

60

A Oedema, dizziness, headache, GI disturbance, purpura, impotence, fatigue.

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM 4mg, 8mg. White, round, biconvex tablet debossed with 2, 4 or 8 on one side. 2mg-30, A8.53; 4mg-30, A12.07; 8mg-30, A16.70. S Hypertension. P In monotherapy or in combination with other antihypertensives. Initially 4mg once daily in the morning, may be increased to 8mg/day after 1 month. Patients with a strongly activated reninangiotensin-aldosterone system: Initially 2mg/day under supervision. Discontinue diuretics 3 days beforehand; if not possible, commence with 2mg and monitor renal function and serum K+. Renal impairment: See SPC. R Initially 2mg, may be progressively increased to 4mg after 1 month then to 8mg depending on renal function. Q Not recommended. D History of angioedema associated with previous ACE inhibitor therapy. Hereditary or idiopathic angioedema. Pregnancy, lactation. B If unstable angina pectoris occurs in 1st month, reappraise benefit/risk before continuing treatment. Volume depletion, symptomatic HF may cause symptomatic hypotension. Caution: Mitral valve stenosis, aortic stenosis, hypertrophic cardiomyopathy, collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, diabetes. Renal impairment: Adjust dosage according to cc and response to treatment. Anaphylactoid reactions may occur during dialysis with high flux membrane or low-density lipoproteins apheresis with dextran sulphate. Discontinue if angioedema occurs. May occur: Hepatic syndrome, neutropenia/ agranulocytosis, thrombocytopenia, anaemia, persistent non-productive cough, elevation in serum K+. Discontinue 1 day prior to surgery. C Avoid: Diuretics, K+ sparing diuretics, K+containing salt substitutes, K+ supplements, lithium. Caution: NSAIDs, other antihypertensives and vasodilators, antidiabetics, TCAs, antipsychotics, anaesthetics, sympathomimetics, antacids. A Headache, dizziness, vertigo, paresthaesia, vision disturbance, tinnitus, hypotension and related effects, cough, dyspnoea, GI disturbances, rash, pruritus, asthenia.

HYPERTENSION 2.4 electrolyte disturbance, mitral valve stenosis, obstruction in the outflow of the left ventricle, collagen vascular disease, anaesthesia (discontinue one day prior to surgery), patients at risk of hyperkalemia. May occur: Unstable angina pectoris (re-evaluate), jaundice, angioedema (promptly discontinue), anaphylactoid reactions (interrupt during LDL aphaeresis or desensitisation). Contains lactose. C Not recommended: Lithium, K+-sparing diuretics, K+ suppl, diuretics. Caution: Immunosuppressant, allopurinol or procainamide, oral antidiabetics, NSAIDs, vasodilators, certain anaesthetics, TCAs, antipsychotics, sympathomimetics. A Headache, dizziness, vertigo, paresthaesia, vision disturbance, tinnitus, hypotension, cough, dyspnoea, GI disorders, rash, pruritus, muscle cramps, asthenia.

calcium antagonists (allow several days following discontinuation before administering b-blocker). Caution: Myocardial depressants, anti-arrhythmic agents, a or b-adrenoceptor stimulants, MAOIs, TCAs, general anaesthetics, clonidine (do not discontinue until several days after Prestim withdrawal). Adrenergic neuron blocking agents (e.g. guanethidine, reserpine), diuretics and other antihypertensives (incl. vasodilators). A GI disturbances, bradycardia, hypotension, cold extremities. May occur in susceptible individuals: Bronchospasm, sleep disturbances, depression. Hyperuricaemia, skin rashes.

PRETERAX ARGININE

Servier

5MO

ACE inhibitor/antihypertensive diuretic. Perindopril arginine 2.5mg, indapamide 0.625mg. White rodshaped scored tab. 30, A18.62. PLENDIL AstraZeneca S Essential hypertension. 2NO P 1 daily in the morning before a meal. Double dose if necessary. Class II Ca++ antagonist. Felodipine 2.5mg, 5mg, Q Not recommended. 10mg. Sust.-release film-ctd tabs. marked A/FM orA/FE. 2.5mg-28, A7.34; 5mg-28, A9.49; 10mg-28, D Hereditary/idiopathic angioneurotic A12.76. oedema. Severe renal failure or impaired hepatic S All grades of hypertension. function, hypokalaemia. Pregnancy, lactation. P Initially 5mg once daily adjust if B Electrolyte imbalance, diabetes, gout, necessary. Maintenance 5-10mg once daily. Max. hypotension, cardiac or renal failure, 20mg daily. atherosclerosis, renal artery stenosis, elderly, Q Not recommended. immunosuppressed patients, hepatic impairment, D Pregnancy, lactation. haemodialysis. B Severe hepatic insufficiency, recent C Lithium, K+ -sparing diuretics, K+ salts, myocardial ischaemia. non antiarrhythmic drugs which cause torsade de C Cimetidine, phenytoin, carbamazepine, pointes, anaesthetics, cytostatic or phenobarbitone. immunosuppressive agents. A Ankle oedema, dizziness, fatigue, A Asthenia, dizziness, headache, mood headache, flushing, palpitations, rash, mild swings, sleep disturbances, cramps, hypotension, gingival enlargement. allergic reactions, skin rashes, GI disorders, anorexia, nausea, dry cough, dry mouth, risk of PRESTIM Meda dehydration in elderly and heart failure, altered blood test results. Rarely angioneurotic oedema, 5NO haematological disorders. b-blocker/thiazide. Timolol maleate, 10mg; bendroflumethiazide, 2.5mg. White, flat, petalClonmel shaped tab. with ICN on 1 side and 132 and score PRINDACE 2MO line on the other. 30, A4.89; 100, A4.89. ACE inhibitor. Perindopril tert-butylamine 4mg, S Hypertension. PERCARNIL Actavis P Initially 1 tab. daily. May be increased 8mg. 4mg-30, A7.24; 8mg-30, A11.56. S Hypertension. after 2 weeks to 2 tab. max. Recommended dose 2MO P Initially, 4mg once daily in the morning 1-2 tabs/day either as single dose in morning or ACE inhibitor. Perindopril (tert-butylamine salt) before food in monotherapy or in combination. 4mg, 8mg. White tabs, PP marked on one side and divided doses morning and evening. If BP control May be increased to 8mg once daily after one strength on reverse. 4mg oblong with a break-line not achieved on 2 tab/day, consider titrating month. Strongly activated RAA system: Initially timolol and bendroflumethiazide separately or on both sides; 8mg circular. 4mg-30, A9.92; 8mg2mg daily. Renal impairment, see SPC. adding another hypotensive. Hepatic failure: May 30, A16.29. R Initially 2mg daily; may be progressively require dose adjustment. S Hypertension. P As monotherapy or in combination with D Asthma/history of asthma, 2nd and 3rd increased to 4mg after one month then to 8mg if necessary depending on renal function. degree atrioventricular block, severe bradycardia, other anti-hypertensives. Initially 4mg once daily Q Under 18 years, not recommended. uncontrolled or digitalis/diuretic refractory HF, in the morning or 2mg daily in patients with D Angioedema. Pregnancy, lactation. cardiogenic shock, digitalis intoxication or strongly activated renin-angiotensin-aldosterone B Increased risk of symptomatic hypokalaemia, precoma associated with hepatic, system or on diuretics (if possible discontinue 2-3 hypotension eg. salt depletion, hypovolaemia, days before). May be increased to 8mg once daily renal or Addisons’ disease. Pregnancy, lactation diuretics; correct, if possible, prior to therapy. (unless essential). after one month. Renal impairment: Based on cc Monitor BP, renal function, serum K+ closely, B Discontinue if marked bradycardia (see SPC). before and during treatment. Hyperkalemia, develops. Caution: Controlled CHF (discontinue if R 2mg daily, may be progressively increases in blood urea and plasma creatinine. increased to 4mg after one month then to 8mg if deteriorates), elderly, family history of asthma, Caution: Mitral valve stenosis, obstruction in the impaired hepatic or renal function, potential necessary depending on renal function (see SPC). Q Not recommended. outflow of left ventricle, diabetes. LDL apheresis. urinary tract obstruction, disorders rendering D Angioedema, history of ACEI related Jaundice, angioedema (facial/ intestinal) reported electrolyte balance precarious, uncontrolled or angioedema. Pregnancy, lactation. rarely; discontinue promptly. Discontinue one day brittle diabetes. May mask symptoms of B Symptomatic hypotension may occur. thyrotoxicosis and hypoglycaemia. Ocular changes prior to surgery. Contains lactose. Correct salt depletion / hypovolaemia, if possible, C Lithium, K+ supplements (not may occur (conjunctivitis, dry eye; consider prior to therapy. Monitor renal function and recommended), diuretics. Caution: NSAIDs, discontinuation). Monitor fluid and electrolytes. serum K+ before and during treatment. Caution: antihypertensives, vasodilators, antidiabetics, Withdraw gradually. Severe HF impaired renal function, tendency for C Contra: Lithium salts, verapamil or other anaesthetics, TCAs, antipsychotics, AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

61


2.4 HYPERTENSION

CIRCULATORY SYSTEM

B Aortic stenosis or outlaw obstruction (not recommended). Renal impairment risk (dosage reduction and/or discontinue); assess renal function prior to and during treatment. Caution: Impaired liver function, volume- and salt-depletion (symptomatic hypotension risk), anaesthesia, RAMIC surgery. May occur rarely: Agranulocytosis and bone marrow depression, reduction in red cell 2MO RAMITACE Clonmel count, haemoglobin content and platelet count, ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Hard hyperkalaemia, hyperkalaemia (hypertensive caps. with light grey body and light green, green, 2 M O patients), angioneurotic oedema. Avoid and dark green cap marked R on cap and strength ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Cap.haemodialysis using high flux polyacrylonitrile on body. 2.5mg-28, A6.07; 5mg-28, A8.46; 10mg- shaped, flat tabs. scored on one side. 2.5mg: membranes and low-density lipoprotein apheresis Yellow marked R2. 5mg: Pink marked R3. 10mg: 28, A11.54. with dextran sulphate. White marked R4. 2.5mg-28, A5.80; 5mg-28, S Hypertension. C Caution: Antidiabetics, NSAIDs. A8.10; 10mg-28, A11.04. P Initially, 2.5mg once a day; should be A Nausea, dizziness, headache, increased at intervals of 1-2 weeks, up to max. S Essential hypertension. symptomatic hypotension, MI, cerebrovascular 10mg once a day. Consider combination treatment P Initially, 2.5mg once a day; usual dose accident, chest pain, palpitations, rhythm if 10mg not effective. Patients with CHF also: 2.5-5mg/day; maximum 10mg once a day. Dose disturbances, angina pectoris, impaired renal 1.25mg initially under close supervision. Diuretic adjustments should occur after 2-3 weeks of function, GI disorders, hypersensitivity reactions, treated patients: Discontinue diuretic 2-3 days treatment. Consider combination treatment if prior to therapy. If diuretic cannot be 10mg not effective. Hypertension with HF: Initially cutaneous and mucosal reactions, vasculitis, muscle and joint pains, fever or eosinophilia, dry tickling discontinued, start with 1.25mg. Renal impairment: 1.25mg once daily. On diuretics: Discontinue See SPC. diuretic 2-3 days before therapy (or earlier if long- cough, disturbances of balance, nervousness, restlessness, terror, sleep disorders, confusion, loss Q Not recommended (contra). acting). If diuretic cannot be discontinued, initial of appetite, depressed mood, feeling of anxiety, D History of angioneurotic oedema dose 1.25mg. Renal impairment: cc Q50ml/min, paraesthesiae, taste change/reduction/loss, muscle relating to previous ACE inhibitor treatment. initially 1.25mg once daily; max. 5mg once daily; cramps, erectile impotence, reduced sexual desire, Pregnancy, lactation. cc Q20ml/min, initially 1.25mg every second day; increased blood urea nitrogen and serum B Aortic stenosis, outflow obstruction (not max. 2.5mg once daily. creatinine, deterioration of pre-existing recommended). Hypotension, agranulocytosis, Q Not recommended. proteinuria. bone marrow depression, hyperkalaemia, D Hypersensitivity to any ACE inhibitors. angioneurotic oedema may occur. Assess renal Angioneurotic oedema. Renal artery stenosis, RASILEZ Novartis function prior to and during treatment. Impaired kidney transplantation. Renal dysfunction or 2MO liver function (reduce dose), collagen vascular hypotension in patients with acute MI. Primary Renin inhibitor. Aliskiren (as hemifumarate) disease; monitor. Correct volume/salt depletion hyperaldosteronism. Pregnancy, lactation. 150mg, 300mg. Biconvex film-ctd tabs. marked before initiating therapy. Surgery/ anaesthesia. B Mitral valve stenosis or outflow NVR on one side. 150mg: Light-pink, round Haemodialysis using high-flux membranes (avoid). obstruction (caution). Jaundice (discontinue). Driving/ operating machines. Haemodialysis using high-flux membranes (risk of marked IL on reverse. 300mg: Light-red, ovaloid marked IU on reverse. 150mg-28, A23.56; 300mgC Caution: Antidiabetics, NSAIDs. anaphylactoid reactions). Fluid/salt abnormalities, 28, A31.30. A Nausea, dizziness, headache, GI severe hypertension, elderly. If potential for disturbances, dry tickling cough, skin/mucosal symptomatic hypotension; monitor closely. S Essential hypertension. reactions, sinusitis, bronchitis, conjunctivitis, hair Surgery/anaesthesia. Bone marrow depression, P 150mg once daily with light meal, loss. hyperkalaemia, angioneurotic oedema have been preferably same time each day; may be increased reported. Contains lactose. Driving/using machines. to 300mg once daily. Effect substantially present RAMILO Rowex C Caution: K+ sparing diuretics, K+ within 2 weeks. Use alone or in combination with supplements, diuretics, nitrates, other vasodilators, other antihypertensives. 2MO heparin, alcohol, allopurinol, procainamide, Q Under 18 years, not recommended. ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, cytostatics or immunosuppressants, trimethoprim, D Concomitant use with ciclosporin and 10mg. White, oblong, biplane with facet tabs. antidiabetics, sympathomimetics, NSAIDs. Avoid other potent P-gp inhibitors (quinidine, marked R 1.25, R 2.5, R 5, and R 10 on one side. verapamil). Lactation (not recommended), Both sides with breaking notch. 1.25mg-30, A4.39; lithium. A Dizziness and headache, orthostatic pregnancy. 2.5mg-30, A6.21; 5mg-30, A8.65; 10mg-30, effects, diarrhoea, vomiting, cough, renal B Volume- and/or salt-depleted patients, A11.78. impairment. supervise closely. Caution in: Severe heart failure, S Hypertension. severe renal dysfunction, renal artery stenosis, P Initially 2.5mg once daily swallowed RAMYTE Actavis history of dialysis, nephrotic syndrome, or whole with plenty of liquid. May be increased at renovascular hypertension. Increased risk of intervals of 2-3 weeks to 5mg, then to max. 10mg 2 M O hyperkalaemia in patients treated with RAS ACE inhibitor Ramipril 2.5mg, 5mg, 10mg. Size 4 once daily, or to max. 5mg once daily if agents, reduced kidney function, diabetes mellitus. + hard cap. containing white powder, with light concomitant diuretic or Ca channel blocker is Persistent diarrhoea, discontinue. grey body and resp. light green, green or dark used. Concomitant diuretic treatment/ C Caution: Furosemide, drugs that may green cap, marked R on cap and strength on nephropathy: Initially 1.25mg once daily. Renal increase serum K+, digoxin, irbesartan, meals with body. 2.5mg-28, A5.76; 5mg-28, A8.02; 10mg-28, impairment: See SPC. Impaired hepatic function: high fat content, inducers of P-gp (St. Johnâ&#x20AC;&#x2122;s wort, A10.92. Max. 2.5mg daily. rifampicin), moderate P-gp inhibitors. Avoid S Hypertension. Q Not recommended. grapefruit juice. P Without diuretics and without CHF, D Angioedema, history of angioedema A Diarrhoea. initially 2.5mg once daily. Increase dose with previous ACE inhibitor therapy. Pregnancy, incrementally at intervals of 1-2 weeks up to max lactation. RASILEZ HCT Novartis 10mg once daily. Usual effective dose: 2.5-10mg. B If possible, discontinue diuretic Combination treatment recommended if response 5 M O treatment 2-3 days before therapy initiation. unsatisfactory at 10mg. Diuretic-treated patients, Renin inhibitor/Thiazide. Aliskiren (as Volume depletion may cause symptomatic discontinue diuretic 2-3 days before initiating. hemifumarate)/HCTZ, 150mg/12.5mg; 150mg/25mg; hypotension. Caution: LV valvular and outflow Renal/hepatic impairment, see SPC. 300mg/12.5mg; 300mg/25mg. Biconvex, ovaloid tract obstruction, renal impairment, renal artery R Caution. film-ctd tab. marked NVR on one side. 150mg/ stenosis, haemodialysis patients, surgery. D History of angioneurotic oedema 12.5mg: White, marked LCI on other side. 150mg/ Discontinue if jaundice occurs. Driving/ operating relating to previous ACE inhibitor treatment. 25mg: Pale yellow, marked CLL on other side. machines. Pregnancy, lactation. Use in children. 300mg/12.5mg: Violet white, marked CVI on other C Lithium (not recommended). Caution: Other anti-hypertensive agents, K+suppl. or K+sparing diuretics, diuretics, TCAs, anaesthetics, antipsychotics, antidiabetics, NSAIDs, sympathomimetics. A Dizziness, headache, cough, orthostatic effects (incl. hypotension), diarrhoea, vomiting, Pinewood renal dysfunction.

sympathomimetics, injectable gold. A Hypotension, headache, dizziness, vertigo, paraesthesia, vision disturbance, tinnitus, cough, dyspnoea, GI disorders, dysgeusia, dyspepsia, rash, pruritus, muscle cramps, asthenia.

62

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM side. 300mg/25mg: Light yellow marked CVV on other side. 150mg/12.5mg-28, A23.34; 150mg/ 25mg-28, A23.72; 300mg/12.5mg-28, A30.29; 300mg/25mg-28, A30.62. S Essential hypertension: In patients with BP not adequately controlled on aliskiren or HCTZ alone or as substitution therapy in patients adequately controlled with aliskiren and HCTZ, given concurrently, at same dose as combination. P 1 tab. daily with a light meal, preferably at same time. Max effect seen within 4 weeks. Adjust dose according to clinical response, up to max 300mg/25mg. Q Under 18 years, not recommended. D History of angioedema with aliskiren. Pregnancy, lactation. Severe renal impairment. Refractory hypokalaemia, hypercalcaemia. Severe hepatic impairment. B Correct volume- and/or salt-depletion before treatment. Caution: Serious CHF (NYHA class III-IV), impaired hepatic function, progressive liver disease, aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy, renal artery stenosis, or stenosis to solitary kidney (discontinue if renal failure occurs). Discontinue if angioedema occurs. May occur: Electrolyte imbalance, hyperuricaemia, precipitation of frank gout, SLE exacerbation or activation. Increased risk of hypokalaemia: Liver cirrhosis, brisk diuresis, inadequate oral electrolyte intake, concomitant corticosteroids / adrenocorticotropic hormone. Increased risk of hyperkalaemia: Concomitant RAS agents, reduced kidney function, diabetes mellitus. Discontinue before carrying out tests for parathyroid function. Persistent diarrhoea, discontinue. Contains lactose, wheat starch. C Contra: Ciclosporin and other potent Pgp inhibitors (quinidine, verapamil). Caution: K+ sparing diuretics, K+ supplements and salts , other products that may increase serum K+ levels (e.g. heparin Na+), digitalis glycosides, antiarrhythmics, other antihypertensives, moderate P-gp inhibitors, furosemide, NSAIDs, meals with high fat content, lithium, alcohol, antidiabetics, anionic exchange resins, pressor amines, antigout medications, Ca+ supplements or Ca+-sparing products (e.g. vitamin D therapy), curare derivatives, b-blockers, diazoxide, anticholinergics, amantadine, cytotoxic products (e.g. cyclophosphamide, methotrexate). Avoid grapefruit juice. A Diarrhoea.

HYPERTENSION 2.4 one side and 200 or 400 on reverse. 200mg-28 (Cal/Pk), A12.08; 400mg-28 (Cal/Pk), A15.11. S Mild to moderate hypertension. P 200mg once daily. In case of inadequate response, increase to 400mg once daily taken one hour before or two hours after meals. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.. Acute HF or during episodes of HF decompensation requiring IV inotropic therapy.

P 1 daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

TENORMIN

AstraZeneca

3MO

Cardioselective b-blocker. Atenolol 25mg, 50mg, 100mg. White, white, orange biconvex film-ctd tabs. marked Tenormin 25, Tenormin 50, and Tenormin respectively. 100mg bisected on reverse. 25mg-28, A1.97; 50mg-28, A2.54; 100mg-28, SOPROL Helsinn Birex A3.23. 3MO S Cardiac arrhythmias. Early intervention in acute MI. Angina pectoris. Hypertension. Cardioselective b-blocker. Bisoprolol fumarate P 50-100mg daily. 5mg, 10mg. White film-ctd tabs. marked Q Not recommended. BISOPROLOL and tab. strength on one side. 5mgA A D See 2.4, b-blockers Drug Presc. Notes. 28, 3.45;10mg-28, 3.86. S Hypertension. TEVETEN Solvay P 5-20mg once daily, usually 10mg once daily. 2MO Q Not recommended. Angiotensin II antagonist. Eprosartan mesylate D See 2.4, b-blockers Drug Presc. Notes. 400mg pink oval film-ctd tab.; 600mg white cap.Acute HF or during episodes of HF shaped film-ctd tab. 400mg-56, A24.02; 600mg-28, decompensation requiring IV inotropic therapy. A18.01. C See 2.4, b-blockers Drug Presc. Notes. S Essential hypertension. Avoid: Floctafenine, sultopride. Caution: P Usual maintenance dose 600mg once Rifampicin, baclofen, iodated contrast products, daily. mefloquine, corticosteroids. Q Not recommended. D Severe hepatic impairment. Pregnancy, SOTACOR BMS lactation. 3MO B Severe renal impairment, patients Non-cardioselective b-blocker. Sotalol (HCl) 80mg, undergoing dialysis, moderate hepatic impairment, severe cardiac insufficiency or renal artery stenosis. 160mg. Both white tabs. scored on one side and Correct vol/salt depletion prior to therapy. Primary tab. strength marked on other side. 80mg-28, A1.60; 160mg-28, A3.16. hyperaldosteronism (avoid). Aortic and mitral valve stenosis, hypertrophic cardiomyopathy. S Prevention of myocardial infarction. Contain lactose. Cardiac arrhythmias. Angina. Hypertension. P Reinfarction: 320mg once daily, starting C Caution: K+sparing diuretics, K+suppl, 5-14 days after infarction. Arrhythmias: Initial dose lithium. 80mg either singly or as 2 divided doses. Allow 2-3 A Viral infection, hypertriglyceridaemia, days between increments. Most respond to dose headache, dizziness, fatigue, depression, pain (incl. of 160-320mg admin. in 2 divided doses at 12 hr chest / back), palpitation, rhinitis, pharyngitis, intervals. In renal impairment; cc q60ml/min: dyspnoea, upper RTIs, cough, arthralgia, UTIs, GI Normal dose; cc 30-60ml/min: Half normal dose; cc disorders, asthenia, injury. 10-30ml/min: Quarter normal dose; cc Q10ml/min: TEVETEN PLUS Solvay Avoid. Q Not recommended. 5MO D See 2.4, b-blockers Drug Presc. Notes. Angiotensin II antagonist/thiazide diuretic. Prolonged QT interval, torsades de pointes, renal Eprosartan (as mesylate) 600mg and HCTZ 12.5mg. failure. Butterscotch, capsule-shaped film-ctd tab. marked B Caution: Pre-existing arrhythmias, QT 5147 on one side and SOLVAY on reverse. 28, interval q 550msec. Electrolyte disturbances esp. RUSTIN Helsinn Birex hypokalaemia or hypomagnesaemia. Caution: Left A18.68. S Essential hypertension for patients 2MO ventricular dysfunction, recent MI. See b-blockers whose BP is not adequately controlled on Prescribing Notes. See 2.4, b-blockers Drug Presc. Ca++ antagonist. Amlodipine 5mg, 10mg (as eprosartan alone. amlodipine besilate). White, round, slightly arched Notes. P 1 once daily in the morning. tabs. marked with AB 5 or AB 10 resp. 10mg tab. TENORET 50 AstraZeneca Q Under 18 years, not recommended. is scored. 5mg-28, A4.40; 10mg-28, A6.58. D Severe hepatic impairment. Severe renal 5MO S Essential hypertension. impairment, therapy resistant hypokalaemia or P 5mg once daily, may be increased to Cardioselective b-blocker/thiazide diuretic. hypercalcaemia, biliary obstructive disorders, max. dose of 10mg daily depending on response. Atenolol 50mg, chlorthalidone 12.5mg. White symptomatic hyperuricaemia/gout. Pregnancy, Q Not recommended. film-ctd tab. marked TENORET 50 one side. 28, lactation. A2.77. D Lactation, pregnancy (unless clearly B Renal artery stenosis, severe cardiac necessary). S Hypertension, particularly in the elderly. insufficiency, aortic and mitral valve stenosis or B Heart failure, hepatic impairment. P 1 daily. obstructive hypertrophic cardiomyopathy, mild to A Somnolence, dizziness, headache, Q Not recommended. moderate hepatic insufficiency; caution. Monitor palpitations, flushing, abdominal pain, nausea, D See 2.4, b-blockers Drug Presc. Notes. serum electrolytes periodically. Impaired renal oedema, fatigue. function, diabetes mellitus; risk of increased serum TENORETIC AstraZeneca K+. Primary hyperaldosteronism; not SELECTOL sanofi-aventis 5 M O recommended. May exacerbate systemic lupus 3MO Cardioselective b -blocker/thiazide diuretic. erythematosus. Atenolol 100mg, chlorthalidone 25mg. White film- C Caution: K+-sparing diuretics, K+ suppl. Vasodilating cardioselective b-blocker. Celiprolol ctd tab. marked TENORETIC. 28, A3.92. (HCl) 200mg yellow heart-shaped tab.; 400mg or other drugs increasing K+ level (eg. heparin), white heart-shaped tab. Both marked with logo drugs affected by serum K+ disturbances (eg. S Mild to moderate hypertension. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

63


2.4 HYPERTENSION

CIRCULATORY SYSTEM

100mg. White tabs. 25mg: Circular, flat, scored on one side. 50mg and 100mg: Biconvex, film-ctd, marked 1U1 and 2U1 resp. 25mg-30, A2.54; 50mg30, A3.90; 100mg-30, A5.50. S Hypertension. P Usually, 50mg as a single daily dose. Effects fully established after 1-2 weeks. 100mg as single daily dose or combination with other agent may be required. Renal failure: Reduce dose (see SPC). Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. B Caution: Patients with poor cardiac reserve. Will reduce heart rate. Contains lactose (50mg and 100mg). See 2.4, b-blockers Drug Presc. TILDIEM LA Sanofi Notes. C See 2.4, b-blockers Drug Presc. Notes. 2MO A Precipitation of atrioventricular block, Class III Ca++ antagonist. Diltiazem (HCl) 200mg purpura, thrombocytopenia, impotence. See 2.4, bpink/grey cap.; 300mg white/yellow cap.; blockers Drug Presc. Notes. containing immediate release and sust.-release pellets. 200mg-28, A11.87; 300mg-28, A12.95. TRIALIX sanofi-aventis S Hypertension. P Initially 1 x 300mg once daily, increasing 5 M O if necessary to 2 x 200mg once daily, or then 1 x ACE inhibitor/loop diuretic. Ramipril 5mg, 200mg plus 1 x 300mg daily. piretanide 6mg. Yellow/white scored tab. marked R Initially 1 x 200mg daily increasing to 1 LC one side, ARD on reverse. 28, A15.87. x 300mg once daily. S Hypertension insufficiently controlled Q Not recommended. with monotherapy but stabilised on individual 2MO components given in same proportions. P 1 daily taken in the morning. ALSO TILDIEM RETARD Diltiazem (HCl) 90mg, Q Not recommended. 120mg. Off-white sust.-release tabs. 90mg-56, A13.66; 120mg-56, A15.19. D History of angioneurotic oedema, aortic stenosis, outflow obstruction. Precomatose states P 90-120mg twice daily. Max. 360mg associated with cirrhosis. Pregnancy, lactation. daily. R Initially 120mg daily adjusting to 90B CHF, hepatic impairment, blood 120mg twice daily as required. dyscrasias. Cerebrovascular disease, renal Q Not recommended. impairment; reduce dose and asses renal function D Pregnancy. Sick sinus syndrome; 2nd or prior and during treatment. Gout. Diabetes. 3rd degree AV block; marked bradycardia. Prostatic hypertrophy or impaired micturition. B Observe patients with mild bradycardia Haemodialysis (avoid in patients dialysed with or a prolonged PR interval. Measure heart rate high flux membranes). Ability to drive or operate regularly in the elderly and in patients with machinery may be impaired. hepatic or renal impairment. C Antihypertensive agents, K+sparing C b -blockers, digitalis. diuretics, K+suppl., lithium, antidiabetic agents, A Bradycardia, 1st degree AV block, ankle NSAIDs, digitalis, aminoglycosides, cephalosporins. oedema, nausea, headache, rash. A Electrolyte imbalance. Nausea, vomiting, dizziness, fatigue, headache, abdominal pain, TRANDATE UCB diarrhoea, cough. Liver dysfunction. Rarely, 3MO symptomatic hypotension, angioneurotic oedema, syncope, renal impairment. Hypersensitivity a/b-blocker. Labetalol (HCl) 100mg, 200mg. Orange film-ctd tabs. marked with tab. name and reactions. strength. 100mg-50, A5.07; 56, A5.67; 250; sanofi-aventis A24.16; 200mg-50, A8.18; 56, A9.16; 250, A38.27. TRIAPIN S Hypertension, incl. hypertension of 2NO pregnancy and for long term management of Ca++ antagonist/ACE inhibitor. Felodipine/ramipril hypertension following acute myocardial 2.5mg/2.5mg, 5mg/5mg. Both circular, biconvex, infarction. Angina. prolonged release tabs. marked with strength. P Initially 100mg twice daily with food 2.5mg, apricot coloured, marked H above OD on increasing if necessary at fouteen day intervals. reverse; 5mg, reddish-brown, marked H above OE Max. 2.4g daily in three or four divided doses. on reverse. 2.5mg-28, A22.23; 5mg-28, A28.23. Q Not recommended. S Essential hypertension when BP not 3NO adequately controlled on felodipine or ramipril ALSO TRANDATE INJECTION Labetalol (HCl) 5mg/ alone. ml. Amp. 5 x 20ml, A16.41. P 1 tablet 2.5mg/2.5mg or 5mg/5mg once S Severe hypertension incl. severe daily without food or following light meal. Max. hypertension of pregnancy; as a hypertensive 5mg/5mg once daily. Swallow whole, do not agent in anaesthesia following acute myocardilal divide, crush or chew. infarction. Q Not recommended. B See 2.4, b-blockers Drug Presc. Notes. D History of angioneurotic oedema, Liver damage. Contains sodium benzoate. unstable haemodynamic conditions (cardiovascular shock, untreated HF, acute MI, unstable angina TRANTALOL Pinewood pectoris, stroke), AV block II or III. Severely 3MO impaired hepatic or renal renal function (ccQ20ml/ Cardioselective b-blocker. Atenolol 25mg, 50mg, min), dialysis. Pregnancy, lactation. antiarrhythmics), other antihypertensives, barbiturates, narcotics or alcohol, lithium. HCTZ: Kaliuretics, laxatives, corticosteroids and ACTH, cardiac glycosides, Ca++ suppl. or Ca++ sparing drugs, b-blockers and diazoxide, gout treatment, anticholinergics, sympathicomimetics, amantadine, anionic exchange resins, cytotoxic substances, NSAIDs, non-depolarizing skeletal muscle relaxants, tetracyclines. A CNS disorders (eg. dizziness, headache, sleeplessness, depression), bronchitis, abdominal pain, albuminuria, UTIs, arthrosis, back pain, increased serum transaminases, hyperkalaemia, hyperglycaemia, leucocytosis.

64

B Angio-oedema (discontinue if occurs). Monitor renal and liver function (discontinue if jaundice or marked elevations of hepatic enzymes occur). Activated renin-angiotensin system, mild to moderate renal impairment, renovascular hypertension/renal artery stenosis, recent kidney transplantation. Symptomatic hypotension, proteinuria, agranulocytosis and neutropenia may occur. Surgery/ anaesthesia, aortic stenosis/ hypertrophic cardiomyopathy, HF, coronary or cerebrovascular insufficiency. Dialysis or haemofiltration with certain high-flux membranes (avoid). Hyperkalaemia (monitor if used concomitantly with other drugs which increase serum potassium levels). Contains lactose. Driving/ operating machines. C Not recommended: Potent CYP3A4 inhibitors or inducers, K+-sparing diuretics, K+ salts. Caution: Antihypertensives, diuretics, nitrates, lithium, antipsychotics, narcotics, anaesthetics, allopurinol, immunosuppressants, corticosteroids, procainamide, alcohol, cytostatics, NSAIDs, vasopressor sympathomimetics, antidiabetics, theophylline, tacrolimus, heparin, salt. A Headache, flush, peripheral oedema, dry tickling cough.

TRITACE

sanofi-aventis

2MO ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, 10mg. White, yellow, red and white oblong tabs. with score line on both sides. 1.25mg-28, A2.59; 2.5mg-28, A3.66; 5mg-28, A5.10; 10mg-28, A6.94. S All grades of hypertension. P The initial dose in patients not on diuretics is 2.5mg once daily, increasing to 5mg with max. 10mg once daily increasing at intervals of 1-2 weeks. R No special dosage recommendations for elderly patients apart from general warning about patients with renal or hepatic insufficiency or CHF which may be common in elderly and concomitant use of diuretic drugs. Dose titrated according to need for BP control. Q Not recommended. D History of angioneurotic oedema. Aortic stenosis, outflow obstruction. Pregnancy, lactation. Hypersensitivity to ramipril. B CHF, hepatic impairment, blood dyscrasias. Renal impairment: reduce dose and assess renal function prior to and during treatment. Haemodialysis (avoid in patients dialysed with high flux membranes). Use with caution in surgery and during anaesthesia. C Antihypertensive agents, K+sparing diuretics, K+suppl., lithium, antidiabetic agents, NSAIDs. A Nausea, vomiting, dizziness, fatigue, headache, abdominal pain, diarrhoea, cough. Liver dysfunction, renal impairment, hypersensitivity reactions. Rarely, symptomatic hypotension, angioneurotic oedema, syncope.

VASCACE

Roche

2MO ACE inhibitor. Cilazapril 0.5mg, 1mg, 2.5mg, 5mg. White, yellow, red or brown oval film-ctd scored tabs. marked CIL and strength. 0.5mg-28, A5.02; 1mg-28, A8.11; 2.5mg-28, A13.06; 5mg-28, A18.79. S All grades of essential hypertension and renovascular hypertension where standard therapy is ineffective or inappropriate. P Hypertension: initially 1mg once daily.

2

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Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM

HYPERTENSION 2.4 inhalation anaesthetics, quinidine, digoxin, lithium, carbamazepine, cimetidine, ranitidine, grapefruit juice. A Constipation, dizziness, giddiness, nervousness, headaches, fatigue, flush, paresthesia.

stenosis, post kidney transplant. History of angioneurotic oedema. Aortic or mitral valve stenosis, hypertrophic cardio-myopathy. Systolic BP Q100mmHg before treatment initiation. Permanent haemodialysis. Primary hyperaldosteronism. VERISOP Gerard B Diuretics (q80mg frusemide), hypovolaemia, hyponatraemia, hyperkalaemia. 2MO Hypotension (first dose). Acute MI and cardiac Class I Ca++ antagonist. Verapamil chlor. 40mg, failure (if unstable), renal impairment, high-dose 80g, 120mg. White tabs. marked VL and strength vasodilator therapy. LDL-cholesterol apheresis. one side, G on reverse. 40mg-100, A3.53; 80mgElderly. 100, A5.16; 120mg-100, A10.59. C Diuretics incl. K+sparing, K+suppl., other S Mild to moderate hypertension. antihypertensives, analgesics/anti-inflammatories, P 40-120mg three times daily. lithium, alcohol, anaesthetics, narcotics, hypnotics. Q Not recommended. Sympathomimetics, oral antidiabetic agents, D Cardiogenic shock. 2nd or 3rd degree insulin. AV block. Severe bradycardia. Uncompensated A Hypotension, dizziness, fatigue, cardiac failure. Sick sinus syndrome. arrhythmias. Proteinuria, dry cough, nausea B 1st degree AV block. Poor cardiac (occasionally), abdominal pain, rash, headache. reserve should be controlled with digitalis and VERAMIL Orion diuretics. Hepatic impairment. Acute phase of MI. ZESGER PLUS Gerard 2MO Bradycardia. 5MO C b-blockers, quinidine or digoxin. Class I Ca++ antagonist. Verapamil chlor. 40mg, A Constipation, headache, flushes. 80mg, 120mg. White film-ctd tabs. coded VL-40, ACE inhibitor/diuretic. Lisinopril (as dihydrate) VL-80 and VL-120. 40mg-100, A5.17; 80mg-100, 20mg and HCTZ 12.5mg. Pink, round tab. marked A8.67; 120mg-100, A11.56. LHZ on one side and 32.5 on reverse. 28, A10.75. S Essential hypertension. S Essential hypertension where BP not P 40-120mg three to four times daily. adequately controlled on lisinopril or HCTZ alone. ZANIDIP Recordati P Once daily depending on clinical Severe liver dysfunction: Use 1/3 dose. D Severe left ventricular dysfunction. evaluation at about the same time each day. Max. 2MO Severe hypotension, cardiogenic shock. 2nd or 3rd Class II Ca++ antagonist. Lercanidipine HCl 10mg, 40mg lisinopril/ 25mg HCTZ. degree AV block. Marked bradycardia. Sick sinus Q Under 18 years, not recommended. 20mg. Yellow, pink resp. scored film-ctd tab. syndrome. CHF incl. including uncompensated HF. 10mg-28, A10.93; 20mg-28, A17.85. D Renal artery stenosis. Angioneurotic Lactation. oedema. Severe renal/hepatic impairment. S Mild to moderate essential B 1st degree AV block reported. Pregnancy, lactation. hypertension. Hypertrophic cardiomyopathy, elderly, attenuated P 10mg once a day at least 15 mins. B Symptomatic hypotension may occur, neuromuscular transmission. Mild to moderate HF before meals; may be increased to 20mg. especially in patients with volume/salt depletion. (control with digitalis and diuretics). Porphyria Recent renal transplantation, dialysis; avoid. Q Not recommended. (unsafe). Hepatic impairment (monitor during Anaphylactoid reactions. Risk of hyperkalaemia, D Severe renal/hepatic dysfunction. LV long-term therapy). Contains lactose. Pregnancy. renal impairment, diabetes mellitus, major surgery, outflow tract obstruction. Untreated congestive C Grapefruit juice, digitalis intoxication, IV cardiac failure. Unstable angina pectoris. Within 1 impaired liver function; caution. Withdraw if b-blockers (contra). Colchicine, cisapride (avoid). a/ month of a MI. Pregnancy (women of childneutropenia, angioedema or jaundice occurs. b-blockers, CYP3A4 inhibitors/substrates, C Lithium (avoid). K+ suppls, K+-sparing bearing potential should use adequate antiarrhythmics, CCBs, cardiac glycosides, diuretics or K+-containing salts, trimethoprim, contraception), lactation. theophylline, imipramine, glyburide, doxorubicin, diuretics. Caution: Lisinopril: NSAIDs, other B Sick sinus syndrome, LV dysfunction, paclitaxel, tamoxifen, cimetidine, statins, antihypertensive agents, TCAs, sympatomimetics, ischaemic heart disease. Elderly. Mild/moderate almotriptan, halothane, dantrolene, Ca++ salts, antidiabetics, allopurinol, ciclosporin, lovastatin, renal or hepatic dysfunction. Contains lactose. immunosuppressive agents. HCTZ: Amphotericin B alcohol, lithium, timolol eye drop, quinidine, C Contra: CYP3A4 inhibitors (e.g. (parenteral), carbenoxolone, corticosteroids, antihypertensives. ketoconazole, ritonavir, erythromycin), corticotropine, stimulating laxants, Ca++ salts, A Constipation, headache, dizziness, cyclosporine, grapefruit juice. Avoid: alcohol, fatigue, rash, bradycardia, hypotension, cardiac cardiac glycosides, colestyramine resin, colestipol, CYP3A4 substrates (terfenadine, astemizole, class insufficiency, swelling of ankles. non-depolarizing muscle relaxants, drugs III antiarrhythmics). Caution: CYP3A4 inducers associated with torsades de pointes, sotalol. (anticonvulsants, phenytoin, carbamazepine), VERAP Rowex A Dizziness, headache, fatigue, dry and midazolam, digoxin, b-blockers, cimetidine. persistent cough, hypotension incl. orthostatic 2MO ZESGER Gerard hypotension. Class I Ca++ antagonist. Verapamil (HCl) 120mg, 240mg. Beige scored and green oblong scored 2MO ZESTAN Clonmel both sides; both film-ctd prolonged release tabs. ACE inhibitor. Lisinopril 2.5mg, 5mg, 10mg, 20mg. 2MO 120mg-30, A5.43; 240mg-30, A10.85. Round, flat beveled edge, square biconvex and S Mild to moderate hypertension. ACE inhibitor. Lisinopril 2.5mg, 5mg white tabs. pentagonal biconvex tabs. debossed on one side P 240mg in the morning increasing if marked with strength and scored both sides; with 2.5, 5, 10 and 20 resp. All white with necessary to 240mg twice daily with a 12 hour breakline on other side. 2.5mg-28, A5.38; 5mg-28, 10mg, 20mg white tabs. marked with strength interval. and quadrisected both sides. 2.5mg-28, A4.84; A7.59; 10mg-28, A9.37; 20mg-28, A10.75. R 120mg in the morning, increasing by 5mg-28, A6.95; 10mg-28, A8.35; 20mg-28, A9.76. S Arterial hypertension. 120mg at weekly intervals according to response. S Arterial hypertension. P Initially 5mg in the morning; titrate to Q Not recommended. P Initially 5-10mg once daily in the optimum BP control. Time interval between dose D Cardiovascular shock, recent cardiac morning, increasing in intervals of at least 3 weeks increase q3 weeks. Maintenance, 10-20mg once infarction with complications, grade II and III AV up to 20mg daily maintenance dose. Max. 80mg daily. Max 40mg once daily. Renal dysfunction, block, sinu-atrial blockage, sick sinus syndrome. once daily. A lower initial dose 2.5mg in patients patients who do not tolerate discontinuation of B Monitor BP at regular intervals diuretic treatment, volume/salt depleted, severe or with renal impairment, HF, volume and/or salt particularly in 1st degree AV block, hypotension, depletion, severe or renovascular hypertension, renovascular hypertension, initiate with 2.5mg in bradycardia, atrial fibrillation/flutter or patients who do not tolerate discontinuation of the morning. simultaneous pre-excitation syndrome. Impaired diuretic therapy, elderly. R Initiate with 2.5mg in the morning. hepatic function. Pregnancy, lactation. Q Not recommended. Q Not recommended. C Anti-arrhythmic drugs, b-blockers, D Angioneurotic oedema, severe renal D Pregnancy, lactation. Renal artery Maintenance usually 1-2.5mg once daily. Discontinue any diuretic 2-3 days before initiating therapy with 0.5mg once daily. Renovascular hypertension: initially 0.25-0.5mg once daily. Titrate according to response. R Hypertension: initially 0.5mg once daily. Renovascular hypertension: initially 0.25mg once daily. Q Not recommended. D Ascites, aortic stenosis, hypertrophic cardiomyopathy or outflow obstruction. Pregnancy, lactation. B Haemodialysis. Renal or hepatic impairment, CHF, salt or volume depletion, surgery, anaesthesia. C K+sparing diuretics, NSAIDs. A Headache, dizziness, fatigue, dyspepsia, nausea, rash, coughing. Rarely angioneurotic oedema and alterations in blood count.

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

65


2.5 PERIPHERAL

CIRCULATORY SYSTEM

VASCULAR DISORDERS A Dizziness, headache, fatigue, diarrhoea, cough, rash, asthenia, angioedema, renal failure. Hypotension, palpitations, chest pain, impotence.

and marked M6, resp. B.D. Starter pack (8 x 500mcg plus 32 x 1mg), A4.49; 500mcg-56, A3.17; 1mg-56, A4.07. S Raynaud’s phenomenon. ZOFENIL A. Menarini P Initially 500mcg twice daily for 3-7 days; maintenance 1-2mg twice daily. 2MO Q Not recommended. Cardioprotective ACE inhibitor. Zofenopril 30mg. D Sensitivity other quinazolines. White oval film-ctd tab. 30mg-28, A14.02. B Pregnancy, lactation. Initial low dose S Hypertension. and gradual titration is recommended, monitor P Usually 30mg once daily; max. 60mg. BP. Q Not recommended. C Other antihypertensives. Caution: PDE-5 D Angioneurotic oedema, severe hepatic inhibitors. impairment, renal artery stenosis. Pregnancy, lactation. Women of child-bearing potenial unless MIDON Shire protected by effective contraception. 0MO B Reduce dosage of diuretic if possible before initiating therap. Volume depletion may a-agonist. Midodrine (HCl) 2.5mg white scored cause sympathetic hypotension, dialysis, tab. marked GU and 2.5. 5mg orange scored tab. anaesthesia, renal or heptic impairment. marked GU and 5.0 2.5mg-100, A58.58; 5mg-100, A117.16. C Other anti-hypertensive agents, diuretics, lithium, K+sparing diuretics, K+suppl., S Idiopathic orthostatic hypotension. P Initially 2.5mg two to four times daily, NSAIDs. ZESTORETIC 20 AstraZeneca A Dizziness, fatigue, headache, cough, gradually increasing by 2.5mg at weekly intervals 5NO until optimal response. Last dose should be taken nausea, vomiting, rash, muscle cramp, weakness. at least 4 hours before bedtime. Max. 30mg daily. ACE inhibitor/thiazide diuretic. Lisinopril 20mg, Q Not recommended. HCTZ 12.5mg. White tab. marked ZESTORETIC 20. 2.5 PERIPHERAL VASCULAR DISORDERS D Hypertension, severe organic heart 28 (Cal/Pk), A6.46. ADALAT Bayer Schering disease, hyperthyroidism, thyrotoxicosis, 5NO 2 M O phaeochromocytoma, acute nephritis or urinary ALSO ZESTORETIC 10 Lisinopril 10mg, HCTZ retention, vasovagal hypotension, narrow angle Class II Ca++ antagonist. Nifedipine 5mg, 10mg. 12.5mg. Peach tab. 28 (Cal/Pk), A9.38. glaucoma. Pregnancy, lactation. Orange, gelatin ovoid caps. containing yellow S Management of hypertension in B Renal insufficiency. Driving/using fluid. 5mg-90, A3.03; 10mg-90, A3.85. patients stabilised on the individual components machines. Contains sunset yellow. S Raynaud’s phenomenon. or where no response to monotherapy with C Sympathomimetic agents, guanethidine, P Initially 5mg eight hourly adjusted lisinopril. reserpine, atropine, antihistamine, thyroid according to response, increasing to max. 20mg P 1 once daily. hormones, methyldopa, tricyclic antidepressants. every 8 hrs. Q Not recommended. MAOIs. Digitalis or other glycosides, Q Not recommended. D Pregnancy. Anuria, aortic stenosis, mineralcorticoids or glucocorticoids. D Women of child-bearing potential, hyperkalaemia, history of angioneurotic oedema. lactation. Cardiogenic shock, aortic stenosis. Acute A Nausea, vomiting, dyspepsia, chills, B First dose hypotension in fluid or headache, dizziness, rash, urinary retention. angina attacks, unstable angina pectoris, MI electrolyte depletion, renal impairment, hepatic Hypotension, tachycardia, arrhythmias, (within 1 month). disease, lactation. + + palpitations, reflex bradycardia, parasthesic, B Poor cardiac reserve, HF, hepatic C K sparing diuretics, K suppl., lithium, impairment, severe hypotension. Diabetes, dialysis. pruritus, flushing, dysuria. indomethacin, antidiabetics, corticosteroids. Elderly. Driving/using machines. Palpitations, A Dizziness, headache, cough, NIFED Rowex hypotension, syncopes, fatigues, rash, GI disorders, hypotension, tachycardia reported. C Contra: Rifampicin. Avoid grapefruit 2MO impotence, muscle cramps, paraesthesia. juice. Caution: Antihypertensive agents, Class II Ca++ antagonist. Nifedipine 10mg. Oblong ZESTRIL AstraZeneca cimetidine, quinidine, digoxin, phenytoin, brown caps. 100, A7.01. diltiazem, cisapride, quinupristin/dalfopristin, S Raynaud’s phenomenon. 2MO CYP3A4 inhibitors. P 30-60mg daily in divided doses. ACE inhibitor. Lisinopril 2.5mg, 5mg, 10mg, 20mg. A Headache, vasodilatation, nausea, R 15mg in divided doses. White, pink, pink, red tabs. resp. marked with dizziness, peripheral oedema. Q Not recommended. heart shape, strength and ZESTRIL. 2.5mg-28, D Cardiogenic shock. unstable angina A3.23; 5mg-28, A4.56; 10mg-28, A5.63. 20mg-28, HEXOPAL Clonmel pectoris, advanced aortic stenosis, porphyria, acute A6.46. 2O myocardial infarction. Women of child-bearing S All grades of essential and renovascular Nicotinic acid deriv. Inositol nicotinate 500mg. potential. Pregnancy, lactation. hypertension. White scored tab. marked HXV. 100, A20.27. B Caution: Severe hypotension, poor P Initially 10mg once daily; maintenance S Intermittent claudication, Raynaud’s cardiac reserve, diabetes, malignant hypertension, 10-20mg once daily. Renovascular hypertension: disease, peripheral arteriosclerosis, acrocyanosis, irreversible renal failure with hypovolaemia, risk of initiate with 2.5-5mg daily. Discontinue diuretic 2chilblains. hypotensive crisis (medical supervision). 3 days before initiating with 5mg daily or reduce P 2 three times daily. C Not recommended: Rifampicin, antidiuretic dose. Q Not recommended. epileptics. Caution: Cimetidine, erythromycin, Q Not recommended. 2 nefazodone, azole antifungals, digoxin, diltiazem, D History of angioneurotic oedema. Not ALSO HEXOPAL FORTE Inositol nicotinate 750mg. cyclosporine, tacrolimus, vincristine, antidiabetics, recommended: Lactation, pregnancy (contra 2ndWhite oval scored tab. marked HEX 750. 112 (Cal/ qinidine, cisapride. Avoid grapefruit juice. 3rd trim.). Pk), A35.27; 250, A95.87. A Headache, facial reddening, B Renal impairment; monitor renal palpitations, dizziness, leg oedema. P 2 twice daily. function before and during treatment. Aortic stenosis, cor pulmonale, outflow tract obstruction. Q Not recommended. NIMOTOP Bayer Schering B Pregnancy. 1st dose hypotension. Anaphylactoid reactions 2MO (during haemodialysis using high flux membranes, HYPOVASE Pfizer Class II Ca++ antagonist. Nimodipine 30mg. Yellow LDL apheresis, desensitisation). 2MO film-ctd tab. marked with Bayer cross on one side C K+ sparing diuretics, K+ suppl., other and SK on reverse. 100, A42.25. antihypertensives, indomethacin, lithium, Selective a-blocker. Prazosin (HCl) 500mcg, 1mg. injectable gold. White tab. marked Pfizer and white tab. scored S Prevention of ischaemic neurological impairment, haemodynamically unstable patients after MI, haemodynamically relevant aortic or mitral valve stenosis or hypertrophic cardiomyopathy, systolic BP R 100 mmHg before initiation of treatment, cardiogenic shock. B Haemodialysis. Hypotension, renovascular hypertension, renal impairment, monitor renal function before and during treatment, severe CHF, primary hyperaldosteronism, aortic stenosis, hypertrophic cardiomyopathy. Low-density apheresis/ desensitisation therapy. C Diuretics, K+ sparing diuretics, K+ suppl., Na+ Cl, lithium, anti-hypertensives, analgesics, anti-inflammatories, alcohol, anaesthetics, narcotics, hypnotics, sympathomimetics, oral antidiabetics, insulin, antacids, NSAIDs. A Hypotension, angioedema, dizziness, weakness, impaired vision, renal dysfunction, dry cough, sore throat, hoarseness, bronchitis, GI disturbances, rash, headache, tiredness.

66

2

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Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM deficits following aneurysmal subarachnoid haemorrhage. P 2 tabs. four hourly starting within 4 days of subarachnoid haemorrhage and continued for 21 days. If cerebral ischaemia occurs, continue tab. to complete 21 days or substitute by soln. Q Not recommended.

2N ALSO NIMOTOP SOLUTION Nimodipine 0.2mg/ml. Soln. for inf. in vial. 5 x 50ml vial (with 5 inf. lines), A74.47. S Treatment of ischaemic neurological deficits following aneurysmal subarachnoid haemorrhage. P 1mg per hour by IV inf. for first 2 hrs, then 2mg per hr for min. 5 days, max. 14 days. If surgical intervention during treatment, admin. should be continued for at least 5 days. If tabs. and inf. are admin. sequentially, total duration of treatment should not exceed 21 days. Patients under 70kg or with unstable BP, start on 0.5mg per hr or less if necessary. Q Not recommended. D Unstable angina episode, MI (within 1 month). B Cerebral oedema, raised IOP. Hypotensive patients. Pregnancy. Monitor BP in cirrhotic patients. Renal impairment (inf.) Transient rise in liver enzymes (inf.). Nimotop inf. is incompatible with PVC and contains ethanol, Na+. C Oral nimodipine: Contraindicated with antiepileptics, phenobarbital, phenytoin, carbamazepine, rifampicin. Caution: Quinupristin/ dalfopristin. Nimodipine inf: Caution, nortriptyline, nephrotoxic drugs. Both: Grapefruit juice, not recommended. Caution: Diuretics, b-blockers, ACE inhibitors, A1 antagonists, methyldopa, other Ca++ antagonists, a-adrenergic blocking agents, PDE5 inhibitors, fluoxetine, cimetidine, Na+ valproate, zidovudine, CYP3A4 inducers and inhibitors. Do not use tab. and inf. concomitantly.

PROPHYLAXIS

OF

MI,

STROKE AND VASCULAR DEATH

min. after catheter removal; monitor neurological signs and symptoms), hip fracture surgery (no data). Monitor for bleeding or anaemia during treatment, especially in at-risk patients. Caution: Moderate renal impairment, high surgical mortality risk, thromboembolic risk. Contains sunset yellow. C Contra: Quinidine. Not recommended: Heparins, fondaparinux, desirudin, thrombolytic agents, GPIIb/IIIa receptor antagonists, clopidogrel, ticlopidine, dextran, sulfinpyrazone, vit. K antagonists. Caution: Amiodarone, strong Pglycoprotein inhibitors (e.g. verapamil, clarithromycin), potent P-glycoprotein inducers (e.g. rifampicin, St John’s wort). A Bleeding events, anaemia, haematoma, haematuria, decreased Hb, wound secretion.

PRAXILENE

Merck Serono

2MO Peripheral and cerebral activator. Naftidrofuryl oxalate 100mg. Pink cap. marked PRAXILENE. 100, A11.87. S Cerebral and peripheral vascular disorders. P 1-2 three times daily. Q Not recommended. D History of hyperoxaluria or recurrent Ca++-containing stones. Pregnancy, lactation. A Nausea, epigastric pain, skin rash, insomnia. Rarely; hepatitis, kidney stones.

2.6

B Caution: Patients at increased bleeding risk, renal impairment (ccQ15ml/min, not recommended), moderate hepatic impairment. Spinal/epidural anaesthesia or puncture, monitor for symptoms of neurological impairment. Not recommended for hip fracture surgery. Contains lactose. C Not recommended: CYP3A4 and P-gp inhibitors (ketoconazole, itraconazole, voriconazole, posaconazole, HIV protease inhibitors). Caution: Fluconazole, other anticoagulants, clopidogrel, NSAIDs, platelet aggregation inhibitors, strong CYP3A4 inducers. Affects clotting parameters. A Increased GGT, increased transaminases , anaemia, nausea, post-procedural haemorrhage.

2.6 PROPHYLAXIS OF MI, STROKE AND VASCULAR DEATH

ACERYCAL

Servier

2MO

ACE inhibitor / Ca++ antagonist. Perindopril arginine / amlodipine, 5mg/5mg, 5mg/10mg, 10mg/5mg and 10mg/10mg. White tab. engraved with strength on 1 side and Servier logo on the other. 5/5mg, rod-shaped; 5/10mg, square-shaped; 10/5mg, triangular-shaped; 10/10mg, round. 5/ 5mg-30, A25.66; 5/10mg-30, A31.13; 10/5mg-30, A34.41; 10/10mg-30, A39.88. S Substitution therapy for treatment of essential hypertension and/or stable coronary TRENTAL sanofi-aventis artery disease, in patients already controlled with perindopril and amlodipine given concurrently at 2MO same dose level. Xanthine. Pentoxifylline 400mg. Pink oblong P 1 tab./day as single dose, preferably the modified-release ctd tab. 100, A20.64. morning before a meal. Not suitable for initial S Peripheral vascular disease and therapy. cerebrovascular insufficiency. Q Not recommended. P 400mg, 2 or 3 times daily. D Hypersensitivity to ACE inhibitors and Q Not recommended. dihydropyridines. History of angioedema D Acute MI or cerebrovascular accident. associated with previous ACE inhibitor therapy. PRADAXA Boehringer Ing. Massive bleeding or extensive retinal bleeding. Hereditary or idiopathic angioedema. Severe B Monitor patients with hypotension, 2NO hypotension. Shock, including cardiogenic shock. severe coronary artery disease, severe cardiac Obstruction of the outflow-tract of the left Direct thrombin inhibitor. Dabigatran etexilate (as arrhythmias, renal impairment or increased ventricle (e.g. high grade aortic stenosis). Unstable mesilate), 75mg, 110mg. Light blue and cream bleeding tendency. May potentiate effects of angina pectoris (excluding Prinzmetal’s angina). HF capsules filled with yellowish pellets, imprinted insulin or oral antidiabetic agents. Pregnancy, after acute MI (during first 28 days). Pregnancy, with company symbol and R75 and R110 resp. lactation. lactation. 75mg-10, A23.95, 75mg-60, A143.70, 110mgC Hypoglycaemics, antihypertensives, B May rarely occur: Hypersensitivity, 10,A23.95, 110mg-60, A143.70. theophyilline, anticoagulants, antiplatelets, angioedema (discontinue if occurs) or S Primary prevention of venous ketorolac. anaphylactoid reactions during LDL-apheresis and thromboembolic events in adults after elective A GI disorders, flushing, headache, desensitisation, neutropenia, agranulocytosis, total hip replacement surgery or total knee dizziness, agitation, sleep disorders, cardiac thrombocytopenia, anaemia, hepatic failure, replacement surgery. arrhythmias , hypersensitivity reactions including symptomatic hypotension (in patients with salt or P Initially, 110mg within 1-4 hours of anaphylactic / anaphylactoid reactions. volume depletion), hyperkaliemia. Caution: Aortic surgery, then 220mg once daily for 10 days (knee) or 28-35 days (hip). If haemostasis not secured, XARELTO Bayer Schering and mitral valve stenosis, hypertrophic cardiomyopathy, heart failure, collagen vascular initiation of treatment should be delayed. If 2NO disease, immunosuppressant therapy, treatment treatment not started on day of surgery, starting Antithrombotic agent. Rivaroxaban 10mg. Light with allopurinol or procainamide, hepatic dose is 220mg once daily. Moderate renal red, round film-ctd tab. marked with Bayer-cross impairment. Renal impairment: Adjust dosage impairment: Initially 75mg within 1-4 hours of according to individual dose titration with the surgery, then 150mg once daily. Concomitant use one side and 10 and a triangle on the other. 30; 100. Prices on request. monocomponents. Discontinue 1 day prior to with amiodarone: reduce dose to 150mg. S Prevention of venous thromboembolism surgery. Closely monitor glycaemic control in R Over 75 years, initially 75mg within 1-4 hrs of surgery, then 150mg once daily for 10 days (VTE) in adult patients undergoing elective hip or diabetic patients. Contains lactose. knee replacement surgery. C Not recommended: K+-sparing diuretics, (knee) or 28-35 days (hip). P 10mg once daily. Initially, 6-10 hours K+ supplements, K+-containing salt substitutes, Q Under 18 years, not recommended. lithium, estramustine, dantrolene. Caution: after surgery, if haemostasis established. Hip D Severe renal impairment. Active NSAIDs, antidiabetics (insulin, hypoglycaemic surgery: Continue for 5 weeks. Knee surgery: 2 bleeding, organic lesion at risk of bleeding, sulphonamides), CYP3A4 inducers / inhibitors, impairment of haemostasis. Hepatic impairment or weeks. baclofen, corticosteroids, tetracosactide, alphaQ Not recommended. liver disease expected to have impact on survival. blockers, amifostine, TCAs, antipsychotics, D Clinically significant active bleeding. Pregnancy (unless necessary), lactation. Hepatic disease associated with coagulopathy and anaesthetics. Diuretics, sympathomimetics, gold, bB Not recommended: Elevated liver blockers, vasodilatators. clinically relevant bleeding risk. Pregnancy, enzymes (q2xULN), anaesthesia with postoperative indwelling epidural catheters (wait 2 hrs lactation. A Somnolence, dizziness, headache, AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

67


2.6 PROPHYLAXIS

OF

MI,

CIRCULATORY SYSTEM

STROKE AND VASCULAR DEATH

patients. Withdraw if patient requires thrombolytic therapy or CABG. Monitor patients with decreased renal function for bleeding. Monitor the anticoagulant effect of heparin by repeated determination of APTT. Perform regular blood tests. ACTILYSE Boehringer Ing. C Clopidogrel, adenosine, dipyridamole, sulphinpyrazone, prostacyclin, warfarin, LWHs, 2N Fibrinolytic. Alteplase 10mg, 20mg, 50mg. Powder ticlopidine, dextran solutions. A Bleeding, nausea, fever, headache. in vials. 10mg-1 pack (1 x 10mg vial, 1 x 10ml WFI), A203.16; 20mg-1 pack (1 x 20mg vial, 1 x ANGIOX The Medicines Co. 20ml WFI, 1 transfer device), A274.26; 50mg-1 2JN pack (1 x 50mg vials, 1 x 50ml WFI, 1 transfer device), A612.01. Antithrombotic. Bivalirudin 250mg. White S MI, pulmonary embolism, ischaemic lyophilised powder for concentrate for soln for inj. stroke. or inf. 10 vials, A5,292.94. P MI/PE: Total dose 100mg IV. MI - over S Anticoagulant in patients undergoing 90 mins. if within 6 hours of symptom onset, over percutaneous coronary intervention (PCI). 3 hours if 6-12 hours. PE - over 2 hours. See SPC. P Intravenous bolus of 0.75mg/kg Ischaemic stroke: Total dose 90mg as IV inf. over followed by inf. of 1.75 mg/kg/hr for duration of 60 mins. with 10% dose admin. as initial IV bolus procedure for up to 4 hours post-PCI. Arterial within 3 hours of onset. See SPC. sheath can be removed 2 hours after inf. Renal Q Not recommended. insufficiency: Monitor ACT, see SPC. Moderate D Current or recent haemorrhage, renal insufficiency: Reduce Inf. rate to 1.4mg/kg/ hr. haemorrhagic diathesis; severe hypertension with Q Under 18 years, no data. known or possible cerebrovascular haemorrhage, D Active bleeding or increased risk of recent trauma, severe liver disease, acute bleeding, severe uncontrolled hypertension, pancreatitis, bacterial endocarditis, active peptic subacute bacterial endocarditis, severe renal ulceration. impairment, dialysis-dependent patients. B Recent surgery, diabetes mellitus, proliferative diabetic retinopathy, hepatic or renal B Not for IM use. Monitor for bleeding. If bleeding observed or suspected stop treatment. dysfunction. Pregnancy, lactation. Avoid No known antidote to bivalirudin, but its effect intramuscular inj. and vascular puncture. wears off quickly. Hypersensitivity reactions C Anticoagulants. reported uncommonly. Fatal anaphylaxis reported A Localised bleeding. Intracerebral very rarely. Caution: Previously treated patients haemorrhage. Bleeding in GI and genitourinary who had developed lepirudin antibodies. Caution: tracts. Nausea, vomiting, headache, rash and Use during b-brachytherapy procedures. Pregnancy pruritus. (unless clearly necessary), lactation (no data). AGGRASTAT MSD C Start Angiox 30 min. after IV unfractionated heparin or 8 hours after SC low 2N molecular weight heparin. Caution: AntiCompetitive GPIIb/IIIa receptor antagonist. coagulants. Tirofiban 0.25mg/ml. Conc. for soln. for infusion. A Bleeding events. 0.25mg/ml-50ml, A232.79. paresthaesia, vertigo, visual disturbances, tinnitus, palpitations, flushing, hypotension, GI disturbances, pruritus, rash, muscle cramps, oedema, peripheral oedema, fatigue, asthenia, dry cough.

hypersensitivity reactions, iron deficiency anaemia.

CAPRIN

Pinewood

2MO Salicylate. Aspirin 75mg, 300mg. Pink ent-ctd tab. 75mg-100, A5.40; 300mg-100, A3.72. S To reduce risk of myocardial infarction in patients with unstable angina or ischaemic stroke or with history of MI. P 1 daily before meal. Q Not recommended. D Active peptic ulceration, coagulation deficiency disorders, lactation. B Reyeâ&#x20AC;&#x2122;s syndrome in children. Avoid: Stroke patients, severe hepatic/renal impairment, history of peptic ulceration or coagulation abnormalities, dehydration. Pregnancy (avoid at term). Elderly. C Hypoglycaemic agents (esp.sulphonylureas), uricosuric agents, methotrexate, antacids, antiepilectic agents (phenytoin & Na+ valproate), sulphonamides, antihypertensives, iron salts and alkali. A Allergic or asthmatic reactions. Bronchospasm.

CLEXANE

sanofi-aventis

2NO Anticoagulant. Enoxaparin Na+ 100mg/ml (equiv. 10,000 IU anti Factor Xa activity). Single dose prefilled syringes. 20mg/0.2ml-10; A29.84; 40mg/ 0.4ml-10; A50.97; 60mg/0.6ml-10; A50.78; 80mg/ 0.8ml-10; A61.46; 100mg/1ml-10;A74.65.

2NO

ALSO CLEXANE FORTE Enoxaparin Na+ 150mg/ml (equiv. 15,000 IU anti Factor Xa activity). Single dose pre-filled syringes. 120mg/0.8ml-10, A108.43; 150mg/1ml-10, A139.48. S Prophylaxis and treatment of venous thromboembolic (VTE) disorders including deep venous thrombosis (DVT) and pulmonary embolism (PE). Prevention of thrombus formation during haemodialysis. Treatment of unstable angina (UA) and non-Q-wave myocardial infarction (NQWMI). S Prevention of early myocardial of acute ST Elevation Myocardial ASASANTIN RETARD Boehringer Ing. Treatment infarction in patients with unstable angina of nonInfarction (STEMI) +/- Percutaneous Coronary Q-wave myocradial infarction with last episode of 2 M O Intervention (PCI) (100mg/ml only). chest pain within 12 hours and with ECG changes Antiplatelet/salicylate. Modified release P Prophylaxis of VTE: Low-mod risk (e.g. dipyridamole 200mg, standard release aspirin and/or elevated cardiac enzymes.To be used with general surgery), 20mg SC inj. 2 hrs pre-op, then 25mg. 60, A12.35. aspirin and unfractionated heparin, under 20mg once daily for 7-10 days. High risk (e.g. S Secondary prevention of ischaemic specialist supervision. orthopaedic surgery), 40mg SC inj. 12 hrs pre-op, stroke and transient ischaemic attacks. P Initially 0.4mcg/kg per min. of the then 40mg once daily for 7-10 days. Medical P One cap. swallowed whole twice daily. diluted soln. by IV infusion for 30 mins. starting patients: 40mg once daily SC inj. for 6-14 days. Intorable headache, only 1 daily at bedtime and within 12 hours of the last angina episode. Then Treatment of DVT or PE: 1.5mg/kg daily SC inj or low dose ASA in morning; return to usual regimen 1mg/kg twice daily SC inj. for complicated VTE. All 0.1mcg/kg per min. by IV infusion for at least 48 asap, usually within 1 week. hours. Max. treatment period 108 hours. for r 5 days and until adequate oral Q Under 16 years, not recommended. Q Not recommended. anticoagulation established. Haemodialysis: R 4 D Active gastric or duodenal ulcers, D Stroke within 30 days, intracranial hrs: 1mg/kg bolus dose into arterial line prior to bleeding disorders. Pregnancy (especially last trim), session. q4 hrs or if fibrin rings found: further disease, GI bleeding within 30 days, malignant lactation. hypertension, surgery or trauma past 6 weeks, dose of 0.5-1mg/kg. Treatment of UA and NQWMI: thrombocytopenia (platelet count Q100,000/mm3), B Severe coronary artery disease, 1mg/kg 12 hourly SC inj. with oral aspirin (100clotting disturbances, severe liver failure. coagulation disorders, asthma, allergic rhinitis, 325mg once daily) for 2-8 days and until clinical Pregnancy, lactation. nasal polyps, chronic or recurring gastric or stabilisation. Treatment of acute STEMI: 30mg B Cardiopulmonary resuscitation, organ duodenal complaints, impaired renal or hepatic single IV bolus plus 1mg/kg SC inj. followed by biopsy or ithotripsy within last 2 weeks, active function or G6PD deficiency, hypersensitivity to 1mg/kg SC inj. every 12 hrs for 8 days or until peptic ulcer within 3 months, uncontrolled NSAIDs. Contains lactose. hosp. discharge. (max 100mg for the first 2 doses hypertension, acute pericarditis, vasculitis, aortic C Adenosine, antihypertensives, only, followed by 1mg/kg for remaining doses). dissection, haemorrhagic retinopathy, haematuria, anticoagulants, other antiplatelets, valproic acid, Elderly (r75 years): do not use initial IV bolus. occult blood in stools. Recent relevant bleeding SSRIs, other NSAIDs, corticosteroids, chronic 0.75mg/kg SC every 12 hrs (max. 75mg for first 2 within 1 year, severe acute or chronic HF, alcohol use, hypoglycaemics, methotrexate, doses only, followed by 0.75mg/kg for remaining cardiogenic shock, mild to moderate liver spironolactone, uricosuric agents. doses). PCI: If the last SC admin was Q 8 hrs insufficiency, platelet function disturbances, A Dizziness, vomiting, diarrhoea, nausea, before balloon inflation, no additional dosing thrombocytopenia (platelet count Q150,000/mm3), dyspepsia, epigastric distress, headache, myalgia, needed. q 8 hrs give 0.3mg/kg IV bolus. anaemia, female, elderly or low body weight hypotension, hot flushes, tachycardia, Q Not recommended.

68

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM D Acute bacterial endocarditis, active major bleeding disorders, high risk of uncontrolled haemorrhage (including recent hemorrhagic stroke or subdural haematoma), thrombocytopenia, jaundice, active gastric/duodenal or hiatal ulcer, threatened abortion, retinopathy. Pregnancy, lactation (unless essential). B Not via IM route. Monitor platelet count (prior to and thereafter during treatment). Increases in aPTT and ACT. Hyperkalaemia. Caution in impaired haemostasis, history of peptic ulcer or bleeding, recent ischaemic stroke, severe arterial hypertension, severe liver or kidney dysfunction, diabetic retinopathy, recent ophtalmologic or neuro surgery or trauma, mechanical prosthetic heart valves (especially in pregnant women), elderly, severe renal impairment (dose adjustment), low body weight, spinal/epidural anaesthesia. C Medications affecting hemostasis: Salicylates, aspirin, NSAIDs, dextran 40, ticlopidine, clopidogrel, systemic glucocorticois, thrombolytics, anticoagulants, other anti-platelet agents (incl. glycoprotein IIb/IIIa antagonists). A Injection site pain, haematoma, mild local irritation. Asymptomatic and reversible increases in platelet counts and liver enzyme levels. Hypoaldosteronism.

PROPHYLAXIS

OF

MI,

STROKE AND VASCULAR DEATH

pathological conditions or treatment, incl. lesions with propensity to bleed (particularly GI and intraocular). Renal impairment, moderate hepatic impairment with bleeding diatheses. Discontinue 7 days prior to surgery. Monitor carefully for any signs of bleeding, especially during 1st weeks and after invasive cardiac procedures or surgery; perform blood count and appropriate test if bleeding suspected. Not recommended during the 1st 7 days after acute ischaemic stroke. Thrombotic Thrombocytopenic Purpura reported very rarely. Contains hydrogenated castor oil. C Avoid anticoagulants. Caution: ASA, heparin, thrombolytics, glycoprotein IIb/IIIa inhibitors, NSAIDs incl. Cox-2 inhibitors. A Haematoma, epistaxis, GI disorders, bruising, bleeding at puncture site.

CLOPIDOGREL TAD

Clonmel

2MO

Antiplatelet. Clopidogrel (HCl) 75mg. Pink, round and slightly convex film-ctd tab. 28, A33.58. S Prevention of atherothrombotic events in adult patients suffering from MI (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. P Single daily 75mg dose. Q Safety and efficacy not established. CLODEL Rowex D Severe liver impairment. Active 2MO pathological bleeding such as peptic ulcer or Antiplatelet. Clopidogrel (as HCl) 75mg. Pink, film- intracranial haemorrhage. Pregnancy, lactation A ctd, round shaped tab. 28, 36.43. (precautionary measure). S Prevention of atherothrombotic events B Not recommended: Acute ischaemic in adults suffering from MI (from a few days until stroke (within 7 days). Caution: Patients at risk of Q 35 days), ischaemic stroke (from 7 days until Q increased bleeding from trauma, surgery or other 6 months) or established peripheral arterial pathological conditions or treatment, incl. lesions disease. with propensity to bleed (GI and intraocular); P 75mg daily as single dose. renal impairment, patients with moderate hepatic D Severe liver impairment. Active disease who may have bleeding diatheses. pathological bleeding (peptic ulcer or intracranial Discontinue 7 days prior to surgery. Consider haemorrhage). Pregnancy, lactation (no data). blood cell count determination and/or other B Not recommended: Acute ischaemic appropriate testing if clinical symptoms suggestive stroke (within 7 days). Caution: Renal impairment, of bleeding arise during treatment. Thrombotic moderate hepatic impairment in patients with Thrombocytopenic Purpura (TTP) reported very bleeding diatheses. Risk of bleeding (caution: rarely. Contains hydrogenated castor oil. Trauma, GI or intraocular lesions with a propensity C Not recommended: Anticoagulants. to bleed, surgery); discontinue 7 days prior to Caution: ASA, heparin, thrombolytics, glycoprotein elective surgery; warn patients to report unusual IIb/IIIa inhibitors, NSAIDs. bleeding. Thrombotic Thrombocytopenic Purpura A Haematoma, epistaxis, GI disorders, reported rarely. Contains hydrogenated castor oil. bruising, bleeding at puncture site. C Not recommended: Oral anticoagulants. COVERSYL ARGININE Servier Caution: Glycoprotein IIb/IIIa inhibitors, acetylsalicylic acid, heparin, thrombolytics, NSAIDs. 2 M O A Haematoma, epistaxis, GI disorders (incl. ACE inhibitor. Perindopril arginine 5mg, 10mg. haemorrhage), bruising, bleeding at puncture site. 5mg: Light green, rod-shaped scored film-ctd tab with a symbol. 10mg: Green, round, biconvex, CLOPIDOGREL HCS Teva film-ctd tab with heart on one side and symbol on 2MO reverse. 5mg-30, A14.12; 10mg-30, A22.59. Antiplatelet. Clopidogrel (HCl) 75mg. Pink, round, S Stable coronary artery disease slightly convex film-ctd tab. 28, A 34.79. reduction of risk of cardiac events in patients with S Prevention of atherothrombotic events history of MI and/or revascularisation. in patients suffering from MI (from a few days to P 10mg once daily. Initially, 5mg once Q 35 days), ischaemic stroke (from 7 days to Q 6 daily for 4 weeks, if tolerated increase to 10mg months) or established peripheral arterial disease. once daily. Discontinue diuretic 3 days P Single daily dose of 75mg. beforehand. If not possible commence with 2.5mg. Q Children and adolescents, not Renal insufficiency, 2.5mg according to creatinine recommended. clearance. D Severe liver impairment. Active R Initially, 2.5mg once daily; increase to pathological bleeding such as peptic ulcer or 5mg after 4 weeks, then 10mg if necessary. intracranial haemorrhage. Pregnancy, lactation Q Not recommended. (precautionary measure). D ACE inhibitor hypersensitivity. History of B Caution: Patients at risk of increased angioneurotic oedema (previous ACE treatment), bleeding from trauma, surgery or other hereditary or idiopathic angioedema. Pregnancy,

2.6

lactation. B Symptomatic hypotension may occur in patients with salt or volume depletion. Caution: Mitral valve stenosis, obstruction in the outflow of the left ventricle. Renal impairment. Dialysis with highflux membranes. Kidney transplantation, no data. Angioedema reported rarely (discontinue if occurs). Patients at risk of hyperkalaemia. Contains lactose. Surgery, anaesthesia. C Diuretics, K+ sparing diuretics, K+containing salt substitutes, K+ supplements, lithium, NSAIDs, other antihypertensives and vasodilators, antidiabetics, TCAs, antipsychotics, anesthetics, sympathomimetics. A Headache, dizziness, vertigo, paresthaesia, vision disturbance, tinnitus, hypotension, cough, dyspnoea, GI disorders, rash, pruritus, muscle cramps, asthenia.

GREPID

Pinewood

2MO Antiplatelet. Clopidogrel (as besilate) 75mg. Pink, round, biconvex, film-ctd tab. 28, A34.79. S Prevention of atherothrombotic events in adult patients suffering from MI (from a few days to Q 35 days), ischaemic stroke (from 7 days to Q 6 months) or established peripheral arterial disease. P Single daily dose of 75mg. D Severe liver impairment. Active pathological bleeding (peptic ulcer or intracranial haemorrhage). Pregnancy, lactation (precautionary measure). B Not recommended during 1st 7 days after acute ischaemic stroke. Caution: Patients at risk of increased bleeding from trauma, surgery or other pathological conditions or treatment, including lesions with a propensity to bleed (particularly GI and intraocular); renal impairment, moderate hepatic disease with bleeding diatheses. Discontinue 7 days prior to surgery. Monitor carefully for any signs of bleeding, especially during the 1st weeks of treatment and/or after invasive cardiac procedures or surgery; perform blood count and appropriate test if bleeding suspected. Thrombotic Thrombocytopenic Purpura (TTP) reported very rarely. Contains lactose. C Not recommended: Anticoagulants. Caution: ASA, heparin, thrombolytics, glycoprotein IIb/IIIa inhibitors or NSAIDs (incl. Cox-2 inhibitors). A Haematoma, epistaxis, GI disorders, bruising, bleeding at puncture site.

HEPSAL

Pinewood

2NO Anticoagulant. Heparin Na+ 10units/ml in saline, preservative free. Amp. 10 x 5ml, price on request. D Not for systemic use.

INNOHEP

LEO Pharma

2NO Anticoagulant. Tinzaparin 20,000 anti-Factor Xa IU per ml. Syringes x 10: 10,000 IU-0.5ml, A77.47; 14,000 IU-0.7ml, A108.13; 18,000 IU-0.9ml, A139.44. Vial x 1: 20,000/ml-2ml, A28.86. S Venous thrombosis and thromboembolic disease incl. deep vein thrombosis and pulmonary embolism. P 175 IU/kg body weight once daily by SC inj. for at least 6 days and until adequate oral anticoagulation is achieved. Routine monitoring of anticoagulant effect not necessary. Q Not recommended.

2NO

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

69


2.6 PROPHYLAXIS

OF

MI,

occurs. Hepatic impairment. Increased risk of bleeding with thrombolytics, oral anticoagulants, dextran solns., adenosine, LMWH, sulphinpyrazone, prostacyclin, NSAIDs, dypyridamole, ticlopidine, clopidogrel. Pregnancy. C Other parenteral GPIIb/IIIa inhibitors. A Bleeding or cardiac events.

C Caution: Fibrates, niacin, colchicine, ciclosporin, warfarin and other coumarin derivatives, rifampicin (long-term), glibenclamide (monitor patients on 80mg/day fluvastatin), bile acid sequestrants (e.g. cholestyramine; admin. fluvastatin at least 4 hrs after), fluconazole, phenytoin. A Insomnia, headache, fatigue, dizziness, Novartis GI disorders, arthralgia.

ALSO INNOHEP 10,000 IU/ML Tinzaparin 10,000 anti-Factor Xa IU per ml. Fixed dose syringes and vials. 2500 IU, A25.12; 3500 IU, A35.16; 4500 IU, A45.20 (syringes x10); 10,000/ml-2ml (vials x 10), A144.34. S Prophylaxis of deep vein thrombosis. Prevention of clotting in in-dwelling intravenous lines for extracorporeal circulation during haemodialysis. P Prophylaxis of DVT: Admin. by SC route only. Low to moderate risk DVT, e.g. all general surgery, 3500 IU starting 2 hrs before surgery. Admin. dose once daily for 7-10 days post-op. or for the required period of cover. High risk of DVT, e.g. orthopaedic surgery, either 4,500 IU starting 12 hrs pre-op. and followed by once daily dose or alternatively 50 IU/kg 2 hrs before surgery followed by once daily dose. Haemodialysis: Shortterm haemodialysis (Q4 hrs) bolus dose of 20002500 IU into arterial side of dialyser (or IV) at beginning of dialysis. Long term haemodialysis (q4 hrs) bolus dose of 2500 IU into arterial side of dialyser (or IV) at beginning of dialysis followed by inf. of 750 IU/hr. Q Not recommended. D Haemorrhagic tendency, incl.: Uncontrolled severe hypertension, severe liver failure, septic endocarditis, intracranial haemorrhage, injuries/operations on CNS, eyes or ears, active peptic ulcer, threatened abortion, heparin induced thrombocytopenia. Spinal/ epidural anaesthesia (full dose).Vials in premature babies and neonates. B Do not admin. by IM inj. Severe renal failure, increased risk of bleeding complications. Regular platelet counts necessary. Increased risk of hyperkalaemia. Sulphite sensitivity (20,000IU/ml). Pregnancy (avoid 2ml vial), lactation. C Caution: Drugs affecting platelet function, salicylates, NSAIDS, vitamin K antagonists, dextran. A Bleeding events, reversible increase in liver enzymes, reversible thrombocytopenia, skin reactions.

ALSO LESCOL Fluvastatin (as Na+) 20mg, 40mg. Brown/yellow caps. marked with XU, strength and company logo. 20mg-28 (Cal/Pk), A6.98; 40mg-28 (Cal/Pk). A8.23; 40mg-56 (Cal/Pk), A15.43. S Secondary prevention of major adverse cardiac events (coronary revascularization, cardiac death and non-fatal MI) in patients with CHD after coronary transcatheter therapy. P 80mg daily. Q Under 18 years, not recommended. D Active liver disease or persistent unexplained elevation of transaminase levels, cholestasis. Myopathic disorders. Caution if history of liver disease, high alcohol consumption. Pregnancy, lactation. B Monitor serum transaminase levels before and periodically during treatment. Severe renal impairment. Unexplained diffuse myalgias, muscle tenderness, muscle weakness and/or marked elevated creatine phosphokinase (CPK) values due to myopathy, myositis or rhabdomyolysis; discontinue. C Cholestyramine (admin. min. 4 hrs before Lescol). Caution: Rifampicin, warfarin, immunosuppressants (incl. cyclosporin), gemfibrozil, nicotinic acid, erythromycin, glibenclamide. A Dyspepsia, abdominal pain, nausea, insomnia, headache.

INTEGRILIN

LOCHOL

GSK

LESCOL XL 2MO

Statin. Fluvastatin (as Na+) 80mg. Yellow prolonged release tab. marked LE one side, NVR on reverse. 28 (Cal/Pk), A10.91.

2MO

Clonmel

2MO

2N

Statin. Fluvastatin 20mg, 40mg. Resp. size 3 or 1 Antiplatelet. Eptifibatide 2mg/ml soln. in vial for hard cap. with blue or green cap and white body. inj.; 0.75mg/ml soln. in vial for inf. Inj.-10ml, 20mg-28, A7.56; 40mg-28, A8.92. A20.77. Inf.-100ml, A65.21. S Secondary prevention of coronary S Prevention of early myocardial infarction in patients with unstable angina or non- events in patients with coronary heart disease after coronary transcatheter therapy. Q-wave MI with the last episode of chest pain P 80mg daily. within 24 hours and with ECG changes and/or elevated cardiac enzymes. For use with aspirin and Q Under 18 years, not recommended. D Active liver disease, or unexplained, unfractionated heparin. persistent elevations in serum transaminases. P Initially 180mcg/kg by IV bolus inj., Pregnancy, lactation. followed by continuous inf. of 2mcg/kg/min. for B Monitor liver function before and up to 72 hours. If percutaneous coronary periodically during treatment; discontinue if intervention (PCI) is performed during therapy, increase in AST or ALT exceeds 3 x ULN and continue inf. for 20-24 hours post-PCI for a total persists. Caution: History of liver disease, heavy max. duration of 96 hours. alcohol consumption. Caution (measure CK levels Q Under 18 years, not recommended. before starting treatment): Renal impairment, D GI, genitourinary or other abnormal bleeding within previous 30 days. Stroke within 30 hypothyroidism, personal or familial history of hereditary muscular disorders, previous history of days or history of haemorrhagic stroke. muscular toxicity with a statin or fibrate, alcohol Intracranial disease. Major surgery or severe trauma within past 6 weeks. Thrombocytopenia, abuse, elderly (if other predisposing factors prothrombin time q1.2 times control or INR q2. present). May occur: Myopathy (rarely), myositis Severe hypertension. Severe renal or hepatic and rhabdomyolysis (very rarely); advise patients impairment. Hiistory of bleeding diathesis. to promptly report if occur; stop treatment if CK Lactation. levels q5 x ULN. If symptoms are severe and cause B Monitor patients for bleeding. Stop daily discomfort, consider discontinuation even if immediately if thrombolytic therapy or emergency CK levels Q5 x ULN. Homozygous familial cardiac surgery required or if serious bleeding hypercholesterolemia: Not recommended.

70

CIRCULATORY SYSTEM

STROKE AND VASCULAR DEATH

LUVINSTA

Actavis

2MO Statin. Fluvastatin (as Na+) 20mg, 40mg. Resp. orange/ivory or orange/yellow opaque hard cap. marked with FST and strength. 20mg-28, A10.93; 40mg-28, A12.89. S Secondary prevention of coronary events in patients with CHD and hypercholesterolaemia after percutaneous coronary intervention. P 40mg twice daily. D Active liver disease, or unexplained, persistent elevations in serum transaminases. Pregnancy, lactation. B Monitor liver function before and periodically during treatment; discontinue if increase in AST or ALT q 3 x ULN persists. Caution: History of liver disease, heavy alcohol consumption, pre-disposing factors for rhabdomyolysis (measure CK levels before starting treatment). May occur: Myopathy (rarely), myositis and rhabdomyolysis (very rarely); advise patients to promptly report if occur. Discontinue if interstitial lung disease occurs. Homozygous familial hypercholesterolemia: Not recommended. C Caution: Fibrates, niacin, colchicine, ciclosporin, warfarin and other coumarin derivatives (monitor prothrombin times), rifampicin (long-term), glibenclamide (monitor patients on 80mg/day fluvastatin), bile acid sequestrants (admin. fluvastatin at least 4 hrs after), fluconazole, phenytoin. A Headache, fatigue, dizziness, GI disorders, joint pain, insomnia.

METALYSE

Boehringer Ing.

2N Fibrinolytic. Tenecteplase 40mg (8 000 IU), 50mg (10 000 IU). Powder in vial and pre-filled syringe containing powder and solvent for soln. for inj. 40mg-1,A1184.96; 50mg-1,A1244.20. S Thrombolytic treatment of suspected MI with persistent ST elevation or recent left Bundle Branch Block within 6 hours after the onset of acute MI symptoms. P Admin. on the basis of body weight as a single IV bolus over 10 secs, max. 10,000 IU. Under 60kg, 6,000 IU; 60-70kg, 7,000 IU; 70-80kg, 8,000 IU; 80-90kg 9,000 IU; q90kg, 10,000 IU. Adjunctive therapy: Patelet inhibitors and anticoagulants should be admin. according to guidelines. Unfractionated heparin and enoxaparin have been used. Acetylsalicylic acid should be initiated as soon as possible after symptom onset and continued with lifelong treatment unless contraindicated. Q Under 18 years, not recommended. D Bleeding disorders within past 6 months, CNS damage, haemorrhagic diathesis, severe uncontrolled hypertension, major surgery within past 2 months, recent trauma of the head, cardiopulmonary resuscitation within the past 2 weeks, acute pericarditis and/or subacute bacterial endocarditis, acute pancreatitis, severe hepatic

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Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM

PROPHYLAXIS

OF

MI,

STROKE AND VASCULAR DEATH

D Hypoprothrombinaemia, haemophilia, cerebral haemorrhage, active peptic ulceration, lactation. B Not for short-term relief of pain. Renal, cardiac or hepatic impairment. May induce GI haemorrhage. Long-term use, elderly; review regularly. Caution: History of IBD, coagulation abnormalities. Hypertension, monitor. Pregnancy (avoid at term). C Avoid: Warfarin, heparin, other NSAIDs, antacids (simultaneous use). Caution: Antihypertensives, diuretics, cardiac glycosides, lithium, methotrexate, ciclosporine, tacrolimus, corticosteroids, aminoglycosides, probenecid, oral hypoglycemics, anticoagulants, antiplatelets, fibrinolytics, carbonic anhydrase inhibitors, ibuprofen. MICARDIS Boehringer Ing. A Asthma, urate kidney stones, chronic GI blood loss, tinnitus, nausea, vomiting. 2MO Angiotensin II antagonist. Telmisartan 20mg, OMACOR Solvay 40mg, 80mg. White tabs. marked 50H, 51H, 52H 2MO resp. on one side and company symbol on other. 20mg: Round. 40mg, 80mg: Oblong. 20mg-28, Polyunsaturated fatty acid. Omega-3-acid ethyl A19.16; 40mg-28, A19.16; 80mg-28, A23.14. esters 1000 mg (including EPA and DHA 840 mg). S Reduction of cardiovascular morbidity in Soft, oblong, transparent gelatin caps. containing pale yellow oil. 28, A17.56. patients with manifest atherothrombotic cardiovascular disease (history of coronary heart S Secondary prevention after MI, in disease, stroke, or peripheral arterial disease) or addition to other standard therapy. type 2 diabetes mellitus with documented target P 1 daily with food. organ damage. Q Not recommended. P 80mg once daily. Close monitoring of D Pregnancy, lactation (no data). BP recommended. B Exogenous hypertriglyceridaemia (type 1 Q Not recommended. hyperchylomicronaemia); not indicated. Hepatic D Biliary obstructive disorders, severe impairment (monitor hepatic function, especially hepatic impairment. Pregnancy, lactation. with high dosage). Patients at high risk of B Mild moderate hepatic impairment, haemorrhage. Moderate increase in bleeding time renovascular hypertension, renal impairment, may occur with high dosage (i.e. 4 cap.) kidney transplant, intravascular volume depletion C Oral anticoagulants (monitor and adjust (correct prior to admin.), RAA stimulation, primary dose). aldosteronism, aortic and mitral valve stenosis, A GI disturbances. obstructive cardiomyopathy. May cause hyperkalaemia (monitor serum K+ in at risk PENDREX Rowex patients). Contains sorbitol. Apparently less 2MO effective in black patients than other racial ACE inhibitor. Perindopril tert-butylamine 2mg, groups, ischaemic cardiopathy or CVD. C Not recommended: K+ sparing diuretics 4mg, 8mg. White, round, biconvex tablet debossed with 2, 4 or 8 on one side. 2mg-30, or K+ supplements, lithium. Caution: NSAIDs, A8.53; 4mg-30, A12.07; 8mg-30, A16.70. diuretics, heparin, immunosuppressors, S Reduction of risk of cardiac events in trimethoprim. Concomitant use to be taken into patients with a history of MI and/or account: Other antihypertensives, baclofen, revascularisation. amifostine alcohol, barbiturates, narcotics or P Initially 4mg once daily for 2 weeks, antidepressants, systemic corticosteroids. increased to 8mg depending on renal function. MONOPARIN CP Pharm. Renal impairment: See SPC. R 2mg once daily week 1, 4mg once daily 2N week 2, increased to 8mg depending on renal Anticoagulant. Heparin Na+ 25 000units/ml in WFI. function. Preservative-free, single dose amps. 10 x 0.2ml (5 Q Not recommended. 000 IU), price on request. D History of angioedema associated with MULTIPARIN Pinewood previous ACE inhibitor therapy. Hereditary or idiopathic angioedema. Pregnancy, lactation. 2N B If unstable angina pectoris occurs in 1st Anticoagulant. Heparin Na+ 1000, 5000 units/ml in month, reappraise benefit/risk before continuing WFI. Multidose vials. 10 x 5ml, prices on request. treatment. Volume depletion, symptomatic HF may cause symptomatic hypotension. Caution: NU-SEALS 75 Alliance Mitral valve stenosis, aortic stenosis, hypertrophic 2MO cardiomyopathy, collagen vascular disease, Salicylate. Aspirin 75mg. White ent-ctd tab. immunosuppressant therapy, treatment with marked with strength. 28, A1.90; 56, A3.81. allopurinol or procainamide, diabetes. Renal S Prevention of secondary MI. impairment: Adjust dosage according to cc and Antithrombotic in patients with unstable angina response to treatment. Anaphylactoid reactions or ischaemic stroke. may occur during dialysis with high flux P Acute: 2 tabs chewed. Maintenance: 1 membrane or low-density lipoproteins apheresis tab. daily. with dextran sulphate. Discontinue if angioedema Q Not recommended. occurs. May occur: Hepatic syndrome, neutropenia/ dysfunction, active peptic ulceration, arterial aneurysm, neoplasm with increased bleeding risk, history of dementia. History of haemorrhagic stroke or stroke of unknown origin; or of ischaemic stroke/TIA in the preceding 6 months. B Bleeding, systolic BP q160mmHg, cerebrovascular disease, recent GI or genitourinary bleeding, left heart thrombus, elderly over 75 years, low body weight, arrhythmias. Primary percutaneous coronary intervention (metalyse should not be given). A Reperfusion arrhythmias, bleeding, epistaxis, GI haemorrhage, nausea, vomiting, ecchymosis, urogenital haemorrhage, superficial bleeding, decreased BP, increased body temperature.

2.6

agranulocytosis, thrombocytopenia, anaemia, persistent non-productive cough, elevation in serum K+. Discontinue 1 day prior to surgery. C Avoid: Diuretics, K+ sparing diuretics, K+containing salt substitutes, K+ supplements, lithium. Caution: NSAIDs, other antihypertensives and vasodilators, antidiabetics, TCAs, antipsychotics, anaesthetics, sympathomimetics, antacids. A Headache, dizziness, vertigo, paresthaesia, vision disturbance, tinnitus, hypotension and related effects, cough, dyspnoea, GI disturbances, rash, pruritus, asthenia.

PERSANTIN RETARD

Boehringer Ing.

2MO Antiplatelet. Dipyridamole 200mg. Red/orange modified release hard gelatin cap. containing yellow pellets. 60, A12.80. S Secondary prevention of ischaemic stroke and transient ischaemic attacks either alone or in conjunction with aspirin. Adjunct to oral anti-coagulation for prophylaxis of thromboembolism associated with prosthetic heart valves. P 1 twice daily with meals. Caps. should be swallowed whole without chewing. Q Not recommended. D Acute hypotension, particularly after MI. B Severe coronary artery disease (unstable angina, recent MI, LV outflow obstruction, haemodynamic instability), myasthenia gravis, coagulation disorders. Pregnancy, lactation. C Adenosine, oral anticoagulants, hypotensive agents, cholinesterase inhibitors. A GI disturbances, dizziness, nausea, headache, myalgia, hypotension, hot flushes, tachycardia, hypersensitivity reactions (rash, urticaria, bronchospasm).

PLAVIX

sanofi-aventis/BMS

2MO Antiplatelet. Clopidogrel (hydrogen sulphate) 75mg, 300mg. Pink film-ctd tabs. 75mg round marked 75 and 1171. 300mg oblong marked 300 and 1332. 75mg-28, A45.54 (GMS); 300mg-30, A202.48 (not GMS). S Prevention of atherothrombotic events in patients suffering from MI (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. In combination with aspirin in non-ST segment elevation acute coronary syndrome (unstable angina or non-Q wave MI) and ST segment elevation acute MI (STEMI) in medically treated patients eligle for thrombolytic therapy. P 75mg daily. Non-ST segment elevation acute coronary syndrome: 300mg followed by 75mg daily given in combination with 75-100mg aspirin daily. STEMI: 300mg followed by 75mg daily in combination with aspirin +/- thrombolytics (no loading dose in patients q75 years). Q Under 18 years, not recommended. D Severe liver impairment, active bleeding (peptic ulcer or intracranial haemorrhage). Pregnancy, lactation (no data). B Not recommended: Acute ischaemic stroke (within 7 days). Caution: Renal impairment, moderate hepatic impairment in patients with bleeding diatheses. Risk of bleeding (caution: Trauma, GI or intraocular lesions with propensity to bleed, surgery); discontinue 7 days prior to elective surgery; warn patients to report unusual

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

71


2.6 PROPHYLAXIS

OF

MI,

Impaired liver function, volume- and salt-depletion (symptomatic hypotension risk), anaesthesia, surgery. May occur rarely: Agranulocytosis and bone marrow depression, reduction in red cell count, haemoglobin content and platelet count, hyperkalaemia, hyperkalaemia (hypertensive patients), angioneurotic oedema. Avoid haemodialysis using high flux polyacrylonitrile membranes and low-density lipoprotein apheresis with dextran sulphate. C Caution: Antidiabetics, NSAIDs. PRINDACE Clonmel A Nausea, dizziness, headache, symptomatic hypotension, MI, cerebrovascular 2MO accident, chest pain, palpitations, rhythm ACE inhibitor. Perindopril tert-butylamine 4mg, disturbances, angina pectoris, impaired renal 8mg. 4mg-30, A7.24; 8mg-30, A11.56. function, GI disorders, hypersensitivity reactions, S Reduction of risk of cardiac events in cutaneous and mucosal reactions, vasculitis, muscle patients with history of MI and/or and joint pains, fever or eosinophilia, dry tickling revascularisation. P Initially, 4mg once daily for two weeks, cough, disturbances of balance, nervousness, restlessness, terror, sleep disorders, confusion, loss if tolerated then increase to 8mg once daily of appetite, depressed mood, feeling of anxiety, depending on renal function. Renal impairment, paraesthesiae, taste change/reduction/loss, muscle see SPC. cramps, erectile impotence, reduced sexual desire, R Initially 2mg once daily for one week, increased blood urea nitrogen and serum then 4mg once daily the next week, before creatinine, deterioration of pre-existing increasing up to 8mg once daily depending on proteinuria. renal function. Q Under 18 years, not recommended. RAPILYSIN Actavis D Angioedema. Pregnancy, lactation. 2N B Increased risk of symptomatic Fibrinolytic. Reteplase 10 units. Powder in vial. 1 hypotension eg. salt depletion, hypovolaemia, pack-(2 vials, 2x10ml WFI, 2 transfer devices, 2 diuretics; correct, if possible, prior to therapy. + needles), A1163.08. Monitor BP, renal function, serum K closely, S Acute myocardial infarction. before and during treatment. Hyperkalemia, P Two x 10 unit bolus inj.s 30 mins. apart, increases in blood urea and plasma creatinine. each by slow IV inj. over max. 2 mins. within 12 Caution: Mitral valve stenosis, obstruction in the hrs of MI. See SPC. outflow of left ventricle, diabetes. LDL apheresis. Q Not recommended. Jaundice, angioedema (facial/ intestinal) reported rarely; discontinue promptly. Discontinue one day D Haemorrhagic diathesis, intracranial neoplasm, arteriovenous malformation or prior to surgery. Contains lactose. aneurysm, CVA, within 10 days of external heart C Lithium, K+ supplements (not recommended), diuretics. Caution: NSAIDs, massage, uncontrolled hypertension, active peptic antihypertensives, vasodilators, antidiabetics, ulceration, portal hypertension, severe renal or anaesthetics, TCAs, antipsychotics, liver dysfunction, acute pancreatitis, pericarditis, sympathomimetics, injectable gold. bacterial endocarditis, within 3 months of severe A Hypotension, headache, dizziness, bleeding, surgery or major trauma, neoplasm with vertigo, paraesthesia, vision disturbance, tinnitus, increased bleeding risk, pregnancy, lactation. cough, dyspnoea, GI disorders, dysgeusia, B Cerebrovascular disease, systolic BP dyspepsia, rash, pruritus, muscle cramps, asthenia. above 160mmHg, recent GI or genito-urinary bleeding, increased risk of left heart thrombus, RAMYTE Actavis septic thrombophlebitis or occluded arteriovenous cannula, increased risk of bleeding. Elderly. 2MO C Anticoagulants, drugs affecting platelet ACE inhibitor Ramipril 2.5mg, 5mg, 10mg. Size 4 function, Vit. K antagonists, heparin. hard cap. containing white powder, with light A Haemorrhage, arrhythmias, grey body and resp. light green, green or dark hypotension, recurrent angina, heart failure. green cap, marked R on cap and strength on body. 2.5mg-28, A5.76; 5mg-28, A8.02; 10mg-28, REFLUDAN Pharmion A10.92. 2N S Prevention of MI, stroke or Recombinant DNA anticoagulant. Lepirudin 50mg. cardiovascular death in patients with increased Powder in vial for soln. 10 x 50mg. Price on cardiovascular risk, already taking standard request. therapy and in type 2 diabetic patients with S Heparin-induced thrombocytopenia increased cardiovascular risk. P Initially, 2.5mg once daily. Double dose (HIT) type II and thromboembolic diseases requiring antithrombotic therapy. after 1 week, after 3 further weeks increase to P Initially 0.4mg/kg body weight followed 10mg. Maintenance: 10mg daily. Renal/hepatic by 0.15mg/kg body weight per hour as continuous impairment, see SPC. IV inf. for 2-10 days. See SPC. R Caution. Q Not recommended. D History of angioneurotic oedema D Pregnancy, lactation. Recent puncture relating to previous ACE inhibitor treatment. of large vessels, organ biopsy, cardiovascular Pregnancy, lactation. Use in children. accident, recent major surgery, overt signs of B Aortic stenosis or outlaw obstruction bleeding, uncontrolled hypertension or bacterial (not recommended). Renal impairment risk (dosage reduction and/or discontinue); assess renal endocarditis. B Renal insufficiency. Monitor APTT levels function prior to and during treatment. Caution: bleeding. Thrombotic Thrombocytopenic Purpura reported rarely. CYP2C19 poor metaboliser status (diminished response). Contains lactose, hydrogenated castor oil. C Not recommended: Oral anticoagulants, CYP2C19 inhibitors, PPIs. Caution: Glycoprotein IIb/ IIIa inhibitors, aspirin, heparin, thrombolytics, NSAIDs. A GI Bleeding, bleeding at puncture site, bruising, haematoma, epistaxis, GI disturbances.

72

CIRCULATORY SYSTEM

STROKE AND VASCULAR DEATH

during prolonged therapy. C Thrombolytics. A Bleeding at puncture site, epistaxis, GI bleeding, haematoma, anaemia, allergic reactions, fever, kidney failure.

REOPRO

Lilly

2N Antiplatelet. Abciximab 2mg per ml. Colourless and clear soln in vial. 10mg/5ml-1, A352.07. S Adjunct to heparin and acetylsalicylic acid for the prevention of ischaemic cardiac complications in patients undergoing percutaneous coronary intervention (balloon angioplasty, atherectomy, and stent). Adjunct to heparin and acetylsalicylic acid for short-term (1month) reduction of MI risk, in patients with unstable angina, not responding to full conventional therapy who have been scheduled for percutaneous coronary intervention. P 0.25mg/kg by bolus IV 10-60 mins. prior to PTCA and immediately followed by a 0.12510mcg/min. continuous IV inf. for 12 hours. Angina patients, start up to 24hours prior to PTCA, Admin. oral acetylsalicylic acid at least 300mg daily. Admin. heparin in a low-dose weight adjusted regimen; see SPC. Q Not recommended. D Hypersensitivity to murine monoclonal antibodies or to papain (may contain traces). Active internal bleeding, cerebrovascular accident within 2 years, recent intracranial or intraspinal surgery or trauma, recent major surgery, intracranial neoplasm, arteriovenous malformation or aneurysm, bleeding diathesis, severe uncontrolled hypertension, thrombocytopenia, vasculitis, hypertensive retinopathy, severe hepatic failure, severe renal failure (requiring haemodialysis). Pregnancy, lactation. B Identify pre-existing coagulation abnormalities before treatment (measure platelet count, ACT, prothrombin time, APTT). Risk of anaphylaxis; cardio-pulmonary resuscitation facilities must be available. Perform full blood tests and platelet counts before and after therapy; transfuse platelets if count drops below 50,000 cells/mcl. Careful attention to potential bleeding sites; minimise venous sheaths use, only puncture anterior wall of artery/vein when establishing vascular access. Pretreat with H2 antagonist to prevent GI bleeding. Pulmonary haemorrhage may occur rarely. Discontinue if serious uncontrolled bleeding occurs or if emergency surgery needed. Renal/ peripheral vascular disease. See SPC. C Additive effect with thrombolytics. A Thrombocytopenia, bradycardia, nausea, vomiting, chest pain, pyrexia, puncture site pain, back pain, headache, bleeding; hypotension.

WARFANT

Antigen

2MO Coumarin anticoagulant. Warfarin Na+ 1mg brown scored tab. 3mg blue scored tab. 5mg pink scored tab. Marked W1, W3 or W5. 1mg-100, A3.09; 3mg-100, A5.03; 5mg-100, A7.11. S Prophylaxis against venous thrombosis and pulmonary embolism and treatment of these conditions to prevent their extension. Prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation. V See lit. D Pregnancy. Within 3 days of surgery. B Avoid abrupt withdrawal. Monitor prothrombin times. Renal or hepatic impairment,

2

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Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM

HAEMORRHAGE 2.7

severe hypertension. Elderly. Patients at risk of serious haemorrhage. Warfarin resistance (suspect if unusually large dose required). See SPC. C Alcohol, aspirin, NSAIDs, oral hypoglycaemics, cimetidine. Other drugs and remedies (e.g. St John’s Wort). See SPC. A Bleeding, skin rashes,purpura, ecchymosis, skin necrosis, alopecia, diarrhoea, fall in haematocrit, jaundice, liver dysfunction, fever, nausea, vomiting, pancreatitis, hypersensitivity reactions. See SPC.

WARFARIN TEVA

Teva

2MO Coumarin anticoagulant. Warfarin (Na+) 1mg, 3mg. 5mg Brown, blue, pink flat, caps. shaped scored tabs with WARFARIN on top of TARO marked on one side and 1, 3, 5 on reverse, resp. Score line only to facilitate swallowing; not to divide into equal doses. 1mg-100, A2.96; 3mg-100, A4.83; 5mg-100, A6.83. S Prophylaxis of venous thrombosis and pulmonary embolism, and for use in the treatment of these conditions to prevent their extension. Prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation. P Initially, 10mg daily for 2 days; then adjust according to results of prothrombin time, usually reported as the INR. Daily maintenance, usually 3-9mg at same time each day. Q Not recommended. D Pregnancy. Within 3 days of surgery. B Perform baseline coagulation screen and liver function before therapy. Monitor prothrombin times. Renal or hepatic impairment, severe hypertension, cerebrovascular disease, HF, elderly, patients at risk of serious haemorrhage (see SPC). Warfarin resistance. Skin necrosis reported. Withdraw gradually. C Contra: St John’s Wort. Caution: Alcohol, aspirin, NSAIDs, cimetidine, other drugs and remedies (see SPC). A Bleeding, purpura, ecchymosis, rashes.

ZIBOR

Helsinn Birex

2NO Antithrombotic. Bemiparin Na+ 2500 IU anti Factor Xa/0.2ml, 3500 IU anti Factor Xa/0.2ml. Soln for inj. in pre-filled syringe. 10 syringes/pack. 2500 IU, A17.72; 3500 IU, A30.23. S Prevention of thromboembolic disease in patients undergoing general and orthopaedic surgery. Prevention of clotting in the extracorporeal circuit during haemodialysis. P General surgery: Admin. 2,500 IU by SC inj., 2 hours before or 6 hours after surgery. On subsequent days admin. 2,500 IU by SC inj. every 24 hours for at least 7-10 days. Orthopaedic surgery: Admin. 3,500 IU by SC inj., 2 hours before or 6 hours after surgery. On subsequent days admin. 3,500 IU by SC inj. every 24 hours for at least 7-10 days. Prevention of clotting in the extracorporeal circuit during haemodialysis (R4 hours): Single bolus inj. into the arterial line at the beginning of the dialysis session. Patients R60kg: 2,500 IU, patients r60kg: 3,500 IU. Q Not recommended.

2NO ALSO ZIBOR 25000 Bemiparin Na+ 25000 IU anti Factor Xa/ml. 10 syringes/per pack. 5000 IU/0.2ml, A60.39; 7500 IU/0.3ml, A80.82; 10000 IU/0.4ml, A108.75. S Treatment of established deep vein

thrombosis, with or without pulmonary embolism, during the acute phase. P DVT: Admin. 25,000 IU by the SC route at a dose of 115 IU anti-Xa/kg weight, once daily. Duration of treatment: 7 +/- 2 days. Commence oral anticoagulation after 3-5 days and adjust dose to keep INR value between 2-3 times the control value. Stop Bemiparin admin. as soon as the said INR value achieved. Continue oral anticoagulation for at least 3 months. Q Not recommended. D Hypersensitivity to heparin or substances derived from pigs. Heparin induced thrombocytopenia (or history of). Active haemorrhage or increased risk of bleeding. Severe liver/pancreas impairment. Injuries to and operations on the CNS, eyes and ears. Disseminated Intravascular Coagulation (DIC). Acute bacterial endocarditis and endocarditis lenta. Organic lesion with high risk of bleeding. Lactation. B Do not admin. by IM and avoid IM injection of other agents. Liver/renal failure, uncontrolled arterial hypertension, history of gastro-duodenal ulcer disease, thrombocytopenia, nephrolithiasis and/or urethrolithiasis, choroid and retinal vascular disease, or any other organic lesion with an increased risk of bleeding complications. Patients undergoing spinal or epidural anaesthesia and/or lumbar puncture (prophylactic use of heparin may very rarely be associated with epidural or spinal haematoma). May cause hyperkalaemia, particularly in at risk patients. In rare cases antibody-mediated severe thrombocytopenia has been observed. Perform platelet counts before admin., day 1, regularly thereafter (3-4 days) and at the end of therapy. Cutaneous necrosis, has been reported (discontinue immediately if occurs). Pregnancy. C Not recommended: Vitamin K antagonists and other anticoagulants, acetyl salicylic acid and other salicylates, NSAIDs, ticlopidine, clopidogrel and other platelet inhibitors systemic glucocorticoids and dextran. Products that increase the serum potassium (use under careful medical supervision). Intravenous nitroglycerine. A Ecchymosis at inj. site, haematoma and pain at injection site, bleeding complications, mild and transient elevations of ASAT, ALAT and gamma-GT levels.

2.7 HAEMORRHAGE

BENEFIX 2JN

patients post-operatively, neonates, or patients at risk of thrombotic phenomena or DIC. If agglutination of RBCs in the tubing/syringe occurs, discard and resume with new package. Use for immune tolerance induction (safety and efficacy has not been demonstrated). Pregnancy, lactation (only if clearly indicated).

CYKLOKAPRON

Meda

2MO Antifibrinolytic. Tranexamic acid 500mg. White oblong scored film-ctd tab. marked CY. 60, A15.04. S Short term use in haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Bleeding from local fibrinolysis e.g. menorrhagia, epistaxis, dental extractions in haemophiliacs. P Menorrhagia: 2-3 tabs. 3-4 times daily for 3-4 days. For other indications See SPC. Q 25mg/kg/dose. D Thromboembolic disease. B Early pregnancy. Impaired renal function. Haematuria in haemophilia. History of thromboembolic disease. Perform regular eye tests in patients with angioneurotic oedema. Rapid IV infusion may cause dizziness and/or hypertension. A GI upset. Colour vision disturbance.

CYKLOKAPRON INJECTION

Pfizer

2NO

Antifibrinolytic. Tranexamic acid 100mg/ml; 500mg/5ml. Soln for inj or inf. 10 x 5ml amp, A15.67; 30 x 5ml amp, A18.10. S Short term management of haemorrhage or risk of haemorrhage in increased fibrinolysis of fibrinogenolysis. Haemorrhage complications associated with: 1) Thrombolytic therapy. 2) disseminated intravascular coagulation (DIC) with predominant activation of fibrinolytic system. P Upper GI haemorrhage: 1g by IV inj 6 hourly for 3 days, then 1-1.5g orally 6 hourly for 3-4 days. Prostatectomey: 1g by IV inf. 8 hourly for 3 days; then 1g 3-4 times daily until macroscopic haematuria no longer present. Neutralisation of thrombolytic therapy: 10mg/kg by IV inj. DIC: See SPC. Renal Impairment: Reduce dose, see SPC. Q 25mg/kg/dose. D Thromboembolic disease, subarachnoid haemorrhage. B Caution: Haematuria of the urinary tract. Patients with high risk of thrombosis. Wyeth Pregnancy (unless essential), lactation. A Nausea, vomiting, diarrhea.

Recombinant coagulation factor IX. Nonacog alfa with antihaemophilic factor activities of 250 IU, 500 IU, 1000 IU Powder and solvent for soln for inj. 250 IU-1; 500 IU-1; 1000 IU-1. Price on request. S Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). V Admin. by IV inf. according to severity of factor IX deficiency, the location and extent of bleeding, and patient’s clinical condition. See SPC for dose calculations. B Monitor for factor IX inhibitors in previously treated patients and patients experiencing allergic reactions. Potentially lifethreatening anaphylactic/anaphylactoid reactions may occur. Monitor patients with major factor IX gene deletion mutations. Admin. initial inf. under medical observation. Risk of thrombotic complications: Monitor patients with liver disease,

DDAVP DESMOPRESSIN

Ferring

2JN Vasopressin analogue. Desmopressin acetate 4mcg/ ml. Amp. 10 x 1ml, A134.12. S In the control of bleeding in patients with mild to moderate haemophilia and von Willebrand’s disease undergoing surgery or following trauma. V 0.4mcg/kg body weight by IV inf. Dose should be diluted in 50ml of 0.9% sodium chloride for inj. and given over 20 mins. immediately prior to surgery or following trauma. Further doses may be admin. at 12 hour intervals, as long as cover is PRESCRIBING NOTES INFUSIONS Intravenous infusions are prohibited except for those legitimately received in the course of hospital admissions or clinical investigations.

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

73


2.8 HYPERCHOLESTEROLAEMIA -

CIRCULATORY SYSTEM

LIPIDAEMIC

platelet count r 50 x 109/l. Assess weekly until stable (r 50 x 109/l for at least 4 weeks without dose adjustment) then monthly thereafter. Max. 10mcg/kg once weekly. Dose adjustment: See SPC. D Pregnancy (unless clearly necessary). Lactation (assess risk/benefit). B Renal / hepatic impairment, elderly. Increased risk of bleeding upon discontinuation. Increased bone marrow reticulin (assess morphological changes in blood cells). Do not use for treatment of thrombocytopenia due to MDS or any other cause other than ITP. Theoretical risk for thrombotic/ thromboembolic complications and loss of response to romiplostim. Alterations in blood cell parameters. C Caution: Other drugs for treatment of KOGENATE BAYER Bayer Schering ITP (monitor), corticosteroids, danazol, and azathioprine. 2N Recombinant coagulation Factor VIII (rDNA) (bhk). A Headache, dizziness, paraesthesia, Octocog alfa with antihaemophilic factor activities migraine, GI disorders, skin disorders, pulmonary embolism, flushing, insomnia. Bone marrow of 250 IU, 500 IU, 1000 IU. Powder in single-dose vial with self contained, needle-less reconstitution disorders, thrombocytopenia. Arthralgia, myalgia, pain (extremity, back, bone), muscle spasm. device (BIO-SET). 250 IU-1, A272.50; 500 IU-1, Fatigue, inj. site reactions, oedema peripheral, A545.00; 1000 IU-1, A1090.00. influenza like illness, pain, asthenia, pyrexia, chills, S Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital Factor contusion. VIII deficiency). 2.8 HYPERCHOLESTEROLAEMIA V Admin. by IV inj (max 2ml/min) or by continuous inf. according to body weight, severity LIPIDAEMIC of disorder, site and extent of bleeding, titre of BELLPRAV Ranbaxy inhibitors and factor VIII level desired. See SPC. 2MO D Hypersensitivity to mouse or hamster protein. As Kogenate does not contain von Statin. Pravastatin (Na+) 10mg, 20mg, 40mg. Dark Willebrand Factor, not for use in von Willebrand yellow to yellow coloured mottled, circular, disease. biconvex tabs. marked with P1, P2 and P3 resp. on B Hypersensitivity and anaphylactic shock. one side. 20mg and 40mg with breakline on Monitor for the formation of neutralising reverse. 10mg-30, A13.03; 20mg-30, A25.13; antibodies to factor VIII. Pregnancy, lactation (only 40mg-30, A31.54. if clearly indicated). S Primary hypercholesterolemia (HC) or mixed dyslipidaemia, as adjunct to diet, when KONAKION Roche response to diet inadequate. Moderate or severe 2NO HC in patients at high risk of 1rst cardiovascular Vit. K deriv. Phytomenadione 10mg/ml. Amps. 10, event, as adjunct to diet. History of MI or unstable A4.76. angina pectoris with either normal or increased cholesterol levels as an adjunct to correction of S Treatment of haemorrhage. P 10-20mg as required. other risk factors. Post transplantation 2NO hyperlipidaemia in patients receiving immunossuppressive therapy following solid organ ALSO KONAKION MM PAED. Phytomenadione transplantation. 2mg per 0.2ml in mixed micelles. Amp. 5, A5.41. P HC: 10-40mg once daily preferably in S Prophylaxis and treatment of the evening. Full effect within 4 weeks. Max. haemorrhagic disease of the new born. Q Prophylaxis: initially 2mg orally at birth, 40mg daily. Cardiovascular prevention: 40mg daily. Post transplantation: Initially 20mg a day; can be then 2mg at 4-7 days. In exclusively breast-fed babies a further 2mg oral dose should be given at adjusted up to 40mg. Significant hepatic/renal impairment: Initially 10mg daily. 1 month. Monthly 2mg oral doses are advised until formula fed. Treatment: initially 1mg IV and Q Under 18 years, not recommended. further doses as required; see SPC. Preterm and D Pregnancy, lactation. Active liver special risk neonates; see SPC. disease. A Anaphylactoid reactions may occur with B Renal/hepatic impairment, inj. Flushes, sweating, cyanosis. hypothyroidism, history of hereditary muscular disorders, alcohol abuse, elderly q70. Discontinue NPLATE Amgen if liver enzymes q3x ULN. Risk of myalgia/ myopathy; monitor creatine kinase (CK) if ;JM predisposing factors or if symptoms occur Antihemorrhagic. Romiplostim 250mcg. Powder (interrupt if CK levels q 5xULN). Contains lactose. for sln for inj. in vial. A708.82. C Fibrates (avoid). Bile acid-binding resin S Adult chronic immune (idiopathic) eg. cholestyramine, colestipol (take 1 hr before or thrombocytopenic purpura (ITP) splenectomised 4 hrs after resin). Caution: Ciclosporin, patients who are refractory to other treatments (e.g. corticosteroids, Igs). Second line treatment for erythromycin, clarithromycin, nicotinic acid. adult non-splenectomised patients where surgery BYSTAT Helsinn Birex is contraindicated. P Once weekly as SC inj. Initially, 1mcg/kg 2 M O Statin. Pravastatin (Na+) 10mg, 20mg, 40mg. Pink, body weight. Vol. inj. (ml): Dose in mcg x 1ml/ light yellow, light green tabs. marked 771, 7201, 500mcg. Increase by increments of 1mcg/kg until

required. D Habitual and psychogenic polydipsia, unstable angina pectoris, decompensated cardiac insufficiency, von Willebrandâ&#x20AC;&#x2122;s disease Type IIB. B Renal impairment, CVD, fluid and/or electrolyte imbalance, cystic firbosis. Pregnancy. Avoid fluid overload. C Indomethacin, NSAIDs, substances suspected to induce SIADH (e.g. TCAs, SSRIs, chlorpromazine, carbamazepine). A Headache, stomach pain and nausea, fluid retention/hyponatraemia with accompanying symptoms (headache, nausea, vomiting, weight gain, decreased serum Na+ and in serious cases, convulsions).

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7202 resp. on one side. All round shallow convex, marked 93 on reverse. 10mg-30, A7.80; 20mg-30, 40mg-30, A18.76. S Primary hypercholesterolemia (HC) or mixed dyslipidaemia, as adjunct to diet, when response to diet inadequate. Moderate or severe HC in patients at high risk of 1rst cardiovascular event, as adjunct to diet. History of MI or unstable angina pectoris in patients with normal or increased cholesterol levels, as adjunct to correction of other risk factors. Post transplantation hyperlipidaemia in patients receiving immunossuppressive therapy following solid organ transplantation. P HC: 10-40mg once daily preferably in the evening. Full effect within 4 weeks. Max. 40 mg daily. Cardiovascular prevention: 40mg daily. Post transplantation: Initially 20mg a day; can be adjusted up to 40mg. Q Heterozygous familial HC: 8-13 years, 10-20mg once daily; 14-18 years, 10-40mg daily. D Pregnancy and lactation. Active liver disease. B Renal/hepatic impairment, hypothyroidism, history of hereditary muscular disorders or liver disease, alcohol abuse, children before puberty. Discontinue if liver enzymes q3x ULN. Risk of myalgia/myopathy; monitor creatine kinase (CK) if predisposing factors or if symptoms occur (discontinue if CK levels q 5xULN). Contains lactose. C Fibrates (avoid). Caution: Cholestyramine (take 1 hr before or 4 hrs after resin), colestipol, cyclosporin, erythromycin, clarithromycin, nicotinic acid. A14.99;

CRESTOR

AstraZeneca

2NO Statin. Rosuvastatin (Ca++) 5mg, 10mg, 20mg, 40mg. Film-ctd tabs. marked ZD 4522 and strength. 5mg, round yellow. 10mg, 20mg, round pink. 40mg, oval pink. 5mg-28, A18.22; 10mg-28, A22.41; 20mg-28, A36.56; 40mg-28, A37.56. S Primary hypercholesterolaemia (HC) incl. heterozygous familial HC, homozygous familial HC, or mixed dyslipidaemia in patients unresponsive to diet and other nonpharmacological measures. P Initially 5mg or 10mg once daily (incl. patients switched from other statins). Starting dose of 5mg recommended for: Patients q70 years, moderate renal impairment, Asian ancestry, predisposing factors to myopathy. If necessary, increase to next dose level after 4 weeks. Max. 40mg daily (only in severe HC at high cardiovascular risk, under specialist supervision). Q Not recommended. D Active liver disease or unexplained persistent elevation in serum transaminases, severe renal impairment, myopathy. Pregnancy, lactation. Women of childbearing potential not using contraception. 40mg dose: Pre-disposing factors for myopathy/ rhabdomyolysis (eg. moderate renal impairment, hypothyroidism, history of hereditary muscular disorders, alcohol abuse, Asian patients, concomitant fibrates). B History of liver disease, alcoholism, predisposing factors for myopathy/rhabdomyolysis; caution. Perform liver function tests prior to and 3

2

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Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM

HYPERCHOLESTEROLAEMIA -

B Increased risk of myopathy. Measure CK level before starting treatment in: Elderly (q70 years), renal impairment, uncontrolled hypothyroidism, personal or familial history of hereditary muscular disorders, previous history of muscular toxicity with a statin or fibrate, alcohol abuse. If CK levels q5xULN, do not start treatment. If muscular symptoms occur measure CK levels and discontinue if found q5xULN. If muscular symptoms severe even if CK levels Q5xULN, consider discontinuation. Moderate or severe hepatic insufficiency (not recommended). Severe renal insufficiency (caution). EZETROL MSD-SP Ltd C Potent CYP3A4 inhibitors (contraindicated), fibrates, amiodarone or 2MO Cholesterol absorption inhibitor. Ezetimibe 10mg. verapamil, grapefruit juice. Caution: Ciclosporin, danazol, gemfibrozil, niacin, diltiazem, White cap.-shaped tabs. marked 414 on one side. cholestyramine, fusidic acid, coumarin 28, A33.60 anticoagulants, fluindione. S Adjunctive therapy to diet for: Primary A GI disorders, headache, myalgia, fatigue. (heterozygous familial and non-familial) hypercholesterolaemia, as combination therapy Novartis with statin where statin alone is ineffective, or as LESCOL XL 2MO monotherapy where statin is inappropriate; homozygous familial hypercholesterolaemia as Statin. Fluvastatin (as Na+) 80mg. Yellow combination therapy with statin with or without prolonged release tab. marked LE one side, NVR on reverse. 28 (Cal/Pk), A10.91. adjunctive treatments (e.g. LDL apheresis); 2MO homozygous sitosterolaemia (phytosterolaemia). P 10mg daily with or without food. CoALSO LESCOL Fluvastatin (as Na+) 20mg, 40mg. admin. with statin: Use usual initial statin dose, or Brown/yellow caps. marked with XU, strength and continue established higher statin dose. company logo. 20mg-28 (Cal/Pk), A14.55; 40mg-28 Q 10 years or under, not recommended. (Cal/Pk). A17.16; 40mg-56 (Cal/Pk), A32.15. D When co-admin. with statin: Pregnancy, S Adjunct to diet for the reduction of lactation, active liver disease or unexplained elevated total and LDL cholesterol in patients with persistent elevations in serum transaminases. primary hypercholesterolaemia (HC) and mixed B Moderate or severe liver dysfunction dyslipidaemia (Frederickson Types IIa and IIb). (not recommended). Perform liver function tests P 40mg or 80mg once daily at night when starting co-admin. with statin. Monitor for swallowed whole with water with or after meal. signs of myopathy. Lactation (not recommended), Titrate to lowest effective dose at 4-week pregnancy (no data). Contain lactose. intervals. Range, 20-80mg. C Fibrates, possible risk of cholelithiasis Q Over 9 years with familial HC: Initially and gallbladder disease. Caution: Ciclosporin, 40mg once daily; titrate to 80mg if necessary; coumarin anticoagulants or fluindione (monitor 20mg may be adequate in mild cases. Under 9 International Normalised Ratio). Bile acid years: Not recommended. sequestrant (e.g. cholestyramine), admin. at least 4 D Active liver disease or persistent hrs before or 2 hrs after ezetimibe. unexplained elevation of transaminase levels, A Headache, GI disorders. Also fatigue cholestasis. Myopathic disorders. Caution if history and myalgia when co-admin. with statin. of liver disease, high alcohol consumption. Pregnancy, lactation. INEGY MSD-SP Ltd B Monitor serum transaminase levels before and periodically during treatment. Severe 2MO renal impairment. Unexplained diffuse myalgias, Cholesterol absorption inhibitor/statin. Ezetimibe muscle tenderness, muscle weakness and/or 10mg and simvastatin 20mg, 40mg, 80mg. White to off-white cap.-shaped tab. with code 312, 313, marked elevated creatine phosphokinase (CPK) or 315. 10/20mg-28, A42.00; 10/40mg-28, A49.00; values due to myopathy, myositis or rhabdomyolysis; discontinue. 10/80mg-28, A51.80. S As adjunctive therapy to diet in primary C Cholestyramine (admin. min. 4 hrs before Lescol). Caution: Rifampicin, warfarin, hypercholesterolaemia (HC) or mixed immunosuppressants (incl. cyclosporin), hyperlipidaemia in patients not appropriately gemfibrozil, nicotinic acid, erythromycin, controlled with a statin alone, or already treated glibenclamide. with a statin and ezetimibe. A Dyspepsia, abdominal pain, nausea, P 10/20mg/day or 10/40mg/day as single insomnia, headache. dose in the evening. 10/80mg dose only

months after start of treatment. Reduce doses or discontinue if levels of serum transaminases q 3 x upper limit of normal. Monitor renal function with 40mg dose. Stevens-Johnson syndrome has been reported. Contains lactose. C Contra: Cyclosporin. Not recommended: Protease inhibitors. Gemfibrozil, other lipidlowering agents, vit. K antagonists, antacids, erythromycin, oral contraceptives, HRT. 40mg dose: Fibrates (contra). A Headache, dizziness, constipation, nausea, abdominal pain, myalgia, asthenia.

recommended in severe HC and high risk for cardiovascular complications. Make any adjustments at min. 4-week intervals. Homozygous Familial HC: 10/40mg/day or 10/80mg/day in the evening. May be used as adjunct to other lipidlowering treatments (e.g., LDL apheresis). Coadmin. with other drugs: See SPC. Q Children and adolescents, not recommended. D Pregnancy and lactation. Liver disease or unexplained persistent elevations in serum transaminases.

LIPIDAEMIC

2.8

phototoxic reactions with fibrates or ketoprofen. Pregnancy, lactation. B Renal impairment. Monitor serum transaminase every 3 months during first 12 months of treatment. Pancreatitis has been reported. Patients with pre-disposing factors for rhabdomyolysis. Discontinue if muscle toxicity occurs. Hyperlipidaemic patients taking oestrogens, determine if primary or secondary hyperlipidaemia. C Caution: Anti-coagulants, cyclosporin, HMG-CoA reductase inhibitors or other fibrates. A GI upset, skin reactions, headache, fatigue, vertigo,

LIPANTIL SUPRA

Solvay

2MO Fibrate. Fenofibrate (nanoparticles) 145mg. White, oblong, film-ctd tab. engraved 145 on one side and Fournier logo on the other. 30, A19.50. S Hypercholesterolaemia and hypertriglyceridaemia alone or combined in patients unresponsive to dietary and other nondrug therapeutic measures, particularly when evidence of associated risk e.g. hypertension, smoking. Secondary hyperlipoproteinaemias, if hyperlipoproteinaemia persists despite effective treatment of underlying disease. Appropriate dietary measures initiated before therapy should be continued. P 1 tab, once daily, swallowed whole with water. Renal impairment: Lower dose recommended, 100mg or 67mg. Q Contra. D Hepatic/renal insufficiency, children, known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen, gallbladder disease. Peanut, arachis oil, soya allergy. Pregnancy, lactation. B Treat secondary cause of hypercholesterolemia before initiating therapy. Hyperlipidaemic patients taking oestrogens, determine if primary or secondary hyperlipidaemia. Monitor transaminase levels every 3 months for 1st year. Pancreatitis, reported. Risk of muscle toxicity (discontinue). Pre-disposing factors for myopathy/rhabdomyolysis. Monitor renal function for first 3 months and interrupt if cc increases q 50%. Contains lactose, sucrose. C Oral anticoagulants, not recommended. Caution: Cyclosporin, HMG-A reductase inhibitors, other fibrates. A GI disorders, moderately elevated levels of serum transaminases.

LIPAPRAV

Gerard

2MO

Statin. Pravastatin (Na+) 10mg, 20mg, 40mg. Pinkpeach (10mg), yellow (20mg, 40mg) indented cap.shape, film-ctd tablets with either 10, 20 or 40 on one side. 10mg-28, A12.10; 20mg-28, A23.99; 40mg-28, A29.99. S Primary hypercholesterolemia (HC) or LIPANTIL MICRO Solvay mixed dyslipidaemia, as adjunct to diet, when 2MO response to diet and other non-pharmacological Fibrate. Fenofibrate (micronised) 200mg, 67mg. treatments is inadequate. Moderate or severe HC Orange cap. and yellow cap. resp. 200mg-30, in patients at high risk of a 1rst cardiovascular A18.32; 67mg-90,A18.85. event, as adjunct to diet. History of MI or unstable angina pectoris with either normal or increased S Hyperlipidaemia resistant to diet. cholesterol levels, as adjunct to correction of other P 3 x 67mg daily in divided doses or 1 x risk factors. Post transplantation hyperlipidaemia 200mg daily with food. in patients receiving immunossupressive therapy Q Not recommended. D Severe renal or hepatic dysfunction, gall following solid organ transplantation. P Taken once daily, preferably the bladder disease, biliary cirrhosis. Photoallergy or

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

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2.8 HYPERCHOLESTEROLAEMIA -

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LIPIDAEMIC

40mg-28, A17.99. S Primary hypercholesterolaemia (HC)or mixed dyslipidaemia, as adjunct to diet where response to diet and other non-pharmacological measures has been inadequate. Adjunct to diet to prevent cardiac events in patients with HC and at high risk. Adjunct to correction of other risk factors in patients with history of MI or unstable angina regardless of cholesterol levels. Reduction of post transplantation hyperlipidaemia in patients receiving immunosuppressive therapy. P HC: Usual range, 10-40mg once daily at bedtime. Full effect within 4 weeks. Cardiovascular prevention: 40mg daily. Post transplantation: Initially 20mg daily; max. 40mg daily. Renal/ hepatic impairment: Initially 10mg daily. Q Heterozygous familial HC: 8-13 years, 10-20mg once daily; 14-18 years, 10-40mg daily. D Active liver disease. Pregnancy, lactation. B Hepatic disease. Withdraw if ALT and AST q3xULN and persist. Measure CK prior to therapy in patients at risk of myopathy. Monitor for signs of myopathy (interrupt if severe symptoms or CKq5xULN). Children before puberty (evaluate benefit/risk). Dizziness and visual disturbances may occur. LIPITOR Pfizer C Fibrates (avoid). Take 1 hr before or 4 hrs after cholestyramine or colestipol. Caution: 2MO Cyclosporin, erythromycin, clarithromycin. Statin. Atorvastatin 10mg, 20mg, 40mg, 80mg. A Uncommon. White elliptical film-ctd tabs. marked with code and tab. strength. 10mg-28, A21.39; 20mg-28, LOCHOL Clonmel A33.74; 40mg-28, A56.43; 80mg-28, A65.09. 2MO S Adjunct to diet in primary Statin. Fluvastatin 20mg, 40mg. Resp. size 3 or 1 hypercholesterolaemia, heterozygous familial hard cap. with blue or green cap and white body. hypercholesterolaemia, mixed hyperlipidaemia. 20mg-28, A7.56; 40mg-28, A8.92. Homozygous familial hypercholesterolaemia as S Primary hypercholesterolaemia and adjunct to other lipid-lowering treatments or if mixed dyslipidaemia (Fredrickson Types IIa and IIb) such treatments are unavailable. Raises HDLas adjunct to diet to reduce elevated total cholesterol and lowers LDL/HDL and total cholesterol and low-density lipoprotein cholesterol cholesterol/HDL ratios. Prevention of when response to diet and other noncardiovascular events in patients estimated to have pharmacological treatments is inadequate. a high risk for a first cardiovascular event, as P Before treatment start cholesteroladjunct to correction of other risk factors. lowering diet and continue during treatment. P Initially 10mg once daily, increase as Initially 20mg to 40mg daily. May be increased to necessary at 4 week intervals; max. 80mg once 80mg (max). Max lipid-lowering effect is achieved daily. within 4 weeks. Q Severe dyslipidaemias in 4-17 years: Q Under 18 years, not recommended. 10mg per day. May be increased to 80mg daily. D Active liver disease, or unexplained, No developmental safety data available. persistent elevations in serum transaminases. D Active liver disease, persistent raised Pregnancy, lactation. liver enzymes (q 3xULN), myopathy. Pregnancy, B Monitor liver function before and lactation. Ensure adequate contraception. periodically during treatment; discontinue if B History of alcohol abuse or liver disease. increase in AST or ALT exceeds 3 x ULN and Perform liver function tests before treatment, at persists. Caution: History of liver disease, heavy 12 weeks or elevation of dose and periodically alcohol consumption. Caution (measure CK levels thereafter. Myalgia, myopathy, and very rarely before starting treatment): Renal impairment, rhabdomyolysis have been reported. Patients with hypothyroidism, personal or familial history of pre-disposing factors for rhabdomyolysis; monitor hereditary muscular disorders, previous history of CPK before therapy, see SPC. Contains lactose. muscular toxicity with a statin or fibrate, alcohol C Cyclosporin, fibrates, macrolide abuse, elderly (if other predisposing factors antibiotics, azole antifungals, niacin, drugs present). May occur: Myopathy (rarely), myositis metabolised by cytochrome P450 3A4, digoxin, and rhabdomyolysis (very rarely); advise patients erythromycin, oral contraceptives, colestipol, to promptly report if occur; stop treatment if CK antacids, warfarin, protease inhibitors. levels q5 x ULN. If symptoms are severe and cause A GI disturbances, headache, myalgia, daily discomfort, consider discontinuation even if asthenia, insomnia. Elevated serum transaminases CK levels Q5 x ULN. Homozygous familial and CPK levels. hypercholesterolemia: Not recommended. C Caution: Fibrates, niacin, colchicine, LIPOSTAT BMS ciclosporin, warfarin and other coumarin 2MO derivatives, rifampicin (long-term), glibenclamide (monitor patients on 80mg/day fluvastatin), bile Statin. Pravastatin (as Na+ salt) 10mg, 20mg, 40mg. Lemon oval scored tabs. marked 10, 20 and acid sequestrants (e.g. cholestyramine; admin. fluvastatin at least 4 hrs after), fluconazole, 40 resp. 10mg-28, A7.49; 20mg-28 , A14.40;

evening. HC: 10-40mg. Full effect within 4 weeks. Cardiovascular prevention: 40mg. After transplantation: Initially 20mg, may be adjusted to 40mg depending on lipid parameters. Moderate/ severe renal impairment, significant hepatic impairment: Initially 10mg daily. Q Heterozygous familial HC: 8-13 years, 10-20mg; 14-18 years, 10-40mg. D Active liver disease including unexplained persistent elevations of serum transaminase (q3xULN). Pregnancy, lactation. B Not evaluated for homozygous familial HC. Not suitable for elevated HDL-cholesterol. Discontinue if liver enzymes q3xULN. Caution: History of liver disease, heavy alcohol ingestion. May occur: Myalgia, rhabdomyolysis, myopathy; monitor creatinine kinase (CK) if predisposing factors, see SPC. C Avoid: Fibrates; if necessary, monitor CK. Caution: Erythromycin, clarithromycin, cyclosporin. Cholestyramine/colestipol: Take pravastatin 1 hr before or at least 4 hrs after.

76

phenytoin. A Insomnia, headache, fatigue, dizziness, GI disorders, arthralgia.

LOPID

Pfizer

2MO Fibrate. Gemfibrozil 300mg. White/maroon cap. marked Lopid 300. 112, A31.93.

2MO ALSO LOPID TABLETS 600MG Gemfibrozil 600mg. White elliptical film-ctd scored tab. marked LOPID on one side. 56, A31.93. S As adjunct to diet and exercise in: Mixed dyslipidaemia; primary hypercholesterolaemia, particularly when a statin is inappropriate/not tolerated; reduction of cardiovascular morbidity in males with increased non-HDL cholesterol and at high risk for a first cardiovascular event, particularly when a statin is inappropriate/not tolerated. P Usually 600mg twice daily, although 900mg daily may be sufficient. Mild-moderate renal impairment: Start treatment at 900mg daily. Q Not recommended. D Hepatic dysfunction, severe renal impairment, pre-existing gall bladder or biliary tract disease, incl. gallstones. History of photoallergy or phototoxic reaction during treatment with fibrates. Pregnancy, lactation. B Myositis, myopathy and elevated CPK have been reported. Rhabdomyolysis has been reported rarely. Measure CPK levels before combination with statins in patients with predisposing factors for rhabdomyolysis. Perform lipid profile, blood count and liver functon tests before treatment. Check blood count every 2 months during first 12 months of treatment. Monitor serum lipids periodically. Discontinue if persistent liver function abnormality. C Contraindicated: Repaglinide. Avoid statins. Caution: Rosiglitazone, oral anticoagulants. Bexarotene, not recommended. Admin. resingranule drugs e.g. colestipol 2 hours apart. A Vertigo, headache, GI disorders, eczema, rash, fatigue.

LUVINSTA

Actavis

2MO Statin. Fluvastatin (as Na+) 20mg, 40mg. Resp. orange/ivory or orange/yellow opaque hard cap. marked with FST and strength. 20mg-28, A10.93; 40mg-28, A12.89. S Primary hypercholesterolaemia and mixed hyperlipidaemia (Fredrickson Types IIa and IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments is inadequate. P Initially 20mg to 40mg daily in the evening. May be increased to 80mg (max). Q 40 mg once or twice daily. 20mg may be adequate in mild cases. D Active liver disease, or unexplained, persistent elevations in serum transaminases. Pregnancy, lactation. B Monitor liver function before and periodically during treatment; discontinue if increase in AST or ALT q 3 x ULN persists. Caution: History of liver disease, heavy alcohol consumption, pre-disposing factors for rhabdomyolysis (measure CK levels before starting treatment). May occur: Myopathy (rarely), myositis and rhabdomyolysis (very rarely); advise patients to promptly report if occur. Discontinue if interstitial lung disease occurs. Homozygous

2

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c

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Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


I can’t imagine doing anything else. Three generations of my family, it’s in the blood. When waves are 10 times bigger than the boat you hold on a bit tighter. Never underestimate the sea.

Abbreviated prescribing information: Lipitor¡ Presentation: Lipitor is supplied as film-coated tablets of 10, 20, 40 or 80mg of atorvastatin. Indications: Hypercholesterolaemia: As an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in adults with primary hypercholesterolaemia, including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Also indicated to reduce total cholesterol and LDL cholesterol in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. Lipitor also raises HDL-cholesterol and lowers the LDL/HDL and total cholesterol/HDL ratios. Prevention of Cardiovascular Disease: Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors. Dosage: The usual starting dose is one Lipitor 10mg tablet daily. Doses should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response. Doses may be given at any time of the day with or without food. The maximum daily dose is 80mg once daily. Current consensus guidelines should be consulted to establish treatment goals for individual patients. Contraindications: Hypersensitivity to any of the ingredients, active liver disease, unexplained persistent elevations in serum transaminases exceeding 3-times the upper limit of normal, myopathy, pregnancy, breast-feeding and in women of child-bearing potential not using contraception. Warning and precautions: Liver function tests should be performed before initiation, 12 weeks after initiation or a dose increase and periodically LIP/2009/034 thereafter as well as in patients who show signs Lipitor is manufactured in Ireland

and symptoms of liver injury (monitor raised transaminases until they return to normal). Drug dosage should be reduced or therapy discontinued if persistent elevations occur above 3-times the upper limit of normal. Lipitor should be used with caution in patients with a history of liver disease and/or alcoholism. Statin treatment has been associated with the onset of myalgia, myopathy, and very rarely rhabdomyolysis. Myopathy must be considered in patients presenting with unexplained muscle symptoms and in such cases creatine phosphokinase (CPK) levels should be measured. Lipitor should be discontinued if CPK levels are markedly or persistently raised or myopathy is diagnosed or suspected. Lipitor should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis. Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medications that may increase the plasma concentration of atorvastatin. If possible alternative (non-interacting) therapies should be considered. If co-administration of such medications with atorvastatin is necessary, the benefit and the risk of concurrent treatment should be carefully considered, and a lower starting dose of atorvastatin is recommended. In the case of ciclosporin, clarithromycin and itraconazole, a lower maximum dose of atorvastatin should be considered. For concomitant use of clarithromycin or itraconazole with atorvastatin doses exceeding 40mg, clinical monitoring, including CPK measurement, of these patients is recommended. If these levels are significantly elevated (>5 times ULN), treatment with atorvastatin should be stopped until the clarithromycin/itraconazole treatment course is completed and CPK has returned to baseline values. Although interaction studies with atorvastatin and fusidic acid have not been conducted, severe muscle problems such as rhabdomyolysis have been reported in postmarketing experience with this combination – therefore patients should be closely monitored, including measurement of serum creatine phosphokinase (CPK) and temporary suspension of atorvastatin treatment may be appropriate. As with other drugs in this class, rhabdomyolysis with acute renal failure, has been reported. For patients with prior haemorrhagic stroke or lacunar infarct, the balance of risks and benefits of atorvastatin 80 mg is

uncertain and the potential risk of haemorrhagic stroke should be carefully considered before initiating treatment. Patients with rare hereditary problems of galactose intolerance, the Lapp Lactase deficiency or glucose-galactose malabsorption should not take this medication. Pregnancy and lactation: Lipitor is contraindicated in pregnancy and lactation. A 1 month interval should be allowed from stopping treatment to conception if pregnancy is planned. Side effects: Side effects most frequently reported in controlled clinical studies: constipation, flatulence, dyspepsia, abdominal pain, headache, nausea, myalgia, asthenia, diarrhoea, insomnia, elevations in serum transaminases and CPK levels. Other side effects have been reported in clinical trials and for post marketing surveillance: (See Summary of Product Characteristics). Legal category: S1A. Date of revision: December 2008. Package quantities and marketing authorisation numbers: Lipitor 10mg (28 tablets), PA841/1/1; Lipitor 20mg (28 tablets), PA841/1/2; Lipitor 40mg (28 tablets), PA841/1/3; Lipitor 80mg (28 tablets), PA841/1/4. Marketing Authorisation Holder: Pfizer Ireland Pharmaceuticals, Pottery Road, Dun Laoghaire, Co Dublin, Ireland. Lipitor is a registered trade mark. Further information is available on request from: Medical Information, Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, United Kingdom. Company Reference LR7_0. Date of Preparation: July 2009.

My life.

Your decision.


2.8 HYPERCHOLESTEROLAEMIA -

CIRCULATORY SYSTEM

LIPIDAEMIC

dyslipidaemia as adjunct to diet when inadequate response to diet. Moderate or severe HC in patients at high risk of cardiovascular events as Polyunsaturated fatty acid. Omega-3-acid ethyl adjunct to diet. History of MI or unstable angina esters 1000mg (including EPA and DHA 840 mg). pectoris regardless of cholesterol levels. Post Soft, oblong, transparent gelatin caps. containing transplantation hyperlipidaemia in patients pale yellow oil. 28, A17.56. receiving immunosuppressive therapy following S Endogenous hypertriglyceridaemia as solid organ transplantation. supplement to diet when dietary measures alone P HC: 10-40mg once daily preferably in are insufficient: Type IV in monotherapy; type IIb/ the evening. Response seen within a week and full III in combination with statins when control of effect within 4 weeks. Max. 40mg daily. Cardiovascular prevention: 40mg daily. After MAXEPA Seven Seas triglycerides is insufficient. P Initially, 2 daily with food; increase to 4 transplantation: Initially, 20mg daily; may be 2M if necessary. adjusted up to 40mg. Moderate/severe renal Polyunsaturated fatty acids. Eicosapentaenoic acid Q Not recommended. impairment, significant hepatic impairment: (EPA) 170mg, docosahexaenoic acid (DHA) 115mg. D Pregnancy, lactation (no data). Initially 10mg daily. Yellow oblong gelatin cap. marked Maxepa. 200, B Exogenous hypertriglyceridaemia (type 1 Q Heterozygous familial HC: 8-13 years, A39.97. hyperchylomicronaemia); not indicated. Hepatic 10-20mg once daily; 14-18 years, 10-40mg daily. S Reduction of plasma triglyceride levels impairment (monitor hepatic function, especially Evaluate benefit/risk in children before puberty. in patients with severe hypertriglyceridaemia who with high dosage). Patients at high risk of D Active liver disease incl. unexplained are at special risk of ischaemic heart disease and/ haemorrhage. Moderate increase in bleeding time persistent elevations of serum transaminase or pancreatitis. Use in conjunction with may occur with high dosage (i.e. 4 cap.) elevation (q3xULN). Pregnancy, lactation. appropriate dietary measures. C Oral anticoagulants (monitor and adjust B Caution: Renal impairment, P 5 twice daily with food. dose). hypothyroidism, previous history of muscular Q Not recommended. A GI disturbances. toxicity with a statin/fibrate, history of hereditary D Non-insulin dependent diabetic patients muscular disorders. Homozygous familial HC (not PRAVAMEL Clonmel studied). History of liver disease, heavy alcohol with aspirin sensitive asthma. B Monitor patients with bleeding ingestion. Increased transaminase levels; 2MO disorders Statin. Pravastatin (Na+) 10mg, 20mg, 40mg. Pink/ discontinue if q3xULN and persists. Monitor for C Anticoagulants, aspirin, cephalosporins. peach tab. marked 10. Yellow tab. marked 20. signs of myalgia, myopathy; interrupt if CK levels A Nausea, eructation. q5xULN or if severe symptoms. Dizziness when Yellow tab. marked 40. All cap. shaped film-ctd. driving vehicles or operating machines. Contains 10mg-30. A11.02; 20mg-30, A21.18; 40mg-30, NIASPAN Abbott A26.46. lactose. C Fibrates (avoid), bile acid-binding resins 2MO S Primary hypercholesterolaemia (HC) (admin. 1 hr before or min 4 hrs after resin). when response to diet and other nonNicotinic acid. Nicotinic acid 375mg, 500mg, Caution: Ciclosporin, erythromycin or pharmacological treatments is inadequate, 750mg, 1000mg. White to off-white cap.-shaped clarithromycin. moderate or severe HC in patients at high risk of tab. marked with strength on one side. 375mg-7, 1st cardiovascular event (as adjunct to diet). A4.19; 500mg-7, A5.58; 750mg-7, A8.38; 500mgPRAVITIN Rowex History of MI or unstable angina pectoris with 56, A21.24; 750mg-56, A33.65; 1000mg-56, normal or increased cholesterol levels (as adjunct 2MO A38.27. to other risk factor correction). Post transplant Statin. Pravastatin (Na+) 10mg, 20mg, 40mg. S Dyslipidaemia, particularly combined hyperlipidaemia reduction in patients on Yellow, oval, convex, side wall scored tab. marked mixed dyslipidaemia, primary immunosuppressive therapy following solid organ P10, P20 or P40. 10mg-30, A13.38; 20mg-30, hypercholesterolaemia. In combination with transplantation. A25.67; 40mg-30, A32.12. statins, when statin monotherapy is inadequate. P HC: 10-40mg daily, preferably in the S Primary hypercholesterolaemia (HC) or As monotherapy only in patients who do not evening; max. 40mg daily. Cardiovascular mixed dyslipidaemia, as adjunct to diet when no tolerate statins. prevention: 40mg daily. After transplantation: response to dietary measures. Reduction of P (Week1) 375mg once daily, (week2) Initially, 20mg daily; may titrate up to 40mg. cardiovascular mortality and morbidity: a) patients titrate to 500mg, (week3) 750mg, (week 4-7) Moderate to severe renal impairment: Initially with moderate or severe HC and at high risk of 1000mg (two 500mg tabs.), all once daily at 10mg daily. cardiovascular event as adjunct to diet; b) patients bedtime after low-fat snack. Maintenance dose: Q Under 18 years, not recommended. with history of MI or unstable angina pectoris as 1000mg (two 500mg tabs.) or 1500mg (two 750mg D Active liver disease. Pregnancy, adjunct to correction of other risk factors. tabs.) or 2000mg (two1000mg tabs.), all once lactation. Reduction of post transplantation hyperlipidaemia daily. Do not increase by more than 500mg in any B Elevated serum transaminase and/or in patients receiving immunosuppressive therapy 4-week period after initial titration to 1000mg. creatine kinase levels (monitor). Renal impairment, following solid organ transplantation. Max., 2000mg per day. Tab. strengths not hypothyroidism, liver disease (history), heavy P HC: 10-40mg once daily preferably in interchangeable. alcohol ingestion. Risk of myopathy, myalgia. the evening. Full effect within 4 weeks. Adjust Q Children and adolescents, not C Fibrates, cholestyramine, colestipol, dosage according to periodic lipid determination. recommended. cyclosporin, erythromycin, clarithromycin. Max. daily dose, 40 mg. Cardiovascular prevention: D Significant hepatic dysfunction, active 40mg daily. Following organ transplantation: peptic ulcer disease, arterial bleeding. Pregnancy PRAVASTATIN SODIUM (INN) Initially 20mg a day; can be adjusted up to 40mg. (unless essential), lactation. Teva Renal or hepatic impairment: Initially, 10mg a day B Do not replace with other nicotinic acid and adjusted according to response of lipid preparations. Substantial alcohol intake, history of 2 M O parameters. Concomitant therapy: Lipid lowering Statin. Pravastatin (Na+) 10mg, 20mg, 40mg. 10mg- effects enhanced when combined with bile acidliver disease. Monitor liver function. Combined A11.24; 20mg-28, A21.61; 40mg-28, A27.00. 28, therapy, monitor for signs of rhabdomyolysis. binding resin (1 hr before or at least 4 hrs after Diabetes, unstable angina, acute phase of MI, resin). Patients taking cyclosporin: Initially, 20mg Pinewood surgery. History of jaundice, hepatobiliary disease, PRAVAT once daily; titration to 40mg with caution. 2MO or peptic ulcer. May affect platelets count, uric Q Under 18 years, not recommended. + acid and P levels. Statin. Pravastatin (Na ) 10mg, 20mg, 40mg. Light D Pregnancy and lactation. Active liver C Alcohol. Caution: Anti-coagulants, pink, light yellow, light green tabs resp. All round, disease. ganglionic blocking agents (e.g. transdermal unscored, marked APO on one side and PRA over B Renal impairment, hypothyroidism, nicotine or vasoactive drugs), HMG-CoA reductase strength on reverse. 10mg-28, A12.45; 20mg-28, history of hereditary muscular disorders or liver A23.92; 40mg-28, A29.92. inhibitors. disease, alcohol abuse. Discontinue if: Liver enzymes q3x normal upper limit (ULN); CK levels A Flushing, GI disorders, rash, pruritus. S Hypercholesterolaemia (HC) or mixed familial hypercholesterolemia: Not recommended. C Caution: Fibrates, niacin, colchicine, ciclosporin, warfarin and other coumarin derivatives (monitor prothrombin times), rifampicin (long-term), glibenclamide (monitor patients on 80mg/day fluvastatin), bile acid sequestrants (admin. fluvastatin at least 4 hrs after), fluconazole, phenytoin. A Headache, fatigue, dizziness, GI disorders, joint pain, insomnia.

78

OMACOR

Solvay

2MO

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM q5x ULN or if myopathy suspected. C Fibrates. Caution: Cholestyramine, colestipol, cyclosporin, erythromycin, clarithromycin.

HYPERCHOLESTEROLAEMIA -

shaped, pink tab. 10mg-28, A13.75; 20mg-28, A23.39; 40mg-28, A23.39; 80mg-28, A23.39. S CHD: In patients with plasma cholesterol r5.5mmol/L. Hyperlipidaemia: Adjunct to diet for reduction of total and LDL-cholesterol, QUESTRAN BMS apolipoprotein B and triglycerides in patients with primary hypercholesterolaemia, combined 2MO hyperlipidaemia when response to diet is Bile acid sequestrant. Cholestyramine 4g. Powder inadequate. A in sachet. 50, 24.32. P CHD: Initially 20mg/day, adjusted if S Type II hyperlipoproteinaemias. P 12-24 g daily in divided doses; max. 36g necessary at intervals r 4 weeks, to max. of 40mg/day, or exceptionally 80mg/day. daily. Q Under 6 years, not recommended; over Hyperlipidaemia: Recommended dose, 10mg/day. Dose range, 10 to 80mg/day. In combination with 6 years, in proportion to dose for 70kg adult. ciclosporin, fibrates or niacin: Max. dose, 10mg/ D Complete biliary obstruction. B On long term, suppl. diet with vitamins day. Take all daily doses as single doses in the A, D and K. Pregnancy, lactation. Contain sucrose. evening. Standard cholesterol lowering diet recommended before and during treatment. C Digitalis, antibiotics, diuretics. Take all Reduce dosage if LDL-cholesterol levels fall below drugs 1 hour before or 4-6 hours after Questran. 1.96mmol/l or total serum cholesterol levels fall A Constipation. below 3.6mmol/l. Renal Insufficiency: Doses RITECHOL Niche q10mg/day, caution. Q Under 18 years, not recommended (no 2MO data). Statin. Simvastatin 10mg, 20mg, 40mg. Oval, tabs. D Active liver disease or unexplained marked 10 and 20 resp. on one side; round tab. persistent elevation of serum transaminase values. plain on one side (40mg). All white, film-coated Porphyria, myopathy. Pregnancy, lactation. with a breakline on the reverse. 10mg-28, A12.84; Women of child bearing age (unless adequate 20mg-28, A21.82; 40mg-28, A21.82. contraception used). S Hypercholesterolaemia: Adjunct to diet B Risk of myopathy. Monitor liver for reduction of elevated total and LDL-cholesterol function. Impaired renal function. Tabs. contain in patients with hypercholesterolaemia (type IIa) lactose. or combined hyperlipidaemia (type IIb) when C Ketoconazole, itraconazole and HIVresponse to diet and other non-pharmacological protease inhibitors, delaviradine, mibefradil. measures is inadequate. CHD: Secondary Caution: Gemfibrozil and other fibrates, niacin, prevention in patients with elevated plasma potent inhibitors of CYP3A4, telithromycin, cholesterol (q5.5mmol/L). coumarin anticoagulants, digoxin. Avoid P Hypercholesteroleamia: Initially 10mg grapefruit juice. once daily at night, adjusting at min. 4-week A GI disturbances. intervals according to response. Usual range 1040mg daily as a single dose at night. CHD: Initially SIMTAN Clonmel 20mg once daily at night adjusting at min. 4-week 2MO intervals according to response; max. 40mg daily Statin. Simvastatin 5mg, 10mg, 20mg, 40mg. as single dose at night. Yellow (5mg) and white oblong biconvex film-ctd. Q Under 18 years, not recommended. tabs. scored on one side and marked SVT5, SVT10, D Active liver disease or unexplained SVT20 and SVT40 resp. 5mg-28, A11.78; 10mg-28, persistent elevation of serum transaminases. A11.87; 20mg-28, A20.15; 40mg-28, A20.15. Pregnancy, lactation. Women of child-bearing S Hypercholesterolaemia: Adjunct to diet potential unless adequate contraception is used. for reduction of elevated total and LDL-cholesterol Porphyria, myopathy. B History of liver disease, alcoholism, renal in patients with hypercholesterolaemia (type IIa) impairment, hypothyroidism, history of hereditary or combined hyperlipidaemia (type IIb) when response to diet and other non-pharmacological muscular disorders or muscular toxicity with a measures is inadequate. CHD: Secondary statin or fibrate. Elderly (q70 years). prevention in patients with elevated plasma Rhabdomyolysis. Perform liver function tests cholesterol (q5.5mmol/L). before and during therapy. Significantly elevated P Hypercholesterolaemia: Initially 10mg CK levels (q5xULN), treatment should not be once daily at night, adjusting at min. 4-week started. intervals according to response. Usual range 10C Digoxin, coumarin anticoagulants, 80mg daily as a single dose at night. CHD: Initially cyclosporin, gemfibrozil and other fibrates, 20mg once daily at night adjusting at min. 4-week nicotinic acid derivatives, azole antifungals, intervals according to response; max. 80mg daily macrolide antibiotics, HIV-protease inhibitors, as single dose at night. delaviridine, amiodarone, verapamil, nefazodone, Q Not recommended. grapefruit juice. D Active liver disease or unexplained A Abdominal pain, constipation, persistent elevation of serum transaminases. flatulence, nausea. Headache, indigestion, Pregnancy or women trying to become pregnant diarrhoea, rash, itch, asthenia. Rarely myopathy. or suspect pregnancy, lactation. Porphyria, myopathy. SIMATOR Pinewood B History of liver disease, alcoholism, renal 2MO impairment, hypothyroidism, history of hereditary muscular disorders or muscular toxicity with a Statin. Simvastatin 10mg, 20mg, 40mg, 80mg. All film-ctd tabs. marked SV 10, SV 20, SV 40 or SV 80 statin or fibrate. Perform liver function tests before and during therapy. resp. on one side and qq on the other. 10mg, C Digoxin, coumarin anticoagulants, 40mg: Shield-shaped, pink tab.; 20mg: Round, cyclosporin, gemfibrozil and other fibrates, orange tab. with a score line. 80mg: Capsule-

LIPIDAEMIC

2.8

nicotinic acid derivatives, azole antifungals, macrolide antibiotics, HIV treatments, amiodarone, verapamil. A Abdominal pain, constipation, flatulence, nausea. Headache, indigestion, diarrhoea, rash, itch, asthenia. Rarely myopathy.

SIMVASTATIN BENTLEY

Bentley

2MO Statin. Simvastatin 10mg, 20mg, 40mg. Oval, biconvex, film-ctd tabs. 10mg: Peach scored marked 0 on each side of scoreline. 20mg and 40mg: Tan-coloured and brick red marked 20 and 40 resp. 10mg-28, A10.20. 20mg-28, A17.35. 40mg-28, A17.35. S Cardiovascular prevention in manifest atherosclerotic CVD or diabetes mellitus with either normal or increased cholesterol levels. As adjunct to diet for treatment of primary hypercholesterolaemia (HC), familial hypercholesterolaemia (FHC) or mixed dyslipidaemia, when no response to diet. P CVD prevention: 20-40mg/day as single dose in the evening. Hyperlipidaemia: Recommended, 10mg once daily in the evening; range 10-80mg. Results within 2 weeks; max. response by 4-6 weeks. Homozygous FHC: 40mg/ day in the evening or 80mg/day in 3 divided doses of 20mg, 20mg and evening dose of 40mg. Max. dose 10mg/day if admin. with ciclosporin, fibrates or niacin. Q Not recommended. D Active liver disease, persistant elevation of serum transaminases, porphyria. Pregnancy, lactation. B Perform liver function tests before and during therapy. Increased risk of myopathy; discontinue if severe symptoms occur, or if CK levels are q 5 x ULN. Check CK levels prior to therapy if: History of muscular disorders, alcoholism, renal impairment, uncontrolled hypothyroidism, elderly (q 70 years). Contains lactose. C Contra: Potent CYP 3A4 inhibitors (see annexe). Avoid grapefruit juice, gemfibrozil, other fibrates, niacin, less potent CYP 3A4 inhibitors, danazol (unless benefit outweighs risk). Caution: Coumarin anticoagulants.

SIMZOR

Gerard

2MO Statin. Simvastatin 10mg, 20mg, 40mg. White to off-white film-ctd oblong scored tabs. 10mg-30, A13.78; 20mg-30, A23.42; 40mg-30, A23.42. S Reduction of elevated plasma and LDLcholesterol in patients with hypercholesterolaemia and combined hyperlipidaemia in combination with dietary measures. For the secondary prevention of CHD in patients with elevated plasma cholesterol levels. P Hyperlipidaemia: Initially 10mg once daily at night, adjusting at min. 4-week intervals according to response. Usual range 10-80mg daily as a single dose at night. CHD: Initially 20mg daily as a single dose in the evening adjusting at min. 4-week intervals according to response; max. 80mg daily as single dose at night. Q Not recommended. D Active liver disease or unexplained persistent elevation of serum transaminases. Women of child-bearing potential, unless adequate contraception is used. Pregnancy, lactation. B Severe renal impairment. History of liver

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

79


2.9 ERYTHROPOIESIS,

CIRCULATORY SYSTEM

GRANULOCYTOPENIA

release nicotinic acid, initiate at starting dose and advance to maintenance dose after 4 weeks. Take whole with food, evening or at bedtime. Avoid alcohol, hot drinks, spicy food at time of ingestion to reduce flushing. Q Not recommended. D Significant or unexplained hepatic dysfunction. Active peptic ulcer disease. Arterial bleeding. Pregnancy (unless clearly necessary), lactation. B Substantial alcohol intake, history of liver disease. Monitor liver function. Combined SIVATIN Rowex therapy, monitor for signs of rhabdomyolysis. Renal dysfunction, diabetes, unstable angina, 2MO acute phase of MI, surgery, predisposition to gout, Statin. Simvastatin 10mg, 20mg, 40mg. Light red, patients at risk of hypophosphataemia, history of orange, red-brown tabs. All film-ctd, oval, scored jaundice, hepato-biliary disorder, peptic ulcer. May and marked SIM 10, SIM 20 or SIM 40. 10mg-30, affect liver function tests, platelets count, uric acid A14.75; 20mg-30, A25.08; 40mg-30, A25.08. and P levels. Contains lactose. S Primary hypercholesterolaemia (HC) or C Nitrates, Ca++ channel blockers, mixed dyslipidaemia as adjunct to diet. Familial adrenergic receptor blockers, bile acid homozygous HC when other treatments not sequestrants, midazolam, zidovudine, clopidogrel, appropriate. Secondary prevention of CHD in cupric sulphate solutions (Benedict’s reagent). patients at high risk with normal or high plasma Simvastatin in Chinese patients. cholesterol levels. A Elevations in ALT and/or AST, fasting P Usual initial dose 10-20mg for high cholesterol and 20-40mg for CHD as single dose in glucose, uric acid. Dizziness, headache, paraesthesia, diarrhoea, dyspepsia, nausea, the evening. Dosage adjustment at min. 4 week intervals. May be increased to 80mg in exceptional vomiting, erythema, pruritus, rash, urticaria, flushing, feeling hot. cases as single dose in the evening. Familial homozygous HC: 40mg in the evening or 80mg in ZOCOR MSD 3 divided doses. Severe renal insufficiency: Caution 2MO with daily doses q10mg. Statin. Simvastatin 10mg, 20mg, 40mg, 80mg. Q Under 18 years, not recommended. Peach oval, tan, red oval and red cap. shaped filmD Active liver disease or unexpected persistent elevation of serum transaminase values, ctd tabs. marked ZOCOR 10, ZOCOR 20, MSD 749, and 543 one side ’80’ on reverse, resp. 10mg-28 porphyria, myopathy. Pregnancy, lactation. B Perform liver functions tests before and (Cal/Pk), A8.27. All 20mg-28, 40mg-28, 80mg-28 (Cal/Pk): A14.06. during therapy. Increased risk of myopathy; S As an adjunct to diet for reduction of discontinue if severe symptoms occur, or if CK elevated total cholesterol, LDL-cholesterol, levels q5xULN. Caution: History of muscular apoloprotein B and triglycerides in patients with disorders or alcoholism, renal insufficiency, uncontrolled hypothyroidism, elderly (q70 years); primary hypercholesterolaemia, heterozygous familial hypercholesterolaemia or combined check CK levels before initiating therapy. Major (mixed) hyperlipidaemia when response to diet surgery (discontinue). Contains lactose. and other non-pharmacological measure is C Potent CYP3A4 inhibitors, i.e. inadequate. To lower LDL/HDL ratio and total itraconazole, ketoconazole, HIV protease cholesterol/HDL ratio by raising HDL.As an adjunct inhibitors, erythromycin, clarithromycin, to diet and other non-dietary measures in telithromycin and nefazodone (all contraindicated), grapefruit juice (avoid). Caution: reducing elevated total cholesterol, LDLcholesterol and apolipoprotein B in patients wihth Gemfibrozil and other fibrates, niacin, other homozygous familial hypercholesterolaemia when CYP3A4 inhibitors, coumarin anticoagulants. response to these measures is inadequate. A GI disturbances. P Hyperlipidaemia: Initially 10mg once TREDAPTIVE MSD daily at night, adjusting at min. 4-week intervals according to response. Usual range 10-80mg daily 2MO as single dose at night. CHD: Initially 20mg daily Nicotinic acid and derivatives. Nicotinic acid, as single evening dose adjusting at min. 4-week 1000mg; laropiprant, 20mg. Cap.-shaped, white to intervals according to response; max. 80mg daily off-white modified-release tabs, with 552 as single dose at night. Homozygous familial debossed on 1 side. 28, A16.79; 56, A33.59. hypercholesterolaemia: 40mg as single dose at S Dyslipidaemia, particularly mixed night or 80mg daily in three divided doses of dyslipidaemia and primary hypercholesterolaemia. 20mg, 20mg and 40mg taken in the evening. In combination with HMG-CoA reductase Q Not recommended. inhibitors (statins), when HMG-CoA reductase D Active liver disease or unexplained inhibitor monotherapy inadequate. As persistent elevation of serum transaminases. monotherapy only if HMG-CoA reductase Pregnancy or women likely to become pregnant, inhibitors inappropriate or not tolerated. lactation. B History of liver disease, alcoholism. P Initially, 1 tab. once a day for 4 weeks. Maintenance: 2 tabs. once daily. If dose missed for Perform liver function tests before and during therapy. Dose related risk of myopathy. Contains q7 consecutive days, resume therapy at 1 tab. daily for 1 week before advancing to maintenance lactose. dose. Switching from r2000mg prolonged-release C Contra: Itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV nicotinic acid, initiate at maintenance dose. protease inhibitors, or nefazodone. Caution: Other Switching from Q2000mg prolonged-release inhibitors of CYP3A4, some lipid-lowering drugs nicotinic acid and switching from immediatedisease or alcoholism. Perform liver function tests before and during therapy. C Gemfibrozil and other fibrates, nicotinic acid derivatives, ketoconazole, itraconazole, HIVprotease inhibitors, delavirdine, mibefradil, nefazodone, verapamil, erythromycin, clarithromycin, telithromycin, grapefruit juice, digoxin, coumarin anticoagulants. A Hypersensitivity reactions. Rarely, depression, erythema multiforme, Stevens-Johnson syndrome, leucopenia, purpura.

80

(gemfibrozil, other fibrates, niacin (r1 g/day)), cyclosporin, danazol, amiodarone, verapamil, diltiazem, grapefruit juice, oral anticoagulants, fusidic acid. A Abdominal pain, constipation, flatulence.

2.9 ERYTHROPOIESIS, GRANULOCYTOPENIA

ARANESP

Amgen

5NT Human erythropoietin. Darbepoetin alfa 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 300 and 500mcg. Soln. for inj. in pre-filled syringe. 10mcg/0.4ml x 4, A97.06; 15mcg/0.375ml x 4, A145.59; 20mcg/0.5ml x 4, A194.12; 30mcg/0.3ml x 4, A291.18; 40mcg/ 0.4ml x 4, A388.24; 50mcg/0.5ml x 4, A485.30; 60mcg/0.3ml x 4, A582.36; 80mcg/0.5ml x 4, A776.48; 100mcg/0.5ml x 4, A970.60; 150mcg/ 0.3ml x 4, A1455.90; 300mcg/0.6ml x 1, A727.95; 500mcg/1ml x 1, A1091.93.

5NT ALSO ARANESP SURECLICK Darbepoetin alfa 20, 40, 60, 80, 100, 150, 300 and 500mcg. Soln. for inj. in pre-filled pen. 20mcg/0.5ml x1, A48.53; 40mcg/ 0.4ml x1, A97.06; 60mcg/0.3ml x1, A145.59; 80mcg/0.4ml x1, A194.12; 100mcg/0.5ml x1, A242.65; 150mcg/0.3ml x1, A363.98; 300mcg/0.6ml x1, A727.95; 500mcg/1ml x1, A1091.93. S Anaemia associated with chronic renal failure in adults and paediatric patients. Anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. V Renal failure patients: See Section 7.3. Cancer patients: See Section 20.1. D Poorly controlled hypertension. Patients suspected or confirmed to have neutralising antibodies to erythropoietin. Lactation. B Evaluate iron status prior and during treatment. Iron suppl. may be required. Monitor BP. Ischaemic heart disease, CHF, sickle cell anaemia, epilepsy. Liver disease (no data). Monitor K+ levels. PCRA (discontinue if occurs). Pregnancy. C Caution: Cyclosporin, tacrolimus. A Headache, hypertension, thrombosis of vascular access, inj. site pain.

EPREX

Janssen-Cilag

5NT Erythropoietin. Epoetin alfa. Range of 1-6 thousand IU, 8000 IU, 10000 IU as well as 40000 IU human recombinant erythropoietin. (r-HuEPO). Soln. in pre-filled syringe. 1000 IU/0.5ml-6x0.5ml, A72.79; 2000 IU/0.5ml-6x0.5ml, A145.59; 3000 IU/ 0.3ml-6x0.3ml, A218.38; 4000 IU/0.4ml-6x0.4ml, A291.18; 5000 IU/0.5ml-6x0.5ml, A363.97; 6000 IU/ 0.6ml-6x0.6ml, A436.76; 8000 IU/0.8ml-6x0.8ml, A582.35; 10,000 IU/1ml-6x1.0ml, A727.94; 40,000 IU/ml-6x1ml, price on request. S Treatment of symptomatic anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis. Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient’s general status (e.g. cardiovascular status, preexisting anaemias at the start of chemotherapy).

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CIRCULATORY SYSTEM To increase yield of autologous blood. To reduce exposure to allogeneic blood transfusions prior to major elective orthopaedic surgery with high risk of transfusion complications. P Haemodialysis: Initially 50 IU/kg three times per week by IV inj. following dialysis. Increase if necessary by 25 IU/kg three times per week every 4 weeks to achieve a Hb 10-12g/dL. Maintenance, recommended total weekly dose, 75-300 IU/kg. Peritoneal dialysis: 50 IU/kg twice weekly by IV inj. Increase if necessary by 25 IU/kg twice weekly every 4 weeks to achieve a Hb 1012g/dL. Maintenance, 25-50 IU/kg per week in two equal doses. Non-dialysis: Initially 50 IU/kg 3 times per week by IV inj. Increase if necessary by 25 IU/ kg 3 times/week every 4 weeks to achieve a Hb 10-12g/dL. Maintenance 17-33 IU/kg/week in 3 divided doses; max. 200 IU/kg 3 times/week. May admin. by SC inj. where IV not readily available. Chemotherapy, autologous predonation and major elective orthopaedic surgery: See SPC. Q Haemodialysis: Initially 50 IU/kg 3 times per week by IV inj. following dialysis. Increase if necessary by 25 IU/kg 3 times per week every 4 weeks to achieve a Hb 9.5-11g/dL. Maintenance, under 10kg, 75-150 IU/kg; 10-30kg, 60-150 IU/kg; over 30kg, 30-100 IU/kg. All 3 times per week. D Uncontrolled hypertension. Severe coronary, peripheral arterial, carotid or cerebral vascular disease in patients scheduled for major elective orthopaedic surgery and not participating in autologous blood donation. Patients unable to receive antithrombotic prophylaxis. Patients who have developed Pure Red Cell Aplasia (PRCA) following erythropoietin treatment. B Caution: Hypertension, ischaemic vascular disease, thrombocytosis, history of epilepsy, liver failure, increased risk of thrombotic vascular events in cancer patients, porphyria. Correct other causes of anaemia; iron suppl. may be required. Monitor BP, Hb, blood count, serum electrolytes. Limit Hb rise to Q2g/dL per month. Chronic renal failure patients treated by SC route: Monitor regularly for loss of efficacy. Theoretically could stimulate malignant growth. Pregnancy, lactation. C Cyclosporin. A Hypertension, headache, deep vein thrombosis, pulmonary embolism, flu-like symptoms, seizures, rash, palpebral oedema, diarrhoea, vomiting, arthralgia, pyrexia, shunt thromboses. Rarely, PRCA, withdraw and do not transfer to other erythropoietins.

ERYTHROPOIESIS, GRANULOCYTOPENIA 2.9 therapies. Renal impairment (ccQ60ml/min). Pregnancy, lactation. B Monitor serum creatinine, cc, and/or plasma cystatin C levels weekly for the 1st month after initiation or modification of therapy, monthly afterwards. Pre-existing renal conditions, concomitant medicines depressing renal function (increased risk). Maintain adequate hydration in case of diarrhoea or vomiting. Reduce dose if necessary; see SPC. Monitor weight, height and sexual development in children every 12 months. Monitor cardiac function in patients with severe iron overload during long-term treatment. Contains lactose. C Not recommended: Aluminiumcontaining preparations. Rifampicin, phenobarbital, phenytoin, CYP2C8 substrates (e.g. paclitaxel, repaglinide). A Headache, GI disorders, increased blood creatinine, proteinuria, increased transaminases, rash, pruritus.

5NT

Recombinant human erythropoietin. Epoetin beta 500 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU, 6000 IU, 10000 IU, 20000 IU, 30000 IU. Pre-filled syringes: 500 IU-6, A36.40; 2000 IU-6, A145.59; 3000 IU-6, A218.38; 4000 IU-6, A291.18; 5000 IU-6, A363.97; 6000 IU-6, A436.76; 10000 IU-6, A727.94; 20000 IU-6, A1455.80; 30000 IU-4, A1237.48. S Anaemia associated with chronic renal failure in dialysis or pre-dialysis patients. Prevention and treatment of anaemia in adult patients undergoing platinum-based chemotherapy, patients with multiple myeloma, non-Hodgkin’s lymphoma or chronic lymphocytic leukaemia with low serum erythropoietin. Prevention of anaemias of prematurity in infants of gestational age less than 34 weeks. To increase yield of autologous blood. V Chronic renal failure, SC initially 3 x 20 IU/kg body weight per week. Increasing every 4 weeks by 3 x 20 IU/kg per week if the increase in PCV is Q0.5% per week. Weekly dose can be GRANOCYTE Chugai given as one inj. or in divided doses. IV admin. initially 3 x 40 IU/kg per week. Increasing after 4 5NT weeks to 3 x 80 IU/kg per week and if further Recombinant human granulocyte-colony increments are required by 3 x 20 IU/kg per week stimulating factor, rHu G-CSF. Lenograstim. at monthly intervals. Max. 720 IU/kg per week. Powder in vial plus prefilled syringe with WFI. Maintenance, initially reduce to half previous Granocyte-34: 33.6 MIU/vial. 5 x 1ml vial plus 5 x dose, then adjust to individual requirements at 1 1ml pre-filled syringe WFI or inf. Granocyte-13: or 2 week intervals. Children, follow 13.4 MIU/vial. 5 x 1ml vial plus 5 x 1ml pre-filled recommended dosing schedule. Solid tumours, by syringe WFI or inf. Price available on request. SC inj. initially 450 IU/kg per week, this dose may S Non-myeloid malignancy: reduction in be doubled if patient does not show a satisfactory duration of neutropenia and associated response in terms of haemoglobin values. complications following bone-marrow Continue therapy for up to 3 weeks after end of transplantation or following treatment with chemotherapy. Haematological tumours, see SPC. cytotoxic chemotherapy associated with significant Autologous blood pre-donation, by IV or SC incidence of febrile neutropenia. Granocyte may be admin. to patients with de novo acute myeloid admin. over approx. 2 mins. twice weekly over 4 weeks, see SPC. leukaemia aged above 55 years. Mobilisation of D Uncontrolled hypertension. For peripheral blood progenitor cells (PBPCs). P Cytotoxic-induced neutropenia: 150mcg/ increasing yield of autologous blood if the month preceding treatment the patients have suffered m2/day (equiv. 5mcg/kg/day) by SC inj. started on MI, stroke, have unstable angina, are at risk of day after completion of chemotherapy, continue DVT. until neutrophil count stable in acceptable range B Hypertension, thrombocytosis. History of (max. 28 days). Bone marrow transplantation: epilepsy. Chronic hepatic failure. Correct other 150mcg/m2/day (equiv. 5mcg/kg/day) by IV inf. started on day after completion of chemotherapy; causes of anaemia; iron suppl. may be necessary. continue until stable in acceptable range (max. 28 Monitor Hb, BP, platelet count, serum electrolytes. days). Mobilisation of PBPCs used alone: 10mcg/kg/ Limit Hb rise to Q2g/dL per month. Theoretically could stimulate malignant growth. Neonates day daily for 4-6 days by SC inj. following adjunctive myelosuppressive chemotherapy 5mcg/ (except NeoRecormon 500). Pregnancy, lactation. A Hypertension, shunt thrombosis, kg/day by SC inj. started on day after completion anaphylactoid reaction, increased platelets. of chemotherapy until neutrophil count in acceptable range. For timing of leukapheresis EXJADE Novartis consult lit. NEULASTA Amgen 2NT Q Over 2 years, cytotoxic-induced 5NT neutropenia 150mcg/m2/day (equiv. 5mcg/kg/day Iron chelating agent. Deferasirox 125mg, 250mg, Recombinant human granulocyte colony 500mg. Off-white, round, flat dispersible tab. with by SC inj. started on day after completion of stimulating factor (G-CSF). Pegfilgrastim 6mg/ NVR on one face and J125, J250, J500 resp. on the chemotherapy, continue until neutrophil count 0.6ml. Pre-filled syringe. 1, A1212.00. stable in acceptable range (max. 28 days). Bone other. 125mg-28, A207.90; 250mg-28, A415.80; S Reduction in the duration of marrow transplantation 150mcg/m2/day (equiv. 500mg-28, A831.60. neutropenia and incidence of febrile neutropenia S Treatment of chronic iron overload due 5mcg/kg/day) by IV inf. started on day after in patients treated with cytotoxic chemotherapy to frequent blood transfusions (r7ml/kg/month of completion of chemotherapy continue until stable for malignancy with the exception of chronic in acceptable range (max. 28 days). packed red blood cells) in patients with beta myeloid leukaemia, myelodysplastic syndrome and D Myeloid malignancy. De novo acute thalassaemia major aged 6 years and older. secondary acute myeloid leukemia (AML). myeloid malignancy aged below 55 years and/or Treatment of chronic iron overload due to blood P 6mg SC inj. for each chemotherapy cycle with good cytogenics. transfusions when deferoxamine therapy is 24 hours after cytotoxic chemotherapy. B Myelodysplasia, severe hepatic or renal contraindicated or inadequate in patients with Q Under 18 years, not recommended. impairment. Monitor for leucocytosis, pulmonary other anaemias; in patients aged 2 to 5 years; in D Pregnancy, lactation. adverse effects graft vs host disease in BMT. patients with beta thalassaemia major with iron B Caution: Patients with AML, sickle cell Pregnancy, lactation. overload due to infrequent blood transfusions disease. If preliminary signs of ARDS appear, C Cytotoxic drugs. (Q7 ml/kg/month of packed red blood cells). discontinue. Splenic rupture. Monitor platelet A Bone pain, headache. P See SPC. count and haematocrit. Needle cover contains dry Q See SPC. natural rubber (may cause allergic reactions). NEORECORMON Roche Interpreting bone-imaging results: Consider D Combination with other iron chelator AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

81


2.9 ERYTHROPOIESIS,

increased haematopoietic activity of bone marrow in response to growth factor therapy. Contains sorbitol, Na+ acetate. C Admin. 24 hours after cytotoxic chemotherapy. A Skeletal pain, inj. site pain, chest pain (non-cardiac), pain, headache, arthralgia, myalgia.

NEUPOGEN

Amgen

5NT Recombinant human granulocyte colony stimulating factor (G-CSF). Filgrastim 30 MU/ml. Liquid in single dose vial. 30 MU-5 x 1ml, A521.75.

5NT ALSO NEUPOGEN SINGLEJECT Filgrastim 30 MU, 48 MU per 0.5ml. Pre-filled syringes. 30 MU-5 x 0.5ml, A597.73. 48 MU-5 x 0.5ml. A953.13. S Reduction in duration of neutropenia and incidence of febrile neutropenia after established cytotoxic chemotherapy; reduction in duration of neutropenia after myeloablative therapy followed by bone marrow transplantation. Long term treatment to increase neutrophil counts (NC) and reduce incidence and duration of infection-related events in patients with severe congenital, cyclic or idiopathic neutropenia and history of severe or recurrent infections. Mobilisation of peripheral blood progenitor cells (PBPCs). HIV associated neutropenia . V Established cytotoxic chemotherapy: 0.5MU daily IV or SC 24 hrs after therapy. Bone marrow transplantation: Initially 1MU daily, as 30 mins. or 24 hr IV inf. or 24 hr SC inf. within 24 hrs. Both uses: Titrate against neutrophil response once nadir passed. Mobilisation of PBPCs: Alone, 1MU daily SC as 24 hr inf. or single inj. for 5-7 days. Leukapheresis: 1 or 2 on days 5 and 6. Following myelosuppressive chemotherapy: 0.5MU SC daily from day 1 post therapy until neutrophil nadir passed and NC at normal range. Leukapheresis: When the ANC rises from Q0.5 x 109/L to q5 x 109/L. Patients who have not had extensive chemotherapy, single apheresis often sufficient. Other circumstances, additional leukaphereses recommended. HIV Infections: See SPC. Severe chronic neutropenia: Congenital neutropenia, 1.2MU daily; Idiopathic or cyclic neutropenia, 0.5 MU SC; as single inj. or in divided doses. Continue until NC at q1.5 x109/L, ascertain min. required to maintain. After 1-2 weeks double or half depending on response; adjust every 1-2 weeks thereafter to maintain average NC between 1.5 x 109/L and 10 x 109/L. Severe infections, consider faster dose escalation; long-term safety of q 2.4MU daily not established. B Myelodysplastic syndrome, chronic myelogenous leukaemia. Sickle cell disease; caution. Monitor for leukocytosis, osteoporosis, pulmonary symptoms, splenomegaly. Contains sorbitol. Pregnancy (only if benefit outweighs risk), lactation. Needle cover of pre-filled syringe contains dry natural rubber. Increased haematopoietic activity of the bone marrow has been associated with transient positive boneimaging findings. A Musculo-skeletal pain, reversible increase in liver enzymes and serum uric acid, transient hypotension, rarely allergic-type reactions, cutaneous vasculitis, proteinuria, haematuria.

RATIOGRASTIM

ratiopharm

5NT Recombinant human granulocyte colony

82

CIRCULATORY SYSTEM

GRANULOCYTOPENIA stimulating factor (G-CSF) Filgrastim 60MIU/ml. Clear, colourless sln for inj. or inf. in pre-filled syringes. 30 MIU/0.5ml-5, A448.37; 48MIU/0.8 ml-5, A 714.96. S Reduction in duration of neutropenia and incidence of febrile neutropenia after established cytotoxic chemotherapy; reduction in duration of neutropenia after myeloablative therapy followed by bone marrow transplantation. Long term treatment to increase neutrophil counts (NC) and reduce incidence and duration of infection-related events in patients with severe congenital, cyclic or idiopathic neutropenia and history of severe or recurrent infections. Mobilisation of peripheral blood progenitor cells (PBPC). HIV associated neutropenia. V Established cytotoxic chemotherapy: 0.5MIU/kg/day as a daily SC injection or IV infusion less than 24 hours following therapy. Bone marrow transplantation: Initially 1MIU/kg/day as 30 min or 24 hr IV inf. or by continuous SC inf. within 24 hrs. Titrate against neutrophil response (see SPC). Mobilisation of PBPCs: Alone, 1MIU/kg/ day as 24 hour SC continuous inf. or a single daily SC inj. for 5-7 consecutive days. Leukapheresis: 1 or 2 on days 5 and 6. PBC mobilisation after myelosuppressive chemotherapy: 0.5MIU/kg/day by SC inj. from 1st day after chemotherapy completion until neutrophil nadir passed and ANC in normal range; leukapheresis: When ANC rises from Q0.5 x 109/L to q5 x 109/L. Patients who have not had extensive chemotherapy, single leukapheresis often sufficient. Severe chronic neutropenia: Congenital neutropenia, 1.2MIU/kg/ day SC as single dose or in divided doses. Idiopathic or cyclic neutropenia, 0.5MIU/kg/day SC; as single dose or in divided doses. Continue until ANC at q1.5 x109/L, establish minimum required to maintain this level. After 1-2 weeks double or half depending on response; adjust every 1-2 weeks thereafter to maintain average ANC between 1.5 x 109/L - 10 x 109/L. Severe infections, consider faster dose escalation; long-term safety of doses q 2.4MIU/kg/day not established. HIV Infections: Reversal of neutropenia, initially 0.1MIU/kg/day by SC inj. with titration up to max 0.4MIU/kg/day until a normal ANC reached and maintained (ANC q 2.0 x 109/L). Doses up to 1MIU/kg/day may be needed in some patients. Maintaining normal ANC: Establish minimal effective dose; initial dose adjustment to alternate day dosing with 30MIU/day by SC injection. Further dose adjustment may be necessary depending on patientâ&#x20AC;&#x2122;s ANC. Long term admin. may be required. B Myelodysplastic syndrome, chronic myelogenous leukaemia: Safety not established. Caution: Secondary AML, underlying osteoporotic bone diseases (treatment q 6 months, monitor bone density), recent history of pulmonary infiltrates or pneumonia, high dose chemotherapy. Perform white blood cell count regularly. Regular monitoring of platelet count and haematocrit recommended. Increased haematopoietic activity of the bone marrow has been associated with transient positive bone-imaging findings. Pregnancy (only if benefit outweighs risk), lactation. Contains sorbitol. See SPC. C Not recommended within 24 hours of chemotherapy. A Musculoskeletal pain. Cancer patients: Elevated alkaline phosphatase/LDH/uric acid, headache, cough, sore throat, GI disorders, elevated GGT, alopecia, skin rash, chest pain, fatigue, generalised weakness. Mobilisation of

PBPCs: Leukocytosis, thrombocytopenia, elevated alkaline phosphatise/LDH, headache. SCN patients: Anaemia, splenomegaly, thrombocytopenia, decreased glucose, elevated alkaline phosphatase/ LDH, hyperuricaemia, headache, epistaxis, diarrhoea, hepatomegaly, alopecia, cutaneous vasculitis, injection site pain, rash, osteoporosis. HIV patients: Spleen disorder.

RETACRIT

Hospira

5NT Erythropoietin. Epoetin zeta. Clear, colourless sln for inj. in pre-filled syringe. 1000 IU/0.3ml-6, A54.59; 2000 IU/0.6ml-6, A104.82; 3000 IU/0.9ml-6, A155.05; 4000 IU/0.4ml-6, A203.83; 5000 IU/0.5ml6, A272.98; 6000 IU/0.6ml-6, A314.47; 8000 IU/ 0.8ml-6, A436.76; 10,000 IU/1ml-6, A509.56; 20000IU/0.5ml-1, A182.01; 30000IU/0.75m-1, A273.01; 40000 IU/1ml-1, A363.97. S Anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis. Severe anaemia of renal origin with clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by patientâ&#x20AC;&#x2122;s general status. To increase yield of autologous blood from adult surgery patients in a predonation programme (see SPC). P Chronic renal failure (haemodialysis): Correction phase, 50 IU/kg IV) thrice weekly; adjust dose if necessary by 25 IU/kg thrice weekly in steps of at least 4 weeks. Maintenance total weekly dose 75-300 IU/kg. Chronic renal failure (peritoneal dialysis): Correction phase, 50 IU/kg (IV) twice weekly; maintenance, 25-50 IU/Kg (IV) twice weekly. Renal insufficiency without dialysis: Correction phase, 50 IU/kg (IV) thrice weekly; adjust dose if necessary by 25 IU/kg thrice weekly in steps of at least 4 weeks. Maintenance, 17-33 IU/kg thrice weekly. Cancer patients receiving chemotherapy: Initially 150 IU/kg subcutaneously thrice weekly, alternatively 450 IU/kg once weekly. Continue until 1 month after the end of chemotherapy (see SPC for dose adjustment). Autologous predonation programme: Mildly anaemic patients (Hct 33-39%) requiring predeposit of q4 blood units, 600 IU/kg (IV) twice weekly after blood donation procedure for 3 weeks prior to surgery, with adequate iron supplement. Q Chronic renal failure (haemodialysis): Correction phase as per adults. Maintenance, see SPC. D Patients with Pure Red Cell Aplasia (PRCA) following erythropoietin treatment. Uncontrolled hypertension. Patients unable to receive adequate antithrombotic prophylaxis. Autologous predonation programme: MI or stroke in month preceding treatment, unstable angina pectoris, increased DVT risk . B Correct other causes of anaemia; ensure adequate iron stores. Monitor BP, platelet count, reticulocyte count, Hb. Chronic renal failure: Monitor serum electrolytes; hyperkalaemia may occur (discontinue until corrected). Caution: Epilepsy, chronic liver failure. PRCA may occur (discontinue immediately, see SPC). Increased risk of thrombotic vascular events in cancer patients. Tumour growth potential cannot be excluded. Pregnancy, lactation (only if benefit outweighs risk). Contains phenylalanine.

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CNS weeks, max. 4 weeks including tapering off process. R Reduced dose. Q Not recommended. D Myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic insufficiency. Pregnancy, lactation (unless essential). 3.1 INSOMNIA B Great caution: Renal/hepatic impairment, elderly, debilitated, chronic CIRCADIN Lundbeck pulmonary insufficiency, history of alcohol or drug 2N abuse. Anterograde amnesia, psychiatric and paradoxical reactions, dependence; may occur. Melatonin 2mg. White to off white round, Withdraw gradually (warn patient about possible biconvex prolonged-release tabs. 21, A14.51. rebound phenomena). Driving/using machines. S Short-term treatment of primary insomnia characterised by poor quality of sleep in Contains lactose. C Avoid alcohol. Caution: Antipsychotics, patients aged 55 or over. hypnotics, anxiolytics/ sedatives, antidepressants, P 2mg once daily swallowed whole, 1-2 narcotic analgesics, AEDs, anaesthetics and hours before bedtime and after food. Continue sedative antihistamines, P450 inhibitors. for three weeks. A Start: Drowsiness, numbed emotions, Q Under 18 years, not recommended. B Not recommended: Hepatic impairment, dizziness, confusion, fatigue, headache, muscle weakness, ataxia, double vision. autoimmune diseases, pregnancy, lactation, lactose/sugar intolerance. Caution: Renal HALCION Pharmacia insufficiency, driving/using machines. C Avoid alcohol, fluvoxamine. Caution: 2NO Hypnotics, 5 and 8-MOP, cimetidine, smoking, Short-acting benzodiazepine. Triazolam 0.125mg, oestrogens, CYP1A2 inhibitors (eg. quinolones), 0.25mg. Lavender ellipitical tab. marked UPJOHN CYP1A2 inducers (e.g. carbamazepine, rifampicin). 10 and blue elliptical flat bevelled edge, single Potential interaction with adrenergic agonists/ score tab. marked UPJOHN 17 resp. 0.125mg-30, antagonists and certain CNS drugs. A1.96; 0.25mg-30, A1.73; 250, A14.41. A Headache, pharyngitis, back pain, S Short-term management of insomnia asthenia. which is severe, disabling or causing extreme distress. DALMANE Meda P 0.125-0.25mg at bedtime. Max. 2NO treatment duration, 4 weeks. Long-acting benzodiazepine. Flurazepam (HCl) R 0.125mg. At bedtime. Max. treatment 15mg, 30mg. 15mg Grey/yellow cap. marked duration, 4 weeks. ICN15. 30mg black/grey cap. marked ICN30. 15mg- Q Not recommended. 30, A3.49; 30mg-30, A4.62. D Myaesthenia gravis, severe respiratory S Insomnia, when severe and disabling. or hepatic insufficiency, sleep apnoea syndrome. P 5-30mg at bedtime. Duration: A few B Tolerance, dependence & associated days to 2 weeks, max. 4 weeks. Hospitalised withdrawal symptoms. Discontinue if psychiatric patients, single dose of 20mg may be given. and paradoxical reactions occur. Anterograde R Max. 15mg amnesia may occur. History of alcohol or drug Q Not recommended. abuse. Should not be used alone to treat D Myasthenia gravis, severe respiratory depression or anxiety associated with depression. insufficiency, sleep apnoea, severe hepatic Elderly, children. Pregnancy, lactation (only if insufficiency, phobic or obsessional states, chronic considered essential). Driving or using machinery. psychosis. Pregnancy, lactation. C Alcohol, CNS depressants. B Chronic respiratory insufficiency. Driving A Drowsiness, numbed emotions, reduced or operating machinery, history of alcohol or drug alertness, confusion, fatigue, headache, dizziness, abuse. Anterograde amnesia, psychiatric and muscle weakness, ataxia, double vision. paradoxical reactions, dependence; may occur. INSOMNIGER Gerard Reevaluate when extension beyond max. is necessary. Discontinue gradually. Elderly. 2NO C Not recommended: Alcohol. Caution: Benzodiazepine. Temazepam 10mg, 20mg. WhiteAntipsychotics, hypnotics, anxiolytics/sedatives, pale yellow, round, flat beveled-edge scored tabs. antidepressants, narcotic analgesics, antiepileptic marked T/10 and T/20 resp. on the scored side, drugs, anaesthetics, sedative antihistamines, and G on the other. 10mg-100, A3.73; 20mg-100, CYP450 inhibitors. A5.74. A Drowsiness, numbed emotions, fatigue, S Short-term management of insomnia reduced alertness, confusion, headache, dizziness, only when severe, disabling or subjecting the muscle weakness, ataxia, double vision. individual to extreme distress. Premedication prior to minor surgery or other related procedures. DALMAPAM Pinewood P Insomnia: 10-20mg on retiring or up to 2NO 30 mins before bedtime. Exceptionally may be Long-acting benzodiazepine. Flurazepam (HCl) increased to 30-40mg. Duration, a few days to 2 15mg, 30mg. Ivory/light grey and grey/black hard weeks. Max., incl. tapering-off, 4 weeks. gelatin caps. marked FLU 15 and FLU 30, resp. Premedication: 20-40mg, 30-60 mins before 15mg-30, A3.45; 30mg-30, A4.60. procedure. R Insomnia: 10mg. Exceptionally, may be S Insomnia, when severe and disabling. increased to 20mg. Premedication: Possibly half P 15-30mg before retiring. Duration as the normal adult dose or less. short as possible, generally from few days to 2 C Ciclosporin. A Headache, dose-dependent increase in BP, hypertensive crisis with encephalopathy-like symptoms, skin rashes, flu-like symptoms, PRCA, antibodies to erythropoietins, hypersensitivity reactions, thrombotic/vascular events, shunt thromboses.

INSOMNIA 3.1 Q Under 18 years, not recommended. D Myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic insufficiency. Pregnancy, lactation. B Anterograde amnesia may occur. Caution: Chronic respiratory insufficiency, impaired renal or liver function, history of alcohol or drug abuse. Driving/operating machines. Reevaluate when extension beyond max. is necessary. Discontinue gradually. C Alcohol (not recommended). Caution: CNS depressants, antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, antiepileptic drugs, anaesthetics and sedative antihistamines, disulfiram, inhibitors of cyt. P450. A Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or double vision. Usually transient.

MOGADON

Meda

2NO Long-acting benzodiazepine. Nitrazepam 5mg. White scored tab. marked ICN. 30, A1.11. S Short-term treatment of insomnia when severe, disabling or subjecting the individual to extreme distress. P Elderly, 2.5mg; others, 5-10mg. Both at bedtime. Hospitalised patients; single dose of 20mg may be given. Q Not recommended. D Myasthenia gravis, severe respiratory insufficiency, sleep apnoea, severe hepatic insufficiency, phobic or obsessional states, chronic psychosis. Pregnancy, lactation. B Tolerance, physical dependence; withdraw gradually. Do not exceed 4 weeks without re-evaluation. Anterograde amnesia, psychiatric reactions may occur. Caution: Children (duration kept to min.), elderly, history of alcohol/ drug abuse. Not for treatment of psychotic illness. Driving/operating machinery. C Not recommended: Alcohol. Caution: CNS depressants, CYP450 inhibitors. A Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, double vision.

NOCTAMID

Bayer Schering

2NO Int.-acting benzodiazepine. Lormetazepam 1mg. White round scored tab. marked in a hexagon with CF. Can be divided into equal halves. 30, A3.52 S Short-term treatment of insomnia. P 1mg at bedtime. R 0.5mg at bedtime. Q Depends on patient’s age, weight and general condition. Keep duration to a minimum D Myasthenia gravis. Severe respiratory insufficiency (e.g. severe COPD), sleep apnoea syndrome. Acute intoxication with alcohol, hypnotics, analgesics or psychotropic drugs (neuroleptics, antidepressants, lithium). B Not recommended for the primary treatment of psychotic illness. Not to be used alone for the treatment of sleep disorders associated with depression. Keep treatment duration as short as possible (usually few days to 2 weeks; 4 weeks max. incl. gradual dose reduction). May lead to the development of physical and psychic dependence; withdraw gradually. May induce anterograde amnesia. Caution: Severe

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

83


3.1 INSOMNIA

CNS

hepatic / renal insufficiency, chronic respiratory insufficiency, elderly. Increased risk of falling due to adverse effects incl. ataxia, muscle weakness, dizziness, somnolence/sleepiness, fatigue. Discontinue if psychiatric and paradoxical reactions occur. Contains lactose. C Not recommended: Alcohol. Caution: CNS depressants, narcotic analgesics. A Headache. Quinckeâ&#x20AC;&#x2122;s oedema, anxiety, decreased libido, dizziness, sedation, somnolence, disturbance in attention, amnesia, visual impairment, speech disorder, dysgeusia, slowed thinking, tachycardia, GI disorders, pruritus, micturition disorder, asthenia, sweating.

ROHYPNOL

Roche

2LO

Orion

2LO

Int.-acting benzodiazepine. Flunitrazepam 1mg. Greyish-green oval scored tab. marked 542. 30, A4.03. S Short-term treatment of disabling or severely distressful insomnia. P Elderly, v at bedtime; others, v-1 at bedtime. Duration: Usual, a few days - 2 weeks; max. 4 weeks. Q Contraindicated. D Respiratory depression, phobic or obsessional states, myasthenia gravis, sleep apnoea, severe hepatic insufficiency, acute pulmonary insufficiency. Pregnancy, lactation. NORTEM Teva B Tolerance, physical and psychological dependence; withdraw gradually. Anterograde 2LO amnesia may occur. Psychiatric reactions. Caution: Int.-acting benzodiazepine. Temazepam 10mg, Elderly, history of alcohol/drug abuse. Contains 20mg. White scored tabs. marked with twin lactose. Driving/operating machinery. triangle logo one side and coded TMZ 10 or TMZ 20 on reverse. 10mg-100, A4.39; 20mg-100, A6.75. C Neuroleptics, tranquillisers, S Short term treatment of insomnia when antidepressants, hypnotics, analgesics, anaesthetics, anti-epileptics, sedative anti-histamines. CYP450 severe, disabling or subjecting the individual to inhibitors/inducers. extreme distress. Premedication prior to minor A Drowsiness, numbed emotions, reduced surgery or other related procedures. alertness, confusion, fatigue, headache, dizziness, P Insomnia: Elderly, 10mg; max. 20mg. muscle weakness, ataxia, double vision. Others, 10-30mg; max. 40mg. Both at bedtime. Max. duration: 4 weeks. Pre-medication: 20-40mg SONATA Meda 30-60 min before procedure. 2NO Q Not recommended. Pyrazolopyrimidine hypnotic. Zaleplon 5mg. Both D Myasthenia gravis, severe respiratory hard caps. White/light brown with gold band and insufficiency, sleep apnoea, severe hepatic white with pink band resp. Both marked W and insufficiency. Pregnancy, lactation. strength. 5mg-14, A3.28; 10mg-14, A4.71. B Tolerance, dependence, rebound S Short-term treatment of insomnia in insomnia and anxiety: Withdraw gradually. Anterograde amnesia, psychiatric and paradoxical patients who have difficulty falling asleep. reactionss may occur. Elderly. History of alcohol or P 10mg immediately before or after going to bed. drug abuse. Narrow angle glaucoma. Periodic R 5mg. blood and liver function tests for repeated Q Under 18 years, not recommended. therapy. Driving/using machines. D Severe hepatic insufficiency, myasthenia C Avoid alcohol. Caution: CNS gravis, severe respiratory insufficiency. depressants, CYP450 inhibitors. A Drowsiness, numbed emotions, reduced B Chronic renal or hepatic disease. Physical and psychic dependence. Pregnancy, alertness, confusion, fatigue, headache, dizziness, lactation. muscle weakness, ataxia, double vision. C Alcohol and other CNS depressants, NYTAMEL Clonmel cimetidine, rifampicin, carbamazepine, phenobarbitone. 2NO A Amnesia, depression, restlessness, Imidazopyridine hypnotic. Zolpidem tartrate 5mg irritation, aggression, delusions, rages, nightmares, white oval film-ctd tab. marked ZIM and 5; 10mg hallucinations, dependence. white oval film-ctd tab. scored both sides and marked ZIM and 10. 5mg-28, A2.25; 10mg-28, STILNOCT Sanofi A4.51. 2NO S Short term management of insomnia. Imidazopyridine hypnotic. Zolpidem hemitartrate P 10mg before retiring. 5mg white film-ctd tab. 10mg white scored R 5mg before retiring. oblong film-ctd tab. marked SN 10. 5mg-28, Q Not recommended. A1.41; 10mg-28, A2.82. D Severe hepatic insufficiency, sleep S Short term treatment of insomnia. apnoea syndrome, myasthenia gravis, severe P 10mg before retiring. respiratory insufficiency, psychotic illness. R 5mg before retiring. B Renal hepatic or respiratory Q Not recommended. insufficiency. Depression, history of alcohol or drug abuse. Pregnancy, lactation. Warn of possible D Obstructive sleep apnoea, myasthenia gravis, severe hepatic or acute pulmonary drowsiness. insufficiency, respiratory depression, psychotic C Alcohol, CNS depressants, drugs that illness. inhibit certain hepatic enzymes (particularly B Hepatic or renal impairment. cytochrome P450). Depression. History of drug or alcohol abuse. A Drowsiness, headache, dizziness, Pregnancy, lactation. Warn of possible drowsiness. numbed emotions, reduced alertness, confusion, C Alcohol, other CNS depressants. vertigo, fatigue, muscle weakness, ataxia or A GI upset, dizziness, headache, double vision, GI disturbances, changes in libido, skin reactions, amnesia, depression, psychiatric and drowsiness. Very rarely, memory loss, tremor, depression, confusion, perceptual disturbances. paradoxical reactions, dependence.

84

TENOX

Int.-acting benzodiazepine. Temazepam 10mg, 20mg. Off-white scored tab. A10mg-100, A5.13; 20mg-100, A11.46. S Short term management of insomnia. P 10-30mg before retiring, increasing to max. 60mg. R Usually 10mg. Q Not recommended. D See SPC.

ZILEZE

Pinewood

2NO Cyclopyrrolone. Zopiclone 3.75mg, 7.5mg. Orange and white film-ctd tabs. marked ZOC 3.75 and ZOC 7.5, resp. 3.75mg-28, A5.23; 7.5mg-28, A6.11. S Short-term management of insomnia. P Start with lowest recommended dose. 7.5mg 30-60 minutes before retiring for max. 4 weeks including tapering off process. Diminished hepatic/renal function: Minimum dose recommended. Moderate hepatic/renal insufficiency: 3.75mg/day (caution). Severe hepatic/ renal insufficiency: Max 3.75mg/day . R Initially 3.75mg. Q Not recommended. D Myasthenia gravis, severe respiratory insufficiency, sleep apnoea, severe hepatic insufficiency. Pregnancy, lactation. B Renal, hepatic or respiratory insufficiency; half dose. Driving/using machines. History of alcohol or drug abuse. Withdraw gradually to avoid rebound insomnia. May lead to physical and psychic dependence and result in withdrawal phenomena (high dosage). Amnesia, Psychiatric and paradoxical reactions may occur. C Avoid alcohol. Caution: Antipsychotics, hypnotics, anxiolytics/ sedatives, antidepressants, narcotic analgesics, AEDs, anaesthetics, sedative antihistamines, P450 inhibitors, erythromycin, quinupristin/dalfopristin. A Headache, dizziness, bitter taste, dry mouth, blurred vision, depression, GI disturbances. Psychiatric and paradoxical reactions eg. restlessness, aggressiveness, psychoses. Anterograde amnesia, dependence, morning drowsiness/incoordination, lightheadedness, occasional irritability.

ZIMOCLONE

Gerard

2NO Cyclopyrrolone. Zopiclone 7.5mg. White oval filmctd scored tab. marked zz one side and 7.5 on reverse. 28, A6.13. S Short-term management of insomnia. P 7.5mg at night. R Initially 3.75mg at night. (Dose also applies to patients with hepatic, renal impairment and chronic respiratory insufficiency). Q Not recommended. D Myasthenia gravis, severe respiratory insufficiency, sleep apnoea, severe hepatic insufficiency. Pregnancy, lactation. B Renal, hepatic or respiratory insufficiency. Patients should not drive or operate machinery until it is established that mental and physical ability has not been impaired. History of alcohol or drug abuse. C Alcohol, CNS depressants, drugs that inhibit certain hepatic enzymes (particularly cytochrome P450). A Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness,

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Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CNS slowly. C Alcohol, other CNS depressants, antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, anti-epileptics, sedative antihistamines. ZIMOVANE Meda A Drowsiness, headach, dizziness, numbed emotions, reduced alertness, confusion, vertigo, GI 2NO disturbances (diarrhoea, nausea, vomiting), double Cyclopyrrolone. Zopiclone 7.5mg. White scored vision, skin reactions, amnesia. A film-ctd tab. 28, 3.68. S Short term management of insomnia. ZOPITAN Clonmel P 1 at night. R Initially 3.75mg. Dosage should be kept 2 N O to a minimum. Hepatic insufficiency: Max. 3.75mg Cyclopyrrolone. Zopiclone 3.75mg orange film-ctd daily. Renal insufficiency: Max. 7.5mg daily. tab. marked ZOC 3.75; 7.5mg white film-ctd tab. Q Not recommended. marked ZOC 7.5 and scored both sides. 3.75mg-28, A5.15; 7.5mg-28, A5.99 D Myasthenia gravis, respiratory failure, sleep apnoea, severe hepatic insufficiency. S Short-term management of insomnia. Pregnancy, lactation. P 7.5mg at night. B Epilepsy, renal, hepatic or respiratory R Initially 3.75mg at night. (Dose also insufficiency. Patients should not drive or operate applies to patients with hepatic, renal impairment machinery until it has been established that and chronic respiratory insufficiency). mental and physical ability has not been impaired. Q Not recommended. History of alcohol abuse. D Myasthenia gravis, severe respiratory C Alcohol, CNS depressants, trimipramine, insufficiency, sleep apnoea, severe hepatic drugs dependent on hepatic oxidative pathways insufficiency. Pregnancy, lactation. for metabolism (e.g. cimetidine). B Renal, hepatic or respiratory A Morning drowsiness, inco-ordination, insufficiency. Patients should not drive or operate headache, dizziness, bitter taste and dry mouth. machinery until it is established that mental and Irritability, depression or nervousness. Amnesia, physical ability has not been impaired. History of automatism, confusion, nightmare, hangover. alcohol or drug abuse. C Alcohol, CNS depressants, drugs that ZOLDEM Gerard inhibit certain hepatic enzymes (particularly cytochrome P450). 2NO A Drowsiness, numbed emotions, reduced Imidazopyridine hypnotic. Zolpidem (tartrate) 10mg. White to off-white cap. shaped tab. marked alertness, confusion, fatigue, headache, dizziness, ZM breakline 10 on one side and G on reverse. 28, muscle weakness, ataxia or double vision, GI disturbances, changes in libido, skin reactions, A4.69. bitter taste, amnesia, depression, psychiatric and S Short term treatment of severe, paradoxical reactions, dependence. disabling insomnia. P 10mg immediately before going to bed. ZORCLONE Teva Debilitated patients, hepatic insufficiency: 5mg. 2NO R 5mg. Q Under 18 years, not recommended. Cyclopyrrolone. Zopiclone 7.5mg. White film-ctd D Severe hepatic insufficiency, sleep tab. marked Zoc 7.5 and scored both sides. 28, A5.52. apnoea syndrome, myasthenia gravis, severe respiratory insufficiency. Pregnancy, lactation (no S Short-term treatment of insomnia. data). P 7.5mg at night. B Treat cause of insomnia first. Evaluate R Initially 3.75mg at night. (Dose also psychiatric or physical disorder (if no remission applies to patients with hepatic, renal impairment after 7-14 days treatment). and chronic respiratory insufficiency). C Alcohol. Caution: Antipsychotics Q Not recommended. (neuroleptics), hypnotics, anxiolytics/sedatives/ D Myasthenia gravis, severe respiratory muscle relaxants, antidepressant agents, narcotic insufficiency, sleep apnoea, severe hepatic analgesics, antiepileptic drugs, anaesthetics and insufficiency. Pregnancy, lactation. sedative antihistamines. B Renal, hepatic or respiratory A Drowsiness, headache, dizziness, insufficiency. Patients should not drive or operate numbed emotions, reduced alertness, confusion, machinery until it is established that mental and vertigo, GI disturbances, double vision, skin physical ability has not been impaired. History of reactions, amnesia. alcohol or drug abuse. C Alcohol, CNS depressants, drugs that ZOLNOD Rowex inhibit certain hepatic enzymes (particularly cytochrome P450). 2NO Imidazopyridine hypnotic. Zolpidem tartrate 10mg. A Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, White scored oblong film-ctd tab. 30, A5.03. muscle weakness, ataxia or double vision, GI S Short term treatment of insomnia. P 10mg daily before retiring. Elderly, 5mg disturbances, changes in libido, skin reactions, daily. Duration of treatment should be as short as bitter taste, amnesia, depression, psychiatric and paradoxical reactions, dependence. possible, max. 4 weeks. Q Under 18 years, not recommended. 3.2 ANXIETY DISORDERS D Severe hepatic insufficiency, sleep apnoea syndrome, myasthenia gravis, severe ANXICALM Clonmel respiratory insufficiency. B Some loss of efficacy may develop after 2 N O Long-acting benzodiazepine. Diazepam 2mg, 5mg, repeated use. Pregnancy, lactation. Reduce dose muscle weakness, ataxia or double vision, GI disturbances, changes in libido, skin reactions, bitter taste, amnesia, depression, psychiatric and paradoxical reactions, dependence.

ANXIETY

DISORDERS

3.2

10mg. White scored tab. marked D2, yellow scored tab. marked D5, blue scored tab. marked D10. 2mg-90, A1.01; 5mg-90, A1.54; 10mg-90, A3.81. S Anxiety, tension, psychosomatic disorders. P 2-10mg three times daily. D See SPC. C Compounds which can inhibit certain hepatic enzymes.

ATIVAN

Wyeth

2NO Int.-acting benzodiazepine. Lorazepam 1mg. White, round, flat bevelled-edged scored tab. impressed with 1.0 on one side. 1mg-100, A3.03. S Short term treatment of moderate to severe anxiety. P Elderly, 0.5-2mg daily; others, 1-4mg daily in divided doses. Q Not recommended. D See SPC.

BETA-PROGRANE

Tillomed

3MO Non-cardioselective b-blocker. Propranolol (HCl) 80mg, 160mg. White hard prolonged.-release cap. 160mg-28, A8.13; 80mg (HALF BETA-PROGRANE)28, A6.27. S Anxiety, essential tremor. P H80mg every morning or evening; may be increased if necessary to 160mg daily up to 240mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.

CALMAX

Ergha

2NO Medium-acting benzodiazepine. Alprazolam 0.25mg, 0.5mg, 1mg. White tab. marked ’apzm 0.25’, pink tab. marked ’apzm 0.5’, light blue tab. marked ’apzm 1’ resp. All tabs. oblong, scored. 0.25mg-100, A2.03. 0.5mg-100, A3.92. 1mg-100, A8.18. S Anxiety disorders. P 0.25-0.5mg three times daily. Max. 4mg daily. R 0.25mg two or three times daily. Q Not recommended. D See SPC.

CENTRAX

Parke-Davis

2NO Long acting benzodiazepine. Prazepam 10mg. Blue scored tab. marked W and 10. 60, A3.77. S Anxiety, when the disorder is severe, disabling or subjecting the individual to extreme distress. P Elderly, 5-15mg daily; others, 10-60mg daily in single or divided doses. Duration: Max 4-6 weeks. Q Not recommended. D Myasthenia gravis, severe respiratory/ hepatic insufficiency, sleep apnoea syndrome, acute narrow-angle glaucoma. B Long term use: Tolerance may develop; risk of dependence. Withdraw gradually. Caution: History of alcohol/drug abuse, elderly, children. Contains lactose. May induce anterograde amnesia. Risk of psychiatric and paradoxical reactions, discontinue if occurs. Not recommended for primary treatment of psychotic illness. Should not be used alone to treat depression/anxiety associated with depression (suicide may be precipitated). Driving or using machinery.

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

85


3.2 ANXIETY

CNS

DISORDERS

ciprofloxacin, or enoxacine (all contraindicated), other MAOIs (not recommended). Caution: Anticoagulants, St Johnâ&#x20AC;&#x2122;s wort, warfarin, CYP2D6 substrates, other centrally acting and sedative drugs, smoking. A Weight decrease, palpitations, tremor, paraesthesia, blurred vision, tinnitus, yawning, GI disorders, increased sweating, rash, musculoCITROL Rowex skeletal pain, muscle tightness, muscle spasm, decreased appetite, flushing, fatigue, abdominal 2NO pain, erectile dysfunction, insomnia, agitation, SSRI. Citalopram (hydrobromide) 10mg, 20mg, 30mg. 10mg, round tab; 20mg and 30mg, oblong decreased libido, anxiety, abnormal orgasm, biconvex tabs. with one sided score notch marked abnormal dreams. C20 and C30. All white film-ctd. 10mg-28, A10.33; DIAZEMULS Actavis 10mg-30, A11.08; 20mg-28, A16.40; 30mg-28, 2NO A28.00. S Panic disorder with or without Benzodiazepine. Diazepam 5mg/ml. Emulsion for agoraphobia. inj. 10, A7.20. P 10mg once daily for the 1st week, then S Severe anxiety or agitation incl. delirium may be increased to 20mg per day, and up to tremens; acute muscle spasm including that 60mg per day. 1st effects after 2-4 weeks; full associated with tetanus; convulsions and status response after up to 3 months. epilepticus; pre-operative medication in minor R 10mg daily. Max. 30mg daily. surgery. Q Under 18 years, not recommended. P By slow IV inj. (1ml/min), IM inj., or inf. B Risk of suicide until therapeutic effects (min. 4ml/h). Anxiety/agitation: Usually 10mg are achieved. Diabetes, unstable epilepsy, history repeated 4 hourly. Acute muscle spasm: 0.1-0.3mg/ of mania, bleeding disorders, hepatic or severe kg IV repeated every 1-4 hrs as required, or renal impairment. Driving/operating machines. continuous inf. of 3-10mg/kg every 24 hrs. ECT. Lactation, pregnancy (only if essential). Convulsions: 10-20mg IV or IM. Status epilepticus, Withdraw slowly. initially, 0.15-0.25mg/kg IV repeated in 30 to 60 C MAOIs (within 14 days); contraindicated. mins; may be followed by IV inf. of up to 3mg/kg Alcohol, St Johnâ&#x20AC;&#x2122;s Wort, 5-HT agonists, tryptophan; over 24 hrs. Premedication: 0.1-0.2mg/kg IV not recommended. Caution: CYP2D6 substrates, titrated to patient response. Duration max. 8 cimetidine, lithium, desipramine, neuroleptics, weeks for anxiety, 4 weeks for insomnia incl. anticoagulants and drugs increasing bleeding risk tapering off process. (e.g. NSAIDs, antipsychotics, TCAs). R Elderly or debilitated, reduce initial dose A Somnolence, insomnia, agitation, by half. nervousness, headache, tremor, dizziness, Q Convulsions: 0.2-0.3mg/kg IV or IM (or palpitations, nausea, dry mouth, GI disorders, 1mg per year of life). increased sweating, abnormal accommodation, D Myasthenia gravis, severe respiratory asthenia, tachycardia, hypotension, hypertension, insufficiency, sleep apnoea syndrome, severe micturition disorder, polyuria, weight change, hepatic insufficiency. Pregnancy, lactation. rhinitis, sinusitis, sexual disorders, rash, vision or B Chronic respiratory insufficiency, history taste abnormalities. of alcohol or drug abuse. Not recommended: Use in depression, anxiety associated to depression, CYMBALTA Lilly psychotic illness. Children. Tolerance may develop after repeated use. Driving or using machines. 2NO 5HT/NA reuptake inhibitor. Duloxetine (HCl) 30mg, Discontinue gradually. C Alcohol (avoid). Caution: Antipsychotics, 60mg. Opaque caps. White body marked 30mg hypnotics, anxiolytics/ sedatives, antidepressants, with blue cap marked 9543; green body marked narcotic analgesics, anti-epileptics, anaesthetics, 60mg with blue cap marked 9542 resp. 30mg-28, sedative antihistamines, P450 inhibitors. A 20.50; 60mg-28, A 34.15. A Drowsiness, numbed emotions, reduced S Generalised Anxiety Disorder. alertness, confusion, fatigue, headache, dizziness, P Initially 30mg once daily; if insufficient muscle weakness, ataxia, double vision, response increase to 60mg (usual maintenance restlessness, agitation, irritability, aggressiveness, dose). Max. 120mg daily. After consolidation of delusion, rages, nightmares, hallucinations, response, continue treatment for several months. psychoses, inappropriate behaviour. Physical and Discontinue gradually over 1-2 weeks. psychic dependence, anterograde amnesia. PreQ Under 18 years, not recommended. existing depression may be unmasked. Psychiatric D Liver disease resulting in hepatic and paradoxical reactions. impairment, severe renal impairment (ccQ30ml/ Pregnancy, lactation. C Alcohol, not recommended. Caution: Other CNS depressants, cytochrome P450 inhibitors, oral contraceptives. A Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, double vision.

min), uncontrolled hypertension. Pregnancy (unless essential), lactation. B History of mania, bipolar disorder, seizures, increased IOP or risk of acute narrowangle glaucoma. Hypertensive crisis reported. Hypertension, cardiac disease; monitor BP at least 1st month. Elderly. Suicidal thoughts; monitor carefully. May occur: Liver injury, incl. severe elevations of liver enzymes, hepatitis and jaundice. Akathisia may develop. Driving/using machines. Contains sucrose. C Non-selective, irreversible MAOIs and potent CYP1A2 inhibitors, eg. fluvoxamine,

86

EFEXOR XL

once daily with food. May be increased to max 225mg/day. Make increments at 2 weeks intervals or more. Maintain lowest effective dose. Panic disorder: Initially 37.5mg/day for the 1st 7 days, then 75mg once daily. Max. 225mg/day if necessary. Increases at 2 week intervals or more. Severe renal impairment: 1/2 dose. Mild-moderate hepatic impairment: 1/2 dose; further reduction may be required in some patients. R Use lowest effective dose. Q Under 18 years, not recommended. B For prescribing information, see venlafaxine Drug Presc. Notes.

FRISIUM

sanofi-aventis

2NO Benzodiazepine. Clobazam 10mg. White tab. marked Hoechst one side, scored and coded B/GL on reverse. 100, A9.44. S Acute or chronic anxiety, relief of symptoms associated with anxiety states, phobia and psychosomatic disorders. P Elderly, 20mg; others, 20-30mg. Both daily in divided doses or as a single dose at night. Max. 60mg daily. Duration: 2-4 weeks. Q Under 3 years, not recommended; 3-12 years, up to half adult dose. D Myasthenia gravis, severe respiratory insufficiency, sleep apnoea, severe hepatic insufficiency, drug or alcohol dependence. Pregnancy, lactation (use only if essential). Children (6 months-3 years) other than in exceptional cases. B Tolerance, dependence, anterograde amnesia, psychiatric and paradoxical reactions may occur. Caution: Pre-existing muscle weakness, spinal/cerebellar ataxia. Elderly, acute respiratory insufficiency, renal/hepatic impairment; reduce dose. Driving/operating machinery. C Not recommended: Alcohol. Caution: CNS depressants. A Drowsiness, reduced alertness, numbed emotions, confusion, fatigue, headache, dizziness, muscle weakness, fine tremor, double vision.

GERAX

Gerard

2NO Medium-acting benzodiazepine. Alprazolam 0.25mg, 0.5mg, 1mg. White oval scored tab. marked GL 0.25 one side, pink oval scored tab. marked GL 0.50 one side, blue oval scored tab. marked GL1.0 one side resp. All marked G on reverse. 0.25mg-100, A3.51; 0.5mg-100, A6.76; 1mg-100, A14.12.

INDERAL LA

AstraZeneca

3MO Non-cardioselective b-blocker. Propranolol (HCl) 160mg. Lavender/pink hard prolong.-release cap. marked INDERAL LA. 28, A8.41.

3MO ALSO HALF-INDERAL LA Propranolol (HCl) 80mg.

Wyeth Lavender/pink hard prolong.-release cap. marked

2NO 5HT/NA reuptake inhibitor. Venlafaxine (as HCl) 37.5mg, 75mg, 150mg. Resp., opaque peach with opaque light crey caps, opaque peach, opaque dark orange, marked W and strength. All prolonged-release hard caps. 37.5mg-7, A2.39; 75mg-28, A13.70; 150mg-28, A23.10. S Generalised anxiety disorder. Social anxiety disorder. Panic disorder, with or without agoraphobia. P Generalised anxiety/social anxiety: 75mg

HALF-INDERAL LA. 28, A6.13. S Anxiety. P 80mg or 160mg daily. Max. 240mg daily. Q Not recommended.

3MO ALSO INDERAL TABLETS Propranolol (HCl) 10mg. Pink film-ctd tab. marked Inderal 10. 10mg-100, A1.20. P Initially 40mg two or three times daily increasing if necessary at weekly intervals.

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Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CNS

ANXIETY

Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. Tabs contain lactose.

LEXAPRO

Lundbeck

2NO SSRI. Escitalopram (oxalate) 5mg, 10mg, 15mg, 20mg. Round white film-ctd tab. marked EK and oval white scored film-ctd tabs. marked with EL, EM and EN, resp. 5mg-28, A14.00; 10mg-28, A22.40; 15mg-28, A33.90; 20mg-28, A44.80. S Major depressive episodes. Generalised anxiety disorder (GAD). Panic disorder with or without agoraphobia. Social anxiety disorder (SAD). Obsessive-compulsive disorder (OCD). P Panic disorder: Initially 5mg for 1st week, may increase to max. 20mg daily. Max. effect reached after 3 months. GAD: 10mg once daily, may increase to max. 20mg. SAD: 10mg once daily. Relief of symptoms 2-4 weeks. Depending on response adjust dose between 5mg-20mg daily. Continue for up to 12 weeks. Depression, OCD: See section 3.4. Reduced hepatic function: Initially 5mg for 2 weeks, may increase to 10mg. R Over 65 years, initially half adult dose and lower max. dose. Q Under 18 years, not recommended. B Hyponatraemia observed with SSRI use. History of mania/hypomania, co-admin. of ECT in patients on SSRI’s, bleeding disorders, coronary heart disease, paradoxical anxiety. Monitor patients with unstable epilepsy, diabetes. Withdraw gradually. Closely monitor patients for suicide and self harm during initiation of therapy (all SSRIs). Driving/using machine. Pregnancy, lactation. C Contra: Non-selective, irreversible MAOIs. Reversible MAOI-A (moclobemide), not recommended. Caution: Selegiline, lithium, tryptophan, St. John’s Wort, drugs lowering epilepsy seizure threshold, oral anticoagulants, cimetidine, substrates or inhibitors of CYP2C19 (eg. omeprazole), CYP2D6 substrates, other serotonergic drugs, alcohol. A Nausea, sweating, somnolence, fatigue, dizziness, insomnia, constipation, diarrhoea, appetite decrease, sexual dysfunction, pyrexia, sinusitis, yawning.

LEXOTAN

Roche

2NO Intermediate-acting benzodiazepine. Bromazepam 1.5mg, 3mg. Slighly yellow cylindrical tab. marked Roche 1.5mg and pink cylindrical tab. marked Roche 3 resp. 1.5mg-30, A2.71. 3mg-30, A3.43. S Short-term treatment of anxiety. P 3-18mg daily. Both in divided doses. R 1.5-9mg daily. Q Not recommended. D Respiratory depression, acute respiratory insufficiency, sleep apnoea syndrome, severe hepatic insufficiency, myasthenia gravis. B Pregnancy, lactation, renal and hepatic impairment. C Alcohol, antipsychotics, hypnotics, anxiolytics/sedatives, narcotic analgesics, antiepileptic drugs, anaesthetics and sedative antihistamines. A Drowsiness, reduced alertness, confusion, fatique, headache, dizziness, muscle weakness, double vision. Amnesia, restlessness, agitation, irritability, aggression, hallucinations, psychosis, dependence. See SPC.

DISORDERS

3.2

A81.70. S Generalised Anxiety Disorder (GAD). P Initial daily dose, 150mg in either two Long-acting benzodiazepine. Chlordiazepoxide or three divided doses; may be increased to 5mg, 10mg. Green/yellow cap. and green/black 300mg, 450mg, and to max. 600mg/day with 1cap resp. Both marked LIB and cap. strength 5mg- week intervals. Discontinue gradually over a min. 100, A5.37; 10mg-100, A7.47. of 1 week. Renal impairment: Adjust dosage (see S Short-term treatment of anxiety that is SPC). severe, disabling or subjecting the individual to Q Under 18 years, not recommended. unacceptable distress; symptoms of acute alcohol D Pregnancy (unless essential), lactation. withdrawal; control of muscle spasm. B Withdrawal symptoms may occur. P Anxiety: Up to 30mg daily; max. 100mg Driving/using machines. Contains lactose. daily. All in divided doses. Alcohol withdrawal: 25- C Caution: Ethanol, lorazepam, 100mg repeated if necessary in 2-4 hours. antidiabetics (adjust dose). R Do not exceed half adult dose. A Dizziness, tiredness. Increased appetite, D Myasthenia gravis, severe respiratory weight gain, euphoric mood, confusion, change in insufficiency, sleep apnoea, severe hepatic libido, irritability, attention disturbances, insufficiency. Pregnancy, lactation. clumsiness, memory impairment, tremor, speech B Tolerance, physical dependence. Caution: difficulty, paraesthesia, visual disturbances, Alcohol/drug abuse (or history of). Withdraw vertigo, dry mouth, GI disorders, erectile gradually. Do not exceed 4 weeks without careful dysfunction, peripheral oedema, drunken feeling, re-evaluation. Anterograde amnesia, psychiatric abnormal gait. reactions may occur. Caution: Children (duration kept to min.). Elderly. Not for treatment of STELAZINE Goldshield psychotic illness. Driving/operating machinery. 2MO C Not recommended: Alcohol. Caution: Phenothiazine group III. Trifluoperazine (HCl) 1mg, CNS depressants, CYP450 inhibitors. 5mg. Blue sug-ctd tabs. marked SKF. 1mg-112, A Drowsiness, numbed emotions, reduced A 2.75; 5mg-112, A3.92. alertness, confusion, fatigue, headache, dizziness, 2MO muscle weakness, ataxia, double vision. ALSO STELAZINE SYRUP Trifluoperazine (HCl) LUSTRAL Pfizer 1mg/5ml. 200ml, A1.93. S Anxiety states, depressive symptoms 2NO secondary to anxiety, agitation. SSRI. Sertraline (HCl) 50mg, 100mg. White, capP 2-4mg daily in divided doses. Max. 6mg shaped, film-ctd tabs. marked PFIZER and ZLT-50 daily. or ZLT-100 resp. 50mg tab. scored. 50mg-28, Q Under 6 years, not recommended; 6-12 A12.63. 100mg-28, A18.94. years, up to 4mg daily. All in divided doses. S Panic disorder with or without D Comatose states, bone marrow agoraphobia. Social anxiety disorder. Postdepression, liver damage, existing blood dyscrasia. traumatic stress disorders. Uncontrolled cardiac decompensation. P Initially, 25mg daily increasing to 50mg B Elderly. CVD. Parkinsonism. Pregnancy, daily after 1 week. Dose may be increased in lactation. Epilepsy. 50mg increments over a period of weeks, to max. A See SPC. 200mg daily. Q Not recommended. STESOLID Actavis D Significant hepatic insufficiency. 2NO Pregnancy, lactation. Unstable epilepsy or Benzodiazepine. Diazepam 2mg, 4mg per ml. convulsant disorders. Rectal soln. in 5mg and 10mg tubes. 5mg-5, B Monitor for suicidality during 1st few A5.39; 10mg-5, A6.75. weeks of treatment. Discontinue if patient enters S Acute severe anxiety and agitation, a manic phase. Controlled epilepsy. ECT, not epileptic and febrile convulsions, tetanus, as recommended. Driving or using machines. sedative in minor surgical and dental procedures, C Contraindicated: MAOIs (or within 14 or when rapid effect required but IV inj. days), pimozide. Monitor alcohol, lithium, impracticable. warfarin, phenytoin, sumatriptan. Caution: St P 10mg. Repeat dose if no response John’s wort, diazepam, tolbutamide, cimetidine, within 5 mins. TCAs, other centrally acting drugs, other R 5mg. Repeat dose if no response within serotonergic drugs. 5 mins. A Anorexia, insomnia, dizziness, Q 1-3 years, 5mg; over 3 years, 10mg. somnolence, tremor, GI disorders, increased Repeat dose if no response within 5 mins. sweating, ejaculatory delay. D Acute pulmonary insufficiency, respiratory depression, sleep apnoea syndrome. Pregnancy, lactation. B Should not be used in phobic or obsessional states, chronic psychosis, bereavement. Not to be used alone for depression or anxiety LYRICA Pfizer associated with depression. Caution: Personality 2MO disorders, renal or hepatic dysfunction, chronic GABA analogue. Pregabalin 25mg, 50mg, 75mg, pulmonary insufficiency, closed-angle glaucoma. 100mg, 150mg, 200mg, 300mg. Hard gelatine cap., Elderly or debilitated patients. Amnesia, marked Pfizer on cap., and PGN and strength on withdrawal symptoms may occur. Do not drive or body. 25mg-56, A81.70; 84, A122.55; 50mg-84, operate machines. A122.55; 75mg-56, A81.70; 100mg-84, A122.55; C CNS depressants (avoid), alcohol. 150mg-56, A81.70; 200mg-84, A122.55; 300mg-56, A Drowsiness, light-headedness,

LIBRIUM

Meda

2NO

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

87


3.3 PSYCHOSES

CNS

Severe hepatic impairment, history of seizure disorder or conditions associated with seizures, diabetes mellitus, CVD, cerebrovascular disease, predisposition for hypotension or hypertension, nightmares) 2NO family history of QT prolongation, risk of C Alcohol, CNS depressants. Nonbenzodiazepine anxiolytic. Hydroxyzine HCI aspiration pneumonia. Monitor for signs of A Amnesia, drowsiness, depression, 25mg. White, oblong, film-ctd biconvex scored pychiatric and paradoxical reactions, dependence. hyperglycaemia, tardive dyskinesia, neuroleptic tabs. 25, A1.31. malignant syndrome. Not approved for dementia2NO 3.3 PSYCHOSES related psychosis. Driving/using machines. ALSO UCERAX SYRUP Hydroxyzine HCI 10mg/5ml. Hypersensitivity reactions may occur. Clear to slightly yellow syrup (2 flavours). 200ml, ABILIFY BMS C Caution: Potent inhibitors of CYP2D6 A2.75. 2NO (eg. quinidine, fluoxetine, paroxetine) or CYP3A4, S Anxiety/tension states, psychomotor potent CYP3A4 inducers, certain antihypertensives, Atypical antipsychotic. Aripiprazole 5mg, 10mg, agitation and acute stress situations e.g. minor 15mg, 30mg. Rect. and blue, rect. and pink, round drugs causing QT prolongation, alcohol or other surgical procedures or allergic states. Pruritus due CNS drugs. and yellow, round and pink tabs., marked A-007 to allergic conditions e.g. chronic urticaria, atopic/ and 5, A-008 and 10, A-009 and 15, A-011 and 30 A Somnolence, dizziness, headache, contact dermatitis, histamine-mediated pruritus. resp. 5mg-28, A123.79; 10mg-28, A128.41; 15mg- akathisia, nausea, vomiting, restlessness, insomnia, P Anxiety: 50mg daily in 3 doses of anxiety, extrapyramidal disorder, akathisia, tremor, 28, A128.41; 30mg-28, A256.82 12.5mg-12.5mg-25mg. More severe cases, up to dizziness, somnolence, sedation, blurred vision, GI S Schizophrenia (adults and adolescents 300mg daily. Pruritus: Initially 25mg before disorders, fatigue. q 15 years). Treatment of moderate to severe resting, then if necessary up to 25mg, 3-4 times manic episodes in Bipolar I Disorder and daily. Max.: Single dose, 200mg; daily dose, Clonmel prevention of new manic episodes in patients who CLONACTIL 300mg. Hepatic dysfunction, reduce daily dose by experienced predominantly manic episodes and 2MO 33%. whose manic episodes responded to aripiprazole. Phenothiazine group I. Chlorpromazine (HCl) R Initially, half recommended dose. P 10 or 15mg (10 or 15ml) once daily; 25mg, 50mg, 100mg. White film-ctd tabs. marked Q Over 6 years: 1mg/kg up to 2mg/kg Maintenance, 15mg daily. Max. 30mg daily. with tab. name and strength. 25mg-250, A6.18; daily in divided doses. R Consider lower starting dose. 50mg-250, A9.03; 100mg-250, A15.13. D Pregnancy and lactation. Porphyria. Q Under 15 years, not recommended. Over S Anxiety and tension states; B Caution: Glaucoma, bladder outflow 15 years, schizophrenia: Initially 2mg for 2 days schizophrenia and other psychoses. Terminal illness obstruction, decreased GI motility, myasthenia titrated to 5mg for 2 additional days to reach and intractable hiccup. gravis, dementia. Increased potential for recommended daily dose (10mg). May be P Anxiety, agitation and psychoses: 75convulsions; known predisposing factor to cardiac increased in 5mg increments to max 30mg daily. 300mg daily, taken in divided doses. Psychoses, arrhythmia or concomitant treatment with 2 N O potentially arrhythmogenic drugs. Young children, dose may be up to 1g daily. Intractable hiccup: 10elderly, moderate/severe renal impairment (reduce ALSO ABILIFY ODT Aripiprazole 10mg, 15mg. 25mg 6 to 8 hourly, increasing to 25-50mg 6-8 Orodispersible round tab. marked with strength dose). Stop at least 5 days before allergy testing. hourly if necessary. Terminal illness: 10-25mg, 4-6 on one side and A over 640 or 641 resp. on Contains ethanol, sucrose. Driving or using hourly. reverse. 10mg, pink; 15mg, yellow. 10mg-28, machines. R Agitated states: 10-25mg once or twice A141.12; 15mg-28, A141.12. C Avoid: MAOIs, alcohol. Barbiturates, daily. Other conditions: 1/3 to 1/2 usual adult dose S Schizophrenia. Treatment of moderate other CNS depressants, anticholinergics, with gradual titration upward. to severe manic episodes in Bipolar I Disorder and Q Anxiety, agitation and psychoses: 1-5 betahistine, anticholinesterases, phenytoin, prevention of new manic episodes in patients who cimetidine, CYP2D6 substrates. years, 0.5mg/kg every 4-6 hours to max 40mg/day. experienced predominantly manic episodes and 6-12 years,1/3 to 1/2 of adult dose to max of VALIUM Roche whose manic episodes responded to aripiprazole. 75mg/day. Terminal illness: 0.5mg/kg every 4-6 2NO hours. 1-5 years: Max 40mg/day. 6-12 years: Max 2NO ALSO ABILIFY ORAL SOLUTION Aripiprazole 1mg/ 75mg/day. Long-acting benzodiazepine. Diazepam 5mg. 1ml. Bottle. 150 ml, A137.36 D Coma due to CNS depressants. Scored yellow tab.and marked with 5 and ROCHE. S Schizophrenia. Moderate to severe Lactation. Use with other potentially haemotoxic 5mg-100, A1.08. manic episodes in Bipolar I Disorder and drugs. S Anxiety; acute alcohol withdrawal; short prevention of new manic episodes in patients who B Risk of: Angle-closure glaucoma, urinary term treatment of insomnia where daytime experienced predominantly manic episodes and retention, dyskinesias, neuroleptic malignant sedation is acceptable. Night terrors and whose manic episodes responded to aripiprazole. syndrome. History of jaundice, existent liver somnambulism in children. 2N dysfunction or blood dyscrasias. Long term use, P 3-30mg daily in divided doses. ALSO ABILIFY SOLUTION FOR INJECTION monitor regularly. Caution: High doses, elderly, R 3-15mg daily. Aripiprazole 7.5mg/ml. Clear, colourless, aqueous extremes of temperature, CVD, parkinsonism, Q See SPC. sln for inj. epilepsy. Patients with risk factors for ventricular D See SPC. S Rapid control of agitation and disturbed arrhythmias. Establish accurate diagnosis if using XANAX Pharmacia behaviours in patients with schizophrenia or in to relieve severe vomiting. Pregnancy. Contains patients with manic episodes in Bipolar I Disorder, lactose. Driving or using machines (if drowsiness 2NO when oral therapy is not appropriate. Treatment occurs). Medium-acting benzodiazepine. Alprazolam with aripiprazole solution for inj. should be C CNS depressants, antihypertensives, 0.25mg, 0.5mg, 1mg. White, pink and lavender discontinued as soon as clinically appropriate and anticholinergics, MAOIs, analgesics, antioval scored tabs. marked UPJOHN 29, UPJOHN 55 use of oral aripiprazole should be initiated. Parkinsonian drugs. Drugs which prolong QT and UPJOHN 90 resp. 0.25mg-100, A2.11; 0.5mgP For IM use. Initially, 9.75mg (1.3 ml), as interval. Deferoxamine, lithium, oral 100, A4.06; 1mg-100, A8.48. a single IM inj. Effective dose range: 5.25-15mg as hypoglycaemics, insulin. Antacids (admin. 2 hours S Anxiety when the disorder is severe, a single inj. A lower dose of 5.25 mg (0.7 ml) may apart). disabling or causing extreme distress. be given, according to clinical status. A 2nd inj. A Postural hypotension, anticholinergic P 0.5-1mg daily in divided doses, may be admin 2 hrs after the 1st inj. Max 3 inj. in effects, drowsiness, thermoregulation disorders, increasing in increments not greater than 1mg 24 hr. Max daily dose 30mg (incl. all formulations weight gain, hyperglycaemia, changes in glucose every 3-4 days to 3-4 daily. Max. treatment of aripiprazole). tolerance, tachycardia, QT interval prolongation, duration, 8-12 weeks. R Consider lower starting dose. allergic skin reactions, rash, photosensitivity, R 0.25mg twice daily. Q Under 18 yrs, not recommended. haematological disorders. Q Not recommended. D Pregnancy (unless benefit outweighs D Myaesthenia gravis, severe respiratory risk), lactation. CLOPIXOL Lundbeck or hepatic insufficiency sleep apnoea syndrome. B Monitor for suicidal behaviour particularly after initiation or switching of therapy. 2 N O B Tolerance, physical and psychic pendence, anterograde amnesia, psychiatric and paradoxical reactions (e.g restlessness, agitation,

unsteadiness, ataxia.

UCERAX

88

UCB irritability, aggressiveness, delusion, rages,

2

5

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c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


Treat today for tomorrow ABILIFY® is indicated for the treatment of schizophrenia in adults and in adolescents* 15 years and older. ABILIFY® is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. ABILIFY® (aripiprazole) PRESCRIBING INFORMATION. TABLETS, ORODISPERSIBLE TABLETS, ORAL SOLUTION AND SOLUTION FOR INJECTION. See Summary of Product Characteristics before prescribing. PRESENTATION: Tablets: 5mg, 10mg, 15mg, 30mg aripiprazole; orodispersible tablets (ODT): 10mg, 15mg aripiprazole; oral solution (OS): 1mg/ml aripiprazole, solution for injection for intramuscular use (IM): 7.5mg/ml aripiprazole (1.3ml vial containing 9.75mg aripiprazole). INDICATIONS: Oral formulations: Adults: Schizophrenia. Moderate to severe manic episodes in Bipolar I Disorder & prevention of new manic episodes in aripiprazole respondent patients. Paediatric patients: Schizophrenia in adolescents 15 years and older. IM: Rapid control of agitation & disturbed behaviours in schizophrenia or manic episodes in Bipolar I Disorder. DOSAGE: Oral formulations: Adults: Schizophrenia: Usual starting dose is 10 or 15mg once daily with or without food. Effective dose range is 10 to 30mg with a recommended maintenance dose of 15mg. Mania in Bipolar I Disorder: Usual starting dose is 15mg once daily with or without food as monotherapy or combination therapy. For recurrence prevention, continue at same dose. Dose adjustment on basis of clinical status. Paediatric patients: Schizophrenia: Recommended dose is 10 mg/day once daily with or without food. Treatment to be initiated at 2mg (using ABILIFY Oral Solution 1 mg/ml) for two days, titrated to 5mg for two more days to reach recommended daily dose of 10 mg. Effective dose range is 10 to 30 mg/day. IM: Initial dose 9.75mg (1.3ml) injection. Effective dose range: 5.25 to 15 mg as single injection. Lower dose of 5.25 mg (0.7 ml) may be given. Second injection may be administered two hours after the first, on basis of individual clinical status. No more than three injections in any 24-hour period. For all formulations (adult and paediatric patients): Maximum daily dose 30mg. No dosage adjustment required in renal or mild to moderate hepatic impairment. Elderly (≥ 65 years): Efficacy not established. Consider lower starting dose. Not recommended for use in paediatric patients below 15

*indicated in oral formulations only

years of age: Safety and efficacy not established. CONTRAINDICATIONS: Hypersensitivity to any ingredient. WARNINGS AND PRECAUTIONS: Clinical improvement may take several days to some weeks: monitor patient throughout this period. Reduce dose or discontinue if signs of tardive dyskinesia appear. Discontinue if patient develops signs and symptoms indicative of neuroleptic malignant syndrome. Caution in patients with a history of seizure, cardiovascular disorders, conduction abnormalities, diabetes and elderly demented patients with psychosis and those at risk of aspiration pneumonia (see SPC). Do not use in pregnancy unless benefit outweighs risk; breastfeeding not advised. Until individual patient response established, caution not to drive or operate machinery. IM: observe patients for orthostatic hypotension and regularly monitor blood pressure, pulse, respiratory rate and level of consciousness. If additional parenteral benzodiazepine therapy is deemed necessary, monitor patients for excessive sedation and for orthostatic hypotension. DRUG INTERACTIONS: Increased hypotensive effect with certain antihypertensives. Caution is advised when combining with alcohol or other CNS medication with overlapping side effects such as sedation; also with certain antifungals, antituberculous drugs, antivirals, anticonvulsants, St John’s Wort and medicines known to cause QT prolongation or electrolyte imbalance. Reduce aripiprazole dose with concomitant use of potent CYP3A4 or CYP2D6 inhibitors, e.g. fluoxetine, paroxetine. Increase aripiprazole dose with concomitant use of potent CYP3A4 inducers, e.g. carbamazepine. See SPC. IM: increased sedation when combined with lorazepam. UNDESIRABLE EFFECTS: In adult placebocontrolled trials, the following adverse drug reactions were reported: Tablets, ODT, OS, IM common (> 1/100 < 1/10): somnolence, dizziness, headache, akathisia, nausea, vomiting: Tablets, ODT, OS common: restlessness, insomnia, anxiety, extrapyramidal disorder, tremor, sedation, blurred vision, dyspepsia, constipation, salivary hypersecretion, fatigue; Tablets ODT, OS, IM uncommon:

(> 1/1000 < 1/100): tachycardia, orthostatic hypotension; IM: uncommon (> 1/1000 < 1/100): increased diastolic blood pressure, fatigue, dry mouth.; Tablets, ODT, OS: uncommon (> 1/1000 < 1/100): depression. In adolescent (13-17 years) placebo-controlled trials, the adverse drug reactions reported were similar to those for adults. The following adverse drug reactions were reported more frequently than for adults: very common (≥ 1/10): somnolence, sedation, extrapyramidal disorder; common (≥ 1/100 < 1/10): dry mouth, increased appetite, orthostatic hypotension. Other adverse events from postmarketing surveillance include; allergic reaction (anaphylaxis & angioedema), pancreatitis, priapism, suicide, rhabdomyolysis, hyperglycaemia, diabetes, dysphagia, convulsions, cardiac disorders including arrhythmias & sudden unexplained death, thromboembolic events, hypertension, hepatitis, leukopenia and thrombocytopenia. Symptoms of dystonia may occur in susceptible individuals during the first few days of treatment, with an elevated risk of acute dystonia observed in males and younger age groups. Other findings, see SPC. OVERDOSAGE: Treatment should be symptomatic and supportive: adequate airway maintenance, cardiovascular monitoring and close medical supervision. Activated charcoal reduces serum concentrations. LEGAL CATEGORY: POM. AUTHORISATION NUMBERS: 28 tablets: 5mg (EU/1/04/276/002), 10mg (EU/1/04/276/007), 15mg (EU/1/04/276/012), 30mg (EU/1/04/276/017). 28 orodispersible tablets: 10mg (EU/1/04/276/025), 15mg (EU/1/04/276/028). 150mL bottle 1mg/ml oral solution: (EU/1/04/276/034). 1.3ml vial 7.5mg/ml solution for injection: (EU/1/04/276/036). MARKETING AUTHORISATION HOLDER: Otsuka Pharmaceutical Europe Ltd, Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU. ADDITIONAL INFORMATION AVAILABLE ON REQUEST FROM: Bristol-Myers Squibb Pharmaceuticals, South County Business Park, Leopardstown, Dublin 18. Tel: 1-800-749-749. DATE OF P.I. PREPARATION: October 2009 (II-48).

570IE09PM043


3.3 PSYCHOSES

CNS

alcohol, CNS depressants, antihistamines, lithium, MAOIs, anticholinergics. Drugs effecting hepatic enzymes, highly protein bound drugs, cimetidine, phenytoin, adrenaline, drugs with hypotensive or respiratory depressant effects, fluvoxamine. A Neutropenia leading to life threatening agranulocytosis. Drowsiness, fatigue, hypersalivation, tachycardia, dizziness, headache, 2NO urinary retention and incontinence, transient ALSO CLOPIXOL INJECTION Zuclopenthixol tremor, akathisia, rigidity, NMS rarely, postural decanoate 200mg/ml oily inj. Amp. 10 x 1ml, hypotension, hypertension, weight gain, isolated A34.96. P Usually 200-400mg by deep IM inj. every skin reactions, autonomic effects. GI upset. ECG changes, myocarditis. Seizures, confusion, 2-4 weeks. Max. 600mg a week. restlessness, agitation, delirium. Circulatory Q Not recommended. collapse, respiratory depression or arrest, 2NO ALSO CLOPIXOL-CONC. Zuclopenthixol decanoate aspiration, dysphagia, hyperglycaemia, rarely CPK increase. 500mg/ml oily inj. Amp. 5 x 1ml, A42.02. P 250-500mg by deep IM inj. every one to DENZAPINE Merz four weeks. 2N Q Not recommended. 2NO Dibenzodiazepine. Clozapine 25mg, 50mg, 100mg, 200mg. 25mg, 50mg, 100mg: Round flat yellow ALSO CLOPIXOL ACUPHASE Zuclopenthixol acetate 50mg/ml. 1ml, 2ml amps. 5 x 1ml, A26.06. bevel edged tabs marked with strength over a pressure sensitive breakline. 200mg: Large, ovalS Initial treatment for acute psychoses, shaped yellow tab. with strength on one side and incl. mania or exacerbation of chronic psychosis. a breakline on the other. 25mg-84, A40.00; 50mgP 50-150mg deep IM inj. repeated if 50, A47.62; 100mg-84, A160.00; 200mg-50, necessary after 2 or 3 days. A190.48. Q Not recommended. D Comatose states, apathy or withdrawal, 2 N pregnancy, lactation. ALSO DENZAPINE ORAL SUSPENSION Clozapine, B Intolerance to oral neuroleptic drugs, 50mg/ml. Free-flowing yellow susp. 100ml, A95.24. S Treatment-resistant schizophrenia in Parkinson’s disease, renal, hepatic, cardiovascular patients unresponsive to or intolerant of or respiratory disease. Elderly may need dose conventional neuroleptics. Psychotic disorders reduction. occurring during the course of Parkinson’s disease, C See SPC if standard treatment has failed. CLOZARIL Novartis P Schizophrenia: Initially 12.5mg once or twice on first day increasing by 25-50mg 2N increments up to 300mg daily within 2-3 weeks; Dibenzodiazepine. Clozapine 25mg, 100mg. may be further increased in 50-100mg increments Yellow, circular, scored tabs marked L/O and Z/A at half-weekly or, preferably, weekly intervals. resp. on one side and SANDOZ on reverse. 25mgUsual range: 200-450mg/day given in divided 84, A57.03; 100mg-84, A228.12. doses. Max. 900mg daily. Parkinson’s: Initially S Treatment-resistant schizophrenia in 12.5mg/day in the evening. Increase by 12.5mg patients unresponsive to or intolerant of increments, with max. 2 increments a week up to conventional neuroleptics. Commence therapy in 50mg once daily. Usual range: 25-37.5mg/day. hospital. Max. 50mg/day, exceptionally 100mg/day. P Initially 12.5mg once or twice on first R Initially 12.5mg daily increasing day increasing slowly up to 300mg daily within 14- gradually in increments of 25mg daily. 21 days, max. 900mg daily. After max. benefit Q Not recommended. achieved titrate down to maintenance dose. See D Patients unable to undergo regular SPC. blood tests. History of granulocytopenia/ R Initially 12.5mg daily increasing agranulocytosis (except if from chemotherapy). gradually in increments of 25mg daily. Impaired bone marrow function. Uncontrolled Q Not recommended. epilepsy. alcoholic and other toxic psychoses, drug D History of drug induced neutropenia/ intoxication, comatose conditions. Circulatory agranulocytosis or myeloproliferative disorders. collapse and/or CNS depression. Severe renal or Alcoholic and toxic psychoses, drug intoxication, cardiac disorders. Active liver disease associated comatose states, uncontrolled epilepsy, circulatory with nausea, anorexia or jaundice; progressive collapse, CNS depression, severe hepatic or renal liver disease, hepatic failure. Paralytic ileus. disease. Lactation. Lactation. B Patients must register with CPMS. B Can cause agranulocytosis. Initiation Monitor leucocyte counts weekly during first 18 restricted to WBC countq3500/mm3 and weeks and every 2 weeks thereafter; withdraw neutrophil count q 2000/mm3). Monitor these immediately if wbc count below 3 x 109/l and/or counts weekly for first 18 weeks and at least 49 neutrophil count below 1.5 x 10 /l. Patients should week intervals thereafter including 4 weeks after report symptoms of infection. Pregnancy; complete discontinuation (see SPC). Discontinue adequate contraception must be used. Monitor immediately if neutropenia or agranulocytosis. patients with a history of epilepsy. Prostatic Caution: CVD or family history of QT hypertrophy, narrow angle glaucoma, paralytic prolongation, risk factor for stroke, liver disorders, ileus. Liver disease. Orthostatic hypotension, prostatic enlargement, narrow-angle glaucoma. cardiovascular, renal or hepatic disorders, transient Reported: Myocarditis, pericarditis/ pericardial temperature elevations. effusion, cardiomyopathy, impairment of intestinal C Other drugs which cause peristalsis, neuroleptic malignant syndrome, hyperglycaemia, thromboembolism. Withdraw agranulocytosis, narcotics, benzodiazepines, Thioxanthene. Zuclopenthixol (HCl) pink tab.;10mg light brown tab.; 25mg brown tab. All film-ctd tabs. 10mg-100, A8.70; 25mg-100, A17.40. S Psychoses, especially schizophrenia. P Initially 20-30mg daily in divided doses. Maintenance, 20-60mg daily. Max. 150mg daily. Q Not recommended.

90

gradually over 1-2-weeks. Pregnancy. Driving/using machines. Contains lactose. C Contra: Drugs causing agranulocytosis (co-trimoxazole, chloramphenicol, sulphonamides, pyrazolone analgesics e.g. phenylbutazone, penicillamine, carbamazepine, cytotoxic agents); avoid depot antipsychotics, drugs causing electrolyte imbalance, drugs prolonging QT, alcohol. Caution: CNS depressants, drugs with anticholinergic, hypotensive, or respiratory depressant effects, norepinephrine, epinephrine, CYP1A2 inhibitors (caffeine) and inducers (omeprazole), smoking, fluvoxamine, paroxetine, carbamazepine, phenytoin, rifampicin, CNS-active agents. See SPC. A Leucopoenia/decreased WBC/ neutropenia, eosinophilia, leukocytosis, weight gain, drowsiness, dizziness, blurred vision, headache, tremor, rigidity, akathisia, extra pyramidal symptoms, seizures, tachycardia, ECG changes, hypertension, postural hypotension, syncope, GI disorders, dry mouth, elevated liver enzymes, urinary incontinence/ retention, fatigue, fever, temperature regulation disturbances.

DEPIXOL

Lundbeck

2NO Thioxanthene. Flupenthixol decanoate 20mg/ml oily inj. Amps. 10 x 1ml, A18.01.

2NO ALSO DEPIXOL CONC. INJECTION 100 MG/ML Flupenthixol decanoate 100mg/ml oily inj. Amps. 10 x 1ml, A74.21. S Schizophrenia and other psychoses, particularly in patients who are withdrawn or apathetic. P 20-40mg or more as required every two to four weeks. Give by deep IM inj. Q Not recommended.

2NO ALSO DEPIXOL 200MG Flupenthixol decanoate 200mg/ml oily inj. Amp. 5 x 1ml, A115.11. P 50-200mg by deep IM inj. Repeat usually every two to four weeks. Max. 400mg weekly. Q Not recommended. D Comatose states, pregnancy, lactation, excitation or overactive patients. B Intolerance to oral neuroleptic drugs, Parkinson’s disease, renal, hepatic, cardiovascular or respiratory disease. Elderly may need dose reduction. C See SPC.

DOLMATIL

Sanofi

2MO Substituted benzamide. Sulpiride 200mg white scored tab. marked D200; 400mg white scored stick-shaped film-ctd tab. 200mg-100, A24.45; 400mg-100, A42.51. S Acute and chronic schizophrenia. P Over 14 years, initially 400-800mg daily in two divided doses (morning and evening). Adjust to 100-1200mg twice daily according to required response. See SPC. Q Under 14 years, not recommended. D Phaeochromocytoma. B Hypomania. Hypertension. Renal impairment. Epilepsy. Pregnancy. C See SPC.

GEODON

Pfizer

2NO 5-HT2A and dopamine (D2) receptor antagonist.

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CNS Ziprasidone (as HCl monohydrate) 20mg blue/ white cap. 40mg blue cap. 60mg white cap. 80mg blue/white cap. All marked with Pfizer and ZDX 20, ZDX 40, ZDX 60 or ZDX 80. 20mg-56, A104.01; 40mg-56, A109.48; 60mg-56, A120.43; 80mg-56, A158.75. S Schizophrenia. P Acute treatment, 40mg twice daily with food. Max. 80mg twice daily. Maintenance, lowest effective dose, 20mg twice daily may be sufficient. Hepatic insufficiency: Consider lower dose. Q Not recommended. D Known QT-interval prolongation, congenital long QT syndrome. Recent MI, uncompensated HF. Pregnancy, lactation. B Bradycardia, electrolyte disturbances. If cardiac symptoms occur, a cardiac evaluation should be performed. Neuroleptic malignant syndrome and torsade de pointes have been reported rarely. Tardive extrapyramidal syndrome after long-term treatment, reduce dose or discontinue. History of seizures, hepatic impairment. Patients with risk factors for stroke. Contains lactose. Ability to drive or operate machinary my be impaired. Women of child bearing potential should use contraception. C Contra: Class IA and III antiarrhythmics, arsenic trioxide, halofantrine, levomethadyl, mesoridazine, thioridazine, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, dolasetron mesylate, mefloquine, sertindole, cisapride, drugs that prolong the QT interval. Caution: CNS drugs, alcohol, ketoconazole, carbamazepine. A Restlessness, dystonia, akathisia, extrapyramidal disorder, parkinsonism, tremor, dizziness, sedation, somnolence, headache, vision blurred, GI disorders, musculoskeletal rigidity, asthenia, fatigue.

PSYCHOSES 3.3 thyrotoxicosis, phaeochromocytoma, hepatic/renal dysfunction, epilepsy or predisposing conditions, severe cardiovascular disease, hyperthyroidism, risk factors for stroke. May occur: Hypotension, hypertension (less common). C Contra: Other QT prolonging drugs. Caution: Alcohol, hypnotics, sedatives, strong analgesics, lithium, levodopa, methyldopa, adrenaline and other sympathomimetic agents, adrenergic blocking agents (e.g. guanethidine), tricyclic antidepressants, cytochrome P450 inhibitors (esp. ketoconazole, paroxetine), CYP2D6 inhibitors, quinidine, buspirone, fluoxetine, anticonvulsants, carbamazepine, phenobarbital, rifampicin, phenodione. A Agitation, insomnia, depression, psychotic disorder, extrapyramidal disorder, hyperkinesia, headache, tardive dyskinesia, oculogyric crisis, dystonia, dyskinesia, akkathisia, bradykinesia, hypokinesia, hypertonia, masked facies, somnolence, tremor, dizziness, visual disturbance, orthostatic hypotension, hypotension, GI disorders, abnormal liver function test, rash, urinary retention, erectile dysfunction, inj. site reaction, increased/decreased weight.

A Headache, akathisia, dizziness, dystonia, extrapyramidal disorder, hypertonia, parkinsonism, sedation, somnolence, tremor, AV block 1st degree, bradycardia, bundle branch block, sinus tachycardia, tachycardia, orthostatic hypotension, GI disorders, asthenia, fatigue, weight increased.

MODECATE

BMS

2NO Depot phenothiazine group III. Fluphenazine decanoate 25mg/ml oily inj. Multi-dose vial. 10ml x 1, A28.00. S Maintenance treatment of psychotic disorders particularly schizophrenia.

2NO

ALSO MODECATE CONCENTRATE Fluphenazine decanoate 100mg/ml oily inj. Amps. 0.5ml x 10, A58.21; 1ml x 5, A56.89. P Initially 12.5mg by deep IM inj. into gluteal region to test susceptibility to extrapyramidal reactions, then adjust dose according to response. Usual dosage range, 12.5100mg every two to five weeks. See SPC. Elderly patients, initial test dose of 6.25mg, then same as adult. Q Not recommended. INVEGA Janssen-Cilag D Comatose states, phaeochromocytoma, 2MO marked cerebral atherosclerosis, renal or hepatic Other antipsychotics. Paliperidone 3mg, 6mg, 9mg. failure, severe cardiac insufficiency, severely Trilayer cylindrical-shaped longitudinal prolonged- depressed states, blood dyscrasias. release tabs. 3mg, white marked PAL 3; 6mg, B Caution: Liver disease, cardiac beige marked PAL 6; 9mg, pink marked PAL 9. arrhythmias, CVD, family history of 3mg-28, A125.92; 6mg-28, A132.36; 9mg-28, QTprolongation or narrow angle glaucoma, A170.46. thyrotoxicosis, severe respiratory disease, epilepsy, S Treatment of schizophrenia. Parkinson’s disease, elderly, hypothyroidism, P 6mg once daily, in the morning. Range: myasthenia gravis, prostatic hypertrophy, very hot 3-12mg once daily. Always take in fasting state or weather, surgery. Perform blood count and liver always take with breakfast and do not alternate function tests (1st few months). Pregnancy, the two. Adjust dose only after clinical lactation. Driving/ using machines. HALDOL DECANOATE Janssen-Cilag between reassessment. Swallow tab. whole with liquids. C Avoid: Other antipsychotics, QT 2NO Mild renal impairment: 3mg once daily; increase if prolonging drugs and drugs causing elecrolyte Butyrophenone. Haloperidol (as decanoate) 50mg/ necessary. Moderate renal impairment: 3mg once imbalance. Large doses of hypnotics (contra). daily. Severe renal impairment: 3mg every other ml, 100mg/ml. Slightly amber, slightly viscous oily Caution: Alcohol, sedatives, strong analgesics, bday, may increase to once daily after clinical sln for IM inj. in 1ml amps. 50mg/ml-5, A25.88; blockers, thiazide diuretics, ACE-inhibitors, reassessment. 100mg/ml-5, A34.30. sympathomimetics, L-dopa, anti-convulsants, S Long term management of behavioural Q Under 18 years, no experience. anticoagulants, MAOIs, TCAs, antidepressants, D Pregnancy (unless clearly necessary), disorders, schizophrenia, hypomania and mania lithium, antidiabetics, corticosteroids, digoxin, lactation. and allied conditions. neuromuscular blocking agents, anti-Parkinsonians, P Initially 50mg every 4 weeks by deep IM B Known CVD or family history of QT anticholinergics, quinidine and other antiprolongation. Neuroleptic Malignant Syndrome/ inj. May be increased to 200mg every 4 weeks in arrythmics. tardive dyskinesia reported (discontinue). Monitor A Parkinsonian-like states. Lethargy, 50mg increments. Higher doses may be given if diabetics (and patients with risk factors). necessary. blurred vision, dry mouth, nasal congestion, R Start with low doses 12.5-25mg every 4 Cerebrovascular disease, conditions that predispose constipation, urinary disorders, mild hypotension, to hypotension. History of seizures. Potential for weeks increasing according to response. cognitive disorders, epileptiform attacks, rash, GI obstruction; only use in patients who are able Q Not recommended. hypothermia, oedema. to swallow the tab. whole. Conditions with D Comatose states. Parkinson’s disease and/or lesion of the basal ganglia. CNS depression decreased GI transit time (caution). Renal NOZINAN sanofi-aventis impairment, dose adjustment may be required; due to alcohol or other depressant drugs. 2NO Clinically significant cardiac disorders, QTc interval ccQ10ml/min, not recommended. Severe hepatic Phenothiazine group I. Levomepromazine (HCl) prolongation, history of ventricular arrhythmia or impairment, not recommended. Elderly patients 2.5%. Sln for inj. or inf. 10 x 1ml, A14.25. with dementia (particularly with risk factors for Torsades de pointes, bradycardia or 2nd or 3rd S Schizophrenia, other major psychoses stroke). Parkinson’s disease, dementia with Lewy degree heart block, uncorrected hypokalaemia. bodies. Risk of priapism (seek urgent medical care incl. mania and hypomania. As adjunct in the Pregnancy, lactation. if not resolved within 3-4 hours). Conditions which relief of severe terminal pain with accompanying B To exclude unexpected adverse may elevate core body temperature. An antiemetic anxiety, restlessness or distress. sensitivity, start patients on oral haloperidol. P 12.5-25mg IM or IV after dilution, every effect may occur; which may mask overdosage/ Baseline ECG recommended prior to treatment 6 to 8 hrs. Severe cases, up to 50mg every 6 to 8 esp. in elderly and patients with positive personal other conditions. 3mg tab. contains lactose. C Not recommended: Risperidone. Caution: hrs. Alternatively 25-200mg daily, diluted with or family history of cardiac disease or abnormal Drugs prolonging QT interval, other centrally cardiac clinical findings; ECG monitoring during saline by continuous SC infusion. acting drugs or alcohol, levodopa and other therapy may be needed. Reduce dose if QT Q Not recommended. prolonged; discontinue if QTc q 500ms. Rare cases dopamine agonists, other agents that induce D Coma (particularly if associated with orthostatic hypotension or lower the seizure of sudden death reported in patients on other CNS depressants). Closed angle glaucoma threshold or that affect GI transit time. antipsychotic drugs (incl. haloperidol). Cardiac risk. Risk of urinary retention related to Carbamazepine, rifampicin and St John’s wort effects reported very rarely. Caution: Risk factors urethroprostatic disorders. History of for ventricular arrhythmias (assess risk vs benefit), (dose re-evaluation needed). agranulocytosis. Lactation. Pregnancy (only use if AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

91


3.3 PSYCHOSES

CNS

60, A124.64; 6mg-30, A100.88. S Schizophrenia. Maintenance treatment in order to prevent relapse in chronic schizophrenia in responsive patients. Aggression and pronounced psychotic symptoms in patients with dementia in whom such disorders can cause suffering, potential danger or risk of self-harm in the patient. Manic episodes in association with bipolar disorder. Serious acting out conduct disorders such as behavioural disorder and oppositional defiant disorder according to DSM IV in patients with psychological development disorders. Serious conduct disorders in children and adolescents with autism. P Swallow tabs with water. Acute and chronic treatment of schizophrenia: Taken once daily or twice daily. Initially 2 mg/day. May be increased to 4mg/day on day 2. Usual range: 4mg6mg/day. Caution doses q 10mg daily. Max: 16mg/day. Serious conduct disorders: r50kg: Initially 0.5mg daily; increase as required by 0.5mg daily every other day. Optimal dose: 1mg daily; range 0.5mg-2mg once daily. Q50kg: Initially 0.25mg daily. Dose can be increased as required by 0.25mg daily every other day. Optimal dose: 0.5mg daily; range 0.25mg-2mg once daily. Aggression and pronounced psychotic symptoms in patients with dementia: Initially 0.25mg twice daily. Increase as required by 0.25mg twice daily every other day. Optimal dose: 1mg daily. Some patients may need 2mg daily. When optimal dose obtained, consider a once daily dose. Manic episodes in association with bipolar disorder: Initially 2mg once daily. May increase as required by 1mg daily at 24 hour intervals. Optimal dose: 16mg/day. Impaired renal function: Half starting dose and titrate slower. ORAP Janssen-Cilag R Acute and chronic treatment of schizophrenia: Initially 0.5mg twice daily. May 2MO increase by 0.5mg twice daily to 1-2mg twice Diphenylbutylpiperidine. Pimozide 4mg. Green daily. Manic episodes in association with bipolar scored tab. marked 0/4 one side, JANSSEN on disorder: Initially 0.5mg twice daily. Adjust reverse. 100, A36.48. individually to 1-2 mg twice daily. S Management of schizophrenia and Q Acute and chronic treatment of allied psychoses incl. monosymptomatic schizophrenia: Under 15 years, not recommended. hypochondriacal psychoses. Serious conduct disorders: As per adults. Under 5 P Schizophrenia and allied psychoses: years of age, limited data. Autism: Initially 0.25mg/ Initially 2-4mg daily, maintenance 2-12mg daily day for patients Q 30kg and 0.5mg/day for depending on individual response. Max. 20mg patients r 30kg. Day 4, may increase as required daily. Elderly, half starting dose. by 0.25mg for patients Q 30kg and 0.5mg for Q Not recommended. patients r 30kg. Maintain dose and evaluate on D Patients with pre-existing congenital QT day 14. Dosage can be increased at 2-weekly prolongation and patients with history of cardiac intervals by 0.25mg for patients Q 30 kg and 0.5 arrhythmias. mg for patients r 30 kg. Maximum dosage in B Endogenous depression. Parkinsonism, clinical studies did not exceed 1.5mg for patients epilepsy. Cardiovascular disorders. Pregnancy, Q 30 kg, 2.5 mg for patients r 30 kg or 3.5 mg lactation. for patients q 45 kg. See SPC. Under 5 years of C Inhibitors of CYP3A4 and CYP2D6 (eg. age, limited data. Manic episodes: Under 18 years, quinidine), drugs prolonging QT interval eg. no data. certain anti-arrhythmics, TCAs, maprotiline, D Pregnancy (unless essential), lactation. phenothiazines, sertindole, astemizole, B Caution: Cardiovascular disorders, Lewy terfenadine, cisapride, bepridil, halofantrine and body dementia or Parkinson’s disease, epilepsy. sparfloxacin; all contra. Drugs causing electrolyte Tardive dyskinesia may develop. Neuroleptic disturbances (avoid). Caution: Anticholinergics, malignant syndrome may occur. Reduce/ levodopa. discontinue if excitation, agitation and aggression occur. Elderly, hepatic and renal impairment. PERDAMEL Clonmel Elderly patients with dementia (weigh the risks 2NO against the benefits; avoid dehydration). Non Selective monoaminergic antagonist. Risperidone drug-related hyperprolactinaemia, prolactin0.5mg, 1mg, 2mg, 3mg, 4mg, 6mg. Brownish-red/ dependent tumours. Diabetics and patients with white/salmon/yellow/ light green or yellow film-ctd risk factors. Withdraw gradually. There is a lack of tabs, resp. All marked R and strength. All (except experience of preventative long-term treatment of 6mg) oblong and scored. 6mg, round, not scored. bipolar disorder. Contains lactose. Driving, using 0.5mg-20, A8.36; 1mg-20, A10.86; 1mg-60, machines. A32.55; 2mg-60, A64.23; 3mg-60, A94.44; 4mgC Avoid: Alcohol. Caution: Centrally acting essential). B Should not be used in PD (except special cases). Caution: Liver dysfunction, blood dyscrasias, history of jaundice, stroke risk factors, elderly, dementia, severe hepatic/renal insufficiency, cardiovascular disease, risk factors for thromboembolism. May occur: Extrapyramidal side effects, dyskinesia, akathisia, dystonia, tardive dyskinesia, neuroleptic malignant syndrome. Dose dependent QT interval prolongation. Hypotension. Lowers seizure threshold in epilepsy. Avoid alcohol. Surveillance for eye changes. May interfere with thermoregulation. Driving/using machinery. C Contra: Dopaminergic agonists (except in Parkinson’s disease), sultopride, benzamide neuroleptic. Not recommended: Alcohol, levodopa, class Ia anti-arrhythmics, class III anti-arrhythmics, phenothiazines, benzamides, butyrophenones, pimozide, bepridil, cisapride, diphenmanil, erythromycin IV, mizolastine, vincamine IV, halofantrine, moxifloxacin, pentamidine, sparfloxacin. Caution: Antihypertensives, atropine and atropine-like substances, guanethidine, CNS depressants, drugs metabolised by cyt. P450 2D6, alkaline solutions. A Postural hypotension, anticholinergic effects, sedation/drowsiness, indifference, anxiety reactions, mood changes, early-onset dyskinesia, extrapyramidal syndrome, tardive dyskinesia, hyperprolactinemia, alteration in temperature regulation, weight gain, hyperglycemia, glucose tolerance alteration, allergic skin reactions, photosensitisation, leucopenia, hyperleucocytosis/ granulocytopenia (discontinue), brownish deposits in anterior eye segment.

92

drugs, other antipsychotics, lithium, antidepressants, antiparkinson agents, drugs that have a central anticholinergic effect, alphablocking sympatholytics, methyldopa, reserpine, centrally acting antihypertensive agents, guanethidine, levodopa and other dopaminergic agonists, carbamazepine. Potent CYP2D6 inhibitors. Drugs prolonging QT-interval. Drugs that may cause electrolyte disturbances. Furosemide in elderly patients with dementia. A Agitation, anxiety, insomnia, headache, sedation, weight gain.

RESDAL

Niche

2NO Selective monoaminergic antagonist. Risperidone 0.5mg, 1mg, 2mg. Round, slightly convex, pink marbled orodispersible tablets. 0.5mg-28, A7.45; 1mg-28, A16.03; 2mg-28, A32.11. S Treatment of schizophrenia. Maintenance treatment in order to prevent relapse in chronic schizophrenia in responsive patients. P Initially 2mg daily; may increase dose to 4mg on day 2. Usual optimal dose: 4-6mg daily. Doses q10mg daily did not increase therapeutic effect. Over 16mg, not recommended. If sedation required benzodiazepine can be administered concomitantly. Renal disorders: Initially 1 mg/day with slow titration to optimal dose (v adult doses). Moderate to severe hepatic impairment: Caution. R Initially 0.5mg twice daily. Maintain or adjust individually with 0.5mg twice daily increments up to 1-2mg twice daily. Q Over 15 years, as per adults. Under 15 years, not recommended. D Pregnancy (unless benefits outweigh risk), lactation. B Elderly patients with dementia: Avoid dehydration, increased risk of cerebrovascular events (assess risks against benefits). May cause orthostatic hypotension (consider dose reduction). Possible induction of tardive dyskinesia. Neuroleptic malignant syndrome may occur. Caution: Lewy body dementia, Parkinson’s disease, epilepsy, family history of QT prolongation, known cardiovascular disease, non drug-related hyperprolactinaemia, prolactin-dependent tumours, diabetes (or at risk patients). Driving/ using machines. Contains: Phenylalanine (aspartame), sorbitol. C Avoid alcohol. Caution: Drugs acting on CNS including other antipsychotics, lithium, antidepressants, antiparkinson agents and active substances with a central anticholinergic effect, levodopa and other dopaminergic agonists, carbamazepine or other hepatic enzyme inducing drugs, phenothiazines, TCAs and certain bblockers, strong CYP2D6 inhibitors , cimetidine, ranitidine, drugs prolonging QT-interval or causing electrolyte disturbances. A Agitation, anxiety, insomnia, headache and sedation, weight gain.

RISPAL

Pinewood

2NO Selective monoaminergic antagonist. Risperidone 0.5mg, 1mg, 2mg, 3mg. Resp. red-brown, white, peach, yellow round biconvex film-ctd tabs. 0.5, 1 and 2mg scored. 0.5mg-20, A8.75; 1mg-60, A34.08; 2mg-60, A67.24; 3mg-60, A98.90. S Schizophrenia and other psychoses: Acute and chronic, in which positive and/or negative symptoms are prominent; affective

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CNS symptoms; maintenance in responsive patients. Bipolar disorder: Short-term treatment of acute mania or mixed episodes, as monotherapy or in combination with lithium or valproate. Severe behavioural disturbances in: Patients with dementia; adults/children with impaired social functioning; children with autism/ developmental disorders. P Schizophrenia: Take once or twice daily. Initially, 2mg/day; may be increased to 4mg/day on day 2. Usual range: 4-6mg/day. Caution with dose q10mg/day. Max. 16mg/day. 1st episode, may benefit from lower doses and slower titration. Renal and liver disease: 0.5mg twice daily; may be adjusted with 0.5mg twice daily increments to 12mg twice daily. Bipolar mania: Once daily. Range 2-6mg/day. Monotherapy, start 2mg; may be increased by increment of max 1mg per 24 hrs. Adjunctive therapy, start 2mg; may be increased by increment of max 2mg/day every other day. Dementia: Initially 0.25mg twice daily adjusted by increments of 0.25mg twice daily every other day if needed. Optimum dose 0.5mg twice daily; may be increased up to 1mg twice daily. When target dose is reached, a once daily dosing regimen can be considered. Disruptive behaviour disorders: r50kg, initially 0.5mg once daily, adjusted by increments of 0.5mg once daily every other day, if needed. Optimum dose 1mg once daily; range 0.51.5mg once daily. R50kg, initially 0.25mg once daily, adjusted by increments of 0.25mg once daily every other day, if needed. Optimum dose 0.5mg once daily; range 0.25-0.75mg once daily. R Schizophrenia: 0.5mg twice daily; may be adjusted with 0.5mg twice daily increments to 1-2mg twice daily. Q Schizophrenia: Under 15 years, not recommended. Autism: 5 years and over, see SPC. Disruptive behaviour,: See adult dose; limited experience under 5 years. D Pregnancy (unless benefit outweighs risk), lactation. B Renal, hepatic, CVD, epilepsy, dementia, elderly. May occur: Orthostatic hypotension, tardive dyskinesia, extrapyramidal symptoms, neuroleptic malignant syndrome (discontinue), hyperglycaemia, possible weight gain. Contains lactose. 0.5mg, 2mg and 3mg tabs contain sunset yellow. Driving/operating machinery. C Caution: CNS acting drugs, levodopa and other dopamine agonists, carbamazepine or other hepatic enzyme inducing drugs, CYP2D6 inhibitors (e.g.fluoxetine, paroxetine), furosemide (patients with dementia). A Insomnia, agitation, anxiety, headache, mild and transient sedation.

PSYCHOSES 3.3 ALSO RISPERDAL LIQUID Risperidone 1mg/ml. Liquid. 100ml plus pipette, A50.53. S Schizophrenia. Moderate to severe manic episodes associated with bipolar disorders. Short-term treatment (up to 6 weeks) of persistent aggression in with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and at risk or harm to self or others. Short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children r 5 years with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, requiring pharmacologic treatment. P Schizophrenia: Take once or twice daily. Initially, 2mg/day; may be increased to 4mg/day on day 2. Usual range: 4-6mg/day. Caution with dose q10mg/day. Max. 16mg/day. Some patients may benefit from lower doses and slower titration. Bipolar mania: Once daily. Range 2-6mg/day. Initally 2mg/day; may be increased by increment of max 1mg per 24 hrs. Dementia: Initially 0.25mg twice daily adjusted by increments of 0.25mg twice daily every other day if needed. Optimum dose 0.5mg twice daily; may be increased up to 1mg twice daily. Renal/hepatic impairment: Half dose; slower dose titration. R Schizophrenia/bipolar mania: 0.5mg twice daily; may be adjusted with 0.5mg twice daily increments to 1-2mg twice daily. Q Schizophrenia: Under 18 years, not recommended. Disruptive behaviour disorders: q50kg, initially 0.5mg once daily, adjusted by increments of 0.5mg once daily every other day, if needed. Optimum dose 1mg once daily; range 0.51.5mg once daily. Q50kg, initially 0.25mg once daily, adjusted by increments of 0.25mg once daily every other day, if needed. Optimum dose 0.5mg once daily; range 0.25-0.75mg once daily.

2NO

ALSO RISPERDAL CONSTA Risperidone 25mg, 37.5mg, 50mg prolonged release. Susp. for inj. 25mg-1, A120.28; 37.5mg-1, A173.65; 50mg-1, A226.86. S Maintenance treatment of schizophrenia in patients stabilised with oral antipsychotics. P 25mg every 2 weeks (alternate buttocks); consider 37.5mg if stabilised on more than 4mg/day oral. Consider increase after 4 weeks. Max. 50mg every 2 weeks. Ensure prior tolerability with oral risperidone. suppl. with oral risperidone for first 3 weeks as appropriate. Hepatic and renal impairment, caution, 25mg every 2 weeks if min 2mg oral tolerated following titration. See SPC. R 25mg every 2 weeks plus oral cover as RISPERDAL Janssen-Cilag above. 2NO Q Under 18 years, not recommended. D Pregnancy (unless essential), lactation. Selective monoaminergic antagonist. Risperidone B Caution: Elderly, diabetics, 0.5mg, 1mg, 2mg, 3mg, 4mg, 6mg. Brownish-red, white, orange, yellow, green oblong film-ctd tabs. hyperprolactinaemia, seizures. Higher incidence of cerebrovascular adverse events. May occur: marked Ris/0.5, Ris/1, Ris/2, Ris/3 and Ris/4 resp. Orthostatic hypotension, tardive dyskinesia, 6mg:Yellow, round film-ctd tab. marked Ris/6. neuroleptic malignant syndrome (esp. Parkinson’s 0.5mg-20, A5.72; 1mg-20, A7.43; 60, A22.28; 2mg-60, A43.96; 3mg-60, A64.64; 4mg-60, disease, dementia with Lewy bodies), QT A85.31; 6mg-28, A69.05. prolongation, priapism, disruption of body 2NO temperature regulation. Contains lactose and aspartame. ALSO RISPERDAL QUICKLET Risperidone 1mg, C Antiarrhythmics class Ia and III, TCA, 2mg, 3mg, 4mg. 1mg, 2mg: Light coral, square some antihistaminics, other antipsychotics, some biconvex tabs. marked R1, R2 resp. 3mg, 4mg: antimalerials (chinice, mefloquine), medicines Coral, round biconvex tabs. marked R3, R4 resp. causing electrolyte imbalance, centrally acting 1mg-28, A13.40; 2mg-28, A25.24; 3mg-28, A73.72; 4mg-28, A94.95. drugs, levodopa, dopamine agonists, carbamazepine or other hepatic enzyme-inducing 2NO

drugs, CYP2D6 inhibitors (fluoxetine, paroxetine, quinidine), verapamil, phenothiazines, some bblockers, furosemide (elderly dementia patients). A Increased blood prolactin, increased weight, tachycardia, parkinsonism, headache, akathisia, dizziness, tremor, dystonia, somnolence, sedation, lethargy, dyskinesia, blurred vision, dyspnoea, epistaxis, cough, nasal congestion, GI disorders, enuresis, rash, erythema, arthralgia, back pain, pain in extremity, increased/decreased appetite, pneumonia, influenza, bronchitis, upper RTIs, UTIs, pyrexia, fatigue, peripheral oedema, asthenia, chest pain, insomnia, anxiety, agitation, sleep disorder.

RISPERGER

Gerard

2NO Selective monoaminergic antagonist. Risperidone 0.5mg, 1mg, 2mg, 3mg. Resp. reddish-brown, white, orange and yellow circular biconvex filmctd tab with break-line. 0.5mg-20, A9.45; 1mg-20, A12.38; 2mg-60, A73.20; 3mg-60, A107.01. S Treatment of schizophrenia; maintenance in responsive patients. Aggression and pronounced psychotic symptoms in patients with dementia. Manic episodes associated with bipolar disorder. Behavioural disorders according to DSM-IV in children (q5 years), adolescents and adults. Serious conduct/behavioural disorder in children with autism aged 5-12 years; continued treatment of adolescents with autism where treatment was started in childhood. P Schizophrenia: Initially 2mg/day, may be increased to 4mg/day from the 2nd day; adjust to individual response. Optimal dose: 4-6mg/day. Doses q10mg/day show no additional antipsychotic effects. q16mg/day, safety not established. Behavioural disorders: q50kg: initially 0.5mg daily, can be increased as required by 0.5mg daily every other day. Optimal dose: 1mg/ day, max: 1.5mg once daily. Q50kg: Initially 0.25mg daily, can be increased by 0.25mg daily every other day. Optimal dose: 0.5mg daily, max: 0.75mg once daily. Dementia: Initially 0.25mg twice daily, may be increased by 0.25mg twice daily every other day. Optimal dose: 1mg daily. Bipolar mania: Initially, 2mg/day, may be increased by 1mg daily. Optimal dose: 1-6mg daily. R Schizophrenia: Initially 0.5mg twice daily, can be increased by 0.5mg twice daily to 12mg twice daily. Other indications: As per adults. Q Schizophrenia: Not recommended under 15 years. Behavioural disorders: As per adults. Autism: Initially 0.25mg/day for patients Q20kg; 0.5mg for patients q20kg. Maintain and evaluate dose on day 14 of treatment. Dosage can be increased at 2-weekly intervals by 0.25mg and 0.5mg for patients Q20kg and q20kg respectively. See SPC. D Pregnancy, lactation. B Caution: Hepatic/renal impairment, elderly, Lewy body dementia, Parkinson’s disease, epileptics, elderly patients with dementia (avoid dehydration), pronounced brachycardia, cardiovascular disease, hereditary long QT syndrome, hyperprolactinaemia, prolactindependent tumours, diabetics (or at risk patients). May occur: Orthostatic hypotension (consider dose reduction), tardive dyskinesia, neuroleptic malignant syndrome (discontinue), exacerbation of excitation, agitation and aggression. Contains lactose and sunset yellow. Driving/operating machinery. C Avoid alcohol. Caution: CNS acting drugs, other antipsychotics, lithium,

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

93


3.3 PSYCHOSES

CNS 1mg-20, A10.84; 60, A32.48; 2mg-60, A64.10; 3mg-60, A94.26; 4mg-60, A124.42; 6mg-28, A100.68.

symptoms. P Initially, 4mg once daily; increase by increments of 4mg after 4-5 days on each dose until optimal daily maintenance dose of 12-20mg 2NO ALSO RISPONE ORAL SOLUTION Risperidone 1mg/ reached. Consider max. 24mg only exceptionally. Q Under 18 years, not recommended. ml. Clear colourless sln. 100ml, A44.22. D History of CVD, CHF, cardiac S Treatment of schizophrenia. hypertrophy, arrhythmia, or bradycardia (Q50 Maintenance of schizophrenia in responsive patients. Moderate to severe manic episodes. Soln beats/min). Congenital long QT syndrome (or family history), or acquired QT interval and 0.5mg tab: Severe behavioural disturbances prolongation (QTc q 450msec in males and associated with aggressiveness and self-inflicted 470msec in females). Hypokalaemia, injury diagnosed according to DSM-IV criteria in hypomagnesaemia. Severe hepatic impairment. patients with mental retardation. RISPEVA Teva P Swallow tabs. with water. Schizophrenia: Pregnancy, lactation. B Monitor ECG before and during Take once or twice daily. Initially 2mg daily. May 2NO treatment (see SPC); discontinue if QTc prolonged increase to 4mg on day 2. Usual optimal dose: 4Selective monoaminergic antagonist. Risperidone q 500msec. Tardive dyskinesia, Neuroleptic 0.5mg, 1mg, 2mg, 3mg, 4mg. Brownish-red, round 6mg daily. Caution with dose q10mg/day. Max. Malignant Syndrome reported (discontinue). tab. marked R on one side and with score line on 16mg/day. Manic episodes: Initially 2mg once History of seizure, elderly, risk factor for stroke or daily. Adjust dose if indicated at intervals of 24 the other (0.5mg). White (1mg), pale brown diabetes, mild/moderate hepatic impairment hours. Recommended dose: 2-6mg daily. Daily (2mg), yellow (3mg) or pale green (4mg) round, (slower titration and lower maintenance dose). dose q 6mg, no data. Behavioural disturbances: bevelled biconvex film-ctd tabs, scored and Withdraw gradually. Contains lactose. Driving/ marked with RIS above the score line and strength Patients Q 50kg: Initially 0.25mg once daily; can under the score line on one side. 0.5mg-20, A8.59; be increased by 0.25mg once daily no sooner than using machines. C Contra: Potent CYP3A inhibitors, drugs every 2nd day. Usual maintenance dose, 0.5mg 1mg-20, A11.15; 60, A33.42; 2mg-60, A65.94; (0.25-0.75mg) once daily. Patients r 50kg: Initially prolonging QT interval eg. class Ia and III 3mg-60, A96.98; 4mg-60, A127.98. 0.5mg once daily; can be increased by 0.5mg once antiarrhythmics, thioridazine, erythromycin, S Treatment of schizophrenia; terfenadine, astemizole, gatifloxacin, moxifloxacin, daily no sooner than every 2nd day. Usual maintenance of improvement in patients who cisapride, lithium. Caution: CYP2D6 inhibitors e.g. maintenance dose, 1mg (0. 5-1.5mg) once daily. have shown initial response. Moderate to severe fluoxetine, paroxetine, CYP3A inducers. Hepatic/renal impairment: Half starting/ manic episodes in BD patients. A Rhinitis/nasal congestion, abnormal P Schizophrenia: Take once or twice daily. maintenance dose, slower titration. ejaculation, dizziness, dry mouth, postural Initially 2mg daily. May increase to 4mg on day 2. R Schizophrenia and manic episodes: hypotension, weight gain, peripheral oedema, Initially 0.5mg twice daily. Adjust individually with Usual optimal dose: 4-6mg daily. Caution with dyspnoea, paraesthesia, prolonged QT interval. 0.5mg twice daily increments to 1-2mg twice daily. dose q10mg/day. Max. 16mg/day. Manic episodes: Red/white blood cells urine positive. Initially 2mg once daily. Adjust dose if indicated at Q Schizophrenia: Under 15 years, not intervals of min. 24 hours. Recommended dose: 2- recommended. Manic episodes: Under 18 years, SERENACE Teva not recommended. Behavioural disturbances: 6mg daily. Daily dose q 6mg, no data. Hepatic/ Under 5 years, not recommended. 2NO renal impairment: Initially 0.5mg twice daily. D Pregnancy (unless benefit outweighs Adjust individually with 0.5mg twice daily CAPSULES. Butyrophenone. Haloperidol 0.5mg. risk), lactation. Soln: Hyperprolactinaemia (not increments up to 1-2mg twice daily. Two-tone, green hard gelatine cap. marked drug induced). R Both conditions: Initially 0.5mg twice NORTON 500 on one half, Serenace on the other. B Elderly with dementia (avoid daily. Maintain or adjust individually with 0.5mg 30, A0.71. dehydration). Dementia patients with history of twice daily increments up to 2mg twice daily. 2NO CVA, TIA, hypertension or diabetes. Can cause Q Schizophrenia: Under 15 years, not orthostatic hypotension (consider dose reduction). ALSO SERENACE TABLETS Haloperidol 1.5mg, recommended. Manic episodes: Under 18 years, Long term treatment: Tardive dyskinesia can occur. 5mg, 10mg, 20mg. White, bright pink, pale pink, not recommended. dark pink, resp., biconvex tabs marked NORTON Neuroleptic malignant syndrome may occur. D Pregnancy (unless benefit outweighs followed by strength resp. on one side and Caution: Hepatic/renal impairment, elderly, lewy risk), lactation. SERENACE on reverse. 1.5mg-30, A1.22; 5mg-30, body dementia or Parkinson’s disease, epileptics, B Elderly with dementia (avoid A2.27; 10mg-30, A4.58; 20mg-30, A13.32. diabetics, CVD or family history of QT dehydration). Dementia patients with history of 2 NO prolongation, prolactin-dependent tumours, CVA, TIA, hypertension or diabetes (avoid). Can ALSO SERENACE ORAL SOLUTION Haloperidol exposure to extremes of temperature. Psychocause orthostatic hypotension (consider dose organic disturbances, increased risk of undesirable 2mg/ml. 100ml, A7.35; 500ml, A36.76. reduction). Tardive dyskinesia, neuroleptic S Schizophrenia, mania, hypomania, effects. Patients at risk for aspiration pneumonia. malignant syndrome may occur. Caution: Hepatic/ Tabs contain lactose. Driving/using machines. paranoid psychosis, agitation, psychotic illness, renal impairment, elderly, lewy body dementia or C Avoid alcohol, antipsychotics. Caution: childhood behaviour disorders, severe motor tics, Parkinson’s disease, epilepsy, diabetes, CVD, Centrally acting drugs, lithium, antidepressants, Gilles de la Tourette syndrome, intractable hiccup, prolactin-dependent tumours. Contains lactose. anti-parkinsonian drugs, drugs with central severe nausea/vomiting except hyperemesis Driving/ using machine. anticholinergic effect, levodopa and other gravidarum. Caps are also indicated as adjunct in C Avoid alcohol. Caution: CNS acting dopaminergic agonists, carbamazepine or other anxiety states. drugs, other antipsychotics, lithium, hepatic enzyme inducing drugs, strong CYP2D6 P Initially 1.5-20mg daily, increasing as antidepressants, anti-parkinsonian drugs, central inhibitors, diuretics, antacids, cimetidine, required for control, then decreasing for anticholinergics, levodopa and other dopaminergic ranitidine, drugs prolonging QTc interval. maintenance, usually 3-10mg daily. Gilles de la agonists, carbamazepine or other hepatic enzyme A Insomnia, agitation, anxiety, headache, Tourette: Initially 2mg daily increasing to 6-50mg inducing drugs, strong CYP2D6 inhibitors, sedation, weight increase. followed by gradual reduction to maintenance cimetidine, ranitidine, drugs prolonging QTaround 4mg. interval or causing electrolyte disturbances. SERDOLECT Lundbeck R Half dose. A Insomnia, agitation, anxiety, headache, 2 N O Q Initially 0.025-0.05mg/kg daily to max. sedation. 10mg. Maintenance 0.05mg/kg. Limbic selective antipsychotic. Sertindole 4mg, 12mg, 16mg, 20mg. Oval biconvex tabs. marked S D Comatose states. Parkinson’s disease. RISPONE Rowex and strength. Yellow, beige, rose, pink resp. 4mg- Pregancy (unless essential). Lactation. Tabs: 2NO 30, A35.13; 12mg-28, A92.99; 16mg-28, A106.95; Clinically significant cardiac disorders, QTc Selective monoaminergic antagonist. Risperidone prolongation, history of ventricular arrhythmia or 20mg-28, A120.49. 0.5mg, 1mg, 2mg, 3mg, 4mg, 6mg. Red, white, Torsades de pointes. Uncorrected hypokalaemia. S Schizophrenia in patients intolerant to pink, yellow, dark pink, yellow oblong scored B Great Caution: Basal ganglial lesions, at least one other antipsychotic. Do not use in emergency situations for urgent relief of (6mg, twice) film-ctd tabs. resp. 0.5mg-20, A8.37; thyrotoxicosis. Hepatic/ renal dysfunction, epilepsy,

antidepressants, anti-parkinson agents, central anticholinergics, phenoxybenzamine, labetalol and other a-blocking sympatholytics, methyldopa, reserpine and other centrally acting antihypertensive agents, guanethidine, levodopa and other dopamine agonists, carbamazepine or other hepatic enzyme inducing drugs, strong CYP2D6 inhibitors, cimetidine, ranitidine, drugs prolonging QT-interval or causing electrolyte disturbances. A Agitation, anxiety, insomnia, headache, sedation, weight gain.

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Prohibited in specific sports

Restricted b2 agonists

Declaration required


CNS CVD, family history of QT prolongation. Tabs: Perform baseline ECG (reduce dose if QT prolonged and discontinue if QTc q500ms), monitor electrolyte periodically. Driving/using machines. Tardive dyskinesia with long-term treatment. High dose: Rarely sudden death, impaired body temp. control, malignant neuroleptic syndrome, hyperthermia, autonomic dysfunction, rigidity, coma. Withdraw gradually. Tabs and caps contain lactose. 20mg tabs contain E124. C Avoid other antipsychotics. Caution: CNS depressants, QT prolonging drugs, lithium (maintain Q1mmol/l), methyldopa, sympathomimetics. A Headaches, dizziness, feeling drowsy/ dulled, anxiety, insomnia, hypotension, dystonia, GI disturbances, anorexia, blurred vision, tachycardia, abnormal liver function, jaundice, urinary retention, photosensitisation, hypersensitivity reactions.

PSYCHOSES 3.3 C Contra: CYP3A4 inhibitors (eg. HIVprotease inhibitors, azole antifungals, erythromycin, clarithromycin, nefazodone). Caution: Hepatic inducers (eg. carbamazepine, phenytoin), other centrally acting drugs, alcohol, thioridazine. Avoid grapefruit juice. A Leucopenia, hyperprolactinaemia, increased appetite, abnormal dreams and nightmares, dizziness, somnolence, headache, syncope, tachycardia, blurred vision, orthostatic hypotension, rhinitis, GI disorders, withdrawal symptoms, mild asthenia, peripheral oedema, irritability, decreased neutrophil count, weight gain. Elevations in: ALT, AST serum triglyceride, total cholesterol, blood glucose. Decrease in HDL cholesterol.

SOLIAN

Sanofi

2MO

Benzamide. Amisulpride 50mg, 100mg, 200mg, 400mg. White to off white, round, breakable tab. engraved AMI and strength on one side. 50mg-60, SEROQUEL XR AstraZeneca A 20.09; 100mg-60, A40.12; 200mg-60, A73.33; 2NO 400mg-60, A160.48. Dibenzothiazepine. Quetiapine (fumarate) 50mg, S Acute and chronic schizophrenia, 200mg, 300mg, 400mg. Prolonged released tabs. including patients with predominant negative Peach, yellow, pale yellow and white resp. marked symptoms. A with XR and strength. 50mg-60, 63.08; 200mgP Acute episodes, 400-800mg daily. 60, A140.80; 300mg-60, A213.89; 400mg-60, Predominant negative symptoms, 50-300mg daily. A282.13. Doses R400mg admin once daily, q400mg in 2 S Treatment of schizophrenia and divided doses. Renal insufficiency, reduce dose to prevention of relapse. half or third (see SPC). P Admin. at least 1 hr before meal. Initial Q Contra-indicated (up to puberty). titration: 300mg (day 1), 600mg (day 2). D Prolactin-dependent tumours. Recommended dose, 600mg/day. Dose range 400- Phaeochromocytoma. Children (up to puberty). 800mg/day. Maintenance, same dose. Switch from Lactation. tabs at equiv. daily dose. Hepatic impairment: B Neuroleptic Malignant Syndrome Initially 50mg/day; can be increased in increments (discontinue). Caution: Diabetes/risk of diabetes, of 50mg/day. severe renal insufficiency, epilepsy, parkinson’s R Initially 50mg/day; can be increased in disease, QT prolongation risk factors, stroke risk increments of 50mg/day to an effective dose. factors, elderly with dementia, risk factors for Q Children and adolescents, not evaluated. thromboembolism. Risk of serious ventricular 2NO arrhythmias. Gradual withdrawal advisable. ALSO SEROQUEL Quetiapine (fumarate) 25mg, Driving/operating machines. Pregnancy. Contains 100mg, 200mg, 300mg. Film ctd tabs. Peach, lactose. yellow, white and white resp. 25mg-60, A37.77; C Contra: Medications which prolong QT 100mg-60, A107.92; 200mg-60, A123.04; 300mginterval or induce torsade de pointes, levodopa. 60, A200.04. Not recommended: Alcohol, bradycardia-inducing S Treatment of schizophrenia. medications, medications inducing electrolyte P Admin. twice a day. Initial titration: imbalance (in particular those causing 50mg (day 1), 100mg (day 2), 200mg (day 3), hypokalaemia), neuroleptics. Caution: CNS 300mg (day 4). Usual effective dose after day 4, depressants, antihypertensives, hypotensive 300-450mg/day. Dose range 150-750mg/day. medications, dopamine agonists. Hepatic impairment: Initially 25mg/day; should be A Extrapyramidal symptoms, acute increased in increments of 25-50mg/day. dystonia, insomnia, anxiety, agitation, orgasmic R Dose titration may need to be slower dysfunction, GI disorders, raised plasma prolactin, and daily therapeutic dose lower. hypotension, weight gain. Q Children and adolescents, not recommended. STELAZINE Goldshield B Monitor for suicidal tendencies, esp. at 2MO beginning. Caution: Hepatic impairment, Trifluoperazine (HCl) 1mg/5ml. 200ml, A1.93. cardiovascular or cerebrovascular disease, S Schizophrenia, psychosis, severe hypotension, history of seizures, patients at risk psychomotor agitation, dangerous impulsive for aspiration pneumonia. Monitor diabetic behaviour. patients. May increase metabolic risk. May occur: Tardive dyskinesia, neuroleptic Monitor for suicidal P Initially 5mg twice daily, increasing after 7 days to 15mg daily. If required increase further tendencies, esp. at beginning. Caution: Hepatic by 5mg at three-day intervals, then reduce to impairment, cardiovascular or cerebrovascular maintenance dose. See SPC. Up to 25mg. disease, hypotension, history of seizures, patients at risk for aspiration pneumonia. Monitor diabetic R Reduce by at least half. Q Up to 5mg daily in divided doses. See patients. May increase metabolic risk. May occur: lit. Tardive dyskinesia, neuroleptic malignant D Comatose states, bone marrow syndrome, lipid changes. Driving/operating depression, liver damage, existing blood dyscrasis. machines. Pregnancy (only if benefit outweighs risk), lactation (avoid). XR tab. contain lactose. Uncontrolled cardiac decompensation.

B Elderly. CVD. Parkinsonism. Pregnancy, lactation. Epilepsy. C See SPC.

STEMETIL

sanofi-aventis

2MO Phenothiazine group III. Prochlorperazine mesylate 5mg white tab. and 5mg white scored tab. Both marked with tab. name and strength. 5mg-250, A11.09. S Minor mental and emotional disturbances. Acute and chronic psychoses especially schizophrenia. P Minor mental disturbances, 15-20mg daily in divided doses increasing to max. 40mg daily. Schizophrenia, 75-100mg daily. See SPC. Q Not applicable.

2NO ALSO STEMETIL INJECTION Prochlorperazine mesylate 1.25%. Amps. 10 x 1ml, A4.03; 10 x 2ml, A5.08. P 12.5-25mg by deep IM inj. two or three times daily. Transfer to oral therapy as soon as possible. Q Not applicable. D Comatose states. Bone marrow depression. Liver damage. B CVD. Parkinsonism. Pregnancy, lactation. C See SPC

ZYPADHERA

Lilly

2J Thienobenzodiazepine. Olanzapine (as palmoate monohydrate) 210mg, 300mg, and 405mg. Reconstituted suspension contains 150mg/ml olanzapine. Yellow solid powder and clear, colourless to slightly yellow solvent for prolonged release susp. for inj. 210mg-1, A266.89; 300mg-1, A408.59; 405mg-1, A533.79. S Maintenance treatment of adults with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine. P For IM use only. Establish tolerability and response with oral olanzapine, then determine dose depending on oral olanzapine dose: 10mg/day: Initially, 210mg/2 weeks or 405mg/4 weeks; maintenance: 150mg/2 weeks or 300mg/4 weeks. 15mg/day: Initially, 300mg/2 weeks; maintenance: 210mg/2 weeks or 405mg/4 weeks. 20mg/day: Initially, 300mg/2 weeks; maintenance: 300mg/2 weeks. Renal / hepatic impairment: Consider lower starting dose (150mg every 4 weeks) R Over 75, not recommended. Q Not recommended. D known narrow-angle glaucoma risk. Lactation. B Not for use in acutely agitated or severely psychotic states. Post-injection syndrome may occur; monitor patients for 3 hours for signs and symptoms of overdose. Not recommended: Dementia-related psychosis and/or behavioural disturbances. Neuroleptic Malignant Syndrome may rarely occur. Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, (incl. fatal) reported rarely. Regularly monitor patients for lipid alterations. Caution: Prostatic hypertrophy, or paralytic ileus and related conditions; low leukocyte and/or neutrophil counts, medicines known to cause neutropenia, history of drug-induced bone marrow depression/ toxicity, bone marrow depression; history of seizures or risk factors for seizures. VTE may very

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

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OCD

CNS

B Impaired hepatic function, prostatic hypertrophy, paralytic ileus, bone marrow depression, neuroleptic malignant syndrome, seizures, tardive dyskinesia. Parkinsonâ&#x20AC;&#x2122;s/dementiarelated psychosis and/or behavioural disturbances (not recommended). Monitor diabetic patients. Neutropenia when used concomitantly with valproate. Monitor BP in elderly. Undesirable alterations in lipids have been observed (monitor regularly). Sudden cardiac death reported with antipsychotics. Pregnancy. Driving/ using machinery. Contains lactose. Velotab contains aspartame, mannitol, methyl/propyl parahydroxybenzoate. Zyprexa inj: Unstable medical conditions, alcohol/drug intoxication (no data), hypotension, bradyarrhythmia, hypoventilation, level of consciousness (monitor). C Avoid anti-Parkinsonian drugs. Caution: Activated charcoal (take 2 hrs apart), smoking, carbamazepine, dopamine agonists, fluvoxamine, ZYPREXA Lilly drugs inducing CNS depression (incl. alcohol) or hypotension, bradycardia, respiratory nervous 2NO system depression or increase QTc interval. Thienobenzodiazepine. Olanzapine 2.5mg, 5mg, Zyprexa inj: Simultaneous inj. of parenteral 7.5mg, 10mg, 15mg. White film-ctd tabs. marked benzodiazepines. LILLY and 4112, 4115, 4116 or 4117. 15mg A Somnolence, clinically significant weight elliptical, blue film-ctd tab. marked LILLY 4415. gain especially in adolescents, increased appetite, 2.5mg-28, A41.69; 5mg-28, A58.80; 7.5mg-56, dizziness, dyskinesia, asthenia, oedema, orthostatic A176.43; 10mg-28, A117.62; 15mg-28, A185.00. hypotension, anticholinergic effects, eosinophilia, 2NO raised ALT/AST. Worsening of Parkinsonian ALSO ZYPREXA VELOTAB Olanzapine 5mg, 10mg, symptoms. Elderly with dementia: Abnormal gait 15mg, 20mg. Freeze dried orodispersible tabs. and falls, pneumonia, increased body temperature, 5mg-28, A70.57; 10mg-28, A141.15; 15mg- 28, lethargy, erythema, visual hallucinations, urinary A221.23; 20mg-28, A227.52. incontinence. S Schizophrenia. Bipolar Disorder (BD): Treatment of moderate to severe manic episodes; 3.4 MOOD DISORDERS, BULIMIA prevention of recurrence in patients with BD NERVOSA, OCD whose manic episode has responded to olanzapine treatment. ABILIFY BMS P Schizophrenia: Starting dose, 10mg as a single daily dose. Bipolar Disorder: Manic episode, 2 N O initially 15mg as single daily dose in monotherapy Atypical antipsychotic. Aripiprazole 5mg, 10mg, or 10mg daily in combination therapy. Prevention, 15mg, 30mg. Rect. and blue, rect. and pink, round and yellow, round and pink tabs., marked A-007 initially 10mg daily or same dose as prior treatment of manic episode. Continue olanzapine and 5, A-008 and 10, A-009 and 15, A-011 and 30 in combination therapy as required if new manic/ resp. 5mg-28, A123.79; 10mg-28, A128.41; 15mg28, A128.41; 30mg-28, A256.82 mixed/depressive episode occurs. All indications: S Schizophrenia (adults and adolescents Adjust if necessary within range of 5-20mg daily. q 15 years). Treatment of moderate to severe Renal/hepatic impairment: Consider 5mg starting manic episodes in Bipolar I Disorder and dose. Place Velotab in mouth to be dispersed in prevention of new manic episodes in patients who saliva so it can be easily swallowed. R 65 and over, consider starting dose 5mg experienced predominantly manic episodes and whose manic episodes responded to aripiprazole. daily when clinical factors warrant. P 10 or 15mg (10 or 15ml) once daily; Q Not recommended. Maintenance, 15mg daily. Max. 30mg daily. 2NO R Consider lower starting dose. ALSO ZYPREXA 10MG INJECTION Olanzapine Q Under 15 years, not recommended. Over 10mg. Yellow lyophilised powder for soln. for IM 15 years, schizophrenia: Initially 2mg for 2 days A inj. 1, 5.00. S Rapid control of agitation and disturbed titrated to 5mg for 2 additional days to reach behaviours in patients with schizophrenia or manic recommended daily dose (10mg). May be increased in 5mg increments to max 30mg daily. episode, when oral therapy is not appropriate 2NO (short term use). The use of oral olanzapine ALSO ABILIFY ODT Aripiprazole 10mg, 15mg. should be initiated as soon as clinically Orodispersible round tab. marked with strength appropriate. P Starting dose, 10mg as a single IM inj. A on one side and A over 640 or 641 resp. on reverse. 10mg, pink; 15mg, yellow. 10mg-28, second inj. may be admin. 2 hours after first inj. A141.12; 15mg-28, A141.12. based on clinical status. Max. daily dose: 20mg S Schizophrenia. Treatment of moderate with not more than 3 inj. in any 24-hour period. Max. duration: 3 consecutive days. Do not admin. to severe manic episodes in Bipolar I Disorder and prevention of new manic episodes in patients who by IV or SC inj. experienced predominantly manic episodes and R 60 years and over, consider starting whose manic episodes responded to aripiprazole. dose 2.5-5mg with a second injection of 2.5-5mg after 2 hours depending on patient clinical status. 2 N O ALSO ABILIFY ORAL SOLUTION Aripiprazole 1mg/ Q Under 18 years, not recommended. 1ml. Bottle. 150 ml, A137.36 D Narrow angle glaucoma. Lactation. rarely occur, take preventive measures. If tardive dyskinesia occurs consider dose reduction or discontinuation. Postural hypotension risk in elderly; measure BP periodically in patients q 65 years. Pregnancy (use only if benefits outweigh risks). Driving/operating machinery. C Not recommended: Anti-Parkinsonian drugs. Caution: Smoking, carbamazepine, alcohol, CNS depressants, medicinal products known to increase QTc interval, dopamine agonists. Fluvoxamine or other CYP1A2 inhibitors (e.g. ciprofloxacin): Consider lower starting dose. A Eosinophilia, weight gain, elevated cholesterol/triglycerides/glucose levels, glucosuria, increased appetite, somnolence, dizziness, akathisia, parkinsonism, dyskinesia, orthostatic hypotension, GI disorders, transient asymptomatic ALT and AST elevations, rash, asthenia, fatigue, oedema, elevated plasma prolactin levels.

96

S Schizophrenia. Moderate to severe manic episodes in Bipolar I Disorder and prevention of new manic episodes in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole.

2N ALSO ABILIFY SOLUTION FOR INJECTION Aripiprazole 7.5mg/ml. Clear, colourless, aqueous sln for inj. S Rapid control of agitation and disturbed behaviours in patients with schizophrenia or in patients with manic episodes in Bipolar I Disorder, when oral therapy is not appropriate. Treatment with aripiprazole solution for inj. should be discontinued as soon as clinically appropriate and use of oral aripiprazole should be initiated. P For IM use. Initially, 9.75mg (1.3 ml), as a single IM inj. Effective dose range: 5.25-15mg as a single inj. A lower dose of 5.25 mg (0.7 ml) may be given, according to clinical status. A 2nd inj. may be admin 2 hrs after the 1st inj. Max 3 inj. in 24 hr. Max daily dose 30mg (incl. all formulations of aripiprazole). R Consider lower starting dose. Q Under 18 yrs, not recommended. D Pregnancy (unless benefit outweighs risk), lactation. B Monitor for suicidal behaviour particularly after initiation or switching of therapy. Severe hepatic impairment, history of seizure disorder or conditions associated with seizures, diabetes mellitus, CVD, cerebrovascular disease, predisposition for hypotension or hypertension, family history of QT prolongation, risk of aspiration pneumonia. Monitor for signs of hyperglycaemia, tardive dyskinesia, neuroleptic malignant syndrome. Not approved for dementiarelated psychosis. Driving/using machines. Hypersensitivity reactions may occur. C Caution: Potent inhibitors of CYP2D6 (eg. quinidine, fluoxetine, paroxetine) or CYP3A4, potent CYP3A4 inducers, certain antihypertensives, drugs causing QT prolongation, alcohol or other CNS drugs. A Somnolence, dizziness, headache, akathisia, nausea, vomiting, restlessness, insomnia, anxiety, extrapyramidal disorder, akathisia, tremor, dizziness, somnolence, sedation, blurred vision, GI disorders, fatigue.

AFFEX

Astellas

2NO SSRI. Fluoxetine 20mg. Green/yellow cap. marked F.20. 30, A9.01. S Major depressive episodes. Bulimia nervosa. Obsessive-compulsive disorders (OCD). See fluoxetine Drug Prescribing Notes. P Depression: usually 20mg daily. Most patients do not require more than 20mg daily. OCD: initially 20mg daily for several weeks increasing thereafter, up to 60mg. Bulimia nervosa: 60mg daily. Max. daily dose should not exceed 80mg. Q Under 18 years, not recommended.

ANAFRANIL

Novartis

2NO TCA. Clomipramine (HCl) 10mg orange/caramel cap. 25mg brownish orange/caramel cap. 50mg light grey/caramel cap. All marked GEIGY. 10mg84, A3.46; 25mg-84, A6.92; 50mg-56, A8.64. S Depression incl. manic depression, obsessional and phobic states. Adjunctive treatment of cataplexy.

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Restricted b2 agonists

Declaration required


Zyprexa is indicated for the treatment of schizophrenia. Zyprexa is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Zyprexa is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to Zyprexa treatment, Zyprexa is indicated for the prevention of recurrence in patients with bipolar disorder. Full Prescribing Information is Available From: Eli Lilly and Company (Ireland) Limited, Hyde House, 65 Adelaide Road, Dublin 2, Republic of Ireland. Telephone: Dublin (01) 661 4377. ZYPREXA (olanzapine) and VELOTAB are trademarks of Eli Lilly and Company. Marketing Authorisation Numbers and Holder: EU/1/96/022/002. EU/1/96/022/004. EU/1/96/022/006. EU/1/96/022/009. EU/1/96/022/010. EU/1/96/022/012. EU/1/96/022/016. EU/1/99/125/001. EU/1/99/125/002. EU/1/99/125/004. EU/1/99/125/003. Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, The Netherlands. P.O.M IEZYP00119

Date of preparation: August 2009


3.4 MOOD

DISORDERS, BULIMIA NERVOSA,

P Depression: 10mg increasing gradually to 30-150mg daily individed doses or as a single dose at night; max. 250mg daily. Obsessional and phobic states: 25mg daily increasing gradually to 100-150mg daily. Cataplexy: 10mg daily increasing up to 50mg daily. R Initially 10mg daily. Max. 75mg daily Q Not recommended

2NO ALSO ANAFRANIL SR Clomipramine (HCl) 75mg. Pink cap.-shaped sust.-release tab. Scored both sides marked CG one side and GD on reverse. 28, A8.04. S Depression; obsessional and phobic states. Adjunctive treatment of cataplexy. P Depression: 10mg increasing gradually to 30-150mg daily in divided doses or as a single dose at night; max. 250mg daily. Obsessional and phobic states: 25mg daily increasing gradually to 100-150mg daily. Cataplexy: 10mg daily increasing up to 50mg daily. R Initially 10mg daily. Max. 75mg daily. Q Not recommended. D Pregnancy, lactation. Hypersensitivity to dibenzazepines,cardiac arrhythmias, mania, severe liver disease, narrow angle glaucoma, urine retention. B Risk of suicide; monitor carefully. Other psychiatric effects, cardiac and vascular disorders, epilepsy, pregnancy, hepatic disease and tumours of the adrenal medulla. Elderly, driving/using machinery. Contains lactose. C Contra: MAOIs (or within 3 weeks), adrenergic neurone blockers, anticholinergic drugs, CNS depressants, diuretics, MAOIs, SSRIs, CYP2D6 inhibitors, neuroleptics, H2 receptor antagonists, methylphenidate, CYP450 enzyme inducers. A Drowsiness, fatigue, restlessness, increased appetite, confusion, disorientation, hallucinations, sleep disturbances, aggressiveness, aggravated depression, dizziness, tremor, headache, myoclonus, delerium, speech disorders, muscle weakness, dry mouth, blurred vision, disturbances in micturition, hot flushes, mydriasis, tachycardia, postural hypotension, ECG changes, GI disorders, elevated transaminases, skin rash, urticaria, pruritus, weight gain, disturbances of libido and potency, galactorrhea, breast enlargement, taste disturbances, tinnitus.

OCD

CNS

Q Not recommended. B Should not be used under 18 years. Severe renal failure: Not recommended. Impaired hepatic function: Reduce dose, monitor liver function. May occur: Initial anxiogenic effect when starting therapy (reduced dose reduces risk), serotonin syndrome (discontinue), hyponatraemia, syndrome of inappropriate anti-diuretic hormone secretion (elderly), may increase psychotic symptoms. Withdraw gradually. Pregnancy, lactation. Contains lactose. C Contra: MAOI (or within 14 days), 5-HTagonists. Caution: Lithium, metoprolol, desipramine, dimetidine, St John’s Wort. A Headache, tremor, dizziness, migraine, paraesthesia, palpitations, tachycardia, postural hypotension, hypotension and hypertension, GI disorders, micturition disorder, polyuria, weight decrease/increase, rhinitis, sinusitis, ejaculation failure, female anorgasmia, dysmenorrhoea, impotence, increased sweating, rash, pruritus, abnormal accommodation, abnormalities of vision, taste abnormalities.

BELLSERT

Ranbaxy

2MO SSRI. Fluoxetine 20mg (as HCl) Green/off white hard gelatine self locked size 2 cap. containing white powder, imprinted with R/FXT 20 on cap/ body. 20mg-30, A14.48. S Major depressive disorders/episodes. Bulimia nervosa in conjunction with psychotherapy. P Major depressive episodes: 20mg/day. Bulimia nervosa: 60mg/day. Max daily dose 80mg. Reduced liver and/or kidney function (GFR 1050ml/min): Reduce dose (e.g. 20mg every other day). R Caution when increasing dose.Rarely exceed 40mg. Max 60mg. Q Not recommended. D Severe renal failure (GFRQ10ml/min), unstable epilepsy or convulsant disorders. Lactation. See fluoxetine Drug Prescribing Notes.

BIOZAC

Niche

2NO

Ranbaxy SSRI. Fluoxetine (HCl) 20mg. Olive/green cap.

2MO

SSRI. Sertraline 50mg, 100mg. White film-ctd caplet-shaped tab. embossed with strength one side and break-line the other. 50mg-28, A20.57; 100mg-28, A30.69. S Major depressive episodes. P 50mg once daily with sufficient liquid. If required, may be increased to 100mg/day. Increments in steps of 50mg at minimum intervals of 1 week. Aim for lowest possible dosage with adequate therapeutic efficacy during long term therapy. Impaired hepatic function: Reduce dose, prolong interval between doses. Antidepressant effect may start within 7 days, max effect after 2 to 4 weeks (inform patient). May require long term therapy to control remission (at least 6 months). R Lowest possible dosage. Q Under 18 years, not recommended. B Monitor suicidality. Caution: History of mania/hypomania, epilepsy (unstable epilepsy, avoid use; controlled stable epilepsy, careful monitoring; discontinue if seizures occur), ECT, diabetes (check blood glucose levels regularly; adjust insulin and/or hypoglycaemics) history of BELLCITAL Ranbaxy bleeding disorders, instable cardiac disease, elderly, schizophrenia (may aggravate symptoms), 2MO impaired hepatic function. Withdraw gradually. SSRI. Citalopram (hydrobromide) 10mg, 20mg. Pregancy and lactation (use only if benefit White to off-white circular biconvex film-ctd tab. debossed with strength on one side and the other outweighs risk). Driving/operating machinery. C Contra: MAOIs (or within 14 days), side plain or with a lip shaped scoreline, resp. pimozide. Not recommended: Serotonergics 10mg-28, A9.41; 20mg-28, A13.92. (tryptophan, fenfluramine and serotonin agonists), S Major depressive episodes. Panic St John’s Wort. Caution: Drugs bound to plasma disorder with or without agoraphobia. P Major depressive episodes: Single 20mg proteins, diazepam, tolbutamide, cimetidine, hypoglycaemics, anticoagulants, salicylic acid daily oral dose. Can be increased gradually by derivatives and NSAIDs, lithium, diuretics, 10mg. May be increased to max 40-60mg daily. phenytoin, sumatriptan, antipyrine, changeover Antidepressant effect not expected for at least 2 from other SSRIs or other antidepressants. Avoid weeks. Treatment duration at least 4-6 months. Panic disorder: Single dose 10mg/day for 1st week. alcohol. Dose may be increased to max 40-60mg/day. Max A GI disorders, dry mouth, increased sweating, tremor, dizziness, insomnia, somnolence, effect after 3 months. May need to be continued anorexia, sexual disorders, asthenia, tiredness, hot for several months. Reduced hepatic function: flushes, skin rash, chest pain, palpitations, tinnitus, Initially 10mg/day. Max 30mg. headache, motor disorders (incl. hyperkinesia, R Major depressive episodes: 10-20mg increased musle tone, teeth grinding, impaired daily. May be increased to max 30-40mg daily. gait), paraesthesiae, hypaesthesia, yawning, Panic disorder: Initially 10mg once daily, after 1 agitation, anxiety, menstrual disorders, impaired week may be increased to 20mg daily. May be increased to max 40mg daily. vision.

98

BELLZAC

marked FLE 20. 30, A13.34. S Episodes of depression, with or without associated anxiety symptoms, especially where sedation is not required. P 20mg daily recommended. Max. 80mg daily. R Caution. Max. 60mg daily. Q Under 18 years, not recommended. D Severe renal failure, unstable epilepsy. See fluoxetine Drug Prescribing Notes.

CALMAX

Ergha

2NO Medium-acting benzodiazepine. Alprazolam 0.25mg, 0.5mg, 1mg. White tab. marked ’apzm 0.25’, pink tab. marked ’apzm 0.5’, light blue tab. marked ’apzm 1’ resp. All tabs. oblong, scored. 0.25mg-100, A2.03. 0.5mg-100, A3.92. 1mg-100, A8.18. S Anxiety disorders. P 0.25-0.5mg three times daily. Max. 4mg daily. R 0.25mg two or three times daily. Q Not recommended. D See SPC.

CAMCOLIT

Norgine

2NO Lithium salt. Lithium carbonate 250mg (equiv. to 6.8mmol Li+ ) tab. marked CAMCOLIT; 400mg (equiv. to 10.8mmol Li+ ) cont.-release tab. marked CAMCOLIT-S. Both white film-ctd tabs. with a breakline. 250mg-100, A3.41 250mg-1000, A30.66; 400mg-100, A4.59; 400mg-500, A18.73. S Treatment and prophylaxis of mania; bipolar affective disorders, recurrent depression. Treatment of aggressive or self-mutilating behaviour. P Treatment, maintain serum lithium levels in range 0.6-1.0mmol/l 12 hours after last dose. Prophylaxis, maintain serum lithium levels 0.4-0.8mmol/l. R Maintain serum lithium levels 0.40.7mmol/l. Toxic symptoms more likely q 1.0mmol/l. Q Not recommended. D Renal disease, hypothyroidism, cardiac disease, Addison’s disease. Discontinue 24 hours before major surgery. Pregnancy, lactation.

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Restricted b2 agonists

Declaration required


CNS

MOOD

DISORDERS, BULIMIA NERVOSA,

to lower end of dose range. R 20mg daily. May be increased to max 40mg daily. Q Under 18 years, not recommended. B Discontinue if patient enters manic phase. Initial anxiogenic effect may occur when starting therapy (reduce dose). Prolonged bleeding time and/or bleeding abnormalities may occur. Caution: Diabetes, controlled epilepsy (discontinue if seizures develop). Unstable epilepsy (avoid). Monitor for clinical worsening and suicidal behaviour. Pregnancy, lacation. C Contra: MAOI (within 14 days), 5-HTagonists. Caution: Lithium, tryptophan, anticoagulants, NSAIDs, ASA, dipyridamol, ticlopidine, atypical antipsychotics, phenothiazines, TCAs. Avoid alcohol. CIPRAGER Gerard A Increased sweating, headache, tremor, dizziness, abnormal accommodation / vision, 2NO somnolence, insomnia, agitation, nervousness, GI SSRI. Citalopram (hydrobromide) 10mg, 20mg, 40mg. White film-ctd tab. debossed CM 10, CM 20 disorders, palpitation, asthenia, rash, pruritus, paraesthesia, migraine, taste perversion, sleep and CM 40 on one side and G on reverse. 10mg, disorder, decreased libido, impaired concentration, round; 20 and 40mg, oval with breakline. 10mgabnormal dreaming, amnesia, anxiety, increased A A A 28, 9.60; 20mg-28, 15.05; 40mg-28, 31.07. appetite, anorexia, apathy, impotence, suicide S Major depressive episodes, panic attempt, confusion, yawning, weight decrease / disorder with or without agoraphobia. increase, postural hypotension, tachycardia, P Single oral dose (morning or evening) taken with fluid. Major depressive episodes: 20mg rhinitis, micturition disorder, polyuria, ejaculation daily; max: 60mg daily. Continue 4-6 months after failure, female anorgasmia, fatigue. symptom remission. Panic disorder: 10mg daily for CIPRAMIL Lundbeck week 1, then increase to 20mg and up to 60mg 2NO daily as required. SSRI. Citalopram (hydrobromide) 10mg, 20mg. R Major depressive episodes: 10mg daily; max: 30mg daily. Panic disorder: 10mg daily; max: White film-ctd tabs. 10mg, round marked CL. 20mg, oval, scored, marked C and N. 10mg-28 40mg daily. (Cal/Pk), A5.77; 20mg-28 (Cal/Pk), A9.04. Q Under 18 years, not recommended. S Depressive illness in the initial phase D Severe renal impairment (no data). and maintenance therapy against relapse or Pregnancy, lactation. recurrence. Panic disorder with or without B Epilepsy (discontinue if seizures), ECT, agoraphobia. history of mania, psychotic patients. Diabetes, P Depression, 20mg once daily (effect bleeding disorder, hepatic impairment (decrease after 2-4 weeks); panic disorder, 10mg once daily dose). Panic disorder experience (low starting for 1st week then 20mg daily (max. effect after 3 dose). months). May be increased to max. 60mg daily. C MAOI, 5-HT drugs, St John’s wort, Reduced hepatic function: Max. 30mg daily. alcohol. Caution: Substances increasing R Max. 40mg daily. haemorrhage risk (anticoagulants, atypical Q Under 18 years, not recommended. antipsychotics, phenothiazines, tricyclic 2NO antidepressants, aspirin, NSAID), Lithium, cimetidine. ALSO CIPRAMIL DROPS Citalopram (HCl) 40mg/ml A Somnolence, insomnia, anxiety, suicide. (equiv. 20mg per 10 drops). 15ml, A29.72. Dizziness, tremor, headache, paraesthesia, P Depression, 16mg (8 drops) once daily palpitations, tension disorders. Nausea, dry mouth, mixed with water, orange or apple juice; panic GI disorders, sweating, rash, pruritus, abnormal disorder, 8mg for 1st week, increasing to 16mg accommodation, asthenia, polyuria, rhinitis, daily. Increase if necessary to max. 48mg daily. sinusitis, anorgasmia, impotence, dysmenorrhoea. Reduced hepatic function: Max. 24mg daily. R Max. 32mg daily. CIPRALAM Actavis Q Under 18 years, not recommended. B Caution: Seizures, mania (discontinue), 2NO diabetes, history of bleeding abnormalities, SSRI. Citalopram (as hydrobromide) 10mg, 20mg. pregnancy, lactation. Reported: Hyponatraemia, White, circular, biconvex film-ctd tabs. 20mg suicidal thoughts, akathisia, serotonin syndrome. scored on both sides; can be divided into equal Withdraw gradually. Driving/using machines. A A halves. 10mg-28, 9.04; 20mg-28, 14.16. S Depressive illness treatment in the initial C Contra: Pimozide, MAOIs (non-selective, selective A). Caution: Selegiline, 5HTagonists, st phase and as maintenance against potential relapse/recurrence. Panic disorder with or without John’s Wort, lithium, tryptophan, drugs affecting platelet function, ECT, alcohol. agoraphobia. P Depression: Single 20mg daily oral dose. A Nausea, sweating, diarrhoea, If necessary, may be increased to max 60mg daily. somnolence, insomnia, dry mouth. Decreased appetite, tremor, paraesthesia, agitation, anxiety, Treatment duration of at least 6 months usually confusional state, libido decreased, abnormal necessary. Panic disorder: Single dose of 10mg st daily the 1 week. May be increased to 20mg and orgasm, impotence, yawning, tinnitus, pruritus, up to 60mg daily max. Max effect reached after 3 myalgia, arthralgia, fatigue, weight decrease. months. May need to be continued for several Pinewood months. Reduced hepatic function: Restrict dosage CIPRAPINE

Disturbed Na+ balance. B Monitor patients for renal/thyroid/ cardiac function, urine analysis. Patients should be euthyroid before starting therapy. If polyuria, polydipsia, nausea or vomiting occurs, patient should report. Signs of lithium toxicity (discontinue and review). Caution: Elderly patients, patients with CVD or QT prolongation. C Avoid: Other antipsychotics. Diuretics, NSAIDs, phenytoin, carbamazepine, caffeine, QT prolonging drugs, Na+ salts, bulk laxatives (ispaghula). SSRIs, TCADs, caffeine. A Nausea, diarrhoea. Tremor of hands, muscle weakness, psoriasis, hypo/hyperthyroidism, weight gain, oedema, ECG disturbances, polyuria, polydipsia.

OCD

3.4

2NO SSRI. Citalopram (hydrobromide) 10mg, 20mg. Both white, round, film-coated tabs. 10mg-28, A9.57; 20mg-28, A15.00. S Major depressive episodes. P To be taken with fluid. Initially, 20mg/ day as single dose. Increase to 40mg/day, depending on patient response. Max. 60mg/day. Withdraw slowly over 1-2 week. Hepatic Impairment: Initially 10mg/day, max 30mg/day, monitor patient. R Adjust half of recommended dose. Q Under 18 years, not recommended. B Risk of suicide in initial treatment phase (all SSRIs). Risk of overdose. Mania/hypomania, psychosis, epilepsy, seizures, bleeding abnormalities, severe renal impairment. Diabetics, insulin and/or oral hypoglycaemic, dosage may require adjustment. Serotonin Syndrome, hyponatraemia and SIADH, impaired hepatic function, insomnia/agitation, ECG monitoring in cases of overdose or conditions of altered metabolism. Driving and operating machinery. Pregnancy, lactation. C Contraindicated: MAOIs, incl. selegiline (selective MAOI) and moclobemide (reversible MAOI or RIMA). Patients recently discontinued SSRI and commenced a MAOI. Caution: 5-HT receptor agonists (triptans, incl. sumatriptan), tramadol, oxitriptan, tryptophan, St John’s Wort, cimetidine, lithium, tryptophan, desipramine. Anticoagulants/drugs affecting thrombocyte function (NSAIDs, acetylsalicylic acid, dipyridamol, ticlopidine), drugs increasing haemorrhage risk (atypical antipsychotics, phenothiazines, TCAs). Alcohol (not advised). A Sleep disorders, anxiety/nervousness, headache, tremor, dizziness, weight fluctuation, palpitations, GI upset, sweating, visual disturbances, asthenia/fatigue, somnolence, insomnia, agitation, withdrawal reactions.

CIPROTAN

Clonmel

2NO SSRI. Citalopram (hydrobromide) 10mg, 20mg. Round, white film-ctd tabs. 20mg with breakline. 10mg-28, A8.65; 20mg-28, A12.84. S Major depressive episodes. P Initially, 20mg per day. If necessary, the dose can be increased up to 40mg per day. Max., 60mg per day. Admin. as single dose in the morning or in the evening with fluid. Reduced hepatic function: Initially 10mg; max. 30mg daily. R Half of recommended dose. Q Under 18 years, not recommended. B Caution with: Diabetes, epilepsy, electro-convulsive therapy, history of mania/ hypomania, psychotic patients, bleeding disorders. Suicidality. Severe renal impairment; not recommended. Hepatic impairment; monitor liver function. Pregnancy, lactation (only if clearly necessary). C MAOIs (wait 2 weeks after stopping), St John’s wort, 5-HT agonists. Caution: anticoagulants, NSAIDs and other drugs increasing risk of haemorrhage, metoprolol, cimetidine, lithium, desipramine. A Headache, tremor, dizziness, sleep disorders, agitation, confusion, weight change, vision or taste abnormalities, asthenia, palpitations, sweating, rash, sexual disorders, GI disorders, rhinitis, sinusitis.

CITALOPRAM TEVA

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

Teva

99


3.4 MOOD

DISORDERS, BULIMIA NERVOSA,

OCD

CNS

rhinitis, sinusitis, sexual disorders, rash, vision or taste abnormalities.

Pregnancy, lactation (only if essential). Monitor renal function (elderly), suicide risk. Monitor weight/growth in children receiving long-term CYMBALTA Lilly treatment. Withdraw gradually. C Contra: MAOIs, pimozide, alcohol. 2NO 5HT/NA reuptake inhibitor. Duloxetine (HCl) 30mg, Caution: Serotonergics, lithium, St John’s wort, TCAs, anticoagulants, NSAIDs, tolbutamide, 60mg. Opaque caps. White body marked 30mg insuline, diazepam, cimetidine, CYP2D6 substrates, with blue cap marked 9543; green body marked phenytoin. 60mg with blue cap marked 9542 resp. 30mg-28, A GI disorders, dyspepsia, dry mouth, A 20.50; 60mg-28, A 34.15. sweating, tremor, dizziness, insomnia, somnolence, S Major depressive disorder. anorexia, headache, motor disorders, anxiety, male P Recommended dose, 60mg once daily. sexual disorders, menstrual disorders, tiredness, Response usually seen after 2-4 weeks. Max. hot flushes, rash, chest pain, palpitations, tinnitus, 120mg daily given in evenly divided doses. After consolidation of response, continue treatment for impaired vision. Hyperkinesias, tremor, urinary incontinence and fever in children. several months. In responding patients with history of repeated major depressive episodes, DOTHEP Gerard consider further long-term treatment with 60120mg/day. Discontinue gradually over 1-2 weeks. 2 N O Q Under 18 years, not recommended. TCA. Dothiepin (HCl) 25mg. Red/brown cap. D Liver disease resulting in hepatic marked G DN 25. 100, A4.51. impairment, severe renal impairment (ccQ30ml/ S Depression, anxiety associated with min), uncontrolled hypertension. Pregnancy (unless depression. essential), lactation. 2NO B History of mania, bipolar disorder, ALSO DOTHEP TABLETS Dothiepin (HCl) 75mg. seizures, increased IOP or risk of acute narrowRed film-ctd tab. marked DN/75 one side and G on angle glaucoma. Hypertensive crisis reported. reverse. 28, A3.54; 100, A12.32. Hypertension, cardiac disease; monitor BP at least P 75-150mg daily in divided doses or as 1st month. Elderly. Suicidal thoughts; monitor single dose in the evening. carefully. May occur: Liver injury, incl. severe R Initially 50-75mg daily. elevations of liver enzymes, hepatitis and jaundice. Q Not recommended. Akathisia may develop. Driving/using machines. D See SPC. Contains sucrose. EDRONAX Pfizer C Non-selective, irreversible MAOIs and potent CYP1A2 inhibitors, eg. fluvoxamine, 2NO ciprofloxacin, or enoxacine (all contraindicated), Selective NA reuptake inhibitor. Reboxetine 4mg. other MAOIs (not recommended). Caution: White round, convex, scored tab. marked P/U and Anticoagulants, St John’s wort, warfarin, CYP2D6 7671 60, A25.36. substrates, other centrally acting and sedative S For the acute treatment of depressive drugs, smoking. illness/major depression and for maintaining A Weight decrease, palpitations, tremor, clinical improvement. paraesthesia, blurred vision, tinnitus, yawning, GI P 4mg twice daily. Increase if necessary disorders, increased sweating, rash, musculoafter 3-4 weeks to 10mg daily. Max. 12mg daily. CITROL Rowex skeletal pain, muscle tightness, muscle spasm, Renal or hepatic impairment, initially 2mg twice 2NO decreased appetite, flushing, fatigue, abdominal daily. SSRI. Citalopram (hydrobromide) 10mg, 20mg, pain, erectile dysfunction, insomnia, agitation, R Not recommended. 30mg. 10mg, round tab; 20mg and 30mg, oblong decreased libido, anxiety, abnormal orgasm, Q Under 18 years, not recommended. biconvex tabs. with one sided score notch marked abnormal dreams. D Pregnancy, lactation. C20 and C30. All white film-ctd. 10mg-28, A9.61; B History of convulsive disorders or heart 10mg-30, A11.08; 20mg-28, A15.05; 30mg-28, DEPREGER Gerard disease, urinary retention, prostatic hypertrophy, A28.00 glaucoma, bipolar patients. Monitor for suicidality. 2NO S Major depressive episodes. SSRI. Sertraline (as HCl) 50mg, 100mg. White, film- C Not recommended: CYP3A4 inhibitors P Usual dose, 20mg daily increasing to e.g. azole antifungal agents; macrolide antibiotics ctd tab. with ST breakline 50 or 100 on one side max. 60mg daily. Effect after at least 2 weeks; e.g. erythromycin or fluvoxamine. Avoid: MAOIs. and G on reverse. 50mg-28, A18.28; 100mg-28, continue until no symptom for 4-6 months. Caution: Ergot derivatives. Other antidepressants, A31.57. R 10mg daily. Max. 30mg daily. K+ losing diuretics; no data. S Depression (treatment and prevention Q Under 18 years, not recommended. A Insomnia, vertigo, tachycardia, of relapses). Treatment of obsessive-compulsive B Risk of suicide until therapeutic effects palpitation, vasodilation, postural hypotension, disorder (OCD), panic attacks with/without are achieved. Diabetes, unstable epilepsy, history agoraphobia, post-traumatic stress disorder (PTSD). eye disorders (abnormality of accommodation), dry of mania, bleeding disorders, hepatic or severe mouth, constipation, loss of appetite, sweating P Depression, OCD: 50mg daily; max. renal impairment. Driving/operating machines. UTIs and other urinary disorders, male sexual 200mg daily. Panic attacks , PTSD: Initially 25mg ECT. Lactation, pregnancy (only if essential). disorders, chills. daily; increase to 50mg daily after 1 week; max. Withdraw slowly. C MAOIs (within 14 days); contraindicated. 200mg daily. Increase in 50mg steps at min. 1 EFAXIL XL Pinewood Alcohol, St John’s Wort, 5-HT agonists, tryptophan; week intervals. Max. effect reached after 2-4 2MO weeks. not recommended. Caution: CYP2D6 substrates, Q Under 6 years, not recommended. OCD: 5HT/NA reuptake inhibitor. Venlafaxine (as HCl) cimetidine, lithium, desipramine, neuroleptics, anticoagulants and drugs increasing bleeding risk 13-17 years, initially 50mg daily. 6-12 years initially 75mg, 150mg. Resp., flesh opaque/flesh opaque or scarlet opaque/scarlet opaque, size 0 or size 00 25mg daily; increase to 50mg daily after 1 week. (e.g. NSAIDs, antipsychotics, TCAs). Max. 200mg daily. Major depressive episode, panic hard gelatine cap. containing 2 or 3 white round, A Somnolence, insomnia, agitation, disorder, PTSD: Under 18 years, not recommended. biconvex film-ctd tabs. 75mg-28, A22.15; 150mgnervousness, headache, tremor, dizziness, 28, A37.35. D Severe hepatic impairment, unstable palpitations, nausea, dry mouth, GI disorders, S Treatment of depressive illness, incl. epilepsy. increased sweating, abnormal accommodation, depression accompanied by anxiety. Following B Impaired hepatic function, controlled asthenia, tachycardia, hypotension, hypertension, micturition disorder, polyuria, weight change, initial response, for the prevention of relapses of epilepsy, heart disease, risk of haemorrhage.

2NO

SSRI. Citalopram hydrobromide eq. to citalopram 40mg. White oval film-ctd tab. with break-line. 40mg-28, A27.10. S Major depressive episodes. P Single 20mg daily oral dose. If necessary, can be increased up to 40mg daily; max. 60mg daily. Effect not to be expected for at least 2 weeks. Continue until 4-6 months free of symptoms. Mild/moderate hepatic impairment: Initially, 10mg daily for first 2 weeks; may be increased to 30mg daily. R 10-20mg (max. 40mg) daily. Q Under 18 years, not recommended. B Severe renal impairment (avoid). May occur: Akathisia, serotonin syndrome (discontinue), hyponatraemia, bleeding abnormalities, psychotic symptoms. Caution: Diabetes, controlled epilepsy (discontinue if seizures develop), unstable epilepsy (avoid), history of mania/hypomania, ECT. Monitor for clinical worsening and suicidal behaviour. Withdraw gradually over 1-2 weeks. Pregnancy (if clearly necessary), lactation. Contains lactose. C Contra: MAOI (or within 14 days following their discontinuation). Avoid: Serotonergics (e.g. tryptophan, triptans, 5HTP, tramadol), St John’s Wort, alcohol. Caution: QT interval prolonging drugs, drugs lowering seizure threshold (e.g. antidepressants, neuroleptics, mefloquin, bupropion), drugs increasing risk of haemorrhage (e.g. anticoagulants, NSAIDs, acetylsalicylic acid, dipyridamol, ticlopidine, atypical antipsychotics, phenothiazines, TCAs). A Somnolence, insomnia, agitation, headache, tremor, dizziness, paraesthesia, impaired concentration, abnormal dreaming, amnesia, anxiety, increased appetite, anorexia, apathy, confusion, palpitations, tachycardia, BP change, GI disorders, micturition disorder, polyuria, weight change, rhinitis, sinusitis, dysmenorrhoea, sexual disorders, sweating, rash, pruritus, vision/taste disorders, asthenia.

100

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


3.4 MOOD

DISORDERS, BULIMIA NERVOSA,

OCD

CNS

behaviour. Caution: Systemic lupus erythematosus. Pregnancy (careful evaluation benefit/risk). Warn patients about risk of weight gain. May cause false positives in urine tests for diabetes. Hyperammonaemia: Metabolic tests advised before therapy in those at risk. Withdraw carefully. C Avoid salicylates in children Q 3 years. Caution: Antipsychotics, MAOIs, antidepressants, benzodiazepines, phenobarbital, primidone, phenytoin, carbamazepine, lamotrigine, zidovudine, vit K-dependent anticoagulants, felbamate, mefloquine, chloroquine, highly protein Avoid salicylates in children Q 3 years. Caution: Antipsychotics, MAOIs, antidepressants, benzodiazepines, phenobarbital, primidone, phenytoin, carbamazepine, lamotrigine, zidovudine, vit K-dependent anticoagulants, felbamate, mefloquine, chloroquine, highly EFEXOR XL Wyeth protein bound agents (eg. aspirin), cimetidine, erythromycin, carbapenem antibiotics, 2NO colestyramine, rifampicin, newer anti-epileptics 5HT/NA reuptake inhibitor. Venlafaxine (as HCl) (e.g. topiramate). 37.5mg, 75mg, 150mg. Resp., opaque peach with A Congenital disorders, transient GI opaque light crey caps, opaque peach, opaque disorders, increased alertness, aggression, dark orange, marked W and strength. All hyperactivity, behavioural deterioration, confusion, prolonged-release hard caps. 37.5mg-7, A3.98; thrombocytopenia, transient hair loss, 75mg-28, A22.83; 150mg-28, A38.50. S Treatment and prevention of recurrence amenorrhoea, dysmenorrhoea, allergic reactions, increased weight. of major depressive episodes. P Initially 75mg once daily. May be Solvay increased to max. 375mg/day. May be increased at FAVERIN 2NO 2 weeks interval to max 375mg/day. If clinically warranted, reduce interval (minimum 4 days). SSRI. Fluvoxamine maleate 50mg round white Severe renal impairment: 1/2 dose. Mild-moderate film-ctd scored tab. marked S and 291. 100mg hepatic impairment: 1/2 dose; further reduction white oval film-ctd scored tab. marked S and 313. may be required in some patients. 50mg-60, A28.99; 100mg-30, A28.99. R Use lowest effective dose. S Treatment of symptoms of depressive Q Under 18 years, not recommended. illness. Obsessive compulsive disorder. B For prescribing information, see P Depression: Initially 50-100mg in the venlafaxine Drug Presc. Notes. evening. Usual maintenance 100mg daily. Max 300mg. OCD: Initially 50mg/day for 3-4 days. Usual EPILIM sanofi-aventis maintenance 100-300mg. Max. 300mg. Dosesq150mg should be given in divided doses. 2MO Q Depression: Not recommended. OCD: EPILIM CHRONO. Carboxylic acid deriv. Sodium Initially 25mg/day. Increase in 25mg intervals every valproate (as valproate and valproic acid) 200mg, 300mg, 500mg. Violet oblong, film-ctd prolonged 4-7 days till effective dose reached. Max. 200mg. Dosesq50mg should be given in divided doses release tab. 200mg-100, A8.25; 300mg-100, with larger dose given at bedtime. A12.38; 500mg-100, A20.64. D Within 2 weeks of stopping MAOIs. 2MO B Bleeding disorders, diabetes, mania/ ALSO EPILIM CHRONOSPHERE Sodium valproate hypomania, monitor for suicidal ideation. Hepatic (as valproate and valproic acid) 100mg, 250mg, 500mg, 750mg, 1000mg. Prolong. release granules or renal insufficiency. History of epilepsy. Pregnancy, lactation. in sachets. 100mg-30, A9.79; 250mg-30, A10.02; 500mg-30, A13.03; 750mg-30, A19.38; 1000mg-30, C Contra: MAOIs. Caution: TCAs, neuroleptics, tacrine, theophylline, methadone, A18.72. mexiletine, warfarin, thioridazine, propranolol, S Treatment and prevention of mania caffeine, ropinirole, phenytoin, terfenadine, associated with bipolar disorders. astemizole, cisapride, carbamazepine, ciclosporin, P Initially 20mg/kg/day. Usual benzodiazepines, triptans, St. Johnâ&#x20AC;&#x2122;s Wort, lithium, maintenance: 1-2g/day. Max 3g daily. Q Chronosphere, see adults. Epilim Chrono alcohol. A Nausea, vomiting, asthenia, headache, not suitable for children under 20kg. malaise, palpitations, abdominal pain, anorexia, D Active liver disease, personal or family constipation, diarrhoea, dry mouth, dyspepsia, history of severe hepatic dysfunction (esp. drug agitation, anxiety, dizziness, insomnia, related), porphyria. nervousness, somnolence, tremor, sweating. B Risk of severe liver damage (incl.

the initial episode of depression or for the prevention of the recurrence of new episodes. P Swallow whole with food. 75mg once daily for initiation and maintenance. If further clinical improvement required after 2 weeks, may be increased to 150mg once daily. If needed, can be further increased up to 225mg once daily. Increase doses at intervals of 2 weeks or more but no less than 4 days. Discontinue if no evidence of clinical response after 8 weeks. Mild-moderate hepatic impairment: Reduce dose by 50%; further reduction may be required in some patients. Moderate renal impairment: Reduce dose by 50%. R Caution, use lowest effective dose. Q Under 18 years, not recommended. B For prescribing information, see venlafaxine Drug Presc. Notes.

daily. Max. of 3mg daily (doses above 2mg daily should be divided). R Half the recommended dosages. If no effect has been observed within 1 week of max. dosage the drug should be withdrawn. Q Not recommended. D Depressed level of consciousness ,coma, excitable or agitated patients; senile confusional states; severe depression. B Severe atherosclerosis, myocardial insufficiency or severe hepatic/renal insufficiency, Parkinsonism or extrapyramidal disease, patients with risk factors for stroke, CVD or family history of QT prolongation. Neuroleptic malignant syndrome has been reported. Tardive dyskinesia may develop. Withdraw gradually. Driving or operating machinery. Contains lactose and sucrose. C Other CNS depressants, QT prolonging drugs, drugs causing electrolyte imbalance. A Restlessness, visual disturbances, migraine, myalgia, general malaise, hyperprolactinaemia, amenorrhoea, somnolence, dizziness, headache, tremor, GI disorders, insomnia.

FLUZAC

Rowex

2NO SSRI. Fluoxetine (HCl) 20mg. Opaque, light green hard gel cap. 30, A14.18. S Major Depressive episodes, obsessive compulsive disorders (OCD), bulimia nervosa. See fluoxetine Drug Prescribing Notes. P Admin. as single or divided dose. Depression: Initially, 20mg daily; may be increased after 3 weeks if no response. Range 20-60mg/day. OCD: Initially 20mg daily; may be increased after 2 weeks if no response. Range 20-60mg/day. Reconsider after 10 weeks if no response. Bulimia nervosa: 60mg daily. Hepatic impairment: Consider lower or less frequent dose e.g. 20mg every second day.

GAMANIL

Merck Serono

2NO

TCA. Lofepramine (HCl) 70mg. Maroon film-ctd scored tab. 56, A11.64; 250, A51.97. S Symptoms of depressive illness. P 2 or 3 daily in divided doses. R May respond to lower doses in some cases. Q Under 18 years: Contraindicated. D Mania, severe hepatic/renal impairment, heart block, cardiac arrhythmias, recovery phase following MI, narrow angle glaucoma, prostatic hypertrophy with urinary retention. Pregnancy, lactation. B CVD, impaired liver/renal function, narrow angle glaucoma, history of epilepsy, prostatic hypertrophy, hyperthyroidism, blood dyscrasias, porphyria, paralytic ileus. Monitor cerebral/haemopoietic function, cardiac conduction disorders. In adolescents, risk of suicidality with antidepressants and no beneficial effects of TCAs demonstrated. Elderly. Driving/using machines. hepatic failure); increased risk in children Q 3 C MAOIs (or within 2 weeks). FLUANXOL Lundbeck years. Liver function tests advised before therapy Sympathomimetics, adrenergic neuron blockers, 2MO and in first 6 months, especially when risk or CNS depressants, anticholinergics, quinidine, history of liver disease. Pancreatitis may occur, esp. Thioxanthene. Flupenthixol (diHCl) 0.5mg, 1mg. digitalis glycosides, cimetidine, clonidine, thyroid Round, biconvex, yellow, sugar-ctd tab. 0.5mg-60, hormone therapy. in young children (prompt medical evaluation in A A 4.09; 1mg-60, 8.31. patients with acute abdominal pain). A Hypotension, tachycardia, cardiac Monotherapy recommended in children Q 3 years S Short-term management of mild to arrhythmias, dizziness, sleep disturbances, at risk of liver toxicity and pancreatitis. Blood cell moderate depression with or without anxiety. agitation, confusion, headache, dry mouth, count, bleeding time and coagulation tests advised P 1mg daily as a single dose in the constipation, sweating, accommodation morning. May be increased after 1 week to 2mg before therapy. Monitor for suicidal thoughts/ disturbances, urinary hesitancy, urinary retention,

102

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CNS

MOOD

DISORDERS, BULIMIA NERVOSA,

elderly, glaucoma (regulary check IOP), high doses. May trigger or exacerbate absences. Increase in seizure frequency or the onset of new types of GEODON Pfizer seizures may occur. Test blood regularly; discontinue if severe leucopenia or 2NO thrombocytopenia appear. Perform liver function 5-HT2A and dopamine (D2) receptor antagonist. tests periodically. Discontinue if severe Ziprasidone (as HCl monohydrate) 20mg blue/ white cap. 40mg blue cap. 60mg white cap. 80mg dermatological reactions, severe hypersensitivity occur. Avoid sunlight exposure. Driving/operating blue/white cap. All marked with Pfizer and ZDX 20, ZDX 40, ZDX 60 or ZDX 80. 20mg-56, A104.01; machines. C Not recommended: MAOIs. Caution: 40mg-56, A109.48; 60mg-56, A120.43; 80mg-56, Anticonvulsants, CYP450 inducers/inhibitors, A158.75. digoxin, theophylline, cisplatin, doxorubicin, S Treatment of manic or mixed episodes clonazepam, St. John’s Wort, azole antimycotics, of moderate severity in bipolar disorder macrolide antibiotics, isoniazid, Ca++ antagonists, (prevention not established). P Acute treatment, 40mg twice daily with acetazolamide, dextropropoxyphene, propoxyphene, viloxazine, danazol, nicotinamide food. Max. 80mg twice daily may be reached at (at high dose in adults), nefazodone, fluvoxamine, day 3. Hepatic insufficiency: Consider lower dose. terfenadine, loratadine, grapefruit juice, protease Q Not recommended. inhibitors, cimetidine (doses r 800mg), D Known QT-interval prolongation, desipramine, phenobarbital, lamotrigine, congenital long QT syndrome. Recent MI, primidone, clobazam, ethosuximide, tiagabine, uncompensated HF. Pregnancy, lactation. B Bradycardia, electrolyte disturbances. If alprazolam, corticosteroids, doxycycline, dihydropyridines, haloperidol, other neuroleptic cardiac symptoms occur, a cardiac evaluation drugs, TCAs, trazodone, topiramate, methadone, should be performed. Neuroleptic malignant tramadol, anticoagulants, bromperidol, syndrome and torsade de pointes have been olanzapine, quetiapine, praziquantel, caspofungin, reported rarely. Tardive extrapyramidal syndrome fentanyl, midazolam, phenazone, propranolol, after long-term treatment, reduce dose or methylphenidate, flunarizine, quinidine and discontinue. History of seizures, hepatic hydroquinidine, tacrolimus, sirolimus, cyclosporine, impairment. Patients with risk factors for stroke. oral contraceptives, HRT, bupropion, psychotropic Contains lactose. Ability to drive or operate drugs, paracetamol, lithium, hypokalaemic machinary my be impaired. Women of child diuretics (loop and thiazide diuretics), bearing potential should use contraception. C Contra: Class IA and III antiarrhythmics, antiarrhythmics, muscle relaxants, isotretinoin, thyroid hormones, serotonin re-uptake inhibitors, arsenic trioxide, halofantrine, levomethadyl, mesoridazine, thioridazine, pimozide, sparfloxacin, clozapine, procarbazine, alcohol. A Blood dyscrasias, dizziness, somnolence, gatifloxacin, moxifloxacin, dolasetron mesylate, sedation, drowsiness, ataxia, elevated gamma-GT, mefloquine, sertindole, cisapride, drugs that fatigue. prolong the QT interval. Caution: CNS drugs, alcohol, ketoconazole, carbamazepine. GEROZAC Gerard A Restlessness, dystonia, akathisia, 2NO extrapyramidal disorder, parkinsonism, tremor, SSRI. Fluoxetine (HCl) 20mg, 60mg. 20mg: Purple/ dizziness, sedation, somnolence, headache, vision green cap. marked FL20. 60mg: Light yellow blurred, GI disorders, musculoskeletal rigidity, opaque cap. marked FL60 on the body and G on asthenia, fatigue. the cap. 20mg-30, A15.02; 60mg-30, A65.45. GERICARB SR Gerard S Major depressive episodes and associated anxiety. Bulimia nervosa. Obsessive 2MO compulsive disorders (OCD). Dibenzazepine. Carbamazepine 200mg, 400mg. P Depression: Usually 20mg daily. Bulimia White to yellowish, round, flat, cloverleaf shaped nervosa: 60mg daily. OCD: 20-60mg daily. Max. prolonged release tabs with bevelled edge, double-sided cross break-mark, 4 notches on band. daily dose 80mg. R Max. 60mg daily. Can be divided into equal halves. 200mg-56, Q Not recommended. A4.48; 400 mg-56, A8.85. B Contains lactose. See fluoxetine Drug S Prophylaxis of manic or hypomanic Prescribing Notes. phases of manic-depressive psychosis in patients sweating, tremor, induction of glaucoma, testicular disorders, skin rash, nausea, vomiting.

unresponsive or with contraindications to lithium therapy. P Initially 100-400mg, increased gradually until symptoms controlled or to a total of 800mg. Exceptionally, max 1600mg in divided doses. Maintenance: 400-600mg daily in divided doses. D Bone marrow depression, AV conduction abnormalities, acute intermittent porphyria. B Evaluate benefit/risk: Haematological disturbances, disturbed Na+ metabolism, severe cardiac, liver and kidney dysfunction, myotonic dystrophia, pregnancy, lactation. Patients should consult immediately if fever, sore throat, rash, ulcers in the mouth, easy bruising, petechial or purpuric haemorrhage, nausea, skin yellowing and liver enlargement occurs. Caution: Severe cardiovascular disease, liver disease or renal damage,

OCD

3.4

months or longer in some cases. Hepatic/renal impairment, reduce dose 25-50% (see SPC). Q Under 18 years, not recommended. B For prescribing information, see venlafaxine Drug Presc. Notes.

LAMICTAL

GSK

2MO Triazine. Lamotrigine 25mg, 50mg, 100mg, 200mg. Pale yellow, multi-faceted, superelliptical tabs. marked with strength and code on reverse. 25mg56, A25.21; 50mg-56, A39.57; 100mg-56, A68.26; 200mg-56, A122.88.

2MO

ALSO LAMICTAL DISPERSIBLE Lamotrigine 2mg, 5mg, 25mg, 50mg, 100mg, 200mg. White tabs. marked with strength and code on reverse. 2mg30, A6.49; 5mg-28, A8.95; 25mg-56, A25.21; 50mg-56, A39.38; 100mg-56, A68.26; 200mg-56, A123.91. S Prevention of depressive episodes in patients with bipolar I disorder (BD), who predominantly have depressive episodes. P Monotherapy or adjunctive therapy without valproate or enzyme inducers: Initially, 25 mg/day (once a day) for 2 weeks; followed by 50 mg/day (once a day or two divided doses) for 2 weeks; then 100 mg/day (once a day or two divided doses) for 1 week; thereafter usual maintenance dose, 200 mg/day (once a day or two divided doses). Adjunctive therapy with valproate: Initially, 12.5 mg/day (25 mg on alternate days) for 2 weeks; followed by 25 mg/day (once a day) for 2 weeks; then 50 mg/day (once a day or two divided doses) for 1 week; thereafter maintenance dose 100 mg/day (once a day or two divided doses). Adjunctive therapy with enzyme inducers (except valproate): Initially 50 mg/day (once a day) for 2 weeks; followed by 100 mg/day (two divided doses) for 2 weeks; then 200 mg/day (two divided doses) for 1 week; thereafter 300mg/day, increasing to 400mg/day if necessary (2 divided doses). See SPC for dosing of lamotrigine during withdrawal or addition of concomitant psychotropic drugs. Q Safety and efficacy in BP not evaluated. B Renal/hepatic impairment. Rare skin reactions e.g. Stevens Johnson syndrome. Promptly evaluate patients who develop rash. Pregnancy, lactation. Hypersensitivity syndrome. Withdraw gradually. Monitor for clinical worsening and suicidal ideation and behaviour. C Phenytoin, carbamazepine, phenobarbitone, primidone, rifampicin, lopinavir/ ritonavir, ethinyloestradiol/levonorgestrel combination may increase dose requirement. Valproate reduces dose requirement. IREVEN Teva A Headache, agitation, somnolence, dizziness, dry mouth, skin rash, arthralgia, pain, 2NO back pain. 5HT/NA reuptake inhibitor. Venlafaxine (HCl) 75mg, 150mg. Resp. flesh and scarlet opaque hard LAMORO Pinewood gelatine prolonged-release caps containing two 2MO and three round, biconvex film-ctd tabs marked Triazine. Lamotrigine 25mg, 50mg, 100mg, 200mg. VEN on cap and strength on body. 75mg-28, A20.23; 150mg-28, A34.68. Dispersible white to off-white round tabs. 25mg60, A19.53; 50mg-60, A30.50; 100mg-60, A52.92; S Major depressive episodes. 200mg-60, A96.11. P Swallow whole with liquid once daily same time each day during meal. Initially, 75mg. S Prevention of mood episodes in patients May be increased to 150mg, then to 225mg. with bipolar disorder (BP), predominantly by Patients not responding, doses up to 375mg preventing depressive episodes. (limited experience). Increase doses at intervals of P Monotherapy or add on therapy to 2 weeks or more with min. 4 days between each drugs with no interaction with lamotrigine e.g. increment. If no response after 2-4 weeks, no lithium: Initially 25mg once daily for 2 weeks, benefit to be gained from treatment. Duration 4-6 followed by 50mg once daily or 2 divided doses

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

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CNS

Hypersensitivity syndrome. Withdraw gradually. Monitor for clinical worsening and suicidality (increased risk below 18 years). Pregnancy, lactation. Driving/operating machinery. Contains lactose. C Valproate reduces dose requirement. May increase dose requirement: Phenytoin, carbamazepine, phenobarbitone, primidone, rifampicin, ethinyloestradiol/levonorgestrel combination (consider continuous hormonal contraceptives or non-hormonal contraceptives to limit variations in lamotrigine levels). A Headache, agitation, somnolence, dizziness, dry mouth, skin rash, arthralgia, pain, back pain.

symptoms resolve (usually 2-4 weeks), continue for at least 6 months. OCD: Initially 10mg once daily, may be increased to max. 20mg daily; treat for sufficient period to ensure patient is symptom free. Panic disorder, GAD, SAD: See section 3.2. Reduced hepatic function: Initially 5mg for 2 weeks, may increase to 10mg. R Over 65 years, initially half adult dose and lower max. dose. Q Under 18 years, not recommended. B Hyponatraemia observed with SSRI use. History of mania/hypomania, co-admin. of ECT in patients on SSRI’s, bleeding disorders, coronary heart disease, paradoxical anxiety. Monitor patients with unstable epilepsy, diabetes. Withdraw gradually. Closely monitor patients for LARIG Rowex suicide and self harm during initiation of therapy (all SSRIs). Driving/using machine. Pregnancy, 2MO Triazine. Lamotrigine 25mg, 50mg, 100mg, 200mg. lactation. C Contra: Non-selective, irreversible White, square dispersible tab. marked L and MAOIs. Reversible MAOI-A (moclobemide), not strength. 25mg-56, A19.57; 50mg-56, A30.56; recommended. Caution: Selegiline, lithium, 100mg-56, A52.97; 200mg-56, A96.15. S Prevention of mood episodes in patients tryptophan, St. John’s Wort, drugs lowering epilepsy seizure threshold, oral anticoagulants, with bipolar disorder, predominantly by cimetidine, substrates or inhibitors of CYP2C19 preventing depressive episodes. (eg. omeprazole), CYP2D6 substrates, other P Monotherapy or add on therapy to serotonergic drugs, alcohol. drugs with no interaction with lamotrigine eg. A Nausea, sweating, somnolence, fatigue, lithium: Initially 25mg once daily for 2 weeks; dizziness, insomnia, constipation, diarrhoea, target dose, 200mg once daily or in 2 divided appetite decrease, sexual dysfunction, pyrexia, doses (range 100-400mg). Add on therapy with sinusitis, yawning. enzyme inhibitors e.g. valproate: Initially 25mg on alternate days for 2 weeks; target dose, 100mg LUSERT Pinewood once daily or in two divided doses; max. 200mg 2NO daily. Add on therapy with enzyme inducers eg. SSRI. Sertraline (HCl) 50mg, 100mg. White, film-ctd carbamazepine and without valproate: Initially tabs. 50mg, oval biconvex with breakline on the 50mg once daily for 2 weeks; usual target dose side and S3 on opposite side. 100mg, round bevel400mg daily in two divided doses (may be given edged with breakline. 50mg-28, A21.00; 100mgfrom week 7). See SPC for dose escalation in all LAMOTRIGINE RANBAXY Ranbaxy cases. See SPC for dosing of lamotrigine during 28, A31.55. 2MO S Major depressive episodes. withdrawal of concomitant psychotropic drugs. P Usually 50mg daily; may be increased in Triazine. Lamotrigine 25mg, 50mg, 100mg, 200mg. Hepatic impairment: Moderate, half adult dose; 50mg steps at min. 1 week intervals. Max. 200mg White to off-white round tab., debossed with L12, severe, 1/4 adult dose. daily. Max. effect after 2-4 weeks. Continue at L13, L14 or L15 (resp.) on one side. 25mg-56, Q Under 18 years, not recommended. A13.44; 50mg-56, A21.10 ; 100mg-56, A36.40; least 6 months after symptom remission. To be B Renal/hepatic impairment. Rare skin 200mg-56, A66.51. reactions eg. Stevens Johnson syndrome. Promptly taken with sufficient liquid. Reduce gradually to avoid withdrawal symptoms. S Adults q 18 years: Prevention of evaluate patients who develop rash. R Lowest dosage possible. depressive episodes in patients with bipolar I Hypersensitivity syndrome. Pregnancy, lactation Q Under 18 years, not recommended. disorder experiencing predominantly depressive (only if benefit outweighs risk). Driving/using D Severe hepatic impairment, unstable episodes Not indicated for acute treatment of machines. Withdraw gradually. epilepsy. manic or depressive episodes. C Enzyme inducing anti-epileptic drugs P Monotherapy or adjunctive therapy (AEDs) (eg. phenytoin, primidone, carbamazepine, B Hepatic impairment, controlled epilepsy, ECT, diabetes, history of bleeding disorder, without valproate or enzyme inducers: Initially phenobarbitone) may increase dose requirement. unstable cardiac disease, schizophrenia, elderly. 25mg once daily for 2 weeks, followed by 50mg A Rash, irritability, headache, drowsiness, Monitor for risk of suicide. Serotonin syndrome. once daily or 2 divided doses for 2 weeks; then insomnia, dizziness, tremor, vision disorders, GI Suicidal Symptoms among children under 18 years. 100mg/day for 1 week; thereafter 200mg daily, disorders, tiredness, arthralgia, pain, back pain. Monitor for risk of dependence symptoms. once daily or in 2 divided doses; may be increased Activation of mania/hypomania. Pregnancy, up to 400mg. Adjunctive therapy with valproate: lactation (only if benefit outweighs risk). Driving/ Initially 12.5mg )or 25mg on alternate days) for 2 using machines. weeks, followed by 25mg once daily for 2 weeks; C Contra: MAOIs (14 days apart), then 50mg/day (once daily or in 2 divided doses); pimozide. Avoid St John’s wort, serotonergics (eg. thereafter 100mg daily, once daily or in 2 divided trypthophan, fenfluramine, 5-HT agonists), doses, may be increased up to 200mg max. LEXAPRO Lundbeck alcohol. Caution: Cimetidine, diazepam, Adjunctive therapy with enzyme inducers: Initially 2NO tolbutamide, hypoglycaemics, oral anticoagulants, 50mg once daily for 2 weeks, followed by 100mg drugs affecting platelet function (e.g. NSAIDs, in 2 divided doses daily for 2 weeks, then 200mg/ SSRI. Escitalopram (oxalate) 5mg, 10mg, 15mg, 20mg. Round white film-ctd tab. marked EK and most TCAs), lithium, diuretics, phenytoin, day for 1 week; thereafter increasing by 100mg oval white scored film-ctd tabs. marked with EL, sumatriptan, CYP2D6 substrates, warfarin, per week up to target maintenance dose of EM and EN, resp. 5mg-28, A14.00; 10mg-28, phenozone (antipyrine), changeover from other 400mg/day in 2 divided doses. See SPC for dosing A22.40; 15mg-28, A33.90; 20mg-28, A44.80. antidepressants. during withdrawal or addition of concomitant A GI disorders, dry mouth, dyspepsia, psychotropic drugs. Special patient populations: S Major depressive episodes. Generalised tremor, dizziness, insomnia, somnolence, anorexia, See SPC. anxiety disorder (GAD). Panic disorder with or male sexual disorders, tiredness, hot flushes, skin Q Not recommended. without agoraphobia. Social anxiety disorder rash, increased sweating, chest pain, palpitations, B Renal failure (caution). Rare skin (SAD). Obsessive-compulsive disorder (OCD). tinnitus, headache, asthenia, motor disorders, reactions eg. Stevens Johnson syndrome. Promptly P Depression: Usually 10mg once daily, paraesthesia, hypoaesthesia, anxiety, yawning, evaluate patients who develop rash. may be increased to max. 20mg daily. After for 2 weeks; thereafter 100-200mg daily, once daily or in 2 divided doses. Target maintenance dose, 200mg; but may be increased up to 400mg. Add on therapy with enzyme inhibitors e.g. valproate: Initially 25mg on alternate days for 2 weeks, followed by 25mg once daily for 2 weeks; thereafter 50-100mg daily, once daily or in 2 divided doses. Target maintenance dose, 100mg; but may be increased up to 200mg. Add on therapy with enzyme inducers e.g. carbamazepine: Initially 50mg once daily or 2 divided doses for 2 weeks, followed by 100mg in two divided doses daily for 2 weeks, thereafter patients may be increased by 100mg per week up to max. 400mg in two divided doses. Target maintenance dose, 400mg. See SPC for dosing of lamotrigine during withdrawal or addition of concomitant psychotropic drugs. Special patient populations: Refer to SPC. Q Safety and efficacy in BP not evaluated. B Renal/hepatic impairment. Rare skin reactions eg. Stevens Johnson syndrome. Promptly evaluate patients who develop rash. Hormonal contraceptives. Pregnancy, lactation. Hypersensitivity syndrome. Withdraw gradually. Monitor for clinical worsening and suicidality. Driving/operating machinery. C Phenytoin, carbamazepine, phenobarbitone, primidone, rifampicin, ethinyloestradiol/levonorgestrel combination may increase dose requirement. Valproate reduces dose requirement. A Skin rash, irritability, headache, drowsiness, insomnia, dizziness, tremor, nystagmus, ataxia, diplopia, blurred vision, GI disturbance, tiredness, agitation, arthralgia, somnolence, pain, back pain.

104

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Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


3.4 MOOD

DISORDERS, BULIMIA NERVOSA,

OCD

CNS

reported in children and adolescents. Caution with: Epilepsy and organic brain syndrome, hepatic or renal failure, heart disease, hypotension, MIRAP Rowex micturition disturbances, acute narrow-angle 2NO glaucoma and raised intra-ocular pressure, GI 2 N O SSRI. Sertraline (HCl) 50mg, 100mg. White, capobstruction or ileus, diabetes mellitus, tendency to shaped, film-ctd tabs. marked PFIZER and ZLT-50 Presynaptic a2-antagonist. Mirtazapine 15mg, suicidal ideation. Elderly. Driving/using machines. or ZLT-100 resp. 50mg tab. scored. 50mg-28, 30mg, 45mg. Film-coated, biconvex tabs. 15mg, Discontinue if jaundice occurs. Withdraw A12.63. 100mg-28, A18.94. 30mg: Yellow and beige, resp; both oval with score line on one side. 45mg: White, round. 15mg- gradually. Contains aspartame. S Treatment of symptoms of depression, C MAOIs (within 2 weeks), alcohol. 30, A12.41; 30mg-30, A20.65; 45mg-30, A37.20. incl. accompanying symptoms of anxiety. Caution: Benzodiazepines and other sedatives, Prevention of relapse of initial depressive episodes 2 N O other serotonergic drugs, potent CYP3A4 or recurrence of further depressive episodes, ALSO MIRAP ORODISPERSIBLE TABLETS inhibitors, CYP3A4 inducers, cimetidine, warfarin. including accompanying symptoms of anxiety. Mirtazapine 15mg, 30mg, 45mg. White to offA Increased appetite and weight gain, Obsessive compulsive disorder in adults and white, round, flat tabs with bevelled edges and somnolence, dizziness, headache, oedema. children aged 6 years and over. Panic disorder plain on both sides. 15mg-30, A10.67; 30mg-30, with or without agoraphobia. Social anxiety A21.32; 45mg-30, A31.98. MIRTAZAPINE TEVA Teva disorder (SAD). Post-traumatic stress disorders S Major depressive episodes. 2NO (PTSD). P Initially, 15-30mg preferably in the P OCD/Depression: 50mg once daily. Panic evening. Maintenance,15-45mg per day. Renal or Presynaptic a2-antagonist. Mirtazapine 15mg, disorder/SAD/PTSD: Initially, 25mg daily increasing hepatic insufficiency: Also consider divided dose in 30mg, 45mg. Round, white, bevelled edge tab. to 50mg daily after 1 week. All indications: Dose marked 93 one side and 7303, 7304 or 7305, resp. the morning and at bedtime (larger dose). Effect may be increased in 50mg increments over a usually after 1-2 weeks. Withdraw gradually if no on the other. 15mg-30, A9.84; 30mg-30, A19.68; period of weeks, to max. 200mg daily. 45mg-30, A29.51. effect with max. dose after 2-4 weeks. Take tabs Q OCD: Age 13-17 years, 50mg/day; 6-12 S Major depressive episode. with sufficient water; orodisp. tabs with or years, initially 25mg/day, increasing to 50mg/day P Initially, 15mg or 30mg, in the evening. without water. after 1 week. Patients not responding, increase by R Changes in dosage under close Maintenance dose 15mg-45mg per day. 50mg/day increments at 1 week intervals; max. Q Under 18 years, not recommended. supervision. 200mg/day. Under 6 years: Not recommended D Lactation, pregnancy (unless clearly Q Under 18 years, not recommended. D Significant hepatic insufficiency. indicated). D Pregnancy (unless clearly indicated), Pregnancy, lactation. Unstable epilepsy or B Monitor for signs of bone marrow lactation. convulsant disorders. B Monitor patients with history of suicide- depression (discontinue if occurs). Suicide-related B Monitor for suicidality during 1st few related events or exhibiting a significant degree of behaviours and hostility more frequently reported weeks of treatment. Discontinue if patient enters in children and adolescents; monitor patients with suicidal ideation. Monitor for bone marrow depression; discontinue if fever, sore throat, a manic phase. Controlled epilepsy. ECT, not history of suicide-related events, or exhibiting stomatitis or other signs of infections occur. recommended. Monitor children for suicidality if suicidal ideation prior to commencement. Caution: Caution: epilepsy and organic brain syndrome, treating for OCD. Driving or using machines. Epilepsy and organic brain syndrome, hepatic or hepatic and renal impairment, cardiac diseases C Contraindicated: MAOIs (or within 14 renal failure, heart disease, hypotension, GI (conduction disorders, angina pectoris, recent MI), obstruction or ileus, micturition disturbances, days), pimozide. Monitor alcohol, lithium, hypotension, prostate hypertrophy, acute narrow- acute narrow-angle glaucoma and increased IOP, warfarin, phenytoin, sumatriptan. Caution: St angle glaucoma and elevated intra-ocular Johnâ&#x20AC;&#x2122;s wort, diazepam, tolbutamide, cimetidine, diabetes, elderly. May occur: Exacerbation of pressure, diabetes mellitus, elderly, history of TCAs, other centrally acting drugs, other psychotic symptoms, switch to manic phase of mania/hypomania (discontinue if patient enters a serotonergic drugs. bipolar disorder (discontinue). Withdrawal manic phase). May worsen psychotic symptoms in symptoms may occur following abrupt A Anorexia, insomnia, dizziness, patients with schizophrenia or other psychotic somnolence, tremor, GI disorders, increased termination. Discontinue if jaundice occurs. sweating, ejaculatory delay. Also reported in OCD disorders. Discontinue if jaundice occurs. Withdraw Contains aspartame. Driving/operating machines. gradually. Driving/using machines. Tabs contain patients aged 6-17 years: Chest pain, fever, C Contra: MAOIs (or within two weeks). malaise, hyperkinesia, urinary incontinence, other lactose. Orodisp. tabs contain aspartame and Caution: Benzodiazepines and other sedatives, sulphites. psychiatric disorders, breast pain, dysmenorrhea, other serotonergic drugs (e.g. SSRIs), potent C Contra: MAOIs (or within 2 weeks after CYP3A4 inhibitors, HIV protease inhibitors, azole menstrual disorder, epistaxis, skin disorder, discontinuation). Avoid alcohol. Caution: headache, hyperkinesia. antifungals, erythromycin or nefazodone, CYP3A4 Benzodiazepines and other sedatives, other inducers (e.g. carbamazepine, rifampicin, MANERIX Roche serotonergic drugs, strong CYP3A4 inhibitors, phenytoin), cimetidine, warfarin. Avoid alcohol. CYP3A4 inducers, cimetidine, warfarin. A Increased appetite and weight gain, 2NO A Increased appetite, weight gain, somnolence, dizziness, headache, generalised or RIMA (reversible inhibitor of monoamine oxidase somnolence, dizziness, headache, general or local local oedema. A). Moclobemide 150mg, 300mg. Oblong, pale oedema, nausea. yellow film-ctd scored tab. marked ROCHE and MIRZATEN Niche tab. strength on reverse. 150mg-30, A11.18; MIRTAZ Pinewood 2 N O 300mg-30, A17.93. 2NO Presynaptic a2-antagonist. Mirtazapine 15mg, S Moderate or severe depression. 30mg or 45mg. White, round, biconvex Presynaptic a2-antagonist. Mirtazapine 30mg. P Initially 300mg daily in divided doses orodispersible tablets. 15mg-30, A10.93; 30mg-30, White or off-white round orodispersible tab. after meals, max. 600mg daily. A A19.19; 45mg-30, A32.14. marked M2. 30, 22.52. Q Not recommended. S Episode of major depression. S Major depressive episodes. D Acute confusional states. Patients with P Initially, 15-30mg dissolved on the P Initially, 15 or 30mg per day, taken concomitant schizophrenia. Pregnancy and tongue once daily at bedtime. Maintenance,15preferably in the evening. The maintenance dose lactation, unless benefits outway risks. 45mg per day. May be taken twice daily, with is usually between 15-45mg per day. B Depressive patients with excitation, larger dose in the evening. Treatment duration, 4- Q Under 18 years, not recommended. suicidal tendencies, epilepsy. Thyrotoxicosis or 6 months. Withdraw gradually if no effect with D Lactation, pregnancy (unless clearly phaeochromocytoma. See SPC. max. dose after 2-4 weeks. indicated). C Ibuprofen, opiates, cimetidine. CoQ Under 18 years, not recommended. B Monitor for signs of bone marrow admin. with 5-HT re-uptake inhibitors or D Pregnancy (unless clearly indicated), depression (discontinue if occurs). Suicide-related precursors not recommended. lactation. behaviours reported in children and adolescents. A Sleep disturbances, dizziness, nausea, Caution: Epilepsy and organic brain syndrome, headache have occasionally been observed. In very B Monitor for bone marrow depression (discontinue if occurs). Suicide-related behaviours hepatic or renal failure, heart disease, rare cases confusional states have been reported. Some anti-cholinergic-like effects have been reported.

agitation, menstrual disorders, impaired vision.

LUSTRAL

106

Pfizer

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Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CNS

MOOD

DISORDERS, BULIMIA NERVOSA,

OCD

3.4

hypotension, GI obstruction or ileus, micturition disturbances, acute narrow-angle glaucoma and raised intra-ocular pressure, diabetes mellitus, schizophrenia, history of mania/hypomania, elderly. Discontinue if icterus occurs. Withdrawal symptoms may occur following abrupt termination. Contains aspartame, lactose and sorbitol. Driving/using machines. C MAOIs (contraindicated). Avoid alcohol. Caution: Benzodiazepines and other sedatives, other serotonergic drugs, potent CYP3A4 inhibitors, CYP3A4 inducers, cimetidine, warfarin. A Increased appetite and weight gain, somnolence, dizziness, headache, generalised or local oedema.

necessary after one week to 1 three times daily. Maintenance, usually 1 daily. Q Not recommended. D See SPC.

2NO

R Max. 40mg daily. PROTHIADEN Teofarma Q Under 18 years, not recommended. 2NO D Children Q18 years with major TCA. Dothiepin (HCl) 25mg. Red/brown cap. depressive episodes. B Hepatic/severe renal impairment, cardiac marked P25. 100, A4.62; 500, A22.01.

condition, increased risk of bleeding, history of mania, epilepsy, ECT, narrow angle glaucoma, diabetes; caution. Serotonin syndrome, akathisia, hyponatraemia may develop. High risk of suicidal behaviour. Withdraw gradually. Pregnancy, PAROSER Pinewood lactation; only if clearly necessary (risk of serotonergic effects/withdrawal symptoms in 2NO neonates). Driving/using machines. SSRI. Paroxetine (HCl anhydrate) 22.2mg equiv. C Contra: MAOIs (2 weeks apart), 20mg paroxetine. White, oval-shaped, biconvex, film-ctd tabs. engraved 20 with a breakline on one thioridazine, tryptophan. Caution: St John’s Wort, SSRIs, tramadol, other serotonergics, CYP2D6 side. 30, A15.00. substrates (eg. phenothiazine neuroleptics, certain S Major depressive episode, obsessive compulsive disorder (OCD), panic disorder with or TCAs, risperidone, certain 1c antiarrhythmics, metoprolol), alcohol, anticoagulants, NSAIDs, without agoraphobia, Social Anxiety Disorders lithium, procyclidine. (SAD)/social phobia, Generalised Anxiety Disorder A Sexual dysfunction, nausea, decreased (GAD). MOLIPAXIN sanofi-aventis P Once daily in the morning with food. appetite, body weight gain, asthenia, somnolence, yawning, insomnia, dizziness, tremor, blurred 2MO Depression, SAD/social phobia, GAD: vision, GI disorders, sweating. Recommended dose 20mg daily; max. 50mg/day. Triazolopyridine. Trazodone (HCl) 150mg. Pink OCD: 40mg daily. Initially 20mg daily; max. 60mg/ film-ctd scored tab. marked Molipaxin 150. 28, PRIADEL Sanofi A11.88. day. Panic disorder: 40mg daily. Initially 10mg 2NO daily; max. 60mg/day. All doses should be 2MO increased if necessary in 10mg increments. Lithium salt. Lithium carbonate 200mg, 400mg. ALSO MOLIPAXIN CAPSULES Trazodone (HCl) Duration several months or longer for OCD, panic Prolonged release tabs. marked P200 and PRIADEL 50mg, 100mg. Violet/green and violet/fawn cap. resp. Both white scored tabs. 200mg-100, A2.96; disorder; at least six months for depression. A coded R365B and R365C resp. 50mg-84, 17.71; 400mg-100, A4.36. R Max. 40mg/day. 100mg-56, A20.85. S Acute manic or hypomanic episodes, Q Under 18 years, not recommended. S Depression with or without anxiety. depressive disorders where other antidepressants D Pregnancy, lactation (unless absolutely P Initially 75-150mg daily as single failed, prophylaxis of bipolar affective disorders, evening dose, increasing to 200-300mg per day by necessary). control of aggressive behaviour or intentional self end of 1st week. Hospitalised patients with severe B Severe renal impairment (cc Q30ml/ harm. min), hepatic impairment. Increase of suicidal depression, increase to max. 600mg daily in P Initially 400-1200mg daily as a single related behaviours. History of mania, cardiac divided doses. dose. Maintain blood lithium levels in range 0.7conditions, diabetes, epilepsy, increased risk of R Initially 100mg daily in divided doses 1mmol/litre 12 hours after a single daily dose. See after meals or as single night-time dose. Max. bleeding, hyponatraemia reversible on SPC. 300mg daily. discontinuation, narrow angle glaucoma. Q Not recommended. Q Under 18 years. not recommended. Associated with akathisia, Serotonin Syndrome/ D Pregnancy, lactation. Neuroleptic Malignant Syndrome. Contains lactose. O B Suicide and suicidal ideation. Epilepsy. ALSO PRIADEL LIQUID Lithium citrate 520mg Discontinue gradually. Driving / using machines. Severe hepatic, renal or cardiac disease. May C MAOIs, thioridazine, pimozide (contra), (equiv. to 5.4mmol Li+) per 5ml. Sugar free liquid. provoke bradycardia and hypotension. metoprolol, alcohol (avoid). Caution: Serotonergic 150ml, A7.81. Agranulocytosis, thrombocytopenia and anaemia. drugs, lithium, drug metabolising enzyme P Initially 10-30ml daily in two divided Alterations in liver function. Contains lactose. doses. Maintain serum lithium levels in range 0.5inhibitors, procyclidine, anticonvulsants, CYP2D6 Fructose intolerance, glucose-galactose 0.8 mmol/litre 12 hours after previous dose. See substrates (eg. certain TCAs, phenothiazine malabsorption or sucrase isomaltase insufficiency. SPC. neuroleptics, risperidone, certain Type lc Driving/operating machinery. Q Not recommended. antiarrhythmics), NSAIDs, drugs increasing C MAOIs, ketoconazole, ritonavir, D Cardiac failure. Renal impairment. bleeding risk. indinavir, carbamazepine, muscle relaxants, Addison’s disease. Untreated hypothyroidism. A Decrease appetite, somnolence, volatile anaesthetics, alcohol, sedatives, Pregnancy, lactation. insomnia, agitation, dizziness, tremor, blurred antidepressants, clonidine, antihypertensives, B Monitor renal, cardiac, thyroid function vision, yawning, GI disorders, sweating, sexual hypericum perforatum, digoxin, phenytoin. prior to treatment and periodically during. Elderly dysfunction, asthenia, body weight gain. Preparations containing St. John’s Wort. (caution). Check for signs of toxicity and advise A Suicidal ideation/behaviour, dizziness, PAROX Rowex patients about symptoms. Maintain salt and fluid headache, weakness, decreased alertness, weight intake. Advise patients to report polyuria, 2NO loss, tremor, dry mouth, tachycardia, oedema, GI polydipsia nausea, vomiting, diarrhoea, excessive SSRI. Paroxetine (HCl) 20mg, 30mg. White and disorders, rash, blurred vision, restlessness, sweating and/or other conditions leading to salt/ blue tabs. marked 20 and 30 resp. Both oval confused states, insomnia, skin rash. water depletion. Contains Na+. biconvex film-ctd with a breakline. 20mg-30, C Thiazide diuretics, steroids, NSAIDs, ACE A A 15.00; 30mg-30, 22.53. NORZAC Teva inhibitors, metronidazole, methyldopa, S Major depressive episode, obsessive 2NO compulsive disorder (OCD), panic disorder with or tetracyclines, osmotic diuretics, carbonic anhydrase SSRI. Fluoxetine (HCl) 20mg. Light green cap. 30, inhibitors, xanthine, Na+ bicarbonate, Ca++ channel without agoraphobia, social anxiety disorders A13.53. blockers, psychotropic/neuroleptic drugs, (SAD)/social phobia, generalised anxiety disorder S Depression. Bulimia nervosa. carbamazepine, triptan derivatives, serotoninergic (GAD), post-traumatic stress disorder. P Depression, single dose of 20mg daily. antidepressants. P Depression, SAD, social phobia, GAD, Bulimia nervosa, 60mg daily; max. 80mg daily. A Skin reactions, muscle weakness, CNS post-traumatic disorders: 20mg once daily in the Q Not recommended. morning with food; may be increased gradually in and ECG disturbances, GI disorders, thyroid D Severe renal failure, unstable epilepsy. function disturbances, weight increase, QT 10mg increments to max. 50mg once daily. OCD See fluoxetine Drug Prescribing Notes. and panic disorder: Initially 20mg once daily (OCD) prolongation, leucocytosis, polydipsia and/or or 10mg daily (panic disorder); increase weekly in polyuria, diabetes insipidus, confusion, peripheral PARNATE Goldshield 10mg increments to 40mg daily; max. 60mg daily. oedema. MAOI. Tranylcypromine (as sulph.) 10mg red sugctd tab. marked FW 251. 28, A14.79. S Depression. P Initially 1 twice daily, increasing if

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

107


3.4 MOOD

DISORDERS, BULIMIA NERVOSA,

OCD

CNS

SSRI. Fluoxetine (HCl) 20mg. Ivory cap. 30, A14.78. S Major depressive episodes and associated anxiety. Bulimia nervosa. Obsessive compulsive disorder (OCD). P Depression: usually 20mg daily. Bulimia nervosa: 60mg daily. OCD: 20-60mg daily, max. 80mg daily. Q Not recommended. D Severe renal failure, unstable epilepsy, convulsive disorders. See fluoxetine Drug Prescribing Notes.

outweighs risk). Driving /using machines. Withdraw gradually. C Contra: MAOIs (or within 14 days), 2NO pimozide. Avoid alcohol, serotonergics, St John’s ALSO PROTHIADEN TABLETS Dothiepin (HCl) wort. Caution: Lithium, diuretics, drugs increasing 75mg. Red sug-ctd tab. marked P75. 28, A3.62; the risk of haemorrhages (e.g. anticoagulants, 100, A12.33. TCAs, NSAIDs), tolbutamide, insulin, diazepam, P 75-150mg daily in divided doses or as cimetidine, phenytoin, sumatriptan, ECT. single dose in the evening. A GI disorders, dyspepsia, dry mouth, R Initial dose: 50-75mg daily. Increase sweating, tremor, dizziness, insomnia, somnolence, gradually under close supervision. anorexia, headache, motor disorders, yawning, Q Not recommended. agitation, anxiety, male sexual disorders, D See SPC. PROZIT Pinewood menstrual disorders, tiredness, asthenia, hot flushes, rash, chest pain, palpitations, tinnitus, PROZAC Lilly 2 N O impaired vision. 2NO SSRI. Fluoxetine (HCl) 20mg. Olive green cap. SSRI. Fluoxetine (HCl) 20mg. Green/yellow cap. marked FLE 20. 30, A15.00. SERIMEL Clonmel marked Lilly 3105. 30, A9.02. S Major depressive disorders, obsessive 2NO 2NO compulsive disorder, bulimia nervosa. See SSRI. Sertraline (HCl) 50mg, 100mg. White, film-ctd ALSO PROZAC LIQUID Fluoxetine (HCl) 20mg/5ml. fluoxetine Drug Prescribing Notes. caplet-shaped tab. marked with strength on one 70ml, A21.82. P Usually 20mg daily. Most patients do side and breakline on reverse. 50mg-28, A16.24; S Major depressive episodes, obsessive not require more than 20mg daily. Max. 60mg compulsive disorders (OCD), bulimia nervosa. daily. Bulimia nervosa: 60mg. Hepatic impairment: 100mg-28, A29.37. P Admin. as single or divided dose. Consider lower/less frequent dose (e.g. 20mg every S Major depressive episodes. P Usually 50mg daily; may be increased in Depression: Initially, 20mg daily; may be increased 2nd day). Gradually taper when discontinuing to 50mg steps at min. 1 week intervals. Max. 200mg after 3 weeks if no response. Range 20-60mg/day. avoid withdrawal symptoms. daily. Max. effect after 2-4 weeks. Continue at OCD: Initially 20mg daily; may be increased after 2 R Caution. Max dose 60mg/day. least 6 months after symptom remission. weeks if no response. Range 20-60mg/day. Q Not recommended. Q Under 18 years, not recommended. Reconsider after 10 weeks if no response. Bulimia nervosa: 60mg daily. SERETRAL Teva D Severe hepatic impairment, unstable epilepsy. Q Under 18 years, not recommended. 2NO B Hepatic impairment, history of mania/ B Contains sucrose. See fluoxetine Drug SSRI. Sertraline (HCl) 50mg, 100mg. Light blue or hypomania, controlled epilepsy, ECT, diabetes, Prescribing Notes. yellow, elliptical, film-ctd tab. one side scored and history of bleeding disorder, unstable cardiac disease, schizophrenia, elderly. Monitor for risk of PROZAMEL Clonmel marked 9 and 3, the other marked 7176 or 7177 resp. 50mg-30, A17.94; 100mg-30, A28.42. suicide. Serotonin syndrome. Pregnancy, lactation 2NO S Major depressive episodes. (only if essential). Driving/using machines. SSRI. Fluoxetine (HCl) 20mg. Green cap. 30, P 50mg/day once daily with sufficient Withdraw gradually. A13.78. liquid. Can be increased in steps of 50mg at min 1 C Contra: MAOIs (14 days apart), S Major depressive episodes and week intervals. Max, 200mg/day. Max. effect pimozide. Avoid St John’s wort, serotonergics (eg. associated anxiety. Bulimia nervosa. Obsessive generally reached after 2-4 weeks. Consider long- tryptophan, fenfluramine, 5-HT agonists), alcohol. compulsive disorders (OCD). term treatment, at least 6 months, after remission Caution: Cimetidine, diazepam, tolbutamide, P Depression: usually 20mg daily. Bulimia of symptoms. hypoglycaemics, oral anticoagulants, drugs nervosa: 60mg daily. OCD: 20-60mg daily. Max. Q Under 18 years, not recommended. affecting platelet function (e.g. NSAIDs, most daily dose 80mg. TCAs), lithium, diuretics, phenytoin, sumatriptan, D Severe hepatic impairment. Unstable Q Not recommended. CYP2D6 substrates, changeover from other epilepsy (avoid). D Severe renal failure. Unstable epilepsy, B Monitor for risk of suicide. Activation of antidepressants. convulsive disorders. See fluoxetine Drug A GI disorders, dry mouth, dyspepsia, mania or hypomania. Impaired hepatic function Prescribing Notes. tremor, dizziness, insomnia, somnolence, anorexia, (use lower or less frequent dose), controlled male sexual disorders, asthenia, tiredness, hot epilepsy, schizophrenia, heart disease, diabetes, PROZATAN UCB patients at risk of haemorrhage, elderly. Akathisia flushes, sweating, rash, chest pain, palpitations, 2NO tinnitus, headache, motor disorders, paraesthesia, reported. Pregnancy, lactation (only if benefit S Depression, anxiety associated with depression.

Drug Prescribing Notes ● FLUOXETINE Indications Major depressive episodes ● Obsessive-compulsive disorder ● Bulimia nervosa Special Precautions Under 18 years of age: Suicide-related behaviours. Caution with: History of seizures (avoid if unstable seizure disorders/epilepsy), history of mania/hypomania. Discontinue in any patient who develops seizures or enter manic phase ● Significant hepatic dysfunction (lower dose) ● Acute cardiac disease (limited data) ● Suicidal ideation (monitor carefully, especially early treatment and change of dose) ● Discontinue gradually ● patients with a history of bleeding disorders ● Avoid driving/using machines. Pregnancy: Data on a large number of pregnancies do not indicate a teratogenic effect of fluoxetine. Can be used during pregnancy, but caution should be exercised, especially during late pregnancy or just prior to the onset of labour, since side-effects have been reported in neonates. Lactation: Excreted in human breast milk. Adverse events reported in breast-feeding infants. Consider discontinuation of breast-feeding or use lowest effective dose. Drug Interactions Contraindicated: Treatment of fluoxetine should only be started 2 weeks after discontinuation of an irreversible MAOI and the following day after discontinuation of a reversible MAOI-A. Similarly, at least 5 weeks should elapse after discontinuing fluoxetine treatment before starting a MAOI. If fluoxetine has been prescribed chronically and/or at a high dose, a longer interval should be considered. Avoid: Alcohol. Caution: Oral anticoagulants, drugs increasing risk of bleeding, phenytoin, CYP2D6 isoenzyme with narrow therapeutic index (e.g., flecainide, encainide, carbamazepine, TCAs), ECT. Risk of serotonin syndrome (monitoring recommended): St John's Wort, MAOI-B (selegeline), other serotonergics (e.g., L-tryptophan), lithium. Side-Effects Hypersensitivity, chills, serotonin syndrome, photosensitivity, GI disorders, headache, sleep abnormalities, dizziness, anorexia, fatigue, euphoria, transient abnormal movement, seizures, hallucinations, manic reaction, confusion, agitation, anxiety, impaired concentration and thought process, panic attacks, suicidal thoughts and behaviour, urinary retention/frequency, sexual dysfunction, priapism, galactorrhoea, alopecia, yawn, abnormal vision, sweating, vasodilatation, arthralgia, myalgia, postural hypotension, ecchymosis, pharyngitis, dyspnoea. Revised November 2009

108

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CNS

MOOD

DISORDERS, BULIMIA NERVOSA,

tryptophan, fenfluramine, tramadol, St John’s wort. Caution: Centrally active drugs, lithium, sumatriptan, phenytoin, TCAs, drugs affecting SERLAN Rowex platelet function (e.g. anticoagulants, NSAIDs), tolbutamide, diazepam, cimetidine, insulin. 2NO A Anorexia, insomnia, dizziness, SSRI. Sertraline (HCl) 50mg, 100mg. White, cap.somnolence, tremor, diarrhoea, dry mouth, shaped, scored, film-ctd tab. marked SE/strength. dyspepsia, nausea, sweating, sexual dysfunction. 50mg-28, A18.45; 100mg-28, A31.54. S Major depressive episodes. SEROQUEL XR AstraZeneca P Usually 50mg daily; may be increased in 50mg steps at min. 1 week intervals. Max. 200mg 2 N O Dibenzothiazepine. Quetiapine (fumarate) 50mg, daily. Max. effect after 2-4 weeks. Continue at 200mg, 300mg, 400mg. Prolonged released tabs. least 6 months after symptom remission. Peach, yellow, pale yellow and white resp. marked Q Under 18 years, not recommended. with XR and strength. 50mg-60, A63.08; 200mgD Severe hepatic impairment, unstable 60, A140.80; 300mg-60, A213.89; 400mg-60, epilepsy and seizures. A 282.13. B Hepatic impairment, history of mania/ S Moderate to severe manic episodes and hypomania, controlled epilepsy, ECT, diabetes, major depressive episodes in bipolar disorder. history of bleeding disorder, unstable cardiac disease, schizophrenia, elderly. Monitor for risk of Prevention of recurrence in responsive patients. P Manic: Admin. at least 1 hr before meal. suicide. Serotonin syndrome. Pregnancy, lactation Initial titration: 300mg (day 1), 600mg (day 2) (only if benefit outweighs risk). Driving/using (q recommended dose). Dose range 400-800mg/ machines. Withdraw gradually. day. Depressive: Admin once daily at bedtime. C Contra: MAOIs (14 days apart), pimozide. Avoid St John’s wort, serotonergics (eg. 50mg (day 1), 100mg (day 2), 200mg (day 3), 300mg (day 4) (q recommended daily dose); trypthophan, 5-HT agonists, dextromethrophan, pethidine, tramadol, other SSRIs), alcohol. Caution: may be titrated up to 600mg or down to 200mg. Maintenance: Same dose, can be adjusted within Anticoagulants, drugs affecting platelet function range 300-800mg/day. Hepatic impairment: Initially (eg. NSAIDs, TCAs, phenothiazides), lithium, 50mg/day; can be increased in increments of sumatriptan, diuretics, hypoglycaemic drugs, 50mg/day. phenytoin, cimetidine, diazepam, tolbutamide, R Initially 50mg/day; can be increased in some CYP2D6 substrates (eg. propafenone, increments of 50mg/day to effective dose. Over 65 flecainide). years, not evaluated for depressive episodes. A Anorexia, weight loss, male sexual Q Children and adolescents, not evaluated. disorders, insomnia, somnolence, agitation, 2NO anxiety, tremor, dizziness, paraesthesia, ALSO SEROQUEL Quetiapine (fumarate) 25mg, hypoaesthesia, headache, blurred vision, chest 100mg, 200mg, 300mg. Film ctd tabs. Peach, pain, palpitations, vasodilatation, yawning, GI yellow, white and white resp. 25mg-60, A37.77; disorders, dry mouth, dyspepsia, rash, menstrual 100mg-60, A107.92; 200mg-60, A123.04; 300mgirregularities, diaphoresis, fatigue. 60, A200.04. SERLO Actavis S Moderate to severe manic episodes and major depressive episodes in bipolar disorder. Not 2NO indicated for prevention of recurrence. SSRI. Sertraline (as HCl) 50mg, 100mg. Oval and P Manic: Admin. twice a day. Initial round white, scored, biconvex, film-ctd tabs. titration: 100mg (day 1), 200mg (day 2), 300mg marked with L and C resp. 50mg-28, A17.76; (day 3), 400mg (day 4). Further adjustments should 100mg-28, A27.40. be in increments of no greater than 200mg/day. S Depression (treatment and prevention Usual effective dose 400-800mg/day. Dose range of relapses). Treatment of obsessive-compulsive 200-800mg/day. Depressive: See Seroquel XR. disorder (OCD), panic disorder with/without Hepatic impairment: Initially 25mg/day; should be agoraphobia, social phobia and prevention of increased in increments of 25-50mg/day. relapse of initial episode, post-traumatic stress R Dose titration may need to be slower disorder (PTSD). and daily therapeutic dose lower. P Depression, OCD: 50mg daily. Panic Q Children and adolescents, not disorder , social phobia, PTSD: Initially 25mg daily; recommended. increase to 50mg daily after 1 week. Increase in B Monitor for suicidal tendencies, esp. at 50mg steps at min. 1 week intervals up to max. beginning. Caution: Hepatic impairment, 200mg daily. Full effect after 2-4 weeks. cardiovascular or cerebrovascular disease, Q Under 6 years, not recommended. OCD: hypotension, history of seizures, patients at risk 13-17 years, initially 50mg daily. 6-12 years initially for aspiration pneumonia. Monitor diabetic 25mg daily; increase to 50mg daily after 1 week. patients. May increase metabolic risk. May occur: Max. 200mg daily. Other indications: Under 18 Tardive dyskinesia, neuroleptic Monitor for suicidal years, not recommended. tendencies, esp. at beginning. Caution: Hepatic D Significant hepatic dysfunction, epilepsy impairment, cardiovascular or cerebrovascular or convulsant disorders. Pregnancy, lactation. disease, hypotension, history of seizures, patients B Monitor for suicidal tendencies, esp. at at risk for aspiration pneumonia. Monitor diabetic beginning. Activation of mania or hypomania patients. May increase metabolic risk. May occur: (discontinue). Monitor renal function regularly, Tardive dyskinesia, neuroleptic malignant especially in elderly. Controlled epilepsy (stop if syndrome, lipid changes. Driving/operating convulsions occur), ECT (not recommended), machines. Pregnancy (only if benefit outweighs diabetes, patients at risk of haemorrhage. Driving/ risk), lactation (avoid). XR tab. contain lactose. using machines. Withdraw gradually. C Contra: CYP3A4 inhibitors (eg. HIVC Contra: MAOIs (14 days apart), protease inhibitors, azole antifungals, erythromycin, clarithromycin, nefazodone). pimozide. Avoid alcohol, serotonergics e.g. hyperaesthesia, anxiety, agitation, menstrual disorders, impaired vision.

OCD

3.4

Caution: Hepatic inducers (eg. carbamazepine, phenytoin), other centrally acting drugs, alcohol, thioridazine. Avoid grapefruit juice. A Leucopenia, hyperprolactinaemia, increased appetite, abnormal dreams and nightmares, dizziness, somnolence, headache, syncope, tachycardia, blurred vision, orthostatic hypotension, rhinitis, GI disorders, withdrawal symptoms, mild asthenia, peripheral oedema, irritability, decreased neutrophil count, weight gain. Elevations in: ALT, AST serum triglyceride, total cholesterol, blood glucose. Decrease in HDL cholesterol.

SEROXAT

GSK

2NO SSRI. Paroxetine (HCl) 10mg, 20mg, 30mg. 10mg, white to pinkish round tab. marked FC1 on one side and GS on reverse. 20mg, white oval scored tab. marked Seroxat 20. 30mg, blue oval scored tab. marked Seroxat 30. All film-ctd. 10mg-28, A17.36, 20mg-30, A9.02; 30mg-30, A13.52.

2NO ALSO SEROXAT ORAL SUSPENSION Paroxetine (HCl) 20mg/10ml. 150ml, A24.00. S Treatment and prevention of relapse of depressive illness (incl. depression accompanied by anxiety), obsessive compulsive disorder (OCD) and panic disorder with or without agoraphobia. Treatment of generalised anxiety disorder (GAD) and post traumatic stress disorder. P Depression/GAD/post traumatic stress disorder: 20mg once daily. May be increased gradually by 10mg increments to max. 50mg once daily. OCD/panic disorder: Initially 20mg once daily. Increase weekly in 10mg increments to 40mg daily. Max. 60mg daily. Renal insufficiency or chronic hepatic dysfunction: 20mg daily. Take all doses in the morning with food. R Adult starting dose. May be increased weekly in 10mg increments to max. 40mg daily. Q Under 18 years, not recommended. B History of mania, severe renal impairment, hepatic impairment, cardiac disease, diabetes, epilepsy, narrow angle glaucoma, history of glaucoma. May occur: Serotonin syndrome (discontinue), increased suicide risk, akathisia, hyponatraemia (caution if at risk), haemorrhagic manifestations (especially elderly, history of bleeding disorders). Withdraw gradually. ECT. Pregnancy (use only when strictly indicated), lactation. Oral suspension contains parabens, sunset yellow, sorbitol. C Contraindicated: MAOIs (within 2 weeks; moclobemide and linezolid, within 24 hrs), thioridazine, pimozide. Metropolol, not recommended. Caution: Serotonergic drugs (tryptophan, triptans, tramadol, linezolid, SSRIs, lithium, St John’s Wort), TCAs, phenothiazine neuroleptics, risperidone, atomoxetine, type 1c antiarrhythmics (propafenone, flecainide), tamoxifen (consider using alternative antidepressant), anticoagulants, NSAIDs/acetyl salicylic, antiplatelet agents. Antacids, proton pump inhibitors, histamine H2 receptor antagonists (oral suspension only). Avoid alcohol. A Increased cholesterol levels, decreased appetite, somnolence, insomnia, agitation, dizziness, tremor, headache, blurred vision, yawning, GI disturbances, dry mouth, sweating, sexual dysfunction, asthenia, weight gain, tinnitus, suicidal ideation/ behaviours.

SERTRANICHE

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

Niche

109


3.4 MOOD

DISORDERS, BULIMIA NERVOSA,

OCD

CNS

initiation, after around 6 weeks, after around 12 and 24 weeks and thereafter when indicated. Jaundice (discontinue). Severe or moderate renal impairment (limited data). Contains lactose. Pregnancy. Driving/using machines. C Contra: Potent CYP1A2 inhibitors (eg. TEGRETOL Novartis fluvoxamine, ciprofloxacin). Caution: Moderate CYP1A2 inhibitors (eg. propranolol, 2MO grepafloxacine, enoxacine), alcohol (avoid). Dibenzazepine. Carbamazepine 100mg white A Headache, migraine, dizziness, scored tab. marked B/W on one side and GEIGY somnolence, insomnia, fatigue, anxiety, GI on reverse; 200mg white scored tab. Marked C/G disorders, hyperhidrosis, back pain. on one side and G/K on reverse; 400mg white oblong tab. scored and marked CG/CG one side Rowex and scored with tab. name on reverse. 100mg-100, VEDIXAL 2NO A4.16. 200mg-100, A7.69. 400mg-50, A7.57; 400mg-56, A8.47. 5HT/NA reuptake inhibitor. Venlafaxine (as hydrochloride) 37.5mg, 75mg. Pale red-brown 2MO oblong tab. coded 3 and scored tab. coded 7 on ALSO TEGRETOL ORAL SUSPENSION each half, resp. 37.5mg-56, A18.07; 75mg-56, Carbamazepine 100mg/5ml. Sugar-free liquid. A30.13. 300ml, A7.27. S Treatment of mania and prophylaxis of S Treatment of depressive illness including depression accompanied by anxiety. Prevention of manic-depressive psychosis. Alcohol withdrawal relapses of the intial episode of depression or symptoms. prevention of the recurrence of new episodes. V Mania and manic-depressive illness, P To be taken with food. Initiation and initially 100-200mg daily in divided doses maintenance: 75mg. May be increased to 150mg increasing gradually until symptoms controlled; per day in 2 divided doses if needed. In more max. 1600mg daily. severely depressed or hospitalised patients, 150mg 2MO in 2 divided doses may be given initially and ALSO TEGRETOL RETARD Carbamazepine 200mg increased by up to 75mg every 2 or 3 days until beige-orange cap.-shaped scored controlleddesired response achieved. Max dose: 375mg/day. release Divitab marked TEGRETOL 200 one side and HC/HC on reverse; 400mg brown-orange cap.- Gradually reduce to usual dosage according to patient response and tolerance. Moderate renal/ shaped scored controlled-release Divitab marked hepatic impairment, reduce dose by 50%. TEGRETOL 400 one side and ENE/ENE on reverse. R Use lowest effective dose. 200mg-50, A4.76; 400mg-50, A9.37. Q Under 18 years, not recommended. V Same total daily dose as above but in D Children and adolescents under 18 years two divided doses. with Major Depressive Disorder. For other D AV conduction abnormalities unless SURMONTIL sanofi-aventis paced. prescribing information, see venlafaxine Drug Presc. Notes. 2NO B Cardiac hepatic or renal disease. TCA. Trimipramine (maleate) 25mg. White to pale Perform liver function tests periodically. Blood VEDIXAL XL Rowex dyscrasias. Pregnancy, lactation. Test blood yellow, circular, biconvex, film-ctd tab., marked 2NO SURMONTIL on one side and 25 reverse. 25mg-50, regularly. C MAOIs, anticoagulants, antiepileptics, 5HT/NA reuptake inhibitor. Venlafaxine (as A5.12. lithium, macrolide antibiotics (erythromycin), some hydrochloride) 37.5mg, 75mg, 150mg. Resp. light S Depression where sleep disturbance, Ca++ antagonists (verapamil, diltiazem), grey, flesh-coloured and orange prolonged-release anxiety or agitation are present. dextropropoxyphene, viloxazine, cimetidine, hard caps. containing white to off-white pellets. 2NO isoniazid, oral contraceptives, alcohol. 37.5mg-7, A3.04; 75mg-28, A17.47; 150mg-28, ALSO SURMONTIL CAPSULES Trimipramine A29.45. A Gastric upset, diplopia, dry mouth, (maleate) 50mg. Green hard cap. marked SU 50. drowsiness and dizziness. Oedema and S Major depressive episodes. 28, A5.75. P Swallow whole with food. Effective P 50-100mg as single dose, 2 hours before hyponatraemia. Blood dyscrasias, rashes, acute renal failure, hepatitis. See SPC. dose 75-225mg. Initially, 75mg. May be increased retiring. to 150mg, then to 225mg if unsatisfactory Q Not recommended. VALDOXAN Servier response. Patients not responding, doses up to D Known risk of narrow angle glaucoma. 375mg (limited experience). Increase doses at 2NO Risk of urinary retention related to urethroprostatic disorders. Recent MI. Pregnancy & Melatonergic agonist. Agomelatine 25mg. Orange- intervals of 2 weeks or more with a minimum of 4 days between each increment. If no response after yellow, oblong, film-ctd tab. marked with lactation (unless essential). 2-4 weeks, no benefit to be gained from company logo. 28, A37.80. B Caution: Elderly, history of epilepsy or treatment. Treatment usually requires 4-6 months S Major depressive episodes. recent convulsions, urinary retention, glaucoma, of therapy or longer in some cases. Hepatic/renal P 25mg once daily at bedtime. After 2 hyperthyroidism, cardiovascular disorders, blood impairment, reduce dose (see SPC). Patients with weeks of treatment, if no improvement may be dyscrasis, alcoholism, pre-existing brain damage, increased to 50mg once daily at bedtime. Treat for cardiovascular disorder/ hypertension, as per ECT, patients more susceptible to postural at least 6 months. No dosage tapering needed on elderly. hypotension and sedation, chronic constipation R Start with lowest effective dose. discontinuation. (risk of paralytic ileus), prostatic hypertrophy, Q Under 18 years, not recommended. R 65 years and over, caution. Do not use hepatic/renal insufficiency. May occur: D Patients at high risk of a serious cardiac in elderly patients with dementia. Cardiovascular and hepatic adverse events. Keep ventricular arrhythmia or uncontrolled Q Under 18 years, not recommended. patients with severe depression under close hypertension. Children and adolescents under 18 D Hepatic impairment (i.e. cirrhosis or surveillance. Insomnia or nervousness at the start years. Other prescribing information, see active liver disease). Lactation. of treatment may require reduced doses or venlafaxine Drug Presc. Notes. B History of mania or hypomania transient symptomatic treatment. Discontinue if sudden manic episodes occur. Monitor for suicidal (discontinue if manic symptoms develop). Monitor VENEX XL Clonmel suicidal behaviour or thoughts. Elevations of behaviour. Contains lactose. 2NO serum transaminases (discontinue if q 3xULN); C Contra: Sulpiride. Not recommended: 5HT/NA reuptake inhibitor. Venlafaxine perform liver function tests in all patients at Alcohol, clonidine and related compounds, a and

2NO

SSRI. Sertraline 50mg, 100mg. White film-ctd tabs. 50mg: Oval, slightly biconvex, scored on one side and marked with S3 on reverse. 100mg: Round, bevel-edged, scored. 50mg-28, A17.84; 100mg-28, A29.21. S Major depressive episodes. P Usual dose, 50mg daily; may be increased to 100mg daily, max. 200mg. Max. effect seen after 2-4 weeks. Continue treatment at least 6 months after symptom remission. Q Under 18 years, not recommended. D Severe hepatic impairment, unstable epilepsy. B Monitor for risk of suicide. Caution: History of mania/hypomania, controlled epilepsy, ECT, diabetes, bleeding abnormalities, cardiac disease, schizophrenia, elderly. Potential for serotonin syndrome. Pregnancy/lactation (only if benefit outweighs risk). Driving/using machines. Withdraw gradually. C Contra: MAOIs incl. moclobemide and selegiline (14 days apart), pimozide. Avoid: St Johnâ&#x20AC;&#x2122;s wort, serotonergics (e.g. tryptophan, fenfluramine and 5-HT agonists), alcohol. Caution: oral anticoagulants, drugs affecting platelet function (e.g. NSAIDs, most TCAs, phenothiazines), lithium, diuretics, phenytoin, sumatriptan, cimetidine, diazepam, tolbutamide, hypoglycaemic drugs, changeover from use of other antidepressants. A GI disorders, dyspepsia, dry mouth, sweating, headache, motor disorders, paraesthesia, hypoaesthesia, insomnia, somnolence, anorexia, sexual disorders, tiredness, hot flushes, skin rash, chest pain, palpitations, tinnitus, agitation, anxiety, menstrual disorders, impaired vision.

110

b sympathomimetics. Caution: Antiepileptics, serotoninergic antidepressants, antihypertensives, atropine and other atropinic substances, other CNS depressants, thalidomide, guanethidine, zopiclone. A See SPC.

2

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CNS

MOOD

DISORDERS, BULIMIA NERVOSA,

OCD

3.4

less than 4 days. Maintain lowest effective dose. Continue treatment for at least 6 months following remission. Mild and moderate hepatic impairment: consider 50% dose reduction. Severe 2NO hepatic impairment: Caution, consider q50% dose 5HT/NA reuptake inhibitor. Venlafaxine 37.5mg, 75mg. Peach coloured, mottled, uncoated, shield- reduction. Renal impairment: 30ml/minQccQ70ml/ min, caution. ccQ30ml/min, 50% dose reduction. shaped tab. debossed with V and 2 or V and 4, R Use lowest effective dose; careful resp., on one side. 37.5mg-56, A19.94; 75mg-56, monitoring. A33.26. S Treatment of major depressive disorder Q Not recommended. incl. depression accompanied by anxiety. Following D Identified very high risk of serious cardiac ventricular arrhythmia (significant left initial response, prevention of relapses of the ventricular dysfunction, NYHA Class III/IV) or initial episode of depression or prevention of uncontrolled hypertension, closed-angle glaucoma, recurrence of new episodes. micturition disorders (obstruction of urinary flow). P Take with food and sufficient fluid at same time each day. 75mg/day in 2 divided doses. B For prescribing information, see May be increased to 150mg/day in 2 divided doses venlafaxine Drug Presc. Notes. (75mg twice daily). Increase dose only after clinical VENLOFEX Gerard evaluation and at least 3-4 weeks of therapy. 2NO Maintain lowest effective dose. In more severely depressed or hospitalised patients, may be 5HT/NA reuptake inhibitor. Venlafaxine HCl eq. to increased by up to 75mg/day every 2 or 3 days 75mg, 150mg. Resp. flesh or scarlet opaque hard until desired response achieved (close supervision). prolonged-release cap. marked VEN on one side In patients requiring r300mg, initiate treatment and 75 or 150 on the other. 75mg-28, A22.79; under specialist supervision. Max 375mg/day. 150mg-28, A38.48. Prevention of relapse or for prevention of S Major depressive episodes. recurrence of a new episode: Dosage similar to P Swallow whole with food. Effective that used during index episode; regularly re-assess dose 75-225mg. Initially, 75mg. May be increased benefit of long-term therapy. Renal impairment to 150mg, then to 225mg. Patients not VENLAFAXINE TEVA Teva (GFR 10-70mg/ml): Reduce dose by 25-50%. responding, doses up to 375mg (limited 2NO Moderate hepatic impairment (PT 14-18 seconds): experience). Increase doses at intervals of 2 weeks Reduce dose by 50%. Severe renal/hepatic or more with 4 days min between increments. If 5HT/NA reuptake inhibitor. Venlafaxine (HCl) impairment: Insufficient data, consider reducing no response after 2-4 weeks, no benefit to be 37.5mg, 75mg. Contains lactose. Mottled peach, gained from treatment. Treatment usually requires round, flat bevelled tabs scored and marked 9 on dose by q 50%. Not suitable for haemodialysis patients. 4-6 months of therapy or longer in some cases. one side of score and 3 on reverse. On opposite R Start with lowest effective dose. Renal impairment (GFR 10-70ml/min): Reduce dose side of tab: 37.5mg marked with 7380; 75mg Q Under 18 years, not recommended by 25-50%. Severe renal impairment (cc Q 30ml/ marked with 7382. Only 75mg can be divided into min) and haemodialysis: Half dose, postpone (increased risk of suicide related behaviours). equal halves. 37.5mg-56, A21.67; 75mg-56, administration until dialysis is completed. Mild2NO A36.12. moderate hepatic impairment: Reduce dose by ALSO VENLIFT XL Venlafaxine 75mg, 150mg. S Major depressive episodes. 50%. Resp. size 1 or size 0 cap. with pink or caramel P Swallow whole with liquid once daily R Start on the lowest recommended dose. opaque cap and body marked RVn on cap and same time each day during meal. Initially, 75mg. Q Under 18 years, not recommended. strength on body in black ink. 75mg-28, A19.28; May be increased to 150mg, then to 225mg. B For prescribing information, see 150mg-28, A32.51. Patients not responding, doses up to 375mg (limited experience). Increase doses at intervals of S Treatment of major depressive episodes. venlafaxine Drug Presc. Notes. Prevention of recurrence of major depressive 2 weeks or more with min. 4 days between each VENSIR XL Morningside episodes. increment. If no response after 2-4 weeks, no 2NO benefit to be gained from treatment. Duration 4-6 P 75mg once daily with food and sufficient fluid at the same time each day. May be 5HT/NA reuptake inhibitor. Venlafaxine (as HCl) months or longer in some cases. Hepatic/renal increased to 375mg/day maximum at interval of 2 75mg, 150mg. 75mg: Peach opaque hard cap. with impairment, reduce dose 25-50% (see SPC). red radial circular bands, filled with 6 white to weeks or more. If clinically warranted, dosage Q Under 18 years, not recommended. increased intervals may be more frequent, but not off-white round biconvex film-ctd mini tabs. B For prescribing information, see

hydrochloride eq. to 37.5mg, 75mg, 150mg. Resp. size 3 with an orange cap, size 1 with a yellow cap and size 0 with a buff cap prolonged-release transparent cap. containing white to off white granules. 37.5mg-28, A10.10; 75mg-28, A14.80; 150mg-28, A24.84. S Major depressive episodes. P Swallow whole with food. Effective dose 75-225mg. Initially, 75mg. May be increased to 150mg, then to 225mg if unsatisfactory response. Patients not responding, doses up to 375mg (limited experience). Increase doses at intervals of 2 weeks or more with a minimum of 4 days between each increment. If no response after 2-4 weeks, no benefit to be gained from treatment. Treatment usually requires 4-6 months of therapy or longer. Renal impairment (GFR 1070ml/min): Reduce dose by 25-50%. Haemodialysis: Half dose, postpone administration until dialysis is completed. Mild-moderate hepatic impairment: Reduce dose by 50%; further reduction may be required in some patients. R Start on lowest recommended dose. Q Under 18 years, not recommended. B For prescribing information, see venlafaxine Drug Presc. Notes. Contains sucrose. 37.5mg cap. contains ponceau 4R red. 75mg and 150mg cap. contain sunset yellow.

venlafaxine Drug Presc. Notes.

VENLIFT

Ranbaxy

Drug Prescribing Notes ● VENLAFAXINE Special Precautions Monitor for suicidality, especially in early treatment and following dose changes. Monitor serum cholesterol. Withdraw gradually. Caution with: ● History of mania/ hypomania or aggressive behaviour ● Seizure (discontinue if occurs) ● Elderly (regular and careful check-ups, especially if dehydrated or taking diuretics) ● Diabetes (dose of antidiabetics might have to be adjusted) ● Moderate-severe renal impairment or hepatic cirrhosis ● Narrow-angle glaucoma (monitor patients with raised IOP) ● Micturition disorders (e.g. prostate hypertrophy, very small probability of problems) ● High or low BP (monitor) ● Myocardial ischaemia, acute cerebrovascular disease or other cardiac disease ● Increased risk of bleeding ● Driving and using machines. Pregnancy: Limited experience does not suggest any increased risk of congenital abnormalities or any other adverse reactions on pregnancy or the unborn child; however, animal studies have shown reproductive toxicity. The potential risk for humans is unknown. Venlafaxine should not be used during pregnancy unless clearly necessary. Lactation: Venlafaxine and its active metabolite are excreted into breast milk. It is not clear what the effects of this are for the nursing infant. Therefore, a decision should be made whether to continue/discontinue breast-feeding or to continue/discontinue therapy with venlafaxine, taking into account the benefit of breast-feeding to the child and the benefit of venlafaxine therapy to the mother. Drug Interactions Contraindicated: MAOIs (or within 14 days). Avoid: Alcohol, weight loss agents. Caution: Serotonergics (e.g. triptans, linezolide, SSRIs, lithium), antipsychotics, alpha- and beta-sympathomimetics, St John’s wort, ECT, anticoagulants, clozapine, cimetidine (in elderly/hepatic dysfunction), indinavir, haloperidol. Potent CYP3A4 inhibitors (e.g. ketoconazole, erythromycin, cimetidine, verapamil) or drug combinations that inhibit both CYP3A4 and CYP2D6 should only be co-administered with venlafaxine if strictly indicated. Risk of hyponatraemia in patients receiving diuretics. Side-Effects Hypertension, vasodilatation, ecchymosis, mucous membrane bleeding, GI disorders, dry mouth, impaired micturition, asthenia, sweating, headache, increased serum cholesterol, weight loss, reduced appetite, dizziness, drowsiness, increased muscular tone, paresthesia, sedation, tremor, insomnia, nervousness, abnormal dreams, abnormal ejaculation/orgasm, anorgasmia, erectile dysfunction, decreased libido, yawning, abnormal vision, accommodation disorders, mydriasis. Revised November 2009

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

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150mg: Dark orange hard cap. with white radial circular bands, filled with 12 white to off-white round biconvex film-ctd mini tas. 75mg-28, A17.47; 150mg-28, A29.45. S Major depressive disorder. Prevention of relapses of initial episode of depression or prevention of recurrence of new episodes. P Swallow whole with liquid. Take with food. Major depressive disorder: Effective dose 75150mg/day. Initially, 75mg. If clinical response unsatisfactory, may be increased after 3 weeks. In more severely depressed or hospitalised patients, daily dose may be increased by up to 75mg every 2 or 3 days. Max recommended dose: 375mg. Prevention of relapse or recurrence: Dose similar to that used during index episode; re-assess regularly benefit of long-term therapy. Moderate renal impairment (GFR 10-30ml/min): Reduce dose by 50%. Mild-moderate hepatic impairment: Reduce dose by 50%; further reduction may be required in some patients. Severe renal impairment/ severe hepatic impairment: Insufficient data. R Use lowest effective dose, carefully monitor dose increases. Q Under 18 years, not recommended. D Very high risk of serious cardiac ventricular arrhythmia, uncontrolled hypertension. For prescribing information, see venlafaxine Drug Presc. Notes.

XANAX

Pharmacia

2NO Medium-acting benzodiazepine. Alprazolam 0.25mg, 0.5mg, 1mg. White, pink and lavender oval scored tabs. marked UPJOHN 29, UPJOHN 55 and UPJOHN 90 resp. 0.25mg-100, A2.11; 0.5mg100, A4.06; 1mg-100, A8.48. S Anxiety when the disorder is severe, disabling or causing extreme distress. P 0.5-1mg daily in divided doses, increasing in increments not greater than 1mg every 3-4 days to 3-4 daily. Max. treatment duration, 8-12 weeks. R 0.25mg twice daily. Q Not recommended. D Myaesthenia gravis, severe respiratory or hepatic insufficiency sleep apnoea syndrome. B Tolerance, physical and psychic pendence, anterograde amnesia, psychiatric and paradoxical reactions (e.g restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares) C Alcohol, CNS depressants. A Amnesia, drowsiness, depression, pychiatric and paradoxical reactions, dependence.

CNS

patient completely symptom-free for 4-6 months. Swallow tab. with sufficient amount of water. Q Under 18 years, not recommended. D Pregnancy (unless essential), lactation. B Monitor for signs of bone marrow depression. Caution: Epilepsy and organic brain syndrome, hepatic or renal insufficiency, cardiac diseases, hypotension, micturition disturbances, acute narrow-angle glaucoma and increased intraocular pressure, diabetes mellitus, schizophrenia, history of mania/hypomania, elderly. Discontinue if jaundice occurs. Contains lactose. Driving/using machines. C MAOIs (contraindicated), alcohol (avoid). Caution: Benzodiazepines, other SSRIs, potent CYP3A4 inhibitors, CYP3A4 inducers, warfarin. A Increase in appetite and weight gain, somnolence, dizziness, headache, oedema.

Driving/operating machines. C Caution: Drugs increasing QT interval. A Headache, GI disorders, dizziness.

ZISPIN

DOMERID

Schering-Plough

2NO Presynaptic a2-antagonist. Mirtazapine 30mg. Redbrown oval scored tab. marked Organon and coded TZ/5. 28, A11.57. S Episode of major depression. P Initially 15mg daily. Titrate according to response, usually 15-45mg. Q Not recommended.

2NO ALSO ZISPIN SOLTAB Mirtazapine 15mg, 30mg, 45mg. Round, white, standard bevelled-edge orodispersible tabs. with marked TZ/1, TZ/2), TZ/4 resp. 15mg-30, A6.95; 30mg-30, A13.89; 45mg-30, A20.83. P Daily dose 15-45mg. Initially 15mg or 30mg (preferably as single dose at night). Place tab. on tongue. Swallow disintegrated tab. with or without water. Q Not recommended. B Pregnancy, lactation (no data). Renal or hepatic impairment, epilepsy, organic brain syndrome, cardiac conduction disturbance, angina, recent MI, hypotension, prostatic hypertrophy, diabetes, glaucoma. Avoid driving. Elderly (caution). C MAOIs (wait 2 weeks after cessation), alcohol. Benzodiazepines (caution). A Increase of appetite, oedema, weight gain, drowsiness/sedation, dizziness, headache. Granulocytopenia. Warn patients to report signs of infection. Jaundice (discontinue).

BY-VERTIN

Ergha

2MO H1 agonist. Betahistine (HCl) 8mg, 16mg. 8mg white tab marked B8, 16mg white scored tab marked B16. 8mg-120, A5.64; 16mg-84, A7.91. S Vertigo, tinnitus, symptoms of Meniereâ&#x20AC;&#x2122;s syndrome. P 8-16mg three times daily; maintenance 24-48mg daily. Q Not recommended. D Phaeochromocytoma. B Peptic ulcer, asthma, urticaria, allergic rhinitis. C Antihistamines. A GI upset, headache, rash. Rowex

2MO Dopamine antagonist. Domperidone (maleate) 12.72mg equiv. 10mg of domperidone. White, round, biconvex tab. marked Dm10. 100, A6.03. S Nausea and vomiting, epigastric sense of fullness, upper abdominal discomfort, regurgitation of gastric contents. P 1-2 three to four times daily before meal. Max. daily dose: 80mg. Initial duration: 4 weeks. Severe renal insufficiency (prolonged therapy), reduce dose to once or twice daily. Q Over 12 years and weighing 35kg or more, as for adults. Less than 35kg, unsuitable. D Prolactin-releasing pituitary tumour (prolactinoma). GI haemorrhage, mechanical obstruction or perforation. B Lactose intolerance, galactosaemia or glucose/galactose malabsorption (unsuitable). Pregnancy. Lactation, hepatic impairment (not recommended). C CYP3A4 inhibitors. A Increase in prolactin levels.

EMEND

MSD

2NO

Anti-emetic. Aprepitant 125mg, 80mg. Both opaque hard caps. 125mg: White body and pink cap marked with 462 and 125mg. 80mg: White body and cap marked with 461 and 80mg. 3 day pack: 125mg-1 and 80mg-2, A60.91; 125mg-5, A101.53; 80mg-2, A40.61. S As combination therapy for the 3.5 NAUSEA, VOMITING, VERTIGO prevention of acute and delayed nausea and ALOXI Helsinn Birex vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and the 2JNO prevention of nausea and vomiting associated ZISMIRT Gerard 5-HT3 antagonist. Palonosetron (HCl) 250mcg/5ml. with moderately emetogenic cancer A89.25. Soln for inj. in vial. 5ml, 2NO chemotherapy. S Prevention of: Acute nausea and Presynaptic a2-antagonist. Mirtazapine 30mg. vomiting associated with highly emetogenic cancer P 125mg swallowed whole on day 1 and Normal convex, buff film-ctd tab. debossed MR 80mg once daily days 2 and 3 as part of regimen chemotherapy; nausea and vomiting associated scoreline 30 on one side and G on reverse. 28, incl. a corticosteroid and a 5-HT3 antagonist (see with moderately emetogenic cancer A19.29. SPC). Admin. orally 1 hour prior to chemotherapy chemotherapy. 2NO on day 1 and in the morning on days 2 and 3. P 250mcg admin. as single IV bolus over Q Under 18 years, not recommended. ALSO ZISMIRT OROTAB Mirtazapine, 15mg, 30mg, 30 secs approx. 30 mins before start of 2J or 45mg. White, round, orodispersible tabs chemotherapy. Do not repeat within 7 days. marked 36, 37 or 38 resp. 15mg-30, A11.04; 30mg- Highly emetogenic chemotherapy: Efficacy may be ALSO IVEMEND Fosaprepitant 115mg. White to 30, A22.53; 45mg-30, A33.99. off-white powder for solution for infusion. 10ml-1, enhanced by corticosteroid admin. prior to A33.64. S Episode of major depression. chemotherapy. P Initially 15 or 30mg. Effective dose P 115mg by IV infusion over 15 mins on Q Under 18 years, not recommended. usually between 15 and 45mg daily. May be given D Lactation, pregnancy (unless essential). Day 1 only as part of regimen incl. a corticosteroid in sub doses equally divided over the day (once in B History of constipation or signs of and a 5-HT3 antagonist. Admin 30 mins prior to the morning, once at night-time). Discontinue subacute intestinal obstruction; monitor. Existent/ chemotherapy. See SPC and Emend for Day 2 and risk of prolongation of QT interval; caution. gradually if no response within 2-4 weeks, or if 3.

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Prohibited in competition

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Restricted b2 agonists

Declaration required


CNS

NAUSEA,

P 8-32mg a day. Emetogenic chemo/ radiotherapy: 8mg intravenously (immediately) or orally (1-2 hours) before treatment, followed by 8mg orally 12 hours later. Continue with 8mg twice daily for up to 5 days. Highly emetogenic chemo/radiotherapy: 8mg orally twice daily or by IV injection (see relevant SPC), continued for up to 5 days after a course of treatment. PONV: Prevention, can admin. orally or by IV. Orally: 16mg as single dose, 1 hour prior to anaesthesia (or 8mg 1 hour prior followed by 2 further doses of 8mg 8 hourly). Treatment, IV admin. recommended. Moderate/severe hepatic impairment: Max. 8mg daily. Q Under 2 years, not recommended. 2-18 years: Chemo/radiotherapy: Single IV of 5mg/m2 over 15 mins. immediately before chemotherapy, followed by 4mg orally 12 hours later. Continue dose according to body area daily for up to 5 days after course of treatment. Body area 0.6-1.2m2, EMITAL Teva 4mg 3 times a day; over 1.2m2, 8mg 3 times a day. PONV: Parenteral administration recommended, 2NO see relevant SPC. Selective 5HT3 receptor-antagonist. Ondansetron D Hypersensitivity to other 5HT3 receptor (as HCl dihydrate) 4mg, 8mg. White to off-white, antagonists. Pregnancy, lactation. round biconvex film-ctd tabs. marked PA on one B Monitor patients with signs of subacute side and 933 and 934 resp. on reverse. 4mg-30, intestinal obstruction. Not indicated in children A126.16; 8mg-30, A187.61. after intra-abdominal surgery. Arrhythmias or S Nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for cardiac conduction disorders (no data). Adenotonsillar surgery (may mask occult prevention and treatment of post-operative bleeding). nausea and vomiting (PONV). P Emetogenic chemo/radiotherapy: Range C Caution: Antiarrhythmic agents or bblockers, phenytoin, carbamazepine, rifampicin, 8-32mg a day. 8mg 1-2 hrs before treatment, tramadol. followed by 8mg 12 hrs later. Then 8mg twice A Constipation, headache, flushing, IV inj. daily for up to 5 days. Highly emetogenic site reactions. chemotherapy: Rectal, IV or IM administration on day of treatment. Continue for up to 5 days with KYTRIL Roche 8mg orally twice daily. PONV: Prevention, 16mg 1 2N hr prior to anaesthesia; or 8mg 1 hr prior to anaesthesia followed by 2 further doses of 8mg at 5HT3 antagonist. Granisetron (HCl) 1mg/ml. 1ml, eight hourly intervals. Treatment, IV or IM admin. 3ml amps. for IV inf. 1ml, A82.73; 3ml, A209.38. S Prophylaxis or treatment of nausea and recommended. Moderate/severe hepatic vomiting induced by cytostatic therapy. 1mg/ml impairment: Max. 8mg daily. also indicated for management of post operative R PONV: Limited experience. nausea and vomiting. Q Emetogenic chemo/radiotherapy: 2-18 P Post-operative nausea and vomiting: 2 years, single IV dose of 5mg/m over 15 min just 1mg diluted to 5ml, by slow IV inj. (over 30secs.). before chemotherapy, followed by 4mg orally 12 hrs later. Then admin. oral treatment according to Repeat at intervals of 10mins. if necessary; max. 3mg in 24 hours. Chemotherapy induced nausea 2 body area for up to 5 days: 0.6-1.2m , 4mg three and vomiting: 3mg diluted to 15ml infusion, by times a day; q1.2m2, 8mg three times a day. slow IV inj. (over 30secs.) OR diluted to 20-50ml Under 2 years or body area Q0.6m2, not inf. by IV inf. over 5 mins. Repeat at intervals of recommended. PONV: Slow IV inj. recommended. D Children after intra-abdominal surgery. 10 min if necessary; max. dose 9mg in 24 hours. Q Single dose of 40mcg/kg body weights Pregnancy, lactation. (up to 3mg) by IV inf. diluted in 10-30ml inf. fluid B Hypersensitivity to other 5HT3 receptor and admin. over 5 mins. prior to start of cytostatic antagonists. Sub acute intestinal obstruction, therapy. One additional dose of 40mcg/kg body adenotonsillar surgery (may mask occult bleeding). weight (up to 3mg) may be admin. within a 24Contain lactose. hours period if required and not until at least 10 C Caution: Tramadol, potent CYP3A4 mins. after initial inf. inducers (i.e. phenytoin, carbamazepine, 2NO rifampicin). ALSO KYTRIL TABLETS Granisetron (HCl) 1mg, A Constipation, headache, sensations of 2mg. White triangular film-ctd tabs. 1mg-10, flushing or warmth, hiccups. A89.62; 2mg-5, A89.62. S Prevention of acute and delayed nausea EMIZOF Gerard and vomiting associated with cytostatic therapy. 2NO P 1mg twice daily or 2mg once daily for Selective 5HT3 receptor-antagonist. Ondansetron up to 1 week following therapy. First dose within (HCl dihydrate) 4mg, 8mg. Film-ctd yellow, round 1 hour before start of cytostatic therapy. biconvex tab.; marked 41, 42 resp. 4mg-30, Q Not recommended. A140.17; 8mg-10, A69.49. D Lactation. S Management of nausea and vomiting B Pregnancy. Subacute intestinal induced by cytotoxic chemotherapy and obstruction. radiotherapy. Prevention and treatment of postA Headache, constipation, lassitude, rash. Transient rise in liver enzymes. operative nausea and vomiting (PONV).

Q Under 18 years, not recommended. D Pregnancy (unless essential), lactation. B Moderate or severe hepatic insufficiency. Use non-hormonal contraception during, and for 2 months after treatment. Not to be administrated intramuscularly or subcutaneously, not to be given as a bolus injection (Ivemend). Emend contains sucrose. C Contra: Pimozide, terfenadine, astemizole or cisapride. Caution: Drugs metabolised by CYP3A4 and CYP2C9, corticosteroids, irinotecan, fentanyl, benzodiazepines, chemotherapeutic agents, immunosuppressants, oral contraceptives, ketoconazole, warfarin, tolbutamide, phenytoin, acenocoumarol. A Increased ALT and AST, headache, dizziness, hiccups, GI disorders, anorexia, asthaenia/fatigue.

VOMITING, VERTIGO

MAXOLON

3.5

Amdipharm

2MO Antidopaminergic. Metoclopramide monohydrochlor. 10mg. White to off-white scored tab. marked MAXOLON. 84, A6.36.

2MO ALSO MAXOLON SYRUP Metoclopramide (HCl) 5mg/5ml. 100ml, A1.60; 200ml, A3.20.

2NO ALSO MAXOLON INJECTION Metoclopramide (HCl) 5mg/2ml. Amp 12 x 5mg, A3.46. S Adults over 20 years: Nausea and vomiting associated with some cytostatic drugs and radiotherapy. Under 20 years: Vomiting associated with radiotherapy and intolerance to cytotoxic drugs. P 10mg three times daily. Q 15-19 years q60kg, 10mg three times daily; 30-59kg, 5mg three times daily; 9-14 years r30kg, 5mg three times daily; 5-9 years 20-29kg, 2.5mg three times daily; 3-5 years 15-19kg, 2mg two to three times daily; 1-3 year 10-14kg, 1mg two to three times daily; Q1year Q10kg, 1mg twice daily. D Phaeochromocytoma. Epilepsy. GI haemorrhage, mechanical obstruction or perforation. Pregnancy, lactation (unless essential). B Not for use in the immediate postoperative period (up to 3-4 days) following pyloroplasty or gut anastomosis. Assess risk/benefit: Significant hepatic or renal impairment, Parkinson’s disease. If vomiting persists, reassess patient to exclude underlying disorder (e.g. cerebral irritation). Caution: History of atopy (including asthma) or porphyria. May occur: Neuroleptic malignant syndrome, elevation of serum prolactin levels. Rare hereditary problems of galactose intolerance, Lapp lactose deficiency of glucose-galactose malabsorption. C Anticholinergics, phenothiazines, CNS drugs (MAOIs, sympathomimetics), serotonergic drugs, alcohol. A Extrapyramidal reactions.

MOTILIUM

McNeil Healthcare

2K Antidopaminergic. Domperidone 10mg. White to faintly cream circular biconvex film-ctd tabs. 10, A3.67; 20, A6.43.

2K ALSO MOTILIUM FASTMELTS Domperidone 10mg. White or off-white circular orodispersible tab. 10, A3.99; 20, A7.00. S Nausea. P Up to 10mg 3 times daily and at night for 2 weeks max. Q Under 16 years, not recommended. Over 16 years, as per adults. D Prolactin-releasing pituitary tumour (prolactinoma). GI haemorrhage, mechanical obstruction or perforation. Hepatic and/or renal impairment. Pregnancy, lactation. B Contains aspartame. C Strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, erythromycin). A Raised serum prolactin.

MOTILIUM RX

McNeil Healthcare

2OY Antidopaminergic. Domperidone 10mg. White film-ctd tab. marked M/10 on one side and JANSSEN on reverse. 100, A6.04.

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VOMITING, VERTIGO

CNS

emetogenic chemotherapy: 8mg as slow IV inj. or inf. over 15 mins. immediately before chemotherapy, if necessary followed by 2 further IV 8mg doses 4 hours apart or continuous inf. of 1 mg/hour for 24 hrs. In some cases, initial dose may be increased to 32mg diluted with compatible inf. fluid as inf. over 15 mins. immediately before chemotherapy. Efficacy may be enhanced by simultaneous admin. of 20mg dexamethasone/ 2MO ALSO MOTILIUM SUSPENSION Domperidone 1mg glucocorticoids. PONV: Prevention, orally (16mg 1 hr prior to anaesthesia) or 8mg 1 hr prior to per ml. Oral susp. 200ml, A2.08. anaesthesia followed by 2 doses of 8mg at 8 hr S Nausea and vomiting. P 10-20ml 3 to 4 times daily before meals. intervals. Treatment, IV admin recommended. Moderate/severe hepatic impairment: Max. 8mg Max 80ml daily. Reevaluate after 4 weeks. daily. Q 0.25-0.5mg/kg body weight 3-4 times daily before meals to max. 2.4mg/kg daily. Do not Q Under 2 years, not recommended. 2-18 years: Chemo/radiotherapy: Single IV of 5mg/m2 exceed 80mg daily. Over 12 years and weighing body area over 15 mins. immediately before 35kg or more, as per adults. chemotherapy, followed by 4mg orally 12 hours 2MO later. Continue dose according to body area daily ALSO MOTILIUM SUPPOSITORIES Domperidone for up to 5 days after course of treatment. Body 10mg, 30mg, 60mg. 10mg-6, A1.80; 30mg-6, area 0.6-1.2m2, 4mg 3 times a day; over 1.2m2, A1.81; 60mg-6, A7.31. 8mg 3 times a day. PONV: Treatment and S Nausea and vomiting. prevention, slow IV inj. P 1 (60mg) suppos. 2 times daily. D Hypersensitivity to other 5HT3 receptor Q Over 12 years and weighing 35kg or antagonists. Children with body surface Q 0.6 m2. more, as per adults. Less than 5kg, not Lactation. recommended. 5-15kg, 10mg twice daily. More B Monitor patients with signs of subacute than 15kg, 30mg twice daily. intestinal obstruction. Arrhythmias or cardiac D Pregnancy (unless essential), lactation. Patients with prolactin releasing pituitary tumours, conduction disorders (no data). Adenotonsillar surgery (may mask occult bleeding). Contains GI haemorrhage, mechanical obstruction or lactose (tabs). Pregnancy. perforation. Hepatic impairment. C Caution: Antiarrhythmic agents or bB Severe renal insufficiency, especially if blockers, phenytoin, carbamazepine, rifampicin, prolonged use. tramadol. C Anticholinergics, CYP3A4 inhibitors, antacids or antisecretory agents, phenothiazines or A Constipation, local burning sensation following insertion of suppositories, headache, other neuroleptics, dopaminergic agonists. flushing, IV inj. site reactions. A Raised serum prolactin. S Nausea and vomiting associated with cytostatic drugs and radiotherapy. Diagnostic procedures, eg barium meals and duodenal intubation. P 20mg 3-4 times daily 15-30 mins. before meals and before retiring. Q Under 1 year, under specialist supervision.

Meniereâ&#x20AC;&#x2122;s syndrome. P Initially 16mg three times daily; maintenance, 24-48mg daily. Q Not recommended. D Phaeochromocytoma. B Bronchial asthma. Peptic ulcer. C Contra: Antihistamines. A Gastric upset, headache.

STELAZINE

Goldshield

2MO Phenothiazine group III. Trifluoperazine (HCl) 1mg, 5mg. Blue sug-ctd tabs. marked SKF 1mg-112, A2.75; 5mg-112, A3.92. D Comatose states, bone marrow depression, liver damage, existing blood dyscrasis. Uncontrolled cardiac decompensation. B Elderly. CVD. Parkinsonism. Pregnancy, lactation. Epilepsy. A See SPC.

STEMETIL

sanofi-aventis

2MO Phenothiazine. Prochlorperazine maleate 5mg. White tab. marked with tab. name and strength. 5mg-250, A11.09. S Vertigo due to Meniereâ&#x20AC;&#x2122;s disease and other labyrinthine disorders, severe nausea and vomiting. Migraine. P Vertigo, 5mg three times daily. Max. 30mg daily. Nausea and vomiting, 20mg then 10mg two hours later if required. Q Under 10kg, not recommended. Over 10kg, 0.25mg/kg two or three times daily.

2NO

ALSO STEMETIL INJECTION Prochlorperazine mesylate 12.5mg/ml; Amps. 10 x 1ml, A4.03; 10 x 2ml, A5.08. Rowex P 12.5mg by deep IM inj. ONDANSETRON (INN) Teva ROWEX DOMERID Q Not recommended. 2Y 2NO D Comatose states, bone marrow Dopamine antagonist. Domperidone (maleate) Selective 5HT3 receptor-antagonist. Ondansetron depression. Liver damage. 12.72mg equiv. 10mg of domperidone. White, (as hydrochloride dihydrate) 4mg, 8mg. Yellow, B Undiagnosed and prolonged vomiting. round, biconvex tab. marked Dm10. 10, A2.87; 20, Warn patients of impaired dexterity. CVD. oblong film ctd tabs marked with 4 and 8 resp. A4.62. 8mg scored on reverse, not to be broken for half Pregnancy. S Nausea and vomiting, epigastric sense dose admin. 4mg-30, A126.16; 8mg-10, A55.60; C CNS depressants, alcohol, analgesics, of fullness, upper abdominal discomfort, 8mg-50, A277.00. antihypertensives, antidepressants, antidiabetics. regurgitation of gastric contents. 2NO A CNS disturbances. Anticholinergic P 1-2 three to four times daily before effects. ECG and endocrine changes, allergic ALSO ONDANSETRON AMPOULES Ondansetron meal. Max. daily dose: 80mg. Initial duration: 4 effects and extrapyramidal symptoms occur rarely (HCl dihydrate) 2mg per ml. Soln for inj. 2ml, weeks. Severe renal insufficiency (prolonged A58.70; 4ml, A83.84. at low doses. therapy), reduce dose to once or twice daily. 2NO STUGERON McNeil Healthcare Q Over 12 years and weighing 35kg or ALSO ONDANSETRON TABLETS (INN) more, as for adults. Less than 35kg, unsuitable. 2MO Ondansetron (HCl dihydrate) 4mg, 8mg. Film-ctd D Prolactin-releasing pituitary tumour oval tab. marked O on one side and 4 or 8 on the Selective calcium entry blocker. Cinnarizine 25mg. other. 4mg-30, A140.12; 8mg-10, A69.49; 8mg-30, (prolactinoma). GI haemorrhage, mechanical White scored tab. marked JANSSEN one side, S/25 obstruction or perforation. A208.42. on reverse. 50, A4.11. B Lactose intolerance, galactosaemia or S Vertigo of vestibular or cerebrovascular glucose/galactose malabsorption (unsuitable). ONDRAN Pinewood origin. Pregnancy. Lactation, hepatic impairment (not P 1 three times daily. 2NO recommended). Q Not recommended. Selective 5HT3 receptor-antagonist. Ondansetron C CYP3A4 inhibitors. 2 K (HCl dihydrate) 2mg/ml. Soln for inj. and inf. 2ml-5 A Increase in prolactin levels. ALSO STUGERON 15MG Cinnarizine 15mg. White amp., A57.55; 4ml-5 amp., A82.74. scored tab. marked JANSSEN one side S/15 on 2NO SERC Solvay reverse. 15, A2.61. ALSO ONDRAN TABLETS Ondansetron (HCl 2 M O S Motion sickness. dihydrate) 4mg, 8mg. Film-ctd yellow, round P 2 two hours before, then 1 eight hourly Histamine analogue. Betahistine (diHCl) 8mg. biconvex tab.; marked 41, 42 resp. 4mg-10, during journey. White tab. marked with symbol and 256. 120, A45.30; 8mg-10, A69.45. A Q Under 5 years, not recommended; 5-12 5.83. S Management of nausea and vomiting years, half adult dose. 2 M O induced by cytotoxic chemotherapy and D See SPC. ALSO SERC-16 Betahistine (diHCl) 16mg. White radiotherapy. Prevention and treatment of posttab. marked 267 and symbol on reverse. 84 (Cal/ operative nausea and vomiting (PONV). VALOID Amdipharm Pk), A8.15. P Emetogenic chemo/radiotherapy: IV or orally (8mg twice daily for up to 5 days). Highly S Vertigo, tinnitus and hearing loss due to 2 M O

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Prohibited in specific sports

Restricted b2 agonists

Declaration required


CNS

EPILEPSY,

Antihistamine. Cyclizine (HCl) 50mg. White, biconvex branded scored tabs. coded T4A. 100, A4.39. S Prevention and treatment of nausea and vomiting due to motion sickness, narcotic analgesics, radiotherapy, Meniere’s disease and other forms of vestibular disturbance. P 50mg orally, up to 3 times a day. Q 6-12 years, 25mg orally up to 3 times a day. Under 6 years, not recommended. Over 12 years, as per adults.

2MO ALSO VALOID INJECTION Cyclizine (lactate) 50mg. Ampoules containing 1ml soln. for inj. 5, A10.14. S Prevention and treatment of nausea and vomiting due to narcotic analgesics, general anaesthetics, radiotherapy, Meniere’s disease and other forms of vestibular disturbance, motion sickness when oral route cannot be used. P 50mg by IM or IV inj. up to 3 times a day. Post-operative vomiting: First dose by slow IV 20 min. before end of surgery. Regurgitation during emergency surgery: 25mg by IV before anesthesia. Q Not indicated. D Pregnancy, lactation (limited data). B Glaucoma, obstructive disease of GI tract, prostatic hypertrophy, severe HF. Driving or operating machines. Abrupt withdrawal. C Additive effects with alcohol, barbiturates, other CNS depressants. Pethidine. Other anticholinergics (enhance side-effects). A Urticaria, drug rash, drowsiness, dry mouth, nose and throat, blurred vision, tachycardia, urinary retention, constipation, restlessness, nervousness, insomnia, auditory/ visual hallucinations, cholestatic jaundice.

VERTIGON

Gerard

2MO Histamine analogue. Betahistine (diHCl) 8mg white tab. marked BH 8 one side, G on reverse; 16mg white tab. marked BH 16 and 256. 8mg-120, A9.70; 16mg-84, A13.57. S Vertigo, tinnitus and hearing loss due to Meniere’s syndrome. P Initially 8-16mg three times daily; maintenance, 24-48mg daily. Q Not recommended. D Phaeochromocytoma. B Bronchial asthma. Peptic ulcer. A Gastric upset.

ZOFRAN

GSK

2NO 5HT3 antagonist. Ondansetron (hydrochlor. dihydrate) 4mg, 8mg. Yellow, biconvex, oval filmctd tabs. marked Glaxo on one side and 4 or 8 on the other. 4mg-30, A84.10; 8mg-10, A41.69; 8mg30, A125.06. S Management of nausea and vomiting due to cytotoxic chemotherapy and radiotherapy. Prevention of post-operative nausea and vomiting.

R Chemotherapy: No dose adjustment. Post-operative nausea and vomiting: Limited experience. Q Chemotherapy: Single IV dose immediately before chemotherapy. Then 4mg orally after 12 hours. Post-operative nausea and vomiting: IV route.

2N ALSO ZOFRAN INJECTION Ondansetron (HCl dihydrate) 2mg/ml. Clear glass, one point cut (OPC) or snap ring amp. 4mg-5; 8mg-5. Price available on request.

2NO ALSO ZOFRAN SUPPS Ondansetron 16mg. 16mg1, A19.45.

2NO ALSO ZOFRAN SYRUP Ondansetron (HCl) 4mg/ 5ml. Sugar-free soln. 50m, A53.24. S V See SPC. B Pregnancy, lactation. Subacute intestinal obstruction (monitor). Zydis contains aspartame, caution in phenylketonuria patients. C CYP3A4 inducers (phenytoin, carbamazepine, rifampicin), reduced blood levels of ondansetron. Analgesic effect of tramadol may be reduced. A Constipation. Headache, flushing, hiccups.

SEIZURES

3.6

doses; maintenance, usually 4-8mg/kg daily. Max. 300mg daily.

2MO ALSO EPANUTIN SUSPENSION Phenytoin 30mg/ 5ml. Oral susp. 500ml, A7.32. P Initially 15ml three times daily. Q Under 6 years, 5ml twice daily, increasing to 5ml three or four times daily; 6-12 years, same as adult.

2MO ALSO EPANUTIN INFATABS Phenytoin 50mg. Yellow scored triangular chewable tab. 100, A6.37; 112, A12.13. P 2 two to four times daily. Q Under 6 years, v tab.; 7-12 years, 1 tab. Both two to four times daily.

2NO

ALSO EPANUTIN PARENTERAL Phenytoin Na+ 50mg/ml. 5ml amp. 1, A5.69; 10, A56.82. S Status epilepticus; prophylaxis and treatment of seizures in neurosurgery. P 150-250mg by slow IV inj., then 100150mg after 30 mins. if required. See SPC. Q In proportion to dosage for 70kg adult. B Porphyria, impaired liver function. Withdraw gradually. 1st sign of acute toxicity, determine serum drug level. Discontinue if skin rash appears (only resume if mild and it has cleared). Not effective for absence (petit mal) seizures. Hyperglycaemia has been reported. May 3.6 EPILEPSY, SEIZURES interfere with Vitamin D metabolism. Measure serum folate at least once every 6 months. DIAMOX Goldshield Contains galactose. Pregnancy, lactation. 5MO C Certain anticonvulsants, antidepressants, anticoagulants, Ca++ channel blockers, antifungals. Carbonic anhydrase inhibitor. Acetazolamide Amiodarone, chloramphenicol, chlordiazepoxide, 250mg. White scored tab. marked LEDERLE 4395. A diazepam, disulfiram, oestrogens, H2-antagonists, 112, 15.56. halothane, isoniazid, methylphenidate, 5NO omeprazole, phenylbutazone, salicylates, folic acid, ALSO DIAMOX PARENTERAL Acetazolamide Na+ rifampicin, sucralfate, theophylline, vigabatrin, St 500mg. Powder in vial. 1, A20.40. John’s wort, antineoplastics, certain antacids, S Epilepsy in conjunction with other ciprofloxacin, alcohol, phenothiazines. See SPC. anticonvulsants. A CNS disorders, inj. site reactions, rash, P 250-1000mg daily in divided doses. haemopoietic complications, GI disorders, Q 125-750mg daily in divided doses; hypersensitivity, polyarthropathy, interstitial infants, 125mg in divided doses. nephritis, pneumonitis. D Chronic closed angle glaucoma. Renal hyperchloraemic acidosis. Adrenal insufficiency. EPILIM sanofi-aventis Na+ or K+ depletion. B Gout. Diabetes. Pregnancy. K+suppl. may 2 M O be required. Monitor fluid, electrolytes and blood. Carboxylic acid deriv. Sodium valproate 200mg, 500mg. Lilac ent-ctd tabs. 200mg-100, A7.65; C Folic acid antagonists, hypoglycaemics, 500mg-100, A19.07. oral anticoagulants. 2MO A Flushing, thirst, headache, drowsiness, polyuria, paraesthesia, blood dyscrasias, ALSO EPILIM CRUSHABLE Sodium valproate excitement, rash. 100mg. White circular scored tab. 100, A4.62.

EPANUTIN

2MO Parke-Davis ALSO EIPLIM SYRUP Sodium valproate 200mg/5ml.

2MO

Hydantoin. Phenytoin Na+ 25mg, 50mg, 100mg, 300mg. White/purple cap., white/pink cap., white/ orange cap. and white/green cap. resp. All marked with cap. name and strength. 25mg-28, A1.10; 25mg-500, A11.39; 50mg-28, A1.11; 50mg-500, 2NO A11.63; 100mg-84, A6.95; 100mg-500, A15.17; 300mg-28, A6.95; 300mg-100, A10.00. ALSO ZOFRAN ZYDIS Ondansetron 4mg, 8mg. Oral lyophilisate. White round tab. 4mg-10, S Tonic-clonic seizures, partial seizures. A50.73; 8mg-10, A101.45. Prevention and treatment of seizures following P Emetogenic chemo/radiotherapy: 8mg 1- neurosurgery or head injury. Trigeminal neuralgia (2nd line). 2 hours before treatment. Then 8mg orally after 12 hours. Highly emetogenic chemotherapy: 24mg P Initially 3-4mg/kg daily increasing orally, (taken with 12mg oral dexamethasone), 1-2 gradually until control; maintenance, usually 200500mg daily in single or divided doses. hours before treatment. Post-operative nausea Q Neonates, titrate according to serum and vomiting prevention: 16mg orally, 1 hour levels. Others, initially 5mg/kg daily in two divided prior to anaesthesia. Treatment, use IV route.

Clear, cherry red syrup. 300ml, A7.00.

2MO ALSO EPILIM LIQUID Sodium valproate 200mg/ 5ml. Sugar-free. 300ml, A7.00.

2MO ALSO EPILIM CHRONO Sodium valproate (as valproate and valproic acid) 200mg, 300mg, 500mg. Violet oblong, film-ctd prolonged release tab. 200mg-100, A8.25; 300mg-100, A12.38; 500mg-100, A20.64.

2MO ALSO EPILIM CHRONOSPHERE Sodium valproate (as valproate and valproic acid) 100mg, 250mg, 500mg, 750mg, 1000mg. Prolong. release granules in sachets. 100mg-30, A9.79; 250mg-30, A10.02; 500mg-30, A13.03; 750mg-30, A19.38; 1000mg-30, A18.72.

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

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3.6 EPILEPSY,

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SEIZURES

S Generalised, partial or other epilepsy. P Initially 600mg daily increasing by 200mg at three day intervals or for Chronosphere initially 10-15mg/kg/day increasing at 2-3 day intervals. Usual maintenance, 1-2g daily (20-30mg/ kg/day). Max. 2.5g daily. Epilim Chrono and Chronosphere may be given once or twice daily. Q Under 20kg, initially 20mg/kg/day. Over 20kg, initially 400mg daily. Max. 40mg/kg daily. Chronosphere, see adults. Usual maintenance, 2030mg/kg/day. See SPC. Epilim Chrono not suitable for children under 20kg.

Q Under 3 years, not recommended; 3-12 years, up to half adult dose. D Myasthenia gravis, severe respiratory insufficiency, sleep apnoea, severe hepatic insufficiency, drug or alcohol dependence. Pregnancy, lactation (use only if essential). Children (6 months-3 years) other than in exceptional cases. B Tolerance, dependence, anterograde amnesia, psychiatric and paradoxical reactions may occur. Caution: Pre-existing muscle weakness, spinal/cerebellar ataxia. Elderly, acute respiratory insufficiency, renal/hepatic impairment; reduce dose. Driving/operating machinery. C Not recommended: Alcohol. Caution: CNS depressants. A Drowsiness, reduced alertness, numbed emotions, confusion, fatigue, headache, dizziness, muscle weakness, fine tremor, double vision.

GABA analogue. Gabapentin 100mg, 300mg, 400mg. Hard gelatine caps. with white (100mg), yellow (300mg) or orange (400mg) opaque body. 100mg-100, A16.92; 300mg-100, A39.20; 400mg100, A45.36. S Partial seizures with and without secondary generalisation as adjunctive therapy (r6 years) or as monotherapy (r12 years). P 12 years and over, 900-3600mg/day swallowed whole with water. Titrate 300mg once daily (Day 1), twice daily (Day 2) and three times daily (Day 3); alternatively 300mg three times daily on Day 1. Can then be increased in 300mg/day 2N increments every 2-3 days up to max. 3600mg/day. ALSO EPILIM INTRAVENOUS Sodium valproate Admin. in three divided doses with max. 12 hrs A 400mg. Powder in vial plus 4ml WFI. 1, 12.19. between each dose. Discontinue gradually over S Generalised, partial or other epilepsy, min. 1 week. Renal impairment: See SPC. where oral treatment is not possible. Q 6 years and over: Initially, 10-15mg/kg/ P Initially 400-800mg IV inf., followed by day; titrate over approx. 3 days to 25-35mg/kg/ continuous inf. of up to 10mg/kg/day. Max. 2.5g day. Admin. in three divided doses with max. 12 daily. GABAPENTIN TEVA Teva hrs between each dose. Q Usually 20-30mg/kg/day IV inf. Max D Pregnancy, lactation (unless benefit 40mg/kg/day but only if valproic acid levels 2MO outweighs risk). monitored. GABA analogue. Gabapentin 600mg, 800mg. B Acute pancreatitis (discontinue). Mixed D Active liver disease, personal or family White to off-white, oval shaped, bevelled edged, seizures including absences (caution). Long-term history of severe hepatic dysfunction (esp. drug film-ctd tab. engraved 7173 (600mg) or 7174 therapy (q 36 weeks) in children and adolescents related), porphyria. (800mg) on 1 side and 93 the other. 600mg-100, (no data). False positive in dipstick tests (total B Risk of severe liver damage (incl. A83.64; 800mg-100, A101.66. urine protein). Driving/operating machines. hepatic failure); increased risk in children Q 3 S Adjunctive therapy in treatment of Contains lactose. years. Liver function tests advised before therapy partial seizures with and without secondary C Morphine (caution). Take min. 2 hrs and in first 6 months, especially when risk or generalisation in adults and children r 6 years . after antacid. history of liver disease. Pancreatitis may occur, esp. As monotherapy in treatment of partial seizures A CNS effects eg. somnolence, dizziness, in young children (prompt medical evaluation in with and without secondary generalisation in ataxia. Infections eg. viral, RTI, UTI. Psychiatric patients with acute abdominal pain). adults and adolescents r 12 years. Monotherapy recommended in children Q 3 years P Effective dose, 900-3600mg/day. Initiate disorders eg. hostility, confusion, emotional lability. Fatigue, fever, oedema, abnormal gait, at risk of liver toxicity and pancreatitis. Blood cell by dose titration: 300mg once daily on day 1, pain, flu syndrome, arthralgia, myalgia, purpura, count, bleeding time and coagulation tests advised increasing to 300mg twice daily on day 2, then rash, vertigo. Hypertension, vasodilatation, visual before therapy. Monitor for suicidal thoughts/ 300mg three times daily on day 3. Alternatively behaviour. Caution: Systemic lupus erythematosus. initiate with 300mg 3 times/day on day 1. disturbances. Respiratory/GI disorders. Pregnancy (careful evaluation benefit/risk). Warn Incontinence, impotence. WBC decreased, Thereafter, can be increased in 300mg/day patients about risk of weight gain. May cause increments every 2-3 days up to 3600mg/day max. leucopenia, weight gain, appetite change. false positives in urine tests for diabetes. Accidental injury. Aggressive behaviour and Renal impairment, haemodialysis: See SPC. Hyperammonaemia: Metabolic tests advised before R Adjust according to renal function. hyperkinesias in children. therapy in those at risk. Withdraw carefully. Q q12 years, as per adults. r 6 years: C Avoid salicylates in children Q 3 years. GABITRIL Cephalon Initially, 10-15 mg/kg/day. Effective dose: 25-35mg/ Caution: Antipsychotics, MAOIs, antidepressants, kg/day reached by upward titration over a approx. 2 M O benzodiazepines, phenobarbital, primidone, Selective inhibitor of GABA uptake. Tiagabine 3 days. Doses up to 50mg/kg/day well tolerated. phenytoin, carbamazepine, lamotrigine, 5mg, 10mg, 15mg. White film-ctd scored tabs Divide total daily dose in 3 single doses with 12 zidovudine, vit K-dependent anticoagulants, marked 251, 252 or 253. 5mg-100, A72.26;10mghour interval (max) between doses. felbamate, mefloquine, chloroquine, highly 100, A104.16; 15mg-100, A156.24. D Pregnancy, lactation (unless benefit protein Avoid salicylates in children Q 3 years. S Add-on therapy for partial seizures with outweighs risk). Caution: Antipsychotics, MAOIs, antidepressants, or without secondary generalisation not controlled B Consider discontinuation if acute benzodiazepines, phenobarbital, primidone, with other AEDs. pancreatitis develops. Caution in patients with phenytoin, carbamazepine, lamotrigine, P Initially 7.5-15mg/day in three divided mixed seizures incl. absences. Assess risks/benefits zidovudine, vit K-dependent anticoagulants, of prolonged therapy in children and adolescents. doses increasing with weekly increments of 5felbamate, mefloquine, chloroquine, highly 15mg/day. Usual maintenance, 30-50mg/day; max. Monitor for signs of suicidal ideation and protein bound agents (eg. aspirin), cimetidine, 70mg/day. behaviours. False positive in dipstick tests (total erythromycin, carbapenem antibiotics, Q Not recommended. urine protein). Withdraw gradually. Pregnancy, colestyramine, rifampicin, newer anti-epileptics D Severely impaired liver function. lactation. Driving/operating machinery. (e.g. topiramate). Generalised epilepsy, particularly idiopathic forms C Morphine, antacids. A Congenital disorders, transient GI with absences. A IInfections (e.g. viral, UTI, RTI, otitis disorders, increased alertness, aggression, B Withdraw gradually; patients with a media, pneumonia), leucopenia, anorexia, hyperactivity, behavioural deterioration, confusion, increased appetite, psychiatric and nervous system history of serious behavioural problems; perforrm thrombocytopenia, transient hair loss, full blood count if ecchymoses are observed. disorders, visual disturbances, vertigo, amenorrhoea, dysmenorrhoea, allergic reactions, hypertension, vasodilatation, dyspnoea, bronchitis, Pregnancy, lactation. increased weight. A Dizziness, tiredness, somnolence. pharyngitis, cough, rhinitis, GI disorders, facial FRISIUM sanofi-aventis oedema, purpura, rash, pruritus, acne, arthralgia, GERICARB SR Gerard myalgia, back pain, twitching, incontinence, 2NO impotence, fatigue, fever, peripheral or 2MO Benzodiazepine. Clobazam 10mg. White tab. generalized oedema, abnormal gait, asthenia, Dibenzazepine. Carbamazepine 200mg, 400mg. marked Hoechst one side, scored and coded B/GL pain, malaise, flu syndrome, decreased WBC, White to yellowish, round, flat, cloverleaf shaped on reverse. 100, A9.44. weight gain. prolonged release tabs with bevelled edge, S Adjunct in epilepsy. double-sided cross break-mark, 4 notches on band. P 10-20mg daily with increases of 10mg GABIN Rowex Can be divided into equal halves. 200mg-56 increments. Max. 60mg daily. Reassess after 4 2MO A4.48; 400mg-56, A8.85. weeks.

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Restricted b2 agonists

Declaration required


CNS S Epilepsy. Generalised tonic-clonic. Partial seizures. P Initially 100-200mg once or twice daily increasing slowly to 400-600mg morning and night. Max daily dose of 1600-2000mg may be required. Q Not suitable under 5 years. 5-10 years: Initially 200mg at night (or 100mg morning and night). Maintenance: 100-200mg morning and 200400mg at night. 10-15 years: Initially 200mg at night (or 100mg morning and night); maintenance: 100-400mg morning and 400-600mg at night. D Bone marrow depression, AV conduction abnormalities, acute intermittent porphyria. B Evaluate benefit/risk: Haematological disturbances, disturbed Na+ metabolism, severe cardiac, liver and kidney dysfunction, myotonic dystrophia, pregnancy, lactation. Patients should consult immediately if fever, sore throat, rash, ulcers in the mouth, easy bruising, petechial or purpuric haemorrhage, nausea, skin yellowing and liver enlargement occurs. Caution: Severe cardiovascular disease, liver disease or renal damage, elderly, glaucoma (regulary check IOP), high doses. May trigger or exacerbate absences. Increase in seizure frequency or the onset of new types of seizures may occur. Test blood regularly; discontinue if severe leucopenia or thrombocytopenia appear. Perform liver function tests periodically. Discontinue if severe dermatological reactions, severe hypersensitivity occur. Avoid sunlight exposure. Driving/operating machines. C Not recommended: MAOIs. Caution: Anticonvulsants, CYP450 inducers/inhibitors, digoxin, theophylline, cisplatin, doxorubicin, clonazepam, St. John’s Wort, azole antimycotics, macrolide antibiotics, isoniazid, Ca++ antagonists, acetazolamide, dextropropoxyphene, propoxyphene, viloxazine, danazol, nicotinamide (at high dose in adults), nefazodone, fluvoxamine, terfenadine, loratadine, grapefruit juice, protease inhibitors, cimetidine (doses r 800mg), desipramine, phenobarbital, lamotrigine, primidone, clobazam, ethosuximide, tiagabine, alprazolam, corticosteroids, doxycycline, dihydropyridines, haloperidol, other neuroleptic drugs, TCAs, trazodone, topiramate, methadone, tramadol, anticoagulants, bromperidol, olanzapine, quetiapine, praziquantel, caspofungin, fentanyl, midazolam, phenazone, propranolol, methylphenidate, flunarizine, quinidine and hydroquinidine, tacrolimus, sirolimus, cyclosporine, oral contraceptives, HRT, bupropion, psychotropic drugs, paracetamol, lithium, hypokalaemic diuretics (loop and thiazide diuretics), antiarrhythmics, muscle relaxants, isotretinoin, thyroid hormones, serotonin re-uptake inhibitors, clozapine, procarbazine, alcohol. A Blood dyscrasias, dizziness, somnolence, sedation, drowsiness, ataxia, elevated gamma-GT, fatigue.

EPILEPSY, two days. Max. depends on body weight: 1800mg/ day (30-50kg), 2400mg/day (50.1-70kg), 3200mg/ day (r70.1kg). Withdraw gradually (approx. 25% every two days). Q Under 4 years, not recommended. 4 years and older: r 30kg, as per adults. Q30kg: Initially 200mg; may be increased by 200mg/day increments every two days. Max: 1000mg/day or 400mg/day if admin. in combination with valproate. D Severe hepatic impairment. Pregnancy (unless clearly necessary), lactation. B Mild to moderate hepatic impairment. Status epilepticus cases, antiepileptic drug hypersensitivity syndrome (discontinue if suspected). Accidental falls. Women should use contraceptive measures. Driving/using machines. Contains lactose. C Caution: Some AEDs (carbamazepine, phenobarbital, phenytoin, vigabatrin or primidone, valproate), hormonal contraceptives, CYP3A substrates, warfarin, digoxin. A Somnolence, headache, dizziness, nausea, vomiting, fatigue. Pneumonia, flu, upper respiratory/ear infections, eating disorder, decreased appetite and weight, anxiety, insomnia, status epilepticus, convulsion, coordination abnormal, nystagmus, psychomotor hyperactivity, tremor, vision disorders, vertigo, epistaxis, GI disorders, hepatic enzyme increase, rash, acne, back pain, oligomenorrhoea, gait disturbance, head injury, contusion.

SEIZURES

3.6

twice daily every 2 weeks depending upon response. Max. 1500mg twice daily. Adjunctive therapy: As IV inf. over 15 min; dose as per Keppra Oral Soln. Renal impairment, see SPC. Q As IV inf; dose as per Keppra Oral Soln. D Pregnancy (unless clearly necessary), lactation. B Severe hepatic impairment, driving or operating machines. Withdraw gradually. Soln. contains glycerol. Concentrate contains sodium. C Caution: Probenecid, NSAIDs, sulfonamides, methotrexate. A Asthenia, somnolence, amnesia, ataxia, convulsion, dizziness, headache, tremor, depression, emotional lability, hostility, insomnia, nervousness, diarrhoea, dyspepsia, nausea, anorexia, weight increase, vertigo, diplopia, accidental injury, myalgia, infection, nasopharyngitis, cough increased, rash, thrombocytopenia.

LAMICTAL

GSK

2MO Triazine. Lamotrigine 25mg, 50mg, 100mg, 200mg. Pale yellow, multi-faceted, superelliptical tabs. marked with strength and code on reverse. 25mg56, A25.21; 50mg-56, A39.57; 100mg-56, A68.26; 200mg-56, A122.88.

2MO

ALSO LAMICTAL DISPERSIBLE Lamotrigine 2mg, 5mg, 25mg, 50mg, 100mg, 200mg. White tabs. marked with strength and code on reverse. 2mg30, A6.49; 5mg-28, A8.95; 25mg-56, A25.21; KEPPRA UCB 50mg-56, A39.38; 100mg-56, A68.26; 200mg-56, A123.91. 2NO S r 13 years: Adjunctive or monotherapy Pyrrolidone derivative. Levetiracetam 250mg, treatment of partial seizures and generalised 500mg, 1000mg. Blue, yellow and white scored tabs. marked ucb 250, ucb 500 and ucb 1000 resp. seizures, incl. tonic-clonic seizures. Seizures All oblong film-ctd. 250mg-60, A39.44; 500mg-60, associated with Lennox-Gastaut syndrome (as adjunctive therapy; may also be given as initial A69.18; 1000mg-60, A134.93. antiepileptic drug). Children aged 2 to 12 years: 2NO Adjunctive treatment of partial seizures and ALSO KEPPRA ORAL SOLUTION Levetiracetam generalised seizures, incl. tonic-clonic seizures and A 100mg/ml. 300ml, 96.35. seizures associated with Lennox-Gastaut syndrome. S Partial onset seizures with or without Monotherapy of typical absence seizures. secondary generalisation as monotherapy (r16 P Monotherapy: Initially 25mg once daily years) in newly diagnosed epilepsy or as for 2 weeks, followed by 50mg once daily for 2 adjunctive therapy (r4 years); myoclonic seizure weeks; thereafter usual maintenance, 100-200mg (r12 years) in Juvenile Myoclonic Epilepsy; daily, once daily or in 2 divided doses; max. primary generalised tonic-clonic seizures (r12 500mg daily. Adjunctive therapy: With valproate: years) in Idiopathic Generalised Epilepsy. Initially 12.5mg/day (or 25mg on alternate days) P Monotherapy (q16 years): Initially, for 2 weeks, followed by 25mg once daily for 2 250mg twice daily increased to 500mg twice daily weeks; maintenance 100-200mg once daily or in 2 after 2 weeks; can be further increased by 250mg divided doses. With enzyme inducers (except twice daily every 2 weeks up to 1500mg twice valproate): Initially 50mg once daily for 2 weeks, daily. Adjunctive therapy: Initially, 500mg twice followed by 100mg daily in 2 divided doses for 2 daily; can be increased up to 1500mg twice daily weeks; thereafter usual maintenance dose 200in increments of 500mg twice daily every 2-4 400mg daily in 2 divided doses; max. 700mg daily. weeks. Renal impairment, see SPC. Without valproate or enzyme inducers: Initially Q 4-17 years and Q 50kg: Initially 10mg/ 25mg once daily for 2 weeks, followed by 50mg kg twice daily; can be increased up to 30mg/kg daily in 2 divided doses for 2 weeks; thereafter twice daily in increments of max. 10mg/kg twice usual maintenance dose 100-200mg daily in 2 daily every 2 weeks. 50kg or more, as per adults. divided doses. See SPC for dose escalation in all Under 4 years, not recommended. cases. INOVELON Eisai 2 N O Q Under 2 years, not recommended. 2-12 2MO ALSO KEPPRA CONCENTRATE Levetiracetam years: Monotherapy: Initially 0.3 mg/kg/day (once 100mg/ml. Soln for inf. 10-100mg/ml, A190.98. Carboxamide derivative. Rufinamide 100mg, a day or two divided doses) for 2 weeks; followed 200mg, 400mg. Pink, ovaloid, slightly convex, film- S Monotherapy in partial onset seizures by 0.6 mg/kg/day (once a day or two divided ctd tabs. scored on both sides, marked A261, with or without secondary generalisation (r 16 doses) for 2 weeks; thereafter usual maintenance A262, A263 resp. 100mg-10, A6.39; 200mg-60, years) in newly diagnosed epilepsy. Adjunctive 1-10 mg/kg/day (once a day or two divided doses), A61.94; 400mg-60, A121.55. therapy when oral admin. is temporarily not higher doses up to 15 mg/kg/day may be required. feasible. S Adjunctive therapy in treatment of Adjunctive therapy: With valproate: Initially 0.15 seizures associated with Lennox-Gastaut syndrome. P Monotherapy: Initially 250mg IV inf. mg/kg/day (once a day) for 2 weeks; followed by twice daily, should increase to 500mg twice daily P Initially 400mg preferably with food; 0.3 mg/kg/day (once a day); thereafter usual after 2 weeks. Can be further increased by 250mg maintenance 1-5 mg/kg/day (once a day or two may be increased by 400mg/day increments every AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

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3.6 EPILEPSY,

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divided doses); maximum 200mg/day. With enzyme inducers (except valproate): Initially 0.6 mg/kg/day (2 divided doses) for 2 weeks; followed by 1.2 mg/kg/day (2 divided doses) for 2 weeks; thereafter usual maintenance 5-15 mg/kg/day (once a day or 2 divided doses). Without valproate or enzyme inducers: Initially 0.3 mg/kg/day (once a day or 2 divided doses) for 2 weeks; followed by 0.6 mg/kg/day (once a day or 2 divided doses); thereafter usual maintenance 1-10 mg/kg/day (once a day or 2 divided doses). See SPC for dose escalation in all cases. B Renal failure (caution). Rare skin reactions eg. Stevens Johnson syndrome. Promptly evaluate patients who develop rash. Hypersensitivity syndrome. Withdraw gradually. Monitor for suicidality (increased risk below 18 years). Myoclonic seizures may worsen. Pregnancy, lactation. Driving/operating machinery. Contains lactose. C Valproate reduces dose requirement. May increase dose requirement: Phenytoin, carbamazepine, phenobarbitone, primidone, rifampicin, ethinyloestradiol/levonorgestrel combination (consider continuous hormonal contraceptives or non-hormonal contraceptives to LAMOTRIGINE RANBAXY Ranbaxy limit variations in lamotrigine levels). A Aggression, irritability, headache, 2MO LAMORO Pinewood Lamotrigine 25mg, 50mg, 100mg, 200mg. White somnolence, dizziness, tremor, insomnia, ataxia, nystagmus, tremor, diplopia, blurred vision, GI 2MO to off-white round tab., debossed with L12, L13, disorders, tiredness. Triazine Lamotrigine 25mg, 50mg, 100mg, 200mg. L14 or L15 (resp.) on one side. 25mg-56, A13.44; A A Dispersible white to off-white round tabs. 25mg50mg-56, 21.10 ; 100mg-56, 36.40; 200mg-56, LARIG Rowex 60, A19.53; 50mg-60, A30.50; 100mg-60, A52.92; A66.51. 2MO 200mg-60, A96.11. S Adults and adolescents q 13 years: As adjunctive or monotherapy treatment of partial S Epilepsy, partial and generalised Triazine. Lamotrigine 25mg, 50mg, 100mg, 200mg. seizures incl. tonic-clonic seizures and the seizures seizures and generalised seizures, incl. tonic-clonic White, square dispersible tab. marked L and seizures; seizures associated with Lennox-Gastaut associated with Lennox Gastaut Syndrome. strength. 25mg-56, A19.57; 50mg-56, A30.56; P Monotherapy: Initially 25mg once daily syndrome; as adjunctive therapy in Lennox-Gastaut 100mg-56, A52.97; 200mg-56, A96.15. syndrome (may also be the initial antiepileptic for 2 weeks, followed by 50mg once daily for 2 S As adjunctive or monotherapy in the drug). Children and adolescents aged 2-12 years: weeks; thereafter usual maintenance, 100-200mg treatment of epilepsy, for partial seizures and Adjunctive treatment of partial seizures and daily, once daily or in 2 divided doses; max. generalised seizures, incl. tonic-clonic seizures and generalised seizures, incl. tonic-clonic seizures and the seizures associated with Lennox-Gastaut 500mg daily. Add on therapy: Patients taking seizures associated with Lennox-Gastaut syndrome; Syndrome. valproate: Initially 25mg on alternate days for 2 monotherapy of typical absence seizures. weeks, followed by 25mg once daily for 2 weeks; P Monotherapy: Initially 25mg once daily maintenance 100-200mg once daily or in 2 divided P Monotherapy: Initially 25mg once daily for 2 weeks; usual maintenance, 100-200mg once for 2 weeks, followed by 50mg once daily for 2 doses. Patients not taking valproate but taking daily or in 2 divided doses; max. 500mg daily. Add weeks; thereafter usual maintenance, 100-200mg inducers of lamotrigine glucoronidation: Initially on therapy: Initially in those taking enzyme daily, once daily or in 2 divided doses; max. 50mg once daily for 2 weeks, followed by 100mg inducing anti-epileptic drugs (AEDs) and not 500mg daily. Adjunctive therapy with valproate: daily in 2 divided doses for 2 weeks; thereafter taking Na+ valproate: 50mg once daily for 2 Initially 12.5mg/day (or 25mg on alternate days) usual maintenance dose 200-500mg daily in 2 weeks; usual maintenance dose 200-500mg/day in for 2 weeks, followed by 25mg once daily for 2 divided doses; max. 700mg daily. Patients not 2 divided doses; max. 700mg daily. Patients taking weeks; maintenance 100-200mg once daily or in 2 valproate (or AEDs with interaction unknown): taking valproate but taking oxcarbazepine and divided doses. Adjunctive therapy with enzyme without inducers or inhibitors of lamotrigine Initially 25mg on alternate days for 2 weeks; inducers (except valproate): Initially 50mg once glucuronidation: 25mg once daily for 2 weeks, maintenance 100-200mg once daily or in 2 divided daily for 2 weeks, followed by 100mg daily in 2 followed by 50mg once daily for 2 weeks; doses. See SPC for dose escalation in all cases. divided doses for 2 weeks; thereafter usual thereafter usual maintenance dose 100-200mg Hepatic impairment: Moderate, half adult dose; once daily or in 2 divided doses. See SPC for dose maintenance dose 200-400mg daily in 2 divided severe, 1/4 adult dose. escalation in all cases. Special patient populations: doses; max. 700mg daily. Adjunctive therapy Q Under 2 years, not recommended. Over without valproate or enzyme inducers: Initially Refer to SPC. 12 years, as per adults. 2-12 years: Only as add-on 25mg once daily for 2 weeks, followed by 50mg Q Under 2 years, not recommended; 2-12 therapy. Initially in those taking enzyme inducing daily in 2 divided doses for 2 weeks; thereafter years: Patients taking valproate with/without any AEDs and not taking valproate, 0.6mg/kg daily in usual maintenance dose 100-200mg daily in 2 other AED: Initially 0.15mg/kg once daily for 2 2 divided doses for 2 weeks; usual maintenance 5weeks, followed by 0.3mg/kg daily once daily for 2 divided doses. See SPC for dose escalation in all 15mg/kg daily in 2 divided doses; max. 400mg weeks; thereafter increase by max. 0.3mg/kg every cases. daily. In those taking valproate, initially 0.15mg/kg Q Under 2 years, not recommended. 2-12 1-2 weeks until optimal response; usual once daily for 2 weeks; usual maintenance 1-5mg/ years: Monotherapy: Initially 0.3 mg/kg/day (once maintenance 1-5mg/kg once daily or in 2 divided kg once daily or in 2 divided doses; max. 200mg a day or 2 divided doses) for 2 weeks; followed by daily. See SPC for dose escalation in both cases. If doses; max. 200mg daily. Patients not taking 0.6 mg/kg/day (once a day or 2 divided doses) for calculated dose 1-2mg, 2mg may be taken on valproate but taking inducers of lamotrigine 2 weeks; thereafter usual maintenance 1-10 mg/ glucoronidation: Initially 0.6mg/kg daily in 2 alternate days for first 2 weeks. If calculated dose kg/day (once a day or 2 divided doses), higher divided doses for 2 weeks, followed by 1.2mg/kg Q 1mg, do not admin. doses up to 15 mg/kg/day may be required. daily in 2 divided doses for 2 weeks; thereafter B Renal/hepatic impairment. Rare skin Adjunctive therapy: With valproate: Initially 0.15 increase by max. 1.2mg/kg every 1-2 weeks until reactions eg. Stevens Johnson syndrome. Promptly optimum response; usual maintenance 5-15mg/kg mg/kg/day (once a day) for 2 weeks; followed by evaluate patients who develop rash. 0.3 mg/kg/day (once a day); thereafter usual daily given in 2 divided doses; max. 400mg daily. Hypersensitivity syndrome. Pregnancy, lactation maintenance 1-5 mg/kg/day (once a day or 2 Patients taking oxcarbazepine without any (only if benefit outweighs risk). Driving/using

divided doses). With enzyme inducers (except valproate): Initially 0.6 mg/kg/day (two divided doses) for 2 weeks; followed by 1.2 mg/kg/day (two divided doses) for 2 weeks; thereafter usual maintenance 5-15 mg/kg/day (once a day or two divided doses). Without valproate or enzyme inducers: Initially 0.3 mg/kg/day (once a day or two divided doses) for 2 weeks; followed by 0.6 mg/kg/day (once a day or two divided doses); thereafter usual maintenance 1-10 mg/kg/day (once a day or two divided doses). See SPC for dose escalation in all cases. B Renal/hepatic impairment. Rare skin reactions e.g. Stevens Johnson syndrome. Promptly evaluate patients who develop rash. Pregnancy, lactation. Hypersensitivity syndrome. Withdraw gradually. Monitor for suicidal ideation and behaviour. C Phenytoin, carbamazepine, phenobarbitone, primidone, rifampicin, lopinavir/ ritonavir, ethinyloestradiol/levonorgestrel combination may increase dose requirement. Valproate reduces dose requirement. A Aggression, irritability, headache, somnolence, dizziness, tremor, insomnia, ataxia, nystagmus, diplopia, blurred vision, GI disorders, skin rash, tiredness.

118

inducers or inhibitors of lamotrigine glucuronidation: Initially 0.3mg/kg once daily or in 2 divided doses for 2 weeks, followed by 0.6mg/kg once daily or in 2 divided doses for 2 weeks; thereafter increase by max. 0.6mg/kg every 1-2 weeks until optimal response; usual maintenance 1-10mg/kg once daily or in 2 divided doses; max. 200mg daily. See SPC for dose escalation in all cases. B Rare skin reactions eg. Stevens Johnson syndrome. Promptly evaluate patients who develop rash. Hormonal contraceptives. Hypersensitivity syndrome. Renal/hepatic impairment. Withdraw gradually. Driving/ operating machinery. Pregnancy, lactation. C Phenytoin, carbamazepine, phenobarbitone, primidone, rifampicin, ethinyloestradiol/levonorgestrel combination may increase dose requirement. Valproate reduces dose requirement. A Skin rash, irritability, headache, drowsiness, insomnia, dizziness, tremor, nystagmus, ataxia, diplopia, blurred vision, GI disturbance, tiredness, agitation, arthralgia, somnolence, pain, back pain.

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Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CNS machines. Withdraw gradually. C Enzyme inducing anti-epileptic drugs (AEDs) (eg. phenytoin, primidone, carbamazepine, phenobarbitone) may increase dose requirement. A Rash, irritability, headache, drowsiness, insomnia, dizziness, tremor, vision disorders, GI disorders, tiredness, arthralgia, pain, back pain.

EPILEPSY,

SEIZURES

3.6

barbiturates), St John’s Wort. A Drowsiness, listlessness, ataxia, visual disturbances, nystagmus, nausea; all usually transient.

A Fatigue, ataxia, dizziness, somnolence. See SPC.

NEURONTIN

2NO

2MO

PRO-EPANUTIN

Parke-Davis

Pfizer Hydantoin. Fosphenytoin Na+ 75mg per ml (equiv.

GABA analogue. Gabapentin 100mg white cap.; 300mg yellow cap.; 400mg orange cap.; 600mg white tab.; 800mg white tab. All marked with name and strength. 100mg-100, A24.86; 300mg100, A57.65; 400mg-100, A66.71; 600mg-100, A104.55; 800mg-100, A127.08. LYRICA Pfizer S Partial seizures with and without 2MO secondary generalisation as adjunctive therapy GABA analogue. Pregabalin 25mg, 50mg, 75mg, (r6 years) or as monotherapy (r12 years). 100mg, 150mg, 200mg, 300mg. Hard gelatine cap., P Initially 300mg once daily on day 1, marked Pfizer on cap., and PGN and strength on increasing to 300mg twice daily on day 2, then body. 25mg-56, A81.70; 84, A122.55; 50mg-84, 300mg three times daily on day 3. Thereafter dose A122.55; 75mg-56, A81.70; 100mg-84, A122.55; can be increased using increments of 300mg per 150mg-56, A81.70; 200mg-84, A122.55; 300mg-56, day given in three divided doses to a max. of A81.70. 3600mg per day. Effective dose range is 900S Adjunctive therapy in adults with partial 3600mg daily. seizures with or without secondary generalisation. Q Under 6 years, not recommended; 6-12 P Initially, 150mg per day in either two or years, 25-35mg/kg/day given in three divided three divided doses. May be increased to 300mg doses. Initially 10mg/kg/day on day 1, 20mg/kg/day per day after 1 week and to max. 600mg per day on day 2 and 25-35mg/kg/day on day 3. after an additional week. Discontinue gradually B Elderly, haemodialysis, renal impairment over a min. of 1 week. Renal impairment: Adjust (see SPC), mood and behavioural disturbances. dosage (see SPC). Ability to drive or operate machinery may be R Reduce dose in renal dysfunction. affected. Pregnancy, lactation. Discontinuation of Q Under 18 years, not recommended. gabapentin and/or additional or substitution of D Pregnancy (unless essential), lactation. alternative therapy should be gradual over a B Withdrawal symptoms may occur. minimum of 1 week. Not effective in absence Driving/using machines. Contains lactose. seizures. C Caution: Ethanol, lorazepam, C Caution: Morphine, antacids. antidiabetics (adjust dose). A Dizziness, tiredness. Increased appetite, A CNS effects (somnolence, dizziness, weight gain, euphoric mood, confusion, change in ataxia, nystagmus, tremor), fatigue, headache, diplopia, GI disturbances (nausea, vomiting), libido, irritability, attention disturbances, rhinitis, amblyopia. clumsiness, memory impairment, tremor, speech difficulty, paraesthesia, visual disturbances, NEUROSTIL Teva vertigo, dry mouth, GI disorders, erectile dysfunction, peripheral oedema, drunken feeling, 2 M O abnormal gait. GABA analogue. Gabapentin 100mg, 300mg, 400mg. Resp. grey, orange or brown hard cap. MYSOLINE Acorus marked resp. 93 and 38, 93 and 39 or 93 and 40. 100mg-100, A19.89; 300mg-100, A46.12; 400mg2MO 100, A53.37. Pyrimidinedione. Primidone 250mg. White scored S Partial seizures with and without tab. marked MM. 100, A16.00; 1000, A18.79. secondary generalisation as adjunctive therapy S Grand mal and psychomotor (temporal lobe) epilepsy. Also of value in focal or Jacksonian (r3 years) or as monotherapy (r12 years). P Initially 900mg/day. Titrate by 300mg seizures, myoclonic jerks and akinetic attacks. once daily on day 1, 300mg twice daily on day 2, P Initially 125mg at night increasing at 3 300mg three times daily on day 3. Can be day intervals by 125mg to 500mg daily, then increased by 300mg/day increments in 3 equally increase by 250mg to max. 1.5g daily. Usually divided doses, up to 3600mg/day max. Effective twice daily. Q Initially same regimen as adults but use dose range 900-3600mg daily. Max 12 hours between doses. Renal impairement, haemodialysis: 125mg increments. Maintenance: up to 2 years, See SPC. 250-500mg; 2-5 years, 500-750mg; 6-9 years, R Adjust according to renal function. 750mg-1g; 9-12 years, 750mg-1.5g. All as daily Q 3-12 years, initially 10-15mg/kg/day in 3 doses, best divided in 2 equal amounts morning divided doses; titrate over 3 days. r 5 years: 25and evening. 35mg/kg/day in 3 divided doses. 3-5 years: 40mg/ D Porphyria. Pregnancy (only if essential; kg/day in 3 divided doses. Doses up to 50mg/kg/ vit K1 suppl). B Children, elderly, debilitated patients. day well tolerated. Max 12 hours between doses. Impaired renal, hepatic or respiratory function. B Mood and behavioural disturbances Metabolised to phenobarbitone; potential for may occur. Monitor for suicidal ideation. tolerance/ dependance. Withdraw gradually. Vit. D Withdraw gradually over at least 1 week. Not suppl. in long term therapy. Megaloblastic effective in absence seizures. Pregnancy (only use anaemia requiring discontinuation. Lactation if clearly needed), lactation. Driving/using (monitor baby for sedation). machines. C Caution: Other anticonvulsants, C Caution: Morphine, antacids. False coumarin anticoagulants, oral contraceptive positive readings reported with Ames N-Multistix steroids, other CNS depressants (eg. alcohol, SG dipstick test.

to 50mg PE). Clear, colourless to pale yellow soln. in vial. 10 x 10ml, A439.08. S Status epilepticus of tonic-clonic type. Prevention and treatment of seizures connected with neurosurgery or head trauma. Substitute for oral phenytoin where oral admin. is not possible. P Status epilepticus: initially 15mg PE/kg by IV inf. at a rate of 100-150mg PE/min. Maintenance: 4-5mg PE/kg daily by IV inf. or IM inj. Treatment and prophylaxis of seizures: initially 10-15mg PE/kg by IV inf. at a rate of 50-100mg PE/ min. or by IM inj. Maintenance: 4-5mg PE/kg daily by IV inf. or IM inj. Dilute soln before IV inf. Dosage expressed in phenytoin sodium equiv. (mg PE). 1.5mg fosphenytoin sodium1mg PE. Q Under 5 years, not recommended; over 5 years, same mg PE/kg dose as adult by IV inf. D Sinus bradycardia, SA block, 2nd or 3rd degree AV block, Adams-Stokes syndrome, porphyria. Lactation. B Hypotension, severe myocardial insufficiency, acute cerebrovascular event, renal or hepatic disease, elderly (lower dose may be required), hypoalbuminaemia, phosphate intake restriction, diabetes. Monitor ECG, BP and respiration during and for 30 mins. after IV inf.; cardioresuscitation facilities must be available. Withdraw gradually. Discontinue if rash, hypersensitivity or signs of hepatotoxicity or lymphadenopathy occur. Pregnancy. C Amiodarone, antifungals, antineoplastics, benzodiazepines, corticosteroids, coumarin anticoagulants, frusemide, oral contraceptives, quinidine, vit. D, folic acid, theophylline, disulfiram, anticonvulsants, ulcer healing drugs, analgesics, antacids, antipsychotics, antidepressants, tolbutamide. A Cardiovascular complications, CNS effects, blood dyscrasias, hepatitis, liver damage, intestinal nephritis, GI upset, pruritus, headache, hirsutism, hypersensitivity reactions.

RANGABAX

Ranbaxy

2MO GABA analogue Gabapentin 100mg, 300mg, 400mg, 800mg. 100mg: White opaque hard cap. (size 4) marked G100 on cap and body. 300mg: Ivory opaque hard cap. (size 0) marked G300 on cap and body. 400mg: Orange opaque hard cap. (size 0) marked G400 on cap and body. 800mg: White to off-white, oval, biconvex film-ctd tab. marked G800 on one side. 100mg-100, A14.48; 300mg-100, A30.93; 400mg-100, A37.47; 800mg100, A82.91. S As adjunctive therapy in the treatment of partial seizures with and without secondary generalisation in adults and children r 6 years. As monotherapy in treatment of partial seizures with and without secondary generalisation in adults and adolescents r 12 years. P Effective dose, 900-3600mg/day. Initiate by dose titration: 300mg once daily on day 1, increasing to 300mg twice daily on day 2, then 300mg three times daily on day 3. Alternatively, initiate with 300mg 3 times/day on day 1. Thereafter, can be increased in 300mg/day increments every 2-3 days up to 3600mg/day max. See SPC. Renal impairment, haemodialysis: See

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

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EXCIPIENTS Many products contain ingredients other than the active ingredient(s) listed in this index; these are known as excipients. These are â&#x20AC;&#x153;inertâ&#x20AC;? substances used as a diluent or vehicle for a drug and may cause unwanted effects in some individuals. The table below contains a list of excipients and when they should be avoided, when caution should be exercised or their possible side effects.

EXCIPIENT

PRECAUTION

Lactose

Should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Fructose Mannitol Sucrose Sorbitol

Should not be administered to patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

Aspartame

Caution in phenylketonuria.

Ethanol Alcohol

May be harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease, as well as for pregnant women and children. Possible CNS and other effects.

Cetyl alcohol Propylene glycol Parabene Methyl parahydroxybenzoate Propyl parahydroxybenzoate Chlorocresol Metacresol Sunset yellow Polyethoxylated castor oil

May cause allergic reactions.

Associated with a fatal 'gasping syndrome' in neonates. Benzyl alcohol

May cause toxic and anaphylactoid reactions in infants and children up to 3 years of age.

Cetostearyl alcohol

May cause local skin reactions.

Arachis oil

Should not be taken/applied by patients known to be allergic to peanut. Patients with soya allergy should also avoid.

This table was compiled using a number of SPCs. References 1- IPHA website. www.medicines.ie. October 2006.

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CNS SPC. R Adjust according to renal function. Q q 12 years, as per adults. r 6 years: Initially, 10-15 mg/kg/day. Effective dose: 25-35mg/ kg/day. Doses up to 50mg/kg/day well tolerated. Divide total daily dose in 3 single doses with a 12 hour interval (max) between doses. B Consider discontinuation if acute pancreatitis develops. Caution in patients with mixed seizures incl. absences. Assess risks/benefits of prolonged therapy in children and adolescents. Monitor for signs of suicidal ideation and behaviours. False positives in dipstick tests (total urine protein). Withdraw gradually. Driving/ operating machinery. C Morphine (monitor for CNS depression). Antacids. A Infections (e.g. viral, UTI, RTI, otitis media, pneumonia), leucopenia, anorexia, increased appetite, psychiatric and nervous system disorders, visual disturbances, vertigo, hypertension, vasodilatation, dyspnoea, bronchitis, pharyngitis, cough, rhinitis, GI disorders, facial oedema, purpura, rash, pruritus, acne, arthralgia, myalgia, back pain, twitching, incontinence, impotence, fatigue, fever, peripheral or generalised oedema, abnormal gait, asthenia, pain, malaise, flu syndrome, decreased WBC, weight gain.

EPILEPSY, White oval scored tab. marked SABRIL. 100, A53.34.

2MO

ALSO SABRIL SACHETS Vigabatrin 500mg. Powder. 50, A28.59. S In combination with other AEDs for resistant partial epilepsy with or without secondary generalisation not controlled by all other AED combinations. Monotherapy for treatment of infantile spasms (West’s syndrome). P Initially 1g daily added to existing therapy. Adjust dosage by 0.5g increments at weekly intervals according to response. Max. 3g/ day. Q 10-15kg body weight, 0.5-1g daily. 1530kg body weight, 1-1.5g daily. 30-50kg body weight, 1.5-3g daily. q 50kg body weight, same as adult. Infants with West’s syndrome, initially 50mg/kg/day, up to 150mg/kg/day. D Pregnancy, lactation. B Caution: Elderly, renal impairment (ccQ 60ml/min), history of psychosis, depression or behavioural problems. Monitor for signs of suicidal ideation and behaviour; advise patients to seek medical advice immediately if occur. Examine visual field before treatment initiation and every 6 months; advise patients to report new visual problems; refer to ophthalmologist if develop and consider discontinuation. A Increased weight, somnolence, speech RIVOTRIL Roche disorder, headache, dizziness, paraesthesia, disturbance in attention and memory impairment, 2NO Benzodiazepine. Clonazepam 0.5mg, 2mg. Pinkish mental impairment (thought disturbance), tremor, visual field defect, vision blurred, diplopia, or white tab. resp. Both quarter-scored marked ROCHE and tab. strength on one side. 0.5mg-100, nystagmus, GI disorders, fatigue, oedema, irritability, excitation (children), agitation, A5.12; 2mg-100, A10.68. aggression, nervousness, depression, paranoid S All forms of epilepsy. P Initial R1mg daily. Increase gradually to reaction. maintenance dose, usually 4-8mg daily. TEGRETOL Novartis R Initially R 0.5mg daily. 2MO Q Up to 1 year, initially R 0.25mg daily, maintenance, 0.5-1mg daily. 1-5 years, R 0.25mg Dibenzazepine. Carbamazepine 100mg white daily, maintenance, 1-3mg daily. 5-12 years, scored tab. marked B/W on one side and GEIGY initially R 0.5mg daily, maintenance, 3-6mg daily. on reverse; 200mg white scored tab. Marked C/G For all ages increase gradually to maintenance on one side and G/K on reverse; 400mg white dose. oblong tab. scored and marked CG/CG one side 2NO and scored with tab. name on reverse. 100mg-100, A4.16. 200mg-100, A7.69. 400mg-50, A7.57; ALSO RIVOTRIL INJECTION Clonazepam 1mg in 400mg-56, A8.47. solvent plus 1ml diluent. Amp. 5, A3.80; 10, A7.59. 2MO S Status epilepticus. ALSO TEGRETOL ORAL SUSPENSION P 1mg by slow IV inj. Carbamazepine 100mg/5ml. Sugar-free liquid. Q 0.5mg by slow IV inj. See lit. 300ml, A7.27. D Acute pulmonary insufficiency, severe S Epilepsy, generalised tonic clonic and respiratory insufficiency, sleep apnoea, myasthenia partial seizures. gravis, severe hepatic insufficiency. Pregnancy, P Initially 100-200mg once or twice daily lactation. increasing slowly to 800mg-1.2g daily; in some B Elderly, debilitated, spinal or cerebellar cases 1600mg daily may be necessary. ataxia, alcohol/drug abuse, cirrhosis. Withdraw Q Liquid is recommended for children gradually. May modify reaction times. Closely under 5 years. Up to 1 year, 5-10ml daily; 1-5 monitor for depressive illness/suicidal ideation (or years, 10-20ml daily; 5-10 years, 400-600mg daily; history of). Driving/operating machinery. Contains 10-15 years, 600mg-1g daily. lactose. 2MO C Alcohol, hydantoins, phenobarbital, Na+ ALSO TEGRETOL RETARD Carbamazepine 200mg valproate. CYP450 inhibitors/inducers. Phenytoin, beige-orange cap.-shaped scored controlledprimidone. Anaesthetics, hypnotics, psychoactive release Divitab marked TEGRETOL 200 one side drugs, analgesics, muscle relaxants. and HC/HC on reverse; 400mg brown-orange cap.A Fatigue, muscle weakness, dizziness, shaped scored controlled-release Divitab marked ataxia, light-headedness, somnolence, muscular TEGRETOL 400 one side and ENE/ENE on reverse. hypotonia, co-ordination disturbances. 200mg-50, A4.76; 400mg-50, A9.37. V Same total daily dose as above but in SABRIL sanofi-aventis two divided doses.

2MO

2MO

GABA transaminase inhibitor. Vigabatrin 500mg.

ALSO TEGRETOL SUPPOSITORIES Carbamazepine

SEIZURES

3.6

125mg, 250mg. Suppos. 125mg-5, A7.05; 250mg-5, A9.16. S Short term (max. 7 days) treatment of patients for whom oral therapy is not possible. V When switching from oral therapy increase dose by 25%; max. 1g daily in divided doses rectally. D AV conduction abnormalities unless paced. B Cardiac, hepatic or renal disease. Perform liver function tests periodically. Blood dyscrasias. Pregnancy, lactation. Test blood regularly. C MAOIs, anticoagulants, antiepileptics, lithium, macrolide antibiotics (erythromycin), some Ca++ antagonists (verapamil, diltiazem), dextropropoxyphene, viloxazine, cimetidine, isoniazid, oral contraceptives, alcohol. A Gastric upset, diplopia, dry mouth, drowsiness and dizziness. Oedema and hyponatraemia. Blood dyscrasias, rashes, acute renal failure, hepatitis. See SPC.

TOPAMAX

Janssen-Cilag

2MO Sulphamate. Topiramate 25mg, 50mg, 100mg, 200mg. White, light yellow, yellow or salmon filmctd tabs marked with TOP and tab. strength. 25mg-60, A26.55; 50mg-60, A43.62; 100mg-60, A77.85; 200mg-60, A146.35.

2MO ALSO TOPAMAX SPRINKLE Topiramate 15mg, 25mg. Sprinkle cap. 15mg-60, A22.44; 25mg-60, A33.65. S Monotherapy or adjunctive therapy for adults and children over 4 years for partial onset seizures with or without secondarily generalised seizures and primary generalised tonic-clonic seizures. As adjunctive therapy for Lennox Gastaut Syndrome seizures. P Initially 25mg daily for 1 week, then increased by 25-50mg daily, in 2 divided doses at 1-2 week intervals. Target dose: Monotherapy, 100-200mg/day; maximum 500mg. Adjunctive therapy, 200mg-400mg in 2 divided doses; maximum 1600mg/day. Migraine: Initially 25mg daily for 1 week, then increased by 25mg/day at 1week intervals. Recommended dose 100mg/day in 2 divided doses. Maximum 200mg/day. Tab. should not be broken. Q Aged 4 to 16 years: Begin titration at 25mg nightly for 1 week, then increase at 1 or 2 week intervals by 1 to 3mg/kg/day in 2 divided doses; recommended daily dose 5-9mg/kg/day in 2 divided doses. Doses up to 30mg/kg/day generally well tolerated. Under 4 years: Not recommended. D Pregnancy (unless benefits outweigh risks), lactation. B Caution: Hepatic and moderate to severe renal impairment. Patients at risk of nephrolithiasis; maintain adequate hydration. May occur: increased incidence of mood disturbances and depression, acute myopia with secondary angle-closure glaucoma (rare). Monitor serum bicarbonate; reduce dose or withdraw if metabolic acidosis develops. Monitor for weight loss. Hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Driving/using machine. Withdraw gradually. C Caution: Phenytoin, carbamazepine, digoxin, oral contraceptives, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, agents causing nephrolithiasis. A Nasopharyngitis, anaemia, anorexia,

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

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MS

CNS

Lacosamide 10mg/ml. Clear, colourless sln. 1 ampoule, A35.26. S Adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. Sln for inf. is an alternative when oral admin. is temporarily not feasible. P Initially 50mg twice daily, increased after 1 week to an initial therapeutic dose of 100mg twice daily . Maximum daily dose: 400mg (in two 200mg doses). Sln for inf.: Infused over a period of 15 to 60 minutes twice daily. Can be administered IV without further dilution. R Consider age associated decreased renal clearance with an increase in AUC levels. Q Under 16 years, not recommended. Over 16 years, as per adults. D Known 2nd- or 3rd-degree atrioventricular (AV) block. Pregnancy, lactation. B Prolongations in PR interval may occur: Caution in patients with known conduction problems or severe cardiac disease (history of TRILEPTAL Novartis myocardial infarction or heart failure). Syrup contains Na+ propylhydroxybenzoate, Na+ 2NO methylhydroxybenzoate, sorbitol and aspartame. Dibenzazepine. Oxcarbazepine 150mg, 300mg, Sln for inf. contains Na+. Tabs contain soya 600mg. Pale grey green, yellow and pink oval lecithin. film-ctd tabs. scored both sides. 150mg-50, A8.85; C Caution: Carbamazepine, lamotrigine, 300mg-50, A18.41; 600mg-50, A36.71. pregabalin, starting or ending treatment with 2NO rifampicin or St John’s Wort, phenytoin, ALSO TRILEPTAL ORAL SUSPENSION phenobarbital. Oxcarbazepine 60mg/ml. Susp. with oral dosing A Depression, dizziness, balance disorder, syringe. 250ml, A36.50. headache, abnormal coordination, memory S Partial seizures with or without secondary generalised tonic clonic seizures. For use impairment, cognitive disorder, somnolence, tremor, nystagmus, diplopia, blurred vision, as monotherapy or adjunctive therapy. vertigo, nausea, vomiting, constipation, flatulence, P Initially 600mg daily in two divided pruritus, gait disturbance, asthenia, fatigue, fall, doses. Increase if necessary at weekly intervals using increment of up to 600mg daily. Usual daily skin laceration. dose 600-2400mg daily. Parke-Davis Q Under 6 years, not recommended; over ZARONTIN 2MO 6 years, initially 8-10mg/kg daily in two divided doses. Increase if necessary at weekly intervals Succinimide. Ethosuximide 250mg/5ml. Clear using increments of up to 10mg/kg daily. Max. slightly yellow to slightly pink raspberry flavoured 46mg/kg daily. syrup. 200ml, A4.33. B History of hypersensitivity to S Petit mal. carbamazepine. Monitor Na+ levels in at risk P 500mg daily increased as necessary by patients prior and during therapy. Cardiac disease. 250mg daily at intervals of 4-7 days up to 2g daily. Pregnancy, lactation. Q Under 6 years, initially 250mg daily C Phenobarbitone, phenytoin, adjusted by small increments to optimum carbamazepine, Na+ valproate, lamotrigine, response; 6-12years, same as adult. contraceptives, felodipine, verapamil, lithium. B Pregnancy, lactation. Hepatic or renal A Fatigue, asthenia, dizziness, headache, impairment. Withdraw gradually. somnolence, agitation, amnesia, apathy, ataxia, C Phenytoin, valproic acid. impaired concentration, confusion, depression, A Gastric and CNS disturbances. Skin emotional lability, nystagmus, tremor, nausea, rashes, blood dyscrasias, SLE. vomiting, constipation, diarrhoea, abdominal pain, hyponatraemia, acne, alopecia, rash, diplopia, ZONEGRAN Eisai vertigo, vision disorders. decreased appetite, depression, abnormal behaviour, aggression, agitation, anger, anxiety, bradyphrenia, confusional state, depressed mood, disorientation, expressive language disorder, insomnia, altered mood, mood swings, dizziness, parathesia, somnolence, amnesia, balance disorder, cognitive disorder, convulsion, abnormal coordination, attention disturbance, dysarthria, dysgeusia, hypoaesthesia, intention tremor, lethargy, memory impairment, mental impairment, nystagmus, impaired psychomotor skills, sedation, tremor, diplopia, blurred vision, visual disturbance, ear pain, tinnitus, vertigo, dyspnoea, epistaxis, nasal congestion, rhinorrhoea, GI disorders, dysuria, nephrolithiasis, pollakiuria, alopecia, pruritus, rash, arthralgia, muscle spasms, muscle twitching, muscular weakness, musculoskeletal chest pain, myalgia, hypersensitivity, fatigue, asthenia, abnormal feeling, gait disturbance, irritability, malaise, pyrexia, weight decreased/ increased.

2NO

VIMPAT

UCB Benzisoxazole derivative. Zonisamide 25mg, 50mg,

100mg. Hard caps. with white opaque body. Cap white, grey or red resp. marked with logo and ZONEGRAN followed by strength. 25mg-14, A10.95; 50mg-56, A58.07; 100mg-56, A77.59. S Adjunctive therapy in partial seizures, with or without secondary generalisation. P Usually 300-500mg daily. Initially, 50mg in two divided doses; may be increased after 1 week to 100mg daily and thereafter at one 2O weekly intervals in increments of up to 100mg. ALSO VIMPAT SYRUP Lacosamide 15 mg/ml. Clear, Renal/hepatic impairment and patients not slightly yellow to yellow-brown sln. 200ml, receiving CYP3A4-inducing agents: Consider two A50.75. weekly intervals. Can be admin. once or twice 2O daily after titration phase. ALSO VIMPAT SOLUTION FOR INFUSION Q Under 18 years, not recommended.

2O

Functionalised amino acid. Lacosamide 50mg, 100mg, 150mg, 200mg. Resp. pinkish, dark yellow, salmon or blue oval film-ctd tab. debossed with SP one side and 50, 100, 150 or 200 on the other. 50mg-14, A10.38; 100mg-14, A20.77; 100mg-56, A83.05; 150mg-14, A31.14; 150mg-56, 124.58; 200mg-56, A166.10.

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D Pregnancy (unless clearly necessary), lactation. B Renal impairment. Acute renal failure, sustained increase in serum creatinine; discontinue. Hepatic impairment (not recommended if severe). Maintain hydration, avoid exposure to excessive temperatures. Risk factors for nephrolithiasis. Body weight Q40kg, elderly. Major haematological disturbances reported. Unexplained rash, pancreatitis; discontinue if occurs. Monitor for signs of severe muscle pain/weakness. Driving/ operating machines. Withdraw gradually. C Drugs that may lead to urolithiasis (avoid). Caution: Carbonic anhydrase inhibitors, anticholinergics or other drugs predisposing to heat related disorders, rifampicin. Caution with change in dosage of CYP3A4 inducers. A Anorexia, agitation, irritability, confusional state, depression, ataxia, dizziness, memory impairment, speech disorder, somnolence, diplopia, weight loss, hypersensitivity, rash, GI disorders, pyrexia.

3.7 PARKINSON’S, ALZHEIMER’S AND MS

ADARTREL

GSK

2MO Dopamine agonist. Ropinirole (as HCI) 0.25mg, 0.5mg, 2mg. White, yellow and pink resp. oval shaped film-cted tabs., marked GS on one side and MLE, TES, and GYG resp. on the other. 0.25mg-12, A2.89; 0.5mg-28, A12.26; 2mg-28, A33.87. S Moderate to severe idiopathic restless legs syndrome. P Initially 0.25mg once daily for 2 days. If well tolerated can increase to 0.5mg once daily for remainder of week 1. Week 2: 1mg once a day. The dose may be increased by 0.5mg/week over next 2 weeks to 2mg once a day (average dose). In some patients, dose may be increased gradually to a max. of 4mg once a day. Evaluate response after 3 months. R Clearance decreased in patients over 65 years of age. Increase dose gradually, titrate against response. Q Under 18 years, not recommended. D Severe renal or hepatic impairment. Lactation. Pregnancy (unless benefits outweigh risks). B Not for neuroleptic akathisia, tasikinesia or secondary restless legs syndrome. May cause worsening of symptoms with earlier onset, and reoccurrence of symptoms in early morning hours (review if occurs). Major psychotic disorders (do not use unless benefits outweigh risks). Impulse control disorders reported at high doses. Caution: Moderate hepatic impairment, severe cardiovascular disease. Driving/operating machines. Contains lactose. C CYP1A2 inhibitors. May require dose adjustment if HRT or smoking stopped or introduced. Avoid neuroleptics and other centrally active dopamine antagonists. A GI disorders, nervousness, syncope, somnolence, dizziness (incl. vertigo), fatigue.

AKINETON

L Farmaceutico SIT

2MO Anticholinergic. Biperiden (HCl) 2mg. White circular, biplanar tab. with bisecting score on one side. 100, A5.48. S Parkinsonism, drug-induced extrapyramidal symptoms.

2

5

m

c

s

b

d

Permitted

Prohibited

Prohibited in men

Prohibited in competition

Prohibited in specific sports

Restricted b2 agonists

Declaration required


CNS

PARKINSON’S, ALZHEIMER’S

PRESCRIBING NOTES PARKINSON’S DISEASE Idiopathic Parkinsonism (characterised by tremor, rigidity and akinesia) is a progressive disease caused by degeneration of dopaminergic neurones in the nigro-striatal pathway, leading to deficiency of dopamine. Levodopa, a precursor of dopamine, is used in combination with a dopa-decarboxylase inhibitor such as benserazide or carbidopa as replacement therapy. Levodopa is converted to dopamine and can cause vomiting and hypotension, alleviated by reducing the amount which can pass through the blood-brain barrier. Patients should be advised at the beginning of treatment of limitations and possible side effects. These effects are pronounced in prolonged therapy. In the elderly low doses are advised for initiating treatment. Symptoms can be improved by increasing the dosage or by dividing the daily dose into smaller more frequent amounts. Controlled-release preparations may be beneficial. Entacapone, a reversible COMT inhibitor, is used in conjunction with levodopa and a dopadecarboxylase inhibitor (co-beneldopa or co-careldopa) to improve symptom control and reduce end of dose deterioration and incidence of dyskinesias. It acts by allowing more levodopa to pass through the blood brain barrier for conversion to dopamine. Monoamine oxidase-B inhibitors (MAO-B) including selegiline and rasagiline primarily degrade dopamine within the CNS. They are used with levodopa to reduce end of dose deterioration and have also been found effective as monotherapy in early PD. They might even have a neuroprotective effect that slows disease progression (even though evidence is not clear). Reports claim there may be increased risk of mortality in patients taking selegiline with levodopa compared to levodopa alone, but a causal link has not been established. Amantadine was initially developed as an antiviral agent. Although its exact mechanism of action is unclear, it seems to increase release of dopamine from the remaining cells of the substantia nigra of PD patients. This drug may improve mild tremor, rigidity, and bradykinesia. Dopamine receptor agonists act by stimulating surviving dopamine receptors. They are often used as monotherapy in younger patients where there is a risk of long term levodopa side effects. Dopamine agonists include ergot derivatives such as bromocriptine, cabergoline, lisuride, pergolide. Bromocriptine has a longer action than levodopa is useful for patients with severe early-morning disability. Ropinirole is a dopamine D2 agonist used as monotherapy in early PD or as an adjunct to levodopa, reducing the amount of time spent off and allowing levodopa dose reduction. Pramipexole is a D2/D3 agonist also effective both as early monotherapy and as an adjunct to levodopa treatment. Even though pramipexole is not as effective as levodopa in improving total features of the disease, as initial therapy it reduces risk of developing certain dopaminergic motor complications with significantly less development of wearing off, dyskinesias or on-off motor fluctuation. Somnolence may be more common than with other dopaminergic medications. Apomorphine is a potent stimulator of D1 and D2 receptors. Treatment is initiated in hospital in selected patients following at least 2 days anti-emetic domperidone therapy. Apomorphine has been found to be useful in patients experiencing off-periods with conventional levodopa therapy. Antimuscarinic drugs such as benzhexol, benztropine, biperiden, orphenadrine and procyclidine, often called anticholinergics, are less effective than levodopa in treating idiopathic disease. They can relieve mild tremor and stiffness but do not improve akinesia. There are no major differences between these drugs, but some patients do tolerate some better than others. Side effects include glaucoma and urinary retention, and confusional states particularly amongst the elderly. ALZHEIMER‘S DEMENTIA Donepezil, galantamine and rivastigmine are acetylcholinesterase inhibitors that prevent the breakdown of acetylcholine. Memantine is an NMDA receptor antagonist which blocks the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction. These drugs do not cure Alzheimer’s dementia, but may improve early symptoms. MULTIPLE SCLEROSIS Interferon beta is used in relapsing-remitting multiple sclerosis. It is used to reduce frequency and severity of clinical relapses. Glatiramer acetate is an immunomodulating agent. Initiation should be supervised by a specialist. It is indicated for the reduction in frequency of relapses in ambulatory patients with relapsing, remitting multiple sclerosis (MS) characterised by at least two attacks of neurological dysfunction over the preceding two-year period. MOTOR NEURONE DISEASE Riluzole has been used to treat amyotrophic lateral sclerosis (ALS) a form of motor neurone disease (MND). Riluzole, an antiglutamate, exerts a neuroprotective effect slowing the progressive deterioration in muscle strength and improving survival times. Treatment should be initiated by a specialist. References available on request. Revised: August 2007

AND

MS 3.7

P Parkinsonism: Initially: 1mg twice daily. Can increase by 2mg a day to a max. of 16mg daily. Spread doses evenly throughout day. Druginduced movement disorder: 1-4mg, one to four times daily as comcomitant medication to the neuroleptic. Q 1-2mg one to three times daily.

2MO ALSO AKINETON RETARD Biperiden (HCl) 4mg. Pro-longed release yellowish film-ctd oblong tab. scored on both sides. 100, A10.28. P Treatment normally initiated with Akineton 2mg tab., adjust dose individually and switch to Akineton Retard. Usual dose: 4-8mg to a max. of 12mg daily. R Cautious dosing necessary. D Narrow angle glaucoma, GI obstruction, megacolon, prostatic adenoma, diseases that can cause perilous tachycardia. B Caution: Elderly, patients with thyrotoxicosis, cardiac failure, tachycardia, prostatic adenoma, or who have tendency to convulsions. Withdraw gradually. C Other anticholinergic psychotropics, antihistamines, antiparkinsonian drugs, antispasmodics, quinidine, levodopa, carbidopa, metoclopramide, alcohol. A Anticholinergic effects. Confusion in high doses.

APO-GO

Clonmel

2M Dopamine agonist. Apomorphine HCI 10mg/ml. Soln for inj. in prefilled syringe, Penject. 30mg/ 3ml-5, price on request. S Disabling motor fluctuations (’on-off’ phenomena) in patients with Parkinson’s disease, which persist despite individually titrated treatment with levodopa and/or other dopamine agonists. P Initially 1mg (0.1ml) by SC inj. If inadequate response after 30 min., admin. 2nd dose of 2mg (0.2ml) by SC inj. Dose may be increased incrementally with r 40 min. between inj., until satisfactory motor response obtained. Maintenance: Once appropriate dose determined, admin. single SC inj. at 1st signs of an ’off’ episode. Max. total daily dose is 100mg and max. individual bolus inj. is 10mg. Levodopa/ domperidone dose may be reduced in some patients. Continuous Infusion: Patients with a good ’on’ period response during initiation, but whose overall control remains unsatisfactory, or who require many and frequent inj. may be commenced on or transferred to continuous SC inf. For dose, see SPC. Q Under 18 years, contraindicated. D Respiratory depression, dementia, psychotic diseases, hepatic insufficiency. Intermittent treatment in patients who have an ’on’ response to levodopa marred by severe dyskinesia or dystonia. Children and adolescents. Pregnancy, lactation. B Renal, pulmonary or cardiovascular disease, persons prone to nausea and vomiting. Initiation in elderly/debilitated patients. Preexisting cardiac disease/postural hypotension. Perform regular haematology tests with concomitant levodopa use. May cause exacerbations of neuropsychiatric disturbances. Consider dose reduction/termination of therapy if somnolence experienced. Driving / operating machines. Contains Na+ metabisulphite (ampoules) or bisulphite (pen). C Neuroleptics, clozapine, drugs with a

AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions

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CNS

30mcg/ml after reconstitution. Prices on request. S Slowing of disability progression and frequency of clinical relapses in ambulatory patients with relapsing multiple sclerosis who have had at least 2 attacks in the preceding 3 years ARICEPT Pfizer without evidence of progression between relapses. Treatment of patients who have a single 2NO demyelinating event with an active inflammatory Acetylcholinesterase inhibitor. Donepezil (HCl) process if severe enough to warrant treatment 5mg, 10mg. White and yellow round biconvex with IV corticosteroids, if alternative diagnoses film-ctd tab marked Aricept on one side and 5 have been excluded, and if high risk of and 10 resp. on reverse. 5mg-28, A38.78; 10mg-28, developing clinically definite MS. A54.37. P 30mcg once weekly by IM inj. S Mild to moderate severe Alzheimer’s Discontinue if patient develops chronic progressive dementia. disease. P Initially 5mg once daily at bedtime. Q Under 12 years, not recommended. Increase if necessary to 10mg at bedtime after 1 month. Initiated and supervised by an experienced D Natural or recombinant interferon beta, physician. Maintain as long as therapeutic benefit. history of severe depression or suicidal tendencies, uncontrolled epilepsy. Pregnancy, lactation. Q Not recommended. B History of seizures or depression, severe D Pregnancy (unless clearly necessary), hepatic or renal impairment, cardiac disease. lactation. Monitor blood chemistry, haematology and liver B Supraventricular conduction function tests. disturbances, history of GI ulceration, bladder C Drugs metabolised by liver enzymes outflow obstruction, seizures, asthma, COPD, (e.g. antiepileptics and some antidepressants), hepatic impairment. Contains lactose. Driving or caution. using machines. C Avoid cholinergics and anticholinergics. A Influenza-like syndrome, GI upset, Caution: Neuromuscular blockers, CYP3A4 inducers arthralgia, insomnia, dizziness, anxiety, rash, inj. site reactions, hypersensitivity. and inhibitors, CYP2D6 inhibitors (eg fluoxetine), alcohol, anaesthetics. AZILECT Lundbeck A Diarrhoea, muscle cramps, fatigue, 2NO nausea, vomiting, insomnia, cold, anorexia, hallucinations, agitation, aggressive behaviour, Irreversible MAO-B selective inhibitor. Rasagiline syncope, dizziness, rash, urinary incontinence, (as mesilate) 1mg. White, round, flat, bevelled headache, pain, accident. tab., marked with GIL and 1 underneath on one side. 28, A92.96. ARIPEZ Teva S Idiopathic Parkinson’s disease as 2NO monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of Acetylcholinesterase inhibitor. Donepezil (HCl) dose fluctuations. 5mg, 10mg. White and yellow film-ctd oval tabs, P 1mg once daily with or without marked 93 on one side and 7320 and 7321 on A A levodopa. reverse resp. 5mg-28, 49.68; 10mg-28, 70.66. Q Under 18 years, not recommended. S Symptomatic treatment of mild to D Severe hepatic insufficiency. moderately severe Alzheimer’s dementia. B Moderate hepatic impairment (avoid). P Initially 5mg once daily in the evening, Mild hepatic insufficiency (caution). Pregnancy, just prior to retiring. Can be increased after one lactation. month to 10mg once daily. Max. daily dose, C Other MAOIs or pethidine (contra 10mg.Initiated and supervised by experienced within 14 days of rasagiline discontinuation). physician. Avoid fluvoxamine, fluoxetine (See SPC), Q Not recommended. dextromethorphan, sympathomimetics (eg. nasal/ D Hypersensitivity to piperidine oral decongestants or cold medications containing derivatives. Lactation, pregnancy (unless clearly ephedrine or pseudoephedrine). Caution: SSRIs, necessary). tricyclic, tetracylic antidepressants, potent CYP1A2 B Anaesthesia, cardiovascular conditions inhibitors (e.g. ciprofloxacin), smoking, (vagotonic), GI conditions, history of asthma or entacapone. obstructive pulmonary disease (caution). May A Monotherapy: Headache, flu syndrome, cause bladder outflow obstruction, seizures. malaise, neck pain, allergic reaction, fever, angina Contains lactose. Withdraw gradually. pectoris, dyspepsia, anorexia, leucopenia, C Avoid other acetylcholinesterase arthralgia, arthritis, depression, vertigo, rhinitis, inhibitors, cholinergics and anticholinergics. Caution: CYP3A4 inhibitors and CYP2D6 inhibitors conjunctivitis, contact dermatitis, vesiculobullous rash, skin carcinoma, urinary urgency. Adjunct (e.g. fluoxetine), succinylcholine, neuro-muscular therapy: Dyskinesia, dystonia, abnormal dreams, blockers, b-blockers. ataxia, abdominal and neck pain, falls, postural A GI/abdominal disturbances, muscle hypotension, GI disorders, anorexia, dry mouth, cramps, fatigue, insomnia, headache. Common cold, anorexia, hallucinations, agitation, aggressive arthralgia, tenosynovitis, weight loss, rash. behaviour, syncope, dizziness, rash, pruritus, BETAFERON Bayer Schering urinary incontinence, pain, accident. Extrapyramidal symptoms. 2NT Antiviral/immunoregulator. Interferon beta-1b AVONEX Biogen 0.25mg/ml. Powder in vial plus pre-filled glass 2NT syringe of solvent containing 1.2ml sterile sodium Immunomodulator. Interferon b1a 30mcg. Prefilled chloride sln (0.54% w/v). 1 month’s supply-15 x 3ml. Price available on request. syringe: 30mcg/0.5ml; vial with BIO-SET device: narrow therapeutic range, antihypertensives. A Inj. site reactions, nausea, vomiting, transient sedation, somnolence, transient mild confusion, visual hallucinations.

124

S Single demyelinating event with active inflammatory process severe enough to warrant treatment with IV corticosteroids, if high risk of developing clinically definite multiple sclerosis (MS). Relapsing remitting MS and two or more relapses within last two years. Secondary progressive MS with active disease. P 0.25mg (8MIU) by SC inj. every other day. Should be initiated by physician experienced in MS. See SPC. Q Under 18 years, not recommended. D Pregnancy, lactation. Hypersensitivity to albumin. History of severe depression or suicidal tendencies. Decompensated liver disease, uncontrolled epilepsy. B History of seizures or depression, cardiac disorders, myelosuppression, renal impairment, thyroid dysfunction. Monitor for symptoms of depression, suicidal ideation, fever, infection and hypersensitivity reactions; consider withdrawal if occur. Monitor haematology, liver enzymes and renal function. C Avoid immunomodulators other than corticosteroids or ACTH. Caution: Cyto. P450 substrates, drugs with effect on haematopoetic system. A inj. site reactions, flu-like symptoms, hypersensitivity reactions, menstrual disorders, CNS effects.

CABASER

Pharmacia

2NO D2 agonist. Cabergoline 1mg, 2mg, 4mg. White, oval, concave scored tabs., engraved 7 on the left of breakline and 01, 02, or 03 resp. on the right of it. 1mg-20, A79.80; 2mg-20, A92.87; 4mg-16, A86.67. S Parkinson’s disease, as 2nd line therapy where non-ergot compound inappropriate, as monotherapy, or as adjunctive treatment to levodopa plus dopa-decarboxylase inhibitor. P Initially 1mg once daily, increase with 0.5-1mg/day increments every week (initial weeks) or bi-weekly to 2-3mg/day. D Hypersensitivity to ergot alkaloids. History of pulmonary, pericardial and retroperitoneal fibrotic disorders. Anatomical evidence of cardiac valvulopathy of any valve. Pregnancy, lactation. B End-stage renal failure, patients on haemodialysis. Severe hepatic insufficiency. Respiratory disorders, CVD (or history of). Raynaud’s syndrome, peptic ulcer, GI bleeding, psychosis. Driving/using machines. Contains lactose. C Avoid ergot alkaloids, macrolide antibiotics and drugs with dopamine antagonist activity. A Dyskinesia, hyperkinesia, hallucinations, confusion, dizziness, hypotension, symptomatic pleural effusion/fibrosis, nausea, vomiting, dyspepsia, gastritis, decreased BP in minority.

CELANCE

Lilly

2MO Dopamine agonist. Pergolide (mesilate) 50mcg, 250mcg, 1000mcg. Ivory, green or pink rectangular scored tabs. marked LILLY and 4131, 4133 or 4135 resp. 50mcg-100, A41.48; 250mcg-100, A49.80; 1000mcg-100, A169.81. S As monotheraphy or adjunct to levodopa in Parkinson’s disease where non-ergot compound failed. P Monotherapy: Day 1: 50mcg in the evening; day 2-4: 50mcg at noon and in evening;

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Prohibited in men

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Restricted b2 agonists

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3.7 PARKINSON’S, ALZHEIMER’S day 5-7: 50mcg in morning and noon and 100mcg in the evening (total dose: 200mcg). Then increase incrementally every 3 days up to 500mcg in morning, noon and evening on day 30 (total dose:1500mcg). See SPC for detailed titration schedule. After day 30 increase by max. 250mcg twice a week. Max 3mg/day. As adjunct to levodopa: Initially 50mcg daily for first 2 days, increasing by 100-150mcg daily every third day over next 12 days. Then increase by 250mcg daily every third day until optimal response. Usually in 3 divided doses; max. 3mg daily. Reduce levodopa dose cautiously during titration. Q Not recommended. D History of fibrotic disorders. Evidence of cardiac valvulopathy determined by pre-treatment echocardiography. B Perform cardiovascular evaluation before therapy and regularly monitor for progressive fibrosis thereafter. Fibrotic/serosal inflammatory disorders have occurred after prolonged use. Perform baseline investigations of erythrocyte sedimentation rate or other inflammatory markers, lung function/chest X-ray and renal function prior to initiation. Withdraw gradually. Risk of hypotension. History of psychosis. Patients prone to cardiac dysrhythmias or with significant underlying cardiac disease. Driving/using machines (somnolence/sudden sleep onset may occur). Pathological gambling, increased libido and hypersexuality have been reported. Contains lactose. Pregnancy, lactation. C Dopamine antagonists, antihypertensives, anticoagulants, other drugs known to affect protein binding. A Pain, abdominal pain, GI disorders, pyskinesia, hallucinations, somnolence. somnolence, rhinitis, dyspnoea, diplopia, cardiac valvulopathy (incl. regurgitation) and related disorders (pericarditis, pericardial effusion).

AND

MS

CNS

syringes. S Treatment of patients who experienced a well-defined 1st clinical episode and are at high risk of developing clinically definite MS (CDMS). Reduction in frequency of relapses in ambulatory patients with relapsing, remitting multiple sclerosis (MS) characterised by at least two attacks of neurological dysfunction over the preceding twoyear period. Not indicated in primary or secondary progressive MS. P 20mg by SC inj. once daily. Use different site every day. Self-inj. sites include abdomen, arms, hips, thighs. Q 12-18 years, as per adults (limited data). Under 12 years, not recommended. D Pregnancy. B Caution: Pre-existing cardiac disorders. In renal impairment, monitor renal function. May occur (rarely): Convulsions and/or anaphylactoid or allergic reactions. Lactation. C No formal evaluation. Potentially, protein-bound drugs. Corticosteroids. A Infections. benign skin neoplasm, neoplasm, lymphadenopathy, hypersensitivity, anorexia, increased weight, anxiety, depression, nervousness, headache, dysgeusia, hypertonia, migraine, speech disorder, syncope, tremor, diplopia, eye disorder, ear disorder, palpitations, tachycardia, vasodilatation, dyspnoea, cough, rhinitis seasonal, post-injection reactions (see SPC).

D Hypersensitivity to piperidine derivatives. Pregnancy, lactation. B Caution: Anaesthesia, cardiovascular conditions, patients at risk of ulcers (monitor), asthma or COPD. May occur: Urethral obstruction, seizures, exacerbation or induction of extrapyramidal symptoms. Driving/using machines. Contains lactose. C Caution: CYP3A4 inducers and inhibitors, alcohol, anticholinergics, CYP2D6 inhibitors, succinylcholine, other neuro-muscular blocking agents, cholinergic agonists, b-blockers. A Cold, anorexia, hallucinations, agitation, aggression, syncope, dizziness, sleep disturbances, GI disorders, rash, pruritus, muscle spasms, incontinence, headache, fatigue, pain, accident.

DONESYN

Clonmel

2NO

Acetylcholinesterase inhibitor. Donepezil (HCl) 5mg, 10mg. White and yellow round biconvex film-ctd tab marked D9EI on one side and 5 and 10 resp. on reverse. 5mg-28, A44.49, 10mg-28, A62.36. S Mild to moderate severe Alzheimer’s dementia. P Initially 5mg once daily at bedtime. Increase if necessary to 10mg at bedtime after 1 month. Initiated and supervised by experienced physician. Maintain as long as therapeutic benefit. Q Not recommended. DONECEPT Actavis D Pregnancy (unless clearly necessary), 2NO lactation. Acetylcholinesterase inhibitor. Donepezil (HCl) B Supraventricular conduction 5mg, 10mg. White and pale yellow, round, disturbances, history of GI ulceration, bladder biconvex film-ctd tabs marked DZ 5 and DZ 10 outflow obstruction, seizures, asthma, COPD, A A resp. 5mg-28, 47.43; 10mg-28, 68.53. hepatic impairment. Contains lactose. Driving or S Mild to moderate severe Alzheimer’s using machines. dementia. C Avoid cholinergics and anticholinergics. P Initially 5mg once daily at bedtime. Caution: Neuromuscular blockers, CYP3A4 inducers Increase if necessary to 10mg at bedtime after 1 and inhibitors, CYP2D6 inhibitors (eg. fluoxetine), COMTESS Orion month. Initiated and supervised by experienced alcohol, anaesthetics. 2MO physician. Maintain as long as therapeutic benefit. A Diarrhoea, muscle cramps, fatigue, Cathecol-o-methyl transferase inhibitor. Q Not recommended. nausea, vomiting and insomnia, headache. Entacapone 200mg. Brown-orange oval film-ctd D Pregnancy, lactation. Common cold, anorexia, hallucinations, agitation, A tab. marked Comtess one side. 100, 75.97. B May cause vagotonia, supraventricular aggressive behaviour, syncope, dizziness, rash, conduction disturbances, ulcers, bladder outflow pruritis, urinary incontinence, pain, accident. S As an adjunct to levodopa/benserazide or levodopa/carbidopa in patients with Parkinson’s obstruction, seizures. Caution with asthma, COPD. DOZEPT Rowex Contains lactose. Driving or using machines. disease and end-of-dose motor fluctuations, who C Avoid cholinergics and anticholinergics. 2 N O cannot be stabilised on those combinations. Caution: CYP3A4 inducers and inhibitors (see P 200mg taken with each dose of Acetylcholinesterase inhibitor. Donepezil HCl 5mg, levodopa/dopa decarboxylase inhibitor. Max. dose Appendix I), CYP2D6 inhibitors (eg. fluoxetine), 10mg. Resp., white (diameter 7mm) or yellow neuromuscular blockers, b-blockers, alcohol, 200mg ten times daily. See SPC. (diameter 9mm) film-ctd tabs. 10mg tabs have a anaesthesia. Q Not applicable. score line and can be divided into equal halves. D Liver impairment, phaeochromocytoma. A GI disorders, headache. Common cold, 5mg-28, A45.65; 10mg-28, A64.01. anorexia, hallucinations, agitation, aggressive Pregnancy, lactation. Previous history of S Symptomatic treatment of mild to behaviour, syncope, dizziness, insomnia, rash, Neuroleptic Malignant Syndrome and/or nonmoderately severe Alzheimer’s dementia. pruritis, urinary incontinence, muscle cramps, traumatic rhabdomyolysis. P Initially 5mg once daily at bedtime. fatigue, pain, accident. B Rhabdomyolysis 2ndary to severe Increase if necessary to 10mg at bedtime after 1 dyskinesias or Neuroleptic Malignant Syndrome month. Initiated and supervised by an experienced Helsinn Birex (NMS) reported. May aggravate levodopa-induced DONELINN physician. Maintain as long as therapeutic benefit. orthostatic hypotension. Withdraw slowly. Driving/ 2 N O D Hypersensitivity to piperidine using machines. Acetylcholinesterase inhibitor. Donepezil (HCl) derivatives. Lactation, pregnancy (unless clearly C Non-selective MAOIs, TCADs, NA 5mg, 10mg. Resp. white or pale yellow, round, necessary). reuptake inhibitors, catechol-like drugs biconvex film-ctd tabs, marked DZ5 or DZ10. 5mg- B Caution: Anaesthesia, cardiovascular metabolised by COMT, iron preparations. A A 28, 27.41; 10mg-28, 38.41. conditions (sick sinus syndrome, sinoatrial or A Dyskinesias, nausea, GI disorders, S Mild or moderate dementia in atrioventricular block), patients at risk of discoloured urine. Slight decrease in Hb, Alzheimer’s disease. developing ulcers (monitor), asthma or obstructive erythrocyte count and haematocrit. P Initially 5mg once daily at bedtime. If pulmonary disease. May occur: Bladder outflow necessary increase to 10mg (max) after 1 month. obstruction, seizures, exacerbation or induction of COPAXONE sanofi-aventis Maintain as long as therapeutic benefit exists. extrapyramidal symptoms. Driving/operating 2NT Hepatic impairment: Mild to moderate, adjust machines. Contains lactose. Immunomodulator. Glatiramer acetate 20mg according to individual tolerance; severe, no data. C CYP3A4 inducers and inhibitors (see (equiv. 18mg glatiramer base). 28 pre-filled Q Not recommended. Appendix I), CYP2D6 inhibitors (e.g. fluoxetine),

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Restricted b2 agonists

Declaration required


MIMS Ireland

A fundamental part of every doctorâ&#x20AC;&#x2122;s working day


3.7 PARKINSON’S, ALZHEIMER’S succinylcholine, other neuro-muscular blocking agents, cholinergic agonists, b-blocking agents. A Common cold, anorexia, hallucinations, agitation, aggressive behaviour, syncope, dizziness, insomnia, GI disorders, rash, pruritis, muscle cramps, urinary incontinence, headache, fatigue, pain, accident.

DUODOPA

AND

MS

CNS

10mg daily; 3rd week, 15mg daily. From week 4 onwards, 20mg once daily. Maintenance dose: 20mg once daily (max dose). Moderate renal impairment: 10mg/day, can be increased to 20mg using standard titration if well tolerated after 7 days. Severe renal impairment: 10mg/day. Q Under 18 yrs, not recommended.

P Initially 1.5mg morning and evening with meals; may be increased by 1.5mg twice daily at min. 2 week intervals. Maintain patient on highest tolerated dose; up to max. 6mg twice daily. Oral soln. and caps. may be interchanged at equal doses. Q Not applicable.

2NO

2NO

Solvay ALSO EBIXA ORAL DROPS Memantine (HCl) 10mg/

g. Soln. 50g, A90.00; 100g, A180.00. Dopamine precursor/dopa decarboxylase inhibitor. P Initially, 10 drops (5mg) daily (week 1); 2 Levodopa 20mg, carbidopa (as monohydrate) 5mg/ nd week, 20 drops (10mg) daily; 3rd week, 30 ml. White to slightly yellow intestinal gel. 100ml-7, drops (15mg) daily. From week 4 onwards: 40 drops (20mg) once daily. Maintenance dose: 40 price available on request. drops (20mg) once daily max. Moderate renal S Treatment of advanced levodopaimpairment: 20 drops (10mg) daily, can be responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available increased to 40 drops (20mg) using standard titration if well tolerated after 7 days. Severe renal combinations of Parkinson medicinal products impairment: 20 drops (10mg) daily. have not given satisfactory results. Q Under 18 yrs, not recommended. P Gel for continuous intestinal admin. 3 doses/day divided into the following. The morning B Severe hepatic impairment. Epilepsy. dose: Usually 5-10ml (max. 15ml) admin. by pump. Conditions in which urine pH is elevated. MI, CHF, uncontrolled hypertension (closely supervise). Continuous maintenance dose: Range, 1-10ml/ Contains lactose (tablets) / sorbitol (drops). hour; usually 2-6ml/hour. Extra bolus doses: C Amantadine, ketamine, Normally 0.5-2.0ml as required. If the need for dextromethorphan, L-dopa, dopaminergic extra bolus doses q 5/day the maintenance dose agonists, anticholinergics, barbiturates, should be increased. See SPC. neuroleptics, dantrolene, baclofen, cimetidine, Q Not recommended. ranitidine, procainamide, quinidine, quinine, D Narrow-angle glaucoma, severe liver/ nicotine, hydrochlorothiazide renal insufficiency, severe HF, severe cardiac A Dizziness, constipation, hypertension, arrhythmia, acute stroke. Lactation. headache, somnolence. B Not for drug-induced extrapyramidal reactions. Caution: Severe cardiovascular or ELDEPRYL Orion pulmonary disease; bronchial asthma, renal, hepatic or endocrine disease, or history of peptic, 0 M O ulcer disease or of convulsions, chronic wide-angle Monoamine oxidase-B inhibitor. Selegiline (HCl) 5mg. White scored tab. 100, A68.05. glaucoma (control IOP), abrupt dosage changes. S Parkinson’s disease or symptomatic History of MI. Monitor for mental changes, parkinsonism, alone to delay the need for depression with suicidal tendencies. Psychosis (or history of). General anaesthesia (patients must be levodopa or in conjunction with levodopa permitted to take fluids and medicinal products by particularly in patients on levodopa who develop on-off symptoms or other dyskinesias. mouth). Evaluate hepatic, haematopoietic, P Initially 1 increasing to 2 if necessary. cardiovascular and renal function periodically. Q Not applicable. Previous surgery in upper abdomen may lead to D Pregnancy, lactation. difficulty in performing gastrostomy or jejunostomy. Reduced ability to handle the system B Peptic/duodenal ulcer, labile can lead to complications (caregiver should assist). hypertension, cardiac arrhythmias, severe angina pectoris, severe liver or kidney dysfunction, Worsening of bradykinesia may indicate an psychosis. obstruction in device. Pregnancy (unless clearly C Non-specific MAOIs (contra). Avoid necessary). fluoxetine, sertraline, paroxetine, venlafaxine, C Contra: Non-selective MAOIs and pethidine. Caution: Moclobemide, TCAs, oral selective MAO type A inhibitors. Caution: contraceptives. Antihypertensives, TCAs, anticholinergics, dopamine receptor antagonists, benzodiazepines, A Postural hypotension, involuntary movements , cardiac arrhythmias, vertigo (reduce isoniazide, phenytoin, papaverine, selegiline, levodopa dose). Dry mouth, transient ALAT COMT inhibitors (tolcapone, entacapone), increase, sleeping disorders. amantadine, sympathicomimetics, iron, protein rich diet. EXELON Novartis A Anorexia, hallucinations, confusion, nightmares, sleepiness, fatigue, sleeplessness, 2N depression, euphoria, dementia, psychotic Acetylcholinesterase inhibitor. Rivastigmine (as episodes, feeling of stimulation, dyskinesias, hydrogen tartrate) 1.5mg, 3mg, 4.5mg, 6mg. choreatic movements and dystonia, ‘‘ON-OFF’’ Yellow, orange, red or orange/red caps. marked episodes, dizziness, palpitations, irregular with cap. name and strength. 1.5mg-28, A36.33; heartbeat, orthostatic hypotension, syncope, 1.5mg-56, A72.65; 3mg, 4.5mg and 6mg-28; nausea, vomiting, dry mouth, bitter taste. A37.33; 3mg, 4.5mg and 6mg-56, A74.66.

2M

EBIXA

Lundbeck

2NO NMDA-receptor antagonist. Memantine (HCl) 10mg. White to off-white oblong film-ctd tab. scored both sides. 28, A50.40; 56, A100.80. S Moderate to severe Alzheimer’s disease. P Initially, 5mg daily (week 1); 2nd week,

128

2NO ALSO EXELON ORAL SOLUTION Rivastigmine (as hydrogen tartrate) 2mg/ml. Soln. with oral dosing syringe. 120ml, A149.83. S Symptomatic treatment of mild to moderately severe Alzheimer’s dementia or dementia associated with idiopathic Parkinson’s disease.

ALSO EXELON PATCH Rivastigmine 4.6mg, 9.5mg per 24 hours. Transdermal patches. Both strengths30, A102.61. S Symptomatic treatment of mild to moderately severe Alzheimer’s dementia. P Initially 4.6mg/24 h. After min. 4 weeks should be increased to 9.5mg/24 h (maintenance dose). Switching from caps or soln, see SPC. Q Not applicable. D Severe liver impairment. Pregnancy (unless essential), lactation. B Sick sinus syndrome or conduction defects, renal/hepatic impairment, history of GI/ duodenal ulceration, asthma, COPD, urinary obstructions, seizures. Driving, using machines. C Cholinomimetics, anticholinergics, muscle relaxants. A Anorexia, weight loss, GI disorders, asthenia, somnolence, dizziness, headache, tremor, agitation, confusion.

KEMADRIN

GSK

2MO Anticholinergic. Procyclidine (HCl) 5mg. White scored tab. marked WELLCOME S3A. 100, A6.75. S Parkinsonism, particularly drug-induced. P Initially 2.5mg three times daily after meals increasing at intervals of 2 or 3 days by 2.55mg daily; usual max. 30mg daily. Q Not recommended. D Tardive dyskinesia. B GI obstruction. Narrow angle glaucoma. Prostatic hypertrophy. Cardiac disorders. Withdraw slowly. C Phenothiazines, antihistamines, antidepressants, amantadine, butyrophenones. A Anticholinergic effects. Dizziness, mental confusion, impaired cognition and memory, disorientation, anxiety, agitation, hallucinations in high doses.

MADOPAR

Roche

2MO Dopamine precursor/dopa decarboxylase inhibitor. ’62.5’: levodopa 50mg, benserazide (HCl) 12.5mg. ’125’: levodopa 100mg, benserazide (HCl) 25mg. ’250’: levodopa 200mg, benserazide (HCl) 50mg. ’62.5’ and ’125’, white scored dispersible tabs. marked with strength. ’250’, brown/blue hard cap. All marked ROCHE. ’62.5’-100,A9.61; ’125’-100, A17.05; ’250’-100, A26.04. S Idiopathic post-encephalitic Parkinsonism. P Patients not receiving levodopa, initially 1 x ’62.5’ three or four times daily after meals increasing by 1 x ’125’ daily once or twice weekly. Usual maintenance, 4-8 x ’125’ daily in divided doses. See SPC. Not recommended for patients under 25 years. R Initially 1 x ’62.5’ once or twice daily increasing by 1 x ’62.5’ every third or fourth day. Q Not recommended. D Patients Q 25 yrs, severe psychoses, narrow angle glaucoma, history of malignant melanoma. Pregnancy, lactation. B Cardiovascular, hepatic, renal,

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Prohibited in competition

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Restricted b2 agonists

Declaration required


3.7 PARKINSON’S, ALZHEIMER’S

AND

MS

CNS

C Avoid antipsychotics. Caution: Drugs inhibiting or eliminated by renal tubular secretion (eg. cimetidine, amantadine, mexiletine), sedating drugs, alcohol. Levodopa and other antiparkinsonian products, caution during Mirapexin titration. A Abnormal dreams, behavioural symptoms of impulse control disorders and compulsions, confusion, hallucinations, insomnia, restlessness, dizziness, dyskinesia, somnolence, MIRAPEXIN Boehringer Ing. amnesia, headache, visual disturbance including vision blurred and visual acuity reduced, 2MO hypotension, nausea, constipation, vomiting, Selective dopamine agonist. Pramipexole (mg base/mg salt as monohydrate) 0.088/0.125mg, 0.18/ fatigu