RIAPHYLLIN® COMPOSITION: Syrup: Each5 ml contains 60 mg Theophylline BP.
CUNICALPHARMACOLOGY: Riaphyllin pharmacologically acts as a bronchodilator, pulmonary vasodilator and smooth muscle relaxant. Since it directly relaxes the smooth muscles of bronchial airways and pulmonary blood vessels, its actions are believed to be mediated through inhibition of phosphodiesterase and a resultant increase in intracellular cyclic -AMP. INDICATIONS: Riaphyllin is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema
PRECAUTIONS: Theophylline should be used with caution in patients with severe cardiac disease, hypertension, hyperthyroidism, acute myocardial injury, congestive heart failure, hepatic impairment and epilepsy. It should be used with caution in patients with peptic ulcer and in who are sensitive to Xanthine
derivatives.
theophylline clearance and increased doses of theophylline might therefore be required. Smoking may increase
WARNING: Contains Sulphites: Can cause allergic type reactions including anaphylactic symptoms, or severe asthmatic episodes in susceptible persons. The herbal remedy St. Johns wort (Hypericum perforatum) should not be taken at the sametime asthis medicine. If you already take St. Johns wort, consult your doctor before stopping the St. Johns wort preparations. Xanthines can potentiate hypokalemia resulting from Beta-2 agonist therapy, steroids, diuretics, and hypoxia. Particular caution is advised in severe asthma. It is recommended that serum potassium levels are monitored in such situations. ADVERSEREACTIONS: The most common side effects with Theophylline are nau sea, vomiting....diardw-ea headache.Lrestlessness insomnia, mu scle twitching and reflex hyper-excitability. Drug interaction: - Cimetidine, Allopurinol, Corticosteroids or Steroids, Frusem ide, Isoprenaline, oral Contraceptives, Thiabendazole, Cipnofloxacin, Erythromydn or other antibiotics and Calcium Channel Blockers, Diltiazem and Verapamil, Nizatidine, Norfloxacin, Isoniazid, Fluconazole, Carbimazole, Mexiletine, Propafen one, Oxpentifylline, Disulfram, Viloxazine, Interferon Alfa and Influe nza vaccine increase plasma theophylline concentrations, A reducti on of the theophylline dosage is recommended. Phenytoin, Carbamazepine, Barbiturates, Rifampicin, Sulphinpyrazone, Ritonavir, Primidone and Aminoglutethim ide may reduce.plasma.theoobsume oncentration.and therefore.th theophylline dosage may need to be increased. - Theophylline can increase Uthium excretion. - The concomitant use of Theophylline and Fluvoxamine should usually be avoided. Where this is not possible, patients should have their theophylline dose halved and plasma theophylline should be monitored closely.
Revised
October.
USEDURINGPREGNANCYAND LACTATION: Use ofTheophylline in pregnant women should be balanced against the risk of uncontrolled asthma. Excretion of Theophylline in breast milk may cause irritability in the infant. For both cases, Theophylline Should be prescribed only under doctor's supervision. DOSAGE: Majntenance
Dose
Population
Acute Symptoms Oral Theophytline
Group
Premature inhmts newbom bradycardia)
(MG/KG/DAYI
6 weeks (for apnea/
6 weeks - 6 months
10
Infants 6 months - 1 year
12 ·18
Children 1-9~ars
20-24
Children 9 - 12 years and a~nt d~ othHwbe so years.
daily smokers adulttYnOlcrr5
2012
I.
5
••••
W ••
16
Adol~scents 12 - 16 years. Ot~ise healthy elderly patients) cardiac decompensation dysfunction
13
nonsmoking
adults
(includil'l8
Of Ptllmonary and/Of
nve-
10 (not to elCC~ 900 "'IId..,1 S(notlOexc~400 "'IIday)
OVERDOSAGE: Overdose is characterised by nausea,vomiting (often severe), epigastric pain, haematemesis, restlessness, hypertonia, impaired consciousness, exaggerated limb reflexes and convulsions, and arrhythmias. In addition, hypokalemia, hyperglycaemia, hypomagnesaemia and metabolic acidosis may occur. Activated charcoal or gastr1c lavage should be considered ,f a significant overdose has been ingested within 1-2 hours. Management is followed by symptomatic relief. STORAGE: Store below 25·C, protect from t, Do not use the drug after the expiry date printed on the package. PRESENTAnON: Syrup: 100 ml bottles. Do Not Freeze To Report any side eff&et(s) or Quality Problems: National Phannacovigilance Center (NPC)o t-ax :+!lt5o-1-<'U!>-f0t5<' o E-mail: npc.drug@sfda.gov.sa o websrte: www.sfda.gov_sa/npc
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This is a medicament A medicament js a product. ~ d«:ts 'JOAI t.aIlh. and r.s ~ contrary to instructJons is ~ tar)'OO.. Follow strictly the doc:;tgr's pra5Q'lpbDn. the method of use and the Inn'Ucbons the pharmacist who sold the ~ • The doctor and the phamacist en expertS In medcine, ItS beoeftts and nsks. 00 not by yoOOlelf nt8l'TUpt the penod of tncnenl pn!5CI'bed ror you 00 not repeat the same pn!J5CnPbOnwtthout c:::onsUbng you- doctor
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of
medicaments
out of the rea<:h of chUdren CouncH of Arab Health Ministers Union of Arab Phannacists
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pharmacia
Manufactured by Riyadh Pharma Medical and Cosmetic Products Co. Ltd. Riyadh, Saudi Arabia.
pharmacia
RIY~
SYRUP
- Theophylline should not be administered concurrently with other Xanthine medications. Plasma concentration of theophylline can be reduced by concomitant use of the herbal remedy StJohn's wort (hypericum perforatum).
and chronic bronchitis.
CONTRAINDICATIONS: Riaphyllin is contraindicated in patients with hypersensitivity (allergic) to theophylline or any of the other ingredients of this product. Riaphyllin is contraindicated in children taking ephedrine (found in some cough medicines and decongestants).
patients
pharmacia
100ML
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AIAPHYlLiN is a trademark ITEM
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CODE:
PIL0469
••• __ •• _