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An Update on Rational Drug Use

Issue No. 33 & 34 July - December 2008

REVIEW TOPIC

DRUG FOOD INTERACTION What is a drug food interaction?

A

drug food interaction happens when the food or liquid affects the ingredients in a medicine that is taken so that the medicine cannot work the way it should. Drugfood interactions can happen with both prescription and over-the-counter medicines. Drug interaction can also happen with herbal supplements which are consumed for nutritional purposes. When a drug is mixed with food or another herb, each can alter the way the body metabolises the other. Some drugs interfere with the body’s ability to absorb nutrients; some herbs and foods can lessen or increase the impact/absorption of a drug. Not all medicines are affected by food, but many medicines can be affected by what is eaten and when. Taking some medicines at the same time as other food may interfere with the way the stomach and the intestines absorb the medicine. This is why some medicines should be taken on an empty stomach. There are some medicines which are tolerated well when taken with food. The doctor or the pharmacist should be asked whether it is fine to take the medicine with a snack or a meal or whether it should be taken on an empty stomach.

Clinical relevance of drug food interaction

Clinically a drug food interaction can lead to therapeutic failure, increased toxicity, pharmacokinetic interactions altering the bioavailability and pharmacodynamic interactions. Food may decrease drug absorption mainly because of food binding to a drug. There are also medicines that irritate the GI tract, eg aspirin. Medications to be taken on an EMPTY STOMACH:- Food generally decreases and delays absorption of certain drugs. Medications to be taken WITH FOOD:- There are medicines that cause stomach upset where food will help to buffer, like corticosteroids, some antibiotics, a few antiviral drugs used in HIV/AIDS treatment, some NSAIDs and antifungals. Specific drug based food – Interactions: The drug-food interaction of some of the drugs is given in the table below. Drugs

Effects and Precautions

Antibiotics, Anti-infectives Ciprofloxacin

Avoid calcium-containing foods, minerals containing iron and antacids as they decrease drug concentration

Drugs

Effects and Precautions

Erythromycin

Don’t take with fruit juice or wine, which decrease the drug’s effectiveness

Roxithromycin

Take at least 15 minutes before or after a meal

Sulfa drugs

Increase the risk of Megaloblastic anaemia

Tetracycline

Dairy products reduce the drug’s effectiveness. Lowers Vitamin C absorption. Do not take with milk or other dairy products; avoid calciumcontaining foods, minerals containing iron and antacids as they decrease drug concentration

Metronidazole

No alcohol, including medicines containing alcohol while taking the medicine and for 3 days after stopping Anticonvulsants

Phenytoin, Phenobarbital

Increase the risk of anaemia and nerve problems due to deficiency of folate and other B vitamins Antidepressants

Fluoxetine

Reduces appetite and can lead to excessive weight loss

Lithium

A low-salt diet increases the risk of lithium toxicity; excessive salt increases the clearance of lithium

Monoamine oxidase inhibitors (MAO Inhibitors), used in the treatment of depression and anxiety disorder

Foods high in tyramine (processed cheeses, processed meats, legumes, wine, and beer, among others) may lead to fatal increase in blood pressure. More examples of this category are, cured meats such as sausage and salami, protein extracts from meat, yeast, or yeast vitamin supplements, dried fish, shrimp paste, some preparations of ginseng, banana peels, resins, fermented soya products & sauce

Antihypertensives, Heart Medications (Cardiovascular) ACE inhibitors

Concurrent ethanol administration will increase hypotensive effect

Captopril

Take 1 hour before meals for maximum absorption

Alpha blockers

Take with liquid or food to avoid excessive drop in blood pressure

Beta blockers

Take before meals

Digitalis

Calcium and potassium salts can however increase toxicity


Drugs Diuretics

Effects and Precautions

Drugs

Increase the risk of potassium deficiency. Triamterene and spironolactone are potassiumsparingand patients should avoid potassiumrich food. S  hould avoid black licorice (which contains

Digoxin

glycyrrhizin). Together, they can produce irregular heart rhythms and cardiac arrest; licorice and diuretics will produce dangerously low potassium levels leading to muscle pain and even paralysis.

 Oatmeal in large amounts and other highfiber cereals should not be eaten when taking digoxin. The fiber can interfere with the absorption of the drug.  Sudden stopping of cereals could cause digoxin levels to increase to toxic levels. Potassium sparing diuretics

Unless a doctor advises otherwise, don’t take potassium sparing diuretics with potassium supplements or salt substitutes, which can cause potassium overload

Statin like Lovastatin

It is poorly absorbed without food; so the patient is advised to take this with an evening meal

Warfarin

Dietary consistency is important in maintaining a sustained, stable response during warfarin therapy. Patients should be particularly aware of foods high in vitamin K like green leafy vegetables (broccoli, spinach), cauliflower, legumes, mayonnaise and soybean oils, and should maintain a consistent amount of these foods in their diet. Food items like caffeinated beverages (cola, coffee, tea, hot chocolate, chocolate milk) should be avoided or limited, since they also can affect warfarin therapy.

Effects and Precautions Hormone Preparations

Oral contraceptives

Take with food to decrease nausea. Grape fruit juice can increase effect

Steroids

Take with food to avoid gastric irritation

Thyroid drugs

Take on empty stomach with water Laxatives

Mineral Oils

Overuse can cause a deficiency of vitamins A, D, E, and K Painkillers

Aspirin and stronger Always take with food to lower the risk of non-steroidal anti-in- gastrointestinal irritation; avoid taking with alcohol, which increases the risk of bleeding. flammatory drugs Codeine

Increase fiber and water intake to avoid constipation Sleeping Pills, Tranquilizers

Benzodiazepines

Never take with alcohol. Caffeine increases anxiety and reduces drug’s effectiveness Antigout

Allopurinol

Take after meal and with plenty of fluid

Glyburide

Take with breakfast

Antidiabetic Iron Preparation Iron preparations

Asthma Drugs/ Bronchodilators A  void caffeine along with bronchodilators as caffeine also stimulates

CNS

Best absorbed when taken with water on an empty stomach. If GI upset occurs take between meals or with food. If taken with food, avoid bran, eggs, fiber supplements, tea, coffee, dairy products, calcium supplements and dairy products Vitamins

 Lethal dose of Caffeine is 10 gm (100 cups of coffee) and with-

drawal symptoms are observed in people who routinely have more than 600 mg/day (6 cups) Pseudoephedrine

Avoid caffeine, which increase feelings of anxiety and nervousness

Theophylline

Contains xanthines, which are also found in tea, coffee, chocolate, and other sources of caffeine. Consuming large amounts of these substances while taking theophylline increases the risk of drug toxicity. Charbroiled / high carbohydrate foods and high protein diet reduce absorption. High-fat meals may increase theophylline in body. Caffeine increases the risk of drug toxicity. Should be preferably given with meals to avoid gastric irritation

Vitamin K

Large amounts of broccoli, spinach, and other green leafy vegetables high in vitamin K, which promotes the formation of blood clots, can counteract the effects of heparin, warfarin and other drugs given to prevent clotting Antifungal medicines

Griseofulvin

Should be given with fatty meal to increase absorption

Risedronate

Give on empty stomach along with plain water only

Antiosteoporosis

Cholesterol Lowering Drugs Cholestyramine Gemfibrozil

Should be administered as a suspension by mixing with water, juice etc. Administer 30 minutes before meals Heartburn and Ulcer Medications

Antacids

Interfere with the absorption of many minerals; for maximum benefit, take medication 1 hour after eating

Lansoprazole, Omeprazole

Take 30 minutes before eating

2

Issue 33 & 34


Specific Food based Drug – Interactions Grapefruit: The juice modifies the body’s way of metabolising the medication, affecting the liver’s ability to work the drug through a person’s system. Active ingredients in grapefruit juice are CYP inhibitors, which when metabolised slowly are at risk for toxicity and adverse drug effects, and when metabolised fast have unpredictable response. A large number of medicines including HIV/AIDS drugs interact with grapefruit juice. Grapefruit juice interacts with calcium channel blockers, cholesterol control medications, some psychiatric medications, estrogen, oral contraceptives and many allergy medications. Orange juice: It shouldn’t be consumed with antacids containing aluminum. The juice increases the absorption of aluminum. Orange juice and milk should be avoided when taking antibiotics. The juice’s acidity decreases the effectiveness of antibiotics, as does milk. Milk: Does not mix with laxatives containing bisacodyl. The laxative effect is more in the morning. Leafy green vegetables: High in vitamin K; should not be taken in great quantities while taking warfarin. These vegetables could totally negate the effects of the drug and cause blood clotting. Caffeinated beverages: Taken together with asthma drugs can cause excessive excitability. Those taking cimetidine, quinolone antibiotics and oral contraceptives should be aware that these medicines along with their cup of coffee may cause a sudden ‘high’. Grilled meat: It can lead to problems for those on asthma medications containing theophyllines. The chemical compounds formed when meat is grilled somehow prevent this type of medication from working effectively, increasing the possibility of an unmanageable asthma attack. Diet high in fat: Regularly consuming this while taking anti-inflammatory and arthritis medications can cause kidney damage and can leave the patient feeling drowsy and sedated. Alcoholic beverages: These have a tendency to increase the depressive effects of medications such as benzodiazepines, antihistamines, antidepressants, antipsychotics, muscle relaxants, narcotics, or any drug with sedative actions. Alcohol interacts with almost every medication, especially antidepressants and other drugs that affect the brain and nervous system. Antioxidants and beta-carotenes intensify alcohol’s effect on the liver. Alcohol can lower blood pressure with beta blockers and nitrate containing drugs. It can cause liver damage with statin drugs. Dietary fiber: Pectin and other soluble fibers slow down the absorption of acetaminophen (paracetamol), a popular painkiller. Bran and other insoluble fibers have a similar effect on digoxin, a major heart medication. Herbs and Foods Taken with Drugs: There is a notion that, being natural, all herbs and foods are safe. This is not true. Very often, herbs and foods may interact with medications that sometimes result in serious side reactions. It is always a good practice to tell the doctor and/or health practitioners about such food/herb habits so that they can advise on possible complications, if any. The patient should also keep an eye out for unusual symptoms. High-risk patients such as the elderly, patients taking three or more medications for chronic conditions, patients suffering from diabetes, hypertension, depression, high cholesterol or congestive heart failure should be especially on the lookout for reactions. Issue 33 & 34

Drug-food interaction needs to be studied for different health conditions in different situations. A few specific cases are given below as examples. 1) Cancer Treatment: Lapatinib is an oral dual tyrosine kinase inhibitor. It is indicated in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. “Simply by changing the timing — taking this medication with a meal instead of on an empty stomach — we could potentially use 40% or even less of the drug,” Dr Ratain said. In this case, the drug-food interaction has provided an improved treatment option with low drug content thereby even reducing the cost. (Source: Cut Cancer Drug Costs By Exploring Food Interactions, Allison Gandey, J Clin Oncol. 2007. Published online 16 July 2007, http://www.medscape. com/viewarticle/560026) 2) Food and Beverages Affect Drug Bioavailability: Adding a glass of grapefruit juice to a meal may be a common activity in some societies. According to Dr Ratain, “We expect that a 250-mg lapatinib pill accompanied by food and washed down with a glass of grapefruit juice may yield plasma concentrations comparable to 5 pills on an empty stomach.” Dr Cohen says, “If we understood the relationship between, say, grapefruit juice and common drugs, such as the statins, which are taken daily by millions of people to prevent heart disease, we could save a fortune in drug costs.” These statements are not surprising given that food often increases a drug’s bioavailability. Drs Ratain and Cohen say, “The rapidly escalating price of medications has provided incentives to explore pharmacological approaches to lower the costs of drugs.” (Source: www. medscape.com) 3) HIV/AIDS Drug-food interaction: HIV therapy (particularly combination therapy of ARV drugs) drug interactions with food occur when either the pharmacokinetics or the pharmacodynamics of one drug are altered by the administration of food or a concomitant drug. Alcohol can reduce effectiveness of HARRT by reducing adherence. High-fat diet enhances the bioavailability of ARVs like Tenofovir, but reduces absorption of drugs like Indinavir and Zidovudine. Didanosine is a nucleoside reverse transcriptase inhibitor with food interaction and so is Efavirenz, a non-nucleoside reverse transcriptase inhibitor. According to Angela D M Kashuba, there is no data to show whether food effects occur with the Protease Inhibitor combinations of Nelfinavir/Ritonavir or Amprenavir/Ritonavir (Angela D M Kashuba, Medscape HIV/AIDS, February 2001). Consumption of the ARV Didanosine with alcohol can cause inflammation of the pancreas, and alcohol with Isoniazid may increase the risk of inflammation of the liver. References: 1) Family Doctor.org; http://familydoctor.org 2) Risky Cocktails, Risky Business Drug Interactions between Recreational Drugs and HAART: Patricia Martin, Pharm D 3) Food-Drug Interactions, Dr William Diehl-Jones, Faculty of Nursing and Department of Zoology 4) http://nepenthes.lycaeum.org/Misc/maoi.foods.html 5) http://www.foodmedinteractions.com 6) http://www.globalrph.com/drugfoodrxn.htm Global RPh.Com 7) Herbal Medicine, Holistic online.com; http://www.holisticonline.com/ 8) J Clin Oncol. 2007, Published online July 16, 2007, www.medscape.com, 560026 9) HIV Pharmacology and Drug Interactions, 10 February 2001; Medscape Today, www.medscape.com 10) Preventing Food and Drug Interactions by The University of Georgia Cooperative Extension Service

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COMMON SKIN CONDITIONS

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here are a number of skin related conditions that people are concerned with, mainly because of cosmetic implications. Some of the most common skin conditions are presented in this article.

Dandruff and Seborrheic Dermatitis Dandruff and seborrheic dermatitis are conditions that share a common manifestation — the patient’s scalp or skin producing scales. Generally there is common etiology too. Many nonprescription products are also used to treat both conditions.

Etiology Abnormal Cell Turnover: Epidermal cells formed in the stratum germinativum, the innermost layer, gradually begin to migrate upward to the next layers, eventually reaching the uppermost layer, the stratum corneum, after losing their nuclei and gaining keratin. Such keratinized cells act to protect the living tissues beneath them. The timeframe required for stratum germinativum cells to lose their nuclei and become keratinised is 25-30 days. For the most part, normal cell-shedding is not noticed and causes no symptoms. In dandruff, cell turnover is commonly 1315 days and for seborrheic dermatitis it is only 9-10 days. According to the FDA OTC Review Panel in 1982, the cause of dandruff is known to involve an increase in the rate of epidermal turnover. Fungal Etiology: Research on the possible causative role of fungi on dandruff and seborrheic dermatitis resulted in isolating an organism Pityrosporum ovale that inhabits skin follicles. In 1982, FDA OTC Review Panel Report found that though there was support for the use of antimicrobials in controlling dandruff, there is no definite correlation between the presence of P. ovale and the development of dandruff. But in 1984, a researcher, after reviewing literature, came to the conclusion that P. ovale fulfilled all of Koch’s postulates for dandruff and seborrheic dermatitis; the efficacy of ketoconazole in those conditions was supported by the medical opinion. Dandruff: Dandruff is a condition of less severity than seborrheic dermatitis. Even if it is not treated, the patient will not experience any further symptom/s, although some patients may complain of minor itching. Its effects are only cosmetic. It does not cause or result from inflammation, and it is not allergic in origin. Scaling of dandruff is large clumps of dry, white or gray scales that are easily visible. Dandruff is uncommon in children aged 2-10, but the incidence begins to rise from puberty onwards and rises even more rapidly thereafter, until they reach their early twenties when it begins to fall. It is not very common in middle-aged patients and the elderly. 4

Seborrheic Dermatitis: Seborrheic dermatitis is a more severe condition than dandruff. The age of onset is usually puberty, and it is common to have pruritus (severe itching) associated with the condition. The sites most often affected by seborrheic dermatitis are those where sebum production is heaviest, due to a greater concentration of sebaceous glands, like scalp, eyebrows, eyelashes, external ear canal, behind the ears, in nasal folds, the midchest, armpits, between the shoulder blades, and the pubic area and groin. P. ovale is dependent on fatty acids from its surroundings for synthesis. While metabolising these fats, it may cause skin damage by producing irritant metabolites. Treatment Options: For self-treatment of dandruff and seborrheic dermatitis there are different ingredients that are safe and effective. For these two conditions, salicylic acid, selenium sulphide, zinc pyrithione and coal tar are effective. Sulphur and ketoconzole are effective in treating dandruff only, and hydrocortisone is effective for seborrheic dermatitis treatment only. These products can be used for all ages above 2 years except ketoconazole, which should be used for those aged over 12 years. Salicylic Acid 1.8%-3%: Salicylic acid is available in the form of shampoo and foam and it increases hydration of skin. The scales of dandruff and seborrheic dermatitis are removed by the keratolytic action. Selenium Sulphide 1%: Selenium sulphide is highly active in inhibiting the growth of P. ovale. For dandruff, 0.6% micronised form of selenium sulphide is safe and effective. Zinc Pyrithione: For dandruff, zinc pyrithione 0.3%-2%, and for seborrheic dermatitis 0.95%-2% concentration in shampoo is safe and effective. Hydrocortisone 0.25%-1%: Hydrocortisone cream is safe and effective for treatment of seborrheic dermatitis, and should not be used to treat dandruff, as seborrheic dermatitis has an inflammatory component, while dandruff does not. Coal Tar 0.5%-5%: Various forms of coal tar (e.g., coal tar distillate, coal tar extract, coal tar solution) are effective for both conditions, though it is not the best choice. Besides unpleasant odour, it can stain the skin and hair. It also can cause folliculitis, irritant dermatitis, and allergic dermatitis. It may cause photosensitivity reactions, and patients should avoid sun exposure up to 24 hours of using it. It is also potentially carcinogenic. The patient should consult a physician before use if the condition covers a large part of the body. Sulphur 2%-5%: For dandruff, 2%-5% concentration sulphur in shampoo form can be used alone or in combination with salicylic acid. Ketoconazole 1%: Antifungal activity of ketoconazole 1% in shampoo can control the flaking, scaling, and itching of dandruff. If the scalp is broken or inflamed, this should not be used.

Issue 33 & 34


Topical Minoxidil and Scalp Flaking: Use of topical minoxidil in the presence of alcohol for long periods may cause drying of scalp, resulting in flaking. The patient may discontinue the topical minoxidil for a brief period, and use a moisturising shampoo and moisturising conditioner after consulting a dermatologist. Urticaria: In urticaria, recurrent wheals occur which are usually pruritic, pink-to-red swelling plaques with pale centers mostly. The wheal sizes vary from a few millimeters to several centimeters in diameter, and can form plaques. The itch is relieved more by rubbing than by scratching. Urticaria can be diagnosed on the basis of the clinical presentation. Although acute urticaria often has an identifiable trigger (foods, drugs, virus), chronic urticaria tends to remain idiopathic (a primary disease without apparent cause).

Treatment Treatment includes general measures to prevent or avoid triggers and pharmacotherapy. Management of treatment can be classified into first-, second-, and third-line therapies.

First-line Therapy: First-line therapy includes patient education and general non-drug measures followed by a trial of histamine H1 receptor antihistamines if symptoms persist. General measures include avoiding aggravating factors such as overheating, stress, alcohol, acetylsalicylic acid, NSAIDs, and ACE inhibitors. Cooling antipruritic lotions such as menthol 1% or 2% in aqueous cream or calamine lotion is useful. It is important to keep patients well informed about the disease, specifically about the lack of a cure. Histamine H1 Receptor Antihistamines: Antihistamines have the capacity to inhibit histamine release and prevent the actions of mast cell and basophil-derived histamine on its target organs. H1 receptor inhibition also reduces allergeninduced eosinophil accumulation. The second-generation H1 receptor antihistamines like cetirizine and levocetirizine, have anti-inflammatory effects. The response to treatment with antihistamines: • alleviates pruritus and decreasing the number of hives, though all patients will not respond. • only less than half the patients treated with antihistamines experience complete clearing of their symptoms. • they only reduce the severity of pruritus and decrease the number and duration of wheals in some patients. • most effective if taken daily, rather than on a need basis. • more than one antihistamine should be tried since efficacy is patient specific. First-generation H 1 receptor antihistamines include hydroxyzine, diphenhydramine, cyproheptadine, and chlorpheniramine (chlorphenamine). These are not used as much as monotherapy because of their sedating and anticholinergic side effects. But, they are good as adjunctive therapy for patients whose sleep is disturbed by symptoms of urticaria. The second-generation H1 receptor antihistamines are like cetirizine, levocetirizine, loratadine, desloratadine, fexofenadine, ebastine, and mizolastine. Advantage of second-generation antihistamines is the lack of CNS and anticholinergic adverse effects. H 2 Receptor Antagonists: About 15% of histamine receptors in the skin are of the H2 type, for whom H2 Issue 33 & 34

receptor antihistamines are useful in addition to H1 receptor antihistamines in some patients with chronic urticaria. But, H2 receptor antagonists should not be used alone since they have only minimal effects on pruritus. Examples of H2 receptor antagonists are cimetidine, ranitidine, and famotidine. Overall, data supporting the efficacy of H2 receptor antagonists are limited.

Second-line Therapy: Second-line therapies include both pharmacologic and nonpharmacologic measures like, • phototherapy with UV light or photochemotherapy (psoralen plus ultraviolet – PUVA therapy) • relaxation therapies • groups of drugs like antidepressants, corticosteroids, calcium channel antagonists, levothyroxine sodium supplements, leukotriene receptor antagonists, and others.

Third-line Therapy: Patients with urticaria who do not respond to first- and second-line treatments are administered with third-line therapy including use of immunomodulatory agents like cyclosporine, tacrolimus, methotrexate, cyclophosphamide, mycophenolate mofetil, and intravenous immunoglobulins (IVIG). Other third-line therapies include plasmapheresis, colchicine, dapsone, salbutamol, tranexamic acid, terbutaline, sulfasalazine, warfarin and hydroxychloroquine.

Allergies: Besides cosmetics, there are a variety of items like food, pet, pollen, household dust, certain clothing materials, some metals and some drugs which cause allergic conditions on the skin. Though doctors prescribe medicines like anti-histamine ointment to alleviate reaction, the most effective condition is to identify and avoid the offending allergic condition. Reference: 1) W. Steven Pray, PhD, RPh, Professor of Nonprescription Products and Devices, School of Pharmacy, Southwestern Oklahoma State University, Weatherford, OK; U.S. Pharmacist 26(4) 2001. 2) http://www.medscape.com/ 3) Urticaria - A Review; Tasneem Poonawalla, Brent Kelly; American Journal of Clinical Dermatology; Published: 05/08/2009

Warning US FDA Insists Boxed Warning for all Botulinum toxin products With reports of serious adverse events, the US Food and Drug Administration (FDA) announced safety label changes, including a boxed warning, and a risk evaluation and mitigation strategy (REMS), for all botulinum toxin products. The US FDA, has asked the companies to submit the revised safety label changes, including the boxed warning and the Medication Guide, to the FDA within 30 days, or to provide a reason why they do not believe such changes are necessary. The effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids. Dosage strength (potency) expressed in “Units” is different among the botulinum toxin products. Clinical doses expressed in units are not interchangeable from one product to another. Source: http://www.fda.gov/cder/drug/ 5


NEW DRUGS

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hough a number of combination formulations are approved by the Drugs Controller General (India), in practice, it is the rationality of use that matters for the prescriber. In the previous issue we had published the new drugs approved upto 29 August 2006. The following is the list of new drugs approved by the Drugs Controller General (India) from 30 August 2006 to May 2007. Sl. No.

Name of Drug

Indication

Date of Approval

1

Atorvastatin 5mg + Fenofibrate 160mg (additional strength)

Adjunct diet in primary hypercholesterolaemia

01.12.06

2

Aceclofenac Inj. 50mg/ml (additional strength)

01.12.06

3

Amisulpride 400mg tablet (additional strength)

NSAID For schizophrenia

4

Misoprostol tablet 25mcg/100mcg/200mcg (additional strength/indication)

For cervical ripening, prevention of post partum haemorrhage & first trimester of abortion with mifepristone

08.12.06

5

Atazanavir 150mg + Ritonavir 50mg capsules

Anti HIV

12.12.06

6

Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tablet

For IBS

12.12.06

7

Ampicillin 250mg + Dicloxacillin 250mg tablet Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg + Linseedoil 30mg per gm of Gel Racecadotril dispersible tablet 10mg/30mg (new dosage form)

Antibiotic

13.12.06

For acute Musculoskeletal pain

14.12.06

For diarrhea For naturopathic pain & partial seizures

15.12.06

Gabapentin ER 450/600/900mg tablet

11

Aceclofenac dispersible tablet 100mg (new dosage form)

NSAID

15.12.06 21.12.06

12

R-Ondansetron (As Hcl. Dihydrate) 1mg/ml injection

Chemotherapy induced nausea & vomiting

12.01.07

13

Torsemide 10mg + Amiloride 5mg tablets

Edema associated with congestive heart failure & hypertension

17.01.07

14

Fexofenadine suspension (30mg/5ml)

Seasonal allergic rhinitis & chronic idiopathic urticaria

19.01.07

15

8 9 10

01.12.06

Sildenafil Citrate 20mg tablet

For pulmonary osterial hypertension

23.01.07

16

Pioglitazone 15mg/30mg + Metformin ER 1000mg tablet (additional strength)

For Type II Diabetes

23.01.07

17

Fluvastatin Tablet (As calcium) 10mg/20mg/40mg (additional strength)

To treat hypercholesterolemia

29.01.07

18

Halobetazol Propionate Cream 0.05%

Corticosteroid responsive dermatomes

02.02.07

19

Eszopiclone tablet 1mg/2mg/3mg

For insomnia

07.02.07

20

Diltiazem Hcl. 2% gel

For anal fissure

07.02.07

21

Nalbuphine injection 10mg/20mg per ml

For moderate to severe pain

07.02.07

22

Levonorgestrel 1.5mg tablets

For emergency contraceptive

07.02.07

23

Pantaprazole sodium 20mg/40mg Tablet (with sodium bicarbonate, as buffer)

24

Levofloxacin 250mg/500mg + Ambroxol SR 75mg tablet

For gastric ulcer, duodenal ulcer, Z. E Syndrome, GERD For lower respiratory tract infection in adults

25

Testosterone cypionate 100mg/200mg + Cotton seed oil 736/566mg per ml injection

For testosterone deficiency (i) primary hypogonadism (ii) Hypogonadotropine hypogonadism

26

Rosiglitazone 1mg + Metformin Hcl 500mg tablet (additional strength)

For Type II Diabetes; particularly for overweight patients

08.02.07

27

Loteprednol Etabonate 5mg + Tobramycine 3mg per ml ophthalmic solution

For steroid responsive inflammatory ocular condition

14.02.07

28

Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER 25mg Antihypertensive (additional strength)

14.02.07

29

Glibenclamide 5mg + Metformin SR 850mg tablet (additional strength)

Antidiabetic

15.02.07

30

Aceclofenac injection (150mg/3ml)

For short term treatment of pain due to post operative and post traumatic cases

19.02.07

31

Metoprolol (As succinate) 50mg/25mg ER + Amlodipine 5mg/2.5mg tablet (For additional indication)

Angina pectoris in adults

32

Ramipril 10mg + HCTZ 12.5mg tablet (additional strength)

ACE Inhibitor

20.02.07

33

Amlodipine (As besylate) 5mg/5mg/10mg + Valsartan 80mg/160mg/160mg tablet

Essential hypertension

21.02.07

34

Glatiramer Acetate injection 20mg/ml

Multiple sclerosis

21.02.07

35

Baclofen ER (GRS) capsule 45mg/60mg (additional strength)

Muscle relaxant

Amlodipine (As besylate) 5mg/10mg + Perindopril 4mg tablet

22.02.07

36

For hypertension

Olopatadine Hcl. tablet 2.5mg/5mg

23.02.07

37

Allergic nasal inflammation hives, itching with skin diseases

26.02.07

6

07.02.07 08.02.07 08.02.07

20.02.07

Issue 33 & 34


Sl. No.

Name of Drug

Indication

Date of Approval

38

Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg

Essential hypertension

26.02.07

39

Rabeprazole Sodium 20mg/10mg with sodium bicarbonate, as buffer

For Duodenal ulcer, G.U, Z.E.S. & GERD

26.02.07

40

Ciclesonide 160mcg/320mcg + Formoterol Fumarate 12mcg (Dry powder inhaler (additional strength)

Bronchospasm relaxant

27.02.07

41

Moxonidine tablet 0.2mg/0.3mg/0.4mg

For hypertension

27.02.07

42

Ceftriaxone (As sodium) 125mg/250mg + Sulbactam (As sodium) 62.5mg/125mg for injection (additional strength)

Antibiotic

01.03.07

43 44

Quetiapine (As fumarate) SR 400mg tablet (additional strength)

Sedative

05.03.07

Cabergoline 1mg tablet (additional strength)

For Hyperprolactinemia

06.03.07

45

Levofloxacin Oral Solution, each 240ml bottle contains Levofloxacin 125mg/5ml

Antibiotic (For adult use only)

07.03.07

46

Clindamycin 1% + Isotretinoin 0.05% gel

For acne

08.03.07

47

Estradiol topical emulsion 2.5mg/gm

Vasomotor symptoms associated with menopause

48

Levosalbutamol MDI 50mcg/actuation & Dry Powder inhaler 100mcg/capsule (new dosage form)

49

Polonosetron (As Hcl.) for injection 0.25mg/5ml

Chemotherapy induced nausea & vomiting

20.03.07

50

Cifixime 200mg + Erdosteine 300mg capsules

Acute exacerbation of chronic bronchitis

21.03.07

51

Aminophylline CR 225/350mg

Asthma, COPD, Bronchitis

21.03.07

52

Etoricoxib 10mg + Methyl salicylate 20mg per gm. of cream

Acute Musculoskeletal pain

21.03.07

53

Eberconazole cream 1%

Dermatophyte infection of skin such as T-corporis,

22.03.07

16.03.07 Bronchospasm relaxant (not recommended for children) 16.03.07

T-Pedis 54

ISMN 60mg Sr + Atenolol 50mg/100mg

For angina pectoris

23.03.07

55

Levonorgestrel 0.03mg tablet

For control of fertility

23.03.07

56

Bortezomib 2mg/vial (additional pack size)

Chemotherapeutic drug

28.03.07

57

Comb kit of two capsule of Azaranari 150mg each + 1 tablet of Ritonavir 100mg

For HIV infection

02.04.07

58

Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatin capsule

For diabetic neuropathy

02.04.07

59

Propofol 10mg + Lignocain 1mg per ml injection

For induction of anesthesia

60

Ezetimibe 10mg + Fenofibrate 160mg tablet

61

Methylprednisolone Acrponate topical solution 0.1%

62

Citicoline 750mg tablet (additional strength), syrup 500mg/5ml (new dosage form, not for children)

Antiparkinson

10.04.07

63

Ertapenem for injection 1gm/vial

Antibiotic

10.04.07

64

Letrozole 2.5mg tablet (for additional indication)

For induction of ovulation in anovulatory infertility

65

Quetiapine SR tablets 50mg (additional strength)

For schizophrenia

10.04.07 10.04.07

66

Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg (additional strength) Sunitinib Maleate Capsules 12.5mg/25mg/50mg

Antihypertensive

10.04.07

68

Comb pack of 1 bottle of Ciprofloxacin injection 200mg/100ml & 1 bottle of Ornidazole injection 500mg/100ml

Antibiotic

20.04.07

69

Aprepitant 40mg capsules (additional strength)

Prevention of post-operative nausea & vomiting (additional indication)

24.04.07

70

Olopatadime Ophthalmic solution 0.2% (additional strength)

For allergic conjunctivitis

24.04.07

71

Combi pack of 1 tablet of Residronate sodium 35mg + 6 tablets of calcium carbonate equivalent to 500mg calcium each

For osteoporosis in postmenopausal women

01.05.07

72

Levocetirizine 2Hcl. Dispersible tablet 2.5mg

For allergic rhinitis & chronic urticaria

08.05.07

73

Amlodipine (As besylate) 10mg + Perindopril 8mg tablets (additional strength)

Antihypertensive

07.05.07

74

Etodolac ER tablets 400mg/500mg

For osteoarthritis & rheumatoid arthritis

09.05.07

75

Levosulpiride tablet 25mg

For G.I. problem like fanatical dyspepsia, nausea, vomiting and diabetic gastroperisis

10.05.07

76

Rimonabant tablet 20mg

For obese patients BMI 30kg/m2 or overweight patients BMI 27kg/m2 with associated risk factors such as type-I diabetes or dyslipidemia

11.05.07

77

Lactitol monohydrate Syrup 66.67/100ml

For constipation

14.05.07

78

S(-) Metoprolol (As succinate) 25mg + S(-) Amlodipine (As besylate 2.5/5mg

For essential hypertension

16.05.07

67

Issue 33 & 34

04.04.07 For combined hypertipidemia 04.04.07 Atopic dermatitis (eczema) inflammatory and allergic 04.04.07 skin reaction

For G.I. Stromal tumor, advanced renal cell carcinoma 10.04.07

7


Sl. No.

Name of Drug

Date of Approval

Indication

79

Amlexanox Oral Paste 5%

For apthous ulcers in people with normal immune system

16.05.07

80

Lenalidomide capsule 5mg/10mg/15mg/25mg

For transfusion dependent anaemia due to myalodysplastic syndrome associated with deletion 5q cytogenic abnormality

16.05.07

81

Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As so- For surgical prophylaxis (additional indication) dium) 250mg/500mg injection (for additional indication) For Osteoarthritis rheumatoid arthritis Lornoxicam tablet 4mg/ 8mg

82

18.05.07 21.05.07

For essential hypertension

21.05.07

83

Atenolol 25mg/50mg + Indapamide SR 1.5mg

84

Livetiracetam conc. for infusion 100mg/ml (new dosage As adjunctive therapy in partial onset seizures in adults with epilepsy when oral administration is temporarily not feasible form) For abnormality of vibration sense and abnormal change in Eplerstat tablet 50mg heart rate associated with diabetic peripheral neuropathy

85 86 87

21.05.07 25.05.07

Citicoline tablet 200mg (additional strength)

Antiparkinson

25.05.07

Varenicline (As tartrate) 0.5mg/1mg tablets

As an aid to smoking cessation treatment in adults

29.05.07

ALERT

An Invitation

NPPA on Marketing Evion 400 as Dietary Supplement

N

ational Pharmaceutical Pricing Authority (NPPA) is to take action against Merck India Ltd for classifying its leading Vitamin E brand, Evion 400 tablets, into a dietary supplement, so that it is out of price control. The company has obtained the product license with change in the composition from drug authorities of Daman. NPPA has fixed the ceiling price of a strip of 10 caps of Evion 400 tablets as Rs 14.82 inclusive of all taxes. But the company after changing the product from a drug to a dietary supplement has fixed the MRP at Rs 60 for a strip of 10 caps, after recently changed its formulations with the addition of vitamin E 400 IU, wheat gram oil 100mg and Omega3 fatty acid 30mg.

Readers are requested to suggest topics for future issues

A health education publication from the Policy Advocacy Group of CMAI.

Source: Chronicle Pharmabiz

Christian Medical Association of India

Nutri-system advanced diet

T

he nutri-system diet plan was introduced in 1972. After undergoing several changes, the present nutri-system advanced plan was launched in 2008. This plan follows a “glycemic advantage” approach promoting “good carbs”, low fat, healthy protein, and high-fibre prepackaged ready-to-eat meals. Nutri-system advanced meals also contain soluble fibre and Omega-3 fatty acids. Exercise is recommended while following this diet plan. Though it is expected to have certain tangible health benefits, it is not an established tool for weight management. The idea of “good carbs” and “bad carbs” is debatable. Some healthy low glycemic index foods include whole pulses and legumes, vegetables, fruits and low-fat dairy products to help control sugar levels and appetite. Look for the nutrition facts on the food label on prepackaged foods for calories, serving size, total fat, saturated fat (associated with raising blood cholesterol), trans fats (increases risk of heart disease by raising LDL or bad cholesterol level and decreases HDL or good cholesterol level), total cholesterol, sodium, total carbohydrate, dietary fibre, vitamins and minerals.

Source: Chronicle Pharmabiz

Rational Drugs goes electronic Rational Drugs has been a well-appreciated publication. In order to reach more people, we will be sending it only by email from now on. However, if you would prefer to receive a printed version, please send a donation of Rs 100/- by DD to CMAI, Delhi, towards cost of publication and postage. To receive Rational Drugs by email, please send a request by email with the following information - name, address & pin code, phone number, email id, membership number (if CMAI member.) If the label in which you received this issue has the “Reader ID”, please send that to us. This may be sent to communication@cmai.org Please do write and let us know your preference by 30 September 2009. If we do not hear from you, we will assume that you have changed your address, and discontinue mailing to you. 8

Published by The General Secretary, CMAI All correspondence to: Policy Advocacy Group Christian Medical Association of India Plot No 2, A-3 Local Shopping Centre Janakpuri, New Delhi 110 058 Phone: 2559 9991/2/3 or 2552 1502 E-mail: cmai@cmai.org, cmaidel@vsnl.com website: www.cmai.org CMAI Bangalore Office HVS Court, 3rd Floor, 21 Cunningham Road, Bangalore 560 052 Tel: (080) 2220 5464, 2220 5837 E-mail: cmaiblr@vsnl.com Editorial Committee Dr Alice Kuruvilla Dr Sujith Chandy Dr Santanu K Tripathi Sr Jessie Saldanha Dr Vijay Aruldas Ms Jaya Philips Dr Abhijeet Sangma Editor Dr R Sweety Prem Kumar Design & Production Ms Lata Anthony Printed at: Impulsive Creations Issue 33 & 34


Rational Drugs July - December 2008