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7/30/2019 Rational Drugs 33 & 34
1/8
An Update on Rational Drug Use Issue No. 33 & 34July - December 2008
REVIEW TOPIC
What is a drug food interaction?
Adrug food interaction happens when the food or liquidaffects the ingredients in a medicine that is taken so thatthe medicine cannot work the way it should. Drug-
food interactions can happen with both prescription andover-the-counter medicines. Drug interaction can alsohappen with herbal supplements which are consumed fornutritional purposes. When a drug is mixed with food oranother herb, each can alter the way the body metabolises theother. Some drugs interfere with the bodys ability to absorbnutrients; some herbs and foods can lessen or increase theimpact/absorption of a drug.
Not all medicines are affected by food, but many medicinescan be affected by what is eaten and when. Taking somemedicines at the same time as other food may interfere withthe way the stomach and the intestines absorb the medicine.This is why some medicines should be taken on an emptystomach. There are some medicines which are tolerated wellwhen taken with food. The doctor or the pharmacist should beasked whether it is fne 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 interactionClinically a drug food interaction can lead to therapeutic fail-ure, increased toxicity, pharmacokinetic interactions alteringthe bioavailability and pharmacodynamic interactions.
Food may decrease drug absorption mainly because of foodbinding to a drug. There are also medicines that irritate theGI tract, eg aspirin.
Medications to be taken on an EMPTY STOMACH:- Foodgenerally decreases and delays absorption of certain drugs.
Medications to be taken WITH FOOD:- There are medicinesthat cause stomach upset where food will help to buffer, likecorticosteroids, some antibiotics, a few antiviral drugs usedin HIV/AIDS treatment, some NSAIDs and antifungals.
DRUG FOOD INTERACTION
Specic 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-infectivesCiprooxacin Avoid calcium-containing foods, minerals containing
iron and antacids as they decrease drug concentration
Metronidazole No alcohol, including medicines containing al-cohol while taking the medicine and for 3 days
after stopping
Anticonvulsants
Phenytoin,
Phenobarbital
Increase the risk of anaemia and nerve problemsdue to deciency of folate and other B vitamins
Antidepressants
Fluoxetine Reduces appetite and can lead to excessiveweight loss
Lithium A low-salt diet increases the risk of lithiumtoxicity; excessive salt increases the clearanceof lithium
Monoamine oxidaseinhibitors (MAO
Inhibitors), used inthe treatment of de-pression and anxietydisorder
Foods high in tyramine (processed cheeses,processed meats, legumes, wine, and beer,
among others) may lead to fatal increase inblood pressure. More examples of this categoryare, cured meats such as sausage and salami,protein extracts from meat, yeast, or yeast vi-tamin supplements, dried sh, shrimp paste,some preparations of ginseng, banana peels,resins, fermented soya products & sauce
Antihypertensives, Heart Medications (Cardiovascular)
ACE inhibitors Concurrent ethanol administration will in-crease hypotensive effect
Erythromycin Dont take with fruit juice or wine, whichdecrease the drugs effectiveness
Dairy products reduce the drugs effectiveness.Lowers Vitamin C absorption. Do not take withmilk or other dairy products; avoid calcium-containing foods, minerals containing iron andantacids as they decrease drug concentration
Roxithromycin Take at least 15 minutes before or after a meal
Sulfa drugs Increase the risk of Megaloblastic anaemia
Tetracycline
Drugs Effects and Precautions
Captopril
Alpha blockers
Beta blockers
Digitalis
Take 1 hour before meals for maximumabsorption
Take with liquid or food to avoid excessivedrop in blood pressure
Take before meals
Calcium and potassium salts can howeverincrease toxicity
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Unless a doctor advises otherwise, dont takepotassium sparing diuretics with potassiumsupplements or salt substitutes, which cancause potassium overload
It is poorly absorbed without food; so thepatient is advised to take this with an eveningmeal
Dietary consistency is important in maintaininga sustained, stable response during warfarintherapy. Patients should be particularly awareof foods high in vitamin K like green leafyvegetables (broccoli, spinach), cauliflower,legumes, mayonnaise and soybean oils, andshould maintain a consistent amount of thesefoods in their diet. Food items like caffein-ated beverages (cola, coffee, tea, hot chocolate,chocolate milk) should be avoided or limited,since they also can affect warfarin therapy.
Potassium sparingdiuretics
Statin like Lovastatin
Warfarin
Diuretics Increase the risk of potassium deciency. Tri-amterene and spironolactone are potassium-sparingand patients should avoid potassium-rich food.
Should avoid black licorice (which containsglycyrrhizin). Together, they can produceirregular heart rhythms and cardiac arrest;
licorice and diuretics will produce dan-gerously low potassium levels leading tomuscle pain and even paralysis.
Oatmeal in large amounts and other high-fiber cereals should not be eaten whentaking digoxin. The ber can interfere withthe absorption of the drug.
Sudden stopping of cereals could causedigoxin levels to increase to toxic levels.
Digoxin
Should be administered as a suspension bymixing with water, juice etc.
Administer 30 minutes before meals
Drugs Effects and Precautions Drugs Effects and Precautions
Asthma Drugs/ Bronchodilators
Avoid caffeine along with bronchodilators as caffeine also stimulatesCNS
Lethal dose of Caffeine is 10 gm (100 cups of coffee) and with-drawal symptoms are observed in people who routinely have morethan 600 mg/day (6 cups)
Pseudoephedrine Avoid caffeine, which increase feelings ofanxiety and nervousness
Cholesterol Lowering Drugs
Cholestyramine
Gembrozil
Contains xanthines, which are also found intea, coffee, chocolate, and other sources ofcaffeine. Consuming large amounts of thesesubstances while taking theophylline increasesthe risk of drug toxicity. Charbroiled / high
carbohydrate foods and high protein diet re-duce absorption. High-fat meals may increasetheophylline in body. Caffeine increases therisk of drug toxicity. Should be preferablygiven with meals to avoid gastric irritation
Theophylline
Lansoprazole,Omeprazole
Take 30 minutes before eating
Interfere with the absorption of many miner-als; for maximum benet, take medication1 hour after eating
Heartburn and Ulcer Medications
Antacids
Antifungal medicines
Laxatives
Mineral Oils Overuse can cause a deciency of vitaminsA, D, E, and K
Always take with food to lower the risk ofgastrointestinal irritation; avoid taking withalcohol, which increases the risk of bleeding.
Painkillers
Aspirin and strongernon-steroidal anti-in-ammatory drugs
Codeine
Never take with alcohol. Caffeine increasesanxiety and reduces drugs effectiveness
Sleeping Pills, Tranquilizers
Antigout
Benzodiazepines
Take after meal and with plenty of uid
Glyburide Take with breakfast
Antidiabetic
Allopurinol
Iron Preparation
Best absorbed when taken with water onan empty stomach. If GI upset occurs takebetween meals or with food. If taken withfood, avoid bran, eggs, ber supplements, tea,
coffee, dairy products, calcium supplementsand dairy products
Iron preparations
Large amounts of broccoli, spinach, and othergreen leafy vegetables high in vitamin K,which promotes the formation of blood clots,can counteract the effects of heparin, warfarinand other drugs given to prevent clotting
Vitamins
Vitamin K
Griseofulvin Should be given with fatty meal to increaseabsorption
Antiosteoporosis
Give on empty stomach along with plainwater only
Risedronate
Hormone Preparations
Take with food to decrease nausea. Grape
fruit juice can increase effect
Take with food to avoid gastric irritation
Take on empty stomach with water
Oral contraceptives
Steroids
Thyroid drugs
Increase ber and water intake to avoidconstipation
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Drug-food interaction needs to be studied for different healthconditions in different situations. A few specic cases aregiven below as examples.
1) Cancer Treatment:
Lapatinib is an oral dual tyrosine kinase inhibitor. It isindicated in combination with capecitabine for the treat-ment of patients with advanced or metastatic breast cancerwhose tumors overexpress HER2 and who have received
prior therapy, including an anthracycline, a taxane, andtrastuzumab. Simply by changing the timing taking thismedication with a meal instead of on an empty stomach wecould potentially use 40% or even less of the drug, Dr Ratainsaid. In this case, the drug-food interaction has provided animproved treatment option with low drug content therebyeven reducing the cost. (Source: Cut Cancer Drug Costs ByExploring 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 com-mon activity in some societies. According to Dr Ratain,
We expect that a 250-mg lapatinib pill accompanied byfood and washed down with a glass of grapefruit juicemay yield plasma concentrations comparable to 5 pills onan empty stomach. Dr Cohen says, If we understood therelationship between, say, grapefruit juice and commondrugs, such as the statins, which are taken daily by millionsof people to prevent heart disease, we could save a fortunein drug costs. These statements are not surprising giventhat food often increases a drugs bioavailability. Drs Ratainand Cohen say, The rapidly escalating price of medica-tions has provided incentives to explore pharmacologicalapproaches to lower the costs of drugs. (Source: www.medscape.com)
3) HIV/AIDS Drug-food interaction:HIV therapy (particularly combination therapy of ARVdrugs) drug interactions with food occur when either thepharmacokinetics or the pharmacodynamics of one drugare altered by the administration of food or a concomitantdrug. Alcohol can reduce effectiveness of HARRT by reduc-ing adherence.
High-fat diet enhances the bioavailability of ARVs likeTenofovir, but reduces absorption of drugs like Indinavirand Zidovudine. Didanosine is a nucleoside reverse tran-scriptase inhibitor with food interaction and so is Efavirenz,a non-nucleoside reverse transcriptase inhibitor. Accordingto Angela D M Kashuba, there is no data to show whetherfood effects occur with the Protease Inhibitorcombinationsof Nelnavir/Ritonavir or Amprenavir/Ritonavir (AngelaD M Kashuba, Medscape HIV/AIDS, February 2001). Con-sumption of the ARV Didanosine with alcohol can causeinammation of the pancreas, and alcohol with Isoniazidmay increase the risk of inammation of the liver.
References:
1) Family Doctor.org; http://familydoctor.org2) Risky Cocktails, Risky Business Drug Interactions between Recreational Drugs
and HAART: Patricia Martin, Pharm D3) Food-Drug Interactions, Dr William Diehl-Jones, Faculty of Nursing and
Department of Zoology4) http://nepenthes.lycaeum.org/Misc/maoi.foods.html5) http://www.foodmedinteractions.com
6) http://www.globalrph.com/drugfoodrxn.htm Global RPh.Com7) Herbal Medicine, Holistic online.com; http://www.holisticonline.com/8) J Clin Oncol. 2007, Published online July 16, 2007, www.medscape.com, 5600269) HIV Pharmacology and Drug Interactions, 10 February 2001; Medscape Today,
www.medscape.com10) Preventing Food and Drug Interactions by The University of Georgia Cooperative
Extension Service
specific food based drug interactions
Grapefruit: The juice modies the bodys way of metabo-lising the medication, affecting the livers ability to workthe drug through a persons system. Active ingredients ingrapefruit juice are CYP inhibitors, which when metabolisedslowly are at risk for toxicity and adverse drug effects, andwhen metabolised fast have unpredictable response. A largenumber of medicines including HIV/AIDS drugs interact
with grapefruit juice. Grapefruit juice interacts with calciumchannel blockers, cholesterol control medications, somepsychiatric medications, estrogen, oral contraceptives andmany allergy medications.
Orange juice: It shouldnt be consumed with antacidscontaining aluminum. The juice increases the absorption ofaluminum. Orange juice and milk should be avoided whentaking antibiotics. The juices acidity decreases the effective-ness of antibiotics, as does milk.
Milk:Does not mix with laxatives containing bisacodyl. Thelaxative effect is more in the morning.
Leafy green vegetables: High in vitamin K; should notbe taken in great quantities while taking warfarin. Thesevegetables could totally negate the effects of the drug andcause blood clotting.
Caffeinated beverages: Taken together with asthma drugscan cause excessive excitability. Those taking cimetidine,quinolone antibiotics and oral contraceptives should beaware that these medicines along with their cup of coffeemay cause a sudden high.
Grilled meat: It can lead to problems for those on asthmamedications containing theophyllines. The chemical com-pounds formed when meat is grilled somehow prevent thistype of medication from working effectively, increasing thepossibility of an unmanageable asthma attack.
Diet high in fat: Regularly consuming this while takinganti-inammatory and arthritis medications can cause kid-ney damage and can leave the patient feeling drowsy andsedated.
Alcoholic beverages: These have a tendency to increase thedepressive effects of medications such as benzodiazepines,antihistamines, antidepressants, antipsychotics, muscle re-laxants, narcotics, or any drug with sedative actions. Alcoholinteracts with almost every medication, especially antide-pressants and other drugs that affect the brain and nervoussystem. Antioxidants and beta-carotenes intensify alcoholseffect on the liver. Alcohol can lower blood pressure withbeta blockers and nitrate containing drugs. It can cause liver
damage with statin drugs.Dietary ber: Pectin and other soluble bers slow downthe absorption of acetaminophen (paracetamol), a popularpainkiller. Bran and other insoluble bers have a similareffect 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 medicationsthat sometimes result in serious side reactions. It is alwaysa good practice to tell the doctor and/or health practition-ers about such food/herb habits so that they can advise onpossible complications, if any. The patient should also keepan eye out for unusual symptoms. High-risk patients suchas the elderly, patients taking three or more medicationsfor chronic conditions, patients suffering from diabetes, hy-pertension, depression, high cholesterol or congestive heartfailure should be especially on the lookout for reactions.
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COMMON SKIN CONDITIONS
There are a number of skin related conditions thatpeople are concerned with, mainly because of cosmeticimplications. Some of the most common skin condi-
tions are presented in this article.
dandruff and seborrheic dermatitis
Dandruff and seborrheic dermatitis are conditions thatshare a common manifestation the patients scalp orskin producing scales. Generally there is common etiologytoo. Many nonprescription products are also used to treatboth conditions.
etiologyAbnormal Cell Turnover: Epidermal cells formed in thestratum germinativum, the innermost layer, graduallybegin to migrate upward to the next layers, eventuallyreaching the uppermost layer, the stratum corneum, afterlosing their nuclei and gaining keratin. Such keratinizedcells act to protect the living tissues beneath them. Thetimeframe required for stratum germinativum cells to losetheir nuclei and become keratinised is 25-30 days. For themost part, normal cell-shedding is not noticed and causesno symptoms. In dandruff, cell turnover is commonly 13-15 days and for seborrheic dermatitis it is only 9-10 days.According to the FDA OTC Review Panel in 1982, the causeof dandruff is known to involve an increase in the rate ofepidermal turnover.
Fungal Etiology: Research on the possible causative roleof fungi on dandruff and seborrheic dermatitis resulted inisolating an organism Pityrosporum ovale that inhabits skinfollicles. In 1982, FDA OTC Review Panel Report foundthat though there was support for the use of antimicrobi-als in controlling dandruff, there is no denite correlationbetween the presence ofP. ovale and the development ofdandruff. But in 1984, a researcher, after reviewing lit-
erature, came to the conclusion that P. ovale fullled all ofKochs postulates for dandruff and seborrheic dermatitis;the efcacy of ketoconazole in those conditions was sup-ported by the medical opinion.
Dandruff: Dandruff is a condition of less severity thanseborrheic dermatitis. Even if it is not treated, the patientwill not experience any further symptom/s, althoughsome patients may complain of minor itching. Its effectsare only cosmetic. It does not cause or result from inam-mation, and it is not allergic in origin. Scaling of dandruffis large clumps of dry, white or gray scales that are easilyvisible. Dandruff is uncommon in children aged 2-10, butthe incidence begins to rise from puberty onwards and riseseven more rapidly thereafter, until they reach their earlytwenties when it begins to fall. It is not very common inmiddle-aged patients and the elderly.
Seborrheic Dermatitis: Seborrheic dermatitis is a moresevere condition than dandruff. The age of onset is usuallypuberty, and it is common to have pruritus (severe itching)associated with the condition. The sites most often affectedby seborrheic dermatitis are those where sebum production isheaviest, due to a greater concentration of sebaceous glands,like scalp, eyebrows, eyelashes, external ear canal, behindthe ears, in nasal folds, the midchest, armpits, between theshoulder blades, and the pubic area and groin. P. ovale isdependent on fatty acids from its surroundings for synthesis.While metabolising these fats, it may cause skin damage byproducing irritant metabolites.
Treatment Options: For self-treatment of dandruff and se-borrheic dermatitis there are different ingredients that aresafe and effective. For these two conditions, salicylic acid,selenium sulphide, zinc pyrithione and coal tar are effective.Sulphur and ketoconzole are effective in treating dandruffonly, and hydrocortisone is effective for seborrheic dermatitistreatment only. These products can be used for all ages above2 years except ketoconazole, which should be used for thoseaged over 12 years.
Salicylic Acid 1.8%-3%: Salicylic acid is available in the formof shampoo and foam and it increases hydration of skin. Thescales of dandruff and seborrheic dermatitis are removed bythe keratolytic action.
Selenium Sulphide 1%: Selenium sulphide is highly activein inhibiting the growth ofP. ovale. For dandruff, 0.6% micro-nised form of selenium sulphide is safe and effective.
Zinc Pyrithione: For dandruff, zinc pyrithione 0.3%-2%, andfor seborrheic dermatitis 0.95%-2% concentration in shampoois safe and effective.
Hydrocortisone 0.25%-1%: Hydrocortisone cream is safe andeffective for treatment of seborrheic dermatitis, and shouldnot be used to treat dandruff, as seborrheic dermatitis has aninammatory component, while dandruff does not.
Coal Tar 0.5%-5%: Various forms of coal tar (e.g., coal tardistillate, coal tar extract, coal tar solution) are effective forboth conditions, though it is not the best choice. Besides un-pleasant odour, it can stain the skin and hair. It also can causefolliculitis, irritant dermatitis, and allergic dermatitis. It maycause photosensitivity reactions, and patients should avoidsun exposure up to 24 hours of using it. It is also potentiallycarcinogenic. The patient should consult a physician beforeuse if the condition covers a large part of the body.
Sulphur 2%-5%: For dandruff, 2%-5% concentration sulphurin shampoo form can be used alone or in combination withsalicylic acid.
Ketoconazole 1%: Antifungal activity of ketoconazole 1%in shampoo can control the aking, scaling, and itching ofdandruff. If the scalp is broken or inamed, this should notbe used.
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Topical Minoxidil and Scalp Flaking: Use of topicalminoxidil in the presence of alcohol for long periods maycause drying of scalp, resulting in aking. The patient maydiscontinue the topical minoxidil for a brief period, and usea moisturising shampoo and moisturising conditioner afterconsulting a dermatologist.
Urticaria:
In urticaria, recurrent wheals occur which are usually
pruritic, pink-to-red swelling plaques with pale centersmostly. The wheal sizes vary from a few millimeters toseveral centimeters in diameter, and can form plaques. Theitch is relieved more by rubbing than by scratching. Urticariacan be diagnosed on the basis of the clinical presentation.Although acute urticaria often has an identiable trigger(foods, drugs, virus), chronic urticaria tends to remainidiopathic (a primary disease without apparent cause).
treatment
Treatment includes general measures to prevent or avoidtriggers and pharmacotherapy. Management of treatment canbe classied into rst-, second-, and third-line therapies.
f- t:First-line therapy includes patient education and generalnon-drug measures followed by a trial of histamine H
1re-
ceptor antihistamines if symptoms persist. General measuresinclude avoiding aggravating factors such as overheating,stress, alcohol, acetylsalicylic acid, NSAIDs, and ACE inhibi-tors. Cooling antipruritic lotions such as menthol 1% or 2%in aqueous cream or calamine lotion is useful. It is importantto keep patients well informed about the disease, specicallyabout the lack of a cure.
Histamine H1
Receptor Antihistamines: Antihistamineshave the capacity to inhibit histamine release and prevent
the actions of mast cell and basophil-derived histamine onits target organs. H
1receptor inhibition also reduces allergen-
induced eosinophil accumulation. The second-generationH
1receptor antihistamines like cetirizine and levocetirizine,
have anti-inammatory 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 antihistaminesexperience complete clearing of their symptoms.
they only reduce the severity of pruritus and decrease thenumber and duration of wheals in some patients.
most effective if taken daily, rather than on a needbasis.
more than one antihistamine should be tried since efcacyis patient specic.
First-generation H1
receptor antihistamines includehydroxyzine, diphenhydramine, cyproheptadine, andchlorpheniramine (chlorphenamine). These are not usedas much as monotherapy because of their sedating andanticholinergic side effects. But, they are good as adjunctivetherapy for patients whose sleep is disturbed by symptoms ofurticaria. The second-generation H
1receptor antihistamines
are like cetirizine, levocetirizine, loratadine, desloratadine,fexofenadine, ebastine, and mizolastine. Advantage of
second-generation antihistamines is the lack of CNS andanticholinergic adverse effects.
H2
Receptor Antagonists: About 15% of histaminereceptors in the skin are of the H
2type, for whom H
2
receptor antihistamines are useful in addition to H1receptor
antihistamines in some patients with chronic urticaria. But,H
2receptor antagonists should not be used alone since
they have only minimal effects on pruritus. Examples ofH
2receptor antagonists are cimetidine, ranitidine, and
famotidine. Overall, data supporting the efficacy of H2
receptor antagonists are limited.
s- t:Second-line therapies include both pharmacologic and non-pharmacologic measures like,
phototherapy with UV light or photochemotherapy (pso-ralen plus ultraviolet PUVA therapy)
relaxation therapiesgroups of drugs like antidepressants, corticosteroids, cal-
cium channel antagonists, levothyroxine sodium supple-ments, leukotriene receptor antagonists, and others.
t- t:Patients with urticaria who do not respond to rst- andsecond-line treatments are administered with third-linetherapy including use of immunomodulatory agents likecyclosporine, 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 met-als and some drugs which cause allergic conditions on theskin. Though doctors prescribe medicines like anti-histamineointment to alleviate reaction, the most effective condition isto 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 ofClinical Dermatology; Published: 05/08/2009
US FDA Insists Boxed Warning for all Botulinumtoxin productsWith reports of serious adverse events, the US Food and DrugAdministration (FDA) announced safety label changes, includinga boxed warning, and a risk evaluation and mitigation strategy(REMS), for all botulinum toxin products. The US FDA, has askedthe companies to submit the revised safety label changes, includingthe boxed warning and the Medication Guide, to the FDA within 30days, or to provide a reason why they do not believe such changesare necessary. The effects of the botulinum toxin may spread fromthe area of injection to other areas of the body, causing symptomssimilar to those of botulism, including unexpected loss of strength ormuscle weakness, hoarseness or trouble talking, trouble saying wordsclearly, 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 toxinproducts. Clinical doses expressed in units are not interchangeablefrom one product to another.
Source: http://www.fda.gov/cder/drug/
Warning
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Though 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 drugsapproved upto 29August 2006. The following is the list of new drugs approved by the Drugs Controller General (India)from 30August 2006 to May 2007.
NEW DRUGS
Adjunct diet in primary hypercholesterolaemia
NSAID
For schizophrenia
For cervical ripening, prevention of post partumhaemorrhage & rst trimester of abortion withmifepristone
Anti HIV
For IBS
Antibiotic
For acute Musculoskeletal pain
For diarrhea
For naturopathic pain & partial seizuresNSAID
Chemotherapy induced nausea & vomiting
Edema associated with congestive heart failure& hypertension
Seasonal allergic rhinitis & chronic idiopathicurticaria
For pulmonary osterial hypertension
For Type II Diabetes
To treat hypercholesterolemia
Corticosteroid responsive dermatomes
For insomnia
For anal ssure
For moderate to severe pain
For emergency contraceptive
For gastric ulcer, duodenal ulcer, Z. E Syn-drome, GERD
For lower respiratory tract infection in adults
For testosterone deciency (i) primary hypogo-nadism (ii) Hypogonadotropine hypogonadism
For Type II Diabetes; particularly for overweightpatients
For steroid responsive inammatory ocularcondition
Antihypertensive
Antidiabetic
For short term treatment of pain due to postoperative and post traumatic cases
Angina pectoris in adults
ACE Inhibitor
Essential hypertension
Multiple sclerosisMuscle relaxant
For hypertension
Allergic nasal inammation hives, itching withskin diseases
Atorvastatin 5mg + Fenobrate 160mg (additional strength)
Aceclofenac Inj. 50mg/ml (additional strength)
Amisulpride 400mg tablet (additional strength)
Misoprostol tablet 25mcg/100mcg/200mcg(additional strength/indication)
Atazanavir 150mg + Ritonavir 50mg capsules
Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tablet
Ampicillin 250mg + Dicloxacillin 250mg tablet
Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg +Linseedoil 30mg per gm of GelRacecadotril dispersible tablet 10mg/30mg (new dosage form)
Gabapentin ER 450/600/900mg tablet
Aceclofenac dispersible tablet 100mg (new dosage form)
R-Ondansetron (As Hcl. Dihydrate) 1mg/ml injection
Torsemide 10mg + Amiloride 5mg tablets
Fexofenadine suspension (30mg/5ml)
Sildenal Citrate 20mg tablet
Pioglitazone 15mg/30mg + Metformin ER 1000mg tablet(additional strength)
Fluvastatin Tablet (As calcium) 10mg/20mg/40mg(additional strength)
Halobetazol Propionate Cream 0.05%
Eszopiclone tablet 1mg/2mg/3mg
Diltiazem Hcl. 2% gel
Nalbuphine injection 10mg/20mg per ml
Levonorgestrel 1.5mg tablets
Pantaprazole sodium 20mg/40mg Tablet (with sodium bicarbonate,as buffer)
Levooxacin 250mg/500mg + Ambroxol SR 75mg tablet
Testosterone cypionate 100mg/200mg + Cotton seed oil 736/566mgper ml injection
Rosiglitazone 1mg + Metformin Hcl 500mg tablet(additional strength)
Loteprednol Etabonate 5mg + Tobramycine 3mg per mlophthalmic solution
Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER 25mg(additional strength)
Glibenclamide 5mg + Metformin SR 850mg tablet(additional strength)
Aceclofenac injection (150mg/3ml)
Metoprolol (As succinate) 50mg/25mg ER + Amlodipine5mg/2.5mg tablet (For additional indication)
Ramipril 10mg + HCTZ 12.5mg tablet (additional strength)
Amlodipine (As besylate) 5mg/5mg/10mg + Valsartan80mg/160mg/160mg tablet
Glatiramer Acetate injection 20mg/mlBaclofen ER (GRS) capsule 45mg/60mg (additional strength)
Amlodipine (As besylate) 5mg/10mg + Perindopril 4mg tablet
Olopatadine Hcl. tablet 2.5mg/5mg
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Name of Drug IndicationDate of
Approval
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Issue 33 & 34 7
Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg
Rabeprazole Sodium 20mg/10mg with sodium bicarbonate, as buffer
Ciclesonide 160mcg/320mcg + Formoterol Fumarate 12mcg (Drypowder inhaler (additional strength)
Moxonidine tablet 0.2mg/0.3mg/0.4mg
Ceftriaxone (As sodium) 125mg/250mg + Sulbactam (As sodium)62.5mg/125mg for injection (additional strength)
Quetiapine (As fumarate) SR 400mg tablet (additional strength)
Cabergoline 1mg tablet (additional strength)
Levooxacin Oral Solution, each 240ml bottle contains Levo-oxacin 125mg/5ml
Clindamycin 1% + Isotretinoin 0.05% gel
Estradiol topical emulsion 2.5mg/gm
Levosalbutamol MDI 50mcg/actuation & Dry Powder inhaler100mcg/capsule (new dosage form)
Polonosetron (As Hcl.) for injection 0.25mg/5ml
Cixime 200mg + Erdosteine 300mg capsules
Aminophylline CR 225/350mgEtoricoxib 10mg + Methyl salicylate 20mg per gm. of cream
Eberconazole cream 1%
ISMN 60mg Sr + Atenolol 50mg/100mg
Levonorgestrel 0.03mg tablet
Bortezomib 2mg/vial (additional pack size)
Comb kit of two capsule of Azaranari 150mg each + 1 tablet ofRitonavir 100mg
Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatincapsule
Propofol 10mg + Lignocain 1mg per ml injection
Ezetimibe 10mg + Fenobrate 160mg tabletMethylprednisolone Acrponate topical solution 0.1%
Citicoline 750mg tablet (additional strength), syrup 500mg/5ml(new dosage form, not for children)
Ertapenem for injection 1gm/vial
Letrozole 2.5mg tablet (for additional indication)
Quetiapine SR tablets 50mg (additional strength)
Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg(additional strength)
Sunitinib Maleate Capsules 12.5mg/25mg/50mg
Comb pack of 1 bottle of Ciprooxacin injection 200mg/100ml &1 bottle of Ornidazole injection 500mg/100ml
Aprepitant 40mg capsules (additional strength)
Olopatadime Ophthalmic solution 0.2% (additional strength)
Combi pack of 1 tablet of Residronate sodium 35mg + 6 tablets ofcalcium carbonate equivalent to 500mg calcium each
Levocetirizine 2Hcl. Dispersible tablet 2.5mg
Amlodipine (As besylate) 10mg + Perindopril 8mg tablets (ad-ditional strength)
Etodolac ER tablets 400mg/500mg
Levosulpiride tablet 25mg
Rimonabant tablet 20mg
Lactitol monohydrate Syrup 66.67/100ml
S(-) Metoprolol (As succinate) 25mg + S(-) Amlodipine (As be-sylate 2.5/5mg
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Essential hypertension
For Duodenal ulcer, G.U, Z.E.S. & GERD
Bronchospasm relaxant
For hypertension
Antibiotic
Sedative
For Hyperprolactinemia
Antibiotic (For adult use only)
For acne
Vasomotor symptoms associated with menopause
Bronchospasm relaxant (not recommended for children)
Chemotherapy induced nausea & vomiting
Acute exacerbation of chronic bronchitis
Asthma, COPD, BronchitisAcute Musculoskeletal pain
Dermatophyte infection of skin such as T-corporis,
T-Pedis
For angina pectoris
For control of fertility
Chemotherapeutic drug
For HIV infection
For diabetic neuropathy
For induction of anesthesia
For combined hypertipidemiaAtopic dermatitis (eczema) inammatory and allergicskin reaction
Antiparkinson
Antibiotic
For induction of ovulation in anovulatory infertility
For schizophrenia
Antihypertensive
For G.I. Stromal tumor, advanced renal cell carcinoma
Antibiotic
Prevention of post-operative nausea & vomiting(additional indication)
For allergic conjunctivitis
For osteoporosis in postmenopausal women
For allergic rhinitis & chronic urticaria
Antihypertensive
For osteoarthritis & rheumatoid arthritis
For G.I. problem like fanatical dyspepsia, nausea,vomiting and diabetic gastroperisis
For obese patients BMI 30kg/m2 or overweight pa-tients BMI 27kg/m2 with associated risk factors such
as type-I diabetes or dyslipidemia
For constipation
For essential hypertension
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No.Name of Drug Indication
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7/30/2019 Rational Drugs 33 & 34
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8 Issue 33 & 34
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: [email protected],
website: www.cmai.org
CMAI Bangalore Ofce
HVS Court, 3rd Floor, 21 Cunningham
Road, Bangalore 560 052
Tel: (080) 2220 5464, 2220 5837
E-mail: [email protected]
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
Amlexanox Oral Paste 5%
Lenalidomide capsule 5mg/10mg/15mg/25mg
Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As so-dium) 250mg/500mg injection (for additional indication)
Lornoxicam tablet 4mg/ 8mg
Atenolol 25mg/50mg + Indapamide SR 1.5mg
Livetiracetam conc. for infusion 100mg/ml (new dosageform)
Eplerstat tablet 50mg
Citicoline tablet 200mg (additional strength)
Varenicline (As tartrate) 0.5mg/1mg tablets
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For apthous ulcers in people with normal immune system
For transfusion dependent anaemia due to myalodysplasticsyndrome associated with deletion 5q cytogenic abnormality
For surgical prophylaxis (additional indication)
For Osteoarthritis rheumatoid arthritis
For essential hypertensionAs adjunctive therapy in partial onset seizures in adults withepilepsy when oral administration is temporarily not feasible
For abnormality of vibration sense and abnormal change inheart rate associated with diabetic peripheral neuropathy
Antiparkinson
As an aid to smoking cessation treatment in adults
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Readers are requested to
suggest topics for future issues
ALERT A Ivitati
NPPA on Marketing Evion 400 as Dietary Supplement
National Pharmaceutical Pricing Authority (NPPA) is to take action against MerckIndia 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 theproduct license with change in the composition from drug authorities of Daman.NPPA has xed 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 adietary supplement has xed the MRP at Rs 60 for a strip of 10 caps, after recentlychanged its formulations with the addition of vitamin E 400 IU, wheat gram oil 100mg
and Omega3 fatty acid 30mg.
Source: Chronicle Pharmabiz
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 planfollows a glycemic advantage approach promoting good carbs, low fat, healthyprotein, and high-bre prepackaged ready-to-eat meals. Nutri-system advanced meals
also contain soluble bre and Omega-3 fatty acids. Exercise is recommended whilefollowing this diet plan. Though it is expected to have certain tangible health benets,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 pulsesand legumes, vegetables, fruits and low-fat dairy products to help control sugar levelsand 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 decreasesHDL or good cholesterol level), total cholesterol, sodium, total carbohydrate, dietary
bre, vitamins andminerals.Source: Chronicle Pharmabiz
ChristianMedicalAssociation ofIndia
A health education publication from the
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RATIonAL DRugs goEs ELEcTRonIc
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No.Name of Drug Indication
Date ofApproval