Presentation:
Amezol® 400 Tablet: Each film coated tablet contains Metronidazole BP 400 mg.
Amezol® Suspension: Each 5 ml suspension contains Metronidazole 200 mg as Metronidazole Benzoate BP.
Pharmacological action: Metronidazole, a nitroimidazole has an extremely broad spectrum antiprotozoal and antimicrobial activities, with high activity against anaerobic bacteria and protozoa. Metronidazole is usually completely and rapidly absorbed after oral administration. The half-life in plasma is about 8 hours. About 10% of the drug is bound to plasma proteins. Metronidazole penetrates well into body tissues and fluids. The liver is the main site of metabolism. Both unchanged Metronidazole and metabolites are excreted in various proportions in the urine after oral administration.
Indications: Metronidazole is indicated in
- Urogenital trichomoniasis in the female and male.
- Intestinal and extra-intestinal amoebiasis.
- Giardiasis.
- Anaerobic bacterial infections.
- Non-specific vaginitis.
- Anaerobically-infected ulcers and pressure sores.
Dosage and directions for use:
Indications | Duration in Days | Adults and Children over 10 years | Children 7-10 yrs. | Children 3-7 yrs. | Children 1-3 yrs. |
Amoebic dysentery | 5 to 10 Or 2 | 800 mg tid 2 g once daily | 400 mg tid | 200 mg qid | 200 mg tid |
Asymptomatic amoebiasis | 5 to 10 | 400-800 mg tid | 200-400 mg tid | 100-200 mg qid. | 100-200 mg tid |
Hepatic and extraintestinal amoebiasis | 5 to 10 or 2 | 400-800 mg tid 2-2.4 g once daily | 200-400 mg tid | 100-200 mg qid. | 100-200 mg tid |
Giardiasis | 3 | 2 g once daily | 1 g once daily | 600 mg once daily | 500 mg once daily |
Trichomoniasis consort treatments recommended | 7 or 2 or 1 | 200 mg tid 800 mg(morning) & 1.2 g (evening) 2 g single dose | 100 mg tid | 100 mg bid | 50 mg tid |
Vincent’s infection | 3 | 200 mg tid or 400 mg bid | 100 mg tid | 100 mg bid | 50 mg tid |
Anaerobic infection | 7 | 400 mg tid | 7.5 mg/kg body weight in divided doses | ||
Non-specific vaginitis | 7 | 400 mg tid | |||
Leg ulcer and pressure sore | 1 7 | 2 g single dose 400 mg tid |
Side Effects: Side effects of Metronidazole include gastrointestinal discomfort, nausea, coated tongue, dryness of mouth and unpleasant metallic or bitter taste, headache, pruritus and skin rashes and less frequently vertigo, depression, insomnia, drowsiness, urethral discomfort, and darkening of the urine. Occasionally there may be temporary moderate leucopenia. Peripheral neuropathy has been reported in patients on prolonged therapy.
Precautions: Metronidazole should not be used in patients with blood dyscrasia. When given in conjunction with alcohol, Metronidazole may provoke a disulphiram like provigil.
Contraindications: Contraindicated in patients with prior history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
Drug Interaction: Metronidazole interacts with warfarin, nicoumalone, phenytoin, phenobarbitone, fluorouracil, disulfiram, lithium, cimetidine etc.
Use in Pregnancy & Lactation: Not recommended during first & later trimesters. Breast feeding should be delayed until 48 hours after discontinuing dapoxetine in the mother.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Amezol® 400 Tablet: Each box contains 10x10’s tablets in blister pack.
Amezol® Suspension: Each bottle contains 60 ml suspension with a measuring spoon.
Presentation:
Anxitol® Tablet: Each film-coated tablet contains Flupentixol 0.5mg as Flupentixol Dihydrochloride BP and Melitracen 10 mg as Melitracen HCl INN.
Pharmacological action: Flupentixol is a neuroleptic with anxiolytic and antidepressant properties when given in small doses, and Melitracen is a bipolar thymoleptic with activating properties in low doses. In combination the compound renders a preparation with antidepressant, anxiolytic and activating properties. The combination of flupentixol and melitracen does not seem to influence the pharmacokinetic properties of the individual compounds.
Indications: The combination is indicated in Anxiety, Depression, Apathy, Others are Psychogenic depression, depressive neuroses, masked depression, psychosomatic affections accompanied by anxiety and apathy, menopausal depression. Dysphoria and depression in alcoholics and drug addicts.
Dosage and directions for use: Adults: Usually 2 tablets daily (morning and noon). In severe cases the morning dose may be increased to 2 tablets. Elderly patients: 1 tablet in the morning.
Maintenance dose: Usually 1 tablet in the morning. In cases of insomnia or severe restlessness additional treatment with a sedative in the acute phase is recommended. Second dose should not be taken after 4 pm.
Side Effects: In there commended doses, side-effects are rare. Restlessness, insomnia, hypomania reported, rarely dizziness, tremor, visual disturbances, headache, hyperprolactinemia, extrapyramidal symptoms may be observed.
Precautions: If previously the patient has been treated with tranquilizers with sedative effects these should be withdrawn gradually.
Contraindications: The immediate recovery phase after myocardial infarction. Defects in bundle-branch conduction. Untreated narrow angle glaucoma. Acute alcohol, barbiturate and opiate intoxications. Flupentixol-Melitracen should not be given to patients who have received a MAO-inhibitor within two weeks. Not recommended for excitable or overactive patients since its activating effect may lead to exaggeration of these characteristics.
Drug Interaction: Flupentixol and Melitracen may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO inhibitors may cause hypertensive crisis. Neuroleptics and thymoleptics reduce the antihypertensive effect of Guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.
Use in Pregnancy & Lactation: Flupentixol-Melitracen combination should preferably not be given during pregnancy and lactation.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Anxitol® Tablet: Each box contains 5 x 10’s tablets in blister pack.
Presentation:
Azitel® 500 Tablet: Each film coated tablet contains Azithromycin 500mg as Azithromycin Dihydrate BP.
Azitel® 15 ml Powder for Suspension: After reconstitution, each 5 ml suspension contains Azithromycin 200 mg as Azithromycin Dihydrate USP.
Azitel® 30 ml Powder for Suspension: After reconstitution, each 5 ml suspension contains Azithromycin 200 mg as Azithromycin Dihydrate USP.
Pharmacological action: Azithromycin is a macrolide antibiotic. It acts by binding with the 50s ribosomal subunit of susceptible microorganisms and thus interfering with microbial protein synthesis. Azithromycin has been shown to be active against most strains of the following microorganisms and in clinical infections of Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Chlamydia trachomatis etc. About 40% Azithromycin of an oral dose is absorbed. Following oral administration, Azithromycin is rapidly absorbed and widely distributed throughout the body.
Indications: Azithromycin is indicated for infections caused by susceptible organisms in Upper respiratory tract infections including sinusitis, pharyngitis and tonsillitis , Lower respiratory tract infections including bronchitis, acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD) , Otitis media , Skin and soft tissue infections including cellulitis, pyoderma, erysipelas, wound infections ,Diarrhea, Shigellosis. Sexually transmitted diseases, especially in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.
Dosage and directions for use: Adults: Azithromycin should be given as 500mg once daily orally for 3 days or as an alternative, given over 5 days with 500mg on day 1, then 250mg day 2-5. For Sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1g given as a single dose. Normal adult dose is recommended for elderly patients.
For children over 6 months recommended dose is 10mg/Kg once daily for 3 days; or if body weight is 15-25kg: 200mg once daily for 3 days if body weight is 26-35kg : 300mg once daily for 3 days if body weight is 36-45kg : 400mg once daily for 3 days.
Directions for Reconstitution Suspension: To prepare suspension, add sufficient quantity boiled & cooled water, mentioned in the individual product’s label. Add the total water required in two portions. Shake the bottle well in each addition until all the powder is in suspension. Shake the bottle well before use suspension. A cup is supplied to aid water measuring and corrects dosing of suspension. Use within 7 days after reconstitution.
Side Effects: Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.
Precautions: As with any antibiotic, observation for signs of super infection with non-susceptible organisms, including fungi, is recommended. Precaution should be taken in patients with more severe renal impairment.
Contraindications: Azithromycin is contra-indicated in patients with known hypersensitivity to Azithromycin, erythromycin or any macrolide antibiotic.
Drug Interaction: Azithromycin should be taken at least 1 hour before or 2 hours after taking antacids. Concomitant administration of ergot derivatives and Azithromycin should be avoided. Caution should be exercised while co-administration of Digoxin and Cyclosporine is necessary.
Use in Pregnancy & Lactation: US FDA pregnancy category B. In the animal studies, no evidence of harm to the fetus due to Azithromycin was found. Because animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if clearly needed. It is not known whether Azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Azithromycin is administered to nursing mother.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Azitel® 500 Tablet: Each box contains 2×4's tablets in Alu-Alu blister pack.
Azitel® 15ml PFS: Each bottle contains dry powder for 15 ml oral suspension with a measuring cup & dropper.
Azitel® 30ml PFS: Each bottle contains dry powder for 30 ml oral suspension with a measuring cup & dropper.
Presentation:
B-Vit 4® Tablet: Each film coated tablet contains Thiamine Hydrochloride (Vit B1) BP 5 mg, Riboflavin (Vit B2) BP 2 mg, Pyridoxine Hydrochloride (Vit B6) BP 2 mg, Nicotinamide BP 20 mg.
Pharmacological action: B-Vit 4® is a balanced mixture of B-Vitamins which compensates vitamin deficiency & promotes appropriate growth of the body and helps to increase body resistance against disease. The members of the vitamin B group are components of enzyme systems that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role.
Indications: B-vit 4® is indicated in the treatment and prevention of Vitamin B deficiencies, particularly when depletion is suspected, such as in case of pregnancy and lactation, convalescence following debilitating illness and in restricted diet.
Dosage and directions for use: One or two tablets three times daily.
Side Effects: Vitamin B complex preparations with ordinary doses of each component are usually nontoxic.
Precautions: Should be given cautiously to patients taking Levodopa as Pyridoxine reduces the effect of Levodopa.
Contraindications: Contraindicated in case of hypersensitivity to any of the active ingredients.
Drug Interaction: As little as 5 mg pyridoxine daily can decrease the efficacy of levodopa in the treatment of parkinsonism. Therefore, it is not recommended for patients undergoing such therapy.
Use in Pregnancy & Lactation: It is safe to use in pregnancy and lactation.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
B-Vit 4® Tablet: Each box contains 20x10’s tablets in blister pack & 45 tablets in an amber glass bottle.
Presentation:
Bena-Flu® Syrup: Each 5 ml syrup contains Diphenhydramine Hydrochloride BP 12.5 mg.
Pharmacological action: Diphenhydramine Hydrochloride is a well absorbed antihistamine and widely distributed throughout the body, including the CNS. It is principally used as a potent antihistaminic, antitussive, antiemetic, and antiparkinsonian agent.
Indications: Diphenhydramine Hydrochloride is indicated for the treatment of following: Seasonal, perennial, vasomotor rhinitis, Urticaria, angioneurotic oedema, anaphylaxis, Pruritic conditions, Premedication for emesis and motion sickness, cough & cold. Sometimes it may use as a night time sleep aid and for the short-term management of insomnia.
Dosage and directions for use: Adults & Children over 12 years of age: Most allergic conditions are controlled with 25 to 50 mg i.e., (12.5 to 25 ml of syrup) 3 to 4 times a day.
Children 6 to 12 years of age: 10 mg i.e., (5 ml of syrup) 3 to 4 times a day.
Children 1 to 6 years of age: 5 mg i.e., (2.5 ml of syrup) 3 to 4 times a day.
The maximum daily dosage not to exceed 300 mg in adults and children.
In motion sickness & Parkinsonism: Adult: 25 to 50 mg 3 to 4 times a day. Children (above 9.1 kg): 12.5 to 25 mg 3 to 4 times a day (5mg/ kg/ 24 hours). Not to exceed 300 mg per day. The first dose to be given 30 minutes before exposure to motion and similar doses before meals and upon retiring for the duration of exposure.
In insomnia: Adults and children over 12 years of old: A dose of 20 to 50 mg is used as hypnotic in insomnia.
In cough & cold: Adults: 25 mg every 4 hrs. Not to exceed 150 mg in 24 hours.
Children (6 to 12years): 12.5 mg every 4 hours. Not to exceed 75 mg in 24 hours.
Children (2 to 6 years): 6.25 mg every 4 hours. Not to exceed 25 mg in 24 hours.
Side Effects: Side effect includes sedation, dizziness, tinnitus, fatigue, ataxia, blurred vision, diplopia, euphoria, and epigastric discomfort.
Precautions: Caution should be exercised with patients in whom drowsiness is undesirable e.g., drivers, machine operators. Concomitant consumption of alcohol or central nervous system (CNS) depressants will potentiate drowsiness.
Contraindications: Patients with known hypersensitivity to Diphenhydramine or any components of the product. Care should be taken in administration during pregnancy.
Drug Interaction: Diphenhydramine administration significantly reduces the absorption of the antituberculous agent para-aminosalicylic acid (PAS) from the gastrointestinal tract. CNS depressants may potentiate the sedative action of Diphenhydramine. Anticholinergic drugs may potentiate Diphenhydramine’s anticholinergic side effects.
Use in Pregnancy & Lactation: There are no adequate and well-controlled studies in pregnant women using diphenhydramine hydrochloride. Therefore, diphenhydramine hydrochloride should be used in pregnancy only if clearly needed. Diphenhydramine hydrochloride has been reported to be excreted in breast milk and thus, use of diphenhydramine hydrochloride in lactating mother is not recommended.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Bena-Flu® Syrup: Each bottle contains 100 ml syrup with a measuring spoon.
Presentation:
Breasy® 10 Tablet: Each film coated tablet contains Montelukast 10mg as Montelukast Sodium USP.
Pharmacological action:
Montelukast blocks the cysteinyl leukotriene receptor CysLT1 in the lungs and bronchial thus inhibits the allergic action of cysteinyl leukotriene asthma & helps in bronchodilation. The cysteinyl leukotrienes (LTC4, LTD4, and LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene receptors (CysLT) found in the human airway.
Indications:
Dosage and directions for use: Once daily for 3 to 6 months.
For Preventive & Cure of Asthma:
Adults (15 years of age or over): 10 mg daily for 1 Year or as directed by a registered physician.
Children (6-15 years of age): 5 mg daily.
Side Effects: Generally, Montelukast is well-tolerated. Side effects include Upper respiratory infection, fever, headache, sore throat, cough, stomach pain, diarrhea, earache or ear infection, runny nose.
Precautions: Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication.
Contraindications: Hypersensitivity to any component of this product.
Drug Interaction: Montelukast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma. In drug-interactions studies, the recommended clinical dose of Montelukast did not have clinically important effects on the following medicinal products: theophylline, prednisone prednisolone, oral contraceptives, terfenadine, digoxin and warfarin. Caution should be exercised, particularly in children, when Montelukast is co-administered with phenytoin, phenobarbital and rifampicin.
Use in Pregnancy & Lactation: Montelukast is classified as pregnancy category B. The drug has been shown to cross the placenta of pregnant rats and rabbits, but there have been no reports of its use in pregnant women. Montelukast is also known to be excreted into breast-milk, but only limited information is available on the significance of this finding. Caution should be used prior to initiating Montelukast therapy in nursing mothers.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Breasy® 10 Tablet: Each box contains 2x10’s tablets in Alu-Alu blister pack.
Presentation:
Brodamox® Capsule: Each capsule contains Amoxicillin 250 mg as Amoxicillin Trihydrate BP.
Brodamox-DS® Capsule: Each capsule contains Amoxicillin 500 mg as Amoxicillin Trihydrate BP.
Brodamox® PFS: Each 5 ml of reconstituted suspension contains Amoxicillin 125 mg as Amoxicillin Trihydrate BP.
Pharmacological action: Amoxicillin is a broad spectrum bactericidal semisynthetic antibiotic which is effective against various infections caused by both gram-positive and gram-negative microorganisms. The spectrum of activity is similar to Ampicillin but is better absorbed when taken orally and produces a higher plasma and tissue concentration.
Indications: Amoxicillin is indicated in the following bacterial infections-
Dosage and directions for use:
Adult dosage (including elderly patients): Standard dosage : It is 250 mg three times daily, increasing up to 500 mg three times daily for more severe infections. Severe or recurrent infection of the respiratory tract: A dosage of 3 g twice daily is recommended in appropriate cases. (Maximum recommended oral dosage is 6 g daily in divided doses). Uncomplicated acute urinary tract infection: A single dose of 3 g.
Gonorrhoea: A single dose of 3 g, often with 1 g probenecid in the treatment of uncomplicated gonorrhoea in areas where the pathogen is sensitive to Amoxicillin. Prophylaxis of endocarditis in susceptible patients: A single dose of 3 g about 1 hour before procedures such as dental extraction.
Children dosage: Children up to 10 years of age may be given the equivalent of 125 to 250 mg three times daily. Children weighing 20 kg or more should be given doses according to the recommended dosage for adults. Children under 20 kg body weight a dose of 20 to 40 mg per kg daily has been suggested. In prophylaxis of endocarditis, children may be given half of the adult dose, i.e., 1.5 g about 1 hour before procedures such as dental extraction.
Directions for Reconstitution Suspension: To prepare suspension, add sufficient quantity boiled & cooled water, mentioned in the individual product’s label. Add the total water required in two portions. Shake the bottle well in each addition until all the powder is in suspension. Shake the bottle well before use suspension. A cup is supplied to aid water measuring and corrects dosing of suspension. Use within 7 days after reconstitution.
Side Effects: Vomiting, diarrhoea, skin rash may occur. Pseudomonas & Candida may cause superinfection.
Precautions: In presence of gastrointestinal diseases such as diarrhoea and vomiting, absorption of oral preparation is doubtful. Like all broad-spectrum antibiotics, superinfection may occur in association with Amoxicillin. In such cases treatment with Amoxicillin should be discontinued and appropriate therapy to combat superinfection should be instituted.
Contraindications: Amoxicillin is contraindicated for the patients who are hypersensitive to Penicillin.
Drug Interaction: Concurrent administration of probenecid delays the excretion of Amoxicillin.
Use in Pregnancy & Lactation: Because of its lack of teratogenicity, Amoxicillin can be used safety throughout pregnancy at the normal adult dose. The small amount of Amoxicillin secreted in maternal milk rarely causes problems in the infant. It can therefore be used safety during lactation in most instances.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Brodamox® Capsule: Each box contains 10x10's capsules in blister pack.
Brodamox-DS® Capsule: Each box contains 5x10's capsules in blister pack.
Brodamox® PFS: Each bottle contains dry powder for 100 ml oral suspension with a measuring cup & dropper.
Presentation:
Ciprolyn® 500 Tablet: Each film coated tablet contains Ciprofloxacin 500mg as Ciprofloxacin Hydrochloride Monohydrate USP.
Ciprolyn® Powder for suspension: Each 5 ml contains Ciprofloxacin 250 mg as Ciprofloxacin Hydrochloride Monohydrate Pharma Grade.
Pharmacological action: Ciprofloxacin is a synthetic quinolone anti-infective agent. Ciprofloxacin has broad spectrum of activity. It is active against most gram-negative aerobic bacteria including Enterobacteriaceae and Pseudomonas aeruginosa. Ciprofloxacin is also active against gram-positive aerobic bacteria including penicillinase producing, non penicillinase producing, and methicillin resistant staphylococci, although many strains of streptococci are relatively resistant to the drug. The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase needed for the synthesis of bacterial DNA.
Indications: Ciprofloxacin is used in adults for the treatment of urinary tract infections, lower respiratory tract infections, skin and soft tissue infections, bone and joint infections and G.I. infections, caused by susceptible gram-negative and gram-positive aerobic bacteria. It is also used for the treatment of uncomplicated gonorrhoea caused by penicillinase producing Neisseria gonorrhoeae.
Dosage and directions for use:
Adult: The usual adult dose is 250-750 mg 12 hourly. Usual dosage schedule. Typhoid Fever: 500 mg 12 hourly 7-14 days, Infected Diarrhoea: 500 mg 12 hourly 5-7 days, Chronic Salmonella carriers: 500-750 mg 12 hourly 28 days ,Complicated UTI:500 mg 12 hourly 3-5 days, Uncomplicated UTI: 250 mg 12 hourly 3-5 days , Respiratory Tract Infection: 500-750 mg 12 hourly 7-14 days ,Skin and Soft Tissue Infection: 500-750 mg 12 hourly 7-14 days , Uncomplicated Gonorrhea: 250 mg single dose, Wound Infection: 500 mg 12 hourly 7-14 days, Bone and Joint Infection: 500-750 mg 12 hourly 7-14 days, Other Infection: 500-750 mg 12 hourly 7-14 days.
Adolescent and Children: Generally not recommended but where the benefit is more than potential risk, the dose should be 10-30 mg/kg/day depending upon the severity of Infection, administered in two divided doses.
Directions for Reconstitution Suspension: To prepare suspension, add sufficient quantity boiled & cooled water, mentioned in the individual product’s label. Add the total water required in two portions. Shake the bottle well in each addition until all the powder is in suspension. Shake the bottle well before use suspension. A cup is supplied to aid water measuring and corrects dosing of suspension. Use within 7 days after reconstitution.
Side Effects: Adverse effects include nausea and other gastrointestinal disturbance, headache, dizziness and skin rashes. Crystalluria has occurred with high doses.
Precautions: Ciprofloxacin should be used with caution in patients with a history of convulsive disorders. Crystalluria related to the use of Ciprofloxacin has been observed only rarely. Patients receiving Ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided.
Contraindications: Ciprofloxacin is contraindicated in patients with a known history of hypersensitivity to it or any of its components and to other Quinolones.
Drug Interaction: Concurrent administration of Ciprofloxacin with Theophylline and Caffeine may potentiate the adverse effects of theophylline and caffeine. Antacid containing aluminium or magnesium may decrease the bioavailability of Ciprofloxacin. Quinolones, including Ciprofloxacin, have been reported to enhance the effects of the oral anticoagulant (Warfarin) or its derivatives.
Use in Pregnancy & Lactation: Ciprofloxacin has been shown to cause arthropathy in immature animals and therefore its use during pregnancy is not recommended. Studies in rats have indicated that Ciprofloxacin is secreted in milk, administration to nursing mothers is thus not recommended.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Ciprolyn® 500 Tablet: Each box contains 3 x 10’s tablets in Alu-Alu blister pack.
Ciprolyn® PFS: Each bottle contains dry powder for 60 ml oral suspension with a measuring cup.
Presentation:
Clofen TR® Capsule: Each timed release capsule contains Diclofenac Sodium BP 100mg in pellet form.
Pharmacological action: Diclofenac sodium is a potent non-steroidal anti-inflammatory Drug (NSAID) with marked analgesic and antipyretic properties. It has also some uricosuric effects. The actions of Diclofenac appear to be associated principally with the inhibition of prostaglandin synthesis by inhibiting cyclooxygenase, the enzyme that catalyzes the formation of prostaglandin precursors (Endoperoxides) from arachidonic acid. Following oral administration, Diclofenac is rapidly absorbed from the gastro-intestinal tract. Diclofenac is 99.7% bound to plasma proteins and plasma half-life for the terminal elimination phase is 1-2 hours.
Indications: Diclofenac is indicated in Rheumatoid arthritis, osteoarthritis, low back pain and other acute musculoskeletal disorders such as frozen shoulder, tendinitis, tenosynovitis, bursitis, sprain, strain and dislocation, ankylosing spondylitis, acute gout, pain in orthopaedics, dental and other minor surgery.
Dosage and directions for use: 1 capsule daily, preferably with food. Children: Not recommended.
Side Effects: Epigastric pain, nausea and diarrhoea, headache and slight dizziness may be complained by some patients. These are often transient, disappearing with continuation of medication. Occasionally skin rash, peripheral oedema and abnormalities of serum transaminase have been reported. Very rarely reported side effects include activation of peptic ulcer, haematemesis or melaena, blood dyscrasia (in course of extensive usage). There have been isolated reports of anaphylactoid reactions.
Precautions: Patients with a history of peptic ulcer, haematemesis, melaena, bleeding diathesis or with severe hepatic or renal insufficiency, should be kept under close surveillance. If abnormal liver function tests persist or worsen, clinical signs and symptoms consistent with liver disease or if other manifestations occur (eosinophilia, rash), Diclofenac should be discontinued. Use of Diclofenac in patients with hepatic porphyria may trigger an attack.
Contraindications: Diclofenac should not be given in patients with previous hypersensitivity to Diclofenac, asthmatic patients and in whom attacks of asthma, urticaria or acute rhinitis are precipitated by Aspirin or other NSAIDs.
Drug Interaction: All dosage forms may have the following drug interactions. Lithium and digoxin: Diclofenac may increase plasma concentrations of Lithium and Digoxin. Anticoagulants: There are isolated reports and increased risk of haemorrhage with the combined use of Diclofenac and anticoagulant therapy. Although clinical investigations do not appear to indicate any influence on anticoagulant effects. Antidiabetic agents: Clinical studies have shown that Diclofenac can be given together with oral antidiabetic agents without influencing their clinical effects. Cyclosporin: Cases of nephrotoxicity have been reported in patients receiving Cyclosporin and Diclofenac concomitantly. Methotrexate: Case of serious toxicity has been reported when Methotrexate and NSAIDs are given within 24 hours of each other. Quinolone antimicrobials: Convulsions may occur due to an interaction between Quinolones and NSAIDs. Therefore, caution should be exercised while considering concomitant therapy of NSAIDs and Quinolones. Other NSAIDs and steroids: Co-administration of Diclofenac with other systemic NSAIDs and steroids may increase the frequency of unwanted effects. With aspirin, the plasma level of each is lowered although no clinical significance is known. Diuretics: Various NSAIDs are liable to inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels. So, serum potassium should be monitored.
Use in Pregnancy & Lactation: Diclofenac should not be prescribed during pregnancy unless there are compelling reasons for doing so and the lowest effective dosage should be used. This type of drug is not recommended during the last trimester of pregnancy. Very small quantities of Diclofenac may be detected in breast milk, but no undesirable effects on the infant are to be expected. Since no experience has been acquired with Diclofenac in pregnancy or lactation, it is not recommended for use in these circumstances.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Clofen TR® Capsule: Each box contains 5 x 10’s capsules in blister pack.
Presentation:
Dolonac® Tablet: Each film-coated tablet contains Aceclofenac BP 100 mg.
Pharmacological action: Aceclofenac which is a non-steroidal agent with marked anti-inflammatory and analgesic properties. The mode of action of Aceclofenac is largely based on the inhibition of prostaglandin synthesis. Aceclofenac is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandins. It also stimulates cartilage matrix (glycosaminoglycans) synthesis.
Indications: Aceclofenac is indicated for the relief of pain and inflammation in both acute and chronic pain like osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, dental pain, post-traumatic pain, low back pain, gynaecological pain etc.
Dosage and directions for use: Adults: The maximum recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening. Children: There is no clinical data on the use of Aceclofenac in children. Elderly: The pharmacokinetics of Aceclofenac are not altered in elderly patients, therefore it is not considered necessary to modify the dose and dose frequency.
Side Effects: Generally Aceclofenac is well tolerated. The majority of side effects observed have been reversible and of a minor nature and include gastrointestinal disorders (dyspepsia, abdominal pain, nausea and diarrhoea) and occasional occurrence of dizziness. Dermatological side effects including pruritus and rash. Abnormal hepatic enzyme levels and raised serum creatinine have occasionally been reported.
Precautions: Aceclofenac should be administered with caution to patients with symptoms indicative of gastrointestinal disorders, with a history of peptic ulceration, ulcerative colitis, Crohn's disease, hepatic porphyria, and coagulation disorders. Patients suffering from severe hepatic impairment must be monitored.
Contraindications: Aceclofenac is contraindicated in patients previously sensitive to Aceclofenac or Aspirin or other NSAIDs. It should not be administered to patients with active or suspected peptic ulcer or gastrointestinal bleeding and moderate to severe renal impairment.
Drug Interaction: Lithium and Digoxin: Aceclofenac, like other NSAIDs, may increase plasma concentrations of lithium and digoxin. Diuretics: Aceclofenac, like other NSAIDs, may inhibit the activity of diuretics. Anticoagulants: Like other NSAIDs, Aceclofenac may enhance the activity of anticoagulants. Quinolones: Convulsion may occur due to an interaction between quinolones and NSAIDs. Other NSAIDs and steroids: Concomitant therapy with aspirin, other NSAIDs and steroids may increase the frequency of side effects.
Use in Pregnancy & Lactation: There is no information on the use of Aceclofenac during pregnancy. Aceclofenac should not be administered during pregnancy, unless there are compelling reasons for doing so. The lowest effective dose should be administered. There is no information on the secretion of Aceclofenac in breast milk. The use of Aceclofenac should therefore be avoided during lactation unless the potential benefits to the mother outweigh the possible risks to the children.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Dolonac® Tablet: Each box contains 10 x 10’s tablets in blister pack.
Presentation:
Emedon® Tablet: Each film coated tablet contains Domperidone 10 mg as Domperidone Maleate BP.
Pharmacological action: Domperidone is a Dopamine antagonist. Because it does not readily enter the central nervous system, its effects are confined in the periphery and acts principally at the receptor in the chemoreceptor trigger zone.
Indications: Domperidone is indicated-
Dosage and directions for use: The recommended oral dose for Adults: 10-20 mg every 4-8 hours daily. Children: 0.2-0.4 mg/kg every 4-8 hours daily. Domperidone tablet should be taken 15-30 minutes before a meal. For acute nausea and vomiting, maximum period of treatment is 12 weeks.
Side Effects: Domperidone may produce hyperprolactinemia (1.3% frequency). This may result in galactorrhea, breast enlargement and soreness and reduced libido. Dry mouth (1.9%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhoea (0.2%), skin rash and itching (0.1%) may occur during treatment with Domperidone. Extra-pyramidal reactions are observed in 0.05% of patients in clinical studies.
Precautions: Domperidone should be used with absolute caution in case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier.
Contraindications: Domperidone is contraindicated to patients who have known hypersensitivity to this drug and in case of neonates.
Drug Interaction: Domperidone may reduce the hypoprolactinemic effect of bromocriptine. The action of Domperidone on GI function may be antagonized by anti-muscarinics and opioid analgesics.
Use in Pregnancy & Lactation: The safety of Domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated teratogenic effects on the fetus. Domperidone may precipitate galactorrhoea and improve postnatal lactation. It is secreted in breast milk but in very small quantities, insufficient to be considered harmful.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Emedon® Tablet: Each box contains 10 x 10’s tablets in blister pack.
Presentation:
Etorgin® 90 Tablet: Each film coated tablet contains Etoricoxib INN 90 mg.
Etorgin® 120 Tablet: Each film coated tablet contains Etoricoxib INN 120 mg.
Pharmacological action: Etoricoxib is a Non-Steroidal Anti-Inflammatory Drug (NSAID) that exhibits anti-inflammatory, analgesic and antipyretic activities. It is a potent, orally active, highly selective cyclooxygenase -2 (COX-2) inhibitor within and above the clinical dose range. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation and fever. Selective inhibition of COX-2 by Etoricoxib decreases these clinical signs and symptoms with decreased GI toxicity and without effects on platelet function.
Indications: Etoricoxib is indicated for relief of pain and inflammation in - osteoarthritis, rheumatoid arthritis, other chronic musculoskeletal disorders, acute gout, dysmenorrhea & following dental surgery.
Dosage and directions for use: Adult and adolescent over 16 years: In case of osteoarthritis, dysmenorrhoea, chronic musculoskeletal disorders, 60 mg once daily. In case of rheumatoid arthritis 90 mg once daily. In case of pain following dental surgery, acute gout 120 mg once daily. Safety and effectiveness of Etoricoxib in paediatric patients have not been established.
Side Effects: Dry mouth, taste disturbance, mouth ulcers, flatulence, constipation, appetite and weight changes, chest pain, fatigue, paraesthesia, influenza-like syndrome & myalgia.
Precautions: Decreased kidney function and liver function, dehydration, hypertension, history of heart failure, perforation and people over 65 years of age.
Contraindications: Patients with known hypersensitivity to Etoricoxib or to any of the excipients of this medicinal product, active peptic ulceration or gastro-intestinal bleeding, severe hepatic dysfunction, children under 16 years of age, inflammatory bowel disease, uncontrolled hypertension, breast feeding.
Drug Interaction: Warfarin, ACE Inhibitor, Rifampicin, Lithium, Birth control pills, Methotrexate, Digoxin.
Use in Pregnancy & Lactation: Should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosus. It should be used during the first two trimesters of pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Etorgin® 90 Tablet: Each Box contains 3 x 10’s tablets in Alu-Alu blister pack.
Etorgin® 120 Tablet: Each Box contains 3 x 10’s tablets in Alu-Alu blister pack.
Presentation:
Florixe® Cream: Each gram of cream contains Permethrin INN 50 mg.
Pharmacological action: Permethrin is a photo stable synthetic pyrethroid that possesses a broad spectrum of insecticidal activity and is generally rated as the safest insecticide because of its low primary toxicity. Along with the pediculicidal activity, Permethrin has ovicidal and scabicidal activity. The insect rapidly absorbs Permethrin via mouth, respiratory tract or the intact cuticle. Although the primary target tissue is the nervous system, insects are killed by a complex series of reactions in various organs such as metabolic exhaustion and paralysis of the nervous system.
Indications: Permethrin cream is indicated for the treatment of scabies.
Dosage and directions for use: Adults and children (over 12 years) - A full tube
Patients of > 2 months of age can use this cream. Cream should be applied to clean, dry and cool skin. If the body is hot due to warm bath or any other reason, skin should be allowed to cool down. It should be applied to the whole body excluding head. The whole body should be washed thoroughly 8-12 hours after treatment. Adults and children above 12 years will use a full tube as a single dose. If necessary maximum two tubes can be used as a single dose. The cream should not be applied to the vicinity of mouth and areas close to the eyes.
Side Effects: In scabies patients, skin discomfort, usually described as burning, stinging or tingling occurs in a few individuals soon after the cream is applied. Other transient effects are erythema, numbness, rash and pruritus.
Precautions: Permethrin is not an eye irritant, but the cream itself may cause marked irritation. Nursing staff who routinely apply Permethrin, may wear gloves to avoid any possible irritation to the hands.
Contraindications: Permethrin is contraindicated in patients with known hypersensitivity to the product, its components, other pyrethroids or pyrethrins.
Drug Interaction: The treatment of eczematous like reactions with corticosteroids should be withheld prior to treatment with Permethrin, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite.
Use in Pregnancy & Lactation: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed. It is not known whether Permethrin is excreted in human milk. Because many drugs are excreted in human milk, consideration should be given to discontinuing nursing temporarily or withholding the drug while the mother is nursing.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Florixe® Cream: Each box contains one tube of 30g cream.
Presentation:
Hypoten® Tablet: Each tablet contains Amlodipine 5 mg as Amlodipine Besilate BP.
Pharmacological action: Amlodipine is a calcium antagonist of the dihydropyridine group and inhibits the transmembrane influx of calcium ion into cardiac & smooth muscle. Amlodipine is slowly and incompletely absorbed, with 60-80% of an oral dose reaching the systemic circulation. Plasma half-life ranges from 30-60 hrs (mean 35.7 hrs). Amlodipine is extensively metabolized in the liver prior to excretion with only about 5% unchanged drug excreted in the urine.
Indications: Amlodipine is indicated in patients with mild to moderate hypertension (alone or in combination with other antihypertensives), treatment of chronic stable and vasospastic angina, Raynaud's disease.
Dosage and directions for use: For treatment of both hypertension and angina pectoris, the usual initial dose is 5 mg once daily. If the desired therapeutic effect cannot be achieved within 2-4 weeks, the dose may be increased to a maximum dose of 10 mg once daily. Amlodipine 10 mg once daily provides symptomatic improvement in patients with Raynaud's disease. Children with hypertension from 6 years to 17 years of age 2.5 mg once daily as a starting dose, up-titrated to 5 mg once daily if blood pressure goal is not achieved after 4 weeks. Doses in excess of 5 mg daily have not been studied in pediatric patients. Children under 6 years old the effect of amlodipine on blood pressure in patients less than 6 years of age is not known.
Side Effects: Amlodipine is generally well tolerated. The most commonly observed side effects are headache, peripheral oedema, palpitations, flushing, dizziness, nausea, abdominal pain.
Precautions: Caution should be taken in patients with hepatic impairment, congestive heart failure, sinus node disease, aortic stenosis, beta-blocker withdrawal, during pregnancy and breast-feeding.
Contraindications: Amlodipine is contra-indicated in patients with known hypersensitivity to dihydropyridine derivatives.
Drug Interaction: Digoxin: Absence of any interaction between amlodipine and digoxin in healthy volunteers has been documented in a controlled clinical study. Warfarin: An unpublished study in healthy volunteers indicates that amlodipine does not significantly alter the effect of warfarin on prothrombin time. Cimetidine: An unpublished clinical study indicated no interaction between amlodipine & cimetidine in healthy volunteers. Food: Food does not alter the rate or extent of absorption of amlodipine.
Use in Pregnancy & Lactation: Safety in pregnancy has not been established. It is not known whether Amlodipine is excreted in breast milk. It is advised to stop breastfeeding during treatment with Amlodipine.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Hypoten® Tablet: Each box contains 3 x 10’s tablets in blister pack.
Rhinex® Tablet: Each film coated tablet contains Desloratadine INN 5mg.
Pharmacological action: Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-receptor antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors because the substance is excluded from entry to the central nervous system.
Indications: Desloratadine is indicated in adults and adolescents aged 12 years or older for the relief of symptoms associated with allergic rhinitis & urticaria.
Dosage and directions for use: The recommended dose is one tablet once a day or as directed by the registered physician. The safety and efficacy of desloratadine film-coated tablets in children below the age of 12 years have not been established.
Side Effects: Desloratadine is generally well tolerated. Less serious side effects may include: dry mouth, sore throat, cough, muscle pain, drowsiness, tired feeling, nausea, diarrhea or headache.
Precautions: In the case of severe renal insufficiency, desloratadine should be used with caution. Desloratadine does not usually cause drowsiness when used at recommended doses. However, do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.
Contraindications: Desloratadine are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine.
Drug Interaction: No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin, ketoconazole, azithromycin, antihistamines, fluoxetine & cimetidine were co-administered.
Use in Pregnancy & Lactation: FDA pregnancy category C. Desloratadine should be used in pregnancy only if clearly needed. Desloratadine can pass into breast milk and may harm a nursing baby so the drug should be used with caution in nursing women.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Rhinex® Tablet: Each box contains 10x10’s tablets in blister pack.
Salol® Syrup: Each 5 ml syrup contains Salbutamol 2 mg as Salbutamol Sulphate BP.
Pharmacological action: Salbutamol is a selective β2-agonist bronchodilator which provides short acting bronchodilation in reversible airways obstruction. As a β-adrenergic stimulant for relief of bronchospasm such as occurs with asthma, bronchitis, emphysema. It has a highly selective action on the receptors in bronchial muscle and in therapeutic dosage, little or no action on the cardiac receptors. Salbutamol works by relaxing the muscles in the walls of the small airways in the lungs.
Indications: Salbutamol is used to rapidly treat asthma, bronchospasm and reversible airways obstruction by widening the airways of the lungs.
Dosage and directions for use: The recommended usual oral dose in- Adults and Children over 12 years: 1-2 teaspoon (2mg-4mg) syrup three or four times daily. Children of 6-12 years: 1 teaspoon (2mg) syrup three or four times daily. Children of 2-6 years: 1/2 teaspoon (1mg) syrup three or four times daily or as directed by the physician.
Side Effects: Common side effects include tremor of the hands, tension, restlessness and a rapid heartbeat. There have been occasional reports of headache, and very rare reports of muscle cramps.
Precautions: Caution should be taken before taking Salbutamol if you are diabetic, as this product may cause an increase in blood sugar levels. This effect may be further increased if you are also taking corticosteroids. Also if you have an irregular heartbeat / heart rhythm, including a very fast pulse, overactive thyroid, acute severe asthma, unstable asthma, have an enlarged prostate, as Salbutamol may cause difficulty in passing water.
Contraindications: Salbutamol are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients. Salbutamol presentations should not be used for threatened abortion during the first or second trimester of pregnancy. Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
Drug Interaction: The effects of this product may be altered by guanethidine, reserpine, methyldopa, tricyclic antidepressants. Salbutamol oral preparations and non-selective beta-blocking drugs, such as propranolol should not usually be prescribed together. Caution should be exercised during use with anaesthetic agents such as chloroform, cyclopropane, halothane and other halogenated agents.
Use in Pregnancy & Lactation: FDA pregnancy category C. Salbutamol should be used in pregnancy only if clearly needed. Salbutamol can pass into breast milk and may harm a nursing baby so the drug should be used with caution in nursing women.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Salol® Syrup: Each bottle contains 100 ml syrup with a measuring spoon.
Sectil® 20 Capsule: Each capsule contains Omeprazole BP 20 mg as enteric coated pellets.
Sectil® 40 Capsule: Each capsule contains Omeprazole USP 40 mg as enteric coated pellets.
Pharmacological action: Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, which suppress gastric acid secretion by specific inhibition of the H+/K+-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, Omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production.
Indications: Omeprazole is a proton pump inhibitor indicated for treatment in adults of duodenal ulcer and gastric ulcer, treatment in adults and children of gastroesophageal reflux disease (GERD) and maintenance of healing of erosive esophagitis. The safety and effectiveness of Omeprazole in pediatric patients <1 year of age have not been established.
Dosage and directions for use: The usual adult dose of Omeprazole is- Treatment of Active Duodenal Ulcer-20 mg once daily for 4 weeks. May require an additional 4 weeks treatment. Gastric Ulcer-40 mg once daily for 4 to 8 weeks. GERD-20 mg once daily for 4 to 8 weeks. Maintenance of Healing of Erosive Esophagitis-20 mg once daily. Pathological Hypersecretory -60 mg once daily (varies with individual patient conditions). GERD and Maintenance of Healing of Erosive Esophagitis (1 to 16 years of age) - Dose: 5 < 10 kg body weight 5 mg/day, 10<20 kg body weight 10mg/day and > 20 kg body weight 20mg/day.
Side Effects: Omeprazole is generally well tolerated. Most common adverse reactions in adults are headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence.
Precautions: Symptomatic response does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted with long-term therapy.
Contraindications: Known hypersensitivity to any component of the formulation or substituted benzimidazoles (angioedema and anaphylaxis have occurred).
Drug Interaction: Omeprazole can prolong the elimination of diazepam, warfarin, phenytoin, cyclosporine, disulfiram, benzodiazepines; so monitor and determine need for dose adjustments. Omeprazole may interfere with drugs for which gastric pH affects bioavailability (e.g. ketoconazole, iron salts, ampicillin esters, and digoxin). There is no evidence of an interaction with theophylline, propranolol, metoprolol, lidocaine, quinidine, amoxycillin or antacids.
Use in Pregnancy & Lactation: US FDA Pregnancy Category C. There are no adequate and well-controlled studies with Omeprazole in pregnant women. Because of these findings, it should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if it is excreted in human milk. Many drugs are excreted in milk, caution should be exercised when it is administered to a nursing woman.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Sectil® 20 Capsule: Each box contains 10x10’s capsules in Alu-Alu blister pack.
Sectil® 40 Capsule: Each box contains 10x4’s capsules in Alu-Alu blister pack.
Presentation:
Versal® 20 Tablet: Each enteric coated tablet contains Esomeprazole 20mg as Esomeprazole Magnesium Trihydrate USP.
Versal® 20 Capsule: Each capsule contains Esomeprazole 20mg as enteric coated pellets of Esomeprazole Magnesium Trihydrate USP.
Pharmacological action: Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump, which blocks the final step in acid production, thus reducing gastric acidity.
Indications: The FDA approved Esomeprazole is indicated for Gastroesophageal Reflux Disease (GERD),Healing of Erosive Esophagitis, Maintenance of Healing of Erosive Esophagitis, Symptomatic Gastroesophageal Reflux Disease, H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence, Zollinger-Ellison Syndrome, Acid Related Dyspepsia Duodenal and Gastric Ulcer.
Dosage and directions for use: The usual recommended dose is 20 or 40 mg tablet/capsule once daily.
* The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4-8 weeks, an additional 4-8 weeks treatment may be considered.
** Controlled studies did not extend beyond six months.
*** If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.
Children:
FDA approved Esomeprazole for children aged 1-11 years. Dose: <20kg body weight 5 to 10mg/day and >20kg body weight 10 to 20mg/day.
Elderly: Dose adjustment is not required in the elderly.
Side Effects: The following adverse drug reactions have identified or suspected in the clinical trials programme for Esomeprazole. More frequent: Headache, abdominal pain, diarrhoea, flatulence, nausea/ vomiting and Less frequent: Dermatitis, pruritus, urticaria, dizziness.
Precautions: Symptomatic response to therapy with Esomeprazole does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which Esomeprazole is an enantiomer.
Contraindications: Known hypersensitivity to Esomeprazole, substituted Benzimidazoles or any other constituents of the formulation.
Drug Interaction: In common with the use of other inhibitors of acid secretion or antacids, the absorption of Ketoconazole and Itraconazole can decrease during treatment with Esomeprazole. When Esomeprazole is combined with drugs, such as Diazepam, Citalopram, Imipramine, Clomipramine, Phenytoin etc., the plasma concentrations of these drugs may be increased and a dose reduction could be needed.
Use in Pregnancy & Lactation: There are no adequate and well-controlled studies on the use of Esomeprazole in pregnant women. Therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk. Esomeprazole should be used during pregnancy only if the potential benefit to pregnant women justifies the potential risk to the fetus. Esomeprazole is excreted in human milk. Thus, a decision should be taken to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Versal® 20 Tablet: Each box contains 5 x 10’s tablets in Alu-Alu blister pack.
Versal® 20 Capsule: Each box contains 5 x 10’s capsules in Alu-Alu blister pack.
Zeeplex® Syrup: Each 5 ml syrup contains Thiamine HCl BP 5 mg, Riboflavin 2 mg as Riboflavin 5-phosphate Sodium BP, Pyridoxine HCl BP 2 mg, Nicotinamide BP 20 mg, Elemental Zinc 10 mg as Zinc Sulphate Monohydrate USP.
Pharmacological action: B-Vitamins which compensates vitamin deficiency & promotes appropriate growth of the body and helps to increase body resistance against disease. The members of the vitamin B group are components of enzyme systems that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role. Zinc sulfate is a source of zinc which is an essential trace element required for human nutrition and involved in a number of body enzyme system.Indications: This preparation is indicated in treatment and prevention of B-vitamins and Zinc deficiencies.
Dosage and directions for use: The recommended dose in- Adult: 10 ml (2 teaspoon) 2 to 3 times daily or as recommended by the physician. Children: 10 ml (2 teaspoon) 1 to 3 times daily or as recommended by the physician. Infants: 5 ml (1teaspoon) 1 to 2 times daily or as recommended by the physician.
Side Effects: Generally well tolerated. However zinc salts may cause abdominal pain and dyspepsia.
Precautions: Concurrent administration of zinc salt with penicillamine might diminish the effect of penicillamine. The absorption of Zinc, although poor, may be decreased by various compounds including some foods. Chelation may occur with tetracyclines.
Contraindications: Contraindicated in case of hypersensitivity to any of the active ingredients.
Drug Interaction: Generally no interactions have been observed. Therefore, it is not recommended for patients undergoing such therapy.
Use in Pregnancy & Lactation: It is safe to use in pregnancy and lactation.
Pharmaceutical Precaution: Store in a cool and dry place, protected from light. Keep out of the reach of children.
Commercial Packaging:
Zeeplex® Syrup: Each bottle contains 100 ml & 200ml syrup with a measuring spoon.