Human Health Division (HHD) Products
Product List by Therapeutic
Amlodipine + Atenolol
Composition
CVnor A: Each tablet contains Amlodipine Besilate BP equivalent to
Amlodipine 5 mg and Atenolol BP 50 mg.
Pharmacology
CVnor A is a fixed dose combination of Amlodipine and Atenolol. Amlodipine
is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of
calcium ions into vascular smooth muscle and cardiac muscle; it has a greater
effect on vascular smooth muscle cells than cardiac muscle cells. Amlodipine is
a peripheral vasodilator that acts directly on vascular smooth muscle to cause a
reduction in peripheral vascular resistance and reduction in blood pressure.
Amlodipine reduces tone, decreases coronary vasoreactivity and lowers
cardiac demand by reducing after load. Atenolol is a cardio-selective beta-blocker. It does not possess any membrane-stabilizing action. The cardio selectivity is dose related. Atenolol causes a reduction in blood pressure by lowering cardiac output, decreasing the plasma renin activity and sympathetic outflow from CNS. Atenolol also causes a reduction in myocardial oxygen
demand by virtue of its negative inotropic and negative chronotropic effect.
Indication
Hypertension is not controlled by monotherapy, patients with angina pectoris and hypertension as co-existing diseases; post myocardial infarction, refractory angina pectoris where nitrate therapy has failed.
Dose & Administration
Initially, 1 tablet daily. If necessary, the dose may be increased to 2 tablets daily.
Elderly patients or patients with hepatic impairment ½ tablet daily. The dosage,
however, should be individualized or as directed by the physician.
Ospemifene
Composition
Osmina Tablet: Each film coated tablet contains Ospemifene INN 60 mg.
Indication
Osmina is an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia & vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause.
Dosage & Administration
Osmina is an estrogen agonist/antagonist which has agonistic effects on the endometrium. Use of
Osmina should be for the shortest duration consistent with treatment goals and risks for the individual
women.
One tablet should be taken orally once daily with food or as directed by the physician.
Pregabalin Extended Release
Composition
Pregan ER 82.5: Each extended release tablet contains Pregabalin BP 82.5 mg.
Pregan ER 165: Each extended release tablet contains Pregabalin BP 165 mg.
Pharmacology
Pregabalin is a structural derivative of gamma-amino-butyric acid (GABA). It does not bind directly to GABA-A,
GABA-B, or benzodiazepine receptors. It binds with high affinity to the alpha 2-delta site (an auxilliary subunit of
voltage-gated calcium channels) in central nervous system tissues. Oral bioavailability of Pregabalin is 90%.
Pregabalin is eliminated largely by renal excretion and has an elimination half-life of about 6 hours. Pregabalin
can be taken with or without food.
Indication
Pregabalin Capsule- Neuralgia: (a) Pain from diabetic neuropathy, (b) Post-herpetic neuralgia Fibromyalgia
Partial seizure/Epilepsy.
Pregabalin ER Tablet- Diabetic peripheral neuropathy Post-herpetic neuralgia
Pravastatin
Composition
Pravalip 10 Tablet: Each tablet contains Pravastatin Sodium BP 10 mg.
Pravalip 20 Tablet: Each tablet contains Pravastatin Sodium BP 20 mg.
Pharmacology
Pravastatin is a reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA)
reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate limiting step in the biosynthetic pathway for cholesterol. In addition, pravastatin reduces
VLDL and TG and increases HDL-C.
Indications
Pravalip is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:
- Reduce the risk of Myocardial Infarction (MI), revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident Coronary Heart Disease (CHD).
- Reduce the risk of total mortality by reducing coronary death, Myocardial Infarction (MI), revascularization, stroke/Transient Ischemic Attack (TIA), and the progression of coronary atherosclerosis in patients with clinically evident Coronary Heart Disease (CHD).
- Reduce elevated Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Apolipoprotein B (ApoB) and Triglycerides (TG) levels and to increase High Density Lipoprotein Cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.
- Reduce elevated serum Triglycerides (TG) levels in patients with hypertriglyceridemia.
- Treat patients with primary dysbetalipoproteinemia who are not responding to diet.
- Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy.
Dosage & Administration
Adults: The recommended starting dose is 40 mg once daily. Use 80 mg dose only for patients
not reaching LDL-C goal with 40 mg.
Significant renal impairment: The recommended starting dose of pravastatin is 10 mg once daily.
Children (ages 8 to 13 years): The recommended starting dose is 20 mg once daily.
Adolescents (ages 14 to 18 years): The recommended starting dose is 40 mg once daily or as directed by the physicians.
Ezetimibe + Atorvastatin
Composition
Ezitor 10/10: Each film coated tablet contains Ezetimibe USP 10 mg and Atorvastatin
calcium USP equivalent to Atorvastatin 10 mg.
Ezitor 10/20: Each film coated tablet contains Ezetimibe USP 10 mg and Atorvastatin
calcium USP equivalent to Atorvastatin 20 mg.
Pharmacology
Ezitor is a combination of Ezetimibe and Atorvastatin. Ezetimibe reduces blood cholesterol
by inhibiting the absorption of cholesterol by the small intestine. Ezetimibe is localized at
the brush border of the small intestine and inhibits the absorption of cholesterol, leading to
a decrease in the delivery of intestinal cholesterol to the liver. This causes a reduction of
hepatic cholesterol stores and an increase in LDL receptors, resulting in clearance of
cholesterol from the blood.
Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase. The rate-limiting
enzyme responsible for the conversion of 3-hydroxy-3-methyl-glutaryl-coenzyme A to
mevalonate, a precursor of sterols, including cholesterol. Triglycerides (TG) and cholesterol
in the liver are incorporated into VLDL and released into the plasma for delivery to
peripheral tissues. Low-density lipoprotein (LDL) is formed from VLDL and is catabolised
primarily through the high affinity LDL receptor. Atorvastatin lowers plasma cholesterol and
lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver
and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake
and catabolism of LDL.
Indication
Ezitor is indicated as adjunctive therapy to diet to:
• reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in
patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed
hyperlipidemia.
• reduce elevated total-C and LDL-C in patients with homozygous familial
hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments.
Dosage and Administration
• Dosage range is 10/10 mg/day through 10/80 mg/day.
• Recommended starting dose is 10/10 mg/day or 10/20 mg/day.
• Recommended starting dose is 10/40 mg/day for patients requiring a greater than 55%
reduction in LDL-C or as directed by the physician.
Carisoprodol
Composition
Somalax 250 Tablet: Each tablet contains Carisoprodol USP 250 mg. Somalax 350 Tablet: Each tablet contains Carisoprodol USP 350 mg.
Pharmacology
Carisoprodol is a centrally acting skeletal muscle relaxant that does not directly relax tense skeletal muscle in man. The mode of action of Carisoprodol in relieving acute muscle spasm of local origin has not been clearly identified, but may be related to its sedative properties. In animals, Carisoprodol has been shown to produce muscle relaxation by blocking interneuronal activity and depressing transmission of polysynaptic neurons in the spinal cord and the descending reticular formation of the brain. The onset of action is rapid and lasts four to six hours.
Indication
Somalax is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions.
Dosage & Administration
Adults (18 years and older): The recommended dose of Somalax is 250 mg to 350 mg 3-4 times daily (before or after meal and at bedtime) for up to 2-3 weeks or as directed by the physician.
Contraindication
Carisoprodol is contraindicated in patients with history of acute intermittent prophyria or a hypersensitivity reaction to carbamate such as Meprobamate.
Warnings & Precautions
Carisoprodol is metabolized in the liver and excreted by the kidney. To avoid its excess accumulation, caution should be exercised in administration to patients with compromised liver or kidney function & additive sedative effects is found when used with other CNS depressants including alcohol.
Side Effects
Common side effects are drowsiness, dizziness and headache.
Use in Pregnancy & Lactation
The safety of this drug in pregnancy or lactation has not been established. Therefore, use of this drug in pregnancy, in nursing mothers, or in women of childbearing potential requires that the potential benefits of the drug be weighed against the potential hazards to mother and child. Carisoprodol is present in breast milk of lactating mothers at concentrations two to four times that of maternal plasma. This factor should be taken into account when use of the drug is contemplated in breast-feeding patients.
Use in Children & Adolescents
The efficacy, safety and pharmacokinetics of Carisoprodol in paediatric patients less than 16 years of age have not been established.
Drug Interactions
• Caution should be exercised with patients who take other CNS depressants (eg.- alcohol, benzodiazepines, opioids, tricyclic antidepressants) with Carisoprodol.
• Co-administration of CYP2C19 inhibitors (Omeprazole, Fluvoxamine) with Carisoprodol could result in increased exposure of Carisoprodol. Co-administration of CYP2C19 inducers (Rifampin) with Carisoprodol may result in decreased exposure of Carisoprodol.
Overdosage
Overdosage of Carisoprodol commonly produces CNS depression. Death, coma, respiratory depression, hypotension, seizures have been reported with Carisoprodol overdosage. Basic life support measures should be instituted in Carisoprodol overdose. Induced emesis is not recommended due to the risk of CNS and respiratory depression. Gastric lavage should be considered soon after ingestion (within one hour). Circulatory support should be administered with volume infusion and vasopressor agents if needed. Seizures should be treated with intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital. In cases of severe CNS depression, airway protective reflexes may be compromised and tracheal intubation should be considered for airway protection and respiratory support.
Storage
Store below 30°C., away from light and in a dry place. Keep all medicines out of the reach of children.
Packing
Somalax 250 Tablet: Each box contains 3x10 tablets in Alu-Alu blister pack and an insert.
Somalax 350 Tablet: Each box contains 3x10 tablets in Alu-Alu blister pack and an insert.
Olmesartan + Amlodipine
Composition
OlmepinTM 20/5 Tablet:Each film coated tablet contains Olmesartan Medoxomil USP 20 mg & Amlodipine Besilate BP equivalent to Amlodipine 5 mg.
Olmepin TM 40/5 Tablet:Each film coated tablet contains Olmesartan Medoxomil USP 40 mg & Amlodipine Besilate BP equivalent to Amlodipine 5 mg.
Indication
OlmepinTM is indicated for the treatment of hypertension, alone or with other antihypertensive agents. OlmepinTM may also be used as initial therapy in patients
who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.
Dose & Administration
Initial Therapy: The usual starting dose of Olmesartan Medoxomil/Amlodipine Besilate is 20/5 mg one tablet once daily. The dosage can be increased after 1 to 2 weeks of
therapy to a maximum dose of 40/10 mg once daily as needed to control blood pressure. This combination may be taken with or without food. This combination may
be administered with other antihypertensive agents. Initial therapy with this combination products is not recommended in patients >75
years old or with hepatic impairment. Replacement therapy: Olmesartan Medoxomil/Amlodipine Besilate may be substituted for its individually titrated components. When substituting for individual components,
the dose of one or both of the components can be increased if blood pressure control has not been satisfactory.
Add-on Therapy: Olmesartan Medoxomil/Amlodipine Besilate may be used to provide additional blood pressure lowering for patients not adequately controlled with
Amlodipine (or another dihydropyridine Calcium Channel Blocker) alone or with Olmesartan Medoxomil (or another angiotensin II receptor blocker) alone Or as
directed by the physician
Lactic Acid + Citric Acid + Potassium
Composition:
Feelfree Gel: Each gram gel contains Lactic Acid BP 18 mg, Citric Acid BP 10 mg & Potassium Bitartrate USP 4 mg.
Indication:
Feelfree is indicated for the prevention of pregnancy in female of reproductive potential for use as an on-demand method of contraception.
Dose & Administration:
Administer 5 g gel Feelfree vaginally by the applicator immediately before (or up to one hour before) each episode of vaginal intercourse. May use during any part of the menstrual cycle or as directed by the physicians.
Cefaclor
Composition:
Navacef™ 250 Capsule: Each capsule contains Cefaclor Monohydrate USP equivalent to 250 mg of Cefaclor.
Navacef™ 500 Capsule: Each capsule contains Cefaclor Monohydrate USP equivalent to 500 mg of Cefaclor.
Navacef™ PFS (100 ml): Each 5 ml contains Cefaclor Monohydrate USP equivalent to 125 mg of Cefaclor.
Navacef™ PFS (60 ml): Each 5 ml contains Cefaclor Monohydrate USP equivalent to 125 mg of Cefaclor.
Navacef™ Paediatric Drops (15 ml): Each 1.25 ml contains Cefaclor Monohydrate USP equivalent to 125 mg of Cefaclor
Indication
Respiratory Tract Infections: Pneumonia, bronchitis, pharyngitis, tonsillitis, otitis media.
Uninary Tract Infections: Pylonephritis, cystitis etc.
Skin & Soft Tissue Infections: Impetigo, pyodema, cellulitis, pruritis etc.
Dosage & Administration
Adults: 250 mg three times daily (Dose should be doubled in severe cases, max. 4 g daily). Children
over 1 month: 20 mg/kg/ day in three divided doses (Dose should be doubled in severe cases, max 1
g daily). 1-5 years: 125 mg three times daily, over 5 years: 250 mg three times daily, (Dose should be
doubled in severe cases), or as directed by the physician.
Pregabalin
Composition
Pregan™ 50: Each capsule contains Pregabalin INN 50 mg.
Pregan™ 75: Each capsule contains Pregabalin INN 75 mg
Indication
• Neuralgia: (a) pain from diabetic neuropathy, (b) postherpetic neuralgia
• Fibromyalgia
• Partial seizure / epilepsy: Pregabalin is also indicated as adjunctive therapy for adult
patients with partial onset seizures.
• Generalized anxiety disorder
Dose & Administration
Neuropathic pain: Adult 18 years: Initially 150 mg daily in 2-3 divided doses, dose can be increased if necessary after 3-7 days to 300 mg daily in 2-3 divided doses and it can be
increased further if necessary after 7 days to max. 600 mg daily in 2-3 divided doses.
Epilepsy: Adult over 18 years: Initially 25 mg twice daily, dose can be increased at 7 day intervals in steps of 50 mg daily to 300 mg daily in 2-3 divided doses and it can be increased further of necessary after 7 days to max. 600 mg daily in 2-3 divided doses.
Generalized anxiety disorder: Adult over 18 years: Initially 150 mg daily in 2-3 divided doses, dose can be increased if necessary at 7 day intervals in steps of 150 mg daily; max. 600 mg daily in 2-3 divided doses.
Fibromyalgia: The recommended dose of Pregabalin is 300-450 mg/day. Initial dose is 75 mg twice daily and may be increased to 150 mg twice daily within 1 week based on efficacy and tolerability. Patient who does not experience sufficient benefit with 300 mg/ day may be further
increased to 225 mg twice daily. Or as directed by the physician.
Flunarizine
Composition
Imigra™ 5 Tablet: Each film coated tablet contains Flunarizine Dihydrochloride BP equivalent to 5 mg Flunarizine.
Imigra™ 10 Tablet: Each film coated tablet contains Flunarizine Dihydrochloride BP equivalent to 10 mg Flunarizine.
Imigra™ 5 Capsule: Each capsule contains Flunarizine Dihydrochloride BP equivalent to 5 mg Flunarizine.
Imigra™ 10 Capsule: Each capsule contains Flunarizine Dihydrochloride BP equivalent to 10 mg Flunarizine
Indication
O Symptomatic treatment of vestibular vertigo & dizziness.
O Peripheral vascular diseases (Intermittent claudication, Raynaud's phenomenon, paresthesia, cold extremities etc.).
O Epilepsy resistant to conventional anti-epileptic therapy.
O Prophylaxis of classic (with aura) or common (without aura) migraine.
Dose and Administration
For vertigo: The recommended maximum daily dose of Flunarizine in the treatment of vertigo is 10 mg daily in adults and 5 mg daily in children (<40 kg).
For epilepsy: An optimal therapeutic dosage in epileptic patients receiving other anti-epileptic drug is 15 mg to 20 mg daily in adults and 5 to 10 mg daily in children.
For migraine prophylaxis: Starting dose is 10 mg daily at night for adult patients less than 65 years of age and 5 mg daily for patients older than 65 years.
Maintenance treatment: If a patient's response is satisfactory and if a maintenance treatment is needed, the dose should be decreased. The patient should have 5 days treatment in a week at the same daily dose and 2 successive drug free days. Treatment should be stopped after 6 months and reinitiated only if the patient relapses.
Or as directed by the physician
Bisoprolol + Hydroclorothiazide
Composition:
Tabis™ Plus 2.5 Tablet: Each film coated tablet contains Bisoprolol Fumarate USP 2.5 mg and Hydrochlorothiazide BP 6.25 mg.
Tabis™ Plus 5 Tablet: Each film coated tablet contains Bisoprolol Fumarate USP 5 mg and Hydrochlorothiazide BP 6.25 mg.
Indication:
Tabis™ Plus is indicated for the management of hypertension.
Dose & Administration:
The initial dose is 2.5/6.25 mg once daily. Subsequent titration (14 day intervals) may be carried out with Tabis™ Plus tablets up to the maximum recommended dose
20/12.5 mg once daily as appropriate.
Bisoprolol
Composition
Tabis™ 2.5 Tablet: Each film coated tablet contains Bisoprolol Fumarate USP 2.5 mg.
Tabis™ 5 Tablet: Each film coated tablet contains Bisoprolol Fumarate USP 5 mg
Indications
• Hypertension
• Angina
• Adjunct in stable moderate to severe heart failure.
Dose & Administration
Hypertension: The dose of Bisoprolol must be individualized to the needs of the patient. The usual starting dose is 5 mg once daily. In some patients, 2.5 mg may be an appropriate starting dose. If the antihypertensive effect of 5 mg is inadequate, the dose may be increased to 10 mg and then, if
necessary, to 20 mg once daily.
Angina: Usually 10 mg once daily (5 mg may be adequate in some patients) max 20 mg daily.
Heart Failure: Initially 1.25 mg once daily (in the morning) for 1 week then, if well tolerated, increased to 2.5 mg once daily for 1 week, then 3.75 mg once daily for 1 week, then 5 mg once daily for 4 weeks, then 7.5 mg once daily for 4 weeks, then 10 mg once daily, max 10 mg daily.
Or as directed by the physician
Rosuvatatin
Composition
Nestor™ 5 Tablet: Each film coated tablet contains Rosuvastatin Calcium BP equivalent to Rosuvastatin 5 mg.
Nestor™ 10 Tablet: Each film coated tablet contains Rosuvastatin Calcium BP equivalent to Rosuvastatin 10 mg.
Indication
Heterozygous Hypercholesterolemia (Familial and Nonfamilial) Homozygous Hypercholesterolemia (Familial) Mixed Dyslipidemia (Fredrickson Type lla and lib)
Dosage & Administration
For asian people, initial starting dose of Rosuvastatin is 5 mg once daily. The dose range of Rosuvastatin is 5-40 mg once daily. Heterozygous Hypercholesterolemia (Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Type lla and lib) The usual recommended starting dose of rosuvastatin is 10 mg once daily. Initiation of therapy with 5 mg once daily may be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy. For patients with marked hypercholesterolemia (LDLC > 190 mg/dL) and aggressive lipid targets, a 20-mg starting dose may be considered. The 40-mg dose of rosuvastatin should be reserved for those patients who have not achieved goal LDL-C at 20 mg. After initiation and/or upon titration of rosuvastatin, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.
Homozygous Hypercholesterolemia (Familial):
The recommended starting dose of rosuvastatin is 20 mg once daily in patients with homozygous FH. The maximum recommended daily dose is 40 mg. Rosuvastatin should be used in these patients as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. Patients with renal insufficiency: No modification of dosage is necessary for patients with mild to moderate renal insufficiency. For patients with severe renal impairment (CLcr <30 mL/min/1.73 m2) not on hemodialysis, dosing of rosuvastatin should be started at 5 mg once daily and should not be exceeded 10 mg once daily or as directed by the physician.
Clopidogrel + Aspirin
Composition:
Navix™ Plus Tablet: Each film coated tablet contains Clopidogrel Bisulfate USP equivalent to Clopidogrel 75 mg and Aspirin BP 75 mg.
Indication:
The preparation is used for the prevention of ischemic events, myocardial infarction, stroke and cardiovascular death in patients with acute coronary syndrome.
Dosage & Administration:
The recommended dose is once daily or as directed by the physician.
Clopidogrel
Composition:
Navix™ Tablet: Each film coated tablet contains Clopidogrel Bisulfate USP equivalent to 75 mg Clopidogrel.
Indication:
Clopidogrel is indicated for the reduction of atherosclerotic events (myocardial infarction, stroke and vascular death) and in patient with atherosclerosis documented recent stroke, recent myocardial infarction or established peripheral arterial disease (PAD).
Dosage & Administration:
The recommended dose of Clopidogrel is 75 mg once daily with or without food. No dosage adjustment is required for elderly patients or patients with renal disease or as directed by the physician.
Levamlodipine
Composition
L-Amlo 1.25 Tablet:Each tablet contains Levamlodipine Maleate INN equivalent to
Levamlodipine 1.25 mg.
L-Amlo 2.5 Tablet:Each tablet contains Levamlodipine Maleate INN equivalent to
Levamlodipine 2.5 mg.
L-Amlo 5 Tablet:Each tablet contains Levamlodipine Maleate INN equivalent to Levamlodipine
5 mg.
Indication
L-Amlo is a calcium channel blocker which is used alone or in combination with other
antihypertensive agents for the treatment of hypertension. Lowering blood pressure reduces the
risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Dose & Administration
Adult recommended dose: 2.5 mg orally once daily with maximum dose 5 mg once daily. For small, fragile or elderly patients or patients with hepatic insufficiency, 1.25 mg once daily starting dose is recommended.
Paediatric starting dose: 1.25 mg to 2.5 mg once daily or as directed by the physicians
