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Drug Catalog - Product Detail

TELMISARTAN TB 20MG 3X10 UD

NDC Mfr Size Str Form
68382-0471-78 ZYDUS PHARMACEUTICALS (USA) 30 20MG TABLET
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Description
11. DESCRIPTION Telmisartan is a non-peptide angiotensin II receptor (type AT 1 ) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its molecular formula is C 33 H 30 N 4 O 2 , its molecular weight is 514.63, and its structural formula is: Telmisartan, USP is a white or slightly yellowish, crystalline powder. It is practically insoluble in water, slightly soluble in methanol and sparingly soluble in methylene chloride. It dissolves in 1 M sodium hydroxide. Each telmisartan tablets, USP intended for oral administration contains 20 mg or 40 mg or 80 mg of telmisartan. In addition, each tablet contains the following inactive ingredients: ferric oxide red, lactose monohydrate, magnesium stearate, meglumine, povidone, sodium hydroxide, sodium stearyl fumarate and sorbitol. Telmisartan tablets are hygroscopic and require protection from moisture. structure
How Supplied
16. HOW SUPPLIED/STORAGE AND HANDLING Telmisartan Tablets USP, 20 mg are mottled light brown to mottled brown-colored, round-shaped, flat face beveled edge, uncoated tablets debossed with '471' on one side and plain on the other side and are supplied as follows: NDC 68382-471-06 in bottle of 30 tablets NDC 68382-471-16 in bottle of 90 tablets NDC 68382-471-01 in bottle of 100 tablets NDC 68382-471-05 in bottle of 500 tablets NDC 68382-471-10 in bottle of 1000 tablets NDC 68382-471-78 in cartons of 30 tablets (3 x 10 unit-dose) Telmisartan Tablets USP, 40 mg are mottled light brown to mottled brown-colored, oblong-shaped, biconvex, uncoated tablets debossed with '472' on one side and plain on the other side and are supplied as follows: NDC 68382-472-06 in bottle of 30 tablets NDC 68382-472-16 in bottle of 90 tablets NDC 68382-472-01 in bottle of 100 tablets NDC 68382-472-05 in bottle of 500 tablets NDC 68382-472-10 in bottle of 1000 tablets NDC 68382-472-78 in cartons of 30 tablets (3 x 10 unit-dose) Telmisartan Tablets USP, 80 mg are mottled light brown to mottled-brown colored, oblong-shaped, biconvex, uncoated tablets debossed with '473' on one side and plain on the other side and are supplied as follows: NDC 68382-473-06 in bottle of 30 tablets NDC 68382-473-16 in bottle of 90 tablets NDC 68382-473-01 in bottle of 100 tablets NDC 68382-473-05 in bottle of 500 tablets NDC 68382-473-10 in bottle of 1000 tablets NDC 68382-473-78 in cartons of 30 tablets (3 x 10 unit-dose) Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Tablets should not be removed from blisters or bottles until immediately before administration. Dispense in a tightly closed container.
Indications & Usage
1. INDICATIONS AND USAGE Telmisartan tablets, USP are angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) 1.1 Hypertension Telmisartan tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents [see Clinical Studies ( 14.1 )] . Use of telmisartan and ACE inhibitor is not recommended [see Warning and Precautions ( 5.6 )].
Dosage and Administration
2. DOSAGE AND ADMINISTRATION May be administered with or without food ( 2.1 ) Indication Starting Dose Dose Range Hypertension ( 2.1 ) 40 mg once daily 40 to 80 mg once daily 2.1 Hypertension Dosage must be individualized. The usual starting dose of telmisartan tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20 to 80 mg [ see Clinical Studies ( 14.1 )]. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure reduction beyond that achieved with 80 mg telmisartan is required, a diuretic may be added. No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored. Telmisartan tablets may be administered with other antihypertensive agents. Telmisartan tablets may be administered with or without food.