RVP

Drug Catalog - Product Detail

TELMISARTAN TB 80MG 3x10 UD

NDC Mfr Size Str Form
00591-3294-15 ACTAVIS PHARMA 30 80MG TABLET
Product Image
Generic Name
Substance Name
Product Type
Route
Application Number
Description
11 DESCRIPTION Telmisartan Tablets USP are a non-peptide angiotensin II receptor (type AT 1 ) antagonist. Telmisartan, USP is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid and its structural formula is: C 33 H 30 N 4 O 2 M.W. 514.63 Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Telmisartan Tablets USP are available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan, USP. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine and sodium hydroxide. Telmisartan Tablets USP are hygroscopic and require protection from moisture. The chemical structure for Telmisartan
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Telmisartan Tablets USP are available as white or off-white, uncoated tablets containing telmisartan, USP 20 mg, 40 mg, or 80 mg. Tablets are marked with WPI on one side, and on the other side, with either 3292 , 3293 , or 3294 for the 20 mg, 40 mg, and 80 mg strengths, respectively. Tablets are provided as follows: Telmisartan Tablets USP 20 mg are round and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0591-3292-15). Telmisartan Tablets USP 40 mg are capsule shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0591-3293-15). Telmisartan Tablets USP 80 mg are capsule shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0591-3294-15). Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before administration.
Indications & Usage
1 INDICATIONS AND USAGE Telmisartan tablets are an 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 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. Telmisartan tablets may be used alone or in combination with other antihypertensive agents [see Clinical Studies (14.1) ] . Use of telmisartan with an ACE inhibitor is not recommended [see Warnings 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 tablets 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.