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telmisartan 80 MG Oral Tablet

1 INDICATIONS & USAGE Telmisartan tablets, USP 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, 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 infractions. 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 guidlines, 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 woul be expected to benefit from more aggressive treatment to a lower blood pressur goal. Some antihypertensive drugs have smaller blood pressur 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 )].

camber pharmaceuticals, inc.


3 years ago OVAL WHITE H 164 telmisartan 80 MG Oral Tablet

OVAL WHITE H 164

16 HOW SUPPLIED/STORAGE AND HANDLING Telmisartan Tablets USP, 20 mg are white to off white, round, flat bevel edged tablets, debossed with 'H' on one side and '162' on the other side. They supplied as follows: Blister Card of 10 unit dose tablets (Alu-Alu) NDC 31722-802-31 Blister Pack of 250 (25x10) unit dose tablets NDC 31722-802-32 Blister Pack of 30 (3x10) unit dose tablets NDC 31722-802-36 Blister Card of 10 unit dose tablets (Alu-Peel-Push) NDC 31722-802-33 Blister Pack of 250 (25x10) unit dose tablets NDC 31722-802-34 Blister Pack of 30 (3x10) unit dose tablets NDC 31722-802-35 Telmisartan Tablets USP, 40 mg are white to off white, oval shaped, biconvex tablets, debossed with 'H' on one side and '163' on the other side. They supplied as follows: Blister Card of 10 unit dose tablets (Alu-Alu) NDC 31722-803-31 Blister Pack of 150 (15x10) unit dose tablets NDC 31722-803-32 Blister Pack of 30 (3x10) unit dose tablets NDC 31722-803-37 Blister Card of 10 unit dose tablets (Alu-Peel-Push) NDC 31722-803-33 Blister Pack of 150 (15x10) unit dose tablets NDC 31722-803-34 Blister Pack of 30 (3x10) unit dose tablets NDC 31722-803-35 Blister Pack of 10 (1x10) unit dose tablets NDC 31722-803-36 Telmisartan Tablets USP, 80 mg are white to off white, oval shaped, biconvex tablets, debossed with 'H' on one side and '164' on the other side. They supplied as follows: Blister Card of 10 unit dose tablets (Alu-Alu) NDC 31722-804-31 Blister Pack of 150 (15x10) unit dose tablets NDC 31722-804-32 Blister Pack of 30 (3x10) unit dose tablets NDC 31722-804-37 Blister Card of 10 unit dose tablets (Alu-Peel-Push) NDC 31722-804-33 Blister Pack of 150 (15x10) unit dose tablets NDC 31722-804-34 Blister Pack of 30 (3x10) unit dose tablets NDC 31722-804-35 Blister Pack of 10 (1x10) unit dose tablets NDC 31722-804-36 Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before administration.


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