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valsartan 80 mg

1 INDICATIONS AND USAGE Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: • Hypertension , to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ) • Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults ( 1.2 ) • Post-myocardial infarction , for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3 ) 1.1 Hypertension Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients one year of age and older. 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 valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets. 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 (e.g., 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. Valsartan tablets may be used alone or in combination with other antihypertensive agents. 1.2 Heart Failure Valsartan tablets are indicated to reduce the risk of hospitalization for heart failure in adult patients with heart failure (NYHA class II-IV). There is no evidence that valsartan tablets provide added benefits when they are used with an adequate dose of an angiotensin converting enzyme (ACE) inhibitor [see Clinical Studies (14.2) ] . 1.3 Post-Myocardial Infarction In clinically stable adult patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, valsartan tablets are indicated to reduce the risk of cardiovascular mortality [see Clinical Studies (14.3) ] .

Mylan Pharmaceuticals Inc.


11 months ago OVAL BROWN M V13 valsartan 80 mg

OVAL BROWN M V13

11 months ago OVAL BROWN M V13 valsartan 80 mg

M V13 OVAL BROWN

16 HOW SUPPLIED/STORAGE AND HANDLING

VALSARtan Tablets, USP are available containing 40 mg, 80 mg, 160 mg or 320 mg of

VALSARtan, USP. The 40 mg tablets are yellow, film-coated, round, scored tablets debossed with M on one side of the tablet and V above the score and 7 below the score on the other side. They are available as follows: NDC 0378-5807-93 bottles of 30 tablets The 80 mg tablets are light red, film-coated, capsule-shaped, unscored tablets debossed with M on one side of the tablet and V13 on the other side. They are available as follows: NDC 0378-5813-77 bottles of 90 tablets The 160 mg tablets are light orange, film-coated, oval, unscored tablets debossed with M on one side of the tablet and V14 on the other side. They are available as follows: NDC 0378-5814-77 bottles of 90 tablets The 320 mg tablets are dark violet, film-coated, oval, unscored tablets debossed with M on one side of the tablet and V15 on the other side. They are available as follows: NDC 0378-5815-77 bottles of 90 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.


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