Benazepril hydrochloride 40 MG Oral Tablet
1 INDICATIONS AND USAGE Benazepril hydrochloride 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 mm Hg 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 thiazide diuretics. Benazepril hydrochloride tablets are an angiotensin-converting enzyme (ACE) inhibitor 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. ( 1 )
Mylan Pharmaceuticals Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Benazepril Hydrochloride Tablets, USP are available containing 5 mg, 10 mg, 20 mg or 40 mg of benazepril hydrochloride, USP. The 5 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 441 on the other side. They are available as follows: NDC 0378-0441-01 bottles of 100 tablets The 10 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 443 on the other side. They are available as follows: NDC 0378-0443-01 bottles of 100 tablets The 20 mg tablets are white, film-coated, round, unscored tablets debossed with M over 444 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0444-01 bottles of 100 tablets The 40 mg tablets are white, film-coated, oval, unscored tablets debossed with M 447 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0447-01 bottles of 100 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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