1 INDICATIONS & USAGE Torsemide tablets are a loop diuretic indicated for: â€¢ the treatment of edema associated with heart failure, renal disease or hepatic disease. (1.1) â€¢ 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. (1.2) 1.1 Edema Torsemide tablets are indicated for the treatment of edema associated with heart failure, renal disease or hepatic disease. 1.2 Hypertension Torsemide 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. There are no controlled trials demonstrating risk reduction with torsemide. 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 Programâ€™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. The antihypertensive effects of torsemide tablets are on the average greater in black patients than in nonblack patients [see Clinical Pharmacology (12.2)] . 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. Torsemide tablets can be used alone or in combination with other antihypertensive agents.
camber pharmaceuticals, inc.
16 HOW SUPPLIED/STORAGE AND HANDLING
TORSEMIDE tablets USP, 5 mg are white to off white, oval shaped, scored tablets, debossed with â€˜56â€™ on scored side and â€˜Hâ€™ on the opposite side. They are supplied as follows: 31722-529-01, bottle of 100 31722-529-05, bottle of 500
TORSEMIDE tablets USP, 10 mg are white to off white, oval shaped, scored tablets, debossed with â€˜57â€™ on scored side and â€˜Hâ€™ on the opposite side. They are supplied as follows: 31722-530-01, bottle of 100 31722-530-05, bottle of 500
TORSEMIDE tablets USP, 20 mg are white to off white, oval shaped, scored tablets, debossed with â€˜59â€™ on scored side and â€˜Hâ€™ on the opposite side. They are supplied as follows: 31722-531-01, bottle of 100 31722-531-05, bottle of 500
TORSEMIDE tablets USP, 100 mg are white to off white, oval shaped, scored tablets, debossed with â€˜60â€™ on scored side and â€˜Hâ€™ on the opposite side. They are supplied as follows: 31722-532-01, bottle of 100 31722-532-05, bottle of 500 Storage Store at 20Â° to 25Â°C (68Â° to 77Â°F) [see USP Controlled Room Temperature]
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