INDICATIONS AND USAGE Spironolactone tablets, USP are indicated in the management of: Primary Hyperaldosteronism for: Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). edematous Conditions for Patients with: Congestive heart failure: For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures. Spironolactone tablets, USP are also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate. Cirrhosis of the Liver Accompanied by edema and/or Ascites: Spironolactone levels may be exceptionally high in this condition. Spironolactone tablets, USP are indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium. Nephrotic Syndrome : For nephrotic patients when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response. Essential Hypertension Spironolactone 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 infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. 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. 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. Usually in combination with other drugs, spironolactone tablets, USP are indicated for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate. Hypokalemia For the treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate. Spironolactone tablets, USP are also indicated for the prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate. Severe heart failure (NYHA class III to IV) To increase survival, and to reduce the need for hospitalization for heart failure when used in addition to standard therapy. Usage in Pregnancy The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developing toxemia. edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Spironolactone tablets, USP are indicated in pregnancy when edema is due to pathologic causes just as it is in the absence of pregnancy (however, see PRECAUTIONS: Pregnancy ). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is unsupported and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.
Actavis Pharma, Inc.
HOW SUPPLIED Spironolactone Tablets, USP are available as follows: 25 mg â€• Each white to off-white, round, film coated tablet, imprinted with on one side and 803 on the other side contains 25 mg of Spironolactone, USP. Tablets are supplied in bottles of 100 (NDC 0228-2803-11) with a child-resistant closure and bottles of 500 (NDC 0228-2803-50) and 1000 (NDC 0228-2803-96) without a child-resistant closure. 50 mg â€” Each white to off-white, oval, film coated tablet, imprinted with and 672 on one side and partial bisect on the other side contains 50 mg of Spironolactone, USP. Tablets are supplied in bottles of 100 (NDC 0228-2672-11) with a child-resistant closure and bottles of 500 (NDC 0228-2672-50) without a child-resistant closure. 100 mg â€” Each white to off-white, round, film coated tablet, imprinted with and 673 on one side and bisect on the other side contains 100 mg of Spironolactone, USP. Tablets are supplied in bottles of 100 (NDC 0228-2673-11) with a child-resistant closure and bottles of 500 (NDC 0228-2673-50) without a child-resistant closure. Pharmacist: Dispense in a tight, light-resistant, child-resistant container. Store at 20Âº to 25ÂºC (68Âº to 77ÂºF) [See USP Controlled Room Temperature]. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9174 Revised â€” March 2015 01c355c2-figure-04 01c355c2-figure-05 01c355c2-figure-06
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