ALDACTONE is an aldosterone antagonist indicated for:

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The treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1).

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Use as an add-on therapy 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 (1.2).

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The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3).

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Treatment of primary hyperaldosternism for: (1.4)

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Short-term preoperative treatment

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Long-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia

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Heart Failure: Initiate treatment at 25 mg once daily (2.2).

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Hypertension: Initiate treatment at 25 to 100 mg daily in either single or divided doses (2.3).

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Edema: Initiate therapy in a hospital setting and titrate slowly. The recommended initial daily dose is 100 mg in single or divided doses (2.4).

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Primary hyperaldosteronism: Initiate treatment at 100 to 400 mg in preparation for surgery. In patients unsuitable for surgery use the lowest effective dosage determined for the individual patient (2.5).

Tablets: 25 mg, 50 mg, and 100 mg (3)

ALDACTONE is contraindicated in patients with (4):

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Hyperkalemia

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Addison's disease

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Concomitant use of eplerenone

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Hyperkalemia: Monitor serum potassium within one week of initiation and regularly thereafter (5.1).

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Hypotension and Worsening Renal Function: Monitor volume status and renal function periodically (5.2).

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Electrolyte and Metabolic Abnormalities: Monitor serum electrolytes, uric acid and blood glucose periodically (5.3).

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Gynecomastia: ALDACTONE can cause gynecomastia (5.4).

The most common adverse reaction with ALDACTONE treatment is gynecomastia (5.4, 6).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia (5.1, 7.1).

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Lithium: Increased risk of lithium toxicity (7.2).

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NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of ALDACTONE (7.3).

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Digoxin: ALDACTONE can interfere with radioimmunologic assays of digoxin exposure (7.4).

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Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use (7.5).

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Acetylsalicylic Acid (ASA): ASA may reduce the efficacy of ALDACTONE (7.6).

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Abiraterone: May increase prostate-specific antigen (PSA) levels (7.7).

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Pregnancy: Based on animal data, ALDACTONE may affect sex differentiation of the male during embryogenesis (8.1)