ALDACTONE oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula: Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, corn starch, flavor, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, povidone, and titan...

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ALDACTONE is an aldosterone antagonist indicated for: • 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. • 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. • The management of edema in adult patients who are...

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• Heart Failure: Initiate treatment at 25 mg once daily. • Hypertension: Initiate treatment at 25 to 100 mg daily in either single or divided doses. • Edema: Initiate therapy in a hospital setting and titrate slowly. The recommended initial daily dose is 100 mg in single or divided doses. • 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. 2.1 General Cons...

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The oral LD 50 of ALDACTONE is greater than 1000 mg/kg in mice, rats, and rabbits. Acute overdosage of ALDACTONE may be manifested by drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, or diarrhea. Rarely, instances of hyponatremia, hyperkalemia, or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage. Hyperkalemia may occur, especially in patients with impaired renal function. Treatment: Induce vomi...

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• Hyperkalemia: Monitor serum potassium within one week of initiation and regularly thereafter. • Hypotension and Worsening Renal Function: Monitor volume status and renal function periodically. • Electrolyte and Metabolic Abnormalities: Monitor serum electrolytes, uric acid and blood glucose periodically. • Gynecomastia: ALDACTONE can cause gynecomastia. 5.1 Hyperkalemia ALDACTONE can cause hyperkalemia. This risk is increased by impaired renal function or concomitant potassium supplementation, pota...

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• Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia. • Lithium: Increased risk of lithium toxicity. • NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of ALDACTONE. • Digoxin: ALDACTONE can interfere with radioimmunologic assays of digoxin exposure. • Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use. • Acetylsalicylic Acid (ASA): ASA may reduce the efficacy of ALDACTONE. • Abiraterone: May increase prost...

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Based on mechanism of action and findings in animal studies, spironolactone may affect sex differentiation of the male during embryogenesis . Rat embryofetal studies report feminization of male fetuses and endocrine dysfunction in females exposed to spironolactone in utero. Limited available data from published case reports and case series did not demonstrate an association of major malformations or other adverse pregnancy outcomes with spironolactone . There are risks to the mother and fetus asso...

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