Spironolactone

Spironolactone tablets are 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 ( 1.1 ). 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 ). …

• 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
• General Considerations Spironolactone tablets can be taken with or without food, but should be taken consistently with respect to food [ see Clinical Pharmacology ]
• Treatment of Heart Failure In patients with serum potassium ≤5 mEq/L and eGFR >50 mL/min/1.73 m², initiate treatment at 25 mg once daily
• Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated
• Patients who develop hyperkalemia on 25 mg once daily may have their dosage reduced to 25 mg every other day [ see Warnings and Precautions ]
• In patients with an eGFR between 30 and 50 mL/min/1.73 m 2 , consider initiating therapy at 25 mg every other day because of the risk of hyperkalemia [ see Use in Specific Populations ]
• Treatment of Essential Hypertension The recommended initial daily dose is 25 to 100 mg of spironolactone tablets administered in either single or divided doses is recommended
• Dosage can be titrated at two-week intervals. …

Tablets: 25 mg white, round, unscored, debossed MP 35 Tablets: 50 mg white, round, film coated, scored, debossed MP 542 Tablets: 100 mg white, oval shape, film coated, scored, debossed MP 303 Tablets: 25 mg, 50 mg, and 100 mg ( 3 )

• Safety and effectiveness
• In pediatric patients have not been established

Spironolactone tablets are substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, monitor renal function.

• Patients who receive spironolactone tablets should be advised to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes
• Distributed by: Sun Pharmaceutical Industries, Inc
• Cranbury, NJ 08512 Rev 13, December 2025

Spironolactone tablets are contraindicated in the patients with: Hyperkalemia Addison’s disease Concomitant use of eplerenone Spironolactone Tablets are contraindicated in patients with ( 4 ): Hyperkalemia Addison’s disease Concomitant use of eplerenone

Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia ( 5.1 , 7.1 ). Lithium: Increased risk of lithium toxicity ( 7.2 ). NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of spironolactone tablets ( 7.3 ). Digoxin: Spironolactone tablets can interfere with radioimmunologic assays of digoxin exposure ( 7.4 ). Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use ( 7.5 ). Acetylsalicylic Acid (ASA): ASA may reduce the efficacy of spironolactone tablets ( 7.6 ). Abiraterone: May increase prostate-specific antigen (PSA) levels ( 7.7 ). …

Hyperkalemia: Monitor serum potassium within one week of initiation and regularly thereafter (5.1). Hypotension and Worsening Renal Function: Monitor volume status and renal function periodically (5.2). Electrolyte and Metabolic Abnormalities: Monitor serum electrolytes, uric acid and blood glucose periodically (5.3). Gynecomastia: Spironolactone tablets can cause gynecomastia (5.4). 5.1 Hyperkalemia Spironolactone tablets can cause hyperkalemia. …

The following clinically significant adverse reactions are described elsewhere in the labeling: Hyperkalemia [ see Warnings and Precautions (5.1) ] Hypotension and Worsening Renal Function [ see Warnings and Precautions (5.2) ] Electrolyte and Metabolic Abnormalities [ see Warnings and Precautions (5.3) ] Gynecomastia [ see Warnings and Precautions (5.4) ] Impaired neurological function/ coma in patients with hepatic impairment, cirrhosis and ascites [ see Use in Specific Populations (8.7) ] The following adverse reactions associated with the use of spironolactone were identified in clinical trials or postmarketing reports. …

8.1 Pregnancy Risk Summary Based on mechanism of action and findings in animal studies, spironolactone may affect sex differentiation of the male during embryogenesis (see Data) . Rat embryofetal studies report feminization of male fetuses and endocrine dysfunction in females exposed to spironolactone in utero. …

The oral LD 50 of spironolactone tablets is greater than 1000 mg/kg in mice, rats, and rabbits. Acute overdosage of spironolactone tablets 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 vomiting or evacuate the stomach by lavage. There is no specific antidote. …

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