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Spironolactone

SPIRONOLACTONE

Manufacturer: RPK Pharmaceuticals, Inc.

Score: 141.0

Quick Summary

Spironolactone is an aldosterone antagonist used for the treatment of heart failure, hypertension, edema associated with cirrhosis or nephrotic syndrome, and primary hyperaldosteronism. It works by blocking the effects of aldosterone, leading to increased excretion of sodium and water, and retention of potassium. The drug has several important safety considerations, including the risk of hyperkalemia, hypotension, and worsening renal function. It is contraindicated in patients with hyperkalemia, Addison's disease, and concomitant use of eplerenone. Dosing recommendations vary depending on the condition being treated, and special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of heart failure (NYHA Class III-IV) to increase survival, manage edema, and reduce hospitalization
  • Treatment of hypertension to lower blood pressure
  • Management of edema in patients with cirrhosis or nephrotic syndrome
  • Treatment of primary hyperaldosteronism

Important Safety Information

Warning

Risk of hyperkalemia, hypotension, and worsening renal function

Contraindications

  • Hyperkalemia
  • Addison's disease
  • Concomitant use of eplerenone

Adverse Reactions

  • Gynecomastia
  • Hyperkalemia
  • Hypotension
  • Worsening renal function
  • Electrolyte and metabolic abnormalities

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with renal impairment or hepatic impairment

Heart failure

Adult Dose

25 mg once daily, titrate to 50 mg once daily as needed

Pediatric Dose

Not established

Hypertension

Adult Dose

25-100 mg daily, in single or divided doses

Pediatric Dose

Not established

Edema

Adult Dose

100 mg daily, in single or divided doses

Pediatric Dose

Not established

Primary hyperaldosteronism

Adult Dose

100-400 mg daily, in preparation for surgery or as long-term maintenance therapy

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Use during pregnancy may affect sex differentiation of the male fetus
  • Avoid use in pregnant women or advise of potential risk to male fetus

Nursing Mothers

  • Not specified

Pediatric Use

  • Safety and effectiveness not established in pediatric patients

Geriatric Use

  • Monitor renal function in elderly patients due to increased risk of adverse reactions