Aldactone

— THERAPEUTIC CATEGORIES —
  • CHF and arrhythmias
  • Edema
  • Hypertension
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Aldactone Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Spironolactone 25mg, 50mg+, 100mg+; tabs; +scored.

    Pharmacological Class

    Diuretic (K+ sparing).

    How Supplied

    Tabs—100

    Manufacturer

    Pfizer Inc.

    Generic Availability

    YES

    Aldactone Indications

    Indications

    Treatment of NYHA class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure, when used in addition to standard therapy.

    Aldactone Dosage and Administration

    Adult

    Serum potassium ≤5.0mEq/L and eGFR >50mL/min: initially 25mg daily; may increase to 50mg daily if tolerant, or decrease to 25mg every other day if hyperkalemia develops. eGFR 30–50mL/min: consider initiating at 25mg every other day.

    Children

    Not established.

    Aldactone Contraindications

    Contraindications

    Hyperkalemia. Addison's disease. Concomitant eplerenone.

    Aldactone Boxed Warnings

    Boxed Warning

    In toxicity studies, shown to be tumorigenic in rats.

    Aldactone Warnings/Precautions

    Warnings/Precautions

    Increased risk of hyperkalemia in renal impairment; reduce dose or discontinue if occurs. Monitor serum potassium within 1 week of initiation or titration and periodically thereafter (more frequently if clinically indicated). Monitor volume status, renal function (esp. elderly), electrolytes, uric acid, blood glucose periodically. Salt-depleted. Hepatic impairment. Pregnancy (avoid). Nursing mothers.

    Aldactone Pharmacokinetics

    Elimination

    Renal, bile. Half-life: 1.4 hour.

    Aldactone Interactions

    Interactions

    Increased risk of severe hyperkalemia with concomitant K+ supplements, K+ containing salt substitutes, or drugs that increase potassium (eg, ACEIs, ARBs, NSAIDs, heparin, LMWH, trimethoprim); discontinue K+ supplements in heart failure patients. Concomitant abiraterone in prostate cancer patients may increase PSA levels: not recommended. Hyperkalemic metabolic acidosis with cholestyramine. May be antagonized by NSAIDs, acetylsalicylic acid (may need to increase spironolactone dose); monitor. Monitor lithium. May interfere with digoxin assays.

    Aldactone Adverse Reactions

    Adverse Reactions

    Gynecomastia, GI upset, dizziness, drowsiness, headache, leg cramps, renal dysfunction; hypotension, hyperglycemia, hyperuricemia, hyperkalemia, and other electrolyte disturbances.

    Aldactone Clinical Trials

    See Literature

    Aldactone Note

    Not Applicable

    Aldactone Patient Counseling

    See Literature

    Aldactone Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Spironolactone 25mg, 50mg+, 100mg+; tabs; +scored.

    Pharmacological Class

    Diuretic (K+ sparing).

    How Supplied

    Tabs—100

    Manufacturer

    Pfizer Inc.

    Generic Availability

    YES

    Aldactone Indications

    Indications

    Edema due to liver cirrhosis or nephrotic syndrome. Edema in patients with hypokalemia due to other diuretics.

    Aldactone Dosage and Administration

    Adult

    Initially 100mg/day in single or divided doses; usual range 25–200mg daily. Maintain for at least 5 days, then retitrate. Cirrhosis: initiate in hospital setting; titrate slowly.

    Children

    Not established.

    Aldactone Contraindications

    Contraindications

    Hyperkalemia. Addison's disease. Concomitant eplerenone.

    Aldactone Boxed Warnings

    Boxed Warning

    In toxicity studies, shown to be tumorigenic in rats.

    Aldactone Warnings/Precautions

    Warnings/Precautions

    Increased risk of hyperkalemia in renal impairment; reduce dose or discontinue if occurs. Monitor serum potassium within 1 week of initiation or titration and periodically thereafter (more frequently if clinically indicated). Monitor volume status, renal function (esp. elderly), electrolytes, uric acid, blood glucose periodically. Salt-depleted. Hepatic impairment. Pregnancy (avoid). Nursing mothers.

    Aldactone Pharmacokinetics

    Elimination

    Renal, bile. Half-life: 1.4 hour.

    Aldactone Interactions

    Interactions

    Increased risk of severe hyperkalemia with concomitant K+ supplements, K+ containing salt substitutes, or drugs that increase potassium (eg, ACEIs, ARBs, NSAIDs, heparin, LMWH, trimethoprim); discontinue K+ supplements in heart failure patients. Concomitant abiraterone in prostate cancer patients may increase PSA levels: not recommended. Hyperkalemic metabolic acidosis with cholestyramine. May be antagonized by NSAIDs, acetylsalicylic acid (may need to increase spironolactone dose); monitor. Monitor lithium. May interfere with digoxin assays.

    Aldactone Adverse Reactions

    Adverse Reactions

    Gynecomastia, GI upset, dizziness, drowsiness, headache, leg cramps, renal dysfunction; hypotension, hyperglycemia, hyperuricemia, hyperkalemia, and other electrolyte disturbances.

    Aldactone Clinical Trials

    See Literature

    Aldactone Note

    Not Applicable

    Aldactone Patient Counseling

    See Literature

    Aldactone Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Spironolactone 25mg, 50mg+, 100mg+; tabs; +scored.

    Pharmacological Class

    Diuretic (K+ sparing).

    How Supplied

    Tabs—100

    Manufacturer

    Pfizer Inc.

    Generic Availability

    YES

    Aldactone Indications

    Indications

    Adjunct in hypertension.

    Aldactone Dosage and Administration

    Adult

    Initially 25–100mg/day in single or divided doses. Titrate at 2 week intervals.

    Children

    Not established.

    Aldactone Contraindications

    Contraindications

    Hyperkalemia. Addison's disease. Concomitant eplerenone.

    Aldactone Boxed Warnings

    Boxed Warning

    In toxicity studies, shown to be tumorigenic in rats.

    Aldactone Warnings/Precautions

    Warnings/Precautions

    Increased risk of hyperkalemia in renal impairment; reduce dose or discontinue if occurs. Monitor serum potassium within 1 week of initiation or titration and periodically thereafter (more frequently if clinically indicated). Monitor volume status, renal function (esp. elderly), electrolytes, uric acid, blood glucose periodically. Salt-depleted. Hepatic impairment. Pregnancy (avoid). Nursing mothers.

    Aldactone Pharmacokinetics

    Elimination

    Renal, bile. Half-life: 1.4 hour.

    Aldactone Interactions

    Interactions

    Increased risk of severe hyperkalemia with concomitant K+ supplements, K+ containing salt substitutes, or drugs that increase potassium (eg, ACEIs, ARBs, NSAIDs, heparin, LMWH, trimethoprim); discontinue K+ supplements in heart failure patients. Concomitant abiraterone in prostate cancer patients may increase PSA levels: not recommended. Hyperkalemic metabolic acidosis with cholestyramine. May be antagonized by NSAIDs, acetylsalicylic acid (may need to increase spironolactone dose); monitor. Monitor lithium. May interfere with digoxin assays.

    Aldactone Adverse Reactions

    Adverse Reactions

    Gynecomastia, GI upset, dizziness, drowsiness, headache, leg cramps, renal dysfunction; hypotension, hyperglycemia, hyperuricemia, hyperkalemia, and other electrolyte disturbances.

    Aldactone Clinical Trials

    See Literature

    Aldactone Note

    Not Applicable

    Aldactone Patient Counseling

    See Literature

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