CHF and arrhythmias:
Indications for: ALDACTONE
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.
Adult Dosage:
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 Dosage:
Not established.
ALDACTONE Contraindications:
Hyperkalemia. Addison's disease. Concomitant eplerenone.
Boxed Warning:
In toxicity studies, shown to be tumorigenic in rats.
ALDACTONE 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 Classification:
Diuretic (K+ sparing).
ALDACTONE 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.
Adverse Reactions:
Gynecomastia, GI upset, dizziness, drowsiness, headache, leg cramps, renal dysfunction; hypotension, hyperglycemia, hyperuricemia, hyperkalemia, and other electrolyte disturbances.
Drug Elimination:
Renal, bile. Half-life: 1.4 hour.
Generic Drug Availability:
YES
How Supplied:
Tabs—100
Edema:
Indications for: ALDACTONE
Edema due to liver cirrhosis or nephrotic syndrome. Edema in patients with hypokalemia due to other diuretics.
Adult Dosage:
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 Dosage:
Not established.
ALDACTONE Contraindications:
Hyperkalemia. Addison's disease. Concomitant eplerenone.
Boxed Warning:
In toxicity studies, shown to be tumorigenic in rats.
ALDACTONE 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 Classification:
Diuretic (K+ sparing).
ALDACTONE 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.
Adverse Reactions:
Gynecomastia, GI upset, dizziness, drowsiness, headache, leg cramps, renal dysfunction; hypotension, hyperglycemia, hyperuricemia, hyperkalemia, and other electrolyte disturbances.
Drug Elimination:
Renal, bile. Half-life: 1.4 hour.
Generic Drug Availability:
YES
How Supplied:
Tabs—100
Hypertension:
Indications for: ALDACTONE
Adjunct in hypertension.
Adult Dosage:
Initially 25–100mg/day in single or divided doses. Titrate at 2 week intervals.
Children Dosage:
Not established.
ALDACTONE Contraindications:
Hyperkalemia. Addison's disease. Concomitant eplerenone.
Boxed Warning:
In toxicity studies, shown to be tumorigenic in rats.
ALDACTONE 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 Classification:
Diuretic (K+ sparing).
ALDACTONE 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.
Adverse Reactions:
Gynecomastia, GI upset, dizziness, drowsiness, headache, leg cramps, renal dysfunction; hypotension, hyperglycemia, hyperuricemia, hyperkalemia, and other electrolyte disturbances.
Drug Elimination:
Renal, bile. Half-life: 1.4 hour.
Generic Drug Availability:
YES
How Supplied:
Tabs—100
