Maximum Recommended Dose of Spironolactone (Aldactone)
The maximum recommended dose of spironolactone (Aldactone) varies by indication: 400 mg/day for liver cirrhosis with ascites, 50-75 mg/day for heart failure, and 400 mg/day for primary hyperaldosteronism. 1, 2
Indication-Specific Maximum Doses
Heart Failure
- Initial dose: 12.5-25 mg daily 1
- Target maintenance dose: 25-50 mg daily 1
- Maximum dose: 50 mg daily for most patients 1
- Careful monitoring required for potassium and renal function 1
Liver Cirrhosis with Ascites
- Initial dose: 50-100 mg daily 1
- Maximum dose: 400 mg daily 1
- Combination with loop diuretics often required for optimal effect 1
Primary Hyperaldosteronism
- Dose range: 100-400 mg daily 2
- Used for preoperative preparation or long-term maintenance in non-surgical candidates 2
Hypertension
- Initial dose: 25-100 mg daily 2
- Maximum dose: 100 mg daily (higher doses generally do not provide additional blood pressure reduction) 2
Dosing Considerations
Renal Function
- For eGFR 30-49 mL/min/1.73m²: Consider reduced dosing (12.5-25 mg daily or every other day) 1
- For eGFR <30 mL/min/1.73m²: Spironolactone is contraindicated due to risk of hyperkalemia 1
Monitoring Requirements
- Check potassium and renal function:
Risk Factors for Hyperkalemia
- Serum creatinine >1.6 mg/dL 1
- Baseline potassium >5.0 mEq/L (contraindication) 1
- Concomitant use of ACE inhibitors or ARBs 1
- NSAIDs and COX-2 inhibitors (should be avoided) 1
Common Side Effects
- Hyperkalemia (dose-dependent, more common at higher doses) 1, 3
- Gynecomastia or breast pain (in approximately 10% of men) 1, 4
- Anti-androgenic effects (hyposexuality, erectile dysfunction) 1
- Worsening renal function 1
Clinical Pearls
- In heart failure, the RALES trial demonstrated significant mortality benefit with spironolactone 25 mg daily, with minimal hyperkalemia at this dose 4, 3
- For liver cirrhosis, higher doses may be needed due to secondary hyperaldosteronism 1
- When hyperkalemia occurs (K+ >5.5 mmol/L), consider reducing dose by half; if K+ >6.0 mmol/L, discontinue immediately 1
- Eplerenone may be substituted for spironolactone in men experiencing gynecomastia 1
Remember that while guidelines provide maximum doses, the optimal dose is the highest tolerated dose that achieves clinical benefit without causing adverse effects, particularly hyperkalemia 1.