What is the typical dosing regimen for spironolactone (spirololactone) in the treatment of Polycystic Ovary Syndrome (PCOS)?

Spironolactone Dosing for PCOS

For PCOS-related hirsutism and hyperandrogenism, start spironolactone at 50-100 mg once daily, with the option to increase to 200 mg daily if needed for optimal clinical response. 1, 2

Initial Dosing Strategy

• Start with 50-100 mg once daily for most PCOS patients, as this range has demonstrated efficacy in multiple studies 2, 3
• The lower end (50 mg daily) is appropriate for initial therapy, particularly in younger patients or those concerned about side effects 2
• Once-daily dosing is preferred over divided doses for improved adherence, as the total daily dose determines therapeutic effect rather than dosing frequency 4

Dose Escalation

• If clinical response is inadequate after 3-6 months at 50-100 mg daily, increase to 200 mg daily (given as 100 mg twice daily or 200 mg once daily) 3, 5
• The 200 mg daily dose has shown superior efficacy for severe hirsutism in clinical trials 3, 5
• Assess response at 3 and 6 months using objective measures like Ferriman-Gallwey hirsutism scores and menstrual cycle frequency 2, 5

Low-Dose Combination Therapy

• Consider 25 mg daily spironolactone added to metformin (1700 mg/day) as an alternative approach that provides more marked reduction in clinical and biochemical hyperandrogenism than metformin alone 6
• This low-dose combination strategy may be preferable for patients already on metformin or those at higher risk for hyperkalemia 6

Expected Clinical Outcomes

• Hirsutism improvement: 30-40% reduction in facial and body hair, with threefold reduction in frequency of local hair removal treatments by 6-12 months 3
• Menstrual regularity: Restoration of regular cycles in approximately 68-82% of patients within 6 months 6, 2
• Hormonal effects: Significant decreases in testosterone (30%), androstenedione, and LH/FSH ratio 2, 3

Mandatory Monitoring Protocol

• Before initiation: Check baseline serum potassium and renal function (contraindicated if potassium >5.5 mEq/L or creatinine clearance ≤30 mL/min) 1, 7
• Early monitoring: Recheck potassium at 1 week and 4 weeks after starting therapy 7
• Maintenance monitoring: Monthly for first 3 months, then every 3 months thereafter 7
• Dose adjustment for hyperkalemia: If potassium 5.5-5.9 mEq/L, reduce dose by half; if ≥6.0 mEq/L, stop immediately 7

Critical Safety Considerations

• Contraception is mandatory as spironolactone is pregnancy category C and can cause feminization of male fetuses 1
• Concomitant use of combined oral contraceptives is often recommended to regulate menses and prevent pregnancy 1
• Discontinue potassium supplements and counsel patients to avoid high-potassium foods (low-sodium processed foods, coconut water) and NSAIDs 1, 7
• Hyperkalemia risk is rare (0.75% in young healthy women) but increases with renal disease, cardiovascular disease, or concurrent ACE inhibitors/ARBs 1

Common Side Effects

• Menstrual irregularities occur in 22-40.6% of women, typically managed with concurrent oral contraceptives 1, 8
• Breast tenderness (17%) and diuresis (29%) are dose-related 1, 8
• Fatigue, headache, and dizziness may occur but are generally well-tolerated 1, 8
• Gynecomastia in men is common and led to study discontinuation in male PCOS patients 1

Comparative Efficacy

• Spironolactone appears superior to metformin for treating hirsutism, menstrual frequency, and hormonal derangements in head-to-head comparison 2
• For idiopathic hirsutism, spironolactone monotherapy is as effective as cyproterone acetate with fewer systemic hormonal effects 5
• In PCOS patients with polycystic ovaries, cyproterone acetate may provide slightly better hirsutism reduction, but spironolactone remains highly effective 5