From the Guidelines
The maximum recommended dose of spironolactone is 200 mg per day for the treatment of acne, as supported by recent studies 1. When considering the use of spironolactone, especially at higher doses, it is essential to monitor serum potassium, sodium, and renal function regularly, as hyperkalemia is a significant risk.
- Dose adjustments may be necessary for patients with renal impairment, and the medication should be started at lower doses with gradual titration to minimize side effects such as gynecomastia, menstrual irregularities, and hypotension.
- The use of spironolactone in acne treatment is conditionally recommended based on moderate certainty evidence from several studies 1, which showed improvement in acne severity and quality of life.
- Common side effects of spironolactone include menstrual irregularities, diuresis, breast tenderness, breast enlargement, gynecomastia, fatigue, headache, and dizziness, and these side effects may be dose-dependent 1.
- Potassium monitoring should be considered in older patients, patients with medical co-morbidities, and patients taking medications affecting renal, adrenal, and hepatic function, and avoiding a diet high in potassium is also recommended 1.
- Spironolactone should not be used in pregnancy due to the potential risk of feminization of a male fetus, and concurrent use of a contraceptive is often indicated in treating acne with spironolactone 1.
From the FDA Drug Label
DOSAGE AND ADMINISTRATION Primary hyperaldosteronism. Spironolactone tablets may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets. Long test: Spironolactone tablets are administered at a daily dosage of 400 mg for three to four weeks For patients who are considered unsuitable for surgery, spironolactone tablets may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient. Edema in adults (congestive heart failure, hepatic cirrhosis, or nephrotic syndrome) An initial daily dosage of 100 mg of spironolactone tablets administered in either single or divided doses is recommended, but may range from 25 to 200 mg daily
The maximum dose of spironolactone per day is 400 mg as indicated for the diagnosis of primary hyperaldosteronism 2.
From the Research
Spironolactone Maximum Dose
The maximum dose of spironolactone varies depending on the condition being treated.
- For idiopathic hyperaldosteronism and aldosterone producing adenoma, spironolactone is effective at therapeutic doses of 25 to 400 mg per day 3.
- In the treatment of heart failure, the maximum dose of spironolactone is 45 mg/day, as seen in the TOPCAT trial 4.
- For hirsutism, spironolactone has been used at a dose of 200 mg/day, resulting in a clear beneficial effect on facial hair growth 5, 6.
- In advanced heart failure, doses of spironolactone greater than 25 mg/day, up to 200 mg/day, have been found to be necessary to produce natriuresis, and have been shown to be generally safe in selected patients 7.
Conditions and Doses
Some specific conditions and their corresponding spironolactone doses are: