What is the recommended dose of Spironolactone (aldosterone antagonist)?

From the Guidelines

Spironolactone should be initiated at a dose of 25 mg daily for patients with severe heart failure, as recommended by the European Society of Cardiology guidelines 1. The dosing of spironolactone can vary depending on the condition being treated, but for heart failure, the initial dose is typically 25 mg daily.

• For patients with severe heart failure, the dose can be increased to 50 mg daily if symptoms progress and normokalemia exists, as stated in the guidelines 1.
• It is essential to monitor serum potassium and creatinine levels after 4-6 days of initiating spironolactone therapy and adjust the dose accordingly to prevent hyperkalemia, as recommended by the European Society of Cardiology guidelines 1 and the American College of Cardiology Foundation/American Heart Association task force on practice guidelines 1.
• The development of potassium levels in excess of 5.5 mEq per liter should trigger discontinuation or dose reduction of the aldosterone antagonist, unless patients have been receiving potassium supplementation, which should then be stopped, as recommended by the American College of Cardiology Foundation/American Heart Association task force on practice guidelines 1.
• The most recent and highest quality study, the 2013 ACCF/AHA guideline for the management of heart failure, recommends initiating spironolactone at a dose of 12.5 to 25 mg daily and monitoring potassium levels and renal function closely 1. However, considering the context of the question and the provided evidence, the recommended dose of spironolactone is 25 mg daily, with adjustments based on serum potassium and creatinine levels, as stated in the European Society of Cardiology guidelines 1. Key considerations for spironolactone dosing include:
• Monitoring potassium levels regularly, especially when starting therapy or adjusting doses, as hyperkalemia is a potential side effect, as recommended by the European Society of Cardiology guidelines 1 and the American College of Cardiology Foundation/American Heart Association task force on practice guidelines 1.
• Adjusting dosing for renal impairment, as recommended by the European Society of Cardiology guidelines 1 and the American College of Cardiology Foundation/American Heart Association task force on practice guidelines 1.

From the FDA Drug Label

2 DOSAGE AND ADMINISTRATION

2.1 General Considerations Spironolactone tablets can be taken with or without food, but should be taken consistently with respect to food [see Clinical Pharmacology (12.3)] . 2.2 Treatment of Heart Failure In patients with serum potassium ≤ 5.0 mEq/L and eGFR > 50 mL/min/1. 73 m 2, initiate treatment at 25 mg once daily. Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated. Patients who develop hyperkalemia on 25 mg once daily may have their dosage reduced to 25 mg every other day [see Warnings and Precautions (5.1)] . 2. 3 Treatment of Essential Hypertension The recommended initial daily dose is 25 mg to 100 mg of spironolactone tablets administered in either single or divided doses is recommended. 2. 4 Treatment of Edema The recommended initial daily dosage is 100 mg of spironolactone tablets administered in either single or divided doses, but may range from 25 mg to 200 mg daily. 2. 5 Treatment of Primary Hyperaldosteronism Administer spironolactone tablets in doses of 100 mg to 400 mg daily

The recommended dose of spironolactone varies depending on the condition being treated:

• Heart Failure: 25 mg once daily, potentially increasing to 50 mg once daily
• Essential Hypertension: 25 mg to 100 mg daily
• Edema: 100 mg daily, ranging from 25 mg to 200 mg daily
• Primary Hyperaldosteronism: 100 mg to 400 mg daily 2

From the Research

Spironolactone Dose

The dose of spironolactone can vary depending on the patient's condition and response to treatment.

• In patients with resistant hypertension, a dose of 25-50 mg per day has been shown to be effective in reducing blood pressure 3.
• In older patients with congestive heart failure, a dose of 25 mg per day may be sufficient, but the dose may need to be reduced to 12.5 mg per day in patients with renal impairment to avoid hyperkalemia 4.
• In patients with heart failure and chronic kidney disease, spironolactone may be initiated at a dose of 25 mg per day, but careful monitoring of serum potassium levels is necessary to avoid hyperkalemia 5.
• The risk of hyperkalemia and renal insufficiency associated with spironolactone use can be minimized by careful patient selection and monitoring, and the dose may need to be adjusted accordingly 6.
• A liquid suspension formulation of spironolactone is available, which contains 25 mg/5 mL of spironolactone, and can be used in patients who have difficulty swallowing tablets 7.

Patient Selection and Monitoring

Patient selection and monitoring are crucial when using spironolactone, particularly in patients with renal impairment or those at risk of hyperkalemia.

• Patients with estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73 m2 and potassium < 5.0 mEq/L can be considered for spironolactone therapy 5.
• Patients with renal impairment or those at risk of hyperkalemia require careful monitoring of serum potassium levels and renal function 4, 6.
• The dose of spironolactone may need to be adjusted based on the patient's response to treatment and the presence of any adverse effects 3, 4, 6.