What is the recommended dosage and usage of Spironolactone (aldosterone antagonist) for various medical conditions?

From the Guidelines

Spironolactone dosing varies by condition, with the most recent and highest quality study recommending 25-100 mg daily for hypertension, and 50-200 mg daily for acne or hirsutism in women. For heart failure, the recommended dose is 12.5-25 mg once daily, gradually increasing to 25-50 mg daily as tolerated 1. Primary hyperaldosteronism typically requires 100-400 mg daily. For edema associated with liver cirrhosis, start with 100 mg daily, adjusting between 25-200 mg based on response. For diuretic-induced hypokalemia, 25-100 mg daily is effective. Spironolactone works by blocking aldosterone receptors, reducing sodium reabsorption and potassium excretion in the kidneys. This medication should be taken with food to enhance absorption and reduce stomach upset. Regular monitoring of potassium levels and kidney function is essential, especially when initiating therapy or adjusting doses, as hyperkalemia is a potential serious side effect. Patients should avoid potassium supplements and high-potassium foods unless specifically directed by their healthcare provider. Full therapeutic effects may take several weeks, particularly for dermatological conditions.

Some key points to consider when prescribing spironolactone include:

• Monitoring potassium levels and kidney function, especially in patients with renal impairment or those taking other medications that affect potassium levels 1
• Avoiding potassium supplements and high-potassium foods unless specifically directed by the healthcare provider
• Starting with a low dose and gradually increasing as needed and tolerated
• Being aware of potential side effects, such as breast tenderness and enlargement, and switching to eplerenone if necessary 1
• Considering the use of spironolactone in combination with other medications, such as diuretics or beta blockers, for optimal treatment of certain conditions 1

Overall, spironolactone is a valuable medication for the treatment of various conditions, including heart failure, hypertension, and acne or hirsutism in women. By following the recommended dosing guidelines and monitoring for potential side effects, healthcare providers can help patients achieve optimal therapeutic effects while minimizing the risk of adverse events.

From the FDA Drug Label

2 DOSAGE AND ADMINISTRATION

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)] . In patients with an eGFR between 30 and 50 mL/min/1. 73 m 2, consider initiating therapy at 25 mg every other day because of the risk of hyperkalemia [see Use in Specific Populations (8.6)]. 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. Dosage can be titrated at two-week intervals. Doses greater than 100 mg/day generally do not provide additional reductions in blood pressure. 2. 4 Treatment of Edema In patients with cirrhosis, initiate therapy in a hospital setting and titrate slowly [see Use in Specific Populations (8. 7)] . 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. When given as the sole agent for diuresis, administer for at least five days before increasing dose to obtain desired effect. 2. 5 Treatment of Primary Hyperaldosteronism Administer spironolactone tablets in doses of 100 mg to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, spironolactone tablets can be used as long-term maintenance therapy at the lowest effective dosage determined for the individual patient.

The recommended dosage and usage of Spironolactone vary depending on the medical condition being treated.

• Heart Failure: 25 mg once daily, potentially increasing to 50 mg once daily as clinically indicated, or reducing to 25 mg every other day if hyperkalemia develops.
• Essential Hypertension: 25 mg to 100 mg daily, administered in single or divided doses, with dosage titration at two-week intervals.
• Edema: 100 mg daily, administered in single or divided doses, with a range of 25 mg to 200 mg daily.
• Primary Hyperaldosteronism: 100 mg to 400 mg daily in preparation for surgery, or as long-term maintenance therapy at the lowest effective dosage determined for the individual patient 2.

From the Research

Recommended Dosage and Usage of Spironolactone

The recommended dosage and usage of Spironolactone, an aldosterone antagonist, vary depending on the medical condition being treated.

• For idiopathic hyperaldosteronism (IHA) and preoperative management of aldosterone producing adenoma (APA), Spironolactone is the treatment of first choice 3.
• In essential hypertension, Spironolactone can be used as a complementary treatment associated with ACE inhibitors and angiotensin receptor antagonists 3.
• For congestive heart failure (CHF), Spironolactone is indicated in the management of oedematous conditions, and its use as adjunctive therapy is currently under investigation 3.
• The therapeutic dose of Spironolactone ranges from 25 to 400 mg per day, effectively controlling blood pressure and hypokalemia in the majority of cases 3.

Side Effects and Precautions

Spironolactone can cause endocrine side effects, including gynecomastia, decreased libido, and impotence in men, and menstrual irregularities in women 3, 4.

• The incidence of sexual side effects can be minimized by decreasing the daily dose of Spironolactone or using derivatives with improved receptor-binding specificity 4.
• Hyperkalemia is a potential risk when using Spironolactone, especially in combination with ACE inhibitors, and patients should be monitored closely for this side effect 5, 6.
• A daily Spironolactone dose of 25 mg should not be exceeded, especially in patients with renal insufficiency, diabetes, or older age 5.

Safety of High-Dose Spironolactone

High doses of Spironolactone (≥50 mg) may be necessary to produce natriuresis in advanced heart failure patients, but the safety of such doses on plasma potassium concentration has been a concern 7.

• A study found that increased doses of Spironolactone (50-200 mg) were generally safe in selected patients with advanced heart failure, with no significant increase in mean serum potassium or serum creatinine 7.
• However, patients should be closely monitored for potential side effects, including hyperkalemia and renal impairment 7.