From the Guidelines
Spironolactone is primarily indicated for several conditions including heart failure with reduced ejection fraction, primary hyperaldosteronism, edema associated with liver cirrhosis or nephrotic syndrome, hypertension (particularly resistant hypertension), and female pattern hair loss or hirsutism related to polycystic ovary syndrome (PCOS), as well as central serous chorioretinopathy (CSC) based on recent evidence 1.
Indications and Dosage
For heart failure, it's typically dosed at 25-50 mg daily to reduce mortality and hospitalizations by blocking aldosterone receptors, which helps prevent cardiac remodeling and reduces potassium excretion, as shown in the RALES trial 1 and supported by the EPHESUS trial 1.
- In hyperaldosteronism, doses range from 100-400 mg daily to counteract excess aldosterone production.
- For edema management, 25-200 mg daily helps promote diuresis while conserving potassium.
- When treating hirsutism or acne in women, lower doses of 25-200 mg daily are used to block androgen receptors.
- For CSC, spironolactone has been shown to improve visual acuity, reduce choroidal thickness, and decrease subretinal fluid, with dosages ranging from 25-50 mg daily 1.
Important Considerations
Important considerations include monitoring serum potassium levels, as hyperkalemia is a significant risk, especially in patients with renal impairment or those taking other potassium-sparing medications, as noted in several studies 1.
- Spironolactone should be avoided in patients with severe renal dysfunction (GFR <30 mL/min), hyperkalemia, or those taking other potassium-sparing diuretics or potassium supplements without careful monitoring.
- The use of spironolactone in CSC, while promising, requires further prospective randomized controlled trials to fully evaluate its clinical benefits, as highlighted in recent guidelines 1.
From the FDA Drug Label
1 INDICATIONS AND USAGE
Indications and usage 1.1 Heart Failure Spironolactone tablets are indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure. 1.2 Hypertension Spironolactone tablets are indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. 1.3 Edema Associated with Hepatic Cirrhosis or Nephrotic Syndrome Spironolactone tablets are indicated for the management of edema in the following settings: Cirrhosis of the liver when edema is not responsive to fluid and sodium restriction Nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response. 1.4 Primary Hyperaldosteronism Spironolactone tablets are indicated in the following settings: Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery
The indications for spironolactone are:
- Heart Failure: treatment of NYHA Class III-IV heart failure and reduced ejection fraction
- Hypertension: add-on therapy to lower blood pressure in patients not adequately controlled on other agents
- Edema: management of edema associated with hepatic cirrhosis or nephrotic syndrome
- Primary Hyperaldosteronism: short-term preoperative treatment and long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery 2
From the Research
Indications for Spironolactone
The indications for spironolactone include:
- Heart failure with reduced ejection fraction, as it has been shown to halt disease progression and have significant beneficial effects on both morbidity and mortality 3
- Resistant hypertension 3
- Edema in patients with cirrhosis 3
- Heart failure with preserved ejection fraction, as recent data indicate that spironolactone may offer some symptomatic relief in these patients 3
- Congestive heart failure, as spironolactone adds to the activity of thiazide and loop diuretics to enhance the elimination of sodium and water, and minimizes unwanted electrolyte disturbances such as hypokalemia and hypomagnesemia 4
Additional Uses
Spironolactone may also be used in other on- and off-label uses, although the specific details of these uses are not provided in the available evidence 3.
Patient Selection
When selecting patients for spironolactone therapy, it is important to consider factors such as estimated glomerular filtration rate (eGFR) and potassium levels, as patients with eGFR > 30 mL/min/1.73 m2 and potassium < 5.0 mEq/L are at lower risk for hyperkalemia 5. Close follow-up by a dedicated heart failure team can also help minimize the risk of adverse events and complications 6.