Aldactone Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
Aldactone is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
1 INDICATIONS AND USAGE ALDACTONE is an aldosterone antagonist indicated for: • The treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1 ). • Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.2 ). • The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease,.
What should I know before taking it?
ALDACTONE is contraindicated in the patients with: •Hyperkalemia •Addison's disease •Concomitant use of eplerenone
What important warnings are listed?
5 WARNINGS AND PRECAUTIONS • Hyperkalemia: Monitor serum potassium within one week of initiation and regularly thereafter ( 5.1 ). • Hypotension and Worsening Renal Function: Monitor volume status and renal function periodically ( 5.2 ). • Electrolyte and Metabolic Abnormalities: Monitor serum electrolytes, uric acid and blood glucose periodically ( 5.3 ). • Gynecomastia: ALDACTONE can cause gynecomastia ( 5.4 ). 5.1 Hyperkalemia ALDACTONE can cause hyperkalemia. This risk is increased by impaired renal function or concomitant potassium supplementation, potassium-containing salt substitutes or drugs that increase potassium, such as angiotensin converting enzyme inhibitors and angiotensin.
How is this medication usually taken?
Tablets: 25 mg round, light yellow, film-coated, with SEARLE and 1001 debossed on one side and ALDACTONE and 25 on the other side. Tablets: 50 mg oval, light orange, scored, film-coated, with SEARLE and 1041 debossed on the scored side and ALDACTONE and 50 on the other side. Tablets: 100 mg round, peach-colored, scored, film-coated, with SEARLE and 1031 debossed on the scored side and ALDACTONE and 100 on the other side.
What side effects are listed?
The following clinically significant adverse reactions are described elsewhere in the labeling: •Hyperkalemia [see Warnings and Precautions (5.1)] •Hypotension and Worsening Renal Function [see Warnings and Precautions (5.2)] •Electrolyte and Metabolic Abnormalities [see Warnings and Precautions (5.3)] •Gynecomastia [see Warnings and Precautions (5.4] •Impaired neurological function/ coma in patients with hepatic impairment, cirrhosis and ascites [see Use in Specific Populations (8.7)] The following adverse reactions associated with the use of spironolactone were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of.
What interactions are listed?
7 DRUG INTERACTIONS • Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia ( 5.1 , 7.1 ). • Lithium: Increased risk of lithium toxicity ( 7.2 ). • NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of ALDACTONE ( 7.3 ). • Digoxin: ALDACTONE can interfere with radioimmunologic assays of digoxin exposure ( 7.4 ). • Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use ( 7.5 ). • Acetylsalicylic Acid (ASA): ASA may reduce the efficacy of ALDACTONE ( 7.6 ). • Abiraterone: May increase prostate-specific antigen (PSA) levels ( 7.7 ). • Mitotane: Avoid concomitant use of ALDACTONE and mitotane ( 7.8 ). 7.1.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.