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ALDACTONE®(spironolactone)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
ALDACTONE® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Heart Failure
ALDACTONE is indicated for treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival,...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 General Considerations
ALDACTONE can be taken with or without food, but should be taken consistently with respect to food...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
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,...
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Contraindications
4 CONTRAINDICATIONS
ALDACTONE is contraindicated in the patients with:
- •
- Hyperkalemia
- •
- Addison's disease
- •
- Concomitant use of eplerenone
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hyperkalemia
ALDACTONE can cause hyperkalemia. This risk is increased by impaired renal function or concomitant potassium...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- •
- Hyperkalemia [see Warnings and Precautions (5.1...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Drugs and Supplements Increasing Serum Potassium
Concomitant administration of ALDACTONE with potassium supplementation or drugs that can...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on mechanism of...
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Overdosage
10 OVERDOSAGE
The oral LD50 of ALDACTONE is greater than 1000 mg/kg in mice, rats, and rabbits.
Acute overdosage of ALDACTONE may be manifested by drowsiness, mental confusion, maculopapular or...
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Description
11 DESCRIPTION
ALDACTONE oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Spironolactone and its active metabolites are specific pharmacologic antagonists of aldosterone, acting primarily...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Heart Failure
The Randomized Aldactone Evaluation Study (RALES) was a placebo controlled, double-blind study of the effect of spironolactone...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
ALDACTONE 25 mg tablets are round, light yellow, film-coated, with SEARLE and 1001 debossed on one side and ALDACTONE and 25 on the other side, supplied as:
...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Patients who receive ALDACTONE should be advised to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes.
This product's label may have...
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.