WARNING
id: da7b136d-d562-4bca-9fb5-2b8b785044b7
displayName: Boxed Warning section
FDA Article Code: 34066-1
Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats (see PRECAUTIONS). Spironolactone should be used only in those conditions described under INDICATIONS AND USAGE. Unnecessary use of this drug should be avoided.
DESCRIPTION
id: caf9dd3f-0b87-4185-b92d-8a3f8223e00d
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Spironolactone Tablets, USP 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 structural formula:
Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform.
INDICATIONS AND USAGE
id: 2532ff37-8101-427a-89dc-5f5f3e2db21e
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Spironolactone is indicated in the management of:
CONTRAINDICATIONS
id: cc118835-71d5-4f95-965f-89baa701fc57
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Spironolactone is contraindicated for patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, or hyperkalemia.
ADVERSE REACTIONS
id: 1fd5bbdb-7b95-442b-a8ad-9727c68abd17
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity.
Digestive:
Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting.
Endocrine:
Gynecomastia (see
PRECAUTIONS
), inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding. Carcinoma of the breast has been reported in patients taking spironolactone but a cause and effect relationship has not been established.
Hematologic:
Agranulocytosis.
Hypersensitivity:
Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis.
Metabolism:
Hyperkalemia (see
WARNINGS
and
PRECAUTIONS
).
Nervous System/Psychiatric:
Mental confusion, ataxia, headache, drowsiness, lethargy.
Liver/Biliary:
A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.
Renal:
Renal dysfunction (including renal failure).
OVERDOSAGE
id: 3c9955e1-38f1-479f-aaeb-dc9948b8fa09
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
The oral LD50 of spironolactone is greater than 1,000 mg/kg in mice, rats, and rabbits.
Acute overdosage of spironolactone may be manifested by drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, or diarrhea. Rarely, instances of hyponatremia, hyperkalemia, or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage. Hyperkalemia may occur, especially in patients with impaired renal function.
HOW SUPPLIED
id: 46f94b24-ffb8-45dc-99dd-db8aad32d57f
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Spironolactone Tablets, USP are available as:
50 mg: white, oval, scored, film-coated tablets, debossed “58” bisect “81” on one side and debossed “V” on the reverse side, supplied in bottles of 60.
PRINCIPAL DISPLAY PANEL
id: fad5d49f-4b66-4e6f-9169-ece5a5aeea79
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
