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.
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
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Spironolactone is indicated in the management of:
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.
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.
Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting.
), 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.
Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis.
Mental confusion, ataxia, headache, drowsiness, lethargy.
A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.
Renal dysfunction (including renal failure).
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.
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
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4