Spironolactone has been shown
to be a tumorigen in chronic toxicity studies in rats
(see PRECAUTIONS). Aldactone should be used only in
those conditions described under INDICATIONS AND USAGE.
Unnecessary use of this drug should be avoided.
Aldactone oral tablets contain 25 mg, 50 mg, or 100 mg
of the aldosterone antagonist spironolactone, 17-hydroxy-7alpha-mercapto-3-oxo-17alpha-pregn-4-ene-21-carboxylic
acid gamma-lactone acetate. Spironolactone is practically
insoluble in water, soluble in alcohol, and freely soluble
in benzene and in chloroform. Inactive ingredients include
calcium sulfate, corn starch, flavor, hydroxypropyl methylcellulose,
iron oxide, magnesium stearate, polyethylene glycol, povidone,
and titanium dioxide.
