ALDACTONE- spironolactone tablet, film coated
G.D. Searle LLC Division of Pfizer Inc
ALDACTONE oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7?-mercapto-3-oxo-17?-pregn-4-ene-21-carboxylic acid ?-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, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.
ACTIONS CLINICAL PHARMACOLOGY
Mechanism of action
ALDACTONE (spironolactone) is specific pharmacologic antagonist of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. ALDACTONE causes increased amounts of sodium and water to be excreted, while potassium is retained. ALDACTONE acts both as diuretic and as an antihypertensive drug by this mechanism. It may be given alone or with other diuretic agents that act more proximally in the renal tubule.
ALDACTONE is effective in lowering the systolic and diastolic blood pressure in patients with primary hyperaldosteronism. It is also effective in most cases of essential hypertension, despite the fact that aldosterone secretion may be within normal limits in benign essential hypertension.
INDICATIONS AND USAGE
ALDACTONE (spironolactone) is indicated in the management of:
Primary hyperaldosteronism
Edematous conditions
Congestive heart failure
Cirrhosis of the liver accompanied by edema and/or ascites
Nephrotic syndrome
Essential hypertension
Hypokalemia
Severe heart failure (NYHA class III IV)
CONTRAINDICATIONS
ALDACTONE is contraindicated for patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, hyperkalemia, Addison?s disease, and with concomitant use of eplerenone.
WARNINGS
Potassium supplementation
Potassium supplementation, either in the form of medication or as diet rich in potassium, should not ordinarily be given in association with ALDACTONE therapy. Excessive potassium intake may cause hyperkalemia in patients receiving ALDACTONE
ALDACTONE should not be administered concurrently with other potassium-sparing diuretics.
