ALDACTONE 50MG TABLET
Spironolactone is (1) Pregn-4-ene-21-carboxylic acid, 7-(acetylthio)-17-hydroxy-3-oxo-, ?-lactone (7a,17a)-; (2) 17-Hydroxy-7a-mercapto-3-oxo-17a-pregn-4-ene-21-carboxylic acid, ?-lactone acetate.
Its empirical formula is C24H32O4S and molecular weight is 416.57.
Spironolactone contains not <97% and not >103% of C24H32O4S, calculated on the dried basis.
Indications / Uses :
Essential hypertension. Short-term preoperative treatment of patients with primary hyperaldosteronism. Establishing a diagnosis of primary hyperaldosteronism. Congestive heart failure (alone or in combination with standard therapy), including severe heart failure [New York Heart Association (NYHA) Class III-IV] to increase survival and reduce the risk of hospitalization when used in addition to standard therapy. Conditions in which secondary hyperaldosteronism may be present, including liver cirrhosis accompanied by edema and/or ascites, nephrotic syndrome, and other edematous conditions (alone or in combination with standard therapy). Diuretic-induced hypokalemia/hypomagnesemia as adjunctive therapy. Management of hirsutism.
Should be taken with food.
Hypersensitivity to spironolactone or to any of the excipients of Aldactone. Acute renal insufficiency, significant renal compromise, anuria, Addison’s disease, hyperkalemia. Concomitant use of eplerenone.
Special Precautions :
Concomitant use of spironolactone with other potassium-sparing diuretics, ACE inhibitors, nonsteroidal anti-inflammatory drugs, angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparin, or other drugs or conditions known to cause hyperkalemia, potassium supplements, a diet rich in potassium or other potassium-sparing agents is not recommended as it may induce hyperkalemia.
Periodic estimation of serum electrolytes is recommended due to the possibility of hyperkalemia, hyponatremia and possible transient blood urea nitrogen (BUN) elevation, especially in the elderly and/or in patients with pre-existing impaired renal or hepatic function.
Somnolence and dizziness have been reported to occur in some patients. Caution is advised when driving or operating machinery until the response to initial treatment has been determined.
Reversible hyperchloremic metabolic acidosis, usually in association with hyperkalemia, has been reported to occur in some patients with decompensated hepatic cirrhosis, even when renal function is normal.
Hyperkalemia in Patients with Severe Heart Failure: Hyperkalemia may be fatal. It is critical to monitor and manage serum potassium in patients with severe heart failure receiving spironolactone. Avoid using other potassium-sparing diuretics. Avoid using oral potassium supplements in patients with serum potassium >3.5 mEq/L. The recommended monitoring for potassium and creatinine is 1 week after initiation or increase in dose of spironolactone, monthly for the first 3 months, then quarterly for a year, and then every 6 months. Discontinue or interrupt treatment for serum potassium >5 mEq/L or for serum creatinine >4 mg/dL (see Dosage & Administration).
Effects on the Ability to Drive or Operate Machinery: See Precautions.
Impairment of Fertility: Spironolactone was devoid of teratogenic effects in mice. Rabbits receiving spironolactone showed reduced conception rate, increased resorption rate and lower number of live births. No embryotoxic effects were seen in rats administered high dosages, but limited, dosage related hypoprolactinemia and decreased ventral prostate and seminal vesicle weights in males, and increased luteinizing hormone secretion and ovarian and uterine weights in females were reported. Feminization of the external genitalia of male fetuses was reported in another study in rats.