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    Aldactone is used to treat heart failure, high blood pressure (hypertension), or hypokalemia ( low potassium levels in the blood) Aldactone also treats fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver, or a kidney disorder called nephrotic syndrome Aldactone is also used to diagnose or treat a condition ALDACTONE can cause gynecomastia In RALES, patients with heart failure treated with a mean dose of 26 mg of spironolactone once daily, about 9% of the male subjects developed gynecomastia The risk of gynecomastia increases in a dose-dependent manner with an onset that varies widely from 1–2 months to over a year --- pfizermedicalinformation com aldactone warnings--- drugs com aldactone htmlAnimal Data Teratology studies with ALDACTONE have been carried out in mice and rabbits at doses of up to 20 mg kg day On a body surface area basis, this dose in the mouse is substantially below the maximum recommended human dose and, in the rabbit, approximates the maximum recommended human dose 2 3 Treatment of Essential Hypertension The recommended initial daily dose is 25 to 100 mg of ALDACTONE administered in either single or divided doses is recommended Dosage can be titrated at two-week intervals Doses greater than 100 mg day generally do not provide additional reductions in blood pressure ALDACTONE ® ( spironolactone ) This product information is intended only for residents of the United States for Healthcare professionals: ALDACTONE U S Physician Prescribing Information ; ALDACTONE U S Medical Information Page - clinical & safety information, ways to contact Pfizer Medical & other resources --- pfizermedicalinformation com aldactone indications-usage ALDACTONE is indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions By competing with aldosterone for receptor sites, spironolactone provides effective therapy for the edema and ascites in those conditions Spironolactone counteracts secondary aldosteronism induced by the volume depletion and associated sodium loss caused by active diuretic therapy --- pfizermedicalinformation com aldactone medguide--- pfizermedicalinformation com aldactone The recommended initial daily dose is 25 to 100 mg of ALDACTONE administered in either single or divided doses is recommended Dosage can be titrated at two-week intervals Doses greater than 100 mg day generally do not provide additional reductions in blood pressure ALDACTONE is an aldosterone antagonist indicated for: • The treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure • Use as an add-on therapy for the treatment of hypertension, to lower blood pressure Distribution Spironolactone and its metabolites are more than 90% bound to plasma proteins Elimination The mean half-life of spironolactone is 1 4 hour The mean half-life values of its metabolites including canrenone, 7-α- (thiomethyl) spirolactone (TMS), and 6-β-hydroxy-7-α- (thiomethyl) spirolactone (HTMS) are 16 5, 13 8, and 15 hours --- pfizermedicalinformation com aldactone drug-interactions 17 PATIENT COUNSELING INFORMATION Patients who receive ALDACTONE should be advised to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes This product's label may have been updated For current full prescribing information, please visit --- pfizer com Pfizer Safety Pfizer Safety Reporting Site ALDACTONE® (spironolactone) Drug Interactions 7 DRUG INTERACTIONS 7 1 Drugs and Supplements Increasing Serum Potassium Concomitant administration of ALDACTONE with potassium supplementation or drugs that can increase potassium may lead to severe hyperkalemia In general, discontinue potassium --- pfizermedicalinformation com aldactone dosage-adminALDACTONE® (spironolactone) Medication Guide 17 PATIENT COUNSELING INFORMATION Patients who receive ALDACTONE should be advised to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes This product's label may have been updated For current full prescribing or call ALDACTONE® (spironolactone) Indications and Usage 1 INDICATIONS AND USAGE 1 1 Heart Failure ALDACTONE is indicated for treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure ALDACTONE 5 3 Electrolyte and Metabolic Abnormalities In addition to causing hyperkalemia, ALDACTONE can cause hyponatremia, hypomagnesemia, hypocalcemia, hypochloremic alkalosis, and hyperglycemia Asymptomatic hyperuricemia can occur and rarely gout is precipitated --- pfizermedicalinformation com aldactone clinical-pharmacology--- pfizer com products product-detail aldactone1 1 Heart Failure ALDACTONE is indicated for treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure ALDACTONE is usually administered in conjunction with other heart failure therapies ALDACTONE® (spironolactone) This product information is intended only for residents of the United States for Healthcare professionals: ALDACTONE U S Physician Prescribing Information ; ALDACTONE U S Medical Information Page - clinical & safety information, ways to contact Pfizer Medical & other resources--- pfizermedicalinformation com aldactone population-use

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