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--- pfizermedicalinformation com aldactone descriptionALDACTONE® (spironolactone) Dosage and Administration 2 DOSAGE AND ADMINISTRATION 2 1 General Considerations ALDACTONE can be taken with or without food, but should be taken consistently with respect to food [see Clinical Pharmacology (12 3)] 2 2 Treatment of Heart Failure In patients with serumALDACTONE® (spironolactone) Description 11 DESCRIPTION ALDACTONE oral tablets 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: SpironolactoneALDACTONE 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 Combined therapy with spironolactone and an ACE inhibitor has been considered relatively contraindicated because of the potential for developing severe hyperkalemia and inhibition of aldosterone formation; however, clinical studies in patients with moderate or severe heart failure indicate addition of low-dose (25–50 mg daily) spironolactone ALDACTONE® (spironolactone) This product information is intended only for residents of the United States for Consumers: ALDACTONE - U S Medical Information Page - patient information, ways to contact Pfizer Medical & other resources; for Healthcare professionals: ALDACTONE U S Physician Prescribing InformationSpironolactone has been shown to increase the half-life of digoxin Spironolactone enhances the metabolism of antipyrine Spironolactone can interfere with assays for plasma digoxin concentrations Spironolactone binds to the androgen receptor and may increase prostate specific antigen (PSA) levels in abiraterone-treated prostate cancer patients --- drugs com monograph spironolactone htmlALDACTONE 100 mg tablets are round, peach-colored, scored, film-coated, with SEARLE and 1031 debossed on the scored side and ALDACTONE and 100 on the other side, supplied as: NDC - Number Size 0025-1031-31 bottle of 100 Store below 77°F (25°C) Distributed by Pfizer Labs Division of Pfizer Inc New York, NY 10017 Revised: Dec 2022Aldactone may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets Long test: Aldactone is administered at a daily dosage of 400mg for 3to 4weeks Correction of hypokalaemia and hypertension provides presumptive evidence for the diagnosis ofprimary--- pfizermedicalinformation com aldactone dosage-admin--- pfizer com products product-detail aldactoneALDACTONE oral tablets 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 binds to the androgen receptor and may increase prostate specific antigen (PSA) levels in abiraterone-treated prostate cancer patients Use with abiraterone is not recommended labeling pfizer com ShowLabeling aspxALDACTONE® (spironolactone) Indications and Usage Patient information 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® (spironolactone) This product information is intended only for residents of the United States for Consumers: ALDACTONE - U S Medical Information Page - patient information, ways to contact Pfizer Medical & other resources; for Healthcare professionals: ALDACTONE U S Physician Prescribing Information--- pfizermedicalinformation com aldactone highlightsALDACTONE (spironolactone) tablets for oral useInitial U S Approval: To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc at 1-800-438-1985 or FDA at 1 Spironolactone or its metabolites may cross the placental barrier With spironolactone, feminisation has been observed in male rat foetuses The use of Aldactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and foetus Breast-feedingCompared to placebo, spironolactone reduced the risk of death by 30% (plabeling pfizer com ShowLabeling aspx--- rxlist com aldactone-drug htmALDACTONE 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 labeling pfizer com ShowLabeling aspx--- pfizermedicalinformation com patient aldactone indications-usageALDACTONE 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 ( 1 1 )
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