Aldactone

Aldactone

spironolactone

Manufacturer:

Piramal Healthcare

Distributor:

Pfizer
Concise Prescribing Info
Contents
Spironolactone
Indications/Uses
Essential HTN. Short-term pre-op treatment of patients w/ primary hyperaldosteronism. Diagnosis of primary hyperaldosteronism. CHF (alone or in combination w/ standard therapy), including severe heart failure (NYHA class III-IV) to increase survival & 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 &/or ascites, nephrotic syndrome, & other edematous conditions (alone or in combination w/ standard therapy). Diuretic-induced hypokalemia/hypomagnesemia as adjunctive therapy. Management of hirsutism.
Dosage/Direction for Use
Essential HTN Adult 50-100 mg daily. May be gradually increased at interval of 2 wk up to 200 mg daily for difficult or severe cases. Continue treatment for at least 2 wk to ensure adequate response to therapy. CHF Initially 100 mg daily as single or divided doses, but may range from 25-200 mg daily. Severe heart failure in conjunction w/ standard therapy (NYHA class III-IV) Patient w/ serum K ≤5 mEq/L & serum creatinine ≤2.5 mg/dL Initially 25 mg once daily. May be increased to 50 mg once daily if tolerated, or reduced to 25 mg every other day if not tolerated. Cirrhosis Adult w/ urinary Na+/K+ ratio >1 100 mg daily; urinary Na+/K+ ratio <1 200-400 mg daily. Nephrotic syndrome Adult 100-200 mg daily. Edema in childn Initially 3 mg/kg daily in divided doses. Diagnosis & treatment of primary hyperaldosteronism Adult Long test: 400 mg daily for 3-4 wk. Short test: 400 mg daily for 4 days. Short-term pre-op treatment of primary hyperaldosteronism 100-400 mg daily in prep for surgery. Hypokalemia/hypomagnesemia 25-100 mg daily. Management of hirsutism 100-200 mg daily in divided doses.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Acute renal insufficiency, significant renal compromise anuria; Addison's disease; hyperkalemia. Concomitant use of eplerenone.
Special Precautions
Concomitant use is not recommended w/ other K-sparing diuretics, ACE inhibitors, NSAIDs, angiotensin II antagonists, aldosterone blockers, heparin, low molecular wt heparin or other drugs or conditions known to cause hyperkalemia, K supplements, diet rich in K or other K-sparing agents. Possibility of hyperkalemia, hyponatremia & possible transient BUN. Avoid using other K-sparing diuretics. Reversible hyperchloremic metabolic acidosis. Hyperkalemia in patients w/ severe heart failure. May impair ability to drive or operate machines. Pregnancy & lactation.
Adverse Reactions
Benign breast neoplasm in male; agranulocytosis, leukopenia, thrombocytopenia; hyperkalemia, electrolyte imbalance; confusional state, libido disorder; dizziness; nausea, GI disorder; abnormal hepatic function; pruritus, rash, urticaria, TEN, SJS, DRESS, alopecia, hypertrichosis; muscle spasms; acute kidney injury; gynecomastia, breast pain, menstrual disorder; malaise.
Drug Interactions
Severe hyperkalemia w/ drugs known to cause hyperkalemia. May have an additive effect w/ other diuretics & antihypertensives. Reduced vascular responsiveness to norepinephrine. Increased t½ of digoxin. May attenuate natriuretic efficacy w/ NSAIDs eg, aspirin, indomethacin, & mefenamic acid. Enhanced metabolism of antipyrine. Interferes w/ assays for plasma digoxin conc. Hyperkalemic metabolic acidosis w/ ammon Cl or cholestyramine. Decreased efficacy w/ carbenoxolone. May increase PSA levels in abiraterone-treated prostate cancer patients.
MIMS Class
Diuretics / Other Antihypertensives
ATC Classification
C03DA01 - spironolactone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.
Presentation/Packing
Form
Aldactone FC tab 100 mg
Packing/Price
100's (P5,184.98/pack)
Form
Aldactone FC tab 25 mg
Packing/Price
100's (P1,530.66/pack)
Form
Aldactone FC tab 50 mg
Packing/Price
100's (P2,496.35/pack)
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