Aldactone

Aldactone

spironolactone

Manufacturer:

Pfizer

Distributor:

Zuellig
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/day. Difficult or severe cases May be gradually increased at intervals of 2-wk up to 200 mg/day. CHF Initially 100 mg single or divided doses or 25-200 mg daily. Severe heart failure in conjunction w/ standard therapy (NYHA class III-IV) Patient w/ serum K ≤5.0 mEq/L & serum creatinine ≤2.5 mg/dL 25 mg once daily. May be increased to 50 mg once daily if tolerated. Patients who do not tolerate 25 mg/day may have their dose reduced to 25 mg every other day. Cirrhosis 100 mg/day in patient w/ urinary Na+/K+ ratio >1.0 & 200-400 mg/day. Nephrotic syndrome 100-200 mg/day. Edema in childn Initially 3 mg/kg daily in divided doses. Maintenance: Reduce to 1-2 mg/kg. Diagnosis & treatment of primary hyperaldosteronism Long test: 400 mg/day for 3-4 wk. Short test: 400 mg/day 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/day, preferably 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 w/ other K-sparing diuretics, ACE inhibitors, NSAIDs, angiotensin II antagonists, aldosterone blockers, heparin, LMWH. Periodically estimate serum electrolytes. Reversible hyperchloremic metabolic acidosis. Avoid using oral K supplements in patients w/ serum K >3.5 mEq/L. Monitor K & creatinine 1 wk after initiation or increase in dose of spironolactone, mthly for the 1st 3 mth, quarterly for a yr & then every 6 mth. Discontinue or interrupt treatment if serum K is >5 mEq/mL or serum creatinine is >4 mg/dL. May impair ability to drive or operate machinery. Pregnancy & lactation.
Adverse Reactions
Benign breast neoplasm in male; agranulocytosis, leucopenia, thrombocytopenia; electrolyte imbalance, hyperkalemia; changes in libido, confusion; dizziness; nausea, GI disturbances, abnormal hepatic function; pruritus, rash, urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction w/ eosinophilia & systemic symptoms (DRESS), alopecia, hypertrichosis; muscle spasms; acute kidney injury; gynecomastia, breast pain, menstrual disorder; malaise.
Drug Interactions
Severe hyperkalemia w/ drugs known to cause hyperkalemia. Additive effect w/ other diuretics & antihypertensives. Reduce vascular responsiveness to norepinephrine; increase t½ of digoxin; enhance metabolism of antipyrine; interfere w/ assays for plasma digoxin conc. NSAIDs may attenuate the natriuretic efficacy of diuretics. Hyperkalemic metabolic acidosis w/ ammonium Cl or cholestyramine. Decreased efficacy w/ carbenoxolone.
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 (P5,190.22/pack)
Form
Aldactone FC tab 25 mg
Packing/Price
100's (P1,534.35/pack)
Form
Aldactone FC tab 50 mg
Packing/Price
100's (P2,501.07/pack)
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