Aldax

Aldax

spironolactone

Manufacturer:

Maxtar Bio-genics

Distributor:

Cathay YSS
Concise Prescribing Info
Contents
Spironolactone
Indications/Uses
Diagnosis of primary hyperaldosteronism. Short-term pre-op treatment of patients w/ primary hyperaldosteronism. Long-term maintenance therapy for patients w/ discrete aldosterone-producing adrenal adenomas who are poor operative risks or who decline surgery &/ or for patients w/ bilateral micro- or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). CHF, including severe heart failure (NYHA class III-IV) to increase survival & reduce the risk of hospitalization when used in addition to standard therapy. Liver cirrhosis accompanied by edema &/ or ascites. Nephrotic syndrome. Essential HTN. Treatment & prophylaxis of hypokalemia.
Dosage/Direction for Use
Primary hyperaldosteronism Long test: 400 mg daily for 3-4 wk. Short test: 400 mg daily for 4 days. Pre-op: 100-400 mg daily. Edema in adult w/ CHF, hepatic cirrhosis or nephrotic syndrome Initially 100 mg in single or divided doses or 25-200 mg daily. Sole agent for diuresis: Continued for at least 5 days at the initial dosage level, may be adjusted to the optimal therapeutic or maintenance level administered in either single or divided daily doses. Essential HTN Initially 50-100 mg in single or divided doses. Hypokalemia 25-100 mg daily. Severe heart failure (NYHA class III-IV) Patient w/ serum K </5 mEq/L & serum creatinine </2.5 mg/dL 25 mg once daily. May increase to 50 mg once daily if tolerated. May reduce to 25 mg every other day if not tolerated.
Administration
Should be taken with food.
Contraindications
Patients w/ anuria, acute renal insufficiency, significant impairment of renal excretory function, or hyperkalemia.
Special Precautions
Fluid or electrolyte imbalance eg, hypomagnesemia, hyponatremia, hypochloremic alkalosis & hyperkalemia. Hyperkalemia may occur in patients w/ impaired renal function or excessive K intake & can cause cardiac irregularities. Reversible hyperchloremic metabolic acidosis. Dilutional hyponatremia. Gynecomastia. Avoid K supplements & foods containing high levels of K including salt substitutes. Not to be administered concurrently w/ other K-sparing diuretics; lithium. Concomitant use w/ ACE inhibitors or indomethacin. Periodic determination of serum electrolytes at appropriate intervals, particularly in elderly & those w/ significant renal or hepatic impairment. Determine serum & urine electrolyte in vomiting patients. May cause transient elevation of BUN especially in patients w/ preexisting renal impairment. Pregnancy & lactation. Childn.
Adverse Reactions
Gastric bleeding, ulceration, gastritis, diarrhea & cramping, nausea, vomiting; gynecomastia, inability to achieve or maintain erection, irregular menses or amenorrhea, post-menopausal bleeding; agranulocytosis; fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis; mental confusion, ataxia, headache, drowsiness, lethargy; mixed cholestatic/hepatocellular toxicity; renal dysfunction (including renal failure).
Drug Interactions
Severe hyperkalemia w/ ACE inhibitors. Potentiation of orthostatic hypotension w/ alcohol, barbiturates or narcotics. Hypokalemia w/ corticosteroids, ACTH. Reduces the vascular responsiveness to norepinephrine. Increase muscle relaxant responsiveness w/ tubocurarine. Reduce renal clearance & increase toxicity of lithium. Reduce diuretic, natriuretic, & anti-hypertensive effect of loop, K-sparing & thiazide diuretics w/ NSAIDs. Digitalis toxicity w/ digoxin.
MIMS Class
Diuretics / Other Antihypertensives
ATC Classification
C03DA01 - spironolactone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.
Presentation/Packing
Form
Aldax tab 25 mg
Packing/Price
30's
Form
Aldax tab 50 mg
Packing/Price
30's
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