Indications:

Short-term preoperative treatment of primary hyperaldosteronism; long-term maintenance therapy for idiopathic hyperaldosteronism; management of edematous conditions in CHF, cirrhosis of liver, and nephrotic syndrome; essential hypertension; treatment of hypokalemia; long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas; increase survival and reduce need for hospitalization for severe heart failure (New York Heart Association [NYHA] class III to IV). Unlabeled Uses Treatment of hirsutism in women.

Contraindications:

Acute renal insufficiency; anuria; hyperkalemia; impaired renal excretory function.

Adverse reactions:

Cardiovascular Vasculitis. CNS Ataxia; drowsiness; headache; lethargy; mental confusion. Dermatologic Erythematous or maculopapular cutaneous eruptions; urticaria. GI Cramping; diarrhea; gastritis; GI bleeding; nausea; ulceration; vomiting. Genitourinary Amenorrhea; breast carcinoma; gynecomastia; inability to achieve or maintain an erection; irregular menses; postmenopausal bleeding. Hematologic-Lymphatic Agranulocytosis. Hepatic Mixed cholestatic/hepatocellular toxicity. Hypersensitivity Anaphylactic reactions. Metabolic-Nutritional Hyperkalemia. Renal Renal dysfunction including renal failure Miscellaneous Fever.

Interactions:

ACE inhibitors May result in severely elevated serum potassium levels. Alcohol, barbiturates, narcotics Orthostatic hypotension may be potentiated. Angiotensin II receptor antagonists (eg, candesartan, losartan, telmisartan) Risk of hyperkalemia, especially in patients with renal impairment or type 2 diabetes, may be increased. Corticosteroids Increased risk of electrolyte depletion, particularly hypokalemia. Digitalis glycosides May decrease digoxin clearance, resulting in increased serum digoxin levels and toxicity; may attenuate inotropic action of digoxin. Diuretics Risk of dilutional hyponatremia may be increased. Mitotane May decrease therapeutic response to mitotane. Salicylates May result in decreased diuretic effect. Lithium Lithium clearance may be reduced, increasing the risk of toxicity. Nondepolarizing muscle relaxants (eg, tubocurarine) Increased responsiveness to muscle relaxant effect may occur. NSAIDs (eg, indomethacin) Risk of severe hyperkalemia may be increased. Potassium preparations May severely increase serum potassium levels, possibly resulting in cardiac arrhythmias or cardiac arrest. Do not take with potassium preparations. Pressor amines (eg, norepinephrine) Vascular responsiveness to norepinephrine may be decreased. Use with caution in patients receiving regional or general anesthesia.

Warnings:

Pregnancy Category D . Lactation Excreted in breast milk. Children Safety and efficacy not established. Renal Function Contraindicated in patients with anuria, acute renal insufficiency, and/or significant impairment of renal excretory function. Transient elevation of BUN may occur, particularly in patients with preexisting renal impairment. Hepatic Function Use with caution because minor alterations in fluid and electrolyte balance may precipitate hepatic coma. Acidosis Reversible hyperchloremic metabolic acidosis, usually in association with hyperkalemia, has been reported in patients with decompensated hepatic cirrhosis. Electrolyte imbalances and BUN increase Hyperkalemia (serum potassium more than 5.5 mEq/L), hyponatremia, hypochloremia, and increases in BUN may occur. Gynecomastia Gynecomastia, related to both dose and duration of treatment, may occur. Severe heart failure Hyperkalemia may be fatal. Discontinue or interrupt treatment for serum potassium more than 5 mEq/L or serum creatine more than 4 mg/dL.

Form:

SOLUTION FOR INJECTION