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Edematous conditions for patients with CHF, cirrhosis of the liver accompanied edema or ascites, nephrotic syndrome, or essential hypertension.


Patients with anuria; acute renal insufficiency, significant impairment of renal excretory function; severe hepatic failure; hyperkalemia; hypersensitivity to any component of product or sulfonamide-derived drugs.

Adverse reactions:

Cardiovascular Hypotension (including orthostatic). CNS Mental confusion; ataxia; headache; drowsiness; lethargy; vertigo; paresthesia; dizziness; restlessness. Dermatologic Urticaria; rash; purpura; erythema multiforme; pruritus. EENT Transient blurred vision; xanthopsia. GI Gastric bleeding; ulceration; gastritis; diarrhea and cramping; nausea; vomiting; sialadenitis; constipation; gastric irritation; anorexia; pancreatitis. Genitourinary Gynecomastia; inability to achieve and maintain erection; irregular menses; amenorrhea; postmenopausal bleeding; renal dysfunction; renal failure; interstitial nephritis. Hematologic Agranulocytosis; aplastic anemia; leukopenia; hemolytic anemia; thrombocytopenia. Hepatic Mixed cholestatic/hepatocellular toxicity; jaundice (intrahepatic cholestatic jaundice). Metabolic Electrolyte imbalance; hyperglycemia; glycosuria; hyperuricemia. Respiratory Respiratory distress (including pneumonitis and pulmonary edema.) Miscellaneous Hypersensitivity (fever, urticaria, maculopapular or erythematous cutaneous eruptions); vasculitis; weakness; anaphylactic reactions; necrotizing angiitis; photosensitivity; fever; muscle spasm.


ACE inhibitors (eg, captopril) Severe hyperkalemia may occur. Alcohol, barbiturates, narcotics Orthostatic hypotension may be potentiated. Antidiabetic agents (oral and insulin) May require dosage adjustment of antidiabetic agent. Corticosteroids, ACTH Electrolyte depletion, particularly hypokalemia, may occur. Digoxin The t½ of digoxin may be prolonged and serum levels may be elevated, increasing the risk of toxicity. Lithium Renal clearance of lithium may be decreased, increasing the risk of toxicity. Nondepolarizing skeletal muscle relaxants (eg, tubocurarine) Unresponsiveness to muscle relaxant may occur. NSAIDs (eg, indomethacin) The diuretic, natriuretic, and antihypertensive effect of hydrochlorothiazide may be reduced. Pressor amines (eg, norepinephrine) The vascular response to norepinephrine may be reduced.


Pregnancy Category C . Lactation Canrenone, a major and active metabolite of spironolactone, is excreted in breast milk. Children Safety and efficacy not established. Special Risk Patients Use with caution in patients with severe renal disease or impaired hepatic function. Combination Therapy Fixed-dose combination therapy is not indicated for initial therapy of edema or hypertension. Therapy should be titrated to the individual. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. Electrolyte imbalance and BUN increase Hyperkalemia (serum potassium greater than 5.5 mEq/L) hyponatremia, hypochloremia, and increases in BUN may occur. Systemic lupus erythematosus (SLE) Hydrochlorothiazide may exacerbate or activate SLE.



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