Primary Hyperaldosteronism: For establishing the diagnosis of primary hyperaldosteronism by therapeutic trial.
· Short-term preoperative treatment of patients with primary hyperaldosteronism.
· Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery.

· Long-term maintenance therapy for patients with bilateral micro- or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism).
Edematous Conditions for Patients With:
· Congestive Heart Failure: For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures. Spironolactone is also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate.
· Cirrhosis of the Liver Accompanied by Edema and/or Ascites: Spironolactone levels may be exceptionally high in this condition. Spironolactone is indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium.
· The Nephrotic Syndrome: For nephrotic patients when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide on adequate response.
Essential Hypertension: Usually in combination with other drugs, spironolactone is indicated for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate.
Hypokalemia: For the treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate. Spironolactone is also indicated for the prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate.

Potassium supplementation, either in the form of medication or as a diet rich in potassium, should not ordinarily be given in association with spironolactone therapy. Excessive potassium intake may cause hyperkalemia in ... click here to view more

Spironolactone is contraindicated for patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, or hyperkalemia.

The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity.Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting.Endocrine: Gynecomastia (see PRECAUTIONS), inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding.

Carcinoma of the breast has been reported in patients taking spironolactone but a cause and effect relationship has not been established. Hematologic:Agranulocytosis.Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis.Nervous System/Psychiatric: Mental confusion, ataxia, headache, drowsiness, lethargy.Liver/Biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.

ACE Inhibitors: Concomitant administration of ACE inhibitors with potassium-sparing diuretics has been associated with severe hyperkalemia. Alcohol, Barbiturates, or Narcotics: Potentiation of orthostatic hypotension may occur.Corticosteroids, ACTH:

Intensified electrolyte depletion, particularly hypokalemia, may occur.Pressor Amines (e.g., Norepinephrine): Spironolactone reduces the vascular responsiveness to norepinephrine. Therefore, caution should be exercised in the management of patients subjected to regional or general anesthesia while they are being treated with spironolactone.
Skeletal Muscle Relaxants, Nondepolarizing (e.g., Tubocurarine): Possible increased responsiveness to the muscle relaxant may result.Lithium: Lithium generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity.Nonsteroidal Anti-inflammatory Drugs (NSAIDs): In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of loop, potassium-sparing and thiazide diuretics. Combination of NSAIDs, (e.g., indomethacin, with potassium-sparing diuretics) has been associated with severe hyperkalemia. Therefore, when spironolactone and NSAIDs are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained. Digoxin: Spironolactone has been shown to increase the half-life of digoxin. This may result in increased serum digoxin levels and subsequent digitalis toxicity. It may be necessary to reduce the maintenance and digitalization doses when spironolactone is administered, and the patient should be carefully monitored to avoid over- or underdigitalization.

The oral LD50 of spironolactone is greater than 1000 mg/kg in mice, rats, and rabbits.
Acute overdosage of spironolactone may be manifested by drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, or diarrhea. Rarely, instances of hyponatremia, hyperkalemia, or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage. Hyperkalemia may occur, especially in patients with impaired renal function.

Primary Hyperaldosteronism Spironolactone may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.

Edema in Adults: Congestive Heart Failure, Hepatic Cirrhosis or Nephrotic Syndrome: An initial daily dosage of 100 mg of spironolactone administered in either single or divided doses is recommended, but may range from 25 to 200 mg daily. When given as the sole agent for diuresis, spironolactone should be continued for at least five days at the initial dosage level, after which it may be adjusted to the optimal therapeutic or maintenance level administered in either single or divided daily doses. If, after five days, an adequate diuretic response to spironolactone has not occurred, a second diuretic which acts more proximally in the renal tubule may be added to the regimen. Because of the additive effect of spironolactone when administered concurrently with such diuretics, an enhanced diuresis usually begins on the first day of combined treatment; combined therapy is indicated when more rapid diuresis is desired. The dosage of spironolactone should remain unchanged when other diuretic therapy is added.
Essential Hypertension: For adults, an initial daily dosage of 50 to 100 mg of spironolactone administered in either single or divided doses is recommended. Spironolactone may also be given with diuretics which act more proximally in the renal tubule or with other antihypertensive agents. Treatment with spironolactone should be continued for at least two weeks, since the maximum response may not occur before this time. Subsequently, dosage should be adjusted according to the response of the patient.
Hypokalemia: Spironolactone in a dosage ranging from 25 to 100 mg daily is useful in treating a diuretic-induced hypokalemia, when oral potassium supplements or other potassium-sparing regimens are considered inappropriate.

Patients who receive spironolactone should be advised to avoid potassium supplements and foods containing high levels of potassium including salt substitutes.