ALDACTONE (Spironolactone Tablets, USP) 1 Indications

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ALDACTONE (spironolactone) is indicated for:

  • Primary Hyperaldosteronism

    • ALDACTONE (spironolactone) is a useful agent in the diagnosis of primary hyperaldosteronism. In the presence of hypokalemic alkalosis and hypertension, a diagnosis of primary hyperaldosteronism should be considered if both blood pressure (BP) and serum electrolytes return to normal following treatment with ALDACTONE.

    ALDACTONE is useful in the pre-operative treatment of patients with primary hyperaldosteronism and for the maintenance therapy of such patients who decline surgery, or who are unsuitable for surgery.

  • Edematous Conditions
    • Congestive Heart Failure (CHF):
      ALDACTONE is useful in the management of edema and sodium retention in CHF when the patient is only partially responsive to, or intolerant of, other therapeutic measures.
      ALDACTONE may be used alone or with thiazides. It is indicated in patients with CHF taking digitalis when other therapies are considered inappropriate.
    • Cirrhosis of the Liver Accompanied by Edema and/or Ascites:
      Aldosterone levels may be exceptionally high in this condition. ALDACTONE is indicated for maintenance therapy, in combination with bed rest and the restriction of fluid and sodium.
    • The Nephrotic Syndrome:
      ALDACTONE is useful for inducing a diuresis in patients not responsive to glucocorticoid therapy (for the nephrotic syndrome), and not responding to other diuretics. However, ALDACTONE has not been shown to affect the basic pathological process.
  • Essential Hypertension
    ALDACTONE is indicated, usually in combination with other drugs, for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate. ALDACTONE alone has mild to moderate antihypertensive activity.
  • Hypokalemia
    ALDACTONE is indicated for treatment of hypokalemia, when other measures are considered inappropriate or inadequate. It is also indicated for the prophylaxis of hypokalemia in digitalis therapy when other measures are inadequate or inappropriate.

1.1 Pediatrics (<18 years of age):

Based on the data submitted and reviewed by Health Canada, the safety and efficacy of ALDACTONE in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.

1.2 Geriatrics:

Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness.