Usual Adult Dose for Hypertension

Hydrochlorothiazide 50 to 100 mg-Spironolactone 50 to 100 mg orally daily in 1 to 2 divided doses

Uses:

• Treatment of essential hypertension when other measures are considered inadequate or inappropriate.
• Treatment of diuretic-induced hypokalemia in hypertensive patients when other measures are considered inappropriate.
• Treatment of hypertension.

Usual Adult Dose for Edema

Hydrochlorothiazide 25 to 200 mg-Spironolactone 25 to 200 mg orally daily in 1 to 2 divided doses

Usual Adult Dose for Congestive Heart Failure

Hydrochlorothiazide 25 to 200 mg-Spironolactone 25 to 200 mg orally daily in 1 to 2 divided doses

Uses:

• Management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures.
• Treatment of diuretic-induced hypokalemia in patients with congestive heart failure (CHF) when other measures are considered inappropriate.
• Treatment of patients with CHF taking digitalis when other therapies are considered inadequate or inappropriate.

Usual Adult Dose for Ascites

Hydrochlorothiazide 25 to 200 mg-Spironolactone 25 to 200 mg orally daily in 1 to 2 divided doses

Use: Maintenance therapy together with bed rest and fluid and sodium restriction for cirrhosis of the liver accompanied by edema and/or ascites.

Usual Adult Dose for Nephrotic Syndrome

Hydrochlorothiazide 25 to 200 mg-Spironolactone 25 to 200 mg orally daily in 1 to 2 divided doses

Use: For nephrotic patients when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:

• TUMORIGEN: Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats. This drug should only be used in the conditions for which it is indicated. Unnecessary use of this drug should be avoided.
• COMBINATION THERAPY: Fixed-dose combination drugs are not indicated for initial therapy of edema or hypertension. Edema and hypertension require therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. The treatment of hypertension and edema is not static but must be reevaluated as conditions in each patient warrant.

Dialysis

Data not available

Other Comments

General: The spironolactone content of this drug is usually sufficient to minimize potassium loss induced by the hydrochlorothiazide component; concurrent potassium supplementation is not recommended when this drug is used for the long-term management of hypertension or in the treatment of most edematous conditions.

Monitoring: Assess serum electrolytes periodically, especially in the elderly and this with significant renal or hepatic impairment.

Patient advice:

• Inform patients taking this drug to avoid potassium supplements and foods containing high levels of potassium including salt substitutes.
• Advise patients to use caution when driving or operating machinery until the response to initial treatment has been determined.