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Aldactazide (Spironolactone / Hydrochlorothiazide) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Spironolactone, an ingredient of Aldactazide, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions section). Aldactazide should be used only in those conditions described below. Unnecessary use of this drug should be avoided.

Aldactazide is indicated for:

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. The treatment of diuretic-induced hypokalemia in patients with congestive heart failure when other measures are considered inappropriate. The treatment of patients with congestive heart failure taking digitalis when other therapies are considered inadequate or inappropriate.

Cirrhosis of the liver accompanied by edema and/or ascites: Aldosterone levels may be exceptionally high in this condition. Aldactazide 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 an adequate response.

Essential hypertension

For patients with essential hypertension in whom other measures are considered inadequate or inappropriate. In hypertensive patients for the treatment of a diuretic-induced hypokalemia when other measures are considered inappropriate.

Usage in Pregnancy

The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developing toxemia.

Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Aldactazide is indicated in pregnancy when edema is due to pathologic causes just as it is in the absence of pregnancy (however, see Precautions: Pregnancy ). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is unsupported and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

DOSAGE AND ADMINISTRATION

Optimal dosage should be established by individual titration of the components (see boxed Warning ).

Edema in adults (congestive heart failure, hepatic cirrhosis, or nephrotic syndrome)

The usual maintenance dose of Aldactazide is 100 mg each of spironolactone and hydrochlorothiazide daily, administered in a single dose or in divided doses, but may range from 25 mg to 200 mg of each component daily depending on the response to the initial titration. In some instances it may be desirable to administer separate tablets of either Aldactone (spironolactone) or hydrochlorothiazide in addition to Aldactazide in order to provide optimal individual therapy.

The onset of diuresis with Aldactazide occurs promptly and, due to prolonged effect of the spironolactone component, persists for two to three days after Aldactazide is discontinued.

Essential hypertension

Although the dosage will vary depending on the results of titration of the individual ingredients, many patients will be found to have an optimal response to 50 mg to 100 mg each of spironolactone and hydrochlorothiazide daily, given in a single dose or in divided doses.

Concurrent potassium supplementation is not recommended when Aldactazide is used in the long-term management of hypertension or in the treatment of most edematous conditions, since the spironolactone content of Aldactazide is usually sufficient to minimize loss induced by the hydrochlorothiazide component.

HOW SUPPLIED

Aldactazide tablets containing 25 mg of spironolactone (Aldactone) and 25 mg of hydrochlorothiazide are round, tan, film coated, with SEARLE and 1011 debossed on one side and ALDACTAZIDE and 25 on the other side, supplied as:

NDC Number          Size

0025-1011-31        bottle of 100

0025-1011-55        bottle of 2500

Aldactazide tablets containing 50 mg of spironolactone (Aldactone) and 50 mg of hydrochlorothiazide are oblong, tan, scored, film coated, with SEARLE and 1021 debossed on the scored side and ALDACTAZIDE and 50 on the other side, supplied as:

NDC Number          Size

0025-1021-31        bottle of 100

Store below 77°F (25°C).

Rx only

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