Aldactone (spironolactone) is indicated in the management of:

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. Aldactone 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: Aldosterone levels may be exceptionally high in this condition. Aldactone 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

Usually in combination with other drugs, Aldactone 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. Aldactone is also indicated for the prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or 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.

Aldactone 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.

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

Long test: Aldactone is administered at a daily dosage of 400 mg for three to four weeks. Correction of hypokalemia and of hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.

Short test: Aldactone is administered at a daily dosage of 400 mg for four days. If serum potassium increases during Aldactone administration but drops when Aldactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered.

After the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, Aldactone may be administered in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, Aldactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.

Edema in adults (congestive heart failure, hepatic cirrhosis, or nephrotic syndrome). An initial daily dosage of 100 mg of Aldactone 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, Aldactone 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 Aldactone 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 Aldactone 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 Aldactone should remain unchanged when other diuretic therapy is added.

Essential hypertension. For adults, an initial daily dosage of 50 to 100 mg of Aldactone administered in either single or divided doses is recommended. Aldactone may also be given with diuretics which act more proximally in the renal tubule or with other antihypertensive agents. Treatment with Aldactone 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. Aldactone in a dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic-induced hypokalemia, when oral potassium supplements or other potassium-sparing regimens are considered inappropriate.

HOW SUPPLIED

Aldactone 25-mg tablets are round, light yellow, film coated, with SEARLE and 1001 debossed on one side and ALDACTONE and 25 on the other side, supplied as:

NDC Number             Size
0025-1001-31             bottle of 100
0025-1001-51             bottle of 500
0025-1001-55             bottle of 2500

Aldactone 50-mg tablets are oval, light orange, scored, film coated, with SEARLE and 1041 debossed on the scored side and ALDACTONE and 50 on the other side, supplied as:

NDC Number             Size
0025-1041-31             bottle of 100
0025-1041-34             carton of 100 unit dose

Aldactone 100-mg tablets are round, peach colored, scored, film coated, with SEARLE and 1031 debossed on the scored side and ALDACTONE and 100 on the other side, supplied as:

NDC Number             Size
0025-1031-31             bottle of 100
0025-1031-34             carton of 100 unit dose

Store below 77°F (25°C).

Rx only. Revised: July 2003
G.D. Searle LLC., A subsidiary of Pharmacia Corporation., Chicago, IL 60680, USA
FDA rev date: 12/26/2002

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