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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.
- 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;
- ALDACTAZIDE is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with ALDACTAZIDE.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
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 that 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.
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.
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:
|0025-1011-31||bottle of 100|
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:
|0025-1021-31||bottle of 100|
Distributed by: G.D. Searle Division of Pfizer Inc, NY, NY 10017. Revised January 2014
Last reviewed on RxList: 3/21/2014
This monograph has been modified to include the generic and brand name in many instances.
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