INDICATIONS
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
|
|
