INDICATIONS
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 p.o. 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.
DOSAGE AND ADMINISTRATION
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
|
|
