INDICATIONS
Hypertension.
DOSAGE AND ADMINISTRATION
ADULTS
Initiation of Therapy
The usual starting dosage of methyldopa is 250 mg two
or three times a day in the first 48 hours. The daily
dosage then may be increased or decreased, preferably
at intervals of not less than two days, until an adequate
response is achieved. To minimize the sedation, start
dosage increases in the evening. By adjustment of dosage,
morning hypotension may be prevented without sacrificing
control of afternoon blood pressure. When methyldopa is
given to patients on other antihypertensives, the dose
of these agents may need to be adjusted to effect a smooth
transition. When methyldopa is given with antihypertensives
other than thiazides, the initial dosage of methyldopa
should be limited to 500 mg daily in divided doses; when
methyldopa is added to a thiazide, the dosage of thiazide
need not be changed.
Maintenance Therapy
The usual daily dosage of methyldopa is 500 mg to 2 g
in two to four doses. Althoug h occasional patients have
responded to higher doses, the maximum recommended daily
dosage is 3 g. Once an effective dosage range is attained,
a smooth blood pressure response occurs in most patients
in 12 to 24 hours. Since methyldopa has a relatively short
duration of action, withdrawal is followed by return of
hypertension usually within 48 hours. This is not complicated
by an overshoot of blood pressure. Occasionally tolerance
may occur, usually between the second and third month
of therapy. Adding a diuretic or increasing the dosage
of methyldopa frequently will restore effective control
of blood pressure.
A thiazide may be added at any time during methyldopa
therapy and is recommended if therapy has not been started
with a thiazide or if effective control of blood pressure
cannot be maintained on 2 g of methyldopa daily. Methyldopa
is largely excreted by the kidney and patients with impaired
renal function may respond to smaller doses. Syncope in
older patients may be related to an increased sensitivity
and advanced arteriosclerotic vascular disease. This may
be avoided by lower doses.
CHILDREN
Initial dosage is based on 10 mg/kg of body weight daily
in two to four doses. The daily dosage then is increased
or decreased until an adequate response is achieved. The
maximum dosage is 65 mg/kg or 3 g daily, whichever is
less.
HOW SUPPLIED
Methyldopa tablets, USP are available as round, white,
film-coated tablets, debossed 22931, containing 250 mg
of methyldopa USP, packaged in bottles of 100, 500 and
1000 tablets and as round, white, film-coated tablets,
debossed 22932, containing 500 mg of methyldopa USP, packaged
in bottles of 100 and 500 tablets.
PHARMACIST: Dispense in a well-closed
container as defined in the USP. Use child-resistant closure.
Store at controlled room temperature 15º-30º
C (59º-86º F).
CAUTION: Federal law prohibits dispensing
without prescription.
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