DOSAGE AND ADMINISTRATION
Initiation of Therapy
The usual starting dosage of ALDOMET (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 ALDOMET (methyldopa) is given with antihypertensives other than thiazides, the initial dosage of ALDOMET (methyldopa) should be limited to 500 mg daily in divided doses; when ALDOMET (methyldopa) is added to a thiazide, the dosage of thiazide need not be changed.
The usual daily dosage of ALDOMET (methyldopa) is 500 mg to 2 g in two to four doses. Although 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.
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. (See PRECAUTIONS, Pediatric Use.)
No. 3341 — Tablets ALDOMET (methyldopa) , 125 mg, are yellow, film coated, round tablets, coded MSD 135 on one side and ALDOMET (methyldopa) on the other. They are supplied as follows:
NDC 0006-0135-68 bottles of 100.
No. 3290 — Tablets ALDOMET (methyldopa) , 250 mg, are yellow, film coated, round tablets, coded MSD 401 on one side and ALDOMET (methyldopa) on the other. They are supplied as follows:
NDC 0006-0401-68 bottles of 100
(6505-00-890-1856, 250 mg 100's)
NDC 0006-0401-82 bottles of 1000
(6505-00-931-6646, 250 mg 1000's).
No. 3292 — Tablets ALDOMET (methyldopa) , 500 mg, are yellow, film coated, round tablets, coded MSD 516 on one side and ALDOMET (methyldopa) on the other. They are supplied as follows:
NDC 0006-0516-68 bottles of 100
(6505-01-003-4119, 500 mg 100's)
NDC 0006-0516-74 bottles of 500
(6505-01-199-8339, 500 mg 500's).
Store Tablets ALDOMET (methyldopa) in a well-closed container at controlled room temperature [15-30°C (59-86°F)].
Issued July 1998 Printed in USA