Aldoril (Methyldopa / Chlorothiazide) - Indications and Dosage

INDICATION AND USAGE

Hypertension (see box warning).

DOSAGE AND ADMINISTRATION

DOSAGE MUST BE INDIVIDUALIZED, AS DETERMINED BY TITRATION OF THE INDIVIDUAL COMPONENTS (see box warning). Once the patient has been successfully titrated, ALDORIL may be substituted if the previously determined titrated doses are the same as in the combination. The usual starting dosage is one tablet of ALDORIL 15 two or three times a day or one tablet of ALDORIL 25 two times a day. Alternatively, one tablet of ALDORIL D30 or ALDORIL D50 once daily may be used. Hydrochlorothiazide doses greater than 50 mg daily should be avoided.

Hydrochlorothiazide can be given at doses of 12.5 to 50 mg per day when used alone. The usual daily dosage of methyldopa is 500 mg to 2 g. To minimize the sedation associated with methyldopa, start dosage increases in the evening. The maximum recommended daily dose of methyldopa is 3 g.

Occasionally tolerance to methyldopa may occur, usually between the second and third month of therapy. Additional separate doses of methyldopa or replacement of ALDORIL with single entity agents is necessary until the new effective dose ratio is re-established by titration. If ALDORIL does not adequately control blood pressure, additional doses of other agents may be given. When ALDORIL is given with antihypertensives other than thiazides, the initial dosage of methyldopa should be limited to 500 mg daily in divided doses and the dose of these other agents may need to be adjusted to effect a smooth transition.

Since both components of ALDORIL have 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.

Since methyldopa is largely excreted by the kidney, 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. (See PRECAUTIONS, Geriatric Use.)

HOW SUPPLIED

No. 3294 — Tablets ALDORIL 15 are salmon, round, film coated tablets, coded MSD 423 on one side and ALDORIL on the other. Each tablet contains 250 mg of methyldopa and 15 mg of hydrochlorothiazide. They are supplied as follows:

NDC 0006-0423-68 bottles of 100.

No. 3295 — Tablets ALDORIL 25 are white, round, film coated tablets, coded MSD 456 on one side and ALDORIL on the other. Each tablet contains 250 mg of methyldopa and 25 mg of hydrochlorothiazide. They are supplied as follows:

NDC 0006-0456-68 bottles of 100

NDC 0006-0456-82 bottles of 1000.

No. 3362 — Tablets ALDORIL D30 are salmon, oval, film coated tablets, coded MSD 694 on one side and ALDORIL on the other. Each tablet contains 500 mg of methyldopa and 30 mg of hydrochlorothiazide. They are supplied as follows:

NDC 0006-0694-68 bottles of 100.

No. 3363 — Tablets ALDORIL D50 are white, oval, film coated tablets, coded MSD 935 on one side and ALDORIL on the other. Each tablet contains 500 mg of methyldopa and 50 mg of hydrochlorothiazide. They are supplied as follows:

NDC 0006-0935-68 bottles of 100.

Storage

Keep container tightly closed. Protect from light, moisture, freezing, –20°C (–4°F) and store at controlled room temperature, 15-30°C (59-86°F).

MERCK& CO., Inc., Whitehouse Station, NJ 08889, USA

Issued February 2004

Printed in USA

7843556