Methyldopa

Indications

INDICATION AND USAGE Hypertension.

Dosage and administration (summary)

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.

Contraindications

CONTRAINDICATIONS Methyldopa is contraindicated in patients: — with active hepatic disease, such as acute hepatitis and active cirrhosis — with liver disorders previously associated with methyldopa therapy ( see WARNINGS ) — with hypersensitivity to any component of these products. — on therapy with monoamine oxidase (MAO) inhibitors.

Warnings and precautions

WARNINGS It is important to recognize that a positive Coombs test, hemolytic anemia, and liver disorders may occur with methyldopa therapy. The rare occurrences of hemolytic anemia or liver disorders could lead to potentially fatal complications unless properly recognized and managed. Read this section carefully to understand these reactions. With prolonged methyldopa therapy, 10 to 20 percent of patients develop a positive direct Coombs test which usually occurs between 6 and 12 months of methyldopa therapy. Lowest incidence is at daily dosage of 1 g or less.

Storage and supply

HOW SUPPLIED Methyldopa Tablets, USP , 250 mg, are White, round film coated tablets, debossed with “CE” over “87” on one side and plain on the other side. They are supplied as follows: NDC 62135-321-90 bottles of 90 NDC 62135-321-18 bottles of 180 Methyldopa Tablets, USP , 500 mg, are White, round film coated tablets, debossed with “CE” over “88” o…

Source: Methyldopa (Methyldopa) — US FDA prescribing information, 2025-03-26, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.