Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
METHYLDOPA (UNII: 56LH93261Y) (METHYLDOPA ANHYDROUS - UNII:M4R0H12F6M)
Chartwell RX, LLC
ORAL
PRESCRIPTION DRUG
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.
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” on one side and plain on the other side. They are supplied as follows: NDC 62135-322-90 bottles of 90 NDC 62135-322-18 bottles of 180 Storage Store Methyldopa Tablets at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Manufactured for: Chartwell RX, LLC Congers, NY 10920 L71158 Rev. 11/2022
New Drug Application
METHYLDOPA- METHYLDOPA TABLET, FILM COATED CHARTWELL RX, LLC ---------- METHYLDOPA TABLETS, USP DESCRIPTION Methyldopa is an antihypertensive drug. Methyldopa, the _L_-isomer of alpha-methyldopa, is levo-3-(3,4-dihydroxyphenyl)-2- methylalanine. Its empirical formula is C H NO , with a molecular weight of 211.22, and its structural formula is: Methyldopa is a white to yellowish white, odorless fine powder, and is soluble in water. Methyldopa Tablets, USP is supplied as tablets, for oral use, in two strengths: 250 mg and 500 mg of methyldopa per tablet. Inactive ingredients in the tablets are: lactose monohydrate, hypromellose , citric acid, corn starch, colloidal silicon dioxide, microcrystalline cellulose, ethyl cellulose, magnesium stearate, and polyethylene glycol. CLINICAL PHARMACOLOGY Methyldopa is an aromatic-amino-acid decarboxylase inhibitor in animals and in man. Although the mechanism of action has yet to be conclusively demonstrated, the antihypertensive effect of methyldopa probably is due to its metabolism to alpha- methylnorepinephrine, which then lowers arterial pressure by stimulation of central inhibitory alpha-adrenergic receptors, false neurotransmission, and/or reduction of plasma renin activity. Methyldopa has been shown to cause a net reduction in the tissue concentration of serotonin, dopamine, norepinephrine, and epinephrine. Only methyldopa, the _L_-isomer of alpha-methyldopa, has the ability to inhibit dopa decarboxylase and to deplete animal tissues of norepinephrine. In man the antihypertensive activity appears to be due solely to the _L_-isomer. About twice the dose of the racemate ( _DL_-alpha-methyldopa) is required for equal antihypertensive effect. Methyldopa has no direct effect on cardiac function and usually does not reduce glomerular filtration rate, renal blood flow, or filtration fraction. Cardiac output usually is maintained without cardiac acceleration. In some patients the heart rate is slowed. Normal or elevated plasma renin activity may decrease in the course of methyld Đọc toàn bộ tài liệu