国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
METHYLDOPA (UNII: 56LH93261Y) (METHYLDOPA ANHYDROUS - UNII:M4R0H12F6M)
Mylan Pharmaceuticals Inc.
METHYLDOPA
METHYLDOPA ANHYDROUS 250 mg
ORAL
PRESCRIPTION DRUG
Hypertension. Methyldopa is contraindicated in patients:
Methyldopa Tablets, USP are supplied as film-coated tablets containing either 250 mg or 500 mg of Methyldopa, USP. The 250 mg tablets are beige film-coated, round, unscored tablets debossed with MYLAN on one side of the tablet and 611 on the other side. They are available as follows: NDC 0378-0611-01 bottles of 100 tablets The 500 mg tablets are beige film-coated, capsule-shaped, unscored tablets debossed with MYLAN on one side of the tablet and 421 on the other side. They are available as follows: NDC 0378-0421-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED MAY 2015 MD:R14AQ
Abbreviated New Drug Application
METHYLDOPA- METHYLDOPA TABLET MYLAN PHARMACEUTICALS INC. ---------- DESCRIPTION Methyldopa is an antihypertensive and is the L-isomer of alpha-methyldopa. It is levo-3-(3,4- dihydroxyphenyl)-2-methylalanine sesquihydrate. Methyldopa is supplied as tablets for oral administration, containing 250 mg and 500 mg of methyldopa. The amount of methyldopa is calculated on the anhydrous basis. Its molecular formula is C H NO •1 1/2 H O, with a molecular weight of 238.24, and its structural formula is: Methyldopa is a white to yellowish white, odorless fine powder and is sparingly soluble in water. The tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, triacetin, FD&C yellow No. 6 aluminum lake and FD&C blue No. 2 aluminum lake. 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 a 阅读完整的文件