METHYLDOPA tablet, film coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

METHYLDOPA (UNII: 56LH93261Y) (METHYLDOPA ANHYDROUS - UNII:M4R0H12F6M)

MAH:

Chartwell RX, LLC

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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.

leaflet_short:

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

authorization_status:

New Drug Application

SPC

METHYLDOPA- METHYLDOPA TABLET, FILM COATED
CHARTWELL RX, LLC
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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