METHYLDOPA tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Carilion Materials Management

INN (nemzetközi neve):

METHYLDOPA

Összetétel:

METHYLDOPA ANHYDROUS 250 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Hypertension. 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 this product. - on therapy with monoamine oxidase (MAO) inhibitors.

Termék összefoglaló:

NDC:68151-2791-5 in a BOTTLE of 1 TABLET, FILM COATEDS

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

METHYLDOPA- METHYLDOPA TABLET, FILM COATED
CARILION MATERIALS MANAGEMENT
----------
METHYLDOPA TABLETS, USP RX ONLY
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 125 mg, 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 , 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: pregelatinized
starch, sodium starch glycolate,
povidone, microcrystalline cellulose, magnesium stearate,
hypromellose, FD&C yellow #6 lake and
titanium dioxide. In addition 125 mg and 250 mg tablets contain corn
starch.
CLINICAL PHARMACOLOGY
Methyldopa is an aromatic-aminoacid 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