METHYLDOPA tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional Inc.

INN (International Name):

METHYLDOPA

Composition:

METHYLDOPA ANHYDROUS 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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 51079-200-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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 51079-201-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12198 R1 4/16

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLDOPA- METHYLDOPA TABLET
MYLAN INSTITUTIONAL 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
acc