METHYLDOPA tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

METHYLDOPA

Composition:

METHYLDOPA ANHYDROUS 250 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 available as white to off-white, round, convex, unscored, film-coated tablets, debossed “N11” on one side, and plain on the other side, containing 250 mg of methyldopa USP, packaged in bottles of 90 tablets. PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Iss. 12/2008 Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Repackaged by: REBEL DISTRIBUTORS CORP. Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLDOPA- METHYLDOPA TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
----------
METHYLDOPA TABLETS USP
RX ONLY
DESCRIPTION
Methyldopa USP is an antihypertensive drug.
Methyldopa USP is the L-isomer of alpha-methyldopa. Its chemical name
is levo-3-(3,4-
dihydroxyphenyl)- 2-methylalanine sesquihydrate. Its structural
formula is:
C
H NO • 1 1/2 H O M.W. 238.24
Methyldopa USP is a white to yellowish white, odorless fine powder and
is sparingly soluble in water.
Each tablet, for oral administration, contains 250 mg or 500 mg of
methyldopa USP. Potency is
calculated in the anhydrous basis. Inactive ingredients: citric acid,
colloidal silicon dioxide, edetate
disodium, ethylcellulose, hypromellose, magnesium stearate,
methylcellulose, polyethylene glycol,
sodium starch glycolate, and titanium dioxide. In addition, the 250 mg
tablet contains calcium sulfate,
hydroxypropyl cellulose, and talc, and the 500 mg tablet contains
polysorbate 80.
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 mai