Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
METHYLDOPA (UNII: 56LH93261Y) (METHYLDOPA ANHYDROUS - UNII:M4R0H12F6M)
Rebel Distributors Corp
METHYLDOPA
METHYLDOPA ANHYDROUS 250 mg
ORAL
PRESCRIPTION DRUG
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.
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
Abbreviated New Drug Application
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 Lestu allt skjalið