Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
METHYLDOPATE HYDROCHLORIDE (UNII: 7PX435DN5A) (METHYLDOPA ANHYDROUS - UNII:M4R0H12F6M)
American Regent, Inc.
METHYLDOPATE HYDROCHLORIDE
METHYLDOPATE HYDROCHLORIDE 50 mg in 1 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
METHYLDOPATE HYDROCHLORIDE- METHYLDOPATE HYDROCHLORIDE INJECTION, SOLUTION AMERICAN REGENT, INC. ---------- METHYLDOPATE HCL INJECTION, USP DESCRIPTION Methyldopate HCl Injection, USP, is an antihypertensive agent for intravenous use. Sterile, nonpyrogenic. Methyldopate hydrochloride [levo-3-(3,4-dihydroxyphenyl)-2-methylalanine, ethyl ester hydrochloride] is the ethyl ester of methyldopa, supplied as the hydrochloride salt with a molecular weight of 275.73. Methyldopate hydrochloride is more soluble and stable in solution than methyldopa and is the preferred form for intravenous use. The molecular formula for Methyldopate hydrochloride is C H NO ·HCl and the structural formula is: Each mL contains: Methyldopate Hydrochloride ......... 50 mg Citric Acid (Anhydrous) ................. 5 mg Edetate Disodium ......................... 0.5 mg Monothioglycerol ........................... 2 mg Water for Injection ................q.s. to 1 mL Methylparaben 1.5 mg and Propylparaben 0.2 mg added as preservatives, Sodium Bisulfite 3.2 mg added as an antioxidant. pH adjusted with Sodium Hydroxide and/or Hydrochloric Acid. CLINICAL PHARMACOLOGY Methyldopate, an antihypertensive agent, 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-methyl-norepinephrine, 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 Lees het volledige document