Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
Alprazolam (UNII: YU55MQ3IZY) (Alprazolam - UNII:YU55MQ3IZY)
Actavis Elizabeth LLC
Alprazolam
TABLET, EXTENDED RELEASE
0.5 mg
ORAL
ALPRAZOLAM- ALPRAZOLAM TABLET, EXTENDED RELEASE ACTAVIS ELIZABETH LLC ---------- UNKNOWN TITLE DESCRIPTION Alprazolam Extended-Release Tablets contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-chloro-1-methyl-6-phenyl-4_H_-_s_-triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C H ClN which corresponds to a molecular weight of 308.76. The structural formula is represented to the right: Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each Alprazolam extended-release tablet, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam. The inactive ingredients are lactose monohydrate, hypromellose, and magnesium stearate. In addition, the 1 mg tablets also contain D&C yellow #10 aluminum lake. The 2 mg tablets also contain FD&C Yellow #6 aluminum lake, and the 3 mg tablets also contain D&C Yellow #10 aluminum lake, and FD&C Blue #2 aluminum lake. CLINICAL PHARMACOLOGY PHARMACODYNAMICS CNS agents of the 1,4 benzodiazepine class presumably exert their effects by binding at stereospecific receptors at several sites within the central nervous system. Their exact mechanism of action is unknown. Clinically, all benzodiazepines cause a dose-related central nervous system depressant activity varying from mild impairment of task performance to hypnosis. PHARMACOKINETICS Absorption Following oral administration of alprazolam (immediate-release) tablets, alprazolam is readily absorbed. Peak concentrations in the plasma occur in one to two hours following administration. Plasma levels are proportional to the dose given; over the dose range of 0.5 to 3.0 mg, peak levels of 8.0 to 37 ng/mL were observed. Using a specific assay methodology, the mean plasma elimination half-life of 17 13 4 alprazolam has been found to be about 11.2 hours (range: 6.3-26.9 hours) in healthy adults. The mean abso Lestu allt skjalið