Unknown Title

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

Alprazolam (UNII: YU55MQ3IZY) (Alprazolam - UNII:YU55MQ3IZY)

Dostupné s:

Actavis Elizabeth LLC

INN (Mezinárodní Name):

Alprazolam

Léková forma:

TABLET, EXTENDED RELEASE

Složení:

0.5 mg

Podání:

ORAL

Charakteristika produktu

ALPRAZOLAM- ALPRAZOLAM TABLET, EXTENDED RELEASE
ACTAVIS ELIZABETH LLC
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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