ALPRAZOLAM tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

ALPRAZOLAM (UNII: YU55MQ3IZY) (ALPRAZOLAM - UNII:YU55MQ3IZY)

Boleh didapati daripada:

Dispensing Solutions, Inc.

INN (Nama Antarabangsa):

ALPRAZOLAM

Komposisi:

ALPRAZOLAM 1 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension  (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity  (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or l

Ringkasan produk:

Alprazolam Tablets, USP are available as: 0.25 mg: White, oval, debossed "2087" over "V" on one side and scored on the reverse side. Bottles of 10    NDC 0603-2127-10    Bottles of 100    NDC 0603-2127-21 Bottles of 30    NDC 0603-2127-16    Bottles of 120    NDC 0603-2127-22 Bottles of 60    NDC 0603-2127-20    Bottles of 500    NDC 0603-2127-28 Bottles of 90    NDC 0603-2127-02    Bottles of 1000  NDC 0603-2127-32 0.5 mg: Peach, oval, debossed "2088" over "V" on one side and scored on the reverse side. Bottles of 10    NDC 0603-2128-10    Bottles of 100    NDC 0603-2128-21 Bottles of 30    NDC 0603-2128-16    Bottles of 120    NDC 0603-2128-22 Bottles of 60    NDC 0603-2128-20    Bottles of 500    NDC 0603-2128-28 Bottles of 90    NDC 0603-2128-02    Bottles of 1000  NDC 0603-2128-32 1 mg: Blue, oval, debossed "2089" over "V" on one side and scored on the reverse side. Bottles of 10    NDC 0603-2129-10    Bottles of 100    NDC 0603-2129-21 Bottles of 30    NDC 0603-2129-16    Bottles of 120    NDC 0603-2129-22 Bottles of 60    NDC 0603-2129-20    Bottles of 500    NDC 0603-2129-28 Bottles of 90    NDC 0603-2129-02    Bottles of 1000  NDC 0603-2129-32 2 mg: White, oblong, multi-scored, beveled edged, debossed "2090" on one side and debossed "V" on the reverse side. Bottles of 10    NDC 0603-2130-10    Bottles of 500    NDC 0603-2130-28 Bottles of 90    NDC 0603-2130-02    Bottles of 1000  NDC 0603-2130-32 Bottles of 100  NDC 0603-2130-21     Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Dispense in tight, light-resistant container.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

ALPRAZOLAM - ALPRAZOLAM TABLET
DISPENSING SOLUTIONS, INC.
----------
ALPRAZOLAM TABLETS, USP
0.25 MG, 0.5 MG, 1 MG AND 2 MG
CIV
RX ONLY
DESCRIPTION
Alprazolam Tablets, USP 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 structural formula is:
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 tablet, for oral administration, contains 0.25, 0.5, 1
or 2 mg of alprazolam.
Alprazolam tablets, 2 mg, are multi-scored and may be divided as shown
below:
Inactive ingredients: Colloidal silicon dioxide, docusate sodium,
lactose monohydrate, magnesium
stearate, microcrystalline cellulose, sodium benzoate and sodium
starch glycolate. In addition, the 0.5
mg tablet contains FD&C Yellow No. 6 Aluminum Lake and the 1 mg tablet
contains FD&C Blue No. 1
Aluminum Lake.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
CNS agents of the 1,4 benzodiazepine class presumably exert their
effects by binding at stereo specific
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, alprazolam is readily absorbed. Peak
concentrations in the plasma occur
in 1 to 2 hours following administration. Plasma levels are
proportionate 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 alprazolam has
been found to be about 11.2 hours
(range: 6.3–26.9 hours) in healthy adults.
Distribution
_In vitro_, alprazolam is bound (80 percent) to human serum protein.
Serum albumin