ALPRAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RedPharm Drug Inc.

INN (International Name):

Alprazolam

Composition:

Alprazolam .25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 six 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;

Product summary:

Alprazolam tablets, USP for oral administration are available as: 0.25 mg: Oval, white tablets debossed GG 256 on one side and scored on the reverse side and supplied as: NDC 67296-0431-1 bottles of 10 NDC 67296-0431-2 bottles of 30

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALPRAZOLAM - ALPRAZOLAM TABLET
REDPHARM DRUG INC.
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ALPRAZOLAM TABLETS
DESCRIPTION
Alprazolam 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 to off-white crystalline powder, which is
soluble in alcohol but which has no
appreciable solubility in water at physiological pH.
Each alprazolam tablet, for oral administration, contains 0.25, 0.5,
or 1 mg of alprazolam. Inactive
ingredients: docusate sodium, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
pregelatinized starch, and sodium benzoate.
Alprazolam is a white to off-white crystalline powder, which is
soluble in alcohol but which has no
appreciable solubility in water at physiological pH. Additionally, the
0.5 MG also contains FD and C
Yellow No. 6 Aluminum Lake, and the 1 MG also contains FD and C Blue
No. 2 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.
PharmacokineticsAbsorption
Following oral administration, alprazolam is readily absorbed. Peak
concentrations in the plasma occur
in one to two hours following administration. Plasma levels are
proportionate to the dose given; over
the dose range of 0.5 to 3 mg, peak levels of 8 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 to 26.9 hours) in healthy adults.
Distribution
_In vitro_, alprazolam is bound (80 percent) to human serum protein.
Serum albumin accounts for the
majority of the binding