ALPRAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (International Name):

ALPRAZOLAM

Composition:

ALPRAZOLAM 1 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; dizziness or

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 0781-1061-01 bottles of 100 NDC 0781-1061-05 bottles of 500 NDC 0781-1061-10 bottles of 1000 0.5 mg: Oval, peach tablets debossed GG 257 on one side and scored on the reverse side and supplied as: NDC 0781-1077-01 bottles of 100 NDC 0781-1077-05 bottles of 500 NDC 0781-1077-10 bottles of 1000 1 mg: Oval, blue tablets debossed GG 258 on one side and scored on the reverse side and supplied as: NDC 0781-1079-01 bottles of 100 NDC 0781-1079-05 bottles of 500 NDC 0781-1079-10 bottles of 1000 2 mg: Rectangular white multi-scored tablets debossed GG 249 on one side and plain on the reverse side and supplied as: NDC 0781-1089-01 bottles of 100 NDC 0781-1089-05 bottles of 500 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALPRAZOLAM- ALPRAZOLAM TABLET
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
----------
ALPRAZOLAM TABLETS, USP
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, 1
or 2 mg of
alprazolam.
Alprazolam tablets, 2 mg, are multi-scored and may be divided as shown
below:
COMPLETE 2 MG TABLET
TWO 1 MG SEGMENTS
FOUR 0.5 MG SEGMENTS
Inactive ingredients: docusate sodium, lactose monohydrate, magnesium
stearate,
microcrystalline cellulose, pregelatinized starch, and sodium
benzoate. Additionally, the
0.5 MG also contains FD & C Yellow #6 Aluminum Lake, and the 1 MG also
contains FD
& C Blue #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.
PHARMACOKINETICS
Absorption
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 f