ALPRAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

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; dizziness or

Product summary:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. 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
APHENA PHARMA SOLUTIONS - TENNESSEE, 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 SEG MENTS
FOUR 0.5 MG SEG MENTS
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 for the
majority of the b