ALPRAZOLAM- alprazolam tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health

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 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

Product summary:

Alprazolam Tablets, USP are available containing 0.25 mg, 0.5 mg or 1 mg of alprazolam, USP. The 0.25 mg tablets are white, round, scored tablets debossed with MYLAN over A on one side of the tablet and scored on the other side. They are available overbagged with 10 tablets per bag, NDC 55154-5553-0 The 0.5 mg tablets are peach, round, scored tablets debossed with MYLAN over A3 on one side of the tablet and scored on the other side. They are available overbagged with 10 tablets per bag, NDC 55154-5451-0 The 1 mg tablets are blue, round, scored tablets debossed with MYLAN over A1 on one side of the tablet and scored on the other side. They are available overbagged with 10 tablets per bag, NDC 55154-5499-0 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALPRAZOLAM- ALPRAZOLAM TABLET
CARDINAL HEALTH
----------
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 represented below.
M.W. 308.77 C17H13CLN4
M.W. 308.77 C17H13ClN4
Alprazolam, USP is a white crystalline powder, which is soluble in
methanol or ethanol but which has
no appreciable solubility in water at physiological pH.
Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg
or 2 mg of alprazolam, USP.
Inactive ingredients are: colloidal silicon dioxide, croscarmellose
sodium, docusate sodium, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, sodium
benzoate and sodium lauryl
sulfate. 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. 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
ABS ORPTION
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 mg 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.
DIS TRIBUTION
_In vitro_, alprazolam is bound (80 percent) to human serum protein.
Serum albumin accounts for the
majority of the binding.
METABOLIS M/ELIMINATION
Alprazolam is extensively metab