ALPRAZOLAM tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

ALPRAZOLAM

Composition:

ALPRAZOLAM 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alprazolam extended-release tablets USP are indicated for the treatment of panic disorder, with or without agoraphobia. This claim is supported on the basis of two positive studies with alprazolam extended-release tablets USP conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL EFFICACY TRIALS ). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing contr

Product summary:

Alprazolam Extended-Release Tablets USP, 0.5 mg are white to off-white, round, biconvex tablets with beveled edge debossed with ‘X’ on one side and ‘70’ on the other side.                   Bottles of 30                 NDC 63187-518-30                   Bottles of 60             NDC 63187-518-60                   Bottles of 90             NDC 63187-518-90 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALPRAZOLAM- ALPRAZOLAM TABLET, EXTENDED RELEASE
PROFICIENT RX LP
----------
ALPRAZOLAM EXTENDED-RELEASE TABLETS USP CIV
RX ONLY
DESCRIPTION
Alprazolam extended-releasetablets 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 molecular formula is C
H ClN which corresponds to a molecular weight of
308.76.
The structural formula is represented below:
Alprazolam USP is a white to off-white, crystalline powder, which is
soluble in methanol or ethanol but
which has no appreciable solubility in water at physiological pH.
Each alprazolam extended-release tablet USP, for oral administration,
contains 0.5 mg, 1 mg, 2 mg, or 3
mg of alprazolam. The inactive ingredients are colloidal silicon
dioxide, hypromellose, lactose
monohydrate, and magnesium stearate. In addition, the 1 mg and 3 mg
tablets contain D&C Yellow No.
10 aluminum lake and the 2 mg and 3 mg tablets contain FD&C Blue No. 2
lake.
Meets USP Dissolution Test 4.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
CNS agents of the 1,4 benzodiazepine class presumably exert their
effects by binding at stereospecific
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
17
13
4
Following oral administration of alprazolam (immediate-release)
tablets, alprazolam is readily absorbed.
Peak concentrations in the plasma occur in one to two hours following
administration. Plasma levels are
proportional 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 adul