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:

Rebel Distributors Corp.

INN (International Name):

ALPRAZOLAM

Composition:

ALPRAZOLAM 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alprazolam extended-release tablets 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 conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). 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 control; (11) fear of dying; (

Product summary:

Alprazolam Extended-Release Tablets are available as follows: 0.5 mg (green, round, biconvex tablets, debossed "IP 9" on one side) Bottles of 30: NDC 21695-602-60 1 mg (yellow, round, biconvex tablets, debossed "IP 10" on one side) Bottles of 30: NDC 21695-603-60 2 mg (blue, round, biconvex tablets, debossed "IP 12" on one side) Bottles of 30: NDC 21695-604-60 3 mg (white, round, biconvex tablets, debossed "IP 13" on one side) Bottles of 30: NDC 21695-605-60 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Rx Only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALPRAZOLAM - ALPRAZOLAM TABLET, EXTENDED RELEASE
REBEL DISTRIBUTORS CORP.
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ALPRAZOLAM EXTENDED-RELEASE TABLETS
Rx Only
DESCRIPTION
Alprazolam extended-release tablets contain alprazolam which is a
tri-azolo 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-4H-s-triazolo [4,3-a] [1,4]
benzodiazepine.
The molecular formula is C
H CIN which corresponds to a molecular weight of 308.76.
The structural formula is represented below:
Alprazolam is a 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 for oral administration
contains 0.5 mg, 1 mg, 2 mg, or 3 mg of
alprazolam. The inactive ingredients are lactose monohydrate,
hypromellose, calcium silicate and
magnesium stearate. In addition, the 0.5 mg tablet contains FD&C Blue
#2 and D&C Yellow #10. The 1
mg tablet contains D&C Yellow #10. The 2 mg tablet contains FD&C Blue
#2.
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 3.0 mg,
peak levels of 8.0 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: 6.3-26.9
hours) in healthy adults.
The mean absolute bioavailability of alprazolam fro