ALPRAZOLAM tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

RedPharm Drug, Inc.

Designación común internacional (DCI):

ALPRAZOLAM

Composición:

ALPRAZOLAM 0.25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Anxiety Disorders Alprazolam Tablets, USP (alprazolam) 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 cla

Resumen del producto:

Alprazolam Tablets, USP are available as follows: 0.25 mg (white, oval, scored on one side: S left of bisect 900 to right) Bottles of 90 NDC 67253-900-09 Bottles of 100 NDC 67253-900-10 Bottles of 500 NDC 67253-900-50 Bottles of 1000 NDC 67253-900-11 0.5 mg (yellow, oval, scored on one side; S left of bisect 901 to right) Bottles of 100 NDC 67253-901-10 Bottles of 500 NDC 67253-901-50 Bottles of 1000 NDC 67253-901-11 1 mg (green, oval, scored on one side; S left of bisect 902 to right) Bottles of 100 NDC 67253-902-10 Bottles of 500 NDC 67253-902-50 Bottles of 1000 NDC 67253-902-11 2 mg (green, elongated, rectangular-shaped, multi-scored; S left of bisect, 90 center and 3 to right) Bottles of 100 NDC 67253-903-10 Bottles of 500 NDC 67253-903-50 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx only

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ALPRAZOLAM- ALPRAZOLAM TABLET
REDPHARM DRUG, INC.
----------
BOXED WARNING
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound
sedation,
respiratory depression, coma, and death (see WARNINGS, DRUG
INTERACTIONS).
Reserve concomitant prescribing of these drugs for use in patients for
whom
alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and
sedation.
DESCRIPTION
Alprazolam Tablets, 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-4H-s-triazolo [4,3-α]
[1,4] benzodiazepine.
The structural formula is represented to the right:
[Alprazolam Chemical Structure]
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 Tablet, USP, for oral administration, contains 0.25,
0.5, 1 or 2 mg of
alprazolam.
Inactive ingredients: crospovidone, docusate sodium, lactose,
magnesium stearate,
microcrystalline cellulose, silicon dioxide, sodium benzoate and
starch 1500. In addition,
the 0.5 mg tablet contains D&C Yellow No. 10 and the 1 mg and 2 mg
tablet contains
Green Lake Blend.
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 1 to 2 hours following administration. Plasma levels
are proportionate to
the dose given; over the d