ALPRAZOLAM tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

APOTHECA, INC

Designación común internacional (DCI):

ALPRAZOLAM

Composición:

ALPRAZOLAM 1 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Anxiety Disorders Alprazolam tablets, USP 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; dr

Resumen del producto:

Alprazolam Tablets, USP are supplied as follows: 1 mg — Each blue, round tablet imprinted with on one side and 031 and bisect on the other contains 1 mg of Alprazolam, USP. Tablets are supplied in Bottles of 30 NDC 12634-607-71 Dispense in tight, light-resistant containers as defined in the USP. Keep container tightly closed. Store at controlled room temperature 20° to 25°C (68° to 77°F) ANIMAL STUDIES When rats were treated with alprazolam at 3, 10, and 30 mg/kg/day (15 to 150 times the maximum recommended human dose) orally for 2 years, a tendency for a dose related increase in the number of cataracts was observed in females and a tendency for a dose related increase in corneal vascularization was observed in males. These lesions did not appear until after 11 months of treatment.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ALPRAZOLAM- ALPRAZOLAM TABLET
APOTHECA, INC
----------
ALPRAZOLAM TABLETS, USP
CIV
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 and its structural formula is:
Alprazolam, USP 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 tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg,
and 2 mg of alprazolam, USP. The 2
mg tablets are multi-scored, and may be divided in half to provide two
1 mg segments, or quarters to
provide four 0.5 mg segments.
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide, corn
starch, docusate sodium, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, and
sodium benzoate. The 0.5 mg tablet also contains FD&C yellow #6
aluminum lake (sunset yellow lake).
The 1 mg tablet also contains FD&C blue #2 aluminum lake. The 2 mg
tablet also contains D&C yellow
#10 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 1 to 2 hours following administration. Plasma levels are
proportionate 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 to 26