APO-ALPRAZ TS TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ALPRAZOLAM

Disponible desde:

APOTEX INC

Código ATC:

N05BA12

Designación común internacional (DCI):

ALPRAZOLAM

Dosis:

2MG

formulario farmacéutico:

TABLET

Composición:

ALPRAZOLAM 2MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Targeted (CDSA IV)

Área terapéutica:

BENZODIAZEPINES

Resumen del producto:

Active ingredient group (AIG) number: 0115008004; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2001-03-29

Ficha técnica

Page 1 of 41
PRODUCT MONOGRAPH
APO-ALPRAZ
ALPRAZOLAM TABLETS USP
0.25 MG, 0.5 MG AND 1.0 MG TABLETS
APO-ALPRAZ TS
ALPRAZOLAM TABLETS USP 2 MG TRISCORED TABLETS
ANXIOLYTIC-ANTIPANIC
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
November 3, 2021
TORONTO, ONTARIO
M9L 1T9
Submission Control No: 256073
Page 2 of 41
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY PRODUCT INFORMATION
................................................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................................................
3
CONTRAINDICATIONS
...........................................................................................................................................
5
WARNINGS AND PRECAUTIONS
..........................................................................................................................
5
ADVERSE REACTIONS
.........................................................................................................................................
13
DRUG INTERACTIONS
..........................................................................................................................................
16
DOSAGE AND ADMINISTRATION
......................................................................................................................
20
OVERDOSAGE
........................................................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
....................................................................................................
22
STORAGE AND STABILITY
..................................................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................