APO-ALPRAZ TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ALPRAZOLAM

Disponible depuis:

APOTEX INC

Code ATC:

N05BA12

DCI (Dénomination commune internationale):

ALPRAZOLAM

Dosage:

1MG

forme pharmaceutique:

TABLET

Composition:

ALPRAZOLAM 1MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Targeted (CDSA IV)

Domaine thérapeutique:

BENZODIAZEPINES

Descriptif du produit:

Active ingredient group (AIG) number: 0115008003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2001-03-29

Résumé des caractéristiques du produit

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
............................................