APO-AMITRIPTYLINE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

AMITRIPTYLINE HYDROCHLORIDE

Disponible depuis:

APOTEX INC

Code ATC:

N06AA09

DCI (Dénomination commune internationale):

AMITRIPTYLINE

Dosage:

25MG

forme pharmaceutique:

TABLET

Composition:

AMITRIPTYLINE HYDROCHLORIDE 25MG

Mode d'administration:

ORAL

Unités en paquet:

100/1000/3000/(10X10)

Type d'ordonnance:

Prescription

Domaine thérapeutique:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0101524002; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2013-03-19

Résumé des caractéristiques du produit

_APO-AMITRIPTYLINE (Amitriptyline Hydrochloride Tablets) _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr APO-AMITRIPTYLINE
Amitriptyline hydrochloride tablets
Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral
USP
Antidepressant
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada, M9L 1T9
Date of Initial Authorization:
March 13, 2013
Date of Revision:
October 31, 2023
Submission Control Number: 276872
_APO-AMITRIPTYLINE (Amitriptyline Hydrochloride Tablets) _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
10/2023
7 WARNINGS AND PRECAUTIONS
10/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
10/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.................................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
..................................................................................................................
4
1.1
Pediatrics
....................................................................................................................
4
1.2
Geriatrics
....................................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................ 5
4
DOSAGE AND ADMINISTRATION
....................................................................................
6
4.1
Dosing Considerations
................................................................................................
6
4.2
Recommended Dose and