APO-AMITRIPTYLINE TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

AMITRIPTYLINE HYDROCHLORIDE

Tilgjengelig fra:

APOTEX INC

ATC-kode:

N06AA09

INN (International Name):

AMITRIPTYLINE

Dosering :

75MG

Legemiddelform:

TABLET

Sammensetning:

AMITRIPTYLINE HYDROCHLORIDE 75MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0101524004; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2013-03-19

Preparatomtale

_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