PMS-AMITRIPTYLINE TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

AMITRIPTYLINE HYDROCHLORIDE

Tilgængelig fra:

PHARMASCIENCE INC

ATC-kode:

N06AA09

INN (International Name):

AMITRIPTYLINE

Dosering:

75MG

Lægemiddelform:

TABLET

Sammensætning:

AMITRIPTYLINE HYDROCHLORIDE 75MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2014-02-07

Produktets egenskaber

_pms-AMITRIPTYLINE (amitriptyline hydrochloride) _
_Page 1 of 34 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-AMITRIPTYLINE
Amitriptyline Hydrochloride Tablets
Tablets, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg, Oral
USP
Antidepressant
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada H4P 2T4
www.pharmascience.com
Submission Control Number: 267085
Date of Initial Authorization:
December 11, 1998
Date of Revision:
February 3, 2023
_pms-AMITRIPTYLINE (amitriptyline hydrochloride) _
_Page 2 of 34 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
02/2023
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
......................................................................................
5
4.1
Dosing Considerations
..................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...................................