AMITRIPTYLINE HYDROCHLORIDE TABLETS USP

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

AMITRIPTYLINE HYDROCHLORIDE

Saadav alates:

STRIDES PHARMA CANADA INC

ATC kood:

N06AA09

INN (Rahvusvaheline Nimetus):

AMITRIPTYLINE

Annus:

75MG

Ravimvorm:

TABLET

Koostis:

AMITRIPTYLINE HYDROCHLORIDE 75MG

Manustamisviis:

ORAL

Ühikuid pakis:

100

Retsepti tüüp:

Prescription

Terapeutiline ala:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2019-03-05

Toote omadused

Page 1 of 34
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AMITRIPTYLINE HYDROCHLORIDE TABLETS USP
Amitriptyline hydrochloride tablets
Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral
USP
Antidepressant
Strides Pharma Canada Inc.
1565, Boul. Lionel-Boulet,
Varennes, QC J3X 1P7
Canada
Date of Initial Authorization:
March 5, 2019
Date of Revision:
April 12, 2023
Submission Control Number: 269974
Page 2 of 34
RECENT MAJOR LABEL CHANGES
7 Warnings and precautions, Neurologic
04/2023
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
.......................................................... 5
4.4
Administration
.......................................................................................