AMITRIPTYLINE HYDROCHLORIDE TABLETS USP

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

AMITRIPTYLINE HYDROCHLORIDE

MAH:

STRIDES PHARMA CANADA INC

ATC_code:

N06AA09

INN:

AMITRIPTYLINE

dosage:

25MG

pharmaceutical_form:

TABLET

composition:

AMITRIPTYLINE HYDROCHLORIDE 25MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2019-03-05

SPC

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