AMITRIPTYLINE HYDROCHLORIDE TABLETS USP

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

AMITRIPTYLINE HYDROCHLORIDE

Предлага се от:

STRIDES PHARMA CANADA INC

АТС код:

N06AA09

INN (Международно Name):

AMITRIPTYLINE

дозиране:

25MG

Лекарствена форма:

TABLET

Композиция:

AMITRIPTYLINE HYDROCHLORIDE 25MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2019-03-05

Данни за продукта

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