IPG-AMITRIPTYLINE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

AMITRIPTYLINE HYDROCHLORIDE

Доступна з:

MARCAN PHARMACEUTICALS INC

Код атс:

N06AA09

ІПН (Міжнародна Ім'я):

AMITRIPTYLINE

Дозування:

75MG

Фармацевтична форма:

TABLET

Склад:

AMITRIPTYLINE HYDROCHLORIDE 75MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100/1000

Тип рецепту:

Prescription

Терапевтична области:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2016-02-29

Характеристики продукта

_IPG-AMITRIPTYLINE (Amitriptyline Hydrochloride _
_Tablets) _
_Page 1 of 32 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
IPG-AMITRIPTYLINE
Amitriptyline Hydrochloride Tablets
Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral
House Standard
Antidepressant
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite# 112
Ottawa, ON K2E 1A2
Date of Initial Authorization:
July 30, 2014
Date of Revision:
November 10, 2022
Submission Control Number: 266950
_IPG-Amitriptyline (Amitriptyline _
_Hydrochloride Tablets) _
_) _
_Page 2 of 32 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
11/2022
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
Admini