AMITRIPTYLINE-10 TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

AMITRIPTYLINE HYDROCHLORIDE

Доступна з:

PRO DOC LIMITEE

Код атс:

N06AA09

ІПН (Міжнародна Ім'я):

AMITRIPTYLINE

Дозування:

10MG

Фармацевтична форма:

TABLET

Склад:

AMITRIPTYLINE HYDROCHLORIDE 10MG

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: 0101524001; AHFS:

Статус Авторизація:

MARKETED

Дата Авторизація:

1976-12-31

Характеристики продукта

_AMITRIPTYLINE (amitriptyline chlorhydrate) _
_Page 1 of 43 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR AMITRIPTYLINE - 10
PR AMITRIPTYLINE - 25
PR AMITRIPTYLINE - 50
Amitriptyline Hydrochloride Tablets
Tablets, 10 mg, 25 mg and 50 mg, Oral
USP
Antidepressant
PRO DOC LTÉE.
2925 boul. Industriel
Laval, Quebec
H7L 3W9
Submission Control Number: 283162
Date of Initial Authorization:
AUG
09,
2012
Date of Revision:
FEB
16, 2024
_AMITRIPTYLINE (amitriptyline chlorhydrate) _
_Page 2 of 43 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
02/2024
7 WARNINGS AND PRECAUTIONS
02/2024
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
02/2024
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
D