MAR-AMITRIPTYLINE TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

AMITRIPTYLINE HYDROCHLORIDE

可用日期:

MARCAN PHARMACEUTICALS INC

ATC代码:

N06AA09

INN（国际名称）:

AMITRIPTYLINE

剂量:

75MG

药物剂型:

TABLET

组成:

AMITRIPTYLINE HYDROCHLORIDE 75MG

给药途径:

ORAL

每包单位数:

100/1000

处方类型:

Prescription

治疗领域:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

產品總結:

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

授权状态:

MARKETED

授权日期:

2015-04-27

产品特点

MAR-AMITRIPTYLINE (Amitriptyline Hydrochlodride Tablets)
Page 1 of 47
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MAR-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:
AUG 12, 2014
Date of Revision:
JAN 02, 2024
Submission Control Number: 282059
MAR-AMITRIPTYLINE (Amitriptyline Hydrochlodride Tablets)
Page 2 of 47
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
01/2024
7 WARNINGS AND PRECAUTIONS
01/2024
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
01/2024
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 Dosag