IPG-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:

10MG

药物剂型:

TABLET

组成:

AMITRIPTYLINE HYDROCHLORIDE 10MG

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: 0101524001; AHFS:

授权状态:

APPROVED

授权日期:

2016-02-29

产品特点

_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