AMITRIPTYLINE HYDROCHLORIDE TABLETS USP

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

AMITRIPTYLINE HYDROCHLORIDE

可用日期:

STRIDES PHARMA CANADA INC

ATC代码:

N06AA09

INN（国际名称）:

AMITRIPTYLINE

剂量:

25MG

药物剂型:

TABLET

组成:

AMITRIPTYLINE HYDROCHLORIDE 25MG

给药途径:

ORAL

每包单位数:

100

处方类型:

Prescription

治疗领域:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

產品總結:

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

授权状态:

APPROVED

授权日期:

2019-03-05

产品特点

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