APO-AMITRIPTYLINE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

AMITRIPTYLINE HYDROCHLORIDE

Sẵn có từ:

APOTEX INC

Mã ATC:

N06AA09

INN (Tên quốc tế):

AMITRIPTYLINE

Liều dùng:

50MG

Dạng dược phẩm:

TABLET

Thành phần:

AMITRIPTYLINE HYDROCHLORIDE 50MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100/1000

Loại thuốc theo toa:

Prescription

Khu trị liệu:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0101524003; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2013-03-19

Đặc tính sản phẩm

_APO-AMITRIPTYLINE (Amitriptyline Hydrochloride Tablets) _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr APO-AMITRIPTYLINE
Amitriptyline hydrochloride tablets
Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral
USP
Antidepressant
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada, M9L 1T9
Date of Initial Authorization:
March 13, 2013
Date of Revision:
October 31, 2023
Submission Control Number: 276872
_APO-AMITRIPTYLINE (Amitriptyline Hydrochloride Tablets) _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
10/2023
7 WARNINGS AND PRECAUTIONS
10/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
10/2023
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
....................................................................................
6
4.1
Dosing Considerations
................................................................................................
6
4.2
Recommended Dose and