APO-AMITRIPTYLINE TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

AMITRIPTYLINE HYDROCHLORIDE

から入手可能:

APOTEX INC

ATCコード:

N06AA09

INN（国際名）:

AMITRIPTYLINE

投薬量:

25MG

医薬品形態:

TABLET

構図:

AMITRIPTYLINE HYDROCHLORIDE 25MG

投与経路:

ORAL

パッケージ内のユニット:

100/1000/3000/(10X10)

処方タイプ:

Prescription

治療領域:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2013-03-19

製品の特徴

_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