PMS-AMITRIPTYLINE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

AMITRIPTYLINE HYDROCHLORIDE

제공처:

PHARMASCIENCE INC

ATC 코드:

N06AA09

INN (국제 이름):

AMITRIPTYLINE

복용량:

75MG

약제 형태:

TABLET

구성:

AMITRIPTYLINE HYDROCHLORIDE 75MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2014-02-07

제품 특성 요약

_pms-AMITRIPTYLINE (amitriptyline hydrochloride) _
_Page 1 of 34 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-AMITRIPTYLINE
Amitriptyline Hydrochloride Tablets
Tablets, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg, Oral
USP
Antidepressant
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada H4P 2T4
www.pharmascience.com
Submission Control Number: 267085
Date of Initial Authorization:
December 11, 1998
Date of Revision:
February 3, 2023
_pms-AMITRIPTYLINE (amitriptyline hydrochloride) _
_Page 2 of 34 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
02/2023
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
...................................