PMS-AMITRIPTYLINE TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

AMITRIPTYLINE HYDROCHLORIDE

Доступно од:

PHARMASCIENCE INC

АТЦ код:

N06AA09

INN (Међународно име):

AMITRIPTYLINE

Дозирање:

75MG

Фармацеутски облик:

TABLET

Састав:

AMITRIPTYLINE HYDROCHLORIDE 75MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2014-02-07

Карактеристике производа

_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
...................................