IPG-AMITRIPTYLINE TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

AMITRIPTYLINE HYDROCHLORIDE

Tillgänglig från:

MARCAN PHARMACEUTICALS INC

ATC-kod:

N06AA09

INN (International namn):

AMITRIPTYLINE

Dos:

10MG

Läkemedelsform:

TABLET

Sammansättning:

AMITRIPTYLINE HYDROCHLORIDE 10MG

Administreringssätt:

ORAL

Enheter i paketet:

100/1000

Receptbelagda typ:

Prescription

Terapiområde:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Produktsammanfattning:

Active ingredient group (AIG) number: 0101524001; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2016-02-29

Produktens egenskaper

_IPG-AMITRIPTYLINE (Amitriptyline Hydrochloride _
_Tablets) _
_Page 1 of 32 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
IPG-AMITRIPTYLINE
Amitriptyline Hydrochloride Tablets
Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral
House Standard
Antidepressant
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite# 112
Ottawa, ON K2E 1A2
Date of Initial Authorization:
July 30, 2014
Date of Revision:
November 10, 2022
Submission Control Number: 266950
_IPG-Amitriptyline (Amitriptyline _
_Hydrochloride Tablets) _
_) _
_Page 2 of 32 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
11/2022
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
Admini