PMS-AMITRIPTYLINE TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

AMITRIPTYLINE HYDROCHLORIDE

Tillgänglig från:

PHARMASCIENCE INC

ATC-kod:

N06AA09

INN (International namn):

AMITRIPTYLINE

Dos:

75MG

Läkemedelsform:

TABLET

Sammansättning:

AMITRIPTYLINE HYDROCHLORIDE 75MG

Administreringssätt:

ORAL

Enheter i paketet:

100

Receptbelagda typ:

Prescription

Terapiområde:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2014-02-07

Produktens egenskaper

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