PMS-AMITRIPTYLINE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

AMITRIPTYLINE HYDROCHLORIDE

Dostopno od:

PHARMASCIENCE INC

Koda artikla:

N06AA09

INN (mednarodno ime):

AMITRIPTYLINE

Odmerek:

75MG

Farmacevtska oblika:

TABLET

Sestava:

AMITRIPTYLINE HYDROCHLORIDE 75MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2014-02-07

Lastnosti izdelka

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