AMITRIPTYLINE HYDROCHLORIDE TABLETS USP

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

AMITRIPTYLINE HYDROCHLORIDE

Tillgänglig från:

STRIDES PHARMA CANADA INC

ATC-kod:

N06AA09

INN (International namn):

AMITRIPTYLINE

Dos:

10MG

Läkemedelsform:

TABLET

Sammansättning:

AMITRIPTYLINE HYDROCHLORIDE 10MG

Administreringssätt:

ORAL

Enheter i paketet:

100

Receptbelagda typ:

Prescription

Terapiområde:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2019-03-05

Produktens egenskaper

Page 1 of 34
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AMITRIPTYLINE HYDROCHLORIDE TABLETS USP
Amitriptyline hydrochloride tablets
Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral
USP
Antidepressant
Strides Pharma Canada Inc.
1565, Boul. Lionel-Boulet,
Varennes, QC J3X 1P7
Canada
Date of Initial Authorization:
March 5, 2019
Date of Revision:
April 12, 2023
Submission Control Number: 269974
Page 2 of 34
RECENT MAJOR LABEL CHANGES
7 Warnings and precautions, Neurologic
04/2023
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
.......................................................... 5
4.4
Administration
.......................................................................................