AMITRIPTYLINE HYDROCHLORIDE TABLETS USP

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

AMITRIPTYLINE HYDROCHLORIDE

Fáanlegur frá:

STRIDES PHARMA CANADA INC

ATC númer:

N06AA09

INN (Alþjóðlegt nafn):

AMITRIPTYLINE

Skammtar:

50MG

Lyfjaform:

TABLET

Samsetning:

AMITRIPTYLINE HYDROCHLORIDE 50MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100/1000

Gerð lyfseðils:

Prescription

Lækningarsvæði:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Vörulýsing:

Active ingredient group (AIG) number: 0101524003; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2019-03-05

Vara einkenni

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
.......................................................................................