AMITRIPTYLINE HYDROCHLORIDE TABLETS USP

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

AMITRIPTYLINE HYDROCHLORIDE

Beszerezhető a:

STRIDES PHARMA CANADA INC

ATC-kód:

N06AA09

INN (nemzetközi neve):

AMITRIPTYLINE

Adagolás:

25MG

Gyógyszerészeti forma:

TABLET

Összetétel:

AMITRIPTYLINE HYDROCHLORIDE 25MG

Az alkalmazás módja:

ORAL

db csomag:

100

Recept típusa:

Prescription

Terápiás terület:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Termék összefoglaló:

Active ingredient group (AIG) number: 0101524002; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2019-03-05

Termékjellemzők

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