AMITRIPTYLINE HYDROCHLORIDE TABLETS USP

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

AMITRIPTYLINE HYDROCHLORIDE

Disponível em:

STRIDES PHARMA CANADA INC

Código ATC:

N06AA09

DCI (Denominação Comum Internacional):

AMITRIPTYLINE

Dosagem:

25MG

Forma farmacêutica:

TABLET

Composição:

AMITRIPTYLINE HYDROCHLORIDE 25MG

Via de administração:

ORAL

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Área terapêutica:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2019-03-05

Características técnicas

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