APO-AMITRIPTYLINE TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

AMITRIPTYLINE HYDROCHLORIDE

Disponível em:

APOTEX 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:

100/1000/3000/(10X10)

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:

2013-03-19

Características técnicas

_APO-AMITRIPTYLINE (Amitriptyline Hydrochloride Tablets) _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr APO-AMITRIPTYLINE
Amitriptyline hydrochloride tablets
Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral
USP
Antidepressant
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada, M9L 1T9
Date of Initial Authorization:
March 13, 2013
Date of Revision:
October 31, 2023
Submission Control Number: 276872
_APO-AMITRIPTYLINE (Amitriptyline Hydrochloride Tablets) _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
10/2023
7 WARNINGS AND PRECAUTIONS
10/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
10/2023
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
....................................................................................
6
4.1
Dosing Considerations
................................................................................................
6
4.2
Recommended Dose and