APO-AMITRIPTYLINE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

AMITRIPTYLINE HYDROCHLORIDE

Commercializzato da:

APOTEX INC

Codice ATC:

N06AA09

INN (Nome Internazionale):

AMITRIPTYLINE

Dosaggio:

10MG

Forma farmaceutica:

TABLET

Composizione:

AMITRIPTYLINE HYDROCHLORIDE 10MG

Via di somministrazione:

ORAL

Confezione:

100/1000/(10X10)

Tipo di ricetta:

Prescription

Area terapeutica:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2013-03-19

Scheda tecnica

_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