MINT-TOPIRAMATE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

TOPIRAMATE

Disponible desde:

MINT PHARMACEUTICALS INC

Código ATC:

N03AX11

Designación común internacional (DCI):

TOPIRAMATE

Dosis:

200MG

formulario farmacéutico:

TABLET

Composición:

TOPIRAMATE 200MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS ANTICONVULSANTS

Resumen del producto:

Active ingredient group (AIG) number: 0132938006; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2008-08-19

Ficha técnica

_MINT-TOPIRAMATE (topiramate) _
_Page 1 of 78_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-TOPIRAMATE
topiramate tablets, USP tablets, 25 mg, 100 mg and 200 mg, oral
Antiepileptic/Migraine Prophylaxis
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
August 19, 2008
Date of Revision:
November 28, 2023
Submission Control Number: 278199
_MINT-TOPIRAMATE (topiramate) _
_Page 2 of 78_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
09/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential, Teratogenic Risk
11/2023
7 WARNINGS AND PRECAUTIONS, Information for
Patients, Fetal Toxicity
11/2023
7.1.1 Pregnant Women
11/2023
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
4
DOSAGE AND ADMINISTRATION
..................................................................................
4
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...................................