MAR-TOPIRAMATE TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

TOPIRAMATE

Disponível em:

MARCAN PHARMACEUTICALS INC

Código ATC:

N03AX11

DCI (Denominação Comum Internacional):

TOPIRAMATE

Dosagem:

100MG

Forma farmacêutica:

TABLET

Composição:

TOPIRAMATE 100MG

Via de administração:

ORAL

Unidades em pacote:

30/100/500

Tipo de prescrição:

Prescription

Área terapêutica:

MISCELLANEOUS ANTICONVULSANTS

Resumo do produto:

Active ingredient group (AIG) number: 0132938002; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2014-11-10

Características técnicas

_MAR-Topiramate (Topiramate Tablets) Page 1 of 79_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION PR
MAR-TOPIRAMATE
Topiramate Tablets
Tablets, 25 mg, 100 mg and 200 mg, oral
USP
Antiepileptic/Migraine Prophylaxis
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite#112
Ottawa, Ontario
K2E 1A2
Submission Control Number: 271273
Date of Initial Authorization:
NOV 10, 2014
Date of Revision:
FEB
02, 2023
_ _
_ _
_ _
_MAR-Topiramate (Topiramate Tablets) Page 2 of 79 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Serious Skin
Reactions
02/2023
7 WARNINGS AND PRECAUTIONS, Metabolic Acidosis
02/2023
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
02/2023
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
..............................................................................
5
4.1
Dosing Considerations
.....................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................. 5
4.4
Administration
.......................................................................................