TARO-PHENYTOIN SUSPENSION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

PHENYTOIN

Disponível em:

TARO PHARMACEUTICALS INC

Código ATC:

N03AB02

DCI (Denominação Comum Internacional):

PHENYTOIN

Dosagem:

125MG

Forma farmacêutica:

SUSPENSION

Composição:

PHENYTOIN 125MG

Via de administração:

ORAL

Unidades em pacote:

237ML

Tipo de prescrição:

Prescription

Área terapêutica:

HYDANTOINS

Resumo do produto:

Active ingredient group (AIG) number: 0101372001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2004-03-29

Características técnicas

TARO-PHENYTOIN (PHENYTOIN ORAL SUSPENSION)
Page 1 of 39
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TARO-PHENYTOIN
Phenytoin Oral Suspension
Solution, 125 mg/5 mL, Oral
USP
Anticonvulsant
Taro Pharmaceuticals Inc. Date of Initial Authorization:
130 East Drive March 29, 2004
Brampton, Ontario
L6T 1C1 Date of Revision:
September 21, 2022
Submission Control Number: 265248
TARO-PHENYTOIN (PHENYTOIN ORAL SUSPENSION)
Page 2 of 39
RECENT LABEL MAJOR CHANGES
Not Applicable
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT LABEL MAJOR
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
................................................................................................4
4. 2
Recommended Dose and Dosage Adjustment
.............................................................5
4. 3
Missed Dose
...............................................................................................................6
5
OVERDOSAGE
...................................................................