TARO-PHENYTOIN SUSPENSION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

PHENYTOIN

Boleh didapati daripada:

TARO PHARMACEUTICALS INC

Kod ATC:

N03AB02

INN (Nama Antarabangsa):

PHENYTOIN

Dos:

125MG

Borang farmaseutikal:

SUSPENSION

Komposisi:

PHENYTOIN 125MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

237ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

HYDANTOINS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2004-03-29

Ciri produk

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
...................................................................