PHENYTOIN SODIUM INJECTION USP LIQUID

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

PHENYTOIN SODIUM

Mevcut itibaren:

SANDOZ CANADA INCORPORATED

ATC kodu:

N03AB02

INN (International Adı):

PHENYTOIN

Doz:

50MG

Farmasötik formu:

LIQUID

Kompozisyon:

PHENYTOIN SODIUM 50MG

Uygulama yolu:

INTRAMUSCULAR

Paketteki üniteler:

2/5ML

Reçete türü:

Prescription

Terapötik alanı:

HYDANTOINS

Ürün özeti:

Active ingredient group (AIG) number: 0101375003; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2005-09-30

Ürün özellikleri

_Phenytoin Sodium Injection USP _
_ Page 1 of 25_
PRODUCT MONOGRAPH
PR
PHENYTOIN SODIUM INJECTION USP
50 mg/mL
Anticonvulsant agent
Sandoz Canada Inc.
Date of Revision: June 21, 2017
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Control Number: 205185
_Phenytoin Sodium Injection USP _
_ Page 2 of 25_
PR
PHENYTOIN SODIUM INJECTION USP
50 mg/mL
PART I: HEALTH PROFESSIONAL INFORMATION
THERAPEUTIC CLASSIFICATION
Anticonvulsant agent
INDICATIONS
AND CLINICAL USE
Phenytoin Sodium Injection USP is indicated for the control of
generalized tonic-clonic status
epilepticus, and for the prevention and treatment of seizures
occurring during neurosurgery.
Phenytoin Sodium Injection USP should be used only when oral phenytoin
administration is not
possible.
CONTRAINDICATIONS
Phenytoin is contraindicated:

In patients who with a history of hypersensitivity to phenytoin or to
other hydantoins.

In patients who have sinus bradycardia, sino-atrial block, second and
third degree AV block,
and Adams-Stokes syndrome.

In conjunction with delavirdine due to potential for loss of virologic
response and possible
resistance to delavirdine or to the class of non-nucleoside reverse
transcriptase inhibitors.

For intra-arterial administration in view of the high pH of the
preparation.
WARNINGS AND PRECAUTIONS
CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION
THE RATE OF INTRAVENOUS PHENYTOIN SODIUM INJECTION ADMINISTRATION
SHOULD NOT EXCEED 50
MG PER MINUTE IN ADULTS AND 1-3 MG/KG/MIN (OR 50 MG PER MINUTE,
WHICHEVER IS SLOWER) IN
PEDIATRIC PATIENTS BECAUSE OF THE RISK OF SEVERE HYPOTENSION AND
CARDIAC ARRHYTHMIAS. IN
ELDERLY PATIENTS, THOSE WHO ARE GRAVELY ILL, OR THOSE WITH
CARDIOVASCULAR DISEASE, THE DRUG
SHOULD BE ADMINISTERED AT A RATE NOT EXCEEDING 25 MG/MINUTE, AND IF
NECESSARY, AT A SLOW
RATE OF 5 TO 10 MG/MINUTE. CAREFUL CARDIAC MONITORING IS NEEDED DURING
AND AFTER
ADMINISTERING INTRAVENOUS PHENYTOIN SODIUM INJECTION. ALTHOUGH THE
RISK OF CARDIOVASCULAR
TOXICITY INCREASES WITH INFUSION RATES ABOVE THE RECOMMENDED IN