PHENYTOIN SODIUM INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PHENYTOIN SODIUM

Available from:

HIKMA CANADA LIMITED

ATC code:

N03AB02

INN (International Name):

PHENYTOIN

Dosage:

50MG

Pharmaceutical form:

SOLUTION

Composition:

PHENYTOIN SODIUM 50MG

Administration route:

INTRAMUSCULAR

Units in package:

2ML/5ML

Prescription type:

Prescription

Therapeutic area:

HYDANTOINS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-06-23

Summary of Product characteristics

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_Phenytoin Sodium Injection USP _
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PRESCRIBING INFORMATION
PR
PHENYTOIN SODIUM INJECTION USP
50 mg/mL
STERILE
ANTICONVULSANT AGENT
Hikma Canada Limited
Date of Preparation:
5995 Avebury Rd.
JUN 23, 2023
Mississauga, ON L5R 3P9
Control Number: 276186
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_Phenytoin Sodium Injection USP _
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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 an anticonvulsant used to control
tonic-clonic (grand mal)
and psychomotor or partial (focal) seizures.
•
Phenytoin Sodium Injection USP may be used 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 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 TH