PHENYTOIN SODIUM INJECTION USP SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

PHENYTOIN SODIUM

Tilgjengelig fra:

OMEGA LABORATORIES LIMITED

ATC-kode:

N03AB02

INN (International Name):

PHENYTOIN

Dosering :

50MG

Legemiddelform:

SOLUTION

Sammensetning:

PHENYTOIN SODIUM 50MG

Administreringsrute:

INTRAMUSCULAR

Enheter i pakken:

2/5ML

Resept typen:

Prescription

Terapeutisk område:

HYDANTOINS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2018-05-07

Preparatomtale

1
PRODUCT MONOGRAPH
PR
PHENYTOIN SODIUM INJECTION USP
50 mg/mL
STERILE
Anticonvulsant agent
Omega Laboratories Limited
11 177 Hamon
Montreal, Quebec
H3M 3E4
Date of Revision: May 7, 2018
Control number: 208630
2
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 A.V.
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 INFUSION
RATE, THESE EVENTS
HAVE ALSO BEEN REPORTED AT OR BELOW THE RECOMMENDED INFUSION RATE