PHENYTOIN SODIUM injection solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

PHENYTOIN SODIUM (UNII: 4182431BJH) (PHENYTOIN - UNII:6158TKW0C5)

Tersedia dari:

Hospira, Inc.

INN (Nama Internasional):

PHENYTOIN SODIUM

Komposisi:

PHENYTOIN SODIUM 50 mg in 1 mL

Jenis Resep:

PRESCRIPTION DRUG

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

PHENYTOIN SODIUM- PHENYTOIN SODIUM INJECTION, SOLUTION
HOSPIRA, INC.
----------
PHENYTOIN SODIUM
Injection, USP
Ampul
Rx only
IMPORTANT NOTE
THIS DRUG MUST BE ADMINISTERED SLOWLY. IN ADULTS DO NOT EXCEED 50 MG
PER MINUTE
INTRAVENOUS LY.
IN NEONATES, THE DRUG SHOULD BE ADMINISTERED AT A RATE NOT EXCEEDING
1―3 MG/KG/MIN.
DESCRIPTION
Phenytoin Sodium Injection, USP is a sterile solution for intravenous
(no infusion) or intramuscular use,
containing in each mL phenytoin sodium 50 mg, propylene glycol 0.4 mL
and alcohol 0.1 mL in Water
for Injection. pH 10.0-12.3; sodium hydroxide added, if needed, for pH
adjustment.
Phenytoin sodium is related to the barbiturates in chemical structure,
but has a five-membered ring. The
chemical name is sodium 5,5-diphenyl-2,4-imidazolidinedione. The
structural formula is as follows:
C
H N NaO MW 274.25
CLINICAL PHARMACOLOGY
Phenytoin is an anticonvulsant which may be useful in the treatment of
status epilepticus of the grand mal
type. The primary site of action appears to be the motor cortex where
spread of seizure activity is
inhibited. Possibly by promoting sodium efflux from neurons, phenytoin
tends to stabilize the threshold
against hyperexcitability caused by excessive stimulation or
environmental changes capable of reducing
membrane sodium gradient. This includes the reduction of posttetanic
potentiation at synapses. Loss of
posttetanic potentiation prevents cortical seizure foci from
detonating adjacent cortical areas. Phenytoin
reduces the maximal activity of brain stem centers responsible for the
tonic phase of grand mal seizures.
15
11
2
2
The plasma half-life in man after intravenous administration ranges
from 10 to 15 hours. Optimum
control without clinical signs of toxicity occurs most often with
serum levels between 10 and 20
mcg/mL.
A fall in plasma levels may occur when patients are changed from oral
to intramuscular administration.
The drop is caused by slower absorption, as compared to oral
administration, due to the poor water
solubility of phenytoin. Intravenous