Phenytoin Sandoz

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Phenytoin sodium 50 mg/mL

から入手可能:

Novartis New Zealand Ltd

INN（国際名）:

Phenytoin sodium 50 mg/mL

投薬量:

50 mg/mL

医薬品形態:

Solution for injection

構図:

Active: Phenytoin sodium 50 mg/mL Excipient: Ethanol Propylene glycol Sodium hydroxide Water for injection

パッケージ内のユニット:

Ampoule, glass, Clear glass Ph Eur, Type I, 5 x 5 mL, 5 dose units

クラス:

Prescription

処方タイプ:

Prescription

製:

Katwijk Chemie BV

製品概要:

Package - Contents - Shelf Life: Ampoule, glass, Clear glass Ph Eur, Type I, 5 x 5 mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. - Ampoule, glass, Clear glass Ph Eur, Type I, 5 x 2 mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light. Do not freeze

承認日:

2004-12-17

製品の特徴

NEW ZEALAND DATASHEET 

PHENYTOIN SANDOZ 
_PHENYTOIN SODIUM PH EUR SOLUTION FOR INJECTION, 50 MG/ML _
PRESENTATION 
Phenytoin Sandoz injection is a sterile clear, colourless solution
with a pH between 11.5 to 12.1 and 
contains phenytoin sodium 50 mg/ml. Phenytoin Sandoz injection is
packaged in glass ampoules 
containing phenytoin sodium 100 mg in 2 ml or 250 mg in 5 ml. 
USES 
_ACTIONS _
Phenytoin sodium is a hydantoin derivative anticonvulsant. 
PHARMACOTHERAPEUTIC GROUP 
N03AB02 Antiepileptics: hydantoin derivatives, phenytoin. 
MECHANISM OF ACTION 
Phenytoin sodium inhibits the spread of seizure activity in the
motor cortex. Epileptic seizures are 
thought to occur through the development of excessive central
excitability due to post tetanic 
potentiation, which is blocked by phenytoin. 
The antiarrhythmic action of phenytoin sodium may be attributed
to the normalisation of influx of 
sodium and calcium to cardiac Purkinje fibres. Abnormal ventricular
automaticity and membrane 
responsiveness are decreased. It also shortens the refractory
period, and therefore shortens the QT 
interval and the duration of the action potential. 
PHARMACODYNAMIC EFFECTS 
The primary target of phenytoin in the central nervous
system appears to be sodium channels in 
depolarising neurones, where phenytoin binds and blocks sodium
influx, reducing neuronal excitability 
and the spread of electrical activity characteristic of epileptic
seizures.

Phenytoin may also suppress 
sodium action potentials by stimulating the sodium pump. It
appears that by promoting sodium efflux 
from neurons, phenytoin sodium tends to stabilise the threshold
against hyperexcitability caused by 
environmental changes or excessive stimulation capable of reducing
membrane sodium gradient. 
This includes the reduction of post tetanic potentiation of
synapses. Loss of post tetanic potentiation 
prevents cortical seizure foci from detonating adjacent cortical
areas. Phenytoin th