Phenytoin sodium 250mg/5ml solution for injection ampoules

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Phenytoin sodium

Доступно од:

Advanz Pharma

АТЦ код:

N03AB02

INN (Међународно име):

Phenytoin sodium

Дозирање:

50mg/1ml

Фармацеутски облик:

Solution for injection

Пут администрације:

Intravenous; Intramuscular

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 04080200; GTIN: 5021691164180

Карактеристике производа

OBJECT 1
PHENYTOIN SODIUM 50MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 19-Dec-2017 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Phenytoin Sodium 50mg/ml Solution for Injection
2. Qualitative and quantitative composition
Each 5ml of solution contains Phenytoin Sodium 250mg.
Excipient(s) with known effect
Each 5ml of solution also contains 395.75 mg of Ethanol and not more
than 23mg of Sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection.
A clear colourless particle free solution.
4. Clinical particulars
4.1 Therapeutic indications
Phenytoin Injection is indicated for the control of status epilepticus
of the tonic-clonic (grand mal) type
and prevention and treatment of seizures occurring during or following
neurosurgery and/or severe head
injury.
4.2 Posology and method of administration
Posology
_Status epilepticus :_ In a patient having continuous seizure
activity, as compared to the more common
rapidly recurring seizures, i.e. serial epilepsy, intravenous diazepam
or a short-acting barbiturate is
recommended prior to administration of phenytoin because of the more
rapid onset of action of the
former.
Following the use of diazepam in patients having continuous seizures
and in the initial management of
serial epilepsy a loading dose of phenytoin 10 - 15mg/kg should be
injected slowly intravenously, at a
rate not exceeding 50mg per minute in adults (this will require
approximately 20 minutes in a 70kg
patient). The loading dose should be followed by maintenance doses of
100mg orally or intravenously
every 6 to 8 hours.
In neonates, it has been shown that absorption of phenytoin is
unreliable after oral administration, but a
loading dose of 15-20mg/kg of phenytoin intravenously will usually
produce serum concentrations of 10–
20 mg/l phenytoin which is within the generally accepted therapeutic
range. The drug should be injected
slowly intravenously at a rate of 1-3mg/kg/min.
Determination of phenytoin seru