PHENYTOIN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PHENYTOIN SODIUM

Available from:

Accord Healthcare Limited

ATC code:

N03AB02

INN (International Name):

PHENYTOIN SODIUM

Dosage:

250mg/5ml Mg/Ml

Pharmaceutical form:

Solution for Inj/Inf

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

phenytoin

Authorization status:

Authorised

Authorization date:

2017-10-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PHENYTOIN 250 MG/5 ML SOLUTION
FOR INJECTION OR INFUSION
Phenytoin sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor,
pharmacist or nurse.
- This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
- You may have been given Phenytoin injection as a
single dose to control seizures in an emergency (status
epilepticus). In this case, you will only be able to read
this leaflet after you have had the product given to you.
Your doctor will have considered the important safety
information in this leaflet, but your urgent need for
treatment may have been more important than some of
the normal cautions. Check them now, especially if you
are going to continue to be given Phenytoin injection (or
any other form of phenytoin).
WHAT IS IN THIS LEAFLET:
1. What Phenytoin injection is and what it is used for
2. What you need to know before you are given Phenytoin
injection
3. How Phenytoin injection is given
4. Possible side effects
5. How to store Phenytoin injection
6. Contents of the pack and other information 1.
WHAT PHENYTOIN INJECTION IS AND WHAT IT
IS USED FOR
This medicine is a solution for injection or infusion
containing phenytoin, which belongs to a group of
medicines called antiepileptic medicines.
Phenytoin injection can be used to treat severe epileptic
seizures or fits (status epilepticus). It can also be used to
control or prevent seizures during or after brain surgery
and/or severe head injury. Phenytoin injection is also used
to control or prevent seizures for short periods of time
when antiepileptic medicinal products cannot be taken by
mouth.
Phenyt

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phenytoin 250 mg/5 ml solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml ampoule contains phenytoin sodium 250 mg (50 mg/ml).
Excipients with known effect
Each 5 ml also contains 406 mg ethanol 96 %, 21.6 mg of sodium and
2075 mg of propylene glycol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection or Infusion.
Clear, colourless, sterile solution practically free from visible
particles and pH of solution in the range of 11.5 to 12.1.
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.
It is also indicated for the treatment of life-threatening ventricular
arrhythmias or arrhythmias secondary to digitalis
intoxication, when these have not responded to other available
antiarrhythmic treatments or when other antiarrhythmic
agents cannot be used.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Parenteral medicinal products should be inspected visually for
particulate matter and discolouration prior to
administration, whenever solution and container permit. Parenteral
Phenytoin injection is suitable for use as long as it
remains free of haziness and precipitate. Upon refrigeration or
freezing a precipitate might form; this will dissolve
again after the solution is allowed to stand at room temperature. The
product is still suitable for use. Only a clear
solution should be used.
There is a relatively small margin between full therapeutic effect and
minimally toxic doses of this medicine. Optimum
control without clinical signs of toxicity occurs most often with
serum levels between 10 and 20 mg/l (40-80
micromoles/l).
Because of the risk of local toxicity, intravenous Phenytoin injection
should be injected slowly directly into a large vein
through a large-gauge needl