Phenytoin 250 mg/5 ml solution for injection or infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PHENYTOIN SODIUM

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N03AB; N03AB02

INN (International Name):

PHENYTOIN SODIUM

Dosage:

250 mg/5ml

Pharmaceutical form:

Solution for injection/infusion

Therapeutic area:

Hydantoin derivatives; phenytoin

Authorization status:

Not marketed

Authorization date:

2017-10-13

Patient Information leaflet

1
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.
Phen

Summary of Product characteristics

Health Products Regulatory Authority
07 May 2019
CRN008VDJ
Page 1 of 15
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 b