PHENYTOIN SODIUM 250 MG/5ml Solution for Injection

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

PHENYTOIN SODIUM

Tillgänglig från:

Mercury Pharmaceuticals (Ireland) Ltd

ATC-kod:

N03AB02

INN (International namn):

PHENYTOIN SODIUM

Dos:

250 MG/5ml

Läkemedelsform:

Solution for Injection

Receptbelagda typ:

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

Terapiområde:

Hydantoin derivatives

Bemyndigande status:

Authorised

Tillstånd datum:

1992-03-23

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER 
PHENYTOIN SODIUM 250MG/5ML SOLUTION FOR INJECTION 
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
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 or pharmacist or
nurse. 
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any 
possible side effects not listed in this leaflet. See section 4. 
This product will be referred to as Phenytoin Injection
from here on. 
WHAT IS IN THIS LEAFLET: 
1. What Phenytoin Injection is and what it is used for 
2. What you need to know before you use Phenytoin Injection 
3. How to use Phenytoin Injection 
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 
Phenytoin belongs to a group of medicines called anti-epileptic
drugs. 
Phenytoin injection is used to treat: 
• severe epileptic seizures or fits (status epilepticus) 
• and control the condition in which seizures occur continuously 
• or prevent seizures during or after brain surgery 
• specific changes in the rhythm of the heart (cardiac
arrhythmias), particularly when these 
are caused by the digitalis drugs such as digoxin. 

2. WHAT YOU NEED TO KNOW BEFORE YOU USE PHENYTOIN INJECTION 
DO NOT USE PHENYTOIN INJECTION IF: 
• you know that you are allergic (hypersensitive) to
Phenytoin Sodium or other hydantoins or 
any of the other ingredients listed in Section 6 of this leaflet 
• you have a slow heart beat or any heart problems that
interfere with the rate at which your 
heart beats 
• you suffer from sudden fainting with occasional fits. 

WARNINGS AND PRECAUTIONS: 
Talk to your doctor, pharmacist or nurse before using Phenytoin
Injection if: 
• you have low blood press

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phenytoin Sodium 250 mg/5 ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of solution contains 250 mg of Phenytoin Sodium.
Each 1 ml of solution contains 50 mg of Phenytoin Sodium.
Excipients with known effect:
Sodium (23 mg per 5 ml solution)
Ethanol (395 mg per 5 ml solution)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
A clear, colourless, sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Phenytoin Sodium 250mg/5ml Solution for Injection is indicated for the control of status epilepticus and other
persistent convulsive disorders; for the prophylactic control of seizures in neurosurgery. It is also indicated in the
treatment of cardiac arrhythmias when these are digitalis induced.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
Status epilepticus: a loading dose of Phenytoin 10-15mg/kg (150 to 250 mg) should be injected slowly intravenously, at
a rate not exceeding 50mg per minute to avoid hypotension (this will require approximately 20 minutes in a 70Kg
patient). This dose can be repeated if necessary after 30 minutes. The loading dose should be followed by maintenance
doses of 100mg orally or intravenously every 6 to 8 hours. This drug must be administered slowly. In adults,
intravenous administration should not exceed a rate of 50mg per minute.
Use in cardiac arrhythmias: 3.5 - 5mg per kg of bodyweight intravenously initially, repeated once if necessary. The
solution should be injected slowly, and at a uniform rate which should not exceed 50mg per minute.
Neurosurgery: In a patient who has not previously received the drug, Phenytoin Sodium 250mg/5ml Solution for
Injection 100-200mg (2-4ml)