Patient Leaflet Updated 27-Mar-2019 | ADVANZ Pharma
Phenytoin Sodium 50mg/ml Solution for Injection
Package leaflet: Information for the patient
Phenytoin Sodium 50mg/ml
Solution for Injection
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
The name of your medicine is Phenytoin Sodium 50mg/ml Solution for Injection. It will be referred to as Phenytoin Injection for ease hereafter.
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 to you
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 drugs known as hydantoins. It is called an anticonvulsant because it works by controlling the overactivity in the brain that can cause epilepsy or seizures (fits).
Phenytoin Injection is used to:
You should consult your doctor if you are unsure why you have been given Phenytoin Injection if you do not feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PHENYTOIN INJECTION
Do not use Phenytoin Injection:
Make sure your doctor knows if you suffer from any of the above before you are given the injection.
Warnings and precautions
Talk to your doctor or nurse before you are given Phenytoin Injection if you suffer from or have suffered in the past from any of the following conditions:
The risk of these serious skin side effects may be associated with a variant in genes in a subject with Chinese or Thai origin. If you are of such origin and have been tested previously carrying this genetic variant (HLA-B*1502), discuss this with your doctor before using Phenytoin Injection.
Black patients may be at greater risk of liver problems, serious skin reactions and allergic reactions. If you are taking phenytoin at the same time as you receive radiation therapy to your head and the dose of another medication called corticosteroids is reduced, you may more likely to develop a severe skin rash called erythema multiform or one that causes blistering called Stevens Johnson Syndrome or Toxic Epidermal Necrosis (see Possible Side Effects in section 4).
A small number of people being treated with anti-epileptics such as Phenytoin have had thoughts of harming or killing themselves, if at any time you have these thoughts, immediately contact your doctor.
Tell your doctor if any of these apply to you as special care may be needed. Your doctor will take particular care with this medicine if you are elderly or gravely ill.
Phenytoin may precipitate or aggravate absence seizures and myoclonic seizures (two specific types of epilepsy).
Other medicines and Phenytoin Injection
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
This will allow your doctor to decide whether it is safe for you to be given phenytoin.
Some medicines can affect the way Phenytoin Injection works or Phenytoin Injection itself can reduce the effectiveness of other medicines taken at the same time. These include:
Phenytoin Injection with food, drink and alcohol
Speak to your doctor before being given this medicine if you have recently had a drink of alcohol.
Drinking a lot of alcohol can also affect the concentration of Phenytoin in your blood.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
If you do get pregnant while you are taking Phenytoin Injection, you must tell your doctor straight away. It is important that your epilepsy remains well controlled, but, as with other anti-epilepsy treatments, there is a risk of harm to the foetus.
Make sure you are very clear about the risks and benefits of taking Phenytoin Injection.
Do not stop taking Phenytoin Injection until you have seen your doctor as it is important to control your fits. If given during pregnancy phenytoin may affect the baby but your doctor may decide that it is very important that you continue with phenytoin. He or she will explain the risks to you.
As phenytoin is released into breast milk, you should not breast-feed if you are being given this medicine.
Driving and using machines
Phenytoin Injection may cause dizziness or drowsiness. If you experience these symptoms, do not drive or use any tools or machinery.
Ask your doctor for advice before taking any medicine.
Phenytoin Injection contains ethanol and sodium
This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially ‘sodium- free’.
This medicinal product contains 10 % vol ethanol (alcohol), i.e. up to 395.75 mg per dose, equivalent to 7.9ml beer, 3.2ml wine per dose.
Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
3. HOW PHENYTOIN INJECTION IS GIVEN TO YOU
Phenytoin Injection is given by a doctor or nurse. It may be given as an injection slowly into a muscle or a large vein. Alternatively, it may be diluted and given as a drip or infusion into one of your large veins (intravenously). When given as an intravenous infusion, Phenytoin Injection must be diluted with normal saline. Intramuscular or intravenous Phenytoin Injection should not be added to dextrose or dextrose-containing solutions as this could interfere with the dose of this medicine.
The correct dose will be calculated by your doctor according to your body weight and will be written as the equivalent dose of phenytoin sodium (PE). The dose will be as mg per dose if given as an injection or mg per ml of solution if given as an infusion (drip). A repeat injection may be given after 30 minutes if necessary.
During your treatment your doctor may monitor your blood levels of phenytoin by taking regular blood samples. Sometimes it is necessary to give Phenytoin Injection into your muscle if you cannot continue to take it by mouth. This is not normally continued for longer than one week. When switching from oral Phenytoin to intramuscular injection, the dose needs to be increased by approximately 50%. When switching back to oral Phenytoin, the dose should be reduced to half the original oral dose for the same period of time that the intramuscular injection was given. This is because phenytoin continues to be released from your muscles for some time after the injections have been given.
The recommended dose is as follows:
Severe epileptic seizure or fits (Status Epilepticus)
A dose of 10 to 15 mg per kg of body weight is given intravenously at a rate not exceeding 50 mg per minute in adults. This is followed by more Phenytoin Injection given every 6 to 8 hours either by injection or by mouth.
If Phenytoin Injection does not stop your seizures, other treatments will be tried.
A dose of 100 to 200 mg may be given into your muscle (intramuscularly) approximately every 4 hours during surgery and for two to three days afterwards to prevent seizures. This dosage may then be reduced to a maintenance dose of 300 mg daily and adjusted according to your blood levels.
Lower or less frequent dosing may be needed in some elderly patients due to decreased clearance of Phenytoin Injection. Your doctor may not need to change your dose, but side effects can occur more often in the elderly.
Kidney or liver problems
Make sure your doctor knows if you have liver or kidney problems as you may need your dose adjusted.
Use in children and adolescents
No dosage adjustment is required, but children tend to breakdown the medicine faster than adults and this may mean that your doctor has to change the number or timing of the Phenytoin Injection doses.
Use in neonates (Very young babies)
The starting dose is usually 15 to 20 mg per kg of baby weight. Intravenous Phenytoin Injection should not be given to neonates at a rate faster than 1 to 3 mg per kg body weight per minute. Intravenous Phenytoin Injection is more reliably absorbed than oral Phenytoin in very young babies.
If you think you have been given more Phenytoin Injection than you should have
Tell your doctor immediately.
Phenytoin Injection is dangerous in overdose. The initial signs are nystagmus (condition of involuntary eye movement), diplopia (double vision), ataxia (the loss of full control of bodily movements) and dysarthria (motor speech disorder). Other signs are tremor, hyperflexia (muscle spasms), lethargy, nausea, vomiting. The patient may become comatose and hypotensive. Death is due to respiratory and circulatory depression.
If you think you have missed a dose of Phenytoin Injection
If you think that you may have missed a dose, tell your doctor immediately.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side-effects, although not everybody gets them.
Important: If you experience any of the following serious side effects contact your doctor immediately.
Other side effects that may occur are as below:
Not known: frequency cannot be estimated from the available data
Please see your doctor if you notice any of these side effects and they cause you concern or if you notice any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help to provide more information on the safety of this medicine.
5. HOW TO STORE PHENYTOIN INJECTION
Keep this medicine out of the sight and reach of children.
This medicine should not be used after the expiry date which is stated on the ampoule (a small bottle) label and carton, after EXP. The expiry date refers to the last day of that month.
The ampoules should be protected from light and stored at a temperature not greater than 30°C.
If only part of the contents of an ampoule is used, the remaining solution should be discarded.
Solutions in which a haziness or precipitate develops should not be used.
The solution should not be mixed with any other drugs.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Phenytoin Injection contains
The active substance is phenytoin sodium. Each 1ml of this solution contains 50mg of phenytoin sodium.
The other ingredients are propylene glycol BP, ethanol BP and sodium hydroxide BP (as a 10% w/v solution) in water for injections BP.
What Phenytoin Injection looks like and contents of pack
Phenytoin Injection is a clear, colourless, particle-free solution. Each carton contains ten 5ml ampoules of Phenytoin Injection.
Marketing Authorisation Holder
This leaflet was last revised in December 2018.
Capital House, 1st Floor, 85 King William Street, London, EC4N 7BL, UK
+44 (0)208 588 9131
08700 70 30 33
+44 (0)208 588 9273
+44 (0)208 588 9200
+44 (0)20 8588 9200