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PHENYTOIN 250MG/5ML SOLUTION FOR INJECTION

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Patient Information Leaflet:
PHENYTOIN 250MG/5ML SOLUTION FOR INJECTION
(Referred to in this leaflet as Phenytoin Injection)
Please read this leaflet carefully before receiving Phenytoin
Injection.

If you have already received Phenytoin Injection because
of the urgency of your condition, you should still read this
leaflet. This is particularly important if you are to continue
to be given phenytoin

Keep the leaflet in case you want to refer to it again

If you want to know more about Phenytoin Injection or
have any questions, you should ask your doctor.
In this leaflet:
1.
What Phenytoin Injection is used for
2.
Before you are given Phenytoin Injection
3.
How Phenytoin Injection should be given
4.
Possible side effects
5.
Storing Phenytoin Injection
6.
Further information
1. WHAT PHENYTOIN INJECTION 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 prevent seizures for short periods of time when antiepileptics drugs cannot be taken by mouth

or prevent seizures during or after brain surgery and/or
severe head injury

specific changes in the rhythm of the heart (cardiac
arrhythmias), particularly when these are caused by the
drug digoxin.
2. BEFORE YOU ARE GIVEN PHENYTOIN INJECTION
You must NOT be given Phenytoin Injection and you should
talk to your doctor immediately if you have:

shown signs of hypersensitivity (severe allergy) to
phenytoin, phenytoin sodium, other similar drugs
(hydantoins) or any of the other ingredients in this
medicine

a heart condition called heart block
Before you are given Phenytoin Injection, tell your doctor if
you:

have low blood pressure or heart failure

have liver disease

have diabetes

have porphyria (an inherited blood disease)

are due to have a surgical procedure, or if you are to be
given the anaesthetic agent halothane as this may
increase phenytoin levels

are (or think you might be) pregnant or are breast-feeding

drink large amounts of alcohol. You should limit the
amount of alcohol you drink whilst being treated with
phenytoin as the concentration in your blood can be
altered with excess alcohol.

A small number of people being treated with anti-epileptics such
as phenytoin have had thoughts of harming themselves. If at any
time you have these thoughts, immediately contact your doctor.
Taking/using other medicines
Before you are given Phenytoin Injection, tell your doctor if
you are taking medicines used to treat:

epilepsy (carbamazepine, lamotrigine, phenobarbital,
sodium valproate, succinimides e.g. ethosuximide, and
vigabatrin)

fungal infections (amphotericin B, fluconazole,
itraconazole, ketoconazole, miconazole)

tuberculosis or other infections (chloramphenicol,
isoniazid, rifampicin, sulphonamides, doxycycline and
ciprofloxacin)

pain and inflammation (phenylbutazone, steroids and
salicylates e.g.aspirin)

stomach ulcers (omeprazole, sucralfate, medicines known
as H2 antagonists e.g. cimetidine, and some antacids)

sleeplessness, depression or psychiatric disorders
(chlordiazepoxide, clozapine, diazepam, disulfiram,
fluoxetine, methylphenidate, paroxetine, phenothiazines,
trazodone, tricyclic antidepressants and viloxazine)

heart and circulatory problems (dicoumarol, amiodarone,
reserpine, digitoxin, furosemide, quinidine, warfarin and
calcium channel blockers e.g. diltiazem, nifedipine)

diabetes (tolbutamide), cancer, asthma or bronchitis
(theophylline)
Phenytoin may also interact with:

hormone replacement therapy (oestrogens)

the pill (oral contraceptive)

methadone

halothane (anaesthetic)

muscle relaxants used in surgery

ciclosporin (to prevent rejection of organ transplants)

vitamin supplements such as Vitamin D and folic acid

the herbal preparation St John’s wort.
Tell your doctor if you are taking, or have recently taken, any
other medicines, including ones you have bought yourself.
Phenytoin may also interfere with certain laboratory tests that
you may be given.
3. HOW PHENYTOIN INJECTION SHOULD BE GIVEN
You will be in hospital when you are given this medicine. Your
doctor will decide on the dose and how it will be given to you.
A diluted solution will be either injected into one of your veins or,
more rarely, into your muscle. The medicine is injected slowly
into your vein or given as an infusion (drip) over a period of time.
Your heart rhythm, blood pressure and breathing will be
monitored.
As this medicine will be given to you whilst you are in hospital it
is unlikely that you will be given too little or too much, however
tell your doctor or nurse if you have any concerns.
Continued overleaf…..

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Information for the Healthcare Professional:

PHENYTOIN 250MG/5ML SOLUTION FOR INJECTION
Please read this information carefully before using Phenytoin
250mg/5ml Solution for Injection. Further information is contained
in the Summary of Product Characteristics.
PRESENTATION:
Phenytoin 250 mg/5 ml Solution for Injection contains 250 mg phenytoin
sodium in each 5 ml ampoule. Packs contain 1 or 50 ampoules.
METHOD OF ADMINISTRATION:
Phenytoin solution is clear and colourless, it is suitable for use as long as
it remains clear and free of precipitate. Upon refrigeration or freezing a
precipitate might form; this will dissolve again at room temperature. Only a

clear solution should be used. A faint yellow colouration may develop but
this has no effect on potency.
Phenytoin Solution should be injected slowly, directly into a large vein
through a large-gauge needle or intravenous catheter.
Rapid intravenous administration may cause serious cardiovascular
toxicity and death. In adults, i.v. administration should not exceed
50mg per minute. In neonates the drug should be administered at a
rate of 1-3mg/kg/min.
Each injection or infusion should be preceded and followed by an injection
of sterile saline through the same needle or catheter to avoid local venous
irritation due to alkalinity of the solution.

4. POSSIBLE SIDE EFFECTS
As with all medicines, phenytoin may cause some side effects in
some patients.
Serious side effects
If any of the following happen, tell a doctor or nurse
IMMEDIATELY as you may need urgent medical attention:

symptoms of a severe hypersensitivity syndrome which
may include: itchy rash, swelling of the face, lips, tongue
or throat (which may cause difficulty in swallowing or
breathing), raised red patches on the skin, joint pain or
fever

irritation or burning sensation at the site of the injection

rashes, which may be severe, resulting in painful
reddening and blistering of the skin, eyes, mouth, anus or
genital region and may lead to skin shedding.

chest pains, palpitations or feeling faint

joint pains
If you experience any of the following side effects tell your
doctor or nurse as soon as possible:
Effects on the nervous system including:

difficulty in controlling movements

unsteadiness, shaking, nervousness

uncoordinated movements

unusual eye movements

confusion, dizziness, slurred speech

pins and needles, twitching muscles

drowsiness, headaches

sleeplessness

loss of feeling in the hands and feet.
These effects may occur when the amount of phenytoin in your
blood is too high. If you suffer with kidney or liver disease or are
elderly you may experience these side effects at lower doses of
phenytoin.
Very high amounts can cause extreme confusion, psychosis or
encephalopathy (a brain disease), which may lead to irreversible
brain injury. Your doctor should measure the amount of
phenytoin in your blood and adjust your dose if necessary.
Effects on the skin:

minor skin rashes such as measles-like rash or dermatitis.
Tell your doctor if a rash does not clear up, recurs or you show
signs of a serious reaction.

Other side effects:

disorders or swelling of the lymph glands (part of your
body’s defence system)

blood disorders, which may be noticed as bruising,
paleness, fever or sore throat

liver damage or inflammation which may be recognised by
yellowing of the eyes and skin

inflammation of the kidneys

breathing problems

feeling sick, vomiting or constipation

increased levels of blood sugar, decreased levels of folic
acid and calcium

the amount of vitamin D in your body may be altered

there have been reports of bone disorders including
osteopenia and osteoporosis (thinning of the bone) and
fractures. Check with your doctor or pharmacist if you are
on long-term antiepileptic medication, have a history of
osteoporosis, or take steroids.
Other rare side effects:

changes in the hand with difficulty straightening the fingers

changes to facial features, enlarged gums or lips

abnormal facial or body hair

changes to the shape of the penis and painful erection.
Tell your doctor or nurse as soon as possible if you notice
these or any side effect not mentioned in this leaflet.
5. STORING PHENYTOIN INJECTION
Keep out of the sight and reach of children.
Keep in the original packaging.
Do not use after the expiry date printed on the carton.
6. FURTHER INFORMATION
What is in this medicine:
Each 5 ml ampoule contains 250mg of the active ingredient
phenytoin sodium.
The ampoules also contain propylene glycol, ethanol, sodium
hydroxide and water.
What this medicine looks like and contents of the pack:
Phenytoin Injection is a clear liquid. Each pack contains 1 or 50
ampoules.
Marketing authorisation holder: Alliance Pharmaceuticals Ltd,
Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB,
UK.
Manufacturer: Laboratorio Reig Jofré, S.A, Spain.
This leaflet was last revised: April 2012
Alliance and associated devices are registered trademarks of
Alliance Pharmaceuticals Limited
© Alliance Pharmaceuticals Limited 2012

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For infusion administration the Phenytoin Solution should be diluted in 50100ml of normal saline, with the final concentration of phenytoin not
exceeding 10mg/ml. The infusion mixture should not be refrigerated and
is suitable for use as long as it remains clear and free of precipitate.
Administration should begin immediately after preparation of the infusion
mixture and must be completed within one hour. An in-line filter (0.22-0.50
microns) should be used.
PHARMACEUTICAL INFORMATION:
Excipients: propylene glycol, ethanol (96%), sodium hydroxide, water for
injection. Incompatibilities: Phenytoin Solution for Injection should not be
mixed with other drugs because of precipitation of phenytoin acid.

Shelf-life: 2 years.
Storage Precautions: Do not store above 25°C. Store in the original
package. Keep out of sight and reach of children.
Nature of Container: Transparent, type I glass 5ml ampoules.
Instructions for Use and Handling: After administration, discard any
unused solution.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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