This leaflet contains important information about your medicine; read it carefully.
Keep this leaflet; you may want to read it again.
If you have any questions or are not sure about anything, ask your doctor or pharmacist.
Phenytoin Injection BP
- The active substance is phenytoin sodium
- The other ingredients are propylene glycol, ethanol and Water for Injections
The manufacturer and marketing authorisation holder is
What Phenytoin Injection BP is and what it is used for
Phenytoin Injection BP is a medicine which helps control fits and irregular heart rhythm, and is a solution for injection. It can be given as a slow injection via a drip or may occasionally be given as an injection into the muscle.
The medicine is presented in glass containers called ampoules. Each ml (millilitre) of solution contains 50 mg (milligrams) of phenytoin. The medicine is available in packs of 5 x 5 ml glass ampoules, each 5 ml containing 250 mg phenytoin sodium.
Before Phenytoin Injection BP is used
Phenytoin Injection should not be used:
- If you have shown signs of hypersensitivity (severe allergy) to phenytoin or medicines of the same class (hydantoins), or to any of the ingredients of this medicine on previous occasions
- you have certain heart or circulatory problems
Special care will be taken:
- if you have a liver or kidney disorder
- if you suffer from diabetes
- if you are pregnant or breast-feeding
- if you are taking certain other medicines, such as:
- some antibacterials i.e. doxycycline, ciprofloxacin, chloramphenicol, isoniazid, rifampicin, and other sulphonamides
- some antifungals i.e. ketoconazole, fluconazole, miconazole
- some coumarin anticoagulants, e.g. warfarin
- medicines used to control diabetes e.g. insulin or oral anti-diabetic agents
- some pain killers and anti-inflammatory medicines, i.e. phenylbutazone and salicylates such as aspirin
- some medicines used to control anxiety, i.e. chlordiazepoxide, diazepam
- barbiturates, e.g. phenobarbitone and amylobarbitone
- corticosteroids (used in numerous situations to aid the body’s healing process)
- some medicines used to treat mental problems such as psychoses and depression, e.g. haloperidol, methylphenidate, monoamine oxidase inhibitors, trazodone, thioxanthenes and tricyclic antidepressants
- oral contraceptives and other medicines which mimic female hormones, e.g. oestrogen and ethinyloestradiol
- antiepileptic medicines, e.g. carbamazepine, ethosuximide, mephenytoin, primidone, sodium valproate, sulthiame, valproic acid and trimethadione
- halothane (an inhaled general anaesthetic)
- some anti-ulcer medicines, i.e. cimetidine and ranitidine
- medicines taken to help the heart, i.e. aspirin, beta-blockers, diazoxide, digoxin, disopyramide, dopamine, frusemide, mexiletine, nifedipine, quinidine, reserpine and verapamil
- medicines often taken while undergoing cancer treatment, i.e. bleomycin, calcium folinate, carboplatin, carmustine, cisplatin, dacarbazine and vinblastine
- St John’s wort - The herbal remedy St John’s wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take St John’s wort, consult your doctor before stopping the St John’s wort preparations.
- others which you may recognise by name: cyclosporine, disulfiram, folic acid, L-dopa, lignocaine, succinimide, theophylline (a xanthine), methotrexate and vitamin D.
Please tell your doctor if you are taking, or have recently taken, any other medicines, including ones that are not prescribed for you.
Do not drive or use machines:
- if you experience any effect which may impair your ability to drive or use machines.
Important information about some of the ingredients of Phenytoin Injection BP:
- This medicine contains 10% ethanol. Ethanol may be harmful to those suffering from liver disease, alcoholism, epilepsy and brain injury or disease, as well as children and pregnant women. It may also modify or increase the effects of other medicines.
- Propylene glycol can cause allergic-type reactions in susceptible people, especially those with a history of allergy or asthma. Typical early symptoms include a sudden itchy rash, breathing difficulties, coughing, heart palpitations and swelling. The reaction may be life threatening and the doctor must be informed immediately if these symptoms occur.
During treatment with phenytoin
The intake of alcohol while being treated with this medicine may reduce the effectiveness or increase the undesirable effects of phenytoin.
How Phenytoin Injection BP is used
The dose of medicine given to you will depend upon your medical condition, your age and how well your kidneys, liver or heart are working.
This medicine will be given to you by a slow injection via a drip into a vein or, more rarely, via an injection into a muscle.
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 pharmacist if you have any concerns.
Your blood pressure and the performance of your heart may be monitored during treatment. Blood samples may be taken to check whether dosage adjustment is necessary.
Effects when treatment with phenytoin is stopped:
Sudden withdrawal of phenytoin therapy in patients susceptible to fits (seizures) may cause status epilepticus (serious condition in which seizures continue for hours or days). In such cases, phenytoin dosage reduction should be gradual, perhaps following a switch to a form of phenytoin which can be taken by mouth.
Possible side effects
Like other medicines, phenytoin may have some side effects.
If any of the following happen, tell your doctor immediately:
- symptoms of an allergic reaction: sudden itchy rash, breathing difficulties, coughing, heart palpitations, swelling of the face, lips or tongue
- rashes (can be severe resulting in painful reddening and blistering of the skin, eyes, inside of the mouth and ano-genital region and may lead to skin shedding)
- swollen lymph nodes (isolated small raised lumps under the skin)
- chest pains and palpitations
These are very serious side effects. You may need urgent medical attention. All of these very serious side effects are very rare.
If you experience any of the following tell your doctor as soon as possible:
- difficulty with breathing
- headache
- nausea/vomiting
- constipation
- dizziness/fainting
- fever
- a temporary feeling of nervousness
- confusion
- unusual tiredness or weakness
- loss of appetite and weight
- insomnia
- slurred speech
- muscle twitching and/or rapid uncontrollable eye movements
- difficulties associated with muscular movement: loss of muscle co-ordination, clumsiness or unsteadiness, shaking and loss of muscle tone
- the appearance of any kind of rash
- pain and inflammation at the injection site (in rare instances has led to amputation)
- bleeding, tender or enlarged gums (may be reduced by maintaining good oral hygiene and massaging the gums)
- enlargement of facial features including thickening of the lips
- unusual and excessive hair growth on body and face
- persistent pain, tingling or numbness
- Peyronie’s disease (a condition where male patients experience a deformation of the penis which may cause pain when the penis is erect)
- joint pain
- yellowing of the eyes and skin
If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
Your doctor may monitor your breathing, blood pressure, heart and liver function and blood count on a regular basis during treatment.
Storing Phenytoin Injection BP
Keep out of the reach and sight of children.
The ampoules should not be stored above 25°C. They should be kept in the outer carton in order to protect from light.
If there are signs of particulate matter, or if the injection solution is coloured, it should not be used.
This medicine should not be used after the expiry date printed on the ampoule label.
Date of Preparation
January 2004
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