75 mg / ml concentrate for solution for infusion / solution for injection
fosphenytoin sodium
What Pro-Epanutin is and what it is used for
Pro-Epanutin contains the active substance fosphenytoin, which belongs to the group of antiepileptic drugs. These drugs are used to treat epilepsy.
Pro-Epanutin is used:
- to treat severe epileptic seizures or seizures ( status epilepticus ) of the tonic-clonic seizure type (grand mal)
- to control or prevent seizures during or after brain surgery and/or head injury
- to control or prevent seizures for short periods when antiepileptic drugs cannot be taken orally.
Talk to your doctor if you are not sure why you have been given Pro-Epanutin.
What you need to know before you receive Pro-Epanutin
You should not receive Pro-Epanutin
- if you are allergic to fosphenytoin sodium, phenytoin, or any of the other ingredients of this medicine (listed in section 6)
- if you have problems with your heart rhythm
- if you have acute intermittent porphyria (a genetic disease that affects the formation of red blood cells )
- if you are taking delavirdine, an antiviral medicine used to treat human immunodeficiency virus ( HIV ) infection.
Tell your doctor if you have had any of these diseases. If you have any further questions, ask your doctor, pharmacist, or nurse.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse if you have had any of the following:
- liver disease
- heart disease or stroke
- low blood pressure or heart failure
- kidney disease
- low protein content (albumin) in the blood
- diabetes
- a special diet with a limited intake of phosphate.
During treatment with Pro-Epanutin, low blood pressure and severe heart problems may occur. These side effects may be worse in elderly patients, children, and very sick patients. Your doctor will therefore check your heart, blood pressure, and respiration when you receive Pro-Epanutin, while you are receiving infusion one and for approximately 30 minutes after the end of infusion one.
A small number of those treated with antiepileptic drugs such as fosphenytoin have had thoughts of harming themselves or committing suicide. Contact your doctor immediately if you ever have such thoughts.
Serious skin side effects may occur during treatment with Pro-Epanutin in rare cases. For signs and symptoms of serious skin side effects and what to do in these cases, see section 4. In people of Chinese or Asian origin, this risk may be associated with a gene variant. If you have Chinese or Asian origin and tests have shown that you have the gene variant HLA – B * 1502, or if you have Taiwanese, Japanese, Malaysian, or Thai origin and tests have shown that you have the gene variant CYP2C9 * 3, talk to your doctor about this before you receive Pro – Epanutin.
Cases of swelling of the face, mouth (lips, gums, tongue) and throat that can lead to life-threatening breathing difficulties have been reported in people treated with phenytoin or fosphenytoin. If you get these signs or symptoms, contact your doctor immediately.
There is a risk of birth defects if Pro-Epanutin is used during pregnancy. Women of childbearing potential should use effective contraception when receiving Pro-Epanutin (see Pregnancy, contraception for women, and breastfeeding).
Other medicines and Pro-Epanutin
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the way Pro-Epanutin works and Pro-Epanutin may reduce the effect of other medicines taken at the same time. Your doctor must know about all the other medicines you are taking. This applies to both prescription and over-the-counter medicines (including folic acid and vitamin D) as well as herbal medicines.
The list below contains only the diseases/conditions that are treated and not the active substances. Your doctor or pharmacist can provide you with additional information.
Talk to your doctor or pharmacist if you are taking medicines to treat, prevent, or are used for:
- heart and circulation problems
- coagulation disorder (risk of blood clots)
- epilepsy
- fungal infections
- human immunodeficiency virus ( HIV ) infection
- tuberculosis and other infection
- stomach ulcers and heartburn
- asthma and bronchitis (theophylline)
- pain and inflammation
- insomnia, depression, and psychiatric disorders
- diabetes
- cancer
- rejection during organ and tissue transplantation or if you use corticosteroids
- hormone replacement therapies ( estrogens ), oral contraceptives ( birth control pills ) (see section “Pregnancy, contraceptives for women and breastfeeding”).
- muscle relaxants during surgery and certain anesthetics
Your doctor may need to test how much phenytoin you have in your blood to determine if any of your other medicines are affecting your treatment.
The herbal medicine St. John’s wort ( Hypericum perforatum ) should not be taken at the same time as this medicine. If you are already taking St. John’s wort, consult your doctor before stopping taking the St. John’s wort preparation.
Pro-Epanutin may also affect some laboratory tests that may be performed.
Pro-Epanutin with alcohol
If you drink large amounts of alcohol or drink alcohol frequently, it can also affect the concentration of Pro-Epanutin in your blood.
Pregnancy, contraception for women, and breastfeeding
Pregnancy
Consult your doctor as soon as possible if you are pregnant. Do not stop taking this medicine until you have discussed this with your doctor. If you stop treatment without talking to your doctor, you may have seizures that can be dangerous for you and your pregnancy. Your doctor may decide to change your treatment. Careful monitoring of the baby you are expecting may also be considered.
Pro-Epanutin can cause birth defects. If you take Pro-Epanutin during pregnancy, the risk of birth defects is higher. Fetal injuries that have been reported are deformities of the face, skull, nails, fingers, and heart.
If you are of childbearing age and planning to have children, make a doctor’s visit before you become pregnant. Discuss your treatment options with your doctor.
If you take Pro-Epanutin during pregnancy, there is also a risk of bleeding in the baby immediately after birth. Your doctor may give you and your child medicine to prevent this. In addition, your child should be closely monitored.
Contraceptives for women
If you are of childbearing potential, discuss your treatment options and effective contraceptive methods with your doctor. Pro-Epanutin may lead to worse effects than hormonal contraceptives. Therefore, consult your doctor about other effective contraceptive methods.
Breast-feeding
Pro-Epanutin passes into breast milk. You should not use Pro-Epanutin if you are breastfeeding.
Driving and using machines
Pro-Epanutin may cause dizziness or drowsiness. If you get such symptoms, do not drive or use any tools or machines.
Pro-Epanutin contains sodium
When calculating the total amount of sodium, any dilution of fosphenytoin sodium for injection with sodium chloride solution should be taken into consideration.
Each 10 ml vial contains 85 mg of sodium (the main ingredient in table salt/table salt). This corresponds to 4.25% of the maximum recommended daily intake of sodium for adults.
Each 2 ml vial contains 17 mg of sodium which is less than 1 mmol of sodium (23 mg).
How to get Pro-Epanutin
You will receive Pro-Epanutin in hospital.
The drug is given as an injection either into a large vein ( intravenous infusion ) or into a muscle ( intramuscularly ). If Pro-Epanutin is given intravenously, it must be diluted.
Your ECG, blood pressure, and respiration will be monitored at all times during infusion one and for approximately 30 minutes after the end of infusion one.
The dose and concentration of the Pro-Epanutin solution that you receive are determined by your doctor and are expressed in phenytoin sodium equivalents (FE). Dose one is given in milligrams per dose if given as an injection and in milligrams per milliliter (mg/ml) solution if given as an infusion.
Adults
Severe epileptic seizures or seizures ( status epilepticus )
Pro-Epanutin is usually given after treatment with either diazepam or lorazepam in injection.
The first dose of Pro-Epanutin is called the loading dose and is injected into a vein. After a loading dose, you can get a lower dose of Pro-Epanutin given in a vein or a muscle. These are called maintenance doses.
If your seizures cannot be stopped with Pro-Epanutin, try other treatments.
Brain surgery or head injury
The first dose is called a loading dose and it is injected into a vein or muscle. After a loading dose, you can get a lower dose of Pro-Epanutin in a vein or a muscle. These are called maintenance doses.
Maintenance doses
Your doctor may take blood samples to determine the appropriate maintenance dose for you.
If your doctor thinks you need to continue treatment, you can start treatment taken by mouth at the appropriate time. In that case, you will receive phenytoin because Pro-Epanutin (fosphenytoin) cannot be taken orally.
Temporary replacement for oral phenytoin treatment
If you are receiving Pro-Epanutin because you cannot take phenytoin orally (orally), you do not need a loading dose and the dose you receive is the same as your phenytoin dose. Because the dose of Pro-Epanutin is given in FE (phenytoin sodium equivalents), the number of milligrams FE of Pro-Epanutin should be the same as the number of milligrams of phenytoin sodium you take by mouth.
Children from 5 years of age
The dose of Pro-Epanutin per kilogram of body weight is the same for children (from 5 years of age) as for adults.
In children from 5 years of age, Pro-Epanutin is given only as a drip ( infusion ) into a vein ( intravenously ).
Elderly patients over 65 years, very ill patients, and patients with kidney or liver disease
The dose of a Pro-Epanutin may be reduced, alternatively injection into a vein may be given more slowly.
If you take more Pro-Epanutin than you should
An overdose of Pro-Epanutin is dangerous. You will receive Pro-Epanutin in hospital and the dose will be calculated individually for you. Your doctor will monitor you during treatment and equipment for treating heart problems will be available. If you think you have been given too much Pro-Epanutin, contact your doctor immediately.
If you are no longer in hospital and think that you have been given too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital,for risk assessment and advice.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you get any of the following symptoms after taking this medicine. Although rare, these symptoms can be serious.
Uncommon: may affect up to 1 in 100 people
- If you get a severe rash with blisters (which may also occur in the mouth and on the tongue). These skin reactions often occur along with fever and flu-like symptoms. This may be a sign of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In these cases, your doctor will stop your treatment.
Has been reported (occurs in an unknown number of users)
- If you get bruises, fever, look pale or have a very sore throat. These may be the first signs of an abnormal change in the blood such as decreased number of red blood cells, white blood cells, or platelets. Your doctor may take blood samples regularly to check this.
- Skin rash and fever with swollen lymph nodes, yellowing of the skin and eyes, especially during the first two months of treatment. This may be a sign of a hypersensitivity reaction. If the symptoms are severe and you also have pain and inflammation in the joints, it may be due to a condition called systemic lupus erythematosus.
- If you get discolored skin, swelling, and pain where the injection was given, which then begins to spread down the arm to the hands and fingers. This can mean that you have a so-called “purple glove syndrome”. In most cases, it gets better on its own, but in some cases, it can become serious and require urgent medical treatment.
- Red skin areas with small raised blisters filled with white/yellow fluid that is often stronger in skin folds. Swelling of the face may also occur ( acute generalized exanthematous pustulosis (AGEP)).
- Skin rash, fever, swollen lymph nodes, increase in a type of white blood cell ( eosinophilia ), and inflammation of internal organs (liver, lungs, heart, kidneys, and colon). This may be a sign of a hypersensitivity reaction (drug-induced reactions with eosinophilia and systemic symptoms (DRESS)).
- If you become confused or severely mentally ill. This may be a sign that you have high levels of phenytoin in your blood. In rare cases, high levels of phenytoin have remained in the blood and this has led to permanent brain damage. Your doctor may take blood samples to see how much phenytoin you have in your blood and possibly change your dose.
- Sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially all over the body). This may be a sign of a hypersensitivity reaction.
Other side effects that may occur are:
Very common: may affect more than 1 user in 10
- abnormal eye movements, dizziness.
Common: may affect up to 1 in 10 users
- mood swings, tingling and tingling in the skin, feeling of instability, drowsiness, headache, tremors, abnormal or uncoordinated movements, slurred speech, and blurred vision.
- tinnitus, dizziness.
- nausea, dry mouth, vomiting.
- pain or reaction at the injection site.
- weakness, weakness, chills.
Uncommon: may affect up to 1 in 100 people
- with nervousness, confusion, and abnormal/irrational thoughts.
- numbness.
- double vision, impaired hearing.
- impaired sensation in the tongue.
- skin rashes, such as mild measles-like rashes
- muscle weakness, muscle twitching, and muscle aches.
Has been reported (occurs in an unknown number of users)
- swollen lymph nodes.
- inflammation of the arterial walls, and problems with the body’s immune system.
- elevated blood sugar or decreased levels of calcium, folic acid, and vitamin D in the blood. If you also get too little vitamin D through the diet or sunlight, you can get skeletal bone pain or broken bones.
- There have been reports of skeletal diseases such as osteopenia and osteoporosis (osteoporosis) and bone fractures. Talk to your doctor or pharmacist if you are on long-term treatment with antiepileptic drugs, have previously had osteoporosis, or are using steroids.
- altered appetite, difficulty controlling movements, insomnia, and muscle cramps.
- inflammation of the pleura, difficulty breathing.
- swollen gums, constipation.
- inflammation of the liver, liver damage (manifests as yellowing of the skin and whites of the eyes).
- increased or abnormal hair on the body or face, altered facial features, enlarged lips, changes in the hands with difficulty straightening the fingers.
- inflammation of the kidneys.
- Temporary itching, burning, feeling of heat, or tingling sensation in the groin can sometimes occur during injection one or shortly after Pro-Epanutin is injected into a vein. Your doctor may slow down the injection rate or temporarily discontinue the injection of Pro-Epanutin if you experience such sensations.
- hives.
How to store Pro-Epanutin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C ‑ 8 ° C). The undiluted product can be stored at room temperature (8 ° C ‑ 25 ° C) for a maximum of 24 hours.
After dilution, this medicine should be used immediately. For single use only. Unused products must be discarded after opening.
Vials containing particles should not be used.
Contents of the pack and other information
Content declaration
The active substance is fosphenytoin sodium. Each ml contains 75 mg of fosphenytoin sodium. This corresponds to 50 mg of phenytoin sodium (indicated as 50 mg FE).
Each 2 ml vial contains 150 mg of fosphenytoin sodium (equivalent to 100 mg phenytoin sodium and is indicated as 100 mg FE).
Each 10 ml vial contains 750 mg of fosphenytoin sodium (equivalent to 500 mg phenytoin sodium and indicated as 500 mg FE).
The other ingredients are water for injections, trometamol, and hydrochloric acid.
What the medicine looks like and the contents of the pack
Pro-Epanutin concentrate for solution for infusion/solution for injection is supplied in glass vials containing 10 ml or 2 ml clear, colorless to the pale yellow sterile solution.
Pro-Epanutin is available in packs of 5, 10, or 25 vials of 2 ml solution. Pro-Epanutin is also available as multi-packs containing 10 cartons, each containing 5 vials of 2 ml solution (= 50 vials).
Pro-Epanutin is available in packs of 5 or 10 vials of 10 ml solution.
Pro-Epanutin is also available as multi-packs containing 5 cartons, each containing 5 vials of 10 ml solution (= 25 vials).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Pfizer AB
191 90 Sollentuna
Tel: 08-550 520 00
Email: eumedinfo@pfizer.com
Manufacturer
Pfizer Service Company BV
High Road 10
1930 Zaventem
Belgium