Epanutin Parenteral

Leaflet accompanying the packaging: patient information

Epanutin parenteral, 50 mg/ml, solution for injection

Sodium Phenytoin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What Epanutin parenteral is and what it is used for
• 2. Important information before taking Epanutin parenteral
• 3. How to take Epanutin parenteral
• 4. Possible side effects
• 5. How to store Epanutin parenteral
• 6. Contents of the pack and other information

1. What Epanutin parenteral is and what it is used for

The active substance of the medicine, phenytoin, belongs to the group of hydantoin derivatives. It is a medicine with strong antiepileptic action, used:

• to control status epilepticus or recurrent seizures at short intervals;
• to prevent seizures after neurosurgical procedures and/or head injuries;
• in acute cardiac arrhythmias, e.g., in the treatment of life-threatening ventricular arrhythmias or arrhythmias in digitalis glycoside poisoning, under general anesthesia, during cardiothoracic surgery, during cardiac catheterization, and during electrical defibrillation. Phenytoin is used when there is no clinical improvement after administration of another antiarrhythmic drug or when there is any factor that prevents the administration of another drug. Phenytoin does not increase the survival of patients with ventricular arrhythmias.

2. Important information before taking Epanutin parenteral

When not to take Epanutin parenteral

• in patients with hypersensitivity to the active substance or other hydantoin derivatives, or to any of the other ingredients of this medicine (listed in section 6),
• due to the high pH of the solution, the medicine should not be administered into an artery,
• in patients with sinus bradycardia,
• in patients with sinoatrial block,
• in patients with atrioventricular block of second and third degree,
• in patients with episodes of loss of consciousness resulting from the Adams-Stokes syndrome,
• in combination with delavirdine (due to the risk of reduced therapeutic efficacy and development of resistance to delavirdine or non-nucleoside reverse transcriptase inhibitors).

Warnings and precautions

Before starting to take Epanutin parenteral, discuss it with your doctor or pharmacist, especially:

• in patients with severe heart failure,
• in patients with respiratory function disorders,
• in patients with hypotension (systolic blood pressure below 90 mmHg),
• in patients with a history of serious blood cell and bone marrow damage,
• during the first three months after a heart attack,
• in patients with kidney and liver diseases,
• in patients with hypoalbuminemia,
• in patients with hyperbilirubinemia,
• in patients taking preparations containing St. John's wort extract,
• in patients with diabetes,
• in patients with porphyria,
• in women of childbearing age or pregnant women
• in patients of Taiwanese, Japanese, Malaysian, or Thai origin, whose test results showed that they are carriers of the CYP2C9*3 variant

If Epanutin parenteral is used during pregnancy, there is a risk of fetal damage. Women of childbearing age should use effective contraception while taking Epanutin parenteral (see "Pregnancy, breastfeeding, and fertility"). In patients taking antiepileptic drugs for various indications, suicidal thoughts and behaviors have been reported. If symptoms that may indicate suicidal thoughts and behaviors appear, the doctor should be consulted immediately. In patients taking antiepileptic drugs, a hypersensitivity syndrome may occur. The increased risk of hypersensitivity applies to:

• patients of black race
• patients who have had hypersensitivity in the past
• patients with a family history of hypersensitivity
• patients with impaired immunity

Hypersensitivity syndrome causes more severe symptoms in people who have been sensitized before. If a patient is diagnosed with hypersensitivity syndrome, the doctor will decide to discontinue phenytoin administration and take appropriate action. During Epanutin parenteral treatment, potentially life-threatening skin rashes have been observed (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), which initially have the appearance of red, target-like lesions or round patches, often with centrally located blisters. Additional symptoms may occur, such as fever, itching, oral, throat, nose, genital, and eye inflammation (red and swollen eyes). These life-threatening skin rashes are often accompanied by flu-like symptoms. In the further development of the rash, extensive blisters or peeling of large skin areas may appear. The greatest risk of severe skin reactions exists in the first few weeks of treatment. The doctor may recommend that the patient discontinue treatment if a rash appears. If the rash is milder (erythematous or morbilliform), treatment can be resumed after the rash has completely resolved. If a rash appears after resuming treatment, further administration of phenytoin is contraindicated. If a patient develops Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Epanutin parenteral, they should never take this medicine again. If a patient develops a rash or other skin symptoms, they should not take the next dose of the medicine, consult a doctor immediately, and inform them about taking this medicine. Before discontinuing Epanutin parenteral, the patient should consult a doctor. Epanutin parenteral may cause or exacerbate seizures and myoclonic seizures. In patients treated with phenytoin, cases of facial, oral (lips, gums, tongue), and neck edema have been reported, which can lead to life-threatening breathing difficulties. If a patient has ever experienced such symptoms, they should not take the next dose of the medicine and contact a doctor immediately. If the phenytoin serum concentration remains at a high level, it may cause confusion or rarely irreversible cerebellar syndrome and/or cerebellar atrophy.

Important information about potentially serious reactions

In patients receiving Epanutin parenteral, allergic reactions or skin reactions, including severe reactions, may occur, which, if left untreated, can lead to serious complications. While taking Epanutin parenteral, the patient should be aware of these symptoms and carefully observe themselves for their occurrence. These symptoms include: skin rash, fever, lymphadenopathy, and disorders affecting the function of other organs, such as hepatitis, nephritis, hematologic disorders (blood and hematopoietic system), myocarditis, myositis, or pneumonitis. Initial symptoms may resemble acute viral infection. Other symptoms include: arthralgia, jaundice, hepatomegaly, leukocytosis (increased white blood cell count), and eosinophilia (increased percentage of eosinophils in the blood smear above 4%). During Epanutin parenteral treatment, cases of acute hepatotoxicity (liver dysfunction or damage) have been observed, including rare cases of acute liver failure. Such events, associated with hypersensitivity syndrome, usually occur within the first 2 months of treatment. In patients with acute hepatotoxicity, Epanutin parenteral should be discontinued immediately and not administered again. Do not consume alcoholic beverages and do not take other medicines without consulting a doctor.

Epanutin parenteral and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take. Many medicines can increase or decrease phenytoin blood levels. On the other hand, phenytoin can change the blood levels of many medicines. In case of suspected interactions, phenytoin blood levels should be determined. The most common interactions are:

• ethanol (consumption of large amounts of alcohol),
• dicumarol, ticlopidine (anticoagulants),
• chlordiazepoxide, diazepam (benzodiazepines),
• halothane (general anesthetic),
• valproate sodium, succinimides, felbamate, oxcarbazepine, topiramate (antiepileptic drugs),
• salicylates, azapropazone, phenylbutazone (nonsteroidal anti-inflammatory drugs),
• chloramphenicol, erythromycin, isoniazid, sulfonamides, sulfadiazine, sulfamethoxazole-trimethoprim, sulfamethoxazole, sulfisoxazole (antibacterial drugs),
• amphotericin B, fluconazole, ketoconazole, miconazole, itraconazole, voriconazole (antifungal drugs),
• amiodarone, diltiazem, nifedipine (drugs used in cardiovascular disorders),
• fluvastatin (lipid-lowering drug),
• estrogens (hormonal drugs),
• tacrolimus (immunologic drug),
• fluoxetine, fluvoxamine, sertraline, trazodone (antidepressants),
• cimetidine, omeprazole (drugs that reduce gastric acid secretion),
• other psychotropic drugs (e.g., methylphenidate, viloxazine),
• disulfiram (drug used in the treatment of alcohol dependence),
• tolbutamide (drug used in the treatment of diabetes),
• fluorouracil, capecitabine (anticancer drug).

Substances that may decrease phenytoin blood levels*:

• ciprofloxacin, rifampicin (antibiotics),
• vigabatrin (antiepileptic drug),
• bleomycin, carboplatin, cisplatin, doxorubicin, methotrexate (anticancer drugs),
• fosamprenavir, nelfinavir, ritonavir (antiviral drugs),
• reserpine (drug used in the treatment of hypertension and schizophrenia),
• diazoxide (antihypertensive drug),
• theophylline (drug used in asthma and other respiratory disorders),
• folic acid,
• St. John's wort extract,
• chronic alcohol abuse,
• enteral nutrition products and/or related nutritional supplements.

Substances that may increase or decrease phenytoin blood levels*:

• carbamazepine, valproate sodium, valproic acid, phenobarbital (antiepileptic drugs),
• chlordiazepoxide, diazepam, phenothiazines (anxiolytic and sedative drugs),
• ciprofloxacin (antibiotic),
• anticancer drugs,
• certain antacids.

Phenytoin may change the levels and effects of the following medicines*:

• clozapine (antipsychotic drug),
• corticosteroids,
• warfarin, rivaroxaban, dabigatran, apixaban, edoxaban (anticoagulants),
• doxycycline, rifampicin, tetracycline (drugs used in parasitic infections),
• azoles, posaconazole, voriconazole (antifungal drugs),
• albendazole, praziquantel (antiparasitic drugs),
• delavirdine, efavirenz, fosamprenavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir (antiviral drugs),
• lamotrigine, carbamazepine, valproate sodium, valproic acid, phenobarbital, lacosamide (antiepileptic drugs),
• oral contraceptives (their contraceptive effect may be reduced),
• alkuronium, cisatracurium, pancuronium, rocuronium, vecuronium (muscle relaxants),
• paroxetine, quetiapine, sertraline (antidepressants),
• diazoxide, furosemide (antihypertensive drugs),
• digoxin, digitoxin, disopyramide, mexiletine, nicardipine, nimodipine, nisoldipine, quinidine, verapamil (drugs used in cardiovascular disorders),
• methadone (pain reliever),
• chlorpropamide, gliburide, tolbutamide (drugs used in the treatment of diabetes),
• teniposide (anticancer drug),
• tikagrelor (antiplatelet drug),
• theophylline (drug used in asthma and other respiratory disorders),
• cyclosporine (e.g., antitubercular),
• vitamin D,
• estrogens (hormonal drugs),
• atorvastatin, fluvastatin, simvastatin (drugs that regulate lipid metabolism).

In patients taking oral anticoagulants, it is recommended to regularly monitor the Quick test value. An increase in methotrexate toxicity may occur. The effect of phenytoin may be reduced during concomitant administration of folic acid.

Pregnancy, breastfeeding, and fertility

Pregnancy

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine. Epanutin parenteral may cause serious birth defects. If a patient takes Epanutin parenteral during pregnancy, their fetus is up to 3 times more likely to have birth defects than fetuses of women not taking antiepileptic drugs. Serious birth defects have been reported, including growth disorders and birth defects of the skull, face, nails, fingers, and heart. Some of these may occur together as part of the fetal hydantoin syndrome. In infants born to mothers taking phenytoin during pregnancy, cases of developmental disorders (related to brain development) have been reported. The results of some studies show that phenytoin has a negative effect on the neurological development of fetuses exposed to this medicine, while the results of other studies do not confirm this effect. Therefore, it cannot be ruled out that phenytoin has a negative effect on neurological development. Phenytoin crosses the placental barrier in humans. Phenytoin may sometimes cause birth defects in the offspring of patients with epilepsy, so the medicine should not be used as a first-line treatment during pregnancy, especially in early pregnancy, unless the potential benefits outweigh the risk to the fetus. The doctor will provide information on other possible treatment options. Since the occurrence of developmental disorders depends on the dose of phenytoin, in pregnant women, the smallest dose that allows seizure control should be used. The risk of birth defects, such as cleft lip/palate, heart defects, microcephaly, or intellectual disability, is higher if the patient takes phenytoin concurrently with other antiepileptic drugs. Genetic factors or the epilepsy itself may be more significant in the development of birth defects than the use of antiepileptic drugs. During pregnancy, the phenytoin blood level decreases. After delivery, the level increases to pre-pregnancy values. Therefore, the doctor will recommend regular monitoring of phenytoin blood levels throughout pregnancy and after delivery. To prevent bleeding complications in the newborn, the doctor will recommend prophylactic vitamin K to the mother in the last weeks of pregnancy and then to the newborn. The doctor should inform women of childbearing age about the need to use effective contraception during treatment. The use of phenytoin may reduce the effectiveness of hormonal contraceptives.

Breastfeeding

Breastfeeding is not recommended during phenytoin therapy, as the medicine is present in small amounts in human milk. The phenytoin concentration in milk is three times lower than in the mother's blood. The child breastfed by a woman treated with phenytoin should be monitored for adequate weight gain or excessive sleepiness.

Fertility

In animal studies, phenytoin had no direct effect on fertility.

Driving and using machines

Epanutin parenteral has a significant impact on the ability to drive and use machines, so patients should not drive or operate any devices or machines unless their doctor recommends otherwise. In patients in the initial period of Epanutin parenteral treatment or when the medicine is taken in higher doses and/or in combination with other central nervous system-acting drugs, reduced reaction ability has been reported. This applies especially to situations where the patient also consumes alcohol.

Epanutin parenteral contains ethanol, propylene glycol, and sodium

This medicine contains 400 mg of alcohol (ethanol, 96%) in each 5 ml of solution, which is equivalent to 10% of the volume. The amount of alcohol in 5 ml of solution is equivalent to 11 ml of beer or 4.5 ml of wine. The amount of alcohol in this medicine is unlikely to have an effect on adults and adolescents, and its effect on children is likely to be negligible. It may cause some effect in younger children, such as drowsiness. Alcohol in this medicine may alter the effect of other medicines. If a patient is taking other medicines, they should consult a doctor or pharmacist. If a patient is pregnant or breastfeeding, they should consult a doctor or pharmacist before taking this medicine. If a patient is addicted to alcohol, they should consult a doctor or pharmacist before taking this medicine. This medicine also contains 2.072 g of propylene glycol in 5 ml of phenytoin solution, which corresponds to 414.0 mg of propylene glycol per 1 ml. Before administering the medicine to a child under 5 years of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol. Women who are pregnant or breastfeeding should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on such patients. Patients with liver or kidney disorders should not take this medicine unless recommended by a doctor. If it is necessary to take Epanutin parenteral for more than 24 hours, the doctor may perform additional tests. Propylene glycol in this medicine may cause symptoms similar to those after alcohol consumption and increase the likelihood of side effects. The medicine should only be used on a doctor's prescription. The doctor may decide to perform additional tests on a patient taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of solution, which means the medicine is considered "sodium-free".

3. How to take Epanutin parenteral

Epanutin parenteral is intended for use only by a doctor or under medical supervision. The dose and frequency of administration are determined by the doctor. In case of doubts, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Epanutin parenteral can cause side effects, although not everybody gets them. The following side effects have been reported (frequency unknown - cannot be estimated from the available data):

• Nervous system disorders:

The most common symptoms occurring during phenytoin treatment are usually dose-dependent. They include: nystagmus, ataxia, slurred speech, disturbed coordination, confusion, drowsiness, and dizziness; insomnia, transient nervousness, tremor, and headache; paresthesia (sensory disturbances in the form of tingling, burning skin), drowsiness, rarely dyskinesia (uncoordinated and involuntary movements of limbs, lips, tongue), including athetosis, dystonia (superimposition of involuntary muscle spasms on intended movements); peripheral sensory polyneuropathy (damage to peripheral nerves) - mainly in patients taking phenytoin for a long time; tonic seizures (sudden contraction of the whole body or a group of muscles, accompanied by loss of consciousness and fall), taste disorders. Cerebellar atrophy has also been reported, and this effect is more likely to occur in patients taking high doses of phenytoin for a long time.

• Cardiac disorders:

Cardiac arrest/cardiac arrest, bradycardia, and hypotension, severe cardiotoxic reactions, and cases of death due to conduction disorders and ventricular fibrillation. Severe complications occur most often in elderly or severely ill patients.

• Respiratory, thoracic, and mediastinal disorders:

Respiratory function disorders with respiratory arrest, pneumonia.

• General disorders and administration site conditions:

Hypersensitivity reactions, pseudoanaphylactic reactions, anaphylaxis, local irritation, inflammation, and tenderness; necrosis and separation of necrotic tissue from healthy tissue after subcutaneous or perivascular injection (subcutaneous and perivascular injections should be avoided). Also reported are edema, discoloration, and pain at the injection site (described as "Purple Glove Syndrome").

• Skin and subcutaneous tissue disorders:

Skin symptoms, which are sometimes accompanied by fever, include: rash, urticaria; less often other types of dermatitis; severe symptoms (which can be fatal): blistering, exfoliative, or bullous dermatitis, lupus erythematosus. Very rare, life-threatening skin rashes, which can cause blistering (which can occur in the mouth and on the tongue) - Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 2).

• Blood and lymphatic system disorders:

Rare cases of blood system diseases, including those with a fatal outcome. Thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), granulocytopenia (reduced granulocyte count), agranulocytosis (lack of granulocytes), and aplastic anemia (associated with inhibition of bone marrow function or without inhibition of bone marrow function); macrocytosis (excessive increase in mean erythrocyte volume) and megaloblastic anemia (caused by a deficiency of vitamin B or folic acid); often lymphadenopathy (local or generalized), including benign lymph node hyperplasia, pseudolymphoma, lymphoma (cancer of the lymphatic system); reduced count of a specific type of red blood cells (pure red cell aplasia).
Renal and urinary disorders:

Interstitial nephritis.

Taking phenytoin may interfere with thyroid function test results.

• Children and adolescents

Side effects in children and adolescents occur with a similar frequency as in adults. Gingival hyperplasia (drug-induced) occurs more frequently in children and adolescents and in people who do not maintain good oral hygiene.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the marketing authorization holder or to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder or its representative. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Epanutin parenteral

Store at a temperature below 25°C. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Epanutin parenteral contains

• The active substance of the medicine is phenytoin sodium.
• The other ingredients are: propylene glycol, ethanol 96%, sodium hydroxide, water for injections.

What Epanutin parenteral looks like and contents of the pack

The pack contains: 5 glass vials of 5 ml of ready-to-use solution for injection.

Marketing authorization holder:

Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands

Manufacturer:

Pfizer Manufacturing Belgium N.V., Rijksweg 12, B-2870 Puurs-Sint-Amands, Belgium For more detailed information, please contact the representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

tel. 22 546 64 00

Date of last revision of the leaflet:

Information intended only for healthcare professionals:

Detailed information about this medicine (Summary of Product Characteristics) is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

Route of administration and duration of treatment:

The solution for injection is intended for intravenous use only (in a slow bolus or infusion). The occurrence of cardiovascular events may be related to too rapid intravenous administration. After intramuscular administration, absorption is delayed and variable. Intramuscular administration of the medicine may cause pain, necrosis, and abscess formation at the injection site. Due to the risk of local toxic effects, Epanutin parenteral should be administered intravenously directly into a large peripheral or central vein through a large-caliber needle or catheter. Before administration, the patency of the intravenous catheter should be checked by flushing it with sterile saline solution. After each intravenous injection of the medicine, the same catheter should be flushed with sterile saline solution to avoid local irritation of the vein caused by the alkaline reaction of the solution. Intramuscular or perivascular injections should be avoided, as the solution for injection has an alkaline reaction and may cause tissue necrosis. It is recommended to consider oral administration of phenytoin due to the risk of cardiotoxic reactions and local toxic effects associated with intravenous administration of the product. The duration of treatment depends on the underlying disease and its course. It is unlimited, provided that the medicine is well tolerated. The therapeutic range of phenytoin plasma concentrations is usually between 10 and 20 µg/ml. In adults, the intravenous dose should not exceed 50 mg/min. In newborns, the medicine should be injected slowly intravenously at a dose of 1 to 3 mg/kg body weight/min, and in children at a dose of 1 to 3 mg/kg body weight/min or 50 mg/min, whichever is slower. This medicine contains 2.072 g of propylene glycol in 5 ml of phenytoin solution. Therefore, a phenytoin loading dose of 20 mg/kg body weight contains 165.6 mg/kg body weight of propylene glycol. In newborns and infants under 1 year of age, this may cause side effects. A daily dose of 30 mg/kg body weight corresponds to:

A daily dose of 10 mg/kg body weight corresponds to:

• Status epilepticus or recurrent seizures at short intervals

Adults and adolescents from 13 years of age The initial dose is 1 vial of Epanutin parenteral (corresponding to 230 mg of phenytoin). It is administered intravenously at a maximum rate of 0.5 ml/min (corresponding to 23 mg of phenytoin per minute). If seizures do not stop after 20-30 minutes, the dose can be repeated. After the seizures have stopped, 1 vial of Epanutin parenteral (corresponding to 230 mg of phenytoin) can be administered intravenously every 1.5 to 6 hours. To achieve rapid saturation with the medicine, a maximum daily dose of 17 mg/kg body weight can be used. Children up to 12 years of age On the first day, the maximum daily dose is 30 mg/kg body weight, on the second day 20 mg/kg body weight, and on the third day 10 mg/kg body weight. In newborns, the medicine should be injected slowly intravenously at a dose of 1 to 3 mg/kg body weight/min, and in children at a dose of 1 to 3 mg/kg body weight/min or 50 mg/min, whichever is slower. This medicine contains 2.072 g of propylene glycol in 5 ml of phenytoin solution. Therefore, a phenytoin loading dose of 20 mg/kg body weight contains 165.6 mg/kg body weight of propylene glycol. In newborns and infants under 1 year of age, this may cause side effects. A daily dose of 30 mg/kg body weight corresponds to: A daily dose of 20 mg/kg body weight corresponds to:

Dosing in Special Patient Populations

Patients with Renal or Hepatic Disease
See Section 4.4 of the Summary of Product Characteristics.

Elderly Patients
In elderly patients, the clearance of phenytoin is slightly decreased, and therefore smaller doses or a reduced frequency of administration may be required (see Section 5.2 of the Summary of Product Characteristics).
Drug Substitution:
Due to the relatively small range of therapeutic plasma concentrations of phenytoin and the different bioavailability of various pharmaceutical products, the administered drug should not be changed to another phenytoin product without close monitoring of its plasma concentration. Steady-state plasma concentrations of phenytoin (steady state) are only achieved after administration of a constant dose of the drug for a period of 5 to 14 days.
For this reason, the dose of the drug should be reduced (if possible) gradually, and new antiepileptic drugs should be introduced through gradual dose escalation. After sudden discontinuation of Epanutin parenteral, seizures and status epilepticus may occur or worsen. If, in the physician's opinion, it is necessary to reduce the dose, discontinue the drug, or replace it with another antiepileptic treatment, this should be done gradually. In the event of an allergic reaction or hypersensitivity reaction, it may be necessary to administer another antiepileptic drug quickly. In such cases, alternative treatment should be carried out with an antiepileptic drug that is not a hydantoin derivative.
Incompatibilities:
For single use only. After opening, any unused remainder of the product should be discarded.
Epanutin parenteral should be used immediately after opening.
Epanutin parenteral should not be mixed with other solutions (including glucose solution or solutions containing glucose additive), as this results in the precipitation of phenytoin .
The drug should not be used in case of precipitate formation or solution turbidity in the vial.