Phenytoin Injection prescription and dosage sizes information for physicians and healthcare professionals. Pharmacology, adverse reactions, warnings and side. Page 1. Page 4. Malta ADR Reporting website: adrportal 5. How to store Epanutin RMP The storage of Epanutin RMP will not be . Epanutin Injection is used for Seizure, Migraine, Cardiac arrhythmias and other conditions. Epanutin Injection may also be used for purposes not listed in this.

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While macrocytosis and megaloblastic anaemia have occurred, these conditions usually respond to folic acid therapy. Due to an increased fraction of unbound phenytoin in patients with renal or hepatic disease, or in those with hypoalbuminaemia, the interpretation of total phenytoin plasma concentrations should be made with caution as it may not reflect the pharmacologically active unbound concentration.

Pro-Epanutin Concentrate for Infusion / Solution for Injection

Risk related to phenytoin Phenytoin crosses the placenta in humans. Consult your doctor in case of hepatic impairment, cardiovascular disease, sinus bradycardia, heart injectino, hypoalbuminemia, porphyria and seizures Do not drive or operate heavy machinery Do not stop medication even if you feel fine.

Haemodialysis can be considered since phenytoin is not completely bound to plasma proteins. In a patient having continuous seizure activity, as compared to the more common rapidly recurring seizures, i. The pharmacist will ensure that your medicine is kept out of the sight and reach of children. Intramuscular or intravenous Epanutin RMP should not be added to dextrose or dextrose-containing solutions as this could interfere with the dose of this medicine.

Eye disorders Common blurred vision, visual impairment Uncommon diplopia Ear and labyrinth disorders Common tinnitus, vertigo Uncommon hypoacusis Cardiac disorders Uncommon cardiac arrest Not known severe cardiotoxic reactions jnjection atrial and ventricular conduction depression including bradycardia and all degrees of heart blockventricular fibrillation and cardiovascular collapse see section 4.

Phenytoin may affect blood calcium and blood sugar metabolism tests. Phenytoin serum level determinations may be necessary to achieve optimal dosage adjustments.

The mechanism by which phenytoin affects bone metabolism has not been identified. To bookmark a medicine you must sign up and log in. Hyperglycaemia has been reported. Co-administration of phenytoin is contraindicated with delavirdine due to the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.


Care should be taken to ensure the appropriate volume of Pro-Epanutin is withdrawn from the vial when preparing the drug for administration.

Pro-Epanutin should not be used in women of eanutin potential unless other antiepileptic drugs are ineffective or not tolerated and when possible, the woman is made aware of the risk of potential harm to the foetus and the importance of planning pregnancy.

Note, however, that fosphenytoin has important differences in administration from parenteral phenytoin sodium see section 4.

Dose mg phenytoin sodium. Epanutin Injection works by slowing down the abnormal electrical activity of the brain epanuti causes seizures. Cardiac adverse events have also been reported in adults and children without underlying cardiac disease or comorbidities and at recommended doses and infusion rates.

Back to top Pfizer Limited contact details. The syndrome is more severe in previously sensitized individuals. Intravenous Epanutin RMP should not be given to neonates at a rate faster than 1 to 3 mg per kg body weight per minute.

Fosphenytoin is a pro-drug of phenytoin and it is rapidly converted into phenytoin mole for mole. Parenteral phenytoin affects ventricular automaticity. Pro-Epanutin is available in 10 mL and 2 mL vials.

Some of these events have been fatal or life threatening. Most medicines don’t come with a potential for addiction or abuse. To email a medicine you must sign up and log in. Antineoplastic agents fluorouracil Azole antifungals ketoconazole, itraconazole, fluconazole, miconazole Capecitabine Fluvastatin Glibenclamide Sulfaphenazole. Find out more here. The mechanism by which phenytoin affects bone metabolism has not been identified. If you experience these symptoms, do not drive or use eapnutin tools or machines and contact your doctor.

Factors such as previous antiepileptic therapy, seizure control, age and general medical condition must be considered.

Epanutin Ready Mixed Parenteral – Summary of Product Characteristics (SmPC) – (eMC)

Antineoplastic agents bleomycin, carboplatin, cisplatin, doxorubicin, methotrexate Chronic alcohol abuse Diazoxide Folic acid Fosamprenavir Nelfinavir b Theophylline Vigabatrin Ritonavir St John’s Wort. Please refer to Tables for examples of dosing, dilution, and infusion time calculations Population Indication Dosing Table Adults Status epilepticus Loading dose Table 1 Status epilepticus Maintenance eoanutin Table 2 Seizure treatment or prophylaxis Loading dose Table 3 Seizure treatment or prophylaxis Maintenance dose Table 4 Temporary substitution for oral phenytoin Table 5 Children aged 5 years and older Status epilepticus Loading dose Table 6 Status epilepticus Maintenance dose Table 7 Seizure treatment or prophylaxis Ijection dose Table 8 Seizure treatment or prophylaxis Maintenance dose Table 9 Temporary substitution for oral phenytoin Epanutinn Malformations such as orofacial clefts, cardiac defects, dysmorphic facial features, nail and digit hypoplasia, and growth abnormalities including microcephaly have been reported among children born to women with epilepsy injectuon took phenytoin during pregnancy.


It is advised that blood samples to assess phenytoin concentration should not be obtained for at least 2 hours after IV Pro-Epanutin infusion or 4 hours after IM Pro-Epanutin injection. Boxes of 5 vials with 2 mL solution. Lastly, do not self-medicate and increase your body’s dependence to medicines without the advice of a doctor.

Fosphenytoin is not epabutin in urine. Potentially life-threatening skin rashes Stevens Johnson syndrome, toxic epidermal necrolysis have been reported epanjtin the use of Epanutin, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Phenytoin is not effective in absence seizures.

Maintenance doses should be adjusted according to patient response and trough plasma phenytoin concentrations see Therapeutic Drug Monitoring. There are many drugs which may increase or decrease plasma phenytoin concentrations. Phenytoin crosses the placenta in humans.


If the rash recurs upon reinstitution of therapy, further fosphenytoin or phenytoin administration is contraindicated. What you need to know before you are given Epanutin RMP 3. Some of these reactions have been fatal see section 4.

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