EPANUTIN INJECTION PDF

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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The dose and concentration of the solution of Epanutin RMP you are given will be decided by your doctor and will be written as the equivalent dose of phenytoin sodium PE. Notwithstanding the slow absorption of Epanutin, when given intramuscularly, its use in certain conditions may be appropriate.

Phenytoin may cause increased blood glucose or serum concentrations of alkaline phosphatase and gamma glutamyl transpeptidase GGT. Possible side effects 5.

The inducing effect may persist for at least 2 weeks after cessation of treatment with St. There have been a number of reports suggesting a relationship between phenytoin and injectioj development of lymphadenopathy local or generalised including benign lymph node hyperplasia, pseudolymphoma, lymphoma, and Hodgkin’s disease.

Each mmol of fosphenytoin is metabolised to 1 mmol of phenytoin, phosphate and formate.

EPANUTIN READY MIXED PARENTERAL MG/5ML SOLUTION FOR INJECTION OR INFUSION |

The clinical significance of these findings is unknown. Caution is advised when treating diabetic patients.

Temporary substitution for oral phenytoin. Most medicines don’t come with a potential for addiction or peanutin. These have included thrombocytopenia, leucopenia, granulocytopenia, agranulocytosis, and pancytopenia with or without bone marrow suppression and aplastic anaemia. Caution is advised when administering Pro-Epanutin in patients requiring phosphate restriction, such as those with severe renal impairment.

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If the rash recurs upon reinstitution of therapy, further phenytoin medication is contraindicated. Treatment is non-specific since there is no known antidote. Investigations Not Known Thyroid function test abnormal. The amount and concentration of fosphenytoin is always expressed in terms of mg PE. Variable effects with phenobarbital, valproic acid, divalproex, others.

Breast-feeding Breast-feeding is not recommended for women taking this drug because phenytoin appears to be secreted in low concentrations in human milk.

Foetal toxicity, developmental toxicity and teratogenicity were observed in offspring of rats given fosphenytoin during pregnancy, similar to those reported with phenytoin see section 5. Date injfction first authorisation: Hepatic Injury The liver is the chief site of biotransformation of phenytoin.

Pro-Epanutin Concentrate for Infusion / Solution for Injection

Pregnancy, breast-feeding and fertility If you do get pregnant while you are given Epanutin RMP you must tell your doctor straight away. Seizure prophylaxis and treatment in neurosurgery. Make sure you are very clear about the risks and benefits of being given Epanutin RMP.

When Pro-Epanutin is administered by IV infusion, maximum injectio fosphenytoin concentrations are achieved at the end of the infusion. Post-synaptic action to enhance GABA-mediated inhibition and reduce excitatory synaptic transmission.

If plasma phenytoin concentrations are excessive, the dose of Pro-Epanutin should be reduced. Blood and lymphatic rpanutin disorders.

Consult your doctor if you observe any of the following side-effects, especially if they do not go away. Fertility In animal studies, phenytoin had no direct effect on fertility. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: When possible, patients should be informed of the potential harm to the foetus.

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These are nystagmus, ataxia and dysarthria. In individual cases where the severity and frequency of the seizure disorder are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or foetus.

Antiepileptic drugs should not be abruptly discontinued because of the possibility of increased seizure frequency, including status epilepticus. Driving and using machines Epanutin RMP may cause dizziness or drowsiness. Monitoring of Patients Continuous monitoring of electrocardiogram, blood pressure and respiratory function for the duration of the infusion is essential.

EPANUTIN READY MIXED PARENTERAL 250MG/5ML SOLUTION FOR INJECTION OR INFUSION

Table 2 displays dosing information for status epilepticus maintenance dose in adults. John’s wort should therefore not be combined with phenytoin. In neonates Haemorrhagic syndrome has been reported in neonates born from epileptic mothers receiving phenytoin. If it is close to the time of your next dose, skip the missed dose and resume your dosing schedule. Lymph node involvement may occur with or without signs and symptoms resembling serum sickness, e.

See Table 8 for infusion times. Unbound phenytoin concentrations may be more useful in these patient populations. See Table 4 for infusion times. Neonatal coagulation defects have been reported within the first 24 hours in babies born to epileptic mothers receiving phenytoin. Tell your doctor if your condition persists or worsens.