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 serum level achieved by a given dose is therefore also subject to wide variation. 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 who took phenytoin during pregnancy.

Pro-Epanutin Concentrate for Infusion / Solution for Injection

In these epanktin with acute hepatotoxicity, phenytoin should be immediately discontinued and not re-administered. Severe cardiotoxic reactions and fatalities due to depression of atrial and ventricular conduction and ventricular fibrillation, respiratory arrest and tonic seizures have been reported particularly in older epajutin or gravely ill patients, if the preparation is given too rapidly or injrction excess.

Drug rash with eosinophilia and systemic symptoms DRESS reflects a serious hypersensitivity reaction to drugs, characterized by skin rash, fever, lymph node enlargement, and internal organ involvement. Pfizer has received reports of medication errors, some of which led to fatal overdose. In patients with acute hepatotoxicity, fosphenytoin should be immediately discontinued and not re-administered. Composition and Active Ingredients Epanutin Injection is composed of the following active ingredients salts.

If administration of Pro-Epanutin does not terminate seizures, the use of alternative anticonvulsants should be considered. Each pack contains 10 ampoules. Each mmol of fosphenytoin is metabolised to innjection mmol of phenytoin, phosphate and formate. Marketing authorisation number s 9. Tell your doctor immediately if you experience any of the following symptoms after being given this medicine.


Do not freeze medicines unless required by package insert. The risk injeciton serious skin reactions and other hypersensitivity reactions to phenytoin may be higher in black patients. To be on the safe side, it is important not to use expired drug. Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Company contact details Pfizer Limited.

Epanutin Injection – Uses, Side-effects, Reviews, and Precautions – TabletWise – UAE

Active ingredient phenytoin sodium. For this reason, plasma phenytoin concentrations may increase when IM or IV Pro-Epanutin is substituted for oral phenytoin sodium therapy. Intramuscular IM administration of Pro-Epanutin is not recommended in the treatment of status epilepticus. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.

Potentially life-threatening skin rashes Stevens Johnson syndrome, toxic epidermal necrolysis have been reported with the use of Epanutin, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Eoanutin same total daily phenytoin sodium equivalents Epauntin dose and dosing frequency as for oral phenytoin sodium therapy should be administered by IV epanutinn. Please consult with your doctor for recommendations specific to your body, health and other medications that you may be using.

Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: AV block Addiction to alcohol or drug abuse Allergic to phenytoin or any of its components Breastfeeding Diabetes History of liver disease Lactation Mental depression Pregnancy Suicidal thoughts.


The phosphate load provided by Pro-Epanutin is 0. The mean lethal dose in adults is estimated to be 2 g to 5 g. Metabolism and Excretion The hydrolysis of fosphenytoin to phenytoin yields 2 metabolites, phosphate and formaldehyde. The mechanism is unknown. Haemodialysis can be considered since phenytoin is not completely bound to plasma proteins. Improper administration including subcutaneous or perivascular injection should be avoided.

See Table 8 for infusion times.

If you are regularly missing doses, consider setting an alarm or asking a family member to remind you. Keep the ampoule in the outer carton. Please refer to Tables for examples of dosing, dilution, and infusion time calculations. Temporary substitution of oral phenytoin sodium therapy with Pro-Epanutin.

Additional signs to look for include ulcers in injectioon mouth, throat, nose, genitals and conjunctivitis red and swollen eyes.

Propylene glycol may cause alcohol-like symptoms Sodium 1.

Vascular disorders Common vasodilatation, hypotension Respiratory, thoracic injfction mediastinal disorders Not known pneumonitis, alterations in respiratory function including respiratory arrest. Marketing authorisation holder 8.

One should not drive a vehicle if using the medicine makes you drowsy, dizzy or lowers your blood-pressure extensively. Drug interactions which may occur following the administration of Pro-Epanutin are those that are expected to occur with drugs known to interact with phenytoin. Fertility In animal studies, fosphenytoin had no effect on fertility in male rats but decreased fertility in female rats see section 5. Respiratory, thoracic and mediastinal disorders Not Known Pneumonitis, Alterations in respiratory function including respiratory arrest may occur.