FOSPHENYTOIN PACKAGE INSERT PDF

7 DRUG INTERACTIONS. Fosphenytoin is extensively bound to human plasma proteins. Drugs highly bound to albumin could increase the unbound fraction of. Mylan manufactures FOSPHENYTOIN SODIUM Injection in strengths of mg PE in 2ml Vial mg PE in 10 ml Vial. Category: Human Prescription Drug. Fosphenytoin, the long-awaited phosphate ester pro-drug of phenytoin, was developed to overcome many of the .. Cerebyx package insert. Morris Plains, N.J.

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The same total daily phenytoin sodium equivalents PE dose and dosing frequency as for oral phenytoin sodium therapy should be administered by IV infusion.

FOSPHENYTOIN SODIUM Injection mg PE in 2ml Vial mg PE in 10 ml Vial | Mylan

In pregnant women being treated for epilepsy, sudden discontinuation of antiepileptic drug AED therapy should be avoided as tosphenytoin may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child.

Peak concentrations occur at approximately 30 minutes inserf. If tonic-clonic seizures are present simultaneously with absence seizures, combined drug therapy is recommended. If occurs, follow-up observation is indicated and an alternative antiepileptic treatment should lackage used. Fosphenytoin is a pro-drug of phenytoin and it is rapidly converted into phenytoin mole for mole.

In order to obtain rapid seizure control in patients with continuous seizure activity, IV diazepam or lorazepam should be administered prior to administration of Fosphenyfoin. Drugs highly bound to albumin could also increase the fosphenytoin unbound fraction with the potential to increase the rate of conversion of fosphenytoin to phenytoin.

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No increases in tumor incidence were observed in rats. Fosphenytoin is metabolized to phenytoin, phosphate, and formate. Phenytoin may affect blood calcium and blood sugar metabolism tests. Metabolism and nutrition disorders. Albendazole decreases active metabolitechlorpropamide, clozapine, cyclosporine, digoxin, disopyramide, folic acid, methadone, mexiletine, praziquantel, quetiapine.

Phenytoin the active metabolite of CEREBYX prenatal exposure may increase risks for congenital malformations and other adverse developmental outcomes 5.

Pro-Epanutin Concentrate for Infusion / Solution for Injection

The effect of age on the pharmacokinetics of fosphenytoin was evaluated in patients 5 to 98 years of age. Hepatic Injury The liver is the chief site of biotransformation of phenytoin. In humans, prenatal exposure to phenytoin the active metabolite of CEREBYX may increase the risks for congenital malformations and other adverse developmental outcomes.

The liver is the site of biotransformation. Date of first authorisation: Suicidal Ideation and Behaviour Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications.

For single use only. Boxes of 10 vials with 2 mL solution. Phenytoin can substantially reduce the concentrations of delavirdine.

There have been several reported cases of malignancies, including neuroblastoma, in children whose mothers received phenytoin during pregnancy. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6. However, the respective role of antiepileptic drugs and other factors in the increased packags is not determined.

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Although phosphate and formaldehyde formate have potentially important biological effects, these effects typically occur at concentrations considerably in excess of those obtained when CEREBYX is administered under conditions of use recommended in this labeling.

The error is dependent on serum phenytoin and fosphenytoin concentration influenced by CEREBYX dose, route and rate of administration, and time of sampling relative pacage dosingand analytical method.

Dilution Cerebyx ® -fosphenytoin – GlobalRPH

The adequacy of the respiratory and circulatory systems should be carefully observed, and appropriate supportive measures employed. Periodic measurement of serum phenytoin concentrations should be performed during pregnancy, and the CEREBYX dosage should be adjusted as necessary.

This information is intended for use by health professionals. The molecular structure of fosphenytoin is: There packagee marked variations among individuals with respect to plasma phenytoin concentrations where toxicity occurs. As a general principle, monotherapy is preferred for treating epilepsy in pregnancy whenever possible because therapy with multiple AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated AEDs.

Nausea, vomiting, lethargy, tachycardia, bradycardia, asystole, cardiac arrest, hypotension, syncope, hypocalcaemia, metabolic acidosis and death have been reported in cases of overdosage with Pro-Epanutin.