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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Fosphenytoin offers many advantages over phenytoin: Acute alcohol intake may increase plasma phenytoin concentrations while chronic alcohol use may decrease plasma phenytoin concentrations.

Coadministration of Pro-Epanutin is contra-indicated with delavirdine due to the potential for loss of virologic response and possible resistance to delavirdine or to the class unsert non-nucleoside reverse transcriptase inhibitors see section 4.

Injection vials are single-dose only. Caution is recommended in patients performing skilled tasks e. Temporary substitution for oral phenytoin. 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.

Following CEREBYX administration, it is recommended that phenytoin concentrations not be monitored until conversion to phenytoin is essentially complete. Due to an increased fraction of unbound phenytoin in patients with renal or hepatic disease, or in those with hypoalbuminaemia, ihsert interpretation of total phenytoin plasma concentrations should be made with caution as it may not reflect the pharmacologically active unbound concentration.

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

Boxes of 10 vials with 2 mL solution. Dosing Errors Dosing errors associated with Pro-Epanutin have resulted in patients receiving the wrong dose of Pro-Epanutin. Posology Intravenous IV infusion: Cardiac adverse events have also been reported in adults and children without underlying cardiac disease or comorbidities and at recommended doses and infusion rates.

Phenytoin is extensively bound to serum plasma proteins and is prone to competitive displacement. Intramuscular IM administration of Pro-Epanutin is not recommended in the treatment of status epilepticus.

Prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. Binding to plasma proteins is saturable with the result that the percent bound decreases as total fosphenytoin concentrations increase. Blood and the lymphatic system disorders. Hepatic Injury The liver is the chief site of biotransformation of phenytoin.

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In females, altered estrous cycles, delayed mating, prolonged gestation length, and developmental toxicity were observed at all doses, which were associated with maternal toxicity. See Table 4 for infusion times. In all cases of lymphadenopathy, follow-up observation for an extended period is indicated and every effort should be made to achieve seizure control using alternative antiepileptic drugs.

The potential of fosphenytoin to induce intra-arterial irritation was not assessed. Cases of acute hepatotoxicity, including infrequent cases of acute hepatic failure, have been reported with phenytoin.

Pro-Epanutin Concentrate for Infusion / Solution for Injection

This registry is collecting information about the safety of antiepileptic drugs during pregnancy [see Use in Specific Populations 8. Some patients may require more frequent dosing. Women of Childbearing Potential Pro-Epanutin may cause foetal harm when administered to a pregnant woman. Following administration packzge oral phenytoin, phenytoin appears to be excreted in low concentrations in human milk.

Dilution Cerebyx ® -fosphenytoin – GlobalRPH

The IM route should inxert considered for adult patients when there is not an urgent need to control seizures. Reduction in rate of administration or discontinuation of dosing may be needed [see Dosage and Administration 2.

Drug a Mechanism Antineoplastic agents Carbamazepine Chlordiazepoxide Ciprofloxacin Diazepam Phenobarbital Phenothiazines Sodium valproate Valproic acid Certain antacids Unknown a This list is not intended to be inclusive or comprehensive. IM cerebyx is not recommended for tx of status epilepticus. Determination of plasma phenytoin concentrations is especially helpful when possible drug interactions are suspected see section 4. The study demonstrated better local tolerance pain and burning at the infusion sitefewer disruptions of the infusion, and a shorter infusion period for CEREBYX-treated patients Table 5.

The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for fosphenytoin. 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 dose 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 Loading dose Table 8 Seizure treatment or prophylaxis Maintenance dose Table 9 Temporary substitution for oral phenytoin Table In addition, advise the patient that these signs and symptoms should be reported even if mild or when occurring after extended use [see Warnings and Precautions 5.

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Fosphenytoin can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome SJSand toxic epidermal necrolysis TENwhich can be fatal.

Lower or less frequent dosing may be required [see Clinical Ppackage After the initial maintenance dose, subsequent maintenance doses should be individualized by monitoring serum phenytoin concentrations to achieve a target therapeutic concentration of phenytoin [see Dosage and Administration 2.

Decreased serum concentrations of phenytoin the active metabolite of CEREBYX may occur during pregnancy because of altered phenytoin pharmacokinetics [see Clinical Pharmacology Because this disorder is variable in its expression, other organ systems not noted here may be involved.

Inhibition of metabolism may produce significant increases in circulating phenytoin concentrations and enhance the risk of drug toxicity. The carcinogenic potential of fosphenytoin has not been assessed. The following adverse events have been reported in clinical trials in adults receiving Pro-Epanutin.

This can lead to loss of virologic response and possible resistance [see Contraindications 4 ]. Continuous monitoring of electrocardiogram, blood pressure and respiratory function for the insertt of the infusion is essential. Skin and subcutaneous tissue disorders.

Albendazole Antibacterial agents doxycycline, rifampicin, tetracycline Anticoagulants warfarin Antifungal agents azoles, posaconazole, voriconazole Cisatracurium Corticosteroids Cardiovascular agents digoxin, nimodipine, quinidine Delavirdine Furosemide Glibenclamide Hormones oestrogens, oral contraceptives see sections 4. Drugs that may increase serum phenytoin concentrations listed by likely mechanism: Some of these reactions have been fatal see section 4.

See Table 6 for infusion times. The amount and concentration of fosphenytoin is always expressed in terms of mg of phenytoin sodium equivalents PE. In some cases, ten-fold overdoses were associated with fatal outcomes.