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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HIGHLIGHTS OF PRESCRIBING INFORMATION

The product should not be stored at room temperature for more than 48 hours. Vials that develop particulate matter should not be used. Solution Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Fosphenytoin offers many advantages over phenytoin: IM cerebyx is not recommended for tx of status epilepticus. Cerebyx should always be prescribed and dispensed in phenytoin sodium equivalent units PE. Cerebyx has important differences in administration from those for parenteral phenytoin sodium see below.

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Products with particulate matter or discoloration should not be used. Continuous monitoring of the electrocardiogram, blood pressure, and respiratory function is essential and the patient should be observed throughout the period where maximal serum phenytoin concentrations occur, approximately 10 pcakage 20 minutes after the end of Cerebyx infusions. If administration of Cerebyx does not terminate seizures, the use of other anticonvulsants and other appropriate measures should be considered.

Pro-Epanutin Concentrate for Infusion / Solution for Injection

IM Cerebyx should not be used in the treatment of status epilepticus because therapeutic phenytoin concentrations may not be reached as quickly as with IV administration.

If IV access is impossible, loading doses of Cerebyx have been given by the IM route for other indications.

For this reason, plasma phenytoin concentrations may increase modestly when IM or IV Cerebyx is substituted for oral phenytoin sodium therapy.

In controlled trials, IM Cerebyx was administered as a single daily dose utilizing either 1 or 2 injection sites. Some patients may require fosphenygoin frequent dosing.

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Unbound phenytoin concentrations may be more useful in these patient populations. This has the potential to increase the frequency and severity of adverse events. Elderly Patients Age does not have a significant impact on the pharmacokinetics of fosphenytoin following Cerebyx administration.

Dilution Cerebyx ® -fosphenytoin – GlobalRPH

Phenytoin clearance is decreased slightly in elderly patients and lower or less frequent dosing may be required. Pediatric The safety of Cerebyx fosphenytooin pediatric patients has not been established. Disclaimer The authors make no claims of the accuracy of the information fospphenytoin herein; and these suggested doses are not a substitute for clinical judgment.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.