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Cerebyx (Fosphenytoin Sodium) - Summary

 

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CEREBYX SUMMARY

CEREBYX®
(Fosphenytoin Sodium Injection)

Cerebyx® (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. Each Cerebyx vial contains 75 mg/mL fosphenytoin sodium (hereafter referred to as fosphenytoin) equivalent to 50 mg/mL phenytoin sodium after administration. Cerebyx is supplied in vials as a ready-mixed solution in Water for Injection, USP, and Tromethamine, USP (TRIS), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. Cerebyx is a clear, colorless to pale yellow, sterile solution.

Cerebyx is indicated for short-term parenteral administration when other means of phenytoin administration are unavailable, inappropriate or deemed less advantageous. The safety and effectiveness of Cerebyx in this use has not been systematically evaluated for more than 5 days.

Cerebyx can be used for the control of generalized convulsive status epilepticus and prevention and treatment of seizures occurring during neurosurgery. It can also be substituted, short-term, for oral phenytoin.

CEREBYX NEWS HIGHLIGHTS

Published Studies Related to Cerebyx (Fosphenytoin)

Fosphenytoin may cause hemodynamically unstable bradydysrhythmias. [2006.01]

Hyperphosphatemia due to fosphenytoin in a pediatric ESRD patient. [2005.08]

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Clinical Trials Related to Cerebyx (Fosphenytoin)

IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures [Recruiting]

Assess the Safety and Efficacy of a Seizure Medication,Levetiracetam(LEV;Keppra),in Neuroscience Intensive Care Unit Patients [Recruiting]

Intravenous Levetiracetam as First-Line Anticonvulsive Treatment in Patients With Non-Convulsive Status Epilepticus [Recruiting]

more>>

Page last updated: 2007-02-12

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