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| |  Parke-Davis Revises Cerebryx Labels In The U.S. Due To Overdose Complications WASHINGTON, DC -- Jan. 29, 1999 -- Parke-Davis will be revising the vial and carton labels of its drug Cerebryx (fosphenytoin sodium injection) in response to serious adverse events, including death, associated with massive overdoses of the drug. These overdoses have resulted from health care workers' mistaken interpretation of the current vial label (both 2mL and 10mL vials). Specifically, some health care workers withdrawing Cerebyx from the vial have misinterpreted the vial label to mean that the amount of phenytoin equivalents per millilitre actually represents the total amount of phenytoin equivalents in the vial. The revised packaging is designed to further reinforce the total amount of phenytoin equivalents (PE) in each Cerebyx vial. It is important to emphasise that all Cerebyx vials (both current and newly labelled product) contain the same 50mg PE/mL concentration. The change serve to further highlight the total contents of each vial. It is important to realise that supplies of Cerebyx currently available will not have the revised label for several weeks. During this period staff should be particularly cautious when preparing Cerebyx for injection. The revised labels will continue to express Cerebyx dosage in phenytoin sodium equivalents (PE). By using phenytoin sodium equivalents (PE), physicians will not have to make dosing adjustments when converting from phenytoin sodium to Cerebyx or vice versa. For example, in a situation where a physician prescribes a 1,000mg dose of IV phenytoin sodium, a 1,000mg PE dose of Cerebyx would be the therapeutic equivalent. Cerebyx should always be prescribed and dispensed in phenytoin sodium equivalents (PE). The company asks to ensure that pharmacy staff, emergency room personnel, nurses and other medical staff understand the total contents of each Cerebyx vial and that Cerebyx is dosed in phenytoin sodium equivalents (PE). Cerebyx is a parenteral phenytoin therapy indicated for the control of generalised convulsive status epilepticus, the prevention and treatment of seizures occurring during neurosurgery and as a short-term substitute for oral phenytoin. Cerebyx is a water-soluble prodrug that rapidly and completely converts to phenytoin following injection or infusion.
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