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Cerebyx

Fosphenytoin (Cerebyx®, Parke-Davis; Prodilantin®, Pfizer Holding France) is a water-soluble phenytoin prodrug used only in hospitals for the treatment of epileptic seizures. more...

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On 18 November 2004, Sicor Pharms received a tentative approval letter from the United States Food and Drug Administration for a generic version of fosphenytoin.

Uses

Approved

Fosphenytoin is approved in the United States for the short term (five days or less) treatment of epilepsy when more widely used means of phenytoin administration are not possible or are ill-advised, such as endotracheal intubation, status epilepticus or some other type of repeated seizures; vomiting, and/or the patient is unalert or not awake or both.

Unapproved/Off-label/Investigational

In April of 2003, Applebaum and colleagues at the Ben Gurion University of the Negev in Beersheva reported that even though anticonvulsants are often very effective in mania, and acute mania requires rapid treatment, fosphenytoin had no antimanic effect even 60 minutes after administration of doses used in status epilepticus.

Fosphenytoin was more successfully used to relieve pain refractory to opiates in a 37-year-old woman with neuroma, according to Dr. Gary J. McCleane of the Rampark Pain Center in Lurgan, Northern Ireland. She was given 1,500 phenytoin equivalent units of fosphenytoin over a 24 hour period, producing pain relief that last three to fourteen weeks after each infusion, allowing her to use less opiates.

Metabolism

One mmol (millimole) of phenytoin is produced for every mmol of fosphenytoin administered; the hydrolysis of fosphenytoin also yields phosphate and formaldehyde, the latter of which is subsequently metabolized to formate, which is in turn metabolized by a folate dependent mechanism.

Side effects

Side effects are similar to phenytoin, except that fosphenytoin causes less hypotension and more paresthesia. Fosphenytoin can cause hyperphosphatemia in end-stage renal failure patients.

Read more at Wikipedia.org


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More Cerebyx confusion
From Nursing, 7/1/98 by Cohen, Michael R

Last November, we reported on an error that occurred, in part, because of poor labeling on Cerebyx (fosphenytoin). As you can see (below), the volume of the Cerebyx vial is listed in one area of the label and the strength per milliliter (50 mg PE/mL) is listed in another area. At a quick glance, especially during an emergency, the vial may appear to contain only 50 mg PE. As the following new case shows, serious errors continue to occur with this drug.

A 2-year-old child with seizures was brought to the ED. The physician ordered I.V. Cerebyx, 150 mg (100 mg PE), to halt the seizures. Because most medications used in the ED were drawn from floor stock, pharmacy technicians delivered drugs on verbal request. A technician misread the Cerebyx label and delivered three 10 ml vials (1,500 mg PE total). A nurse also misread the label, assuming that each vial contained 50 mg. She drew up 30 ml (1,500 mg PE) instead of 150 mg (100 mg PE) and handed the syringe to another nurse. The second nurse, believing the proper dose had been diluted, didn't question the large volume. She administered the tenfold overdose to the patient, who died soon afterward. Later, excessive amounts of phenytoin were found in the child's blood.

Twice previously, we'd contacted Cerebyx's manufacturer, ParkeDavis, and we've now offered our assistance again. So far, the company's position is that the labeling is adequate and doesn't need to be changed.

Until a change is made, we believe that Cerebyx is too dangerous to store outside the pharmacy and should be removed from unit stock. If circumstances won't allow that, place each vial in a bag with this note: "This 2 ml (or 10 ml) vial contains the equivalent of 100 mg (or SOO mg) of phenytoin (50 mg PE/ml)."

Although nothing replaces following the five "rights" of medication administration, poor drug labeling is a needless additional risk to patient safety.

Copyright Springhouse Corporation Jul 1998
Provided by ProQuest Information and Learning Company. All rights Reserved

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