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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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Cerebyx redux
From Nursing, 11/1/97 by Cohen, Michael R

UNCLEAR LABELING

Dosing for fosphenytoin (Cerebyx, Parke-Davis) continues to cause problems a full year after the product hit th market. Although most problems center around using phenytoin sodium equivalents (PE) incorrectly in written orders, unclear vial labeling presents another problem, as this example shows.

A physician ordered 150 mg PE of Cerebyx for a patient. But the nurse who prepared the dose administered 300 mg PE. Why? Well, for once the PE conundrum didn't play a role-but unclear labeling did (see above). The nurse saw 50 mg PE/mL on the label, but she didn't notice the volume of the vial listed below on the label: 2 mL. Assuming that the vial contained 1 ml (50 mg), she administered the contents of three vials (300 mg) instead of one and one-half vials (150 mg PE). Fortunately, the patient suffered no adverse reactions from the double dose.

In an emergency, it wouldn't be hard to look quickly at this tiny vial and just see the strength per milliliter. And if you don't search specifically for the volume, you may incorrectly assume that the vial contains only 50 mgrather than 100 mg.

We've contacted Cerebyx's manufacturer, Parke-Davis, about this issue and offered assistance in resolving this problem. The ideal solution is to change the label to read 100 mg PE/2 mL. At the least, the volume of the vial should be placed closer to the concentration. In the meantime, if removing the product from patient-care areas isn't an option, ask the pharmacy to affix a cautionary sticker to each vial.

Copyright Springhouse Corporation Nov 1997
Provided by ProQuest Information and Learning Company. All rights Reserved

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