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Safety and Tolerance of Multiple Doses of Intramuscular Fosphenytoin Substituted for Oral Phenytoin in Epilepsy or Neurosurgery
B. J. Wilder, MD;
K. Campbell, MD;
R. E. Ramsay, MD;
W. R. Garnett, PharmD;
J. M. Pellock, MD;
S. A. Henkin, BSN, JD;
A. R. Kugler, PhD
Arch Neurol. 1996;53(8):764-768.
Abstract
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Background
Safety, tolerability, and pharmacokinetics of fosphenytoin sodium, a water-soluble phenytoin prodrug, were investigated after a temporary substitution of intramuscular fosphenytoin for oral phenytoin sodium in 240 epileptic or neurosurgical patients taking oral phenytoin sodium (100-500 mg/d).
Methods
Patients were randomly assigned to 1 of 2 parallel groups. During screening and follow-up, patients were maintained on a regimen of oral phenytoin at an individualized dose. During treatment, the phenytoin-treated patients received intramuscular placebo and their prescribed dose of oral phenytoin; the fosphenytoin-treated patients received oral placebo and intramuscular fosphenytoin equimolar to their phenytoin dose.
Results
Both groups had similar types and frequencies of mild to moderate adverse events. Fosphenytoin was as well tolerated as intramuscular placebo at the injection site. Intramuscular fosphenytoin equimolar to a patient's oral phenytoin dose produced equal or greater plasma phenytoin concentrations.
Conclusions
Dosing adjustments are not required when intramuscular fosphenytoin is temporarily substituted or oral phenytoin therapy is resumed. Intramuscular fosphenytoin is a safe and well-tolerated alternative to oral phenytoin when oral administration is not feasible.
Author Affiliations
From the Department of Neurology, Veterans Affairs Medical Center, Gainesville, Fla (Dr Wilder); North Florida Regional Medical Center, Gainesville (Dr Campbell); Department of Neurology, Veterans Administration Medical Center and University of Miami (Fla) (Dr Ramsay); Departments of Pharmacy and Pharmaceutics (Dr Garnett) and Neurology (Dr Pellock), Medical College of Virginia, Virginia Commonwealth University, Richmond; and Departments of Clinical Communications (Ms Henkin) and Pharmacokinetics and Drug Metabolism (Dr Kugler), Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Co, Ann Arbor, Mich.
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