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- W1570669711 abstract "OBJECTIVE: The primary endpoint of this study is to evaluate the safety of exceeding maximum doses specified by the FDA or manufacturer of commonly used antiepileptic drugs (AEDs) in pediatric patients. BACKGROUND: Since the pharmacokinetics of pediatric patients differs from adults, children often need relatively larger antiepileptic drug doses to attain therapeutic drug levels and thus achieve seizure control. In pediatrics, AED use is frequently off-label due to limited randomized controlled trials in children. Safety and efficacy data are often extrapolated from adult literature, and thus optimal dosing may only be determined anecdotally or based upon expert opinion. With limited pediatric dosing guidelines, milligrams per day may be above the maximum adult dose. DESIGN/METHODS: This study is a single-center, retrospective analysis of all pediatric patients seen in the outpatient clinic between October 2010 and October 2014 who were prescribed a dose which exceeds the maximum approved dose of at least one of the following antiepileptic drugs: oxcarbazepine, zonisamide, topiramate, levetiracetam, lamotrigine, clobazam. Baseline demographics (i.e., gender, age, race/ethnicity, weight, height, diagnosis),serum drug levels, and appropriate laboratory tests will be collected. Side effects will be reviewed. RESULTS: Over the 4 year study period, a total of 41,137 prescriptions were included. Two percent of prescriptions exceeded the maximum dose of one of the included AEDs. The most common AED prescribed above the maximum dose was levetiracetam (2.9[percnt]), while zonisamide was the least common (0.8[percnt]). The highest doses prescribed include exceeding the maximum by 3 fold (i.e. levetiracetam dose of 9000 mg/day). The majority of the patients receiving these orders were male (66[percnt]) with a mean age of 15.9 years. CONCLUSIONS: Prescribing doses exceeding the maximum adult dose is infrequent, but may be indicated when seizure control is incomplete at lower doses. Safety data will be presented. Disclosure: Dr. Misra has nothing to disclose. Dr. DiCarlo has nothing to disclose. Dr. Messinger has nothing to disclose. Dr. Clark has nothing to disclose." @default.
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- W1570669711 date "2015-04-06" @default.
- W1570669711 modified "2023-09-26" @default.
- W1570669711 title "Evaluation of safety in exceeding maximum doses of commonly used antiepileptic drugs in pediatric patients (P4.271)" @default.
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