ABSTRACT
Objective: To evaluate the efficacy and tolerability of intravenousfosphenytoin in children with status epilepticus, and resultingserum total phenytoin levels.Methods: In this prospective study, 51 children aged less than 18years received intravenous loading dose of fosphenytoin (18-20mg/kg). Serum total phenytoin levels were estimated at 90 -100minutes. Outcomes studied were (i) seizure control and local and/or systemic adverse effects in next 24 hours and (ii) phenytoinlevels and its correlation with dose received, seizure control andadverse effects.Results: The actual dose of fosphenytoin received varied from15.1 to 25 mg/kg. Seizures were controlled in 45 (88%) childrenand, two required additional dose of 10 mg/kg. None of thechildren showed any local or systemic adverse effects. Serumtotal phenytoin levels were in the therapeutic range (10-20 μg/mL)in 12 (23.5%), sub-therapeutic in 16 (31.3%) and supra-therapeutic in 25 (49%) children. There was weak correlation ofthe phenytoin levels with dose of fosphenytoin received, seizurecontrol, or adverse effects.Conclusion: Intravenous fosphenytoin loading dose of 20 mg/kgis effective in controlling seizures in 88% of children with statusepilepticus, with a good safety profile. Seizure control and adverseeffects appear to be independent of serum total phenytoin levelsachieved.
ABSTRACT
Background: Generic substitution is preferred to reduce healthcare costs and improve patient adherence. The review of literature showed that physicians all around the world were not comfortable in prescribing generic medications due to the lack of evidence on their safety and efficacy.Methods: A prospective study was conducted over a period of one year in Pune. The patients were categorized on their age and were assessed for the clinical effectiveness data (no. of breakthrough seizures and seizure free days) and safety data (no. of ADR episodes). The mean number of patients controlled and the frequency of adverse events at the 3rd and 6th month were calculated.Results: Authors assessed 150 newly diagnosed pediatric epileptic patients who received anti-epileptic drug monotherapy for at least 6 months, out of which 46 (30.66%) received Oxcarbazepine and 104 (69.33%) received Sodium Valproate. At the end of 3 months of therapy 140 (93.33%) patients were seizure free and 145 (96.66%) patients were seizure free at the end of 6 months. Adverse effects were observed in 14 (30.43) patients on oxcarbazepine and 26 (25%) patients on sodium valproate. The most common adverse effect was weight gain in 34 (22.66%) patients with both the AEDs.Conclusions: Seizure control was achieved in majority of the patients. In addition to the seizure control, the frequency of adverse effects was few and tolerable by the patients when prescribed with low cost branded generics.