Effect of aceclofenac on pharmacokinetics of phenytoin sodium in epileptic patients

Background: Epilepsy is a chronic disorder characterised by recurrent seizures/convulsions that affects people of all ages. Phenytoin sodium is an effective, cheaper, most commonly used first line drug for the treatment of epilepsy. As a result of sure encounter with various painful inflammatory conditions like chronic arthritis at some point of time the co administration of analgesics becomes inevitable in epileptic patients. Aceclofenac is a commonly prescribed, moderately COX-2 selective congener of Diclofenac. Because of similarity in some pharmacokinetic properties between Phenytoin sodium and Aceclofenac; the possibility of drug interaction between them is postulated.Methods: In this prospective randomized observational study diagnosed and stabilized patients of epilepsy of either sex of more than 18 years of age were included. Patient taking Phenytoin sodium 100mg BD and prescribed tab Aceclofenac 100mg bd for 7 days. Serum Phenytoin sodium levels were measured before and after administering Aceclofenac. Graph pad Prism software Version 6 used for statistical analysis.Results: At the end of the study, we found statistically significant effect (p = 0.0104) on serum Phenytoin sodium level. However, no statistical difference was found in any of the other parameters i.e., epilepsy outcome parameters and lab parameters - Urine routine microscopy, CBC, LFT, KFT and RBG.Conclusions: Findings in this study forms a platform for future researchers to explore this field of research by designing an interventional study with well scrutinised study population considering all pharmacokinetic parameters.