Breakthrough seizures with generic carbamazepine: a consequence of poorer bioavailability?

The bioavailability of carbamazepine from two products (Ethical Generics and Ciba-Geigy) and their efficacy with regard to seizure control and incidence of side-effects were compared in 23 children with tonic-clonic or complex partial seizures. Mean plasma concentrations of carbamazepine, carbamazepine 10, 11-epoxide and 10,11-dihydro-10, 11-trans-dihydroxy-carbamazepine at comparable sampling times were not significantly different during treatment with the two drug preparations. The incidence of seizures and occurrence of abnormal EEGs were not significantly different during treatment with the two carbamazepine preparations, and, in addition, the overall incidence of side-effects was not significantly different during the two treatment periods. However, neurological side-effects were significantly less during treatment with the Ciba-Geigy product. On the basis of these observations we are confident that the efficacy of these two carbamazepine preparations in children at steady-state is the same.

RCT Entities:   Population Interventions Outcomes