Post-Marketing Surveillance of Lomefloxacin (LOMEWON^®) in dogs with bacterial otitis externa

Abstract

A post-marketing surveillance study was conducted to assess the safety and efficacy of LOMEWON^®, 0.3% lomefloxacin otic solution, for bacterial otitis externa in dogs. In this study, we performed a safety study to investigate the incidence of adverse drug reactions to LOMEWON^®. We also performed an efficacy study to investigate its efficacy, and to compare its bacteriological efficacy with that of the clinical trial results. Among 613 cases, 3 adverse drug reactions were reported: vomiting, ear abrasion, and external auditory canal lesion. The incidence rate of adverse drug reactions was 0.49%. The efficacy rate of 103 cases in the efficacy study was 66.0%. Furthermore, the disappearance rates of S. intermedius, S. canis, and P. aeruginoca were 77.1%, 79.0%, and 92.3%, respectively, showing that LOMEWON^® had high efficacy in eradicating these bacterial species. These results indicate that LOMEWON^® is a useful drug with a low incidence rate of adverse drug reactions.