Comparative study of tosufloxacin tosilate fine granules 15% for pediatrics: MEIJI^® versus Ozex^®

Abstract

In this study, we compared the efficacy, adverse event incidences, and medication compliance of MEIJI^® (T group) with those of Ozex^® (O group) tosufloxacin tosilate fine granules. Tosufloxacin tosilate fine granule was effective in all but one case (32/33) while the time to defervescence was within 2 days of drug administration in both groups (T and O groups, 1.31 and 1.92 days, respectively). The time to cough improvement was within 3 days of drug administration in both groups (T and O groups, 2.27 and 2.64 days, respectively). Adverse events were observed in 7.3% and 14.1% of the T and O groups (6/82 and 10/71), respectively. The medication compliance was good in both groups and, overall, the mean rate of administration of the T and O groups was 93.8% and 97.0%, respectively. The rate of complete administration was 87.8% (72/82) and 91.5% (65/71) in the T and O groups, respectively. No significant changes were observed between the two groups in efficacy, adverse event incidences, and medication compliance. Therefore, tosufloxacin tosilate fine granule 15% for pediatrics (MEIJI^®) may be equivalent to tosufloxacin tosilate hydrate 15% for pediatrics (Ozex^®) in efficacy, adverse event incidences, and medication compliance.