Evaluation of the safety and efficacy of tosufloxacin granules for pediatric with bacterial pneumonia, otitis media - Evaluation of the safety and efficacy of tosufloxacin granules for pediatric with bacterial pneumonia, otitis media

There were a total of 760 patients included in the compliance analysis, 759 in the safety analysis, 688 in the efficacy analysis and 20 in the bacteriological efficacy analysis. The incidence of adverse drug reactions (ADRs) was 2.77% (21/759), and the major ADRs were gastrointestinal disorders including diarrhea in 16 patients (2.11%). Nausea vomiting and joint disorders were intensively investigated. Vomiting was reported in 8 patients (1.05%), which was not clinically significant. No joint disorders were reported. The overall efficacy rate was 98.1% (675/688). The efficacy rate by the type of infection was 100% (145/145) for bacterial pneumonia and 97.7% (506/518) for otitis media. The eradication rates of Streptococcus pneumoniae and Haemophilus influenzae which are major causative or organisms in pediatric infections of pneumonia and otitis media were 7/8 and 93.3% (14/15), respectively. The compliance was good in 87.5% of the patients (665/760).