Evaluation of safety and efficacy of tosufloxacin granules for children in bacterial pneumonia and otitis media

We conducted a postmarketing surveillance of tosufloxacin granules (OZEX® fine granules 15%), an oral quinolone antibacterial agent for children, between March 2010 and March 2011 to evaluate the safety, efficacy, and compliance in patients with bacterial pneumonia or otitis media. Of 808 patients enrolled, 797 from whom survey forms were collected were analyzed. Of these 797 patients, there were a total of 760 patients included in the compliance analysis, 759 in the safety analysis, 688 in the efficacy analysis, 100 in the clinical efficacy analysis by causative organism, 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 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). Overall, OZEX® fine granules 15% showed good safety, efficacy, and compliance. These results indicate that OZEX® fine granules 15% is a useful agent in children with pneumonia or otitis media. We consider that we should maximize the value of OZEX® fine granules 15% with promotion of the proper use.