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

Satoshi Iwata, Kenji Suzuki, Shinichiro Takayama, Keisuke Sunakawa

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)204-216
Number of pages13
JournalJapanese Journal of Chemotherapy
Volume62
Issue number2
Publication statusPublished - 2014

Fingerprint

tosufloxacin
Bacterial Pneumonia
Otitis Media
Safety
Compliance
Drug-Related Side Effects and Adverse Reactions
Vomiting
Pneumonia
Joints
Quinolones
Haemophilus influenzae
Patient Compliance
Streptococcus pneumoniae
Infection
Nausea
Diarrhea
Pediatrics
Anti-Bacterial Agents

Keywords

  • Child
  • Otitis media
  • Pneumonia
  • Post-marketing surveillance
  • Tosufloxacin

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Evaluation of safety and efficacy of tosufloxacin granules for children in bacterial pneumonia and otitis media. / Iwata, Satoshi; Suzuki, Kenji; Takayama, Shinichiro; Sunakawa, Keisuke.

In: Japanese Journal of Chemotherapy, Vol. 62, No. 2, 2014, p. 204-216.

Research output: Contribution to journalArticle

Iwata, Satoshi ; Suzuki, Kenji ; Takayama, Shinichiro ; Sunakawa, Keisuke. / Evaluation of safety and efficacy of tosufloxacin granules for children in bacterial pneumonia and otitis media. In: Japanese Journal of Chemotherapy. 2014 ; Vol. 62, No. 2. pp. 204-216.
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