Evaluation of prulifloxacin in the treatment of otitis media and otitis externa

Abstract

The concentration of UFX (an active metabolite of PUFX) in middle ear tissue ranged from 5.24 to 8.00μg/g at 2 to 3 hours after orally administering 200mg of PUFX and thereafter remained at a level of 8.25μg/g until 9 hours later. The clinical efficacy rates were 100% for acute otitis media, 63% for an acute exacerbation of chronic Otitis media and 75% for otitis externa in daily PUFX doses ranging from 200 to 600 mg. Regarding bacteriological efficacy, the eradication rates were 72% for otitis media and 83% for otitis externa. In the bacteriological response in cases of otitis media, the eradication rates were 74% for gram-positive bacteria and 86% for gram-negative bacteria-Adverse reactions were observed in 2 cases (including one case each of dizziness and diarrhea-nausea), but these symptoms disappeared after withdrawal. Abnormal changes in the laboratory findings were also observed in 3 cases (including one case each of increased eosinophiles, an elevated S-GOT·S-GPT level, and an elevated serum potassium level).