<p><strong>Pediatric Use</strong>: The safety and effectiveness of ozenoxacin in the treatment of impetigo have been established in pediatric patients 2 months to 17 years of age. Use of ozenoxacin in pediatric patients (2 months to 17 years of age) is supported by evidence from adequate and well-controlled studies of ozenoxacin in which 251 pediatric patients received at least one dose of ozenoxacin. The median age of the patients enrolled in the clinical trials was 10 years; 3% of patients were 2 months to less than 2 years of age, 55 % of patients were 2 to less than 12 years of age, 11% of patients were 12 to less than 18 years of age, and 31 % of patients were 18 years of age or older. In these studies, the maximum dose applied was approximately 0.5 g of ozenoxacin applied twice daily for up to 5 days (i.e., up to 10 applications total). The safety profile of ozenoxacin in pediatric patients 2 months and older was similar to that of adults. The safety and effectiveness of ozenoxacin in pediatric patients younger than 2 months of age have not been established.<br />
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<strong>Geriatric Use</strong>: Clinical studies of ozenoxacin did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.</p>