Xepi (ozenoxacin) Cream, 1%, Indication and Important Safety Information
INDICATION AND USAGE
Xepi™ (ozenoxacin) Cream, 1% is indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older.
Apply a thin layer of Xepi topically to the affected area twice daily for 5 days. Affected area may be up to 100 cm2 in adult and pediatric patients 12 years of age and older or 2% of the total body surface area and not exceeding 100 cm2 in pediatric patients less than 12 years of age.
IMPORTANT SAFETY INFORMATION
Xepi, containing 1% ozenoxacin, is for topical use only. Not for ophthalmic, oral, intranasal or intravaginal use.
Potential for Microbial Overgrowth: Prolonged use of Xepi may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur, discontinue use and institute alternative therapy.
Adverse reactions (rosacea and seborrheic dermatitis) were reported in 1 adult patient treated with Xepi.
There are no available data on the use of Xepi in pregnant women to inform a drug associated risk. No data are available regarding the presence of ozenoxacin in human milk, and the effects of ozenoxacin on the breastfed infant or on milk production.
The safety and effectiveness of Xepi in the treatment of impetigo have been established in pediatric patients 2 months to 17 years of age. The safety profile of Xepi in pediatric patients 2 months and older was similar to that of adults.
The safety and effectiveness of Xepi in pediatric patients younger than 2 months of age have not been established.
Please read the US Full Prescribing Information for Xepi available at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3361dd6c-4b03-4c42-9b95-4ecd43c34294&audience=consumer
You are encouraged to report side effects of Xepi. Please contact FDA at 1-800-332-1088 or www.fda.gov/medwatch.