XEPI® (ozenoxacin) CREAM, 1%
TERMINATES IMPETIGINOUS
BACTERIA* FAST

 

TWICE DAILY FOR 5 DAYS1-3







*S. aureus; S. pyogenes


OZENOXACIN, THE ACTIVE INGREDIENT OF XEPI®, DISRUPTS DNA REPLICATION OF SUSCEPTIBLE BACTERIA1,4

  • Xepi® is the first and only approved topical non-fluorinated quinolone antimicrobial powered with dual mechanism of action that also shows low potential to generate resistant mutants1,4
     
  • Ozenoxacin, the active ingredient of Xepi®, is bactericidal against susceptible strains of S. aureus and S. pyogenes that cause impetigo, with shown activity against methicillin-resistant S. aureus (MRSA) isolates5

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.

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.

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://www.xepicream.com/PI.

You are encouraged to report side effects of Xepi®. Please contact Biofrontera Inc. at 1-844-829-7434 or FDA at 1-800-332-1088 or www.fda.gov/medwatch.

References: 1. Xepi® [package insert]. Woburn, MA: Biofrontera, Inc.; 2020. 2. Gropper S, Albareda N, Chelius K, et al. Ozenoxacin 1% cream in the treatment of impetigo: a multicenter, randomized, placebo- and retapamulin-controlled clinical trial. Future Microbiol. 2014;9(9):1013-1023. 3. Rosen T, Albareda N, Rosenberg N, et al. Efficacy and safety of ozenoxacin cream for treatment of adult and pediatric patients with impetigo: a randomized clinical trial. JAMA Dermatol. 2018;154(7):806-813. 4. Vila J, Hebert A, Torrelo A, et al. Ozenoxacin: a review of clinical and preclinical efficacy. Expert Rev Anti Infect Ther. 2019;17:159-68. 5. Canton R, Morrissey I, Vila J, et al. Comparative in vitro antibacterial activity of ozenoxacin against Gram-positive clinical isolates. Future Microbiol. 2018;13:3-19.