Xepi® is an antibiotic cream that treats impetigo (im-puh-TIE-go) by killing Staphylococcus aureus (STAFF-oh-low-cock-us ORE-ee-us) and Streptococcus pyogenes (STREP-toe-cock-us PIE-oj-en-eez) bacteria.1
- Clearance of impetiginous bacteria* was seen after 5 days of treatment twice a day4,5
- With substantial improvement as early as 2 to 3 days4,5
*Staphylococcus aureus and Streptococcus pyogenes.
S. aureus; S. pyogenes
Medical studies compared the effect of Xepi® and a placebo cream (cream without the active drug) on impetigo in patients with S. aureus and/or S. pyogenes.1,4,5
Xepi® showed a significant improvement at the end of 5 days of therapy when compared to the placebo cream.1,4,5
Xepi® was tested in 2 medical studies that included 723 people aged 2 months or older. Participants were randomly assigned to receive either Xepi® or the placebo cream and did not know which cream they were given (blinded).1,4,5
They applied Xepi® or the placebo cream twice a day for 5 days. The affected body surface could not be larger than 2% for patients aged 2 months to 11 years.1,4,5
The percentage of patients with no more or fewer symptoms and not requiring additional antimicrobial therapy for the treated areas is shown in the table below, grouped according to the type of bacteria causing impetigo (S. aureus or S. pyogenes).1
Xepi® is a prescription drug approved for adults and children 2 months of age and older
Apply Xepi® in a thin layer twice per day, for 5 days, where impetigo sores are present
Do not use Xepi® if the affected area of impetigo is bigger than the size of the child’s two (2) hands (100 cm2)
Use Xepi® only on the skin. Don’t apply Xepi® in your eyes or body cavities (like your mouth or nose)
Wash your hands after applying Xepi® if hands are not the area being treated
Use Xepi® for the entire time recommended by your doctor, even when symptoms have improved
Always follow your doctor’s instructions
The prolonged use of Xepi® may result in hard-to-treat bacteria and fungi
- Talk to your doctor if your infection does not get better after 3 days
Xepi® was proven to be safe in studies of both adults and children 2 months of age and older.1
Uses: Xepi® is a topical prescription medicine approved for the treatment of impetigo, a skin infection caused by the bacteria Staphylococcus aureus or Streptococcus pyogenes, and is approved for adults and children two months of age and older.
When using this product:
Most common side effects were:
Pregnancy Warning: There is no available data on Xepi® use in pregnant women to inform a drug associated risk.
Lactation Warning: There is no available data regarding the presence of the active ingredient (ozenoxacin) in human milk, or the effects of ozenoxacin on the breastfed infant or on milk production.
Pediatric Warning: The safety and effectiveness of Xepi® in the treatment of impetigo have been established in patients 2 months to 17 years of age. The safety profile of Xepi® in patients 2 months and older was similar to that of adults.
The safety and effectiveness of Xepi® have not been established in patients younger than 2 months of age.
Geriatric Warning: Clinical studies of Xepi® did not include sufficient numbers of patients aged 65 and older to find out whether they respond differently from younger patients.
Inactive Ingredients: benzoic acid, octyldodecanol, peglicol 5 oleate, pegoxol 7 stearate, propylene glycol, purified water, stearyl alcohol
References: 1. Xepi® [package insert]. Woburn, MA: Biofrontera, Inc.; 2020. 2. Leeka S, Terrell CL, Edson RS. General principles of antimicrobial therapy. Mayo Clin Proc. 2011;86(2):156-167. 3. 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. 4. 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. 5. 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.