General Information

Xepi (ozenoxacin) is a quinolone antimicrobial.

Xepi is specifically indicated for the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older.

Xepi is supplied as an ointment for topical administration. Apply a thin layer of Xepi topically to the affected area twice daily for five 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.

Mechanism of Action

Xepi (ozenoxacin) is a quinolone antimicrobial. The mechanism of action involves the inhibition of bacterial DNA replication enzymes, DNA gyrase A and topoisomerase IV. Ozenoxacin has been shown to be bactericidal against S. aureus and S. pyogenes organisms. 

Side Effects

Adverse effects associated with the use of Xepi may include, but are not limited to, the following:

• rosacea
• seborrheic dermatitis

Clinical Trial Results

The FDA approval of Xepi was based on two multi-center, randomized, double-blind placebo controlled clinical trials conducted in 723 subjects two months of age and older with an affected body surface area of up to 100 cm2, and not exceeding 2% for subjects aged 2 months to 11 years were randomized to Xepi or placebo. Subjects applied Xepi or placebo twice daily for 5 days. Subjects with underlying skin disease, skin trauma, clinical evidence of secondary infection, or systemic signs and symptoms of infection (such as fever), were excluded from these studies. In both studies, Xepi demonstrated superiority versus placebo on the pre-specified clinical and bacteriological endpoints when applied topically twice daily for 5 days.  Bacterial success, defined as bacterial eradication or presumed eradication, was achieved in 90.8% of patients using Xepi versus 69.8% for placebo (p<0.0001) at the end of treatment. Xepi showed excellent antibacterial activity against s. aureus and s. pyogenes, including methicillin-resistant s. aureus (MRSA).