Ozenoxacin

(Xepi®)

Ozenoxacin

Drug updated on 9/4/2024

Dosage FormCream (topical; 10 mg/1 g [1%])
Drug ClassQuinolone antimicrobials
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the topical treatment of impetigo due to Staphylococcus aureus Streptococcus pyogenes or in adult and pediatric patients 2 months of age and older.

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Summary
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  • Xepi (ozenoxacin) is indicated for the topical treatment of impetigo caused by Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older.
  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Ozenoxacin: In nonendemic settings, ozenoxacin 1% cream demonstrated superior effectiveness in treating impetigo compared to retapamulin and a new minocycline formulation. It was also identified as a costlier but effective alternative to mupirocin and retapamulin.
  • Retapamulin: Retapamulin was effective in treating impetigo in nonendemic settings but less so than ozenoxacin. It was effective against lesions colonized by MSSA and Streptococcus pyogenes but not MRSA.
  • Oral Co-trimoxazole and Benzathine Benzylpenicillin G: Both treatments were equally effective in treating severe impetigo in endemic settings. Mass drug administration was suggested as a strategy to reduce impetigo prevalence in these settings.
  • Adverse events for both ozenoxacin and retapamulin were minimal, with pruritus at the application site being the most commonly reported adverse event.
  • All evaluated topical antibiotics demonstrated greater resolution of impetigo with minimal adverse events compared to the vehicle.
  • Studies indicate that impetigo primarily affects the pediatric population. Effectiveness of treatments varies by setting, with ozenoxacin and retapamulin being effective in nonendemic settings, while oral co-trimoxazole and benzathine benzylpenicillin G are effective in endemic settings. Mupirocin shows clinical efficacy against MRSA, while retapamulin does not, making bacterial culture necessary to rule out resistance.

Product Monograph / Prescribing Information

Document TitleYearSource
Xepi (ozenoxacin) Prescribing Information.2017Teligent Pharma, Inc., Buena, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Pediatric impetigo: an expert panel opinion about its main controversies. 2022Journal of Chemotherapy