Ozenoxacin

(Xepi®)

Xepi®

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Drug updated on 5/17/2024

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.

Summary
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  • Ozenoxacin (Xepi) is indicated for the topical treatment of impetigo due to Staphylococcus aureus and Streptococcus pyogenes in adult and pediatric patients 2 months of age and older. It has demonstrated strong evidence of effectiveness, notably against retapamulin and a new minocycline formulation.
  • The information was derived from two systematic reviews/meta-analyses that focused on the safety and effectiveness comparison between ozenoxacin (Xepi) and other drugs used for treating impetigo.
  • In terms of population types, most clinical trials did not specify the form of impetigo but largely focused on nonbullous impetigo. This indicates a broad application but also highlights research gaps specifically targeting other forms of this condition.
  • For subgroup considerations, given that impetigo primarily affects children, it is crucial to note that ozenoxacin (Xepi), along with other topical antibiotics, has shown effective results with minimal adverse events in pediatric patients.
  • Compared to alternatives like retapamulin or mupirocin ointment, which may require bacterial culture verification or face limitations due to its lack of coverage against MRSA, respectively; ozenoxacin stands out as an effective option despite these being cost-effective choices.
  • While systemic treatments such as oral co-trimoxazole and benzathine benzylpenicillin G injection are equally effective for severe cases, they do not directly compete with Xepi as they are administered differently (systemically versus topically).

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