STEPS

New Drug Reviews

Ozenoxacin (Xepi) for the Treatment of Impetigo

 

Am Fam Physician. 2020 Jun 15;101(12):760-761.

Ozenoxacin (Xepi) is a topical quinolone antibiotic approved for the treatment of bullous or nonbullous impetigo in adults and children older than two months. It is bactericidal against common causative organisms of impetigo, including Staphylococcus aureus (methicillin-susceptible and -resistant isolates) and Streptococcus pyogenes.1

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DrugDosingDose formCost*

Ozenoxacin (Xepi)

Apply a thin layer of 1% cream twice a day for five days (10 total applications)

30-g tube

$320


*—Estimated lowest price for one course of treatment. Actual cost will vary with insurance and by region. Information obtained at https://www.drugs.com (accessed May 1, 2020; zip code: 66211).

DrugDosingDose formCost*

Ozenoxacin (Xepi)

Apply a thin layer of 1% cream twice a day for five days (10 total applications)

30-g tube

$320


*—Estimated lowest price for one course of treatment. Actual cost will vary with insurance and by region. Information obtained at https://www.drugs.com (accessed May 1, 2020; zip code: 66211).

Safety

No significant local or systemic adverse effects have been identified in clinical trials of 362 adults and children treated with ozenoxacin.2,3 Although topical application results in minimal systemic absorption, pregnant and lactating women were not included in the trials and should not take this medication. Ozenoxacin should not be used in patients with underlying eczematous dermatitis because it has not been studied in this patient population.

Tolerability

Ozenoxacin is well-tolerated. In clinical trials, no patients discontinued treatment. One patient experienced rosacea and seborrheic dermatitis after taking ozenoxacin.3

Effectiveness

Ozenoxacin has been studied in two randomized placebo-controlled trials that included 723 adults and children two months or older with bullous or nonbullous impetigo. Total lesion size was 2 cm2 to 100 cm2 or no more than 2% body surface area in patients younger than 12 years. Patients also had mild pus or exudate with the level of infection determined to be mild to moderate in trial 1 and severe in trial 2.2,3 Infections were categorized based on the presence and severity of exudate, pus, crusting, erythema and inflammation, tissue warmth, tissue edema, itching, and pain. Evaluation of clinical success occurred after patients co

Address correspondence to Sarah Eudaley, PharmD, BCPS, at seudaley@uthsc.edu. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.

References

show all references

1. DailyMed. Drug label information. Xepi—ozenoxacin cream. Updated February 15, 2019. Accessed May 5, 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3361dd6c-4b03-4c42-9b95-4ecd43c34294...

2. Gropper S, Albareda N, Chelius K; et al. Ozenoxacin in Impetigo Trial Investigators Group. 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. Poovelikunnel T, Gethin G, Humphreys H. Mupirocin resistance: clinical implications and potential alternatives for the eradication of MRSA. J Antimicrob Chemother. 2015;70(10):2681–2692.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, assistant medical editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

 

 

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