Ozenoxacin

Class: Antibacterials
VA Class: 84:04.04
Chemical Name: 1-cyclopropyl-8-methyl-7-[5-methyl-6-(methylamino) pyridin-3-yl]-4-oxoquinoline-3-carboxylic acid
Molecular Formula: C₂₁H₂₁N₃O₃
CAS Number: 245765-41-7
Brands: Xepi

Medically reviewed by Drugs.com on May 24, 2022. Written by ASHP.

Introduction

Antibacterial; nonfluorinated quinolone anti-infective.

Uses for Ozenoxacin

Impetigo

Topical treatment of impetigo caused by Staphylococcus aureus and Streptococcus pyogenes (group A β-hemolytic streptococci; GAS).

Although impetigo may be self-limiting, anti-infective treatment usually indicated to reduce duration of symptoms and prevent recurrence or transmission to others. Empiric treatment with an appropriate narrow-spectrum anti-infective generally used for initial treatment and considered reasonable for typical cases. Some clinicians suggest in vitro testing (i.e., Gram stain and culture of pus or exudates from skin lesions) to identify causative organism and confirm in vitro susceptibility, especially if impetigo is extensive and/or failed to respond to initial empiric treatment.

Nonbullous and bullous impetigo have been treated with topical and/or systemic anti-infective therapy. Although comparative efficacy of various regimens not established in well-controlled clinical trials, topical anti-infectives generally used for less extensive disease and systemic anti-infectives generally recommended if impetigo is severe or involves numerous lesions or if an outbreak is affecting multiple individuals (e.g., family members, childcare groups, athletic teams).

When empiric treatment used, select appropriate narrow-spectrum anti-infective based on local patterns of resistance reported for S. aureus and S. pyogenes.

Ozenoxacin Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as a 1% cream.

Do not apply to eyes or mucous membranes; do not administer orally, intranasally, or intravaginally.

Apply thin layer of cream to affected area. May be applied to a maximum total treatment area of 100 cm² in adults and pediatric patients ≥12 years of age or a maximum of 2% of total body surface area (≤100 cm²) in pediatric patients 2 months through 11 years of age.

Treated area may be covered with sterile bandage or gauze dressing, if desired.

Wash hands after applying the cream, unless the hands are being treated.

Dosage

Pediatric Patients

Skin Infections

Impetigo

Children ≥2 months of age: Apply thin layer of 1% cream to affected area twice daily for 5 days.

Adults

Skin Infections

Impetigo

Apply thin layer of 1% cream to affected area twice daily for 5 days.

Prescribing Limits

Pediatric Patients

Skin Infections

Impetigo

Pediatric patients 2 months through 11 years of age: Maximum treatment area is 2% of total body surface area (≤100