Ozenoxacin is indicated for the topical treatment of impetigo caused by Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients aged 2 months and older.

Mechanism of Action: Ozenoxacin is a quinolone antimicrobial agent. It works by inhibiting bacterial DNA replication enzymes, specifically DNA gyrase A and topoisomerase IV. It is bactericidal against S. aureus and S. pyogenes.

Absorption: Pharmacokinetic studies in 110 patients using up to 2% ozenoxacin cream showed negligible systemic absorption. In 84 of 86 subjects, no detectable systemic absorption was observed, while only trace levels (0.489 ng/mL) were found in 2 subjects after application to intact or abraded skin.

Distribution: Plasma protein binding is approximately 80–85% and is concentration independent. Due to minimal systemic absorption, tissue distribution in humans has not been studied.

Metabolism: Ozenoxacin is not metabolized in human skin and shows minimal metabolism in human hepatocytes.

Excretion: Excretion studies have not been conducted in humans due to negligible systemic absorption.

Apply a thin layer of Ozenoxacin topically to the affected area twice daily for five days. The affected area may be up to 100 cm in adult and pediatric patients 12 years of age and older or 2% of the total body surface area and not exceeding 100 cm in pediatric patients less than 12 years of age.

• Wash hands after applying Ozenoxacin cream.
• Ozenoxacin cream is for topical use only.
• Not for oral, ophthalmic, intranasal, or intravaginal use.
• The treated area may be covered with a sterile bandage or gauze dressing.

None.

Because clinical trials are conducted under varying conditions, adverse reaction rates observed in trials may not directly reflect real-world use or be comparable with other drugs. The safety of Ozenoxacin was evaluated in two clinical trials involving 362 adult and pediatric patients aged 2 months and older with impetigo. Patients used at least one dose of a 5-day twice-daily regimen. Control groups included 361 placebo users and 152 patients treated with retapamulin ointment.

The median patient age was 10 years: 3% were 2 months to <2 years, 55% were 2 to <12 years, 11% were 12 to <18 years, and 31% were adults.

Adverse reactions were rare; rosacea and seborrheic dermatitis were reported in 1 adult patient treated with Ozenoxacin.

Pregnancy: No adequate data are available in pregnant women. However, systemic absorption of topical ozenoxacin is negligible, so fetal exposure is not expected. Animal studies using oral doses showed no significant developmental toxicity even at exposures far higher than human levels. Background risks of birth defects are estimated at 2–4% and miscarriage at 15–20% in the general population.

Lactation: No data are available on presence in human milk. However, due to minimal systemic absorption, exposure to the breastfed infant is not expected. The benefits of breastfeeding should be weighed against maternal need for treatment.

Prolonged use of Ozenoxacin may lead to overgrowth of non-susceptible bacteria or fungi. If secondary infection occurs, treatment should be discontinued and appropriate therapy started.

Pediatric Use: Safety and effectiveness have been established in children aged 2 months to 17 years. Clinical studies included 251 pediatric patients. The safety profile in children was similar to adults. Safety in infants younger than 2 months has not been established.

Geriatric Use: Insufficient data exist for patients aged 65 years and older, but no differences in response have been observed compared to younger adults.

Overdose, whether topical or accidental ingestion, should be managed symptomatically. No specific antidote is available.

Topical antibiotic preparations.

Store at 20°C–25°C (excursions permitted 15°C–30°C). Protect from light and moisture. Keep out of reach of children.