Ozenoxacin

Approved Indications:

• Impetigo (non-bullous and bullous forms) caused by Staphylococcus aureus (including methicillin-resistant strains) or Streptococcus pyogenes in adults and pediatric patients ≥2 months of age.

Off-label/Clinically Accepted Uses (limited data):

• Localized superficial skin infections such as minor folliculitis, ecthyma, or infected abrasions (not officially approved; requires clinical judgment).

Adults and Children ≥2 Months:

• Apply a thin layer of Ozenoxacin 1% cream to the affected area twice daily for 5 days.
• Do not exceed 5 days of therapy unless directed by a physician.
• Area may be covered with a sterile bandage or left uncovered.
• For external use only; avoid contact with eyes, mouth, inside the nose, or mucous membranes.

Pediatrics <2 months:

• Safety and efficacy not established.

Elderly:

• No dosage adjustment required.

Renal/Hepatic Impairment:

• Not systemically absorbed to a clinically significant extent. No dosage adjustment required.

Ozenoxacin is a non-fluorinated quinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication, repair, and transcription. Its dual-targeted mechanism results in rapid bactericidal activity against susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Unlike traditional fluoroquinolones, Ozenoxacin does not carry a fluorine group, minimizing the risk of phototoxicity and systemic side effects.

• Absorption: Minimal percutaneous absorption. Plasma concentrations are generally undetectable after topical application.
• Distribution: Not systemically distributed to a meaningful extent.
• Metabolism: Not appreciably metabolized due to low systemic exposure.
• Elimination: Primarily eliminated via desquamation of the skin; negligible renal or hepatic elimination.
• Half-life: Not applicable (topical agent).
• Bioavailability: Negligible systemic bioavailability.

• Pregnancy: No FDA pregnancy category assigned. Animal studies show no teratogenic effects; use only if clearly needed. Systemic exposure is negligible with topical use.
• Lactation: It is unknown if Ozenoxacin is excreted in breast milk, but systemic absorption is minimal. Safe to use with precautions. Avoid applying on or near the breast in nursing mothers.

• Topical Antibacterial Agent
• Subclass: Non-fluorinated quinolone antibiotic (quinolone derivative)

• Known hypersensitivity to Ozenoxacin or any component of the formulation.

• Not for ophthalmic, oral, or intranasal use.
• If irritation, allergic reaction, or worsening infection occurs, discontinue use and consult a physician.
• Use with caution in patients with extensive skin damage or severe burns, as increased systemic absorption may occur.
• Avoid unnecessary use to minimize development of antimicrobial resistance.

Common (usually mild):

• Application site reactions (e.g., erythema, pruritus, burning)
• Dry skin

Rare but Serious:

• Hypersensitivity or allergic contact dermatitis
• Superinfection with non-susceptible organisms (e.g., fungal or resistant bacterial overgrowth)

Timing: Most side effects, if any, occur within the first few days of application. Typically mild and self-limiting.

• No known significant drug-drug, drug-food, or drug-alcohol interactions.
• CYP450 interactions: None known – Ozenoxacin is not metabolized via CYP enzymes.
• Avoid simultaneous use with other topical antimicrobials unless directed by a physician.

• Recognized by the FDA as a safe and effective first-line agent for impetigo in children ≥2 months.
• CDC and AAD recommend Ozenoxacin as an alternative to mupirocin or retapamulin, especially for MRSA-related impetigo.
• No major changes in indication or formulation as of recent updates.

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C.
• Do not freeze.
• Keep the tube tightly closed when not in use.
• Protect from excessive heat and light.
• Keep out of reach of children.