Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Xepi: 1% (30 g) [contains benzoic acid, propylene glycol]
Pharmacology
Mechanism of Action
Ozenoxacin is a quinolone antimicrobial that inhibits the bacterial DNA replication enzymes, DNA gyrase A, and topoisomerase IV.
Pharmacokinetics/Pharmacodynamics
Absorption
Negligible
Use: Labeled Indications
Impetigo: Treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients ≥2 months of age
Contraindications
There are no contraindications listed in the manufacturer's labeling.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to ozenoxacin or any component of the formulation
Dosage and Administration
Dosing: Adult
Impetigo: Topical: Apply a thin layer to affected area (up to 100 cm2) twice daily for 5 days.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Impetigo: Infants ≥2 months of age, Children, and Adolescents: Topical: Apply a thin layer to the affected area twice daily for 5 days. Note: Affected area may be up to 2% of the total BSA (not exceeding 100 cm2) for patients <12 years or up to 100 cm2 for patients ≥12 years.
Administration
Topical: For topical use only; not for oral, ophthalmic, intranasal, or intravaginal use. Apply a thin layer to affected area; wash hands after application. Treated area may be covered with a sterile bandage or gauze dressing.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Drug Interactions
There are no known significant interactions.
Adverse Reactions
<1%, postmarketing, and/or case reports: Rosacea-like face eruption, seborrheic dermatitis
Warnings/Precautions
Concerns related to adverse effects:
- Superinfection: Prolonged use may result in fungal or bacterial superinfection; discontinue use if superinfection occurs.
Other warnings/precautions:
- Appropriate use: For topical use only; not for oral, ophthalmic, intranasal, or intravaginal use.
Pregnancy
Pregnancy Considerations
Systemic absorption following topical application is negligible; exposure to the fetus is not expected.
Patient Education
What is this drug used for?
- It is used to treat impetigo.
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Severe skin irritation
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
