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Ozenoxacin

Medically reviewed by Drugs.com. Last updated on May 6, 2020.

Pronunciation

(oz en OX a sin)

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]

Brand Names: U.S.

  • Xepi

Pharmacologic Category

  • Antibiotic, Quinolone
  • Antibiotic, Topical

Pharmacology

Ozenoxacin is a quinolone antimicrobial that inhibits the bacterial DNA replication enzymes, DNA gyrase A, and topoisomerase IV.

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

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 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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe skin irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, 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 limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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