Dosing & Uses
Dosage Forms & Strengths
topical cream
- 1%
Impetigo
Indicated for impetigo due to Staphylococcus aureus (S. aureus) or Streptococcus pyogenes (S. pyogenes) in adults and children aged ≥2 months
Apply a thin layer topically to affected area q12hr for 5 days
Affected area may be up to 100 cm² in adults and adolescents aged ≥12 years
See also Administration
Dosage Forms & Strengths
topical cream
- 1%
Impetigo
Indicated for impetigo due to Staphylococcus aureus (S. aureus) or Streptococcus pyogenes (S. pyogenes) in adult and children ≥2 months
See also Administration
<2 months: Safety and efficacy not established
2 months to <12 years
- Apply a thin layer topically to affected area q12hr for 5 days
- Affected area may be up to 2% of the total body surface area and not exceeding 100 cm²
≥12 years
- Apply a thin layer topically to affected area q12hr for 5 days
- Affected area may be up to 100 cm² in adults and adolescents aged ≥12 years
Adverse Effects
Frequency Not Defined
Rosacea
Seborrheic dermatitis
Warnings
Contraindications
None
Cautions
Prolonged use of ozenoxacin may result in overgrowth of nonsusceptible bacteria and fungi; if such infections occur, discontinue use and institute alternative therapy
Antagonism interactions with ozenoxacin were observed with ciprofloxacin against S. aureus
Pregnancy
Pregnancy
Data are not available on the use of ozenoxacin in pregnant women
Systemic absorption of ozenoxacin in humans is negligible following topical administration of ozenoxacin; owing to the negligible systemic exposure, it is not expected that maternal use of ozenoxacin will result in fetal exposure to the drug
Lactation
No data are available regarding the presence of ozenoxacin in human milk, and the effects of ozenoxacin on the breastfed infant or on milk production
Breastfeeding is not expected to result in exposure of the child to ozenoxacin due to the negligible systemic absorption of ozenoxacin in humans following topical administration of ozenoxacin
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Quinolone antimicrobial drug; it inhibits bacterial DNA replication enzymes, DNA gyrase A, and topoisomerase IV
Ozenoxacin has been shown to be bactericidal against S. aureus (including methicillin-resistant isolates) and S. pyogenes organisms
Absorption
No systemic absorption was observed in 84 of 86 subjects, and negligible systemic absorption was observed at the level of detection (0.489 ng/mL) in 2 subjects
Distribution
Protein binding, [14C]-ozenoxacin: ~80-85%
Tissue distribution has not been investigated in humans
Metabolism
Ozenoxacin was not metabolized in the presence of fresh human skin discs and was minimally metabolized in human hepatocytes
Excretion
Studies have not been investigated in humans due to the negligible systemic absorption observed in clinical studies
Administration
Topical Administration
Topical use only
Apply a thin layer topically to affected area
Wash hands prior to application if the hands are not the area for treatment
Do not swallow ozenoxacin or use it in the eyes, mouth, lips, inside the nose, or inside the female genital area
Treated area may be covered by a sterile bandage or gauze dressing
Storage
Cream: Store at room temperature, 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
Images
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
