Ozenoxacin is a topical quinolone antimicrobial indicated for the treatment of impetigo due to Staphylococcus aureus (including MRSA) or Streptococcus pyogenes. Systemic absorption of ozenoxacin is negligible; therefore, systemic adverse events are expected to be limited. Ozenoxacin is approved for use in adults and in pediatric patients as young as 2 months. Ozenoxacin was FDA-approved in December 2017.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
Cream/Ointment/Lotion Formulations
-Ozenoxacin is for topical use only. It is not for oral, ophthalmic, intranasal, or intravaginal use.
-Wash hands after applying ozenoxacin.
-The treated area may be covered with a sterile bandage or gauze dressing.
Rosacea and seborrheic dermatitis were reported in 1 adult patient treated with ozenoxacin in clinical trials (n = 362).
Prolonged use of antimicrobials, such as ozenoxacin, may lead to overgrowth of non-susceptible pathogens or superinfection.
There are no adequate and well-controlled studies of the use of ozenoxacin in human pregnancy. Systemic absorption is negligible after topical administration; therefore, it is not expected that maternal use of ozenoxacin will result in fetal exposure.
No data are available regarding the presence of ozenoxacin in human milk or the effects of ozenoxacin on the breastfed infant or on milk production. However, breast-feeding is not expected to result in exposure of the child to ozenoxacin due to the negligible systemic absorption of ozenoxacin after topical administration. To minimize oral exposure of the drug to the breast-feeding child, thoroughly wash a breast and/or nipple being treated with ozenoxacin prior to breast-feeding. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.
Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: Staphylococcus aureus (MRSA), Staphylococcus aureus (MSSA), Streptococcus pyogenes (group A beta-hemolytic streptococci)
NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials.
For the treatment of impetigo:
Topical dosage:
Adults: Apply a thin layer to the affected area twice daily for 5 days. The affected area may be up to 100 cm2.
Children 12 years and Adolescents: Apply a thin layer to the affected area twice daily for 5 days. The affected area may be up to 100 cm2.
Infants and Children 2 months to 11 years: Apply a thin layer to the affected area twice daily for 5 days. The affected area may be up to 2% of the total body surface are and not exceeding 100 cm2.
Maximum Dosage Limits:
-Adults
Up to 100 cm2 of body surface area may be covered twice daily.
-Geriatric
Up to 100 cm2 of body surface area may be covered twice daily.
-Adolescents
Up to 100 cm2 of body surface area may be covered twice daily.
-Children
12 years: Up to 100 cm2 of body surface area
11 years and younger: Up to 2% of the total body surface are and not exceeding 100 cm2 may be covered twice daily.
-Infants
2 months and older: Up to 2% of the total body surface are and not exceeding 100 cm2 may be covered twice daily.
1 month and younger: Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Ozenoxacin products.
Ozenoxacin is a quinolone antibiotic and is bactericidal via inhibition of DNA gyrase (topoisomerase II), an enzyme responsible for counteracting the excessive supercoiling of DNA during replication or transcription and topoisomerase IV, an enzyme that helps separate the daughter DNA molecules.
Resistance to ozenoxacin can occur through mutations of one or more of the genes that encode DNA gyrase or topoisomerase IV. Resistant organisms with typically carry a combination of mutations within the gyrA and parC subunits. Antagonism was observed with the use of ciprofloxacin against S. aureus.
Ozenoxacin is administered topically. Plasma protein binding is approximately 80% to 85% and does not appear to be dependent on concentration. Ozenoxacin is not metabolized. Since systemic absorption is negligible, excretion has not been investigated.
Affected cytochrome P450 isoenzymes or transporters: none
-Route-Specific Pharmacokinetics
Topical Route
Studies using up to twice the marketed concentration (up to 2%) of ozenoxacin with single or repeated application to intact or abraded skin (up to 200 cm2 surface area) showed negligible systemic absorption.
-Special Populations
Hepatic Impairment
Although there are no data for the use of ozenoxacin in patients with hepatic impairment, systemic absorption after topical use is negligible.
Renal Impairment
Although there are no data for the use of ozenoxacin in patients with renal impairment, systemic absorption after topical use is negligible.
Pediatrics
No differences in pharmacokinetic parameters are expected for use of ozenoxacin in pediatric patients older than 2 months compared to adults since systemic absorption after topical use is negligible.
Geriatric
Although there are no data differentiating the pharmacokinetics of ozenoxacin in geriatric patients compared to younger patients, systemic absorption after topical use is negligible.