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Ozenoxacin: Drug information

Ozenoxacin: Drug information
(For additional information see "Ozenoxacin: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Xepi
Brand Names: Canada
  • Ozanex
Pharmacologic Category
  • Antibiotic, Quinolone;
  • Antibiotic, Topical
Dosing: Adult
Impetigo

Impetigo (limited number of lesions) (alternative agent): Topical: Apply a thin layer to affected area twice daily for 5 days (total treatment area should not exceed 100 cm2 total BSA) (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric
Impetigo

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.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

<1%, postmarketing, and/or case reports: Rosacea-like face eruption, seborrheic dermatitis

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

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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External:

Xepi: 1% (30 g) [contains benzoic acid, propylene glycol]

Generic Equivalent Available: US

No

Pricing: US

Cream (Xepi External)

1% (per gram): $12.47

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External:

Ozanex: 1% (10 g) [contains benzoic acid, polyethylene glycol (macrogol), propylene glycol]

Administration: Adult

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.

Administration: Pediatric

Topical: For external 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.

Use: Labeled Indications

Impetigo: Treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients ≥2 months of age

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Systemic absorption following topical application is negligible; exposure to the fetus is not expected.

Breastfeeding Considerations

It is not known if ozenoxacin is present in breast milk. However, systemic absorption following topical application is negligible and exposure to the breastfeeding infant is not expected.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Mechanism of Action

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

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Negligible

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Ozanex;
  • (BD) Bangladesh: Zenocin;
  • (ES) Spain: Ozanex;
  • (IN) India: B oze | Chooz | Heteronox | Impinoz | Noxa | Noxof | Noxprin | O2 bact | Ozebrut | Ozecip | Ozefit | Ozepro | Ozewid | Ozx | Prizeno | S clear | Tigotreat | Xepinoxin | Zimba;
  • (IT) Italy: Dubine;
  • (PR) Puerto Rico: Xepi;
  • (PT) Portugal: Ozanex
  1. Baddour LM. Impetigo. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed June 22, 2021.
  2. Gropper S, Albareda N, Chelius K, et al; Ozenoxacin in Impetigo trial investigators group. Ozenoxacin 1% cream in the treatment of impetigo: a multicenter, randomized, placebo- and retapamulin-controlled clinical trial. Future Microbiol. 2014;9(9):1013-1023. doi:10.2217/fmb.14.78 [PubMed 25340832]
  3. Ozanex (ozenoxacin) [product monograph]. Oakville, Ontario, Canada: Cipher Pharmaceuticals Inc; May 2019.
  4. Refer to manufacturer's labeling.
  5. Rosen T, Albareda N, Rosenberg N, et al. Efficacy and safety of ozenoxacin cream for treatment of adult and pediatric patients with impetigo: a randomized clinical trial. JAMA Dermatol. 2018;154(7):806-813. doi:10.1001/jamadermatol.2018.1103 [PubMed 29898217]
  6. Xepi (ozenoxacin) [prescribing information]. Woburn, MA: Biofrontera Inc; January 2020.
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