Ozenoxacin

What is Ozenoxacin?

Ozenoxacin (XEPI) is a quinolone antimicrobial used for the topical treatment of impetigo.

What are the uses of this medicine?

This medicine is used for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older.

How does this medicine work?

• Ozenoxacin is a quinolone antimicrobial drug.
• The mechanism of action involves the inhibition of bacterial DNA replication enzymes, DNA gyrase A and topoisomerase IV.
• Ozenoxacin has been shown to be bactericidal against S. aureus and S. pyogenes organisms.

Who Should Not Use this medicine ?

• This medcine have no usage limitations.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with XEPI.

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

Recommended Dosageː

• Apply a thin layer of XEPI topically to the affected area twice daily for five days.
• Affected area may be up to 100 cm2 in adult and pediatric patients 12 years of age and older or 2% of the total body surface area and not exceeding 100 cm2 in pediatric patients less than 12 years of age.

Administration

• Use XEPI as directed by the healthcare practitioner.
• As with any topical medication, patients and caregivers should wash their hands after application if the hands are not the area for treatment.
• XEPI is for external use only.
• Do not swallow XEPI or use it in the eyes, on the mouth or lips, inside the nose, or inside the female genital area.
• Apply a thin layer of XEPI topically to the affected area.
• Wash hands after applying XEPI cream.
• XEPI cream is for topical use only.
• Not for oral, ophthalmic, intranasal, or intravaginal use.
• The treated area may be covered with a sterile bandage or gauze dressing.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Cream: Each gram contains 10 mg of ozenoxacin (1%)

This medicine is available in fallowing brand namesː

• XEPI

What side effects can this medication cause?

The most common side effects of this medicine include:

• rosacea
• seborrheic dermatitis

What special precautions should I follow?

• The prolonged use of XEPI may result in overgrowth of nonsusceptible bacteria and fungi.
• If such infections occur during therapy, discontinue use and institute appropriate supportive measures.

What to do in case of emergency/overdose?

• Any sign or symptom of overdose, either topically or by accidental ingestion, should be treated symptomatically.
• No specific antidote is known.

Can this medicine be used in pregnancy?

• There are no available data on the use of XEPI in pregnant women to inform a drug associated risk.

Can this medicine be used in children?

• The safety and effectiveness of XEPI in the treatment of impetigo have been established in pediatric patients 2 months to 17 years of age.
• The safety and effectiveness of XEPI in pediatric patients younger than 2 months of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient:

OZENOXACIN

Who manufactures and distributes this medicine?

Manufactured for :

• Cutanea Life Sciences, Inc., Wayne.

What should I know about storage and disposal of this medication?

• Store at 20ºC - 25ºC (68ºF - 77ºF); excursions permitted to 15ºC to 30ºC (59ºF - 86ºF).

• Dailymed label info on Ozenoxacin
• FDA Ozenoxacin

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