Ozenoxacin

What is Ozenoxacin?

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

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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

Ozenoxacin Resources
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