Ozenoxacin

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What is Ozenoxacin?[edit | edit source]

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


Ozenoxacin structure.svg
Ozenoxacin.svg

What are the uses of this medicine?[edit | edit source]

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?[edit | edit source]

  • 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 ?[edit | edit source]

  • This medcine have no usage limitations.

What drug interactions can this medicine cause?[edit | edit source]

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

Is this medicine FDA approved?[edit | edit source]

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

How should this medicine be used?[edit | edit source]

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?[edit | edit source]

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?[edit | edit source]

The most common side effects of this medicine include:

What special precautions should I follow?[edit | edit source]

  • 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?[edit | edit source]

  • 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?[edit | edit source]

  • 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?[edit | edit source]

  • 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?[edit | edit source]

  • Active ingredient:

OZENOXACIN

Who manufactures and distributes this medicine?

Manufactured for :

What should I know about storage and disposal of this medication?[edit | edit source]

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