Ozenoxacin
What is Ozenoxacin?[edit | edit source]
Ozenoxacin (XEPI) is a quinolone antimicrobial used for the topical treatment of impetigo.
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 :
- Cutanea Life Sciences, Inc., Wayne.
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).
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