HIGHLIGHTS OF PRESCRIBING INFORMATION -------------------------------CONTRAINDICATIONS-----------------------------These highlights do not include all the information needed to use XEPITM safely and effectively. See full prescribing information for XEPITM. XEPITM (ozenoxacin) cream, for topical use Initial U.S. Approval: 2017
-----------------------------INDICATIONS AND USAGE-------------------------XEPI is a quinolone antimicrobial indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older (1).
------------------------DOSAGE AND ADMINISTRATION---------------------� Apply a thin layer of XEPI topically to the affected area twice daily for 5 days (2). � 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 (2). � For topical use only (2). � Not for oral, ophthalmic, intranasal, or intravaginal use (2). ---------------------DOSAGE FORMS AND STRENGTHS--------------------Cream: Each gram contains 10 mg of ozenoxacin (1%) (3).
FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use
None (4) ------------------------WARNINGS AND PRECAUTIONS----------------------Potential for Microbial Overgrowth: Prolonged use of XEPI may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur, discontinue use and institute alternative therapy (5).
-------------------------------ADVERSE REACTIONS-----------------------------Adverse reactions (rosacea and seborrheic dermatitis) were reported in 1 adult patient treated with XEPI (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact
INDICATIONS AND USAGE XEPI� is indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older [see Clinical Studies (14)].
2 DOSAGE AND ADMINISTRATION 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. � Wash hands after applying XEPI cream. � XEPI cream is for topical use only
3 DOSAGE FORMS AND STRENGTHS Cream: 1%, pale yellow cream. Each gram of XEPI contains 10 mg of ozenoxacin.
4 CONTRAINDICATIONS None.
5 WARNINGS AND PRECAUTIONS
Potential for Microbial Overgrowth
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.
6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety profile of XEPI was assessed in two clinical trials (Trial 1 and Trial 2) in 362 adult and pediatric patients two months of age and older with impetigo. The patients used at least one dose from a 5-day, twice a day regimen of XEPI. Control groups included 361 patients who used placebo and 152 patients who used retapamulin ointment. The median age of the patients enrolled in the clinical trials was 10 years; 3 % of patients were 2 months to less than 2 years of age, 55 % of patients were 2 to less than 12 years of age, 11 % of patients were 12 to less than 18 years of age, and 31 % of patients were 18 years of age or older. Adverse reactions (rosacea and seborrheic dermatitis) were reported in 1 adult patient treated with XEPI.
PATIENT COUNSELING INFORMATION
Advise patients (and/or their caregivers or guardians) using XEPI
of the following information and instructions:
�
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.
�
The treated area may be covered by a sterile bandage or gauze dressing
.
Reference ID: 4192458
�
Use the medication for the entire time recommended by the healthcare practitioner, even though
symptoms may have improved.
�
Notify the healthcare practitioner if there is no improvement in symptoms within 3 days after starting
use of
XEPI
.
XEPI
is a registered trademark of Medimetriks Pharmaceuticals Inc.
HIGHLIGHTS OF PRESCRIBING INFORMATION -------------------------------CONTRAINDICATIONS-----------------------------These highlights do not include all the information needed to use XEPITM safely and effectively. See full prescribing information for XEPITM. XEPITM (ozenoxacin) cream, for topical use Initial U.S. Approval: 2017
-----------------------------INDICATIONS AND USAGE-------------------------XEPI is a quinolone antimicrobial indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older (1).
------------------------DOSAGE AND ADMINISTRATION---------------------� Apply a thin layer of XEPI topically to the affected area twice daily for 5 days (2). � 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 (2). � For topical use only (2). � Not for oral, ophthalmic, intranasal, or intravaginal use (2). ---------------------DOSAGE FORMS AND STRENGTHS--------------------Cream: Each gram contains 10 mg of ozenoxacin (1%) (3).
FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use
None (4) ------------------------WARNINGS AND PRECAUTIONS----------------------Potential for Microbial Overgrowth: Prolonged use of XEPI may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur, discontinue use and institute alternative therapy (5).
-------------------------------ADVERSE REACTIONS-----------------------------Adverse reactions (rosacea and seborrheic dermatitis) were reported in 1 adult patient treated with XEPI (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks at 866-262-0222 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION
Revised
FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE XEPI� is indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older [see Clinical Studies (14)].
2 DOSAGE AND ADMINISTRATION 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. � Wash hands after applying XEPI cream. � XEPI cream is for topical use only.
PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE XEPI� is indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older [see Clinical Studies (14)].
2 DOSAGE AND ADMINISTRATION 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. � Wash hands after applying XEPI cream. � XEPI cream is for topical use only.
Reference ID: 4192458
DOSAGE FORMS AND STRENGTHS Cream: 1%, pale yellow cream. Each gram of XEPI contains 10 mg of ozenoxacin.
4 CONTRAINDICATIONS None.
5 WARNINGS AND PRECAUTIONS
Potential for Microbial Overgrowth
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
CLINICAL PHARMACOLOGY 12.1 Mechanism of Action XEPI is an antimicrobial drug [see Microbiology (12.4)]. 12.2 Pharmacodynamics Exposure-Response Relationship The exposure response relationship for ozenoxacin following topical application has not been studied, however; a relationship is unlikely because systemic exposure following topical application is negligible [see Clinical Pharmacology (12.3)].
Microbiology Mechanism of Action 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.
