Source: Health Products and Food Branch (CA) Revision Year: 2017
OZANEX (ozenoxacin) is indicated for the topical treatment of impetigo in patients aged 2 months and older.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of OZANEX and other antibacterial drugs, OZANEX should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Geriatrics (≥65 years of age): A limited number of subjects aged ≥65 years have been treated with OZANEX in clinical trials.
Pediatrics (<2 months of age): The safety and efficacy of OZANEX in pediatric patients younger than 2 months of age has not been established.
OZANEX is for cutaneous use only.
There are very limited efficacy data in subjects with impetigo affecting more than 50 cm² total surface area. Efficacy and safety of OZANEX has not been established in subjects with impetigo affecting more than 100 cm² in total surface area (or exceeding 2% of body surface area [equivalent to two palm surface areas of the child] in pediatric patients).
Adults, children and infants 2 months of age and older: Apply a thin layer of OZANEX to the affected area twice daily for 5 days. Scabs do not have to be removed. Patients not showing a clinical response within 3 days should be re-evaluated and alternative therapy should be considered.
Pediatrics (<2 months of age): The safety and efficacy of OZANEX in pediatric patients younger than 2 months of age have not been established.
Geriatrics: No dosage adjustment is necessary.
Hepatic/Renal Impairment: No dosage adjustment is necessary.
If a dose of OZANEX is missed, the patient should be advised to apply the cream as soon as he/she remembers, and then continues with the next application at the proper time interval.
A thin layer of cream should be applied to the affected area. The area treated may be covered with a sterile bandage or gauze dressing if desired.
Overdosage with OZANEX has not been reported. Any signs or symptoms of overdose, either topically or by accidental ingestion, should be treated symptomatically and consistent with good clinical practices.
There is no known antidote for overdoses of OZANEX.
For management of a suspected drug overdose, contact your regional Poison Control Centre.
OZANEX should be stored at room temperature (15 to 30°C).
Use within 45 days of first opening the tube.
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