OZANEX Cream Ref.[27772] Active ingredients: Ozenoxacin

General

Do not ingest.

There are very limited efficacy data in subjects with impetigo affecting more than 50 cm² total surface area. Safety and efficacy 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). In patients aged less than 12 years the total surface area treated should be no more than 2% of the body surface area.

Do not use OZANEX on mucous membranes (oral, intranasal, or intravaginal).

OZANEX contains propylene glycol which may cause skin irritation.

OZANEX contains stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

OZANEX contains benzoic acid which may be an irritant to the skin, eyes and mucous membranes and may increase the jaundice in pre-term and full-term jaundiced neonates because of its absorption through the skin.

Ophthalmologic

Do not use OZANEX in the eyes.

Sensitivity

In the event of sensitization or severe local irritation from OZANEX, treatment should be discontinued, the cream carefully wiped off and appropriate alternative therapy for the infection instituted. No evidence of irritation, photoirritation reactions, sensitization potential or photoallergic reactions were observed with ozenoxacin in clinical studies.

Susceptibility / Resistance

Prescribing OZANEX in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.

As with other antibacterial agents, prolonged use may result in overgrowth of non-susceptible microorganisms, including fungi.

Special Populations

Pregnant Women

No studies with OZANEX have been performed in pregnant women. No effects during pregnancy are anticipated since systemic exposure to ozenoxacin is negligible.

Nursing Women

The safe use of OZANEX during breast-feeding has not been established. It is not known whether ozenoxacin is excreted in human breast milk. Minimal systemic exposure to ozenoxacin is observed in adults, therefore exposure of the breast-feeding infant to ozenoxacin is likely to be negligible. Should OZANEX be used during breast-feeding it is recommended to avoid applying OZANEX to the breast area to protect the nursing infant from unintentional oral drug uptake.

Pediatrics (<2 months of age)

The safety and efficacy of OZANEX in pediatric patients younger than 2 months of age has not been established.

Adverse Drug Reaction Overview

OZANEX has been evaluated for safety in 458 patients with superficial skin infections. In these clinical studies, the most frequently reported adverse events were application site irritation and application site pruritus, which affected less than 1% of patients.

Overall, the frequency of adverse drug reactions for OZANEX in the combined Phase III impetigo studies (n=362) was low with only one (0.3%) patient experiencing an adverse drug reaction. No serious adverse events were reported.

The incidence of discontinuations of OZANEX due to adverse drug reactions was 0.3% - one patient discontinued due to worsening of already present rosacea and seborrheic dermatitis.

Clinical Trial Adverse Drug Reactions

Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

The safety profile of OZANEX was assessed in two randomized, controlled, Phase III clinical studies in 362 adult and pediatric patients ≥2 months of age, who used at least one dose of OZANEX.

OZANEX was generally well tolerated. No adverse drug reactions were reported at a frequency of ≥1%.

Less Common Clinical Trial Adverse Drug Reactions (<1%)

Skin and subcutaneous tissue disorders: worsening of existing rosacea and seborrheic dermatitis.

Pediatric Patients

During the clinical development program, no adverse drug reactions were reported in pediatric patients.

Overview

OZANEX shows negligible systemic absorption (generally below 0.5 ng/ml)

OZANEX does not induce cytochrome P450 enzymes in vitro.

Drug-Drug Interactions

The effect of concurrent application of OZANEX and other topical medicinal products to the same area of skin has not been studied, and it is not recommended.

Drug-Herb Interactions

Interactions with herbal products have not been studied.

Drug-Food Interactions

Interactions with food have not been studied.

Drug-Laboratory Interactions

Interactions with laboratory tests have not been studied.