Ozenoxacin

In human liver microsomes, ozenoxacin showed to cause mild direct competitive inhibition of CYP3A4 at high concentrations (100µM), and possibly cause very mild time-dependent inhibition of CYP2C9 at high concentrations (200µM). However, since systemic exposure to ozenoxacin was not observed following topical application of 10 mg/g cream in adult and paediatric patients aged 6 months and older, it is not expected that concurrent systemic administration of CYP3A4 or CYP2C9 substrates will result in clinically important inhibition of their metabolism by ozenoxacin.

Treatment of bullous impetigo with ozenoxacin is not recommended.

There are no data from the use of ozenoxacin in pregnant women. Studies in animals have shown reproductive toxicity after oral exposure.

No effects during pregnancy are anticipated, since systemic exposure to ozenoxacin is negligible. Dubine can be used during pregnancy.

It is unknown whether ozenoxacin is excreted in human breast milk. The excretion of ozenoxacin in milk has not been studied in animals. No effects on the breastfed infant are anticipated since the systemic exposure of the breast-feeding woman to ozenoxacin is negligible.

Ozenoxacin cream can be used during breast-feeding. As a precaution, it is recommended to avoid applying ozenoxacin cream to the breast area to protect the suckling infant from unintentional oral drug uptake.

Fertility

There are no data on the effects of ozenoxacin on human fertility. No treatment-related effects on male or female fertility have been shown in animal studies.

Ozenoxacin has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

In clinical studies in which 559 patients with superficial skin infections applied ozenoxacin cream, the most commonly reported adverse reaction was application site irritation, which affected less than 1% of patients.

No significant safety issues were reported during the clinical studies.

List of adverse reactions

The following convention has been used for the classification of frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness:

General disorders and administration site condition

Uncommon: Application site irritation, Application site pruritus

Paediatric population

During the clinical development program no adverse drug reactions were reported in the paediatric population. Frequency, type and severity of adverse reactions in the paediatric population are expected to be the same as in adults.