Ozenoxacin

Ozenoxacin Cream is indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and paediatric patients 2 months of age and older.

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 Staphylococcus aureus and Streptococcus pyogenes organisms.

Apply a thin layer of Ozenoxacin cream topically to the affected area twice daily for five days or as directed by the physicians. Use in Children and Adolescents: The safety and effectiveness of Ozenoxacin cream in paediatric patients younger than 2 months of age have not been established.

Rosacea and Seborrheic dermatitis may occur.

There are no available data on the use of Ozenoxacin cream in pregnant women. Systemic absorption of Ozenoxacin cream in human is negligible following topical administration of Ozenoxacin cream (up to twice the concentration of the marketed formulation). Due to the negligible systemic exposure, it is not expected that maternal use of Ozenoxacin cream will result in fetal exposure to the drug. No data are available regarding the presence of Ozenoxacin cream in human milk and the effects of Ozenoxacin cream on the breastfeed infant or on milk production. However, breastfeeding is not expected to result in exposure of the child to Ozenoxacin cream due to the negligible systemic absorption in humans following topical administration of Ozenoxacin cream.

Potential for Microbial Overgrowth: The prolonged use of Ozenoxacin may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur during therapy, discontinue use and institute appropriate supportive measures.

Any sign and symptoms of overdose, either topically or by accidental ingestion, should be treated symptomatically. No specific antidote is known.

Topical Antibiotic preparations

Store below 30ºC, away from light and in a dry place. Keep out of the reach of children.