Retapamulin is indicated for adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm² total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes. Safety in children younger than 9 months has not been established. To reduce the development of drug-resistant bacteria and preserve effectiveness, Retapamulin should be used only for infections proven or strongly suspected to be caused by susceptible bacteria.

Retapamulin selectively inhibits bacterial protein synthesis by binding to a unique site on the 50S subunit of the bacterial ribosome. This binding involves ribosomal protein L3 and occurs near the P-site and peptidyl transferase center. By binding to this site, pleuromutilins inhibit peptidyl transfer, block P-site interactions, and prevent proper formation of functional 50S ribosomal subunits. Retapamulin is bacteriostatic against Staphylococcus aureus and Streptococcus pyogenes at its in vitro minimum inhibitory concentration (MIC).

A thin layer of Topibac should be applied to the affected area (up to 100 cm in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) twice daily for 5 days. The treated area may be covered with a sterile bandage or gauze dressing if desired.

The effect of simultaneous use of Retapamulin with other topical products applied to the same area of skin has not been studied.

Retapamulin is contraindicated in patients with known hypersensitivity to any ingredient of this preparation.

Adverse reactions: Local application site irritation may occur in less than 2% of patients.

Pregnancy Category B. It is not known whether Retapamulin is excreted in human breast milk. Since many drugs are excreted in breast milk, caution should be taken when administering Retapamulin to nursing mothers.

Local irritation: If sensitization or severe local irritation occurs, treatment should be discontinued. Not for systemic or mucosal use: Retapamulin is not intended for oral, intranasal, ophthalmic, or intravaginal use.

Topical Antibiotic preparations

Store below 30°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.