Class: Antibacterial agent
- Ointment, topical 1% (10 mg/g)
Selectively inhibits bacterial protein synthesis, inhibiting peptidyl transfer, blocking P-site interactions, and preventing normal formation of active 50S ribosomal subunits.
Systemic exposure after topical application to intact and debrided skin is low. Following twice-daily topical application, 11% of patients had measurable retapamulin concentrations with a median concentration of 0.8 ng/mL.
Protein binding is approximately 94%.
In vitro studies indicate that CYP3A4 is the major enzyme responsible for the metabolism of retapamulin to numerous metabolites.
Indications and Usage
Topical treatment of impetigo caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes .
None well documented.
Dosage and AdministrationAdults
Topical Apply a thin layer to the affected area (up to 100 cm 2 in total area) twice daily for 5 days.Children 9 mo of age and older
Topical Apply a thin layer to the affected area (up to 2% of total BSA) twice daily for 5 days.
Store between 59° and 86°F.
Drug InteractionsCYP3A4 inhibitors (eg, ketoconazole)
Retapamulin plasma levels may be increased; however, dosage adjustments are unnecessary.
Diarrhea (2%); nausea (1%).
Application-site irritation, application-site pruritus (2%).
Category B .
Safety and efficacy not established in children younger than 9 mo of age.
May promote overgrowth of nonsusceptible microorganisms.
If sensitization or severe local irritation occurs, discontinue use and wipe off ointment.
Mucosal or systemic use
Not intended for ingestion; oral, intranasal, ophthalmic, or intravaginal use; or use on mucosal surfaces.
- Advise patient that product is not intended for ingestion; oral, intranasal, ophthalmic, or intravaginal use; or use on mucosal surfaces (eg, lips, mouth, inside nose).
- Advise patient that treated area may be covered by a sterile bandage or gauze dressing, if desired.
- Instruct patients to use product for the full time recommended by health care provider, even if symptoms have improved.
- Instruct patients to notify health care provider if there is no improvement in symptoms within 3 to 4 days of starting treatment.
- Instruct patients to notify health care provider if irritation, redness, itching, burning, swelling, blistering, or oozing worsens in the area applied.
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