Retapex ointment: Each gram ointment contains Retapamulin INN 10 mg.
Retapamulin is a semi-synthetic pleuromutilin antibiotic. It is active against Staphylococcus aureus as well as Streptococcus pyogenes organisms. Retapamulin is bacteriostatic at minimum inhibitory concentration (MIC) against these pathogens. The bactericidal concentration against relevant pathogens is 1,000 times of the minimum inhibitory concentration (MIC).
Retapamulin ointment is indicated for the topical treatment of impetigo due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes in patients aged 9 months or older. It is also indicated to treat infected small lacerations, abrasions or sutured wounds.
A thin layer of Retapamulin ointment should be applied to the affected area twice daily for 5 days. The treated area may be covered with a sterile bandage or gauze dressing if desired.
The most common drug related adverse reactions are application site irritation, pruritis, eczema, erythema, nasopharyngitis, headache, pyrexia, nausea, diarrhea etc.
In the event of sensitization or severe local irritation from Retapamulin, usage should be discontinued and appropriate alternative therapy for the infection instituted. Retapamulin ointment is not intended for ingestion or for oral, intranasal, ophthalmic, or intravaginal use. Use of Retapamulin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Pregnancy: Pregnancy Category B. It is not known whether Retapamulin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Retapamulin is administered to a nursing woman.
Lactation: The safe use of Retapamulin during breast-feeding has not been established.
Keep out of the reach of children. Store in a cool (below 300C) and dry place.
Retapex ointment: Each tube contains 10 gm of Retapamulin INN ointment.