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Author: Admin | 2025-04-28
Daily or 30 to 40 mgper kg oral erythromycin ethylsuccinate per day (this was an unblinded trial) for8 days. There was a follow-up visit 1 week after treatment ended. Clinicalefficacy rates at the follow-up visit in the evaluable populations (adults andpediatric subjects included) were 93% for BACTROBAN ointment (n = 29) and 78.5%for erythromycin (n = 28). Pathogen eradication rates in the evaluablepopulations were 100% for both test groups.PediatricsThere were 91 pediatric subjects aged 2 months to 15years in the first trial described above. Clinical efficacy rates at end oftherapy in the evaluable populations were 78% for BACTROBAN ointment (n = 42)and 36% for vehicle placebo (n = 49). In the second trial described above, allsubjects were pediatric except 2 adults in the group receiving BACTROBANointment. The age range of the pediatric subjects was 7 months to 13 years. Theclinical efficacy rate for BACTROBAN ointment (n = 27) was 96%, and forerythromycin it was unchanged (78.5%).REFERENCES 1. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-sixth Informational Supplement. CLSI document M100-S26. Clinical and Laboratory StandardsInstitute, 950 West Valley Rd., Suite 2500, Wayne, PA 19087, USA, 2016.2. Patel J, Gorwitz RJ, et al. Mupirocin Resistance. ClinicalInfectious Diseases. 2009; 49(6): 935-41.3. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Tenth Edition. CLSI document M07-A10. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne,Pennsylvania 19087, USA, 2015.4. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard - Twelfth Edition. CLSI document M02-A12. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania19087, USA, 2015.5. Finlay JE, Miller LA, Poupard JA. Interpretive criteria for testing susceptibility of staphylococci to mupirocin. Antimicrob Agents Chemother. 1997; 41(5):1137-1139. Patient Information for Bactroban OintmentBACTROBAN® (BACK-troh-ban) (mupirocin) OintmentWhat is BACTROBAN ointment?BACTROBAN ointment is a prescription medicine used on theskin (topical use) to treat a skin infection called impetigo that is caused bybacteria called Staphylococcus aureus and Streptococcus pyogenes. It is notknown if BACTROBAN ointment is safe and effective in children under 2 months ofage.Who should not use BACTROBAN ointment?Do not use BACTROBAN ointment if: you are allergic to mupirocin or any of the ingredients in BACTROBAN ointment. See the end of this Patient Information leaflet for a complete list of the ingredients in BACTROBAN ointment.What should I tell my healthcare provider before usingBACTROBAN ointment?Before using BACTROBAN ointment, tell your healthcareprovider about all of your medical conditions including if you: have kidney problems are pregnant or plan to become pregnant. It is not known if BACTROBAN ointment will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if BACTROBAN ointment passes into your breast milk. You and your healthcare provider should decide if you can use BACTROBAN ointment while breastfeeding.Tell your healthcare provider about all of themedicines you take, including prescription and over-thecounter medicines,vitamins, and herbal supplements. Do not mix BACTROBAN ointment with otherlotions, creams, or
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