INDICATIONS AND USAGE Bactroban Nasal (mupirocin calcium ointment), 2% is indicated for the eradication of nasal colonization with methicillin-resistant Staphylococcus aureus in adult patients and health care workers as part of a comprehensive infection control program to reduce the risk of infection among patients at high risk of methicillin-resistant S. aureus infection during institutional outbreaks of infections with this pathogen. NOTE: (1) There are insufficient data at this time to establish that this product is safe and effective as part of an intervention program to prevent autoinfection of high-risk patients from their own nasal colonization with S. aureus. (2) There are insufficient data at this time to recommend use of Bactroban Nasal for general prophylaxis of any infection in any patient population. (3) Greater than 90% of subjects/patients in clinical trials had eradication of nasal colonization 2 to 4 days after therapy was completed. Approximately 30% recolonization was reported in one domestic study within 4 weeks after completion of therapy. These eradication rates were clinically and statistically superior to those reported in subjects/patients in the vehicle-treated arms of the adequate and well-controlled studies. Those treated with vehicle had eradication rates of 5% to 30% at 2 to 4 days post-therapy with 85% to 100% recolonization within 4 weeks. All adequate and well-controlled trials of this product were vehicle-controlled; therefore, no data from direct, head-to-head comparisons with other products are available at this time. | ||||
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