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Bactroban Ointment - Indications & Dosage

[Mupirocin]

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.

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(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.

DOSAGE AND ADMINISTRATION

(See INDICATIONS AND USAGE.)

Adults (12 years of age and older): Approximately one-half of the ointment from the single-use tube should be applied into one nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.

After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares.