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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INDICATIONS

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.

The single-use 1.0 gram tube will deliver a total of approximately 0.5 grams of the ointment (approximately 0.25 grams/nostril).

The tube should be discarded after usage; it should not be re-used.

The safety and effectiveness of applications of this medication for greater than 5 days have not been established. There are no human clinical or pre-clinical animal data to support the use of this product in a chronic manner or in manners other than those described in this package insert.

Until further information is known, Bactroban Nasal should not be applied concurrently with any other intranasal products.

Bactroban Nasal (mupirocin calcium ointment), 2% is supplied in 1.0 gram tubes packaged in cartons of 10.

NDC 0029-1526-11 (1.0 gram tubes in packages of 10).

Store at or below 25°C (77°F).

REFERENCE

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically Third Edition; Approved Standard NCCLS Document M7-A3. Vol. 12, No. 25, NCCLS, Villanova, PA, December 1993.

Manufactured by DPT Laboratories
San Antonio, TX 78215

Distributed by SmithKline Beecham Pharmaceuticals
Philadelphia, PA 19101

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