"The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these product"...
BACTROBAN® nasal ointment is indicated for the eradication of nasal colonization with methicillin-resistant Staphylococcus aureus (MRSA) in adult and pediatric patients (aged 12 years and older) and healthcare workers as part of a comprehensive infection control program to reduce the risk of infection among patients at high risk of MRSA infection during institutional outbreaks of infections with this microorganism.
Limitations of Use
- 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 Staphylococcus aureus (S. aureus).
- There are insufficient data at this time to recommend use of BACTROBAN nasal ointment for general prophylaxis of any infection in any patient population.
DOSAGE AND ADMINISTRATION
- For Intranasal Use Only.
- Apply approximately one-half of the ointment from the single-use tube into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.
- After application, close the nostrils by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares.
- Do not apply BACTROBAN nasal ointment concurrently with any other intranasal products [see CLINICAL PHARMACOLOGY].
- The single-use 1-gram tube will deliver a total of approximately 0.5 grams of the ointment (approximately 0.25 grams per nostril).
- Discard the tube after usage. Do not re-use.
Dosage Forms And Strengths
BACTROBAN nasal ointment is a white to off-white ointment that contains 2.15% w/w mupirocin calcium (equivalent to 2% mupirocin free acid) in a soft white ointment base supplied in single-use 1-gram tubes.
Storage And Handling
BACTROBAN nasal ointment, 2% is supplied in single-use 1-gram tubes.
BACTROBAN nasal ointment is a white to off-white ointment that contains mupirocin calcium (equivalent to 2% mupirocin free acid).
NDC 0029-1526-03 Single-use 1-gram tube in Package of 10: NDC 0029-1526-11.
Store between 20°C and 25°C (68°F and 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not refrigerate.
Manufactured by : GlaxoSmithKline, Research Triangle Park, NC 27709. Revised September 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/26/2015
Additional Bactroban Nasal Information
Bactroban Nasal - User Reviews
Bactroban Nasal User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.