Bactroban Nasal Ointment

It is unusual to experience unwanted side-effects with mupirocin. Occasionally it can cause itching or tingling when it's first used, but this soon passes. Rarely, some people have experienced an allergic reaction to it. If you develop a particularly irritating or severe reaction, stop using the ointment and speak with your doctor for further advice as soon as possible.

General

As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi (see DOSAGE AND ADMINISTRATION).

Information for Patients

Patients should be given the following instructions:

• Apply approximately one-half of the ointment from the single-use tube directly into 1 nostril and the other half into the other nostril; • Avoid contact of the medication with the eyes; if BACTROBAN Nasal gets in or near the eyes, rinse thoroughly with water. • Discard the tube after using, do not re-use; • Press the sides of the nose together and gently massage after application to spread the ointment throughout the inside of the nostrils; and • Discontinue usage of the medication and call the healthcare practitioner if sensitization or severe local irritation occurs.

Drug Interactions

The effect of the concurrent application of intranasal mupirocin calcium and other intranasal products has not been studied. Until further information is known, mupirocin calcium ointment, 2% should not be applied concurrently with any other intranasal products.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential of mupirocin calcium have not been conducted.

Results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for mutagenicity: Rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, Salmonella reversion test (Ames), Escherichia coli mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice.

Reproduction studies were performed in rats with mupirocin administered subcutaneously at doses up to 40 times the human intranasal dose (approximately 20 mg mupirocin per day) on a mg/m2 basis and revealed no evidence of impaired fertility from mupirocin sodium.

Pregnancy

Teratogenic Effects: Pregnancy Category B

Reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 65 and 130 times, respectively, the human intranasal dose (approximately 20 mg mupirocin per day) on a mg/m2 basis and revealed no evidence of harm to the fetus due to mupirocin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BACTROBAN Nasal is administered to a nursing woman.

Pediatric Use

Safety in children younger than 12 years has not been established (see CLINICAL PHARMACOLOGY).

BACTROBAN Nasal is supplied in 1.0-gram tubes.

NDC 0029-1526-11 (package of 10 single-tube cartons).

Store between 20° and 25°C (68° and 77°F); excursions permitted to 15°-30°C (59°-86°F). Do not refrigerate.