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Bactroban Ointment

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Bactroban Ointment

Warnings
Precautions

WARNINGS

Bactroban Ointment is not for ophthalmic use.

PRECAUTIONS

If a reaction suggesting sensitivity or chemical irritation should occur with the use of Bactroban Ointment (mupirocin ointment) 2%, treatment should be discontinued and appropriate alternative therapy for the infection instituted.

As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.

Bactroban Ointment is not formulated for use on mucosal surfaces. Intranasal use has been associated with isolated reports of stinging and drying. A paraffin-based formulation - Bactroban Nasal® (mupirocin calcium ointment) - is available for intranasal use.

Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol-based ointments, Bactroban Ointment (mupirocin) should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals to evaluate carcinogenic potential of mupirocin 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 genotoxicity: 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 male and female rats with mupirocin administered subcutaneously at doses up to 14 times a human topical dose (approximately 60 mg mupirocin per day) on a mg/m²basis and revealed no evidence of impaired fertility and reproductive performance from mupirocin.

Pregnancy

Teratogenic Effects

Pregnancy Category B: Reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 22 and 43 times, respectively, the human topical dose (approximately 60 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 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 Ointment (mupirocin) is administered to a nursing woman.

Pediatric Use: The safety and effectiveness of Bactroban Ointment (mupirocin) have been established in the age range of 2 months to 16 years. Use of Bactroban Ointment (mupirocin) in these age groups is supported by evidence from adequate and well-controlled studies of Bactroban Ointment (mupirocin) in impetigo in pediatric patients studied as a part of the pivotal clinical trials. (See CLINICAL STUDIES.)

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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