BACTROBAN Cream (mupirocin calcium cream, 2%) contains the dihydrate crystalline calcium hemi-salt of the antibiotic mupirocin. Chemically, it is (αE,2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate. The molecular formula of mupirocin calcium is (C26H43O9)2Ca•2H2O, and the molecular weight is 1075.3. The molecular weight of mupirocin free acid is 500.6. The structural formula of mupirocin calcium is: BACTROBAN Cream is a white cream that contains 2.15% w/w mupirocin calcium (equivalent to 2.0% mupirocin free acid) in an oil and water-based emulsion. The inactive ingredients are benzyl alcohol, cetomacrogol 1000, cetyl alcohol, mineral oil, phenoxyethanol, purified water, stearyl alcohol, and xanthan gum.

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In 2 randomized, double-blind, double-dummy trials, 339 subjects were treated with topical BACTROBAN Cream plus oral placebo. Adverse events thought to be possibly or probably drug-related occurred in 28 (8.3%) subjects. The incidence of those events that were reported in at least 1% of subjects enrolled in these trials were: headache (1.7%), rash, and nausea (1.1% each). Other adverse events thought to be possibly or probably drug-related which occurred in less than 1% of subjects were: abdominal pain, burning at application site, cellulitis, dermatitis, dizziness, pruritus, secondary wound infection, and ulcerative stomatitis. In a supportive trial in the treatment of secondarily infected eczema, 82 subjects were treated with BACTROBAN Cream. The incidence of adverse events thought to be possibly or probably drug-related was as follows: nausea (4.9%), headache, and burning at application site (3.6% each), pruritus (2.4%) and 1 report each of abdominal pain, bleeding secondary to eczema, pain secondary to eczema, hives, dry skin, and rash. Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of BACTROBAN. Read the Bactroban Cream (mupirocin calcium cream) Side Effects Center for a complete guide to possible side effectsLearn More »

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A small amount of BACTROBAN Cream should be applied to the affected area 3 times daily for 10 days. The area treated may be covered with gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated.

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The effect of the concurrent application of topical mupirocin calcium cream and other topical products has not been studied. Last reviewed on RxList: 6/1/2015
This monograph has been modified to include the generic and brand name in many instances.

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BACTROBAN Cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm² in area) due to susceptible strains of S. aureus and S. pyogenes.

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BACTROBAN Cream is contraindicated in patients with known hypersensitivity to any of the constituents of the product.Last reviewed on RxList: 6/1/2015
This monograph has been modified to include the generic and brand name in many instances.

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Intravenous infusions of 252 mg, as well as single oral doses of 500 mg of mupirocin, have been well tolerated in healthy adult subjects. There is no information regarding overdose of BACTROBAN Cream.

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BACTROBAN Cream is supplied in 15-gram and 30-gram tubes. NDC 0029-1527-22 (15-gram tube)
NDC 0029-1527-25 (30-gram tube) Store at or below 25°C (77°F). Do not freeze. GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: March 2015Last reviewed on RxList: 6/1/2015
This monograph has been modified to include the generic and brand name in many instances.

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General As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi (see DOSAGE AND ADMINISTRATION). BACTROBAN Cream is not formulated for use on mucosal surfaces. 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. Fertility studies were performed in rats with mupirocin administered subcutaneously at doses up to 49 times a human topical dose of 1 gram/day (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. Teratology studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 78 and 154 times, respectively, a human topical dose of 1 gram/day (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 Cream is administered to a nursing woman. Pediatric Use The safety and effectiveness of BACTROBAN Cream have been established in the age groups 3 months to 16 years. Use of BACTROBAN Cream in these age groups is supported by evidence from adequate and well-controlled trials of BACTROBAN Cream in adults with additional data from 93 pediatric subjects studied as part of the pivotal trials in adults (see Clinical Studies). Geriatric Use In 2 well-controlled trials, 30 subjects older than 65 years were treated with BACTROBAN Cream. No overall difference in the efficacy or safety of BACTROBAN Cream was observed in this patient population when compared with that observed in younger patients. Last reviewed on RxList: 6/1/2015
This monograph has been modified to include the generic and brand name in many instances.

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