Bactroban Cream

Bactroban Cream information, interactions and side effects, 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-cream1

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.

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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.

SIDE EFFECTS

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.

DRUG INTERACTIONS

The effect of the concurrent application of topical mupirocin calcium cream and other topical products has not been studied.

WARNINGS

Avoid contact with the eyes. In case of accidental contact, rinse well with water.

In the event of a sensitization or severe local irritation from BACTROBAN Cream, usage should be discontinued, and appropriate alternative therapy for the infection instituted.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including BACTROBAN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

PRECAUTIONS

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.

OVERDOSE

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.

CONTRAINDICATIONS

BACTROBAN Cream is contraindicated in patients with known hypersensitivity to any of the constituents of the product.

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