Data from FDA - Curated by EPG Health - Last updated 01 April 2018

Indication(s)

INDICATIONS AND USAGE 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.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Psoriasis

Psoriasis

See information on psoriasis pathophysiology, signs and symptoms, comorbidities, treatment options, and more.

+ 2 more

Atopic Dermatitis

Atopic Dermatitis

The Atopic Dermatitis Knowledge Centre is an educational resource, intended for healthcare professionals, that provides credible medical information on the epidemiology, pathophysiology and burden of atopic dermatitis, as well as diagnostic techniques, treatment regimens and guideline recommendations.

Psoriasis Academy

Psoriasis Academy

Learn about the burden of psoriasis, unmet needs, the tools used to assess severity and treatment response, what we know about the pathophysiology behind the condition and what the current guidelines say.

+ 1 more

Load more

Related Content

Advisory information

contraindications
CONTRAINDICATIONS BACTROBAN CREAM is contraindicated in patients with known hypersensitivity to any of the constituents of the product.
Special warnings and precautions
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. Information for Patients • Use this medication only as directed by your healthcare provider. It is for external use only. Avoid contact with the eyes. • The treated area may be covered by gauze dressing if desired. • Report to your healthcare provider any signs of local adverse reactions. The medication should be stopped and your healthcare provider contacted if irritation, severe itching, or rash occurs. • If no improvement is seen in 3 to 5 days, contact your healthcare provider. Drug Interactions The effect of the concurrent application of topical mupirocin calcium cream and other topical products has not been studied. 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 studies of BACTROBAN CREAM in adults with additional data from 93 pediatric patients studied as part of the pivotal trials in adults. (See CLINICAL STUDIES.) Geriatric Use In 2 well-controlled studies, 30 patients 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 to that observed in younger patients.
Adverse reactions
ADVERSE REACTIONS In 2 randomized, double-blind, double-dummy trials, 339 patients were treated with topical BACTROBAN CREAM plus oral placebo. Adverse events thought to be possibly or probably drug-related occurred in 28 (8.3%) patients. The incidence of those events that were reported in at least 1% of patients 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 patients were: Abdominal pain, burning at application site, cellulitis, dermatitis, dizziness, pruritus, secondary wound infection, and ulcerative stomatitis. In a supportive study in the treatment of secondarily infected eczema, 82 patients 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.

Usage information

Dosing and administration
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.
Pregnancy and lactation
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.

Interactions

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

More information

Category Value
Authorisation number NDA050746
Agency product number RG38I2P540
Orphan designation No
Product NDC 49999-521
Date Last Revised 28-03-2018
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC