Bactroban Ointment

Bactroban Ointment information, interactions and side effects, Each gram of BACTROBAN Ointment (mupirocin ointment, 2%) contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, N.F.) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Mupirocin is a naturally occurring antibiotic. The chemical name is (E)-(2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4- methylhexyl]tetrahydro-3,4-dihydroxy-P-methyl-2#-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C26H44O9, and the molecular weight is 500.63. The chemical structure is:

mupi1

INDICATIONS

BACTROBAN Ointment is indicated for the topical treatment of impetigo due to: S. aureus and S. pyogenes.

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

BACTROBAN Ointment is supplied in 22-gram tubes.

NDC 0029-1525-44 (22-gram tube)

Store at controlled room temperature 20° to 25°C (68° to 77°F).

SIDE EFFECTS

The following local adverse reactions have been reported in connection with the use of BACTROBAN Ointment: burning, stinging, or pain in 1.5% of subjects; itching in 1% of subjects; rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of subjects.

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema and generalized rash have been reported in patients treated with BACTROBAN formulations

DRUG INTERACTIONS

The effect of the concurrent application of BACTROBAN Ointment and other drug products has not been studied.

WARNINGS

Avoid contact with the eyes. In case of accidental contact, rinse well with water. In the event of sensitization or severe local irritation from BACTROBAN Ointment, usage should be discontinued.

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 two 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

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 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.

BACTROBAN Ointment should not be used with intravenous cannulae or at central intravenous sites because of the potential to promote fungal infections and antimicrobial resistance.

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/m basis 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/m 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 is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of BACTROBAN Ointment have been established in the age range of 2 months to 16 years. Use of BACTROBAN Ointment in these age groups is supported by evidence from adequate and well-controlled trials of BACTROBAN Ointment in impetigo in pediatric subjects studied as a part of the pivotal clinical trials (see Clinical Studies).

CONTRAINDICATIONS

This drug is contraindicated in patients with known hypersensitivity to any of the constituents of the product.

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