Product Description.:
Ointment , white
white to off-white ointment
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-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid.
INDICATIONS AND USAGE
BACTROBAN OINTMENT is indicated for the topical treatment of impetigo due to: S. aureus and S. pyogenes.
CONTRAINDICATIONS
This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components.
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, 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 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.
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 medication should be stopped and your healthcare practitioner contacted if irritation, severe itching, or rash occurs.
If impetigo has not improved in 3 to 5 days, contact your healthcare practitioner.
Drug Interactions
The effect of the concurrent application of BACTROBAN OINTMENT and other drug products has not been studied.
ADVERSE REACTIONS
The following local adverse reactions have been reported in connection with the use of BACTROBAN OINTMENT: Burning, stinging, or pain in 1.5% of patients itching in 1% of patients rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of patients. Systemic reactions to BACTROBAN OINTMENT have occurred rarely.
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.
