POM: Prescription only medicine
This information is intended for use by health professionals
Adults (including elderly/hepatically impaired) and childrenTwo to three times a day for up to ten days, depending on the response.
Renally impairedSee section 4.4
Method of administrationFor topical administration.A small quantity of Bactroban ointment should be applied to cover the affected area. The treated area may be covered by a dressing.Any product remaining at the end of treatment should be discarded.Do not mix with other preparations as there is a risk of dilution, resulting in a reduction of the antibacterial activity and potential loss of stability of the mupirocin in the ointment.
Renal impairmentPolyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol based ointments, mupirocin 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 is not suitable for:- ophthalmic use- intranasal use - use in conjunction with cannulae and- at the site of central venous cannulation.Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the ointment residues have been removed.
PregnancyReproduction studies on Bactroban in animals have revealed no evidence of harm to the foetus (see section 5.3). As there is no clinical experience on its use during pregnancy, Bactroban should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.
Breast-feedingThere is no information on the excretion of Bactroban in milk. If a cracked nipple is to be treated, it should be thoroughly washed prior to breast feeding.
FertilityThere are no data on the effects of mupirocin on human fertility. Studies in rats showed no effects on fertility (see section 5.3).
|Immune system disorders:|
|Very rare:||Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema have been reported with Bactroban Ointment.|
|Skin and subcutaneous tissue disorders:|
|Common:||Burning localised to the area of application.|
|Uncommon:||Itching, erythema, stinging and dryness localised to the area of application. Cutaneous sensitisation reactions to mupirocin or the ointment base.|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report andy suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Symptoms and signsThere is currently limited experience with overdosage of mupirocin.
TreatmentThere is no specific treatment for an overdose of mupirocin. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary. Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Mode of ActionMupirocin is a novel antibiotic produced through fermentation by Pseudomonas fluorescens. Mupirocin inhibits isoleucyl transfer-RNA synthetase, thereby arresting bacterial protein synthesis. Mupirocin has bacteriostatic properties at minimum inhibitory concentrations and bactericidal properties at the higher concentrations reached when applied locally.Mechanism of Resistance Low-level resistance in staphylococci is thought to result from point mutations within the usual staphylococcal chromosomal gene (ileS) for the target isoleucyl tRNA synthetase enzyme. High-level resistance in staphylococci has been shown to be due to a distinct, plasmid encoded isoleucyl tRNA synthetase enzyme.Intrinsic resistance in Gram negative organisms such as the Enterobacteriaceae could be due to poor penetration of the outer membrane of the Gram-negative bacterial cell wall.Due to its particular mode of action, and its unique chemical structure, mupirocin does not show any cross-resistance with other clinically available antibiotics.
Microbiological SusceptibilityThe prevalence of acquired resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infection is questionable.
|Commonly susceptible species|
|Streptococcus spp. (β-haemolytic, other than S. pyogenes)|
|Species for which acquired resistance may be a problem|
|Staphylococcus spp., coagulase negative|
|Inherently resistant organisms|