- mupirocin calcium
POM: Prescription only medicine
This information is intended for use by health professionals
Adults/children ≥ 1 year/elderly3 times a day for up to 10 days, depending on the response. Patients not showing a clinical response within 3 to 5 days should be re-evaluated. The duration of treatment should not exceed 10 days.
Children < 1 yearBactroban Cream has not been studied in infants under 1 year old and therefore it should not be used in these patients until further data become available.Patients with hepatic impairment: No dosage adjustment is necessary.Patients with renal impairment: No dosage adjustment is necessary.
Method of administrationA thin layer of cream should be applied to the affected area with a piece of clean cotton wool or gauze swab.The treated area may be covered by a dressing.Do not mix with other preparations, as there is a risk of dilution, resulting in a reduction in the antibacterial activity and potential loss of stability of the mupirocin in the cream.
Fertility:There are no data on the effects of mupirocin on human fertility. Studies in rats showed no effects on fertility (see section 5.3).
Pregnancy:Reproduction studies on mupirocin 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, mupirocin should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.
Breast-feeding:There is no information on the excretion of mupirocin in milk. If a cracked nipple is to be treated, it should be thoroughly washed prior to breast feeding.
Immune system disorders:
Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema
Skin and subcutaneous tissue disorders:
Application site hypersensitivity reactions including urticaria, pruritus, erythema, burning sensation, contact dermatitis, rash
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
AbsorptionSystemic absorption of mupirocin through intact human skin is low although it may occur through broken/diseased skin. However, clinical trials have shown that when given systemically, it is metabolised to the microbiologically inactive metabolite monic acid and rapidly excreted.
ExcretionMupirocin is rapidly eliminated from the body by metabolism to its inactive metabolite monic acid which is rapidly excreted by the kidney.
Beecham Group plc
980 Great West Road, Brentford
Middlesex TW8 9GS
6 March 2020