POM: Prescription only medicine
This information is intended for use by health professionals
Bactroban 2% Ointment
Each gram of ointment contains 20 mg mupirocin (2% w/w mupirocin free acid).
For the full list of excipients, see section 6.1.
Ointment in a white, translucent, water-soluble, polyethylene glycol base.
Bactroban is a topical antibacterial agent, active against those organisms responsible for the majority of skin infections, e.g. Staphylococcus aureus, including methicillin-resistant strains, other staphylococci, streptococci. It is also active against Gram-negative organisms such as Escherichia coli and Haemophilus influenzae. Bactroban Ointment is used for skin infections, e.g. impetigo, folliculitis, furunculosis.
Adults (including elderly/hepatically impaired) and children
Two to three times a day for up to ten days, depending on the response.
See section 4.4
Method of administration
For 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.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
This Bactroban Ointment formulation is not suitable for ophthalmic or intranasal use.
Should a possible sensitisation reaction or severe local irritation occur with the use of Bactroban Ointment, treatment should be discontinued, the product should be washed off and appropriate therapy instituted.
As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms.
Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. Although this is less likely to occur with topically applied mupirocin, if prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
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, 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.
No drug interactions have been identified.
Reproduction 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.
There 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.
There are no data on the effects of mupirocin on human fertility. Studies in rats showed no effects on fertility (see section 5.3).
No adverse effects on the ability to drive or operate machinery have been identified.
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), including isolated reports.
Common and uncommon adverse reactions were determined from pooled safety data from a clinical trial population of 1573 treated patients encompassing 12 clinical studies. Very rare adverse reactions were primarily determined from post-marketing experience data and therefore refer to reporting rate rather than true frequency.
Immune system disorders:
Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema have been reported with Bactroban Ointment.
Skin and subcutaneous tissue disorders:
Burning localised to the area of application.
Itching, erythema, stinging and dryness localised to the area of application. Cutaneous sensitisation reactions to mupirocin or the ointment base.
Reporting of suspected adverse reactions
Reporting 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 signs
There is currently limited experience with overdosage of mupirocin.
There 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.
Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use.
ATC code: D06AX09
Mode of Action
Mupirocin 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.
The 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
* Activity has been satisfactorily demonstrated in clinical studies
After topical application of Bactroban Ointment, mupirocin is only very minimally absorbed systemically and that which is absorbed is rapidly metabolised to the antimicrobially inactive metabolite, monic acid. Penetration of mupirocin into the deeper epidermal and dermal layers of the skin is enhanced in traumatised skin and under occlusive dressings.
No restrictions unless there is evidence of moderate or severe renal impairment (see section 4.4).
Pre-clinical effects were seen only at exposures which are extremely unlikely to cause concern for humans under normal conditions of use. Mutagenicity studies revealed no risks to man.
Polyethylene glycol 400 USNF
Polyethylene glycol 3350 USNF
Store at room temperature (below 25°C).
Sealed tamper evident lacquered aluminium tube containing 15 g ointment.
Any product remaining at the end of treatment should be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Wash your hands after application.
Beecham Group plc
980 Great West Road,
Middlesex TW8 9GS
Date of first authorisation: 26 March 1985
Date of last renewal: 21 May 2008
25 November 2019