Bactroban 2% has a relatively narrow registered footprint, available in nine countries — a mix that leans toward Western Europe but also reaches into Japan, Egypt, and a few smaller markets such as Cyprus and Malta. It is not one of the more globally distributed dermatological antibacterials, and travellers outside these markets are unlikely to encounter the exact Bactroban 2% brand on a pharmacy shelf.
The active ingredient is mupirocin calcium, classified as a topical antibacterial for dermatological use. Mupirocin acts locally on the skin and is used in the management of bacterial skin infections such as impetigo, folliculitis, and furuncles, as well as in contaminated minor wounds — abrasions, lacerations, and crush injuries — and in cases of secondarily infected eczema. The structured indication list further down this page details the registered uses recognised by national regulators in the markets where the product is authorised.
Outside the nine countries listed above, the brand name Bactroban 2% may be unfamiliar, but the active ingredient mupirocin is widely available internationally under different brand names and as generic topical preparations. A patient who has been using Bactroban 2% at home and is now travelling or relocating will usually find an equivalent mupirocin product in the destination country, sometimes with a different presentation or regulatory status — prescription in some markets, pharmacy-only in others.
Other topical antibacterials in the same dermatological category exist worldwide under various active ingredients, although they are not directly interchangeable; spectrum and clinical positioning differ. A local pharmacist is well placed to identify what is stocked regionally, and any change in topical antibacterial therapy is a decision to take with a healthcare provider rather than at the counter.
Symptoms:
There is currently limited experience with overdosage of Bactroban Cream.
Management:
There is no specific treatment for an overdose of Bactroban Cream. 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.
18 months
Hypersensitivity to mupirocin or any of the excipients.
None known
Xanthan gum
Liquid paraffin
Cetomacrogol 1000
Stearyl alcohol
Cetyl alcohol
Phenoxyethanol
Benzyl alcohol
Purified water
Data from clinical trials was used to determine the frequency of very common to rare undesirable effects. Very rare adverse reactions were primarily determined from post-marketing experience data and therefore refer to reporting rate rather than true frequency.
The following convention has been used for the classification of frequency:-
very common >1/10, common >1/100 and <1/10 , uncommon >1/1000 and <1/100, rare >1/10,000 and <1/1000 , very rare <1/10,000.
Immune system disorders: | |
Very rare: | Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema |
Skin and subcutaneous tissue disorders: | |
Common: | Application site hypersensitivity reactions including urticaria, pruritus, erythema, burning sensation, contact dermatitis, rash |
Skin dryness and erythema have been reported in irritancy studies in volunteers.
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 any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk.yellowcard
Pre-clinical effects were seen only at exposures which are extremely unlikely to cause concern for humans under normal conditions of clinical use. Mutagenicity studies revealed no risks to man.
Pharmacotherapeutic group: Dermatologicals ATC code: D06AX09, Antibiotics and chemotherapeutics for dermatological use
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.
Microbiological Susceptibility
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 |
| Staphylococcus aureus* |
| Streptococcus pyogenes* |
| Streptococcus spp. (β-haemolytic, other than S. pyogenes) |
| Species for which acquired resistance may be a problem |
| Staphylococcus spp., coagulase negative |
| Inherently resistant organisms |
| Corynebacterium spp. |
| Micrococcus spp. |
* Activity has been satisfactorily demonstrated in clinical studies
Absorption
Systemic 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.
Excretion
Mupirocin is rapidly eliminated from the body by metabolism to its inactive metabolite monic acid which is rapidly excreted by the kidney.
9 June 2015
Beecham Group plc
980 Great West Road, Brentford
Middlesex TW8 9GS
Trading as:
GlaxoSmithKline UK
Stockley Park West,
Uxbridge,
Middlesex, UB11 1BT
Do not store above 25°C. Do not freeze.
Squeezable aluminium tubes with a screw cap containing 15 g of white cream.
PL 00038/0372
Fertility:
There are no data on the effects of mupirocin on human fertility. Studies in rats showed no effects on fertility.
Pregnancy:
Reproduction studies on mupirocin in animals have revealed no evidence of harm to the foetus. 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.
Should a possible sensitisation reaction or severe local irritation occur with the use of Bactroban Cream, 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.
Bactroban Cream formulation is not suitable for ophthalmic use and intranasal use.
Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the cream residues have been removed.
Bactroban Cream contains cetyl alcohol and stearyl alcohol. These inactive ingredients may cause local skin reactions (e.g. contact dermatitis).
No adverse effects on the ability to drive or operate machinery have been identified.
Any product remaining at the end of treatment should be discarded.
Wash your hands after application.
28 October 1998
No drug interactions have been identified.
Bactroban 2% is used for bacterial infections of the skin and superficial soft tissue, including impetigo, folliculitis, and furuncles, as well as in the management of contaminated minor wounds such as abrasions, lacerations, and crush injuries. It is also referenced in the context of secondarily infected eczema. The structured indication block further down this page lists every registered use as recorded across the markets where the product is sold.
Bactroban 2% contains mupirocin calcium, classified within the topical antibacterial category for dermatological use. Mupirocin is the same molecule whether sold under the Bactroban brand or another local name; internationally, the active ingredient circulates under several commercial names depending on the manufacturer and the regulatory market in which it is authorised.
Bactroban 2% is registered in nine countries, with a footprint that mixes Western European markets and a few outside that cluster. Examples include the United Kingdom, France, Japan, Egypt, Finland, and Austria. If your country is not on this list, mupirocin-containing topical antibacterials are often available under different brand names — a local pharmacist can confirm what is stocked in that market.
Mupirocin is sold under a number of brand names worldwide, and the broader category of topical antibacterials for skin infections includes several other active ingredients used in similar clinical situations. These products are not freely interchangeable, since spectrum and positioning differ between molecules. To identify a regional equivalent, search the active ingredient mupirocin on Pill2Trip or ask a pharmacist about locally stocked topical antibacterials.
Yes. Topical antibacterials are prescription products in many jurisdictions and over-the-counter in others, and the regulatory status of Bactroban 2% varies between the countries where it is registered. Skin infections also need clinical judgement to distinguish between conditions that warrant a topical antibacterial and those that do not. A healthcare provider — and locally a pharmacist — is the right point of contact before starting, continuing, or substituting this product.
