Bactroban® Cream.

1g Cream contains: 21.5mg Mupirocin calcium equivalent to 20.0mg mupirocin.

For excipients, see Section 6.1.

Cream.

Bactroban Cream is presented as a white cream of homogeneous appearance.

Bactroban Cream is indicated for the topical treatment of secondarily infected traumatic lesions such as small lacerations, sutured wounds or abrasions (up to 10cm in length or 100cm² in area), due to susceptible strains of Staphylococcus aureus and Streptococcus pyogenes.

Dosage

Adults/children/elderly

Three 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.

Hepatic impairment: No dosage adjustment is necessary.

Renal impairment: No dosage adjustment is necessary.

Method of administration

A 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.

Hypersensitivity to mupirocin or any of the excipients (see section 6.1).

Avoid contact with the eyes.

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 alternative therapy for the infection instituted.

As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms.

Bactroban 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.

Bactroban Cream contains cetyl alcohol and stearyl alcohol. These inactive ingredients may cause local skin reactions (e.g. contact dermatitis).

No drug interactions have been identified.

Use in 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.

Use in lactation:

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.

No adverse effects on the ability to drive or operate machinery have been identified.

Data from clinical trials was used to determine the frequency of very common to rare undesirable effects.

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.

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.

The toxicity of mupirocin is very low. In the event of accidental ingestion of the cream symptomatic treatment should be given.

ATC classification

Properties

ATC-code : D06A X09, Antibiotics and chemotherapeutics for dermatological use.

Mode of Action

Mupirocin is an antibiotic produced through fermentation by Pseudomonas fluorescens. Mupirocin inhibits isoleucyl transfer-RNA synthetase, thereby arresting bacterial protein synthesis. Due to this particular mode of action and its unique chemical structure, mupirocin does not show any cross-resistance with other clinically available antibiotics.

Mupirocin has bacteriostatic properties at minimum inhibitory concentrations and bactericidal properties at the higher concentrations reached when applied locally.

Activity

Mupirocin is a topical antibacterial agent showing in vivo activity against Staphylococcus aureus (including methicillin-resistant strains), S. epidermidis and beta-haemolytic Streptococcus species.

The in-vitro spectrum of activity includes but is not limited to the following bacteria which are most often implicated in skin infections:

- Staphylococcus aureus (including beta-lactamase-producing strains and methicillin resistant strains).

- Staphylococcus epidermidis (including beta-lactamase-producing strains and methicillin-resistant strains).

- Other coagulase-negative staphylococci (including methicillin-resistant strains).

- Streptococcus species.

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.

Pre-clinical effects were seen only at exposures which give no cause for concern for man under normal conditions of clinical use. Mutagenicity studies revealed no risks to man.

Xanthan gum, liquid paraffin, cetomacrogol 1000, stearyl alcohol, cetyl alcohol, phenoxyethanol, benzyl alcohol, purified water.

None known

18 months

Do not store above 25^oC. Do not freeze.

Squeezable aluminium tubes with a screw cap containing 15 g of white cream.

Any product remaining at the end of treatment should be discarded.

Beecham Group plc

980 Great West Road, Brentford

Middlesex TW8 9GS

Trading as:

GlaxoSmithKline UK

Stockley Park West,

Uxbridge,

Middlesex, UB11 1BT

PL 00038/0372

28 October 1998

28 October 2008

POM