BACTROBAN 2% CREAM - summary of medicine characteristics

Bactroban 2% cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram of cream contains: 21.5 mg Mupirocin calcium equivalent to 20.0 mg mupirocin.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Cream.

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

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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

4.2 Posology and method of administration

Dosage

Adults/children > 1 year/elderly

3 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 reevaluated.

The duration of treatment should not exceed 10 days.

Children < 1 year

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.

Patients with hepatic impairment: No dosage adjustment is necessary.

Patients with 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.

4.3 Contraindications

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

4.4 Special warnings and precautions for use

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).

4.5 Interaction with other medicinal products and other forms of interaction

No drug interactions have been identified.

4.6 Fertility, pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

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 postmarketing 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

4.9 Overdose

5   PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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.

Staphylococcus aureus1 2

Streptococcus pyogenes2

Streptococcus spp. (ß-haemolytic, other than S. pyogenes)

Staphylococcus spp., coagulase negative

Corynebacterium spp.

6.1 List of excipients

Xanthan gum

Liquid paraffin

Cetomacrogol 1000 Stearyl alcohol Cetyl alcohol

Phenoxyethanol

Benzyl alcohol Purified water

6.2 Incompatibilities

None known

6.3 Shelf life

18 months

6.4 Special precautions for storage

Do not store above 25°C. Do not freeze.

6.5 Nature and contents of container

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