It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

Summary of Product Characteristics last updated on medicines.ie: 27/8/2015

Bactroban Ointment

1. NAME OF THE MEDICINAL PRODUCT

Bactroban 2% w/w Ointment

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram of ointment contains 20 mg mupirocin (2.0% w/w mupirocin free acid).

For the full list excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Ointment in a white, translucent, water-soluble, macrogol base.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Bactroban Ointment is indicated for the treatment of acute primary bacterial skin infections e.g. impetigo and folliculitis due to organisms sensitive to the active ingredient.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Posology

Adults (including elderly) and children:

Bactroban Ointment should be applied to the affected area up to three times a day for up to 10 days, depending on the response. Dosage should not exceed ten days.

The area may be covered with a dressing or occluded if desired.

Method of administration

Cutaneous use.

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 ointment.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

In the rare event of a possible sensitisation reaction or severe local irritation occurring with the use of the product, treatment should be discontinued, the product should be wiped off and appropriate alternative therapy for the infection 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.

Renal impairment

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.

Mupirocin 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.

4.5 Interaction with other medicinal products and other forms of interaction

No drug interactions have been identified.

4.6 Fertility, pregnancy and lactation

Pregnancy

Adequate human data on use during pregnancy are not available. Studies in animals do not indicate reproductive toxicity (see section 5.3).

Breast-feeding

Adequate human and animal data on use during lactation are not available.

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).

4.7 Effects on ability to drive and use machines

Bactroban Ointment has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <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:

Very rare:

Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema have been reported with bactroban ointment.

Skin and subcutaneous tissue disorders:

Common:

Burning localised to the area of application.

Uncommon:

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 any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

Symptoms:

There is currently limited experience with overdosage of mupirocin.

Management:

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.

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.

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

5.2 Pharmacokinetic properties

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.

Elderly patients:

No restrictions unless there is evidence of moderate or severe renal impairment (see section 4.4).

5.3 Preclinical safety data

Carcinogenesis/Mutagenesis

Carcinogenesis

Carcinogenicity studies with mupirocin have not been conducted.

Genotoxicity

Mupirocin was not mutagenic in Salmonella typhimurium or Escherichia coli (Ames assay). In a Yahagi assay, small increases in Salmonella typhimurium TA98 were observed at highly cytotoxic concentrations. In an in vitro mammalian gene mutation assay (MLA), no increase in mutation frequency was observed in the absence of metabolic activation. In the presence of metabolic activation, small increases in mutation frequency were observed at highly cytotoxic concentrations. However, no effects were observed in, yeast cell assays for gene conversion/mutation, an in vitro human lymphocyte assay or in an in vitro unscheduled DNA synthesis (UDS) assay. Furthermore, an in vivo mouse micronucleus assay (chromosome damage) and a rat Comet assay (DNA strand breakage) were negative, indicating the small increases observed at highly cytotoxic concentrations in vitro do not translate to the in vivo situation.

Reproductive Toxicology

Fertility

Mupirocin administered subcutaneously to male rats 10 weeks prior to mating and to female rats 15 days prior to mating until 20 days post coitum at doses up to 100 mg/kg/day had no effect on fertility.

Pregnancy

In embryo-foetal development studies in rats there was no evidence of developmental toxicity at subcutaneous doses up to 375 mg/kg/day.

In an embryo-foetal development study in rabbits at subcutaneous doses up to 160 mg/kg/day, maternal toxicity (impaired weight gain and severe injection site irritation) at the high dose resulted in abortion or poor litter performance. However, there was no evidence of developmental toxicity in foetuses of rabbits maintaining pregnancy to term.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Macrogol 400

Macrogol 3350

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Sealed tamper evident aluminium tube with or without an internal coating of resin lacquer containing 15 g ointment.

6.6 Special precautions for disposal and other handling

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.

7. MARKETING AUTHORISATION HOLDER

GlaxoSmithKline (Ireland) Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

8. MARKETING AUTHORISATION NUMBER(S)

PA 1077/94/1

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 29 April 1986

Date of last renewal: 29 April 2006

10. DATE OF REVISION OF THE TEXT

21 August 2015

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.