Bactroban® 2% Ointment

Mupirocin 2.0% w/w

Ointment in a white, translucent, water-soluble, polyethylene glycol base. For topical administration.

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.

Dosage:

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.

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

Administration:

Topical.

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.

Bactroban ointment should not be given to patients with a history of hypersensitivity to any of its constituents.

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.

Renal impairment

Elderly patients: No restrictions unless the condition being treated could lead to absorption of polyethylene glycol and there is evidence of moderate or severe renal impairment.

Bactroban ointment is not suitable for:

- ophthalmic use

- intranasal use (in neonates or infants)

- use in conjunction with cannulae

- at the site of central venous cannulation.

For intranasal use, a separate presentation, Bactroban nasal ointment, is available.

Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the ointment residues have been removed.

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, Bactroban 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.

None stated.

Pregnancy: Reproduction studies on Bactroban in animals have revealed no evidence of harm to the foetus. 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.

Lactation: 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.

None stated.

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:

Very rare: Systemic allergic reactions 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.

Uncommon: Cutaneous sensitisation reactions to mupirocin or the ointment base.

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

In case of erroneous oral intake of large quantities of the ointment, renal function should be closely monitored in patients with renal insufficiency because of the possible side effects of polyethylene glycol.

Bactroban (mupirocin) potently inhibits bacterial protein and RNA synthesis by inhibition of isoleucyl-transfer RNA synthetase.

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.

None stated.

Polyethylene Glycol 400 USNF

Polyethylene Glycol 3350 USNF

None stated.

Bactroban Ointment has a shelf-life of two years.

Store at room temperature (below 25°C).

Original pack of 5 and 15 g* (sealed tube in a carton) with Patient Information Leaflet.

No special instructions.

Beecham Group plc

980 Great West Road,

Brentford,

Middlesex TW8 9GS

Trading as:

GlaxoSmithKine UK,

Stockley Park West,

Uxbridge,

Middlesex UB11 1BT

PL 00038/0319

21 May 2008

1^st February 2010

POM

* At time of printing only the details relevant to marketed packs will be included.