Bactroban® 2% Nasal Ointment

Mupirocin 2.0% w/w as mupirocin calcium.

White soft paraffin based ointment containing a glycerin ester.

The elimination of nasal carriage of staphylococci, including methicillin resistant Staphylococcus aureus (MRSA).

Dosage: Adults (including the elderly) and children:

Bactroban Nasal Ointment should be applied to the anterior nares two to three times a day as follows:

A small amount of the ointment about the size of a match head is placed on the little finger and applied to the inside of each nostril. The nostrils are closed by pressing the sides of the nose together; this will spread the ointment throughout the nares. A cotton bud may be used instead of the little finger for the application in particular to infants or patients who are very ill.

Nasal carriage should normally clear within 5-7 days of commencing treatment.

Administration: Topical.

Bactroban Nasal Ointment should not be given to patients with a history of hypersensitivity to any of the constituents.

Should a possible sensitisation reaction or severe local irritation occur with the use of Bactroban Nasal Ointment, treatment should be discontinued, the product should be wiped away and appropriate therapy instituted.

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

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

The product is not known to interact with other medicaments.

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.

None known.

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. Uncommon adverse reactions were determined from pooled safety data from a clinical trial population of 422 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: Cutaneous hypersensitivity reactions.

Respiratory, thoracic and mediastinal disorders

Uncommon: Nasal mucosa reactions.

The toxicity of mupirocin is very low. In the event of overdose, symptomatic treatment should be given.

Mupirocin is a novel antibiotic formulated for topical application only. Its spectrum of in-vitro antibacterial activity includes Staphylococcus aureus (including methicillin resistant strains), Staphylococcus epidermidis, Streptococcus species and certain Gram-negative bacteria, particularly Haemophilus influenzae and Escherichia coli. Other Gram-negative bacteria are less susceptible and Pseudomonas aeruginosa is resistant.

Mupirocin is the major antibacterial compound of a group of structurally related metabolites produced by submerged fermentation of Ps. Fluorescens. Mupirocin has a novel mode of action, inhibiting bacterial iso-leucyl transfer-RNA synthetase and thus cross-resistance with other antibiotics is not experienced.

Studies have shown that following topical application of mupirocin there is very little systemic absorption of drug-related material. To mimic possible enhanced systemic penetration of mupirocin by application to damaged skin or a vascular site such as the mucous membrane, intravenous studies have been performed. Mupirocin was rapidly eliminated from the plasma by metabolism to monic acid, which in turn was excreted mainly in the urine.

No further information of relevance.

White soft paraffin and Softisan 649.

None known.

Bactroban Nasal Ointment has a shelf-life of three years.

Store at room temperature (below 25°C).

Lacquered aluminium tube fitted with a nozzle and screw cap - 3 g ointment.

None stated.

Beecham Group plc

980 Great West Road

Brentford

Middlesex TW8 9GS

trading as:

GlaxoSmithKline UK,

Stockley Park West,

Uxbridge,

Middlesex, UB11 1BT

PL 00038/0347

21 May 2008

1^st February 2010

POM