BACTROBAN

Posology 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. Method of administration Topical.

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. Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema.

Respiratory, thoracic and mediastinal disorders Uncommon:

Nasal mucosa reactions. 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.

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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.

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.

This mupirocin nasal ointment formulation is not suitable for ophthalmic use. Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the ointment residues have been removed.

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