MUPIROCIN

Posology:

Adults (including elderly) and Paediatric population: Mupirocin 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.

Method of 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.

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 ( 1/1,000 to <1/100), rare ( 1/10,000 to <1/1,000), 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.

System organ class Frequency Undesirable effects Immune system disorders Very rare Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema have been reported with Mupirocin Ointment. Skin and subcutaneous tissue disorders Common Uncommon Burning localised to the area of application 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 authorisations 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 Mupirocin 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.

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 (in neonates or infants); - use in conjunction with cannulae; - 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.

1 This Mupirocin Ointment formulation is not suitable for ophthalmic or intranasal use.