Bactroban Nasal Ointment

BACTROBAN TOPICAL ointment is indicated for the topical treatment of primary and secondary bacterial skin infections caused by Staphylococcus aureus and other susceptible organisms. Primary skin infections: Impetigo, folliculitis, furunculosis and ecthyma. Secondary infections: Infected dermatoses e.g., infected eczema. Infected traumatic lesions e.g., abrasions, insect bites, minor (not requiring hospitalisation) wounds and burns. Prophylaxis: Mupirocin may be used to avoid bacterial contamination of small wounds, incisions and other clean lesions, and to prevent infection of abrasions and small cuts and wounds.

Adults, children, elderly: 2-3 times a day for up to 10 days, depending on the response. Hepatic impairment: As above. Renal impairment: See WARNINGS AND SPECIAL PRECAUTIONS.

Method of Administration: A small quantity of BACTROBAN ointment should be applied to cover the affected area. The treated area may be covered by a dressing. Any product remaining at the end of treatment should be discarded. 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.

BACTROBAN TOPICAL ointment is not indicated for the treatment of skin lesions infected with Pseudomonas aeruginosa. BACTROBAN TOPICAL ointment should not be given to patients with a history of hypersensitivity to any of its constituents.

This mupirocin ointment formulation is not suitable for:

• ophthalmic use
• intranasal use
• use in conjunction with cannulae
• at the site of central venous cannulation

Avoid contact with eyes. If contaminated, the eyes should be thoroughly irrigated with water until the ointment residues have been removed. Patients with renal impairment: No restrictions, unless the condition being treated could lead to absorption of polyethylene glycol and there is evidence of moderate to severe renal impairment. Polyethylene glycol can be absorbed from open wounds, burns and damaged skin and is excreted by the kidneys. BACTROBAN TOPICAL 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. The excretion of polyethylene glycol may be impaired and could lead to nephrotoxicity and severe metabolic disturbances. In the rare event of a possible sensitisation reaction or severe local irritation occurring with the use of BACTROBAN TOPICAL ointment, treatment should be discontinued, the product should be rinsed off and appropriate alternative therapy for the infection instituted. Prolonged or irregular use may result in overgrowth of non-susceptible strains of S. aureus and other organisms.

The safety in pregnancy and lactation has not been established.

Side effects are listed below by system organ class and frequency. Frequencies are defined as: very common (u22651/10), common (u22651/100, <1/10), uncommon (u2265 1/1 000, < 1/100), rare (u22651/10 000, <1/1 000), very rare (<1/10 000), including isolated reports. Common and uncommon side effects were determined from pooled safety data from a clinical trial population of 1 573 treated patients encompassing 12 clinical studies. Very rare side effects 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 TOPICAL.

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.

See SIDE EFFECTS.