Product Dossier

BACTROBAN

Product Dossier for BACTROBAN (mupirocin calcium, GlaxoSmithKline). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

Bactroban is mupirocin calcium , available as a cream or ointment . Bactroban cream and ointment contain mupirocin calcium 2% w/w equivalent to 20 mg mupirocin as the active ingredient. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase.

Approved indications

— Topical treatment of secondarily infected traumatic skin lesions such as small lacerations, sutured wounds or abrasions (cream formulation) — Topical treatment of mild impetigo (ointment formulation)

Dosing overview

A small amount of Bactroban should be applied to the affected area three times daily. Usually treatment should not continue for more than 10 days.

Key safety warnings

If a reaction suggesting sensitivity or chemical irritation should occur with the use of Bactroban, treatment should be discontinued, the product should be wiped off and appropriate alternative therapy for the infection instituted. Bactroban is not suitable for ophthalmic use, intranasal use or application to other mucosal surfaces, and contact with eyes should be avoided. 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. As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. 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.

Contraindications

Bactroban cream and ointment are contraindicated in patients who have demonstrated hypersensitivity to mupirocin calcium or any components of the formulations.

PBS listing

Bactroban cream 20 mg per g in 15 g tubes is listed on the PBS with restriction, at an ex-manufacturer price of A$11.62. Bactroban ointment 20 mg per g in 15 g tubes is listed on the PBS without restriction, at an ex-manufacturer price of A$11.62.

Regulatory history

Bactroban mupirocin 20 mg/g ointment was first listed on the ARTG on 14 August 1991. Bactroban mupirocin calcium 20 mg/g cream was first listed on the ARTG on 23 April 1998.