Product Dossier

MEDICIANZ

Product Dossier for MEDICIANZ (mupirocin, Medsurge Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

MEDICIANZ contains mupirocin calcium . MEDICIANZ ointment contains 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 . It shows no cross resistance with other commonly used and clinically important antibiotics .

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) — Nasal colonisation of staphylococcus aureus infection in Aboriginal or Torres Strait Islander persons

Dosing overview

A small amount of MEDICIANZ should be applied to the affected area three times daily . Usually treatment should not continue for more than 10 days . The area treated may be covered with a gauze dressing if desired .

Key safety warnings

MEDICIANZ is not suitable for ophthalmic use, intranasal use or application to other mucosal surfaces . Avoid contact with eyes; if contaminated, the eyes should be thoroughly irrigated with water until the residues have been removed . MEDICIANZ is not suitable for application to the site of cannulation or for use in conjunction with cannulae . Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys; MEDICIANZ 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 . Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi; appropriate measures should be taken if this occurs . Although 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

MEDICIANZ is contraindicated in patients who have demonstrated hypersensitivity to mupirocin calcium or any components of the formulations .

PBS listing

MEDICIANZ nasal ointment (5 g pack size) is listed on the PBS with authority required streamlined restriction for nasal colonisation of staphylococcus aureus infection in Aboriginal or Torres Strait Islander persons, recommended by PBAC in July 2019 .

Regulatory history

MEDICIANZ was first approved on 3 April 1998 . MEDICIANZ Mupirocin Ointment was registered on the ARTG on 6 July 2017 . MEDICIANZ Mupirocin Nasal Ointment was registered on the ARTG on 5 April 2019 . PBAC recommended the nasal ointment formulation in July 2019 for use in Aboriginal or Torres Strait Islander persons with nasal colonisation of staphylococcus aureus infection .