Product Dossier

FUCIDIN

Product Dossier for FUCIDIN (sodium fusidate, LEO Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

Fucidin Ointment contains sodium fusidate 20 mg/g. Sodium fusidate is an antibiotic derived from the fungus Fusidium coccineum. Fucidin exerts powerful antibacterial activity against a number of gram-positive organisms, with staphylococci, including strains resistant to penicillin or to other antibiotics, being particularly susceptible.

Approved indications

— Skin lesions primarily and secondarily infected with staphylococci, including abscesses, boils, furunculosis, impetigo, folliculitis, hidradenitis, pyoderma, sycosis barbae, and otitis externa.

Dosing overview

Fucidin Ointment is usually applied two to three times daily, with or without a covering dressing. When a protective dressing is used, one application daily will generally be sufficient. The average period of treatment is 7 days, although severe and chronic infections may require longer treatment.

Key safety warnings

When used for the treatment of facial lesions, care must be taken not to introduce ointment into the eyes as the excipients in the ointment may cause conjunctival irritation. Bacterial resistance among Staphylococcus aureus has been reported to occur with the use of topical Fucidin, and extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance. Because of the potential to induce bacterial resistance and thereby compromise the efficacy of systemically administered Fucidin, the use of Fucidin Topical should be avoided in closed settings such as hospitals. Fucidin ointment contains cetyl alcohol and hydrous lanolin, which may cause local skin reactions such as contact dermatitis. Fucidin ointment contains butylhydroxytoluene (E321) which may cause local skin reactions such as contact dermatitis or irritation to the eyes and mucous membranes. Fusidic acid may cause kernicterus in babies during the first month of life by displacing bilirubin from plasma albumin, and should be avoided when possible during the last month of pregnancy.

Contraindications

Infections caused by non-susceptible organisms. Patients with hypersensitivity to the active substance or any of the excipients.

Regulatory history

Fucidin Ointment (sodium fusidate 20 mg/g) was first listed on the ARTG on 14 August 1991.