ACZONE

What it is

ACZONE is a topical gel containing 75 mg of dapsone per gram (7.5% w/w) . It is supplied as a topical gel .

Approved indications

— Topical treatment of acne vulgaris in patients 12 years of age or older .

Dosing overview

After the skin is gently washed and patted dry, approximately a pea-sized amount of ACZONE 7.5% w/w gel should be applied in a thin layer to the entire face once daily. A thin layer may be applied to other affected areas once daily . ACZONE 7.5% w/w gel should be rubbed in gently and completely . If there is no improvement after 12 weeks, treatment with ACZONE 7.5% w/w gel should be reassessed .

Key safety warnings

Oral dapsone treatment has produced dose-related haemolysis and haemolytic anaemia. Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to haemolysis with the use of certain drugs . In clinical studies, there was no evidence of clinically relevant haemolysis or haemolytic anaemia in patients treated with topical dapsone . Avoid use of ACZONE 7.5% w/w gel in patients who are taking oral dapsone or antimalarial medications because of the potential for haemolytic reactions . The combination of topical dapsone with trimethoprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of haemolysis in patients with G6PD deficiency . Methaemoglobinaemia has been reported for oral dapsone and has been reported in postmarketing cases for topical dapsone. Patients with G6PD deficiency or congenital or idiopathic methaemoglobinaemia are more susceptible to drug-induced methaemoglobinaemia . Signs and symptoms of methaemoglobinaemia may be delayed for some hours after exposure. Initial signs and symptoms of methaemoglobinaemia are characterised by a slate grey cyanosis seen in, for example, buccal mucous membranes, lips and nail beds . Patients should be advised to discontinue ACZONE 7.5% w/w gel and seek immediate medical attention in the event of cyanosis . Topical application of ACZONE 7.5% w/w gel followed by benzoyl peroxide in patients with acne vulgaris may result in a temporary local yellow or orange discolouration of the skin and facial hair .

Contraindications

ACZONE 7.5% w/w gel is contraindicated in individuals who have shown hypersensitivity to any of its components . ACZONE 7.5% w/w gel is contraindicated in individuals with congenital or idiopathic methaemoglobinaemia .

Regulatory history

The TGA approved Aczone (dapsone) 7.5% w/w topical gel on 4 January 2017 for the topical treatment of acne vulgaris in patients 12 years of age and older . ACZONE dapsone 7.5% w/w topical gel was first listed on the ARTG on 10 January 2017 .