EPIDUO

What it is

EPIDUO is a gel containing adapalene 1 mg per gram (0.1%) and benzoyl peroxide 25 mg per gram (2.5%) . It is a white to very pale-yellow opaque gel .

Approved indications

— Cutaneous treatment of acne vulgaris on the face, chest and back when comedones, papules and pustules are present, and the condition has not responded to first line treatment .

Dosing overview

EPIDUO should be applied to the entire acne affected areas once a day on a clean and dry skin . A thin film of gel should be applied, with the fingertips, avoiding the eyes, lips, and mucous membranes . The duration of treatment should be determined by the doctor on the basis of the clinical condition. Early signs of clinical improvement usually appear after 1 to 4 weeks of treatment .

Key safety warnings

Excessive exposure to sunlight or UV radiation (for example, sunlamps) should be avoided . EPIDUO should not be applied to damaged skin, either broken (cuts or abrasions), sunburnt or eczematous skin . This product contains propylene glycol (E1520) that may cause skin irritation . This medicine contains polysorbate 80 (E433), which can cause allergic reactions . If skin irritation appears after application of EPIDUO, the intensity is generally mild or moderate, with local tolerability signs and symptoms (erythema, dryness, scaling, burning and pain of skin including stinging) peaking during the first two weeks and then subsiding spontaneously . Depending upon the severity of local cutaneous adverse reactions, patients should be instructed to use a moisturiser, reduce the frequency of the application of EPIDUO, or discontinue use . As with other topical retinoids, use of waxing as a depilatory method should be avoided on skin treated with EPIDUO . Other retinoids or benzoyl peroxide or drugs with a similar mode of action should not be used concurrently .

Contraindications

Hypersensitivity to the active substances or to any of the excipients . EPIDUO is contraindicated in pregnancy and in women planning a pregnancy .

PBS listing

No information regarding PBS listing is available in the provided documents.

Regulatory history

EPIDUO adapalene/benzoyl peroxide 0.1%/2.5% gel was first listed on the Australian Register of Therapeutic Goods on 22 January 2009 . A bottle formulation of the same strength was registered on 7 August 2014 .