ADVANTAN

What it is

Advantan is a topical formulation containing methylprednisolone aceponate 1 mg/g (0.1%) . Advantan is a potent steroid formulated for topical application . After topical application, Advantan has anti-inflammatory, anti-pruritic and vasoconstrictive actions . Advantan is available in cream, lotion, ointment and fatty ointment formulations . The lotion is an oil-in-water emulsion containing 68% purified water, the cream is an oil-in-water emulsion containing about 60% purified water, the ointment is a water-in-oil emulsion containing 30% purified water, and the fatty ointment is a monophasic ointment with 96.9% hydrocarbons .

Approved indications

— Topical treatment of eczema in adults and children (cream, ointment, fatty ointment) — Topical treatment of psoriasis in adults and children (cream, ointment, fatty ointment) — Topical treatment of eczema in adults and children (lotion)

Dosing overview

Advantan ointment, fatty ointment or cream should usually be applied as a thin coating once per day to the affected areas, with twice daily application required in the treatment of psoriasis . Advantan lotion should be applied sparingly once daily to the affected areas and rubbed in gently . The duration of use should be less than 12 weeks in adults and less than 4 weeks in children .

Key safety warnings

Any of the side effects that have been reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children . As with all potent corticosteroids, the possibility of hypothalamic-pituitary-adrenal (HPA) axis suppression resulting from percutaneous absorption of methylprednisolone must be considered when initiating or reviewing therapy . Extensive application of topical corticosteroids to large areas of the body or for prolonged periods of time, in particular under occlusion, significantly increases the risk of side effects, which is particularly important in children who may absorb proportionately larger amounts of topical corticosteroid and thus be more susceptible to systemic toxicity . Local atrophy, telangiectasia and striae may occur after prolonged treatment or excessive application . Additional specific therapy is required in skin conditions infected with bacteria and/or fungi, and any spread of infection requires withdrawal of topical corticosteroid therapy . Visual disturbance may be reported with systemic and topical corticosteroid use, and if a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy .

Contraindications

Advantan is contraindicated in viral diseases (such as vaccinia, varicella/herpes zoster) and when tuberculous or syphilitic processes and post-vaccination skin reactions are present in the area to be treated . If rosacea, ulcera, atrophic skin diseases, acne vulgaris or perioral dermatitis are present, Advantan must not be applied to the face . Hypersensitivity to methylprednisolone aceponate or any component of the formulations is a contraindication. Children under four months are contraindicated due to lack of experience .

Regulatory history

Advantan cream, ointment and fatty ointment formulations were first listed on the ARTG on 11 July 1994 . The lotion formulation was first listed on the ARTG on 18 December 2001 .