Product Dossier

DESOWEN

Product Dossier for DESOWEN (desonide, Galderma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

DESOWEN contains desonide 0.05% and is available as a lotion, ointment and cream. Desonide is a nonfluorinated corticosteroid. The lotion is a white to off-white, soft, smooth preparation; the ointment is a smooth, soft, translucent, grease-like preparation; and the cream is a white, shiny, semi-solid emulsion.

Approved indications

— Relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses for adults and children aged 2 years and older.

Dosing overview

DESOWEN should be applied as a thin film to the affected areas two to three times daily depending on the severity of the condition. Periods of continuous treatment should not exceed 8 weeks in adults or children. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions.

Key safety warnings

Prolonged use of corticosteroids of medium potency on the face is associated with a risk of corticosteroid-related dermatitis that is paradoxically corticosteroid-responsive, with a rebound after each treatment discontinuation, and gradual withdrawal by tapering is then required. The product is not recommended in patients with perioral dermatitis. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal axis suppression, manifestations of Cushings syndrome, hyperglycemia and glucosuria in some patients. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity, and because of a larger skin surface area to body weight ratio, paediatric patients may show a greater susceptibility to topical corticosteroid induced HPA axis suppression and Cushing's syndrome than mature patients. 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

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. DESOWEN preparations are also contraindicated in most viral infections of the skin (vaccinia, herpes simplex), tuberculosis, acne and rosacea. Application to ulcerated lesions and to the eyelids is also contraindicated due to the risk of glaucoma.

Regulatory history

DESOWEN was first approved and registered on the ARTG on 21 December 1998, with registrations for cream (ARTG 67167), lotion (ARTG 67182) and ointment (ARTG 67174) formulations.