Product Dossier
SUPRIAD
Product Dossier for SUPRIAD (methylprednisolone aceponate, LEO Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: LEO Pharma
- Active ingredient: methylprednisolone aceponate
- Therapeutic area: Dermatology
- Related brand: ADVANTAN
- Related brand: TANILONE
- Related brand: METVANT
- Same area: DERMATANE
- Same area: NEOTIGASON
What it is
SUPRIAD is methylprednisolone aceponate 1 mg/g, available as cream, lotion, ointment or fatty ointment formulations. SUPRIAD is a potent steroid formulated for topical application. After topical application, SUPRIAD has anti-inflammatory, anti-pruritic and vasoconstrictive actions.
Approved indications
— Topical treatment of eczema and psoriasis in adults and children (cream, ointment and fatty ointment) — Topical treatment of eczema in adults and children (lotion)
Dosing overview
SUPRIAD ointment, fatty ointment or cream should usually be applied as a thin coating once per day to affected areas, with twice daily application required in the treatment of psoriasis. SUPRIAD lotion should be applied sparingly once daily to 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. Glaucoma may develop from using topical corticosteroids, especially after large-dose or extensive application over a prolonged period, application under occlusive dressings, or application to skin around or near the eyes. 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. This 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. Treatment should be discontinued if symptoms such as cutaneous atrophy occur. Visual disturbance may be reported with systemic and topical corticosteroid use. 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 (CSCR).
Contraindications
SUPRIAD is contraindicated in viral diseases (such as vaccinia, varicella and 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, SUPRIAD must not be applied to the face. SUPRIAD is contraindicated in hypersensitivity to methylprednisolone aceponate or any component of the formulations. SUPRIAD is contraindicated in children under four months due to lack of experience.
PBS listing
Information regarding PBS listing status for SUPRIAD is not available in the provided source documents.
Regulatory history
SUPRIAD was first listed on the Australian Register of Therapeutic Goods on 18 July 2023, with four formulations registered: fatty ointment, cream, lotion and ointment (ARTG entries 408457, 408455, 408458 and 408456 respectively).