ELEUPHRAT

What it is

ELEUPHRAT contains betamethasone dipropionate equivalent to betamethasone 0.5 mg/g (0.05% w/w). It is supplied as cream, ointment, lotion 0.05% w/w. Betamethasone dipropionate is a potent topically-active corticosteroid producing prompt, marked and prolonged anti-inflammatory, anti-pruritic and vasoconstrictive effects.

Approved indications

— Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses including atopic eczema, infantile eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lichen planus, intertrigo and psoriasis. — Treatment of corticosteroid-responsive dermatoses wherever hair impedes access to the skin, particularly on the scalp, chest and underarms, as well as seborrhoea and psoriasis of the scalp (lotion formulation).

Dosing overview

For cream and ointment, apply a small amount to the affected area twice daily, although for some patients adequate maintenance therapy may be achieved with once daily application. For lotion, apply twice daily by parting the hair with a comb and applying with nozzle directly on the scalp. In most cases, 4 weeks continuous treatment should be considered the maximum.

Key safety warnings

Corticosteroids are known to be absorbed percutaneously, and systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used, with suitable precautions required particularly in infants and children and when long-term use is anticipated. Any of the side effects reported following systemic use of corticosteroids, including adrenal suppression, may occur with topical corticosteroids especially in infants and children, and patients applying large doses over large body surface areas should be evaluated periodically for evidence of HPA axis suppression. Patients applying doses of ELEUPHRAT in excess of 15 g per day should be carefully monitored. Manifestations of Cushing's syndrome can be produced in some patients by systemic absorption of topical corticosteroids, and infrequently, signs and symptoms of corticosteroid withdrawal may occur, requiring supplemental systemic corticosteroid therapy. Topical corticosteroid preparations may produce striae or atrophy of the skin or subcutaneous tissue, and if this occurs, treatment should be discontinued. Visual disturbance may be reported with 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

Hypersensitivity to betamethasone dipropionate, other corticosteroids or any components in ELEUPHRAT. Like other topical corticosteroids, ELEUPHRAT preparations are contraindicated in most viral infections of the skin, such as vaccinia, varicella, Herpes simplex, and also tuberculosis and acne rosacea.

PBS listing

Information regarding PBS listing for ELEUPHRAT is not available in the provided source documents.

Regulatory history

ELEUPHRAT betamethasone 0.05% cream was first listed on the ARTG on 22 September 1992, and ELEUPHRAT betamethasone 0.05% ointment was first listed on 12 November 2007.