BETNOVATE

What it is

Betnovate contains betamethasone valerate equivalent to betamethasone 0.2 mg/g in cream formulation , though it is also registered in strengths of 0.5 mg/g and 1 mg/g as cream, and 0.5 mg/g and 1 mg/g as ointment, as well as a 1 mg/g scalp application . Betamethasone valerate is a topically-active corticosteroid ester with anti-inflammatory, antipruritic and vasoconstrictive actions .

Approved indications

Betnovate is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as atopic eczema, infantile eczema, nummular eczema, anogenital and senile pruritus, contact dermatitis, seborrhoeic dermatitis, neurodermatitis, solar dermatitis, stasis dermatitis and psoriasis . Betnovate is indicated for maintenance therapy .

Dosing overview

Apply a small amount to the affected area two or three times daily . Refractory lesions of psoriasis and other deep seated dermatoses respond better if occlusive dressings are used, applied for 1 to 3 days and repeated three or four times as needed .

Key safety warnings

Betnovate should not be used in or near the eyes . Side effects that occur following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children; systemic absorption will be increased if extensive body surface areas are treated or if occlusive technique is used, and suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children . Chronic corticosteroid therapy may interfere with the growth and development of children; paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and exogenous corticosteroid effects; HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids . Visual disturbance may be reported with topical corticosteroid use, and patients presenting with symptoms such as blurred vision or other visual disturbances should be considered for referral to an ophthalmologist for evaluation of possible causes .

Contraindications

Betnovate is contraindicated in hypersensitivity to betamethasone valerate, other corticosteroids or any components in the formulation, and like other topical corticosteroids, is contraindicated in most viral infections of the skin such as vaccinia, varicella and Herpes simplex, also tuberculosis and acne rosacea .

PBS listing

Betnovate cream 500 micrograms per gram is listed on the PBS (15 g pack) with streamlined restriction at an ex-manufacturer price of A$4.88, cream 1 mg per gram (30 g pack) is listed with unrestricted access at A$12.95, ointment 1 mg per gram (30 g pack) is listed with unrestricted access at A$12.95, and cream 200 micrograms per gram (100 g pack) is listed with restriction at A$6.84 .

Regulatory history

Betnovate was first listed on the ARTG on 13 August 1991 in multiple formulations including cream and scalp application at various strengths . Ointment formulations were added to the ARTG on 19 December 1996 .