CORTIVAL

What it is

CORTIVAL is available in three strengths: cream containing 0.2 mg/g of betamethasone (as betamethasone valerate), cream containing 0.5 mg/g of betamethasone (as betamethasone valerate), and ointment containing 0.5 mg/g of betamethasone (as betamethasone valerate). Betamethasone valerate is a synthetic, fluorinated corticosteroid ester. Topical corticosteroids have anti-inflammatory, anti-pruritic and vasoconstrictive actions.

Approved indications

— Eczema including atopic, infantile, stasis and discoid eczemas — Besnier's (flexural) prurigo — Otitis externa — Neurodermatoses including lichen simplex and lichen planus — Seborrheic dermatitis, contact sensitivity reactions and allergies

Dosing overview

A small quantity should be applied to the affected area once or twice daily until improvement occurs. The 0.2 mg/g strength may be applied up to four times daily. If necessary, cover the area with a dry dressing.

Key safety warnings

Long-term continuous topical therapy should be avoided where possible, particularly in children, as adrenal suppression can occur even without occlusion. When extensive areas are treated, sufficient systemic absorption may occur to produce the features of hypercorticism, an effect more likely to result if occlusive dressings are used or if treatment is prolonged. Rarely, local atrophy or striae may occur after prolonged treatment, with the face more likely to exhibit atrophic changes after prolonged treatment with potent topical corticosteroids, which must be borne in mind when treating conditions such as severe eczema and seborrheic dermatitis. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result. Visual disturbance may be reported with topical corticosteroid use, and patients presenting with symptoms such as blurred vision 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. In children, the risk of systemic absorption and systemic toxicity is greater due to a larger skin surface area to body weight ratio, chronic topical corticosteroid therapy may interfere with growth and development, and HPA suppression, Cushing's syndrome and intracranial hypertension have been reported.

Contraindications

CORTIVAL is contraindicated in patients with hypersensitivity to the preparation, rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, viral infections of the skin such as herpes simplex and chickenpox, gravitational ulcers, and tuberculosis of the skin. Use is not indicated in the treatment of primarily infected skin lesions caused by infections with fungi or bacteria or dermatoses in children under one year of age, including dermatitis and napkin eruptions.

Regulatory history

CORTIVAL 1/5 cream (0.2 mg/g betamethasone as valerate) was first listed on the ARTG on 9 January 2003. CORTIVAL 1/2 cream and ointment (0.5 mg/g betamethasone as valerate) were both first listed on the ARTG on 9 January 2003.