Topical steroids (potent corticosteroids).

Betamethasone Valerate BP 0.122% w/w Clioquinol BP 3.00% w/w

Aqueous Cream

Betamethasone valerate is an active topical corticosteroid which produces a rapid response in those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy, and is often effective in the less responsive conditions such as psoriasis. Clioquinol is an anti-infective agent which has both antibacterial and anticandidal activity. Betnovate-C preparations are indicated for the treatment of the following conditions where secondary bacterial and/or fungal infection is present, suspected, or likely to occur: eczema in children and adults, including atopic and discoid eczemas, prurigo nodularis; psoriasis (excluding widespread plaque psoriasis); neurodermatoses; seborrhoeic dermatitis; contact sensitivity reactions and discoid lupus erythematosus. Betnovate-C can also be used in the management of secondary infected insect bites and anal and genital intertrigo. Betnovate-C cream is often appropriate for moist or weeping surfaces and Betnovate-C ointment for dry, lichenified or scaly lesions, but this is not invariably so.

A small quantity should be applied gently to the affected area two or three times daily until improvement occurs. It may then be possible to maintain improvement by applying once a day, or even less often.

Courses should be limited to five days if possible. Occlusion should not be used.

For topical application.

Rosacea, acne vulgaris and perioral dermatitis. Primary cutaneous viral infections (e.g. herpes simplex, chickenpox). Hypersensitivity to any component of the preparation or to iodine.

Use of Betnovate-C skin preparations is not indicated in the treatment of primary infected skin lesions caused by infection with fungi (e.g. candidiasis, tinea); or bacteria (e.g. impetigo); primary or secondary infections due to yeast; perianal or genital pruritus dermatoses in children under 1 years of age, including dermatitis and napkin eruptions.

Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression, with or without clinical features of Cushing's syndrome, can occur even without occlusion. In this situation, topical steroids should be discontinued gradually under medical supervision because of the risk of adrenal insufficiency.

The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema with Betnovate. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result.

If used in childhood, or on the face, courses should be limited to five days and occlusion should not be used.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important.

If infection persists, systemic chemotherapy is required. Any spread of infection requires withdrawal of topical corticosteroid therapy. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be cleansed before a fresh dressing is applied.

Do not continue for more than 7 days in the absence of clinical improvement, since occult extension of infection may occur due to the masking effect of the steroid.

Betnovate-C may stain hair, skin or fabric, and the application should be covered with a dressing to protect clothing.

Products which contain antimicrobial agents should not be diluted.

The least potent corticosteroid which will control the disease should be selected. These preparations do not contain lanolin or parabens.

There is a theoretical risk of neurotoxicity from the topical application of clioquinol, particularly when Betnovate-C is used for prolonged periods or under occlusion.

Prolonged and intensive treatment with highly active corticosteroid preparations may cause local atrophic changes in the skin such as thinning, striae, and dilatation of the superficial blood vessels, particularly when occlusive dressings are used or when skin folds are involved.

As with other topical corticosteroids, prolonged use of large amounts or treatment of extensive areas can result in sufficient systemic absorption to produce suppression of the HPA axis and the clinical features of Cushing's syndrome. These effects are more likely to occur in infants and children, and if occlusive dressings are used. In infants the napkin may act as an occlusive dressing.

In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the disease.

There are reports of local skin burning, pruritus, pigmentation changes, allergic contact dermatitis and hypertrichosis with topical steroids.

The Betnovate preparations are usually well tolerated, but if signs of hypersensitivity appear, application should be stopped immediately.

Exacerbation of symptoms may occur.

GlaxoSmithKline UK

(POM)

09 April 2009