Dermovate Scalp Application

Clobetasol propionate 0.05 % ^w/w

Scalp application

Psoriasis and recalcitrant eczemas of the scalp.

Clobetasol propionate is a highly active topical corticosteroid which is indicated for use in short courses for conditions which do not respond satisfactorily to less active steroids.

Route of administration: Topical, on the scalp.

Apply sparingly to the scalp night and morning until improvement occurs. As with other highly active topical steroid preparations, therapy should be discontinued when control is achieved. Repeated short courses of Dermovate Scalp Application may be used to control exacerbations. If continuous steroid treatment is necessary, a less potent preparation should be used.

These recommendations apply to both children and adults, including the elderly.

Infections of the scalp.

Hypersensitivity to the preparation.

Dermatoses in children under one year of age, including dermatitis.

Care must be taken to keep the preparation away from the eyes. Do not use near a naked flame.

Long-term continuous topical therapy should be avoided, particularly in infants and children, as adrenal suppression can occur readily even without occlusion.

Development of secondary infection requires withdrawal of topical corticosteroid therapy and commencement of appropriate systemic antimicrobial therapy.

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.

The least potent corticosteroid which will control the disease should be selected. The viscosity of the scalp application has been adjusted so that the preparation spreads easily without being too fluid. The specially designed bottle and nozzle allow easy application direct to the scalp through the hair.

None known.

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development, including cleft palate and intrauterine growth retardation. The relevance of this finding to human beings has not been established; therefore, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods.

The safe use of clobetasol propionate during lactation has not been established.

None known.

The following adverse reactions have been identified during post-approval use of clobetasol propionate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The frequency of these adverse events has therefore been classified as “unknown”.

Immune system disorders

Hypersensitivity

Local hypersensitivity reactions such as erythema, rash, pruritus, urticaria and allergic contact dermatitis may occur at the site of application and may resemble symptoms of the condition under treatment.

If signs of hypersensitivity appear, application should be stopped immediately.

Endocrine disorders

Features of Cushing's syndrome

As with other topical corticosteroids, prolonged use of large amounts, or treatment of extensive areas can result in sufficient systemic absorption to produce the features of Cushing's syndrome. This effect is more likely to occur in infants and children, and if occlusive dressings are used.

Skin and subcutaneous tissue disorders

Local skin burning, local atrophy, pustular psoriasis.

Local atrophy may occur after prolonged treatment.

Treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the disease.

Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercortisolism may appear and in this situation topical steroids should be reduced or discontinued gradually, under medical supervision.

Clobetasol propionate is a highly active corticosteroid with topical anti-inflammatory activity. The major effect of clobetasol propionate on skin is a non-specific anti-inflammatory response partially due to vasoconstriction and decrease in collagen synthesis.

Percutaneous penetration of clobetasol propionate varies among individuals and can be increased by the use of occlusive dressings, or when the skin is inflamed or diseased.

Following percutaneous absorption of clobetasol propionate the drug follows the metabolic pathway of systemically administered corticosteroids, i.e. metabolised primarily by the liver and then excreted by the kidneys. However, systemic metabolism of clobetasol has never been fully characterised or quantified.

There are no preclinical data of relevance to the prescriber which are additional to that in other sections of the SmPC.

Carbomer

Isopropyl Alcohol

Sodium Hydroxide

Purified Water

None known.

24 months

None.

White opaque low density polyethylene squeeze bottle with a polyethylene nozzle and either a polystyrene or high density polyethylene cap

or

White High Density Polyethylene (HDPE) Hostalen GF4750 and Remafin white CEG 020 container with a polyethylene nozzle and either a polystyrene or polyethylene cap.

Pack size: 25ml, 30ml, 100ml.

Patients should be advised to wash their hands after applying Dermovate Scalp Application.

For detailed instructions for use refer to the Patient Information Leaflet in every pack.

Do not use near a naked flame.

Glaxo Wellcome UK Ltd

trading as

Glaxo Laboratories and/or GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

PL 10949/0046

10 November 1999

27 November 2007