Dermal Laboratories Limited

BETACAP™ SCALP APPLICATION 0.1% w/w CUTANEOUS SOLUTION

Betamethasone (as valerate) 0.1% w/w.

Cutaneous solution.

Transparent, slightly gelled emollient scalp application.

For the topical treatment of steroid-responsive dermatoses of the scalp, such as psoriasis and seborrhoeic dermatitis.

For adults, including the elderly, and children over the age of one year, Betacap Scalp Application should be applied sparingly to the scalp night and morning until improvement is noticeable. It may then be possible to sustain improvement by applying once a day, or less frequently.

For the treatment of seborrhoeic dermatitis in children, the product should not be used for longer than 7 days.

Not to be used where there is bacterial, fungal or viral infection of the scalp. Not to be used in cases of sensitivity to any of the ingredients. Not to be used in children under the age of one year.

Keep away from the eyes. Betacap is highly flammable. Do not use near a fire or naked flame. Allow the treated scalp to dry naturally. Continuous long-term treatment should be avoided where possible, particularly in infants and children, as adrenal suppression can occur even without occlusion. Complications sometimes associated with the use of topical corticosteroids in psoriasis include the possibility of 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. Development of secondary infection requires withdrawal of topical corticosteroid therapy and commencement of appropriate systemic antimicrobial therapy. For external use only.

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 intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.

None known.

Betamethasone valerate preparations are usually well tolerated, but if signs of hypersensitivity appear, application should be stopped immediately. 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 hypercorticism and suppression of the HPA axis. These effects are more likely to occur in infants and children, and if occlusive dressings are used. Local atrophy may occur after prolonged treatment, particularly under occlusion.

In rare instances, 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 hypercorticism may appear and in this situation treatment with Betacap Scalp Application should be discontinued.

Betamethasone (as valerate) is a well-established example of a corticosteroid which is used in dermatological therapy in pharmacological doses for its anti-inflammatory and immuno-suppressive glucocorticoid properties. It suppresses the clinical manifestations of a wide range of inflammatory dermatoses and is frequently used at the concentration of 0.1% (as valerate).

Betacap Scalp Application comprises a slightly thickened evaporative alcoholic solution. It includes a coconut-oil related emollient ingredient to reduce the drying effect that a standard alcoholic vehicle may otherwise have on the scalp. The vehicle also contains isopropyl alcohol, which has antiseptic activity. The viscosity of the preparation has been adjusted so that it spreads easily to allow drug availability over the affected area, but is, however, viscous enough to avoid spreading onto uninvolved skin. The squeeze bottle and nozzle also allow easy application direct to the scalp through the hair.

After rapidly drying, the drug substance is deposited uniformly in a micronised crystalline form for efficient absorption into the skin. The lipid characteristics of the drug substance ensure that these micro-fine crystals rapidly dissolve in skin lipids to enhance molecular diffusion through the outer epidermal tissue and to enhance permeation into the deeper layers where it reverses the pathological processes responsible for the inflammatory dermatosis.

No relevant information additional to that contained elsewhere in this SPC.

Macrogol 7 Glycerol Cocoate; Isopropyl Alcohol; Carbopol; Sodium Hydroxide; Purified Water.

None known.

36 months.

Do not store above 25°C. Keep in original container.

100 ml plastic squeeze bottle with integral nozzle applicator and tamper-evident replaceable cap.

No special requirements.

Dermal Laboratories Limited

Tatmore Place, Gosmore

Hitchin, HertsSG4 7QR, UK

PA 278/19/1.

11 October 2008.

November 2008.