BETACAP Cutaneous solution Ref.[49993] Active ingredients: Betamethasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Diomed Developments Limited, T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK

5.1. Pharmacodynamic properties

ATC code: D07AC – Corticosteroids, potent (group III)

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 complies with the specification given in the monograph for Betamethasone Valerate Scalp Application BP. Betacap Scalp Application 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.

5.2. Pharmacokinetic properties

For clinical usage, the betamethasone valerate is presented as a slightly thickened evaporative solution which allows drug availability over the affected area, whilst reducing the propensity to spread onto uninvolved skin. In addition, after rapidly drying, the drug substance is thus 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 encourage permeation into the deeper layers where it reverses the pathological processes responsible for the inflammation.

5.3. Preclinical safety data

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

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