BETESIL Plaster Ref.[27917] Active ingredients: Betamethasone

Corticosteroids applied to the skin are mainly held back by the stratum corneum, and only a small part reaches the dermis where they can be absorbed. Several factors may however favour greater absorption: the location and area of the skin to be treated, the type of lesion, the treatment duration and any occlusive dressing.

In a comparative study conducted in healthy volunteers in whom 6 medicated plasters a day or an equivalent amount of cream were applied during 21 consecutive days, the levels of betamethasone (BM) measured in blood after 4 and 21 days were measurable in 11 out of 17 of the medicated plaster group and in 4 out of 10 in the cream group (LOQ= 50pg/mL). When measurable, BM blood levels in the subjects receiving the medicated plasters appeared to be slightly higher as compared to what measured in those treated with the cream. However, this difference in terms of systemic exposure had no impact on the HPA-axis function, since both the cortisol 24-h profile and the cortisol increase following ACTH stimulation test, evaluated in these same subjects, were not modified after 4 or 21 days of treatment as compared to baseline.

Betamethasone valerate is mainly metabolized in the liver, where it is inactivated. It is then conjugated in the liver and kidneys with sulphate or glucuronic acid and excreted in urine.

There are no significant data from preclinical trials, which may be relevant to physicians other than those already reported in other sections of the Summary of Product Characteristics.