Pharmacodynamic Properties

Alclometasone dipropionate is a non-fluorinated, topically active synthetic corticosteroid. Pharmacological studies in man and animals have demonstrated that alclometasone dipropionate suppresses local inflammation at doses producing minimal systemic effects. Preclinical studies have shown alclometasone dipropionate to be approximately â…” as potent as betamethasone valerate and 60 x as potent as hydrocortisone.

The anti-inflammatory properties of alclometasone dipropionate reduce the erythema, induration and pruritus associated with these conditions.

Alclometasone dipropionate has no effect on hypothalamic-pituitary-adrenal function, as measured by plasma cortisol levels, as demonstrated by application of large amounts of alclometasone dipropionate to healthy volunteer adults under whole body occlusion.

Pharmacokinetic Properties

Not applicable in view of topical action and application.

Preclinical Safety Data

Alclometasone dipropionate appears to be a relatively non-toxic and non-irritating drug product that produces no unusual or unexpected teratologic effects in laboratory animals. A wide margin of safety was demonstrated in all species studied. Acute oral and intraperitoneal doses more than 3,000 times the proposed topical human dose were without any toxicologically significant effects.

Topical administration of corticosteroids to pregnant animals can cause abnormalities in foetal development. The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in pregnancy i.e. in large amounts or for long periods.

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