BECLAZONE 250mg Pressurised inhalation, solution Ref.[28142] Active ingredients: Beclometasone

Source: Υπουργείο Υγείας (CY)  Revision Year: 2011  Publisher: George Petrou Ltd., 50, Areos Str, Latsia 2234, Nicosia, Cyprus

5.1. Pharmacodynamic properties

ATC Code: R03BA01

Beclometasone dipropionate anhydrous given by inhalation has a glucocorticoid anti-inflammatory action within the lungs. The exact mechanism responsible for this anti-inflammatory effect is unknown.

5.2. Pharmacokinetic properties

Beclometasone dipropionate anhydrous is readily absorbed after oral inhalation. About 25% of an inhaled dose reaches the lungs. The drug and its metabolites are excreted chiefly in the faeces via biliary elimination, and to a lesser extent in the urine.

5.3. Preclinical safety data

Preclinical studies in rats and dogs with beclometasone dipropionate anhydrous formulated in HFA-134a propellant have shown dose related typical signs of glucocorticoid excess.

Beclometasone Dipropionate Anhydrous is non-genotoxic. No evidence of carcinogenicity was observed in a 95-week study in rats.

Studies in animals with beclometasone and other corticosteroids have shown foetal abnormalities (cleft palate) and embryolethality at high doses and growth retardation and functional deficiencies (adrenal suppression, increased risk of cardiovascular disease) at lower doses.

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