Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: Chiesi Hellas A.E.B.E., Geroulanou sq & 1, Renou Poggi str., 17455 Alimos, Greece
Pharmacotherapeutic group: Respiratory system, other anti-asthmatics, inhalation remedies, corticosteroids
ATC code: R03BA01
CLENIL contains beclometasone 17,21-dipropionate as its active ingredient, a cortisonic derivative with potent topical anti-inflammatory and antiallergic activity on the airways mucosa. In particular, beclometasone dipropionate carries out a marked antireactive action at the bronchial level, reducing edema, hypersecretion and inhibiting the onset of brochospasm. Inhaled beclometasone dipropionate exclusively acts on the structure of the respiratory tree and, therefore, it is devoid of systemic effects and of any action inhibiting the corticoadrenal function when given at the recommended doses. Beclometasone dipropionate (BDP) is a synthetic corticosteroid, for topical use only, with a potent anti-inflammatory action, reduced mineralcorticoid activity and absence of systemic effects. In McKenzie’s cutaneous vasoconstriction test,BDP is 5000 times more active than hydrocortisone, 625 times more active than betametasone alcohol, 5 times more active than fluocinolone acetonide and 1.39 times more active than betametasone valerate.
It has an intense and long-lasting anti-inflammatory activity against the croton-oil, carrageennan, formalin, albumen and dextran edema as well as against the foreign-body induced granulomatous reaction, with an efficacy higher than the other corticosteroids.
It has no thymolytic, splenolytic or mineralcorticoid activity and with therapeutic doses, it does not inhibit the hypophysis-adrenal axis even after repeated administrations.
CLENIL is particularly used for those patients who do not obtain a satisfactory control of symptoms with the usual inhaled doses of beclometasone dipropionate.
In order to achieve a full therapeutic success, it is indispensable that patients carefully follow the instructions for use concerning the product inhalation.
Kinetic studies with labelled beclometasone dipropionate showed that after inhalation of a high dose, only 20-25% is absorbed. A part of the administered dose is swallowed and eliminated with feces. The absorbed fraction in circulation is metabolised by hepatic route to monopropionate and beclometasone alcohol, then excreted in form of inactive metabolites in bile and urine.
Acute toxicity: by oral route, in rat and mouse, LD50 values are higher than 3000mg/Kg. By nebulization, in rat and mouse, exposures to concentrations of 100mcg/l for 30 minutes are well tolerated.
Chronic toxicity: inhalation in dogs, for 27 weeks, does not cause any impairment with doses higher than the therapeutic ones.
Fetal toxicity: from studies carried out in rats and rabbits, no negative effects on reproduction have been observed.
Propellant HFA 134a did not show any toxic effect at concentrations markedly higher than those used in humans, when administered by nebulization in different animal species daily exposed to therapy for a 2-year period.
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