Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
Ciclesonide
Takeda Pharmaceuticals Australia Pty Ltd
Medicine Registered
_ALVESCO_ _ PI _ _V3 _ _ _ _ _ _ _ _ Page 1 of 14 _ ALVESCO ® PRODUCT INFORMATION NAME OF THE MEDICINE _Active:_ Ciclesonide _Molecular formula: _C 32 H 44 O 7 _Chemical Name:_ [11β,16α(R)]-16,17-[(Cyclohexylmethylene)bis(oxy)]-11-hydroxy-21- (2-methyl-1-oxopropoxy)pregna-1,4-diene-3,20-dione _CAS Reg No:_ 126544-47-76 DESCRIPTION Ciclesonide (pure R-epimer) belongs to a new class of on-site activated non-halogenated inhaled glucocorticosteroids. Ciclesonide is an ester pro-drug with approximately 100-fold lower affinity for the glucocorticoid receptor than its active metabolite (M1; 21-des-isobutyryl- ciclesonide) and budesonide and fluticasone. Endogenous activation occurs primarily via esterases located in the lung, to give M1. The drug is dissolved in a non-halogenated solution and delivered via a pressurised metered dose inhaler (MDI), resulting in an extra fine aerosol. The main particle fraction ranges from 1.1 microns to 2.1 microns, which ensures high lung deposition (> 50% of the ex actuator dose), and less deposition in the oropharynx than marketed suspension formulations of other inhaled corticosteroids. O O O O O H O O H 1 2 3 4 5 6 7 8 9 10 19 11 12 13 18 14 15 16 17 20 21 22 23 24 25 26 27 28 29 31 32 30 _ALVESCO_ _ PI _ _V3 _ _ _ _ _ _ _ _ Page 2 of 14 _ _ _ _Excipients:_ Ethanol, norflurane (HFA-134a) a propellant, which does not contain chlorofluorocarbons (CFCs). PHARMACOLOGY _ _ PHARMACODYNAMICS: Bronchial inflammation is known to be an important component in the pathogenesis of asthma. Inflammation occu Belgenin tamamını okuyun