01罗红霉素盐酸氨溴索片英文说明书.docVIP

ROXISARA? AM Composition : Each tablet of Roxisara AM contains roxithromycin 150 mg and ambroxol hydrochloride 30mg. Description : Roxithromycin is a semisynthetic, long-acting, acid-stable macrolide antibiotic. As compared to erythromycin, it has a very similar antibacterial spectrum of action, better bioavailability by the oral route, better tissue penetration, and much longer duration of action. Chemically it is designated as Erythromycin 9-{0-[(2-methoxyethoxyl) methyl]oxime} (C41H76N2O15 = 837.0). Ambroxol is an active metabolite of bromhexine and has similar but somewhat longer-lasting mucolytic action. Chemically ambroxol (as hydrochloride salt) is designated as trans-4-(2-Amino-3,5 dibromobenzylamino) cyclohexanol hydrochloride (C13H18Br2N2O1HCl=414.6). It has been incorporated in tablet Roxisara AM to facilitate better penetration of roxithromycin into respiratory tract fluids for superior antibacterial action. Pharmacological Actions and Their Mechanisms : Roxithromycin is highly active against Streptococcus pyogenes and S. pneumoniae, Staphylococcus aureus (methicillin-sensitive)*, Clostridia, Corynebacterium diphtheriae, Bacillus anthracis, Erysipelothrix rhusiopathy, Listeria monocytogenes, Propionibacterium acnes, and also against Neisseria gonorrhoeae, Moraxella catarrhalis, Campylobacter, Gardnerella vaginalis, Legionella pneumophilia, and Mycoplasma pneumoniae. Organisms moderately sensitive to the drug include S. viridans, N. meningitides, Haemophilus ducrei, H. Influenzae, Helicobacter pylori, Bordetella pertussis, Campylobacter jejuni, Actinomyces, Chlamydia trachomatis, Rickettsias, Treponema pallidum, Borrelia burgdorferi, and mycobacterium scrofulaceum and M. kansasi. (* Some strains may develop resistance during the course of therapy with roxithromycin). Roxithromycin binds to the 50S ribosomal subunit of susceptible bacteria and inhibits their growth and multiplication by disrupting bacterial protein synthesis. Ambroxol liquefies ten