caa a22 4500 397593732 CHVBK 20180308164946.0 cr unu---uuuuu 161202e199606 xx s 000 0 eng 10.1093/jac/37.suppl_C.143 doi (NATIONALLICENCE)oxford-10.1093/jac/37.suppl_C.143 Paediatric safety of azithromycin: worldwide experience [Elektronische Daten] [G. Treadway, D. Pontani] Adverse events and laboratory abnormalities were monitored over 35 days after the commencement of treatment in 45 open studies conducted in Europe, South America, Africa and Asia. These studies were to assess the clinical efficacies of azithromycin and comparator antimicrobial agents in the treatment of paediatric acute bacterial infections. Children (6 months-16 years of age) had been treated with an oral suspension of azithromycin (10 mg/kg given once daily for 3 consecutive days) or with the approved oral dosing regimen of the comparator (amoxycillin, co-amoxiclav, cefixime, cefaclor, clarithromycin, erythromycin, penicillin V, cloxacillin, or roxithromycin). Adverse events were recorded in 232/2655 (8.7%) children treated with azithromycin and in 180/1844 (9.8%) who received comparator treatment. The majority of the treatment-related adverse events were classed as being of only mild or moderate severity and were gastrointestinal: 140 (5.3%) in azithromycin- and 120 (6.5%) in comparator-treated children. Co-amoxiclav was responsible for proportionately more of such events than any other agent. Treatment was discontinued prematurely due to an adverse event in 34 (1.3%) azithromycin-and in 31 (1.7%) comparator-treated children. Incidences of clinically significant laboratory abnormalities were low and occurred with comparable frequency in both treatment groups. The present analysis confirms that azithromycin can be safely used to treat bacterial infections in children of all ages. © 1996 The British Society for Antimicrobial Chemotherapy Articles nationallicence Treadway G. International Pharmaceuticals Group, Pfizer Inc., New York, USA aut Pontani D. International Pharmaceuticals Group, Pfizer Inc., New York, USA aut Journal of Antimicrobial Chemotherapy Oxford University Press 37(1996-06), 143-149 0305-7453 37<143 1996 37 jac https://doi.org/10.1093/jac/37.suppl_C.143 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1093/jac/37.suppl_C.143 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Treadway G. International Pharmaceuticals Group, Pfizer Inc., New York, USA aut NATIONALLICENCE 700 1- Pontani D. International Pharmaceuticals Group, Pfizer Inc., New York, USA aut NATIONALLICENCE 773 0- Journal of Antimicrobial Chemotherapy Oxford University Press 37(1996-06), 143-149 0305-7453 37<143 1996 37 jac Metadata rights reserved CC BY-NC-4.0 http://creativecommons.org/licenses/by-nc/4.0 nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-oxford