Vol.53 No.5 May 2005
Drug use investigation of azithromycin
Medical Affairs, Pfizer Inc., 3-22-7 Yoyogi, Shibuya-ku, Tokyo, Japan
Abstract
We conducted a drug use investigation of azithromycin -Zithromac® Tablets 250 mg, Zithromac® Fine Granules for Pediatric Use, and Zithromac® Capsules for Pediatric Use 100 mg- for 3 years from 2000. We collected reports on 4,622 cases from 278 medical institutions nationwide and evaluated safety and efficacy of azithromycin in 3,745 cases subject to safety analysis and 3,126 cases subject to efficacy analysis.
The incidence of adverse reactions was 2.40% (90/3,745). Major adverse reactions included 30 cases of diarrhea, 15 of vomiting, 11 of increased alanine aminotransferase (ALT), 7 of increased aspartate aminotransferase (AST), and 6 of nausea.
Efficacy by to indication was 82.0% (418/510) for adult dermatological infection, 82.0% (858/1,046) for adult respiratory tract infection, 80.0% (92/115) for adult sinusitis, 89.4% (320/358) for adult dental/oral infection, 80.8% (813/1,006) for pediatric respiratory tract infection, and 69.2% (63/91) for pediatric otitis media.
Compliance by dosage form -patients who took the drug following the instruction provided- was 97.5% (2,312/2,372) for tablets, 93.5% (1,128/1,206) for fine granules, and 97.1% (133/137) for capsules.
Results were favorable for safety, efficacy, and compliance.
Key word
azithromycin, compliance, post Marketing surveillance
Received
February 24, 2005
Accepted
March 17, 2005
Jpn. J. Chemother. 53 (5): 313-325, 2005
