Vol.57 No.5 September 2009
A specific postmarketing study of clavulanic acid/amoxicillin (1:14) dry syrup for pediatric in pediatric patients with infection
1)Department of Pediatrics, Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, Japan
2)Department of Pediatrics, National Tokyo Medical Center
3)Post-Marketing Surveillance Department, Development and Medical Affairs Division, GlaxoSmithKline KK
Abstract
A specific postmarketing study of a combination preparation of penicillin antibiotic and β-lactamase inhibitor, clavamox® dry syrup for pediatric (clavulanic acid/amoxicillin (1:14), CVA/AMPC (1:14)), was conducted from November 2007 to October 2008 to evaluate postmarketing safety and efficacy in pediatric patients with infections of the respiratory tract, skin, and urinary tract. Subjects were 363 cases from 68 medical institutes. Safety was evaluated for 337 cases and efficacy for 308.
Adverse drug reactions (ADRs) occurred in 337 cases, or 12.8% (43/337 cases). The most frequently observed ADR was diarrhea, observed in 11.9% (40/337 cases). The diarrhea incidence tended to be higher in younger children, but symptoms were mild and were resolved or reduced during administration or after withdrawal of the drug.
Efficacy in 308 cases was 95.1% (293/308 cases). Efficacy by infection type was 95.4% for the respiratory tract (267/280 cases), 96.6% for the skin (28/29 cases), and 1/2 cases for the urinary tract. Efficacy for major causative organism of infections studied, including Streptococcus pneumoniae, Haemophilus influenzae, Streptococcus pyogenes, Staphylococcus aureus, and Moraxella catarrhalis, was 91.7-100%.
Key word
clavulanic acid/amoxicillin, postmarketing surveillance, child, safety, efficacy
Received
July 6, 2009
Accepted
July 30, 2009
Jpn. J. Chemother. 57 (5): 438-452, 2009
