TY - JOUR
T1 - A specific postmarketing study of clavulanic acid/amoxicillin (1:14) dry syrup for pediatric in pediatric patients with infection
AU - Ouchi, Kazunobu
AU - Iwata, Satoshi
AU - Okano, Hideyuki
AU - Abe, Hiroharu
N1 - Copyright:
Copyright 2012 Elsevier B.V., All rights reserved.
PY - 2009
Y1 - 2009
N2 - 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%.
AB - 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%.
KW - Child
KW - Clavulanic acid/amoxicillin
KW - Efficacy
KW - Postmarketing surveillance
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=71049191478&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=71049191478&partnerID=8YFLogxK
M3 - Article
AN - SCOPUS:71049191478
VL - 57
SP - 438
EP - 452
JO - Japanese Journal of Chemotherapy
JF - Japanese Journal of Chemotherapy
SN - 1340-7007
IS - 5
ER -