title: [Efficacy and safety of potassium clavulanate/amoxicillin (CLAVAMOX) dry syrup in children with otitis media].
abstract: To evaluate the efficacy and safety of CLAVAMOX dry syrup (potassium clavulanate/amoxicillin) in children with otitis media, we conducted a postmarketing surveillance from February to September 2006. The analysis was made on the basis of 470 survey sheets collected from 127 medical institutions, of which we investigated 455 cases for safety, and 433 cases for efficacy. The efficacy was 95.2% in the 433 subjects eligible for the efficacy analysis. The clinical improvement rates for major symptoms (otalgia, otorrhea, flare reaction of drum membrane and fever) were 95% or more. The efficacies for the three major offending bacteria of otitis media (Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis) were between 94.6% and 100%. The efficacies for penicillin-resistant Streptococcus pneumoniae (PRSP) and penicillin intermediate resistant Streptococcus pneumoniae (PISP) were 95% or more. Adverse drug reactions (ADRs) were reported in 106 (23.3%) of the 455 subjects eligible for safety analysis. The major ADRs were diarrhea, of which incident was 22.6% (103 of 455). These ADRs were observed at a higher rate in younger age patients. Most of the diarrhea cases were non-serious, reversible on discontinuation or continuation of the drug. No clinically important serious diarrhea cases such as pseudomembranous colitis or dehydration were observed. Our surveillance results demonstrated that CLAVAMOX dry syrup had excellent efficacy and clinically manageable safety in children with otitis media. These findings indicated that this medicine was clinically-useful in children with otitis media.
authors.affiliation: Sugita Otorhinolaryngology Clinic.
authors.forename: Rinya
authors.initials: R
authors.lastname: Sugita
authors.forename: Noboru
authors.initials: N
authors.lastname: Yamanaka
authors.forename: Fumiyo
authors.initials: F
authors.lastname: Kudo
authors.forename: Rie
authors.initials: R
authors.lastname: Ito
authors.forename: Motoji
authors.initials: M
authors.lastname: Kawai
authors.forename: Ichiro
authors.initials: I
authors.lastname: Ohwaki
authors.forename: Satoshi
authors.initials: S
authors.lastname: Asano
authors.forename: Tsutae
authors.initials: T
authors.lastname: Nagata
mesh_terms: D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage* / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D004304:Dosage Forms; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006193:Haemophilus influenzae / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D008297:Male; D001936:Moraxella catarrhalis / Q000302:isolation & purification; D010033:Otitis Media / Q000188:drug therapy* / Q000382:microbiology; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011446:Prospective Studies; D013296:Streptococcus pneumoniae / Q000302:isolation & purification
chemical_list: D004304:Dosage Forms; D019980:Amoxicillin-Potassium Clavulanate Combination