title: [Efficacy and tolerance of a new formulation of amoxicillin 100 mg--clavulanic acid 12.5 mg in acute otitis in infants].
abstract: A multicenter study of the new pediatric formulation of Augmentin (containing 100 mg amoxicillin and 12.5 mg clavulanic acid per ml) in acute otitis media (AOM) in patients aged three months to three years was carried out by hospital-based pediatricians. Study patients seen at the hospital outpatient clinics were given the drug in a daily dosage of 80 mg in three (83% of cases) or four (15%) divided doses for 6 to 10 days; 28% of patients were also given an antiinflammatory agent. A total of 83 patients with a mean age of 13.5 months were included (89% of patients were less than two years of age); one-third of these patients were included after failure of another antimicrobial agent (macrolide 46%, cephalosporin 23%). The AOM was bilateral in most patients (69.5%) and 46% of patients had a history of previous AOM. Temperature was elevated in 85% of cases and more than half the patients had gastrointestinal symptoms (vomiting, diarrhea) prior to initiation of the study drug. At the interim evaluation on the fourth treatment day, tympanic membranes were normal in 43.5% of cases and improved in 22% of cases. Over 92% of patients achieved resolution of their AOM by the end of the treatment period, regardless of whether or not myringostomy had been performed on Do. Among the 27 patients given the study drug as rescue therapy after failure of another antimicrobial, 24 (89%) recovered fully.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: Clinique des Maladies Infectieuses B, Centre Médico-Chirurgical Gui de Chauliac, Montpellier.
authors.forename: J
authors.initials: J
authors.lastname: Astruc
mesh_terms: D000284:Administration, Oral; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019980:Amoxicillin-Potassium Clavulanate Combination; D002626:Chemistry, Pharmaceutical; D002675:Child, Preschool; D002969:Clavulanic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006776:Hospitals, Pediatric; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D002969:Clavulanic Acids; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin
vernacular_title: Efficacité et tolérance d'une nouvelle formulation d'amoxicilline 100 mg--acide clavulanique 12,5 mg dans les otites aiguës du nourrisson.