Efficacy of twice-daily dosing of amoxycillin/clavulanate in acute otitis media in children

Abstract

Children with acute otitis media (AOM), aged 2-12 years, were randomised to 10 days treatment with amoxycillin/clavulanate (A/C) 70/10 mg/kg/day given b.i.d. (231 patients) or to A/C 60/15 mg/kg/day given t.i.d. (232 patients). Clinical success rates at end of therapy (10-17 days) were 91.8% for the b.i.d. group and 90.5% for the t.i.d. group and at follow-up (28-42 days) were 80.1% for the b.i.d. group and 77.6% for the t.i.d. group, indicating that the b.i.d. regimen was as effective as the t.i.d. regimen. There was no statistically significant difference in incidence of adverse experiences between the two groups. The overall incidence of protocol defined diarrhoea assessed from diary booklets was low, with a lower incidence in the b.i.d. group (6.7%) than in the t.i.d. group (10.3%). Significantly more patients in the b.i.d. group (83.1%) than in the t.i.d. group (72.8%) had at least 80% compliance over a 7-10 day treatment period. A/C given twice or three-times daily was highly effective in the treatment of AOM in children. The two regimens showed equivalent clinical efficacy, both were well tolerated, and there was evidence of improved compliance with the b.i.d. regimen.

Development of a twice daily dosing regimen of amoxicillin/clavulanate

“…Clinical success rates from four comparative paediatric trials [8, [12][13][14] (Table 2) show the clinical equivalence between the BD (7:1) and corresponding TID (4:1) dosages. Tolerability was improved by reducing the number of doses per day.…”

Acute otitis media-diagnosis and treatment in the era of antibiotic resistant organisms: Updated clinical practice guidelines

“…Amoxicillinclavulanate at an amoxicillin dose of 45 mg/kg/ day was efficacious in AOM caused by H. influenzae and/or S.pneumoniae, both in achieving bacteriological eradication and also in hastening signs and symptoms of AOM [39][40][41]. In a recent multinational study evaluating the bacteriological and clinical efficacy of high dose oral amoxicillin-clavulanate (90 mg/kg/day amoxicillin) in 521 infants and children with AOM, 98% and 94% of all S. pneumoniae and H. influenzae, respectively, were eradicated while the clinical signs of acute inflammation were completely resolved or improved at end of therapy in 89% of the patients with bacteriologically documented AOM [42].…”

“…Amoxicillin clavulanate (Augmentin) is a combination antibiotic containing amoxicillin and clavulanate potassium, a ß lactamase inhibitor which extends the spectrum of amoxicillin against ß-lactamase producing bacteria [39][40][41][42]. Amoxicillinclavulanate at an amoxicillin dose of 45 mg/kg/ day was efficacious in AOM caused by H. influenzae and/or S.pneumoniae, both in achieving bacteriological eradication and also in hastening signs and symptoms of AOM [39][40][41].…”

Uveitis and JRA

“…[3][4] Practitioners may extrapolate and use bid regimens for other infections including pneumonia even though data on the treatment of pneumonia with bid dosing are limited. 2 (See also AAP Grand Rounds, 2003;9: 5-6.)…”

“…2,3 The aggressor in over 80% of these acts of violence is the music video's main character. Since then, children, adolescents and adults have been bombarded by music videos which often contain graphic sexual behavior, substance abuse and violence.…”