Safety and tolerability of a new formulation (90 mg/kg/day divided every 12 h) of amoxicillin/clavulanate (Augmentin®) in the empiric treatment of pediatric acute otitis media caused by drug-resistant Streptococcus pneumoniae

Bottenfield, Gerald; Burch, Daniel J.; Hedrick, James; Schaten, Robin; Rowinski, Carolyn; Davies, J.

doi:10.1097/00006454-199810000-00041

Cited by 36 publications

(11 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…68 The study reported a failure rate of 31% for high-dose therapy and 32% for the standard dosage at the end of therapy (power of 3%). The recurrence rate at days 22 to 28 was 16% for the high-dose therapy and 21% for the standard therapy (power of 19%).…”

Section: High-dose Versus Standard-dose Amoxicillinmentioning

confidence: 97%

Evidence Assessment of Management of Acute Otitis Media: I. The Role of Antibiotics in Treatment of Uncomplicated Acute Otitis Media

et al. 2001

View full text Add to dashboard Cite

show abstract

Section: High-dose Versus Standard-dose Amoxicillinmentioning

confidence: 97%

Evidence Assessment of Management of Acute Otitis Media: I. The Role of Antibiotics in Treatment of Uncomplicated Acute Otitis Media

et al. 2001

View full text Add to dashboard Cite

show abstract

“…In studies performed over the years, the differences in the rates of diarrhea between children receiving various formulations of A/C and children receiving placebo have for the most part been greater than the differences between children receiving amoxicillin alone and children receiving placebo. In two previous studies in children with AOM treated with A/C, reductions in the total daily dose of clavulanate and in the frequency of dosing resulted in reductions in the rate of diarrhea (5,15). In a review and meta-analysis of 25 randomized placebo-controlled trials involving adults and children of various ages and with various indications, some of whom were treated with amoxicillin alone and others with A/C, diarrhea was attributable mainly to administration of amoxicillinclavulanate, whereas candidiasis was attributable both to administration of amoxicillin alone and to administration of A/C.…”

Section: Discussionmentioning

confidence: 98%

Reduced-Concentration Clavulanate for Young Children with Acute Otitis Media

Hoberman

Paradise

Rockette

et al. 2017

Antimicrob Agents Chemother

View full text Add to dashboard Cite

Amoxicillin-clavulanate (A/C) is currently the most effective oral antimicrobial in treating children with acute otitis media (AOM), but the standard dosage of 90 mg amoxicillin/6.4 mg clavulanate/kg of body weight/day commonly causes diarrhea. We examined whether an A/C formulation containing lower concentrations of clavulanate would result in less diarrhea while maintaining plasma levels of amoxicillin and clavulanate adequate to eradicate middle-ear pathogens and to achieve clinical success. We conducted an open-label study in children with AOM who were 6 to 23 months of age. In phase 1, we treated 40 children with a reduced-clavulanate A/C formulation providing 90 mg amoxicillin/3.2 mg clavulanate/kg/day for 10 days. In phase 2, we treated 72 children with the same formulation at a dosage of 80 mg amoxicillin/2.85 mg clavulanate/kg/day for 10 days. We compared the rates of protocoldefined diarrhea (PDD), diaper dermatitis, and AOM clinical response in these children with rates we had reported in children who received the standard A/C regimen, and we obtained plasma levels of amoxicillin and clavulanate at various time points. Outcomes in phase 1 children and in children who had received the standard regimen did not differ significantly. Rates of PDD in children receiving phase 2 and standard regimens were 17% and 26%, respectively (P ϭ 0.10). The corresponding rates of diaper dermatitis were 21% and 33% (P ϭ 0.04) and of AOM treatment failure were 12% and 16% (P ϭ 0.44). Symptomatic responses did not differ significantly between regimens; both gave clavulanate levels sufficient to inhibit ␤-lactamase activity. In young children with AOM, clavulanate dosages lower than those currently used may be associated with fewer side effects without reducing clinical efficacy. (This study has been registered at ClinicalTrials.gov under registration no. NCT02630992.) KEYWORDS acute otitis media, amoxicillin-clavulanate, antimicrobial treatment N ext to the common cold, acute otitis media (AOM) is the most frequently diagnosed illness in children in the United States (1) and the most commonly cited indication for antimicrobial treatment (2). Findings of two recent placebo-controlled trials support routine antimicrobial treatment of AOM in very young children. In those trials, affected children under 3 years of age who received antimicrobial treatment for 7 or 10 days experienced more-favorable outcomes than those who received placebo (3, 4). In both studies, amoxicillin-clavulanate was used as the active treatment-albeit in different dosing regimens-because it had been previously shown to have the highest rates of eradication of AOM pathogens, with high resultant rates of clinical cure. The efficacy of A/C is attributable in part to inactivation, by the clavulanate

show abstract

“…13 In addition, the only clinical trial comparing standard dose with high dose amoxicillin/clavulanate in which only clinical endpoints and no tympanocentesis were used showed no difference in efficacy between the 2 dosing regimens. 14 The sample size of this study was underpowered to allow definitive conclusions. If PCV7 significantly increases the proportion of H. influenzae pathogens recovered in AOM as observed in recent studies, 6 -8 our data support the theory that cefdinir should be effective.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Five-Day Cefdinir Treatment with Ten-Day Low Dose Amoxicillin/Clavulanate Treatment for Acute Otitis Media

Block¹,

Busman²,

Paris³

et al. 2004

Pediatric Infectious Disease Journal

View full text Add to dashboard Cite

show abstract

Safety and tolerability of a new formulation (90 mg/kg/day divided every 12 h) of amoxicillin/clavulanate (Augmentin®) in the empiric treatment of pediatric acute otitis media caused by drug-resistant Streptococcus pneumoniae

Cited by 36 publications

References 9 publications

Evidence Assessment of Management of Acute Otitis Media: I. The Role of Antibiotics in Treatment of Uncomplicated Acute Otitis Media

Evidence Assessment of Management of Acute Otitis Media: I. The Role of Antibiotics in Treatment of Uncomplicated Acute Otitis Media

Reduced-Concentration Clavulanate for Young Children with Acute Otitis Media

Comparison of Five-Day Cefdinir Treatment with Ten-Day Low Dose Amoxicillin/Clavulanate Treatment for Acute Otitis Media

Contact Info

Product

Resources

About