| Skin infection
One RCT, in 35 infants with impetigo, bullous impetigo, and impetigo complicated by cellulitis aged 6 months to 12 years, compared amoxicillin-clavulanate 25 mg/kg 8 hourly daily versus cefaclor 20 mg/kg 8 hourly. Clinical cure rates were similar: amoxicillin -clavulanate 18/21 (86%) versus cefaclor 18/20 (90%). Nine 9 (43%) of 21 on amoxicillin -clavulanate versus 1 (5%) of 20 taking cefaclor experienced an adverse reaction (diarrhoea in 9 and vomiting and diarrhoea in one).[17] In another controlled clinical trial 200 infants, 10 months to 12 years ago with skin and soft tissue infections (impetigo, ecthyma, folliculitis, furunculosis and infected scabies), received amoxicillin-clavulanate 20mg/kg/dose 8 hourly for 10 days versus amoxicillin or erythromycin or co-trimoxazole. Mild to moderate infections were cleared by all regimens by the 2nd week, and the majority of severe infections cleared by all but co-trimoxazole. [18]
Safety
The most frequently reported adverse events in children were mild gastrointestinal disturbances (< 5%) with diarrhoea largely attributed to the clavulanate component. The incidence of diarrhoea was lower for 12 hourly than 8 hourly regimens (6.7 – 9.6% versus 10.3 – 26.7% respectively). A study on out-patient children showed an increased risk diarrhoea related to amoxicillin-clavulanate use compared with all other antibiotics combined (RR 2.43 CI 95%:1.40 – 4.21; p = 0.003) and was higher in children aged < 2 years. [19] No serious adverse events and a low total incidence of events (3.6%) were reported during post marketing surveillance of 3048 children aged ≤ 14 years with acute otitis media who received amoxicillin-clavulanate 300 – 450 mg/day in three divided doses. [19] Liver toxicity (incidence ranging from 1 to 1.7 per 10,000) is strongly related to amoxicillin-clavulanate treatment, whereas amoxicillin is marginally implicated. Rare cases of Steven–Johnson Syndrome occur with amoxicillin-clavulanate, despite a higher incidence of skin reactions related to amoxicillin. 19]
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