Pediatric Dosing for Amoxicillin-Clavulanate (Clavulin)
For pediatric patients, the recommended dose of amoxicillin-clavulanate (Clavulin) is 90 mg/kg/day of the amoxicillin component divided into 2 doses for most respiratory tract infections, with a maximum of 4000 mg/day. 1
Standard Dosing Regimens
- For children with uncomplicated infections, a standard dose of 45 mg/kg/day of amoxicillin with 6.4 mg/kg/day of clavulanic acid divided into 3 doses can be used 1
- For more severe infections or in areas with high prevalence of resistant pathogens, the high-dose regimen is preferred 1
- For children less than 12 weeks (3 months) old, the recommended upper dose is 30 mg/kg/day divided every 12 hours due to incompletely developed renal function 2
High-Dose Regimen
- High-dose amoxicillin-clavulanate is defined as 90 mg/kg/day of amoxicillin with 6.4 mg/kg/day of clavulanic acid in two divided doses 1
- This high-dose formulation provides a 14:1 ratio of amoxicillin to clavulanic acid in oral suspension 1, 3
- High-dose therapy is particularly recommended for areas with high prevalence of penicillin-resistant Streptococcus pneumoniae (>10%) 1
Specific Indications
- For presumed bacterial pneumonia in outpatient children under 5 years old: amoxicillin-clavulanate with amoxicillin component at 90 mg/kg/day in 2 doses 4
- For non-severe childhood pneumonia where amoxicillin has failed: high-dose amoxicillin-clavulanate (80-90 mg/kg/day amoxicillin component) for 5 days 5
- For β-lactamase producing H. influenzae infections: amoxicillin-clavulanate at 45 mg/kg/day in 3 doses or 90 mg/kg/day in 2 doses 1
Duration of Therapy
- The Infectious Diseases Society of America recommends treatment courses of 10 days for most pediatric infections 1
- For pneumonia, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic 2
- For infections caused by Streptococcus pyogenes, at least 10 days of treatment is recommended to prevent acute rheumatic fever 2
Administration Guidelines
- To minimize gastrointestinal intolerance, amoxicillin-clavulanate should be taken at the start of a meal 2
- Once or twice daily dosing has been shown to be as effective as three times daily dosing, which may improve compliance 6
- Oral suspension should be shaken well before using and can be administered directly or mixed with formula, milk, fruit juice, water, or cold drinks 2
Dosage Adjustments for Special Populations
- For patients with renal impairment (GFR 10-30 mL/min): 500 mg or 250 mg every 12 hours, depending on infection severity 2
- For severe renal impairment (GFR <10 mL/min): 500 mg or 250 mg every 24 hours 2
- For patients on hemodialysis: administer an additional dose both during and at the end of dialysis 2
Common Adverse Effects
- The most frequent adverse events in children are mild gastrointestinal disturbances, particularly diarrhea 1, 7
- Diarrhea is generally less frequent with twice-daily than with three-times-daily treatment 7
- The high-dose formulation has shown similar tolerability to conventional twice-daily formulation in clinical trials 7
Remember that the specific dose should be based on the severity of infection, local resistance patterns, and patient factors. The high-dose formulation was specifically developed to address concerns about increasing resistance among common respiratory pathogens.