From the FDA Drug Label
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection Patients with a less than 10 mL/min. glomerular filtration rate should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection They should receive an additional dose both during and at the end of dialysis.
The recommended dosing of Clavulin (amoxicillin/clavulanic acid) for patients with impaired renal function on dialysis is:
- 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on the severity of the infection
- An additional dose should be given both during and at the end of dialysis 1
From the Research
For patients with impaired renal function on dialysis, Clavulin (amoxicillin/clavulanic acid) dosing should be adjusted to 250-500 mg every 24 hours, with an additional dose after each dialysis session, as supported by the most recent study 2.
Key Considerations
- The initial dose may be 500-875 mg to quickly achieve therapeutic levels.
- For hemodialysis patients specifically, administration should occur after dialysis sessions as both amoxicillin and clavulanic acid are removed during dialysis, as shown in studies 3, 4.
- Dosing frequency should be reduced because renal impairment leads to decreased clearance of both active components, particularly clavulanic acid, which can accumulate and potentially cause adverse effects such as neurotoxicity if not properly adjusted.
- The severity of renal impairment (measured by creatinine clearance) determines the exact dosing regimen.
- Patients should be monitored for signs of toxicity including nausea, vomiting, diarrhea, and neurological symptoms.
- Despite dose adjustments, Clavulin remains effective against susceptible bacteria as the antimicrobial effect depends on time above minimum inhibitory concentration rather than peak levels.
Rationale
The dosing adjustment is necessary due to the altered pharmacokinetics of amoxicillin and clavulanic acid in patients with impaired renal function, particularly those on dialysis. Studies have shown that both components are removed during dialysis, leading to decreased serum concentrations 3, 4. The most recent study 2 highlights the importance of careful consideration of antibiotic dose and frequency in critically ill patients receiving renal replacement therapy.
Monitoring and Adjustments
Patients should be closely monitored for signs of toxicity and therapeutic efficacy. Dose adjustments may be necessary based on individual patient response and renal function. The goal is to maintain therapeutic levels of amoxicillin and clavulanic acid while minimizing the risk of adverse effects.