From the FDA Drug Label
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875 mg/125 mg dose Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection Hemodialysis patients should receive 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.
Yes, Augmentin (amoxicillin-clavulanate) requires renal adjustment in patients with impaired renal function, specifically those with a glomerular filtration rate of less than 30 mL/min 1. The dose and frequency of administration should be adjusted based on the severity of the renal impairment and the severity of the infection.
From the Research
Yes, Augmentin (amoxicillin-clavulanate) requires dose adjustment in patients with renal impairment. The most recent and highest quality study, 2, published in 2020, emphasizes the importance of dose adjustment for antibiotics, including Augmentin, in patients with chronic kidney disease to prevent adverse effects and ensure efficacy.
Key Considerations
- For adults with mild renal impairment (creatinine clearance 30-60 mL/min), the standard dose can be used.
- For moderate impairment (creatinine clearance 10-30 mL/min), the dose should be reduced to 250-500 mg every 12 hours.
- In severe renal impairment (creatinine clearance <10 mL/min), the dose should be further reduced to 250-500 mg every 24 hours.
- Hemodialysis patients should receive doses after dialysis sessions.
Rationale
These adjustments are necessary because both amoxicillin and clavulanic acid are primarily eliminated by the kidneys. Without proper adjustment, these components can accumulate in patients with decreased renal function, potentially leading to toxicity. The clavulanic acid component particularly requires careful adjustment as it has a narrower therapeutic window.
Clinical Practice
Always calculate the patient's creatinine clearance before prescribing Augmentin to determine the appropriate dosing regimen, as recommended by 2 and supported by the principles outlined in 3 regarding the impact of a renal drug dosing service on improving dose adjustment in hospitalized patients with chronic kidney disease. Although 4, 5, and 6 provide valuable insights into the pharmacokinetics and clinical use of antibiotics in renal impairment, the most recent guidance from 2 should be prioritized for clinical decision-making.