From the FDA Drug Label
Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR < 30 mL/min). See PATIENTS WITH RENAL IMPAIRMENT (2.3) for specific recommendations in patients with renal impairment.
The dosage adjustments for Augmentin (amoxicillin-clavulanate) in patients with End-Stage Renal Disease (ESRD) are not explicitly stated in the provided drug labels. However, it is mentioned that dosage adjustment is usually required in patients with severe renal impairment (GFR < 30 mL/min). Key points:
- Dosage adjustment is required in severe renal impairment
- Specific recommendations can be found in PATIENTS WITH RENAL IMPAIRMENT (2.3), but this section is not provided in the given text. 1
From the Research
Augmentin (amoxicillin-clavulanate) requires dose adjustment in patients with end-stage renal disease (ESRD), with a recommended dose of 250-500 mg every 24 hours for patients with creatinine clearance less than 10 mL/min or those on hemodialysis, depending on infection severity. For peritoneal dialysis patients, 250-500 mg every 24 hours is appropriate. The dose should be administered after hemodialysis sessions on dialysis days. This adjustment is necessary because both amoxicillin and clavulanic acid are primarily eliminated by the kidneys, and reduced renal function leads to drug accumulation, increasing the risk of toxicity 2. Clavulanic acid accumulation is particularly concerning as it can cause neurological side effects.
When treating severe infections in ESRD patients, consider consulting with a nephrologist or infectious disease specialist to optimize therapy. Monitor patients closely for signs of adverse effects including gastrointestinal symptoms, rash, and neurological changes. Alternative antibiotics with less renal adjustment requirements may be considered depending on the infection being treated. The pharmacokinetics of amoxicillin and clavulanic acid in patients with ESRD have been studied, with findings indicating that dialysis clearance and total serum clearance during dialysis are significant for both drugs 3.
Key considerations in managing ESRD patients include:
- Close collaboration among primary care physicians, nephrology subspecialists, and other subspecialists 4
- Recognition and management of common issues in patients receiving dialysis or after kidney transplantation 5
- Understanding palliative care for patients with ESRD 4
- Meticulous monitoring of volume status to achieve and maintain control of blood pressure 5
- Management of sleep disorders and pruritus through optimization of metabolic parameters, adequacy of dialysis, and drugs 5
In terms of specific dosage adjustments, the most recent and highest quality study should be prioritized. However, the provided evidence does not include a recent study that directly addresses the dosage adjustment of Augmentin in ESRD patients. Therefore, the recommended dose is based on general principles of pharmacokinetics in renal impairment and expert opinion. It is essential to consult with a nephrologist or infectious disease specialist to optimize therapy in ESRD patients with severe infections.