Can Augmentin (amoxicillin-clavulanate) be used in a patient with end-stage renal disease (ESRD) on dialysis with a diabetic foot ulcer?

From the Guidelines

Augmentin (amoxicillin-clavulanate) can be used in patients with end-stage renal disease (ESRD) on dialysis with a diabetic foot ulcer, but the dosage must be adjusted based on kidney function. For patients on dialysis, a typical adjusted dose would be 250-500 mg every 24 hours after dialysis, with the exact dose determined by the severity of the infection and the patient's residual kidney function 1. The medication should be administered after the dialysis session to prevent removal of the drug during treatment. Augmentin is effective against many bacteria commonly found in diabetic foot infections, including both gram-positive and gram-negative organisms, as well as some anaerobes. The clavulanic acid component helps overcome resistance by inhibiting beta-lactamase enzymes that would otherwise break down the amoxicillin.

Key Considerations

• The treatment should be part of a comprehensive approach that includes proper wound care, debridement if necessary, blood sugar control, and possibly vascular assessment 1.
• Patients should be monitored for side effects such as diarrhea, nausea, and allergic reactions.
• If the infection appears severe or is not responding to treatment, hospitalization and intravenous antibiotics may be necessary.
• The selection of an empiric antibiotic regimen should be based on the severity of the infection and the likely etiologic agent(s), and should be modified later on the basis of availability of additional clinical and microbiological information 1.

Adjusting Dosage

The dosage of Augmentin should be adjusted based on the patient's kidney function, with a typical adjusted dose of 250-500 mg every 24 hours after dialysis. The exact dose should be determined by the severity of the infection and the patient's residual kidney function.

Comprehensive Approach

A comprehensive approach to managing diabetic foot infections is crucial, and should include:

• Proper wound care
• Debridement if necessary
• Blood sugar control
• Possibly vascular assessment
• Monitoring for side effects such as diarrhea, nausea, and allergic reactions
• Consideration of hospitalization and intravenous antibiotics if the infection appears severe or is not responding to treatment.

From the FDA Drug Label

High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin and clavulanate potassium Amoxicillin and clavulanate potassium may be removed from circulation by hemodialysis. [see DOSAGE AND ADMINISTRATION (2.3)]

Use in ESRD patients on dialysis:

• Augmentin (amoxicillin-clavulanate) can be used in patients with end-stage renal disease (ESRD) on dialysis, but with caution.
• The drug label indicates that high blood levels may occur in patients with impaired renal function, and that the drug may be removed by hemodialysis.
• However, there is no direct information on the use of Augmentin in patients with diabetic foot ulcers and ESRD on dialysis.
• Given the potential for high blood levels and the need for dose adjustment, it is recommended to exercise caution and consider dose adjustments as per the DOSAGE AND ADMINISTRATION section of the label 2.

From the Research

Augmentin Use in ESRD Patients with Diabetic Foot Ulcers

• There is no direct evidence from the provided studies that specifically addresses the use of Augmentin (amoxicillin-clavulanate) in patients with end-stage renal disease (ESRD) on dialysis with a diabetic foot ulcer.
• However, a study on diabetic foot infections compared the efficacy of ertapenem versus piperacillin/tazobactam, and patients in this study could be given oral amoxicillin/clavulanic acid after initial intravenous antibiotic treatment 3.
• The management of ESRD patients, including those with diabetic foot ulcers, requires consideration of their specific medical requirements, such as renal replacement therapy and the risk of sepsis 4.
• ESRD patients are at a higher risk of sepsis, and empiric treatment should include both Gram-positive and Gram-negative cover, and methicillin-resistant Staphylococcus aureus cover if the patient has a dialysis catheter 4.
• The epidemiology of ESKD and its management, including the importance of renal replacement therapy and the high rates of cardiovascular-related death, are relevant considerations for ESRD patients with diabetic foot ulcers 5.
• Diabetic kidney disease (DKD) is a chronic complication of diabetes mellitus that may eventually lead to ESKD, and its pathophysiology is complex and multifactorial 6.
• Platelet dysfunction is a common issue in ESRD patients, which can increase the risk of bleeding, and should be considered when managing patients with diabetic foot ulcers 7.