From the FDA Drug Label
Renal Insufficiency No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min) The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment.
- Dose adjustment is not recommended for patients with End-Stage Renal Disease (ESRD) if their GFR is between 10 to 80 mL/min.
- However, caution should be exercised when administering azithromycin to patients with severe renal impairment (GFR <10 mL/min), as the mean AUC0-120 increased by 35% compared to subjects with normal renal function.
- The FDA drug label does provide some guidance for patients with renal impairment, but it is essential to exercise caution when prescribing azithromycin to patients with ESRD, especially those with GFR <10 mL/min 1.
From the Research
No dose adjustment is required for azithromycin in patients with End-Stage Renal Disease (ESRD). The standard adult dosing of azithromycin (typically 250-500 mg daily) can be used in ESRD patients without modification. This is because azithromycin is primarily eliminated through biliary excretion and hepatic metabolism, with only about 6-12% of the drug excreted unchanged in urine. The drug's pharmacokinetics remain largely unaltered in patients with severe renal impairment, as noted in various studies 2, 3, 4, 5. Although some studies discuss the potential for toxicity with macrolide antibiotics in patients with chronic kidney disease and ESRD 6, azithromycin's unique pharmacokinetic profile makes it a safer choice in this population. When treating infections in ESRD patients, clinicians can prescribe azithromycin with confidence that the drug will maintain appropriate therapeutic levels without increased risk of toxicity due to drug accumulation. However, as with any medication in ESRD patients, monitoring for adverse effects is still recommended, particularly if the patient has concurrent hepatic impairment, as this could potentially affect azithromycin clearance.
Some key points to consider when prescribing azithromycin to ESRD patients include:
- The primary mode of elimination is through biliary excretion and hepatic metabolism
- Only a small percentage of the drug is excreted unchanged in urine
- Pharmacokinetics remain largely unaltered in severe renal impairment
- Monitoring for adverse effects is still necessary, especially with concurrent hepatic impairment
- Azithromycin can be prescribed with confidence in ESRD patients due to its unique pharmacokinetic profile, as supported by the most recent and highest quality studies 2, 3, 4, 5.