Stability of Cefepime in Icodextrin Peritoneal Dialysis Solution

Abstract

Icodextrin is a glucose polymer used as an alternative osmotic agent in peritoneal dialysis (PD) solutions. Cefepime may be a suitable antibiotic for the treatment of PD-related peritonitis. The stability of cefepime in icodextrin PD solution has not been examined. To determine the chemical stability of cefepime in icodextrin PD solution over a 7-day period. Samples were prepared by adding cefepime HCl 1000 mg to commercially available 2.0-L bags of icodextrin 7.5% PD solution. Nine bags were prepared and stored in the following conditions: 3 under refrigeration (4 degrees C), 3 at room temperature (20 degrees C), and 3 at body temperature (37 degrees C). Study samples were drawn from each bag immediately after preparation and at predetermined intervals over the subsequent 7 days. Solutions were visually inspected for precipitation, cloudiness, or discoloration at each sampling interval. Total concentration of cefepime in dialysate fluid was determined by liquid chromatography-tandem mass spectrometry. Under refrigeration, a mean +/- SD of 95.7 +/-4.2% of the initial cefepime concentration remained at 168 hours (7 days). At room temperature, 92.0 +/- 17.9% remained at 48 hours. At body temperature, 92.2 +/- 4.7% remained at 4 hours. Beyond these respective time points, <90% of the initial cefepime concentrations remained. Pre-mixed cefepime-icodextrin PD solutions stored at room temperature were stable for up to 48 hours. However, it is recommended that these be kept refrigerated whenever possible. When refrigerated, cefepime-icodextrin solutions were found to be stable for up to 7 days. Solutions stored at body temperature were stable up to 4 hours, permitting the practice of pre-warming solutions prior to administration.