Stability of Cefepime in Icodextrin Peritoneal Dialysis Solution

Abstract

BACKGROUND 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. OBJECTIVE To determine the chemical stability of cefepime in icodextrin PD solution over a 7-day period. METHODS 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 °C), 3 at room temperature (20 °C), and 3 at body temperature (37 °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. RESULTS 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. CONCLUSIONS 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.