Stability of Cefepime Hydrochloride Injection and Metronidazole in Polyvinyl Chloride Bags at 4° and 22°–24° C

Abstract

Cefepime hydrochloride injection 2 g (Maxipime) was mixed with metronidazole injection USP (Flagyl IV ready-to-use, 500 mg/100 mL) and metronidazole hydrochloride IV (Flagyl HCI IV, 500 mg) reconstituted with 0.9% sodium chloride injection USP and/or 5% dextrose injection USP to yield cefepime concentrations of 2, 1, 0.5, and 0.25 g and 500 mg metronidazole per 100 mL of solution. The mixtures were stored in polyvinyl chloride bags up to 168 hours at 4°C and at 22°–24°C. Cefepime and metronidazole mixtures in metronidazole injection USP were stable up to 168 hours and 96–168 hours, respectively, stored in PVC bags at 4°C. The 2.5 mg/mL cefepime and 5.0 mg/mL metronidazole mixtures were stable up to 8 and 72 hours, respectively. Identical mixtures stored at 22°–24°C were stable up to 8–48 and 12–24 hours for cefepime and metronidazole, respectively. Cefepime and metronidazole mixtures in metronidazole HCl IV reconstituted with 0.9% sodium chloride injection USP were stable for 24–168 hours, respectively, stored in PVC bags at 4°C. Identical mixtures of cefepime and metronidazole stored at 22°–24°C were stable for 8–24 and 24–168 hours, respectively. Cefepime and metronidazole mixtures in metronidazole HCl IV reconstituted with 5% dextrose injection USP were stable for 8–48 and 81–68 hours, respectively, stored in PVC bags at 4°C. Identical mixtures of cefepime and metronidazole at 22°–24°C were stable for 8–12 and 168 hours, respectively. In general, cefepime and metronidazole controls were more stable than the mixtures.