Atracurium besylate is available as a 10-mg/mL aqueous solution in 5-mL single-dose vials (preservative-free) and 10-mL multiple-dose vials with benzyl alcohol 0.9% as a preservative.3927 The pH is adjusted with benzenesulfonic acid.3927
pH
From 3 to 3.65.3927
Atracurium besylate is administered undiluted by direct intravenous injection or by intravenous infusion following dilution in a compatible infusion solution (e.g., dextrose 5%, sodium chloride 0.9%, dextrose 5% in sodium chloride 0.9%) to a concentration of 0.2 or 0.5 mg/mL.3927 It must not be given by intramuscular injection.3927
Do not administer in the same syringe or through the same needle as an alkaline solution.3927
Intact vials of atracurium besylate should be stored at 2 to 8°C in the original carton and protected from light and freezing.3927 Potency losses of approximately 6% per year occur under refrigeration.3927 The estimated t90 at 5°C is approximately 18 months.859 At 25°C, the rate of potency loss is stated to increase to about 5% per month.3927 It is recommended that vials that have been removed from refrigeration be used within 14 days, even if re-refrigerated.3927 However, other research indicates that atracurium besylate injection in intact containers may be stable even longer at room temperature. Intact containers were found to retain 92% of the concentration after 3 months at 20°C.777
Diluted solutions for infusion may be stored refrigerated or at room temperature and should be used within 24 hours of preparation.3927 Unused solutions should be discarded.3927
pH Effects
Maximum stability in aqueous solution was observed at about pH 2.5.859
Atracurium besylate, which has an acid pH, should not be mixed with alkaline solutions such as barbiturates.3927 The atracurium besylate may be inactivated and precipitation of a free acid may occur, depending on the resultant pH.3927
Syringes
Atracurium besylate (Burroughs Wellcome) 10 mg/mL was repackaged as 10 mL of solution in 12-mL plastic syringes (Monoject) and stored at 5, 25, and 40°C. The samples remained visually clear throughout the study. No loss occurred in the refrigerated samples and about 4% loss occurred in the room temperature samples after 42 days of storage. At 40°C, 15% was lost in 21 days. Exposure of atracurium to elevated temperatures should be avoided.2141
Atracurium 10 mg/mL repackaged in polypropylene syringes exhibited little change in concentration after 4 weeks of storage at room temperature when not exposed to direct light.2164
For a list of references cited in the text of this monograph, search the monograph titled References.