NIMBEX- cisatracurium besylate injection
Abbott Laboratories
This drug should be administered only by adequately trained individuals familiar with its actions, characteristics, and hazards.
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
DESCRIPTION
NIMBEX (cisatracurium besylate) is a nondepolarizing skeletal muscle relaxant for intravenous administration. Compared to other neuromuscular blocking agents, it is intermediate in its onset and duration of action. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R -[1?,2?(1'R *,2'R *)]]-2,2?-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C53 H72 N2 O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65 H82 N2 O18 S2 and the molecular weight is 1243.50. he log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25�C.
NIMBEX Injection is a sterile, non-pyrogenic aqueous solution provided in 5 mL, 10 mL, and 20 mL vials. The pH is adjusted to 3.25 to 3.65 with benzenesulfonic acid. The 5 mL and 10 mL vials each contain cisatracurium besylate, equivalent to 2 mg/mL cisatracurium. The 20 mL vial, intended for ICU use only , contains cisatracurium besylate, equivalent to 10 mg/mL cisatracurium. The 10 mL vial, intended for multiple-dose use, contains 0.9% benzyl alcohol as a preservative. The 5 mL and 20 mL vials are single-use vials and do not contain benzyl alcohol.
Cisatracurium besylate slowly loses potency with time at a rate of approximately 5% per year under refrigeration (5�C). NIMBEX should be refrigerated at 2� to 8�C (36� to 46�F) in the carton to preserve potency. The rate of loss in potency increases to approximately 5% per month at 25�C (77�F). Upon removal from refrigeration to room temperature storage conditions (25�C/77�F), use NIMBEX within 21 days, even if rerefrigerated.
CLINICAL PHARMACOLOGY
NIMBEX binds competitively to cholinergic receptors on the motor end-plate to antagonize the action of acetylcholine, resulting in block of neuromuscular transmission. This action is antagonized by acetylcholinesterase inhibitors such as neostigmine.
