CISATRACURIUM BESYLATE

The neuromuscular blocking activity of cisatracurium besylate injection is due to parent drug. Cisatracurium plasma concentration-time data following IV bolus administration are best described by a two-compartment open model (with elimination from both compartments) with an elimination half-life (t ½ β) of 22 minutes, a plasma clearance (CL) of 4.57 mL/min/kg, and a volume of distribution at steady state (Vss) of 145 mL/kg. Results from population pharmacokinetic/pharmacodynamic (PK/PD) analyses...

14.1 Skeletal Muscle Relaxation for Intubation of Adult Patients The efficacy of cisatracurium besylate injection to provide skeletal muscle relaxation to facilitate tracheal intubation during surgery was established in six studies in adult patients. In all these studies patients had general anesthesia and mechanical ventilation. Cisatracurium besylate injection doses between 0.15 and 0.2 mg/kg were evaluated in 240 adults. Maximum neuromuscular blockade generally occurred in within 4 minutes for this dose range. When administered during induction using thiopental or propofol and co-induction ...

The most common adverse reactions (0.1% to 0.4%) were bradycardia, hypotension, flushing, bronchospasm, and rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 866-770-7144 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may...

Cisatracurium besylate injection is contraindicated in patients with known hypersensitivity to cisatracurium.Severe anaphylactic reactions to cisatracurium besylate injection have been reported [see Warnings and Precautions (5.4) ]. The use of 10 mL cisatracurium besylate injection multiple-dose vials is contraindicated for use in pediatric patients less than 1 month of age and low birth-weight i...

Residual Paralysis : Patients with neuromuscular diseases are at higher risk. Use a lower initial bolus dose and consider using a reversal agent in these patients. (2.2, 5.1) Benzyl Alcohol : Consider combined daily load of benzyl alcohol from all sources when the 10 mL multiple dose vials are used in infants. (4, 5.2) Risk of Seizure : Monitor level of neuromuscular blockade during long-term administration to limit exposure to toxic metabolites. (5.3) Hypersensitivity Reactions and Anaphylaxis ...

7 DRUG INTERACTIONS Succinylcholine : May decrease time to onset of maximum neuromuscular blockade. (7.1) I nhalational anesthetics, antibiotics, local anesthetics, magnesium salts, procainamide, lithium, quinidine: May potentiate or prolong neuromuscular blockade action of cisatracurium besylate injection. Use peripheral nerve stimulator and monitor clinical signs of neuromuscular blockade. (5.8,...