Cisatracurium

Cisatracurium Besylate Injection is indicated: • as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age • to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU • to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older Cisatracurium Besylate Injection is a nondepolarizing neuromuscular blocker indicated: • as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age. • to provide skeletal muscle relaxation during surgery in adults and in pediatric patients 2 to 12 years of age as a bolus or infusion maintenance. • for mechanical ventilation in the ICU in adults.

Cisatracurium besylate binds competitively to cholinergic receptors on the motor end-plate to antagonize the action of acetylcholine, resulting in blockade of neuromuscular transmission. This action is antagonized by acetylcholinesterase inhibitors such as neostigmine.

Store Cisatracurium Besylate Injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product. • Administer intravenously only by or under the supervision of experienced clinicians familiar with drug's actions and possible complications. • Use only if personnel and facilities for resuscitation and life support, and a Cisatracurium Besylate Injection antagonist are immediately available. • Use a peripheral nerve stimulator to determine adequacy of blockade (e.g., need for additional doses), minimize risk of overdosage or underdosage, assess extent of recovery from blockade, potentially limit exposure to toxic metabolites through dose titration, and facilitate more rapid reversal of Cisatracurium Besylate Injection-induced paralysis.

• Cisatracurium Besylate Injection is contraindicated in patients with known hypersensitivity to cisatracurium. Severe anaphylactic reactions to Cisatracurium Besylate Injection have been reported. • 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 infants because the formulation contains benzyl alcohol. • Known hypersensitivity to cisatracurium. • 10 mL multiple-dose vials contain benzyl alcohol and are contraindicated in pediatric patients less than 1 month of age and low birth-weight infants.

• 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. • Benzyl Alcohol: Consider combined daily load of benzyl alcohol from all sources when the 10 mL multiple-dose vials are used in infants. • Risk of Seizure: Monitor level of neuromuscular blockade during long-term administration to limit exposure to toxic metabolites. • Hypersensitivity Reactions and Anaphylaxis: Severe hypersensitivity reactions including anaphylactic reactions have been reported. Consider cross-reactivity among neuromuscular blocking agents, both depolarizing and non-depolarizing. • Risk of Death due to Medication Errors: Accidental administration can cause death.

The most common adverse reactions (0.1% to 0.4%) were bradycardia, hypotension, flushing, bronchospasm, and rash.

• Succinylcholine: May decrease time to onset of maximum neuromuscular blockade. • Inhalational 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. • Phenytoin and Carbamazepine: May shorten duration of neuromuscular blockade. Use peripheral nerve stimulator and monitor clinical signs of neuromuscular blockade.

Cisatracurium Besylate Injection, USP should be refrigerated at 2°C to 8°C (36°F to 46°F) in the carton to preserve potency. DO NOT FREEZE. Upon removal from refrigeration to room temperature storage conditions (25°C/77°F), use Cisatracurium Besylate Injection, USP within 21 days, even if re-refrigerated. Protect from light.