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 Limitations of Use Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. …

• 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 See the Full Prescribing Information for: o Dosage and administration instructions
• In adults, pediatric patients, geriatric patients, patients with neuromuscular disease, burns, end-stage renal disease, and patients undergoing coronary artery bypass graft surgery with induced hypothermia o Continuous infusion rates o Preparation instructions o Drug compatibility Important Dosage and Administration Instructions Risk of Medication Errors Accidental administration of neuromuscular blocking agents may be fatal
• Store cisatracurium besylate injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product [see Warnings and Precautions ] . …

Cisatracurium besylate injection, USP is available as a clear colorless to slightly yellow or greenish-yellow color solution in the following strengths: • 10 mg of cisatracurium per 5 mL (2 mg/mL) in single-dose vials (equivalent to 2.68 mg/mL cisatracurium besylate). …

• The safety and effectiveness of cisatracurium besylate injection as an adjunct to general anesthesia to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery
• In pediatric patients 1 month through 12 years of age were established from three studies
• In pediatric patients [ see Dosing and Administration and Clinical Studies ]
• The three open-label studies are summarized below
• The safety and effectiveness of cisatracurium besylate injection have not been established
• In pediatric patients less than 1 month of age. …

Of the total number of subjects (135) in clinical studies of cisatracurium besylate injection, 57, 63, and 15 subjects were 65-70 years old, 70-80 years old, and greater than 80 years old, respectively. The geriatric population included a subset of patients with significant cardiovascular disease [ see Clinical Pharmacology (12.3) ]. …

• Hypersensitivity Reactions Including Anaphylaxis Advise the caregiver and/or family that severe hypersensitivity reactions have occurred with cisatracurium besylate injection [ see Warnings and Precautions ]
• Manufactured by: Gland Pharma Limited Hyderabad - 502307, India Revised Date: April 2025

• 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 ]
• 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 [ see Warnings and Precautions and Use …

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, 7.1) Phenytoin and Carbamazepine: May shorten duration of neuromuscular blockade. Use peripheral nerve stimulator and monitor clinical signs of neuromuscular blockade. …

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 : Severe hypersensitivity reactions including anaphylactic reactions have been reported. Consider cross- reactivity among neuromuscular blocking agents, both depolarizing and non-depolarizing. …

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 not reflect the rates observed in practice. …

8.1 Pregnancy Risk Summary The 10 mL cisatracurium besylate injection multiple-dose vials contain the preservative benzyl alcohol. Therefore, if cisatracurium besylate injection is needed during pregnancy, consider using a benzyl alcohol-free formulation (i.e., 5 mL and 20 mL cisatracurium besylate injection single-dose vials). Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. …

Overdosage with neuromuscular blocking agents may result in neuromuscular blockade beyond the time needed for surgery and anesthesia. The primary treatment is maintenance of a patent airway and controlled ventilation until recovery of normal neuromuscular function is assured. Once recovery from neuromuscular block begins, further recovery may be facilitated by administration of a cholinesterase inhibitor (e.g., neostigmine, edrophonium) in conjunction with an appropriate cholinergic inhibitor. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.