Cisatracurium

Cisatracurium besylate injection binds competitively to cholinergic receptors on the motor end-plate to antagonize the action of acetylcholine, resulting in blockade of neuromuscular transmission.

• 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. 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 (1) 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 (1) for mechanical ventilation in the ICU in adults (1) Limitations of Use: Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.

• 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 infants because the formulation contains benzyl alcohol [ see Warnings and Precautions (5.2) and Use in Specific Populations (8.4) ].contraindicated

Store cisatracurium besylate injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product (2.1) Administer intravenously only by or under the supervision of experienced clinicians familiar with drug’s actions and possible complications (2.1) Use only if personnel and facilities for resuscitation and life support, and a cisatracurium besylate injection antagonist are immediately available (2.1) 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 (2.1) 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 (2.2, 2.3, 2.4, 2.5) o Continuous infusion rates (2.6) o Preparation instructions (2.7) o Drug compatibility (2.8) 2.1 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 (5.5)] .

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. (4, 5.4) Risk of Death due to Medication Errors : Accidental administration can cause death. (5.5) Inadequate Anesthesia : Use cisatracurium besylate injection in the presence of appropriate sedation or general anesthesia and monitor patients to ensure level of anesthesia is adequate. (5.6) 5.1 Residual Paralysis Cisatracurium besylate injection has been associated with residual paralysis. Patients with neuromuscular diseases (e.g., myasthenia gravis and myasthenic syndrome) and carcinomatosis may be at higher risk of residual paralysis; thus, a lower maximum initial bolus is recommended in these patients [see Dosage and Administration (2.2) and Use in Specific Populations (8.10)]. To prevent complications resulting from cisatracurium besylate injection-associated residual paralysis, extubation is recommended only after the patient has recovered sufficiently from neuromuscular blockade.

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. Adverse Reactions in Clinical Trials of Cisatracurium Besylate Injection in Surgical Patients The data presented below are based on studies involving 945 surgical patients who received cisatracurium besylate injection in conjunction with other drugs in US and European clinical studies in a variety of procedures [see Clinical Studies (14.1)]. Table 3 displays adverse reactions that occurred at a rate of less than 1%. Table 3. Adverse Reactions in Clinical Trials of Cisatracurium Besylate Injection in Surgical Patients Adverse Reaction Incidence Bradycardia 0.4% Hypotension 0.2% Flushing 0.2% Bronchospasm 0.2% Rash 0.1% Adverse Reactions in Clinical Trials of Cisatracurium Besylate Injection in Intensive Care Unit Patients The adverse reactions presented below were from studies involving 68 adult ICU patients who received cisatracurium besylate injection in conjunction with other drugs in US and European clinical studies [see Clinical Studies (14.3)]. One patient experienced bronchospasm.

Patients with Hemiparesis or Paraparesis : Perform neuromuscular monitoring on non-paretic limb. (8.9) 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. However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol containing drugs [see Contraindications (4), Warnings and Precautions (5.2), and Use in Specific Populations (8.4)] . There are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies conducted in rats administered cisatracurium besylate during organogenesis (Gestational Day 6 to 15) found no evidence of fetal harm at 0.8 times (ventilated rats) the exposure from a human starting IV bolus dose of 0.2 mg/kg ( see Data ). The estimated background risk for major birth defects and miscarriage in the indicated population is unknown.

Metabolism

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.

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. Cholinesterase inhibitors should not be administered when complete neuromuscular blockade is evident or suspected because the reversal of paralysis may not be sufficient to maintain a patent airway and support an appropriate level of spontaneous ventilation. Neostigmine: Administration of 0.04 to 0.07 mg/kg of neostigmine at approximately 10% recovery from neuromuscular blockade (range: 0 to 15%) produced 95% recovery of the muscle twitch response and a T 4 :T 1 ratio ≥ 70% in an average of 9 to 10 minutes. The times from 25% recovery of the muscle twitch response to a T 4 :T 1 ratio ≥ 70% following these doses of neostigmine averaged 7 minutes.

• Feb 3, 2012ANDAANDA200154Sandoz Inc
• Feb 3, 2012ANDAANDA200159Sandoz Inc
• Feb 26, 2015ANDAANDA203183Fresenius Kabi Usa
• Feb 26, 2015ANDAANDA203182Fresenius Kabi Usa
• Mar 30, 2018ANDAANDA203236Hospira
• Mar 30, 2018ANDAANDA203238Hospira
• Feb 20, 2019ANDAANDA206791Somerset Theraps Llc
• Apr 24, 2019ANDAANDA209132Somerset

1. 1Off Label Use1587.3%
2. 2Hypotension1486.9%
3. 3Anaphylactic Shock1225.7%
4. 4Drug Interaction1165.4%
5. 5Anaesthetic Complication Neurological1155.3%
6. 6Anaphylactic Reaction1145.3%
7. 7Drug Ineffective1145.3%
8. 8Rhabdomyolysis843.9%
9. 9Cardiac Arrest823.8%
10. 10Acute Kidney Injury743.4%
11. 11Drug Reaction With Eosinophilia And Systemic Symptoms723.3%
12. 12Hypoxia693.2%
13. 13Tachycardia683.2%
14. 14Bradycardia663.1%
15. 15Respiratory Failure612.8%

The 10 most recently updated of 154 ClinicalTrials.gov registrations naming Cisatracurium as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Intubation Conditions During ERCP With Lidocaine Aerosol Plus Low-dose Cisatracurium or Conventional-dose Cisatracurium
  Completed · Phase 4 · Interventional · 186 enrolled · Jiangang Song
  NCT07185074updated 2026-05-28
• Safety and Efficacy of HRS-9190 Compared to Cisatracurium for Continuous Intravenous Infusion in Adults
  Recruiting · Phase 2 · Interventional · 60 enrolled · Jiangsu HengRui Medicine Co., Ltd.
  NCT07446309updated 2026-04-27
• Comparative Study Between Different Additives to Lidocaine 2٪ for Peribulbar Block in Vitreoretinal Surgery
  Not yet recruiting · Interventional · 90 enrolled · Sohag University
  NCT07519694updated 2026-04-09
• Propofol Versus Sevoflurane Anesthesia on the Intraocular Pressure and Hemodynamics in Patient Undergoing Cyclophotocoagulation
  Not yet recruiting · Interventional · 40 enrolled · Sohag University
  NCT07445672updated 2026-03-27
• Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease
  Recruiting · Phase 4 · Interventional · 490 enrolled · The University of Texas Medical Branch, Galveston
  NCT07203287updated 2026-02-23
• Continuous Versus 1-min Oscillometric Arterial BP Monitoring
  Completed · Interventional · 258 enrolled · Seoul National University Hospital
  NCT05792436updated 2026-01-30
• Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation
  Not yet recruiting · Interventional · 60 enrolled · Jianxing He
  NCT07377123updated 2026-01-29
• Partial Neuromuscular Blockade in Acute Hypoxemic Respiratory Failure
  Recruiting · Interventional · 23 enrolled · University Health Network, Toronto
  NCT04524585updated 2026-01-06
• Differences in Speed of Recovery From Anesthesia for Intraoral Surgery
  Recruiting · Interventional · 42 enrolled · Clinical Hospital Centre Zagreb
  NCT06275087updated 2025-12-24
• Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19
  Completed · Interventional · 40 enrolled · Assiut University
  NCT04922814updated 2025-12-24

Frequently asked questions

How does Cisatracurium work?

Cisatracurium besylate injection binds competitively to cholinergic receptors on the motor end-plate to antagonize the action of acetylcholine, resulting in blockade of neuromuscular transmission.

What is Cisatracurium used for?

According to FDA labeling, Cisatracurium carries indications including: 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. 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 (1) 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 (1) for mechanical ventilation in the ICU in adults (1) Limitations of Use: Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Cisatracurium?

Cisatracurium is classified as Other quaternary ammonium compounds, Nondepolarizing Neuromuscular Blocker, Cholinergic Neuromuscular Nicotinic Antagonists, Competitive Cholinergic Nicotinic Antagonists, Decreased Striated Muscle Contraction, Neuromuscular Nondepolarizing Blockade.

What are the brand names for Cisatracurium?

Cisatracurium is marketed under brand names including Nimbex.

What are the contraindications for Cisatracurium?

Cisatracurium labeling lists contraindications including: 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 infants because the formulation contains benzyl alcohol [ see Warnings and Precautions (5.2) and Use in Specific Populations (8.4) ].. Always consult the full prescribing information and a clinician.