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CISATRACURIUM BESYLATE (cisatracurium besylate) Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CISATRACURIUM BESYLATE INJECTION safely and effectively. See full prescribing information for CISATRACURIUM BESYLATE INJECTION.

CISATRACURIUM BESYLATE injection, for intravenous use
Initial U.S. Approval: 1995

RECENT MAJOR CHANGES

Dosage and Administration (2.7)10/2019

INDICATIONS AND USAGE

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. (1)

DOSAGE AND ADMINISTRATION

  • 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:
    • 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)
    • Continuous infusion rates. (2.6)
    • Preparation instructions. (2.7)
    • Drug compatibility. (2.8)

DOSAGE FORMS AND STRENGTHS

Injection:

  • 10 mg/5 mL (2 mg/mL) in single-dose vials. (3)
  • 20 mg/10 mL (2 mg/mL) and benzyl alcohol as a preservative in multiple-dose vials. (3)
  • 200 mg/20 mL (10 mg/mL) in single-dose vials. (3)

CONTRAINDICATIONS

  • Known hypersensitivity to cisatracurium (4)
  • 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. (4)

WARNINGS AND PRECAUTIONS

  • 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 in the presence of appropriate sedation or general anesthesia and monitor patients to ensure level of anesthesia is adequate. (5.6)

ADVERSE REACTIONS

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 Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Succinylcholine: May decrease time to onset of maximum neuromuscular blockade. (7.1)
  • 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. (5.8, 7.1)
  • Phenytoin and Carbamazepine: May shorten duration of neuromuscular blockade. Use peripheral nerve stimulator and monitor clinical signs of neuromuscular blockade. (5.9, 7.1)

USE IN SPECIFIC POPULATIONS

Patients with Hemiparesis or Paraparesis: Perform neuromuscular monitoring on non-paretic limb. (8.9)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 2/2020

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