Cisatracurium Besylate

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 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 (
  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 ]

  .

  Important Administration Instructions

  • Cisatracurium besylate injection is for intravenous use only.
  • Administer cisatracurium besylate injection in carefully adjusted dosage by or under the supervision of experienced clinicians who are familiar with the drug's actions and the possible complications.
  • Use cisatracurium besylate injection only if the following are immediately available: personnel and facilities for resuscitation and life support (tracheal intubation, artificial ventilation, oxygen therapy); and an antagonist of cisatracurium besylate injection
    [see Overdosage ]
    .
  • The dosage information which follows is intended to serve as an initial guide for individual patients; base subsequent cisatracurium besylate injection dosage on the patients' responses to the initial doses.
  • Use a peripheral nerve stimulator to:
    • Determine the adequacy of neuromuscular blockade (e.g., need for additional cisatracurium besylate injection doses, reduction of the infusion rate).
    • Minimize risk of overdosage or underdosage.
    • Assess the extent of recovery from neuromuscular blockade (e.g., spontaneous recovery or recovery after administration of a reversal agent, e.g., neostigmine).
    • Appropriately titrate doses to potentially limit exposure to toxic metabolites.
    • Facilitate more rapid reversal of the cisatracurium besylate injection-induced paralysis.
  )
• Use only if personnel and facilities for resuscitation and life support, and a cisatracurium besylate injection antagonist are immediately available (
  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 ]

  .

  Important Administration Instructions

  • Cisatracurium besylate injection is for intravenous use only.
  • Administer cisatracurium besylate injection in carefully adjusted dosage by or under the supervision of experienced clinicians who are familiar with the drug's actions and the possible complications.
  • Use cisatracurium besylate injection only if the following are immediately available: personnel and facilities for resuscitation and life support (tracheal intubation, artificial ventilation, oxygen therapy); and an antagonist of cisatracurium besylate injection
    [see Overdosage ]
    .
  • The dosage information which follows is intended to serve as an initial guide for individual patients; base subsequent cisatracurium besylate injection dosage on the patients' responses to the initial doses.
  • Use a peripheral nerve stimulator to:
    • Determine the adequacy of neuromuscular blockade (e.g., need for additional cisatracurium besylate injection doses, reduction of the infusion rate).
    • Minimize risk of overdosage or underdosage.
    • Assess the extent of recovery from neuromuscular blockade (e.g., spontaneous recovery or recovery after administration of a reversal agent, e.g., neostigmine).
    • Appropriately titrate doses to potentially limit exposure to toxic metabolites.
    • Facilitate more rapid reversal of the cisatracurium besylate injection-induced paralysis.
  )
• 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 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 ]

  .

  Important Administration Instructions

  • Cisatracurium besylate injection is for intravenous use only.
  • Administer cisatracurium besylate injection in carefully adjusted dosage by or under the supervision of experienced clinicians who are familiar with the drug's actions and the possible complications.
  • Use cisatracurium besylate injection only if the following are immediately available: personnel and facilities for resuscitation and life support (tracheal intubation, artificial ventilation, oxygen therapy); and an antagonist of cisatracurium besylate injection
    [see Overdosage ]
    .
  • The dosage information which follows is intended to serve as an initial guide for individual patients; base subsequent cisatracurium besylate injection dosage on the patients' responses to the initial doses.
  • Use a peripheral nerve stimulator to:
    • Determine the adequacy of neuromuscular blockade (e.g., need for additional cisatracurium besylate injection doses, reduction of the infusion rate).
    • Minimize risk of overdosage or underdosage.
    • Assess the extent of recovery from neuromuscular blockade (e.g., spontaneous recovery or recovery after administration of a reversal agent, e.g., neostigmine).
    • Appropriately titrate doses to potentially limit exposure to toxic metabolites.
    • Facilitate more rapid reversal of the cisatracurium besylate injection-induced paralysis.
  )
• 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 Recommended Cisatracurium Besylate Injection Dose for Performing Tracheal Intubation

    Tracheal Intubation in Adults

    Prior to selecting the initial cisatracurium besylate injection bolus dose, consider the desired time to tracheal intubation and the anticipated length of surgery, factors affecting time to onset of complete neuromuscular block such as age and renal function, and factors that may influence intubation conditions such as the presence of co-induction agents (e.g., fentanyl and midazolam) and the depth of anesthesia.

    In conjunction with a propofol/nitrous oxide/oxygen induction-intubation technique or a thiopental/nitrous oxide/oxygen induction-intubation technique, the recommended starting weight-based dose of cisatracurium besylate injection is between 0.15 mg/kg and 0.2 mg/kg administered by bolus intravenous injection. Doses up to 0.4 mg/kg have been safely administered by bolus intravenous injection to healthy patients and patients with serious cardiovascular disease

    [see Clinical Pharmacology ]

    .

    Patients with Neuromuscular Disease

    The maximum recommended initial bolus dose of cisatracurium besylate injection is 0.02 mg/kg in patients with neuromuscular diseases (e.g., myasthenia gravis and myasthenic syndrome and carcinomatosis)

    [see Warnings and Precautions ]

    .

    Geriatric Patients and Patients with End-Stage Renal Disease

    Because the time to maximum neuromuscular blockade is approximately 1 minute slower in geriatric patients compared to younger patients (and in patients with end-stage renal disease than in patients with normal renal function), consider extending the interval between administering cisatracurium besylate injection and attempting intubation by at least 1 minute to achieve adequate intubation conditions in geriatric patients and patients with end-stage renal disease. A peripheral nerve stimulator should be used to determine the adequacy of muscle relaxation for the purposes of intubation and the timing and amounts of subsequent doses

    [see Use in Specific Populations and Clinical Pharmacology ]

    .

    Tracheal Intubation in Pediatric Patients

    Infants 1 to 23 Months of Age

    The recommended dose of cisatracurium besylate injection for intubation of pediatric patients ages 1 month to 23 months is 0.15 mg/kg administered over 5 to 10 seconds. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.15 mg/kg of cisatracurium besylate injection produced maximum neuromuscular blockade in about 2 minutes (range: 1.3 to 4.3 minutes) with a clinically effective block (time to 25% recovery) for about 43 minutes (range: 34 to 58 minutes)

    [see Clinical Studies ]

    .

    Pediatric Patients 2 to 12 Years of Age

    The recommended weight-based bolus dose of cisatracurium besylate injection for pediatric patients 2 to 12 years of age is 0.1 to 0.15 mg/kg administered over 5 to 10 seconds. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.1 mg/kg cisatracurium besylate injection produced maximum neuromuscular blockade in an average of 2.8 minutes (range: 1.8 to 6.7 minutes) with a clinically effective block (time to 25% recovery) for 28 minutes (range: 21 to 38 minutes). When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.15 mg/kg cisatracurium besylate injection produced maximum neuromuscular blockade in an average of about 3 minutes (range: 1.5 to 8 minutes) with a clinically effective block for 36 minutes (range: 29 to 46 minutes)

    [see Clinical Studies ]

    .
    ,
    2.3 Recommended Maintenance Bolus Cisatracurium Besylate Injection Doses in Adult Surgical Procedures

    Determine if maintenance bolus doses are needed based on clinical criteria including the response to peripheral nerve stimulation. The recommended maintenance bolus dose of cisatracurium besylate injection is 0.03 mg/kg; however, smaller or larger maintenance doses may be administered based on the required duration of action. Administer the first maintenance bolus dose starting:

    • 40 to 50 minutes after an initial dose of cisatracurium besylate injection 0.15 mg/kg;
    • 50 to 60 minutes after an initial dose of cisatracurium besylate injection 0.2 mg/kg.

    For long surgical procedures using inhalational anesthetics administered with nitrous oxide/oxygen at the 1.25 MAC level for at least 30 minutes, consider administering less frequent maintenance bolus doses or lower maintenance bolus doses of cisatracurium besylate injection

    [see Clinical Pharmacology ]

    . No adjustment to the initial cisatracurium besylate injection maintenance bolus dose should be necessary when cisatracurium besylate injection is administered shortly after initiation of volatile agents or when used in patients receiving propofol anesthesia.
    ,
    2.4 Dosage in Burn Patients

    Burn patients have been shown to develop resistance to nondepolarizing neuromuscular blocking agents; therefore, consider increasing the cisatracurium besylate injection dosages for intubation and maintenance

    [see Use in Specific Populations ]

    .
    ,
    2.5 Dosage for Continuous Infusion

    Continuous Infusion for Surgical Procedures in Adults and Pediatric Patients

    During extended surgical procedures, cisatracurium besylate injection may be administered by continuous infusion to adults and pediatric patients aged 2 or more years if patients have spontaneous recovery after the initial cisatracurium besylate injection bolus dose. Following recovery from neuromuscular blockade, it may be necessary to re-administer a bolus dose to quickly re-establish neuromuscular blockade prior to starting the continuous infusion.

    If patients have had recovery of neuromuscular function, the recommended initial cisatracurium besylate injection infusion rate is 3 mcg/kg/minute

    [see Dosage and Administration ]

    . Subsequently reduce the rate to 1 to 2 mcg/kg/minute to maintain continuous neuromuscular blockade. Use peripheral nerve stimulation to assess the level of neuromuscular blockade and to appropriately titrate the cisatracurium besylate injection infusion rate. If no response is elicited to peripheral nerve stimulation, discontinue the infusion until a response returns.

    Consider reducing the infusion rate by up to 30% to 40% when cisatracurium besylate injection is administered during stable isoflurane anesthesia for at least 30 minutes (administered with nitrous oxide/oxygen at the 1.25 MAC level)

    [see Clinical Pharmacology ]

    . Greater reductions in the cisatracurium besylate injection infusion rate may be required with longer durations of administration of isoflurane or with the administration of other inhalational anesthetics.

    Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery

    Consider reducing the infusion rate in patients undergoing CABG with induced hypothermia to half the rate required during normothermia

    [see Clinical Pharmacology ]

    . Spontaneous recovery from neuromuscular block following discontinuation of cisatracurium besylate injection infusion is expected to proceed at a rate comparable to that following administration of a single bolus dose.

    Continuous Infusion for Mechanical Ventilation in the Intensive Care Unit in Adults

    During extended need for mechanical ventilation and skeletal muscle relaxation in the intensive care unit (ICU), cisatracurium besylate injection may be administered by continuous infusion to adults if a patient has spontaneous recovery of neuromuscular function after the initial cisatracurium besylate injection bolus dose. Following recovery from neuromuscular blockade, it may be necessary to re-administer a bolus dose to quickly re-establish neuromuscular blockade prior to starting the continuous infusion.

    The recommended cisatracurium besylate injection infusion rate in adult patients in the ICU is 3 mcg/kg/minute (range: 0.5 to 10.2 mcg/kg/minute)

    [see Dosage and Administration ]

    . Use peripheral nerve stimulation to assess the level of neuromuscular blockade and to appropriately titrate the cisatracurium besylate injection infusion rate.
    )
  • Continuous infusion rates (
    2.6 Rate Tables for Continuous Infusion

    The intravenous infusion rate depends upon the cisatracurium besylate injection concentration, the desired dose, the patient's weight, and the contribution of the infusion solution to the fluid requirements of the patient. Tables 1and 2provide guidelines for the cisatracurium besylate injection infusion rate, in mL/hour (equivalent to microdrops/minute when 60 microdrops = 1 mL), in concentrations of 0.1 mg/mL or 0.4 mg/mL, respectively.

    Table 1. Cisatracurium Besylate Injection Infusion Rates for Maintenance of Neuromuscular Blockade During Opioid/Nitrous Oxide/Oxygen Anesthesia with a Concentration of 0.1 mg/mL

    Drug Delivery Rate (mcg/kg/minute)
    	1	1.5	2	3	5
    Patient Weight	Infusion Delivery Rate (mL/hour)
    10 kg	6	9	12	18	30
    45 kg	27	41	54	81	135
    70 kg	42	63	84	126	210
    100 kg	60	90	120	180	300

    Table 2. Cisatracurium Besylate Injection Infusion Rates for Maintenance of Neuromuscular Blockade During Opioid/Nitrous Oxide/Oxygen Anesthesia with a Concentration of 0.4 mg/mL

    Drug Delivery Rate (mcg/kg/minute)
    	1	1.5	2	3	5
    Patient Weight	Infusion Delivery Rate (mL/hour)
    10 kg	1.5	2.3	3	4.5	7.5
    45 kg	6.8	10.1	13.5	20.3	33.8
    70 kg	10.5	15.8	21	31.5	52.5
    100 kg	15	22.5	30	45	75
    )
  • Preparation instructions (
    2.7 Preparation of Cisatracurium Besylate Injection

    Visually inspect cisatracurium besylate injection for particulate matter and discoloration prior to administration. If a cisatracurium besylate injection solution is cloudy or contains visible particulates, do not use cisatracurium besylate injection. Cisatracurium besylate injection is a colorless to slight yellow or greenish yellow solution.

    Discard unused portion of the 5 mL and 20 mL single-dose vials.

    Cisatracurium besylate injection may be diluted to 0.1 mg/mL in the following solutions:

    • 5% Dextrose Injection, USP
    • 0.9% Sodium Chloride Injection, USP, or
    • 5% Dextrose and 0.9% Sodium Chloride Injection, USP

    Store these diluted cisatracurium besylate injection solutions either in a refrigerator or at room temperature for 24 hours without significant loss of potency.

    Cisatracurium besylate injection also may be diluted to 0.1 mg/mL or 0.2 mg/mL in the following solution:

    • Lactated Ringer's and 5% Dextrose Injection

    Store this diluted cisatracurium besylate injection solution under refrigeration for no more than 24 hours.

    Do not dilute cisatracurium besylate injection in Lactated Ringer's Injection, USP due to chemical instability.
    )
  • Drug compatibility (
    2.8 Drug Compatibility

    Cisatracurium besylate injection is compatible and may be administered with the following solutions through Y-site administration:

    • 5% Dextrose Injection, USP
    • 0.9% Sodium Chloride Injection, USP
    • 5% Dextrose and 0.9% Sodium Chloride Injection, USP
    • Sufentanil Citrate Injection, diluted as directed
    • Alfentanil Hydrochloride Injection, diluted as directed
    • Fentanyl Citrate Injection, diluted as directed
    • Midazolam Hydrochloride Injection, diluted as directed
    • Droperidol Injection, diluted as directed

    Cisatracurium besylate injection is acidic (pH = 3.25 to 3.65) and may not be compatible with alkaline solution having a pH greater than 8.5 (e.g., barbiturate solutions). Therefore, do not administer cisatracurium besylate injection and alkaline solutions simultaneously in the same intravenous line.

    Cisatracurium Besylate Injection is not compatible with propofol injection or ketorolac injection for Y-site administration. Compatibility studies with other parenteral products have not been conducted.
    )

Cisatracurium Besylate Injection, USP is available as a colorless to slight yellow or greenish yellow solution in the following strengths:

• 10 mg of cisatracurium per 5 mL (2 mg per mL) in single-dose vials (equivalent to 2.68 mg per mL cisatracurium besylate).
• 20 mg of cisatracurium per 10 mL (2 mg per mL) in multi-dose vials (equivalent to 2.68 mg per mL cisatracurium besylate) with benzyl alcohol as a preservative.
• 200 mg of cisatracurium per 20 mL (10 mg per mL) in single-dose vials.

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

  Patients with hemiparesis or paraparesis may demonstrate resistance to nondepolarizing neuromuscular blocking agents in the affected limbs. To avoid inaccurate dosing, perform neuromuscular monitoring on a non-paretic limb.
  )

• 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 Recommended Cisatracurium Besylate Injection Dose for Performing Tracheal Intubation

  Tracheal Intubation in Adults

  Prior to selecting the initial cisatracurium besylate injection bolus dose, consider the desired time to tracheal intubation and the anticipated length of surgery, factors affecting time to onset of complete neuromuscular block such as age and renal function, and factors that may influence intubation conditions such as the presence of co-induction agents (e.g., fentanyl and midazolam) and the depth of anesthesia.

  In conjunction with a propofol/nitrous oxide/oxygen induction-intubation technique or a thiopental/nitrous oxide/oxygen induction-intubation technique, the recommended starting weight-based dose of cisatracurium besylate injection is between 0.15 mg/kg and 0.2 mg/kg administered by bolus intravenous injection. Doses up to 0.4 mg/kg have been safely administered by bolus intravenous injection to healthy patients and patients with serious cardiovascular disease

  [see Clinical Pharmacology ]

  .

  Patients with Neuromuscular Disease

  The maximum recommended initial bolus dose of cisatracurium besylate injection is 0.02 mg/kg in patients with neuromuscular diseases (e.g., myasthenia gravis and myasthenic syndrome and carcinomatosis)

  [see Warnings and Precautions ]

  .

  Geriatric Patients and Patients with End-Stage Renal Disease

  Because the time to maximum neuromuscular blockade is approximately 1 minute slower in geriatric patients compared to younger patients (and in patients with end-stage renal disease than in patients with normal renal function), consider extending the interval between administering cisatracurium besylate injection and attempting intubation by at least 1 minute to achieve adequate intubation conditions in geriatric patients and patients with end-stage renal disease. A peripheral nerve stimulator should be used to determine the adequacy of muscle relaxation for the purposes of intubation and the timing and amounts of subsequent doses

  [see Use in Specific Populations and Clinical Pharmacology ]

  .

  Tracheal Intubation in Pediatric Patients

  Infants 1 to 23 Months of Age

  The recommended dose of cisatracurium besylate injection for intubation of pediatric patients ages 1 month to 23 months is 0.15 mg/kg administered over 5 to 10 seconds. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.15 mg/kg of cisatracurium besylate injection produced maximum neuromuscular blockade in about 2 minutes (range: 1.3 to 4.3 minutes) with a clinically effective block (time to 25% recovery) for about 43 minutes (range: 34 to 58 minutes)

  [see Clinical Studies ]

  .

  Pediatric Patients 2 to 12 Years of Age

  The recommended weight-based bolus dose of cisatracurium besylate injection for pediatric patients 2 to 12 years of age is 0.1 to 0.15 mg/kg administered over 5 to 10 seconds. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.1 mg/kg cisatracurium besylate injection produced maximum neuromuscular blockade in an average of 2.8 minutes (range: 1.8 to 6.7 minutes) with a clinically effective block (time to 25% recovery) for 28 minutes (range: 21 to 38 minutes). When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.15 mg/kg cisatracurium besylate injection produced maximum neuromuscular blockade in an average of about 3 minutes (range: 1.5 to 8 minutes) with a clinically effective block for 36 minutes (range: 29 to 46 minutes)

  [see Clinical Studies ]

  .
  ,
  5.1 Residual Paralysis

  Cisatracurium besylate 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 and Use in Specific Populations ]

  . To prevent complications resulting from cisatracurium besylate-associated residual paralysis, extubation is recommended only after the patient has recovered sufficiently from neuromuscular blockade. Consider use of a reversal agent especially in cases where residual paralysis is more likely to occur

  [see Overdosage ]

  .
  )
• Benzyl Alcohol
  : Consider combined daily load of benzyl alcohol from all sources when the 10 mL multi-dose vials are used in infants (
  4 CONTRAINDICATIONS

  • Cisatracurium besylate is contraindicated in patients with known hypersensitivity to cisatracurium. Severe anaphylactic reactions to cisatracurium besylate have been reported
    [see Warnings and Precautions ]
    .
  • The use of 10 mL cisatracurium besylate multi-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 in Specific Populations ]
    .

  • Known hypersensitivity to cisatracurium
  ,
  5.2 Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative in 10 mL Multi-Dose Vials

  Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including cisatracurium besylate (10 mL multi-dose vials). This warning is not applicable to the 5 mL and 20 mL cisatracurium besylate single-dose vials because these vials do not contain benzyl alcohol. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations.

  When prescribing the 10 mL multi-dose cisatracurium besylate vials in infants consider the combined daily metabolic load of benzyl alcohol from all sources including cisatracurium besylate (multi-dose vials contain 9 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known

  [see Use in Specific Populations ]

  .

  The use of 10 mL cisatracurium besylate multi-dose vials is contraindicated in pediatric patients less than 1 month of age and low birth-weight infants because these patients are more likely to develop benzyl alcohol toxicity

  [see Contraindications ]

  .
  )
• Risk of Seizure
  : Monitor level of neuromuscular blockade during long-term administration to limit exposure to toxic metabolites (
  5.3 Risk of Seizure

  Laudanosine, an active metabolite of cisatracurium besylate, has been shown to cause seizures in animals. cisatracurium besylate-treated patients with renal or hepatic impairment may have higher metabolite concentrations (including laudanosine) than patients with normal renal and hepatic function

  [see Clinical Pharmacology ]

  . Therefore, patients with renal or hepatic impairment receiving extended administration of cisatracurium besylate may be at higher risk of seizures.

  The level of neuromuscular blockade during long-term cisatracurium besylate administration should be monitored with a nerve stimulator to titrate cisatracurium besylate administration to the patients' needs and 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. (
  4 CONTRAINDICATIONS

  • Cisatracurium besylate is contraindicated in patients with known hypersensitivity to cisatracurium. Severe anaphylactic reactions to cisatracurium besylate have been reported
    [see Warnings and Precautions ]
    .
  • The use of 10 mL cisatracurium besylate multi-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 in Specific Populations ]
    .

  • Known hypersensitivity to cisatracurium
  ,
  5.4 Hypersensitivity Reactions Including Anaphylaxis

  Severe hypersensitivity reactions, including fatal and life-threatening anaphylactic reactions, have been reported

  [see Contraindications ]

  . There have been reports of wheezing, laryngospasm, bronchospasm, rash and itching following cisatracurium besylate administration in pediatric patients. Due to the potential severity of these reactions, appropriate precautions such as the immediate availability of appropriate emergency treatment should be taken. Precautions should also be taken in those patients who have had previous anaphylactic reactions to other neuromuscular blocking agents since cross-reactivity between neuromuscular blocking agents, both depolarizing and non-depolarizing, has been reported.
  )
• Risk of Death due to Medication Errors
  : Accidental administration can cause death. (
  5.5 Risk of Death Due to Medication Errors

  Administration of cisatracurium besylate results in paralysis, which may lead to respiratory arrest and death, a progression that may be more likely to occur in a patient for whom it is not intended. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. If another healthcare provider is administering the product, ensure that the intended dose is clearly labeled and communicated.
  )
• 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 Risks Due to Inadequate Anesthesia

  Neuromuscular blockade in the conscious patient can lead to distress. Use cisatracurium besylate in the presence of appropriate sedation or general anesthesia. Monitor patients to ensure that the level of anesthesia is adequate.
  )