cisatracurium (Rx)

Brand and Other Names:Nimbex
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2mg/mL (multidose vial)
  • Contains benzyl alcohol

injectable solution, preservative free

  • 2mg/mL (single-dose vial)
  • 10mg/mL (single-dose vial)

Neuromuscular Blockade

Indicated as an adjunct to general anesthesia to facilitate tracheal intubation

Also indicated for skeletal muscle relaxation during surgical procedures or mechanical ventilation in ICU settings

Initial dose

  • In conjunction with propofol or thiopental/ nitrous oxide/oxygen induction technique
  • 0.15-0.2 mg/kg IV bolus initially  
  • Doses up to 0.4 mg/kg IV bolus have been safely administered to healthy patients and patients with serious cardiovascular disease

Maintenance dose, intermittent

  • 0.03 mg/kg IV bolus; start 40-50 min (after initial dose of 0.15 mg/kg) or 50-60 min (after initial dose of 0.2 mg/kg)
  • Smaller or larger doses may be administered based on required duration of action
  • Consider less frequent or lower maintenance bolus doses for long surgical procedures using inhalational anesthetics administered with nitrous oxide/oxygen at the 1.25 MAC level for at least 30 min
  • No adjustment to initial maintenance bolus dose necessary when administered shortly after initiation of volatile agents or used in patients receiving propofol anesthesia

Maintenance dose, continuous infusion

  • Use during extended surgical procedures OR during extended need for mechanical ventilation and skeletal muscle relaxation in the ICU if spontaneous recovery occurs after initial bolus dose
  • May be necessary to readminister a bolus dose following recovery from neuromuscular blockade to re-establish neuromuscular blockade before starting infusion
  • Infuse at 3 mcg/kg/min initially; subsequently reduce rate to 1-2 mcg/kg/min to maintain neuromuscular blockade
  • Assess level of neuromuscular blockage using peripheral nerve stimulation and titrate appropriately
  • Discontinue if no response is elicited to peripheral nerve stimulation
  • Administration during isoflurane anesthesia or other inhalational anesthetics
    • Consider reducing infusion rate by up to 30-40% during stable isoflurane anesthesia for at least 30 min (administered with nitrous oxide/oxygen at the 1.25 MAC level)
    • Longer durations of administration of isoflurane or with administration of other inhalational anesthetics may require greater reductions in infusion rate

Dosage Modifications

Patients with neuromuscular disease

  • Includes myasthenia gravis, myasthenic syndrome, carcinomatosis
  • Maximum initial dose: 0.2 mg/kg IV bolus

Patients with burn injuries

  • Shown to develop resistance to nondepolarizing neuromuscular blocking agents
  • Consider increasing dosages for intubation and maintenance

Patients undergoing coronary artery bypass graft (CABG) surgery

  • Consider reducing infusion rate for continuous infusions in patients undergoing CABG with induced hypothermia to half the rate required during normothermia
  • Spontaneous recovery from neuromuscular block following discontinuation of infusion is expected proceed at a rate comparable to that following administration of a single bolus dose

Patients with hemiparesis or paraparesis

  • Patients with hemiparesis or paraparesis may demonstrate resistance to nondepolarizing muscle relaxants in affected limbs
  • To avoid inaccurate dosing, perform neuromuscular monitoring on a nonparetic limb

Renal impairment

  • End-stage renal disease
    • Consider extending interval between administration and intubation by at least 1 min to achieve adequate intubation
    • Use peripheral nerve stimulator to determine adequate muscle relaxation for intubation and timing/amount of subsequent doses

Hepatic impairment

  • End-stage liver disease undergoing liver transplantation
    • Pharmacokinetic study reported slightly larger volume of distribution and plasma concentration of cisatracurium
    • Time to maximum blockade for a 1 mg/kg-dose was ~1 min faster

Dosing Considerations

Before initiating, consider desired time of tracheal intubation, anticipated length of surgery, factor affecting onset of complete neuromuscular block (eg, age, renal function), factors that may influence intubation conditions such as presence of co-induction agents (eg, fentanyl, midazolam), and depth of anesthesia

Limitations of use

  • Not recommended for rapid sequence endotracheal intubation due to time required for its onset of action

Dosage Forms & Strengths

injectable solution

  • 2mg/mL (multidose vial)
  • Contains benzyl alcohol

injectable solution, preservative free

  • 2mg/mL (single-dose vial)
  • 10mg/mL (single-dose vial)

Tracheal Intubation

Indicated as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in children aged 1 month to 12 years

1-23 months: 0.15 mg/kg IV bolus  

2-12 years: 0.1-0.15 mg/kg IV bolus

Skeletal Muscle Relaxation During Surgery

Indicated for skeletal muscle relaxation during extended surgical procedures via IV infusion in children aged ≥2 years

Maintenance continuous infusion aged >2 years

  • Use during extended surgical procedures if spontaneous recovery occurs after initial bolus dose
  • May be necessary to readminister a bolus dose following recovery from neuromuscular blockade to re-establish neuromuscular blockade before starting infusion
  • Infuse at 3 mcg/kg/min initially; subsequently reduce rate to 1-2 mcg/kg/min to maintain neuromuscular blockade  
  • Assess level of neuromuscular blockage using peripheral nerve stimulation and titrate appropriately
  • Discontinue if no response is elicited to peripheral nerve stimulation
Administration during isoflurane anesthesia or other inhalational anesthetics
  • Consider reducing infusion rate by up to 30-40% during stable isoflurane anesthesia for at least 30 min (administered with nitrous oxide/oxygen at the 1.25 MAC level)
  • Longer durations of administration of isoflurane or with administration of other inhalational anesthetics may require greater reductions in infusion rate

Dosage Modifications

Patients with neuromuscular disease

  • Includes myasthenia gravis, myasthenic syndrome, carcinomatosis
  • Maximum initial dose: 0.2 mg/kg IV bolus

Patients with burn injuries

  • Shown to develop resistance to nondepolarizing neuromuscular blocking agents
  • Consider increasing dosages for intubation and maintenance

Renal impairment

  • End-stage renal disease
    • Consider extending interval between administration and intubation by at least 1 min to achieve adequate intubation
    • Use peripheral nerve stimulator to determine adequate muscle relaxation for intubation and timing/amount of subsequent doses

Hepatic impairment

  • End-stage liver disease undergoing liver transplantation
    • Pharmacokinetic study reported slightly larger volume of distribution and plasma concentration of cisatracurium
    • Time to maximum blockade for a 1 mg/kg-dose was ~1 min faster

Dosing Considerations

Before initiating, consider desired time of tracheal intubation, anticipated length of surgery, factor affecting onset of complete neuromuscular block (eg, age, renal function), factors that may influence intubation conditions such as presence of co-induction agents (eg, fentanyl, midazolam), and depth of anesthesia

Limitations of use

  • Not recommended for rapid sequence endotracheal intubation due to time required for its onset of action
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Interactions

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            Adverse Effects

            <1%

            Bronchospasm

            Bradycardia

            Flushing

            Pruritus

            Myositis ossificans

            Hypotension

            Rash

            Postmarketing Reports

            Anaphylaxis

            Histamine release

            Prolonged neuromuscular block

            Muscle weakness, myopathy

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            Warnings

            Contraindications

            Hypersensitivity to cisatracurium (or benzyl alcohol if 10 mL vial is used)

            Use of 10 mL vial in pediatric patients <1 month of age and low birth-weight infants (contains benzyl alcohol)

            Cautions

            Laudanosine, an active metabolite, reported to cause seizures in animals; patients with renal or hepatic impairment receiving extended therapy may be at higher risk of seizures; monitor level of neuromuscular blockade during long-term administration to limit exposure to toxic metabolites

            Severe anaphylactic reactions to neuromuscular blocking agents have been reported; some cases have been life threatening and fatal; take necessary precautions, such as the immediate availability of appropriate emergency treatment

            Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings; ensure that the intended dose is clearly labeled and communicated when another healthcare provider is administered

            Neuromuscular blockade in the conscious patient can lead to distress; use drug in presence of appropriate sedation or general anesthesia and monitor patients to ensure level of anesthesia is adequate

            The 20-mL vials contain no preservatives and are intended only for IV infusion in a single patient in the ICU; not to be used as a multidose vial for different patients because there is a higher risk of infection

            Not studied in malignancy hyperthermia (MH)-susceptible patients; MH can develop in absence of established triggering agents; prepare to recognize and treat MH in any patient undergoing general anesthesia

            Residual paralysis

            • Residual paralysis has been associated with therapy
            • Lower maximum initial bolus in patients at higher risk of residual paralysis (eg, patients with neuromuscular diseases, carcinomatosis)
            • Extubation is recommended only after patient has recovered sufficiently from neuromuscular blockade
            • Consider use of a reversal agent especially in cases where residual paralysis is more likely to occur

            Risk of serious adverse reactions in infants due to benzyl alcohol

            • Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and infants treated with benzyl alcohol-containing drugs
            • Multidose 10-mL vials contains benzyl alcohol; not applicable in single-dose 5-mL or 20-mL vials
            • “Gasping syndrome” is characterized by CNS depression, metabolic acidosis, and gasping respirations
            • Use of 10-mL vials is contraindicated in infants <1 month or have low birth-weight

            Drug interaction overview

            • Succinylcholine
              • Use of succinylcholine before cisatracurium administration may decrease onset of maximum neuromuscular blockade but has no effect on duration of neuromuscular blockade
            • Inhalational anesthetics
              • Administration of inhalational anesthetics with nitrous oxide/oxygen for >30 min to achieve 1.25 minimum alveolar concentration may prolong duration of action of initial and maintenance doses; may potentiate the neuromuscular blockade
            • Potentiation of neuromuscular blockade
              • Certain drugs may enhance neuromuscular blocking action including inhalational anesthetics, antibiotics, magnesium salts, lithium, local anesthetics, procainamide and quinidine
              • Additionally, acid-base and/or serum electrolyte abnormalities may potentiate taction of neuromuscular blocking agents
              • Use peripheral nerve stimulation; monitor clinical signs of neuromuscular blockade and adjust dose, if necessary
            • Resistance to neuromuscular blockade with certain drugs
              • Shorter durations of neuromuscular block may occur; may require higher infusion rates in patients chronically administered phenytoin or carbamazepine
              • Use peripheral nerve stimulation and monitor the clinical signs of neuromuscular blockade
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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled studies in pregnant women; animal studies conducted in rats administered cisatracurium besylate during organogenesis 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

            Labor or delivery

            • The action of neuromuscular blocking agents may be enhanced by magnesium salts administered for management of preeclampsia or eclampsia of pregnancy

            Lactation

            It is not known whether drug is present in human milk; developmental and health benefits of breastfeeding should be considered along with mother's clinical need for therapy and any potential adverse effects on breastfed child from treatment or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Non-depolarizing skeletal muscle relaxant; cholinergic receptor antagonist; a cis-isomer of atracurium

            Absorption

            Onset: 2-3 min (IV; mean for 0.15-0.2 mg/kg adult dose)

            Duration: 55-65 min

            Peak plasma time: 3-5 min

            Distribution

            Vd (steady-state): 145 mL/kg

            Metabolism

            Degradation was largely independent of liver metabolism

            Elimination

            Clearance: 4.57 mL/min/kg

            Half-life: 22 min

            Half-life of metabolites are longer in patients with renal or hepatic impairment; metabolite concentration may be higher after long-term administration

            Excretion: 95% (urine); 4% (feces)

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            Administration

            IV Incompatibilities

            Do not administer alkaline solutions have a pH >8.5 (eg, barbiturate solutions) simultaneously in same IV line

            Y-site administration

            • Ketorolac injection
            • Propofol injection

            IV Compatibilities

            • D5W
            • 0.9% NaCl
            • D5W 0.9% NaCl

            Y-site administration

            • D5W
            • 0.9% NaCl
            • D5W 0.9% NaCl
            • Sufentanil
            • Alfentanil
            • Fentanyl citrate
            • Midazolam
            • Droperidol

            IV Preparation

            Visually inspect for particulate matter and discoloration before administration; solution should appear slightly yellow or greenish-yellow solution; discard if solution appears cloudy or contains particulates

            Dilute in following solutions

            • Final concentration 0.1 mg/mL
              • D5W
              • 0.9% NaCl
              • D5W 0.9% NaCl
            Final concentration 0.1-0.2 mg/mL
            • D5W

            IV Administration

            Initial or maintenance bolus dose: Administer undiluted IV push over 5-10 sec

            Continuous infusion: Refer to prescribing information

            Storage

            Unopened vials

            • Refrigerate at 2-8ºC (36-46ºF) in carton to preserve potency; do NOT freeze
            • Protect from light
            • Upon removal from refrigeration to room temperature (25ºC/77ºF), use within 21 days, even if re-refrigerated

            Diluted solutions

            • 0.1 mg/mL concentration: Refrigerate or store at room temperature for up to 24 hr
            • 0.1-0.2 mg/mL concentration: Refrigerate for up to 24 hr
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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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