Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous, as bromide:
Generic: 50 mg/5 mL (5 mL); 100 mg/10 mL (10 mL)
Solution, Intravenous, as bromide [preservative free]:
Generic: 50 mg/5 mL (5 mL); 100 mg/10 mL (10 mL)
Pharmacology
Mechanism of Action
Blocks acetylcholine from binding to receptors on motor endplate inhibiting depolarization
Pharmacokinetics/Pharmacodynamics
Distribution
Vd:
Children: 0.21-0.3 L/kg
Adults: 0.22-0.26 L/kg
Hepatic dysfunction: 0.53 L/kg
Renal dysfunction: 0.34 L/kg
Metabolism
Minimally hepatic; 17-desacetylrocuronium (5% to 10% activity of parent drug)
Excretion
Feces (31%); urine (26%) (Proost 2000)
Clearance: Pediatric patients:
Infants 3 to <12 months: 0.35 L/kg/hour
Children 1 to <3 years: 0.32 L/kg/hour
Children 3 to <8 years: 0.44 L/kg/hour
Onset of Action
Infants ≥3 months and Children: 30 seconds to 1 minute
Adults: Good intubation conditions within 1-2 minutes (depending on dose administered); maximum neuromuscular blockade within 4 minutes
Duration of Action
Infants: 3 to 12 months: 40 minutes
Children: 1 to 12 years: 26-30 minutes
Adults: ~30 minutes (with standard doses, increases with higher doses and inhalational anesthetic agents); hypothermia may prolong the duration of action
Half-Life Elimination
Alpha elimination: 1 to 2 minutes
Beta elimination:
Infants 3 to 12 months: 1.3 ± 0.5 hours
Children 1 to <3 years: 1.1 ± 0.7 hours
Children 3 to <8 years: 0.8 ± 0.3 hours
Adults: 1.4 to 2.4 hours
Hepatic impairment: 4.3 hours
Renal impairment: 2.4 hours
Protein Binding
~30%
Use in Specific Populations
Special Populations: Renal Function Impairment
Patients with renal failure have clinical durations that are similar to but somewhat more variable than what is expected in patients with normal renal function.
Special Populations: Hepatic Function Impairment
Patients with clinically significant hepatic impairment had moderately prolonged clinical duration; patients with cirrhosis had increased Vd, prolonged plasma half-life, and >2.5 times the recovery time compared to patients with normal hepatic function.
Special Populations: Elderly
Onset time and duration of action are slightly longer in elderly patients.
Use: Labeled Indications
Neuromuscular blockade for endotracheal intubation, surgery, or mechanical ventilation: As an adjunct to general anesthesia to facilitate rapid sequence and routine tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation in adequately sedated ICU patients
Note: Neuromuscular blockade does not provide pain control, sedation, or amnestic effects. Appropriate analgesic and sedative mediations should be used before and during administration of neuromuscular blockade to achieve deep sedation.
Use: Off Label
Acute respiratory distress syndromeyes
Based on the Society for Critical Care Medicine Clinical Practice Guidelines for Sustained Neuromuscular Blockade in the Adult Critically Ill Patient, a neuromuscular blocker may be considered for short-term use (up to 48 hours) during the early course of acute respiratory distress syndrome (ARDS) in adults with PaO2/FiO2 <150 mmHg SCCM [Murray 2016]. Some experts recommend that neuromuscular blockers be considered for short-term use (up to 48 hours) only in patients with ARDS and severe gas exchange abnormalities (PaO2/FiO2 ≤120 mmHg) Siegel 2018. Note: Only cisatracurium has been studied in patients with ARDS. Whether or not other neuromuscular blockers will yield similar results is unknown.
Intensive care unit paralysis:cyes
Data from two pharmacodynamic and pharmacokinetic studies of rocuronium use in a limited number of patients in the ICU supports the use of rocuronium in this setting Khuenl-Brady 1995, Sparr 1997. Additional data may be necessary to further define the role of rocuronium in ICU patients who require neuromuscular blockade.
Based on the 2002 and 2016 Society of Critical Care Medicine clinical practice guidelines for sustained neuromuscular blockade in the adult critically ill patient, rocuronium is an effective and recommended agent among other neuromuscular blockers for select adequately sedated patients in the ICU who require neuromuscular blockade (eg, to facilitate mechanical ventilation).
Preinduction defasciculation:b
Data from two prospective randomized double-blinded clinical trials in patients undergoing tracheal intubation administered rocuronium prior to administration of succinylcholine supports the use of rocuronium in the prevention of muscular fasciculations after succinylcholine administration Harvey 1998, Martin 1998. Additional trials may be necessary to further define the role of rocuronium as an agent used for preinduction defasciculation.
Shivering due to therapeutic hypothermia following cardiac arrestyes
Based on the Society for Critical Care Medicine Clinical Practice Guidelines for Sustained Neuromuscular Blockade in the Adult Critically Ill Patient, a neuromuscular blocker may be used to manage overt shivering in therapeutic hypothermia following cardiac arrest.
Contraindications
Hypersensitivity (eg, anaphylaxis) to rocuronium, other neuromuscular-blocking agents, or any component of the formulation
Dosage and Administration
Dosing: Adult
Note: Dose to effect; doses will vary due to interpatient variability. Ensure adequate pain control and sedation prior to and during administration of neuromuscular blockade to achieve deep sedation (SCCM [Murray 2016]).
Intensive care unit paralysis (eg, use for up to 48 hours in patients with early ARDS with PaO2/FiO2 <150, to facilitate mechanical ventilation, or for shivering from therapeutic hypothermia) (off-label dosing): Initial bolus of 0.6 to 1 mg/kg, followed by continuous IV infusion of 8 to 12 mcg/kg/minute (0.48 to 0.72 mg/kg/hour); monitor depth of blockade every 2 to 3 hours initially until stable dose, then every 8 to 12 hours; adjust rate of administration by 10% increments according to desired clinical response and possibly with peripheral nerve stimulation (Greenberg 2013; Rudis 1996; Spar 1997; SSCM [Murray 2002]; Warr 2011).
Note: When possible, minimize depth and duration of paralysis. Stopping the infusion for some time until forced to restart based on patient condition is recommended to reduce post-paralytic complications (eg, acute quadriplegic myopathy syndrome [AQMS]) (SSCM [Murray 2002; Murray 2016]).
Intermittent dosing: Initial loading dose: 50 mg followed by 25 mg given when peripheral nerve stimulation returns (Sparr 1997).
Neuromuscular blockade for endotracheal intubation, surgery, or mechanical ventilation (as adjunct to general anesthesia):
Rapid sequence intubation: IV: 0.6 to 1.2 mg/kg
Obesity: In adult patients with morbid obesity (BMI >40 kg/m2), the use of 1.2 mg/kg using ideal body weight (IBW) provided a short onset of action and excellent or good intubating conditions at 60 seconds in one study (Gaszynski 2011).
Tracheal intubation: IV:
Initial: 0.45 to 0.6 mg/kg; administration of 0.3 mg/kg may also provide optimal conditions for tracheal intubation (Barclay 1997)
Obesity: May use ideal body weight (IBW) for morbidly obese (BMI >40 kg/m2) adult patients (Leykin 2004; Meyhoff 2009); onset time may be slightly delayed using IBW. The manufacturer recommends dosing based on actual body weight in all obese patients.
Maintenance for continued surgical relaxation: 0.1 to 0.2 mg/kg; repeat as needed or a continuous infusion of 10 to 12 mcg/kg/minute (0.6 to 0.72 mg/kg/hour) only after recovery of neuromuscular function is evident; infusion rates have ranged from 4 to 16 mcg/kg/minute (0.24 to 0.96 mg/kg/hour)
Note: Inhaled anesthetic agents prolong the duration of action of rocuronium. Use lower end of the dosing range; redosing interval guided by monitoring with a peripheral nerve stimulator.
Preinduction defasciculation (off-label use): IV: 0.03 to 0.06 mg/kg given 1.5 to 3 minutes before administration of succinylcholine (Harvey 1998; Martin 1998)
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Note: Dose to effect; doses will vary due to interpatient variability. Dosing also dependent on anesthetic technique and age of patient. In general, the onset of effect is shortened and duration is prolonged as the dose increases. The time to maximum nerve block is shortest in infants 1 to 3 months; the duration of relaxation is shortest in children 2 to 11 years and longest in infants. The manufacturer recommends dosing based on actual body weight in all obese patients; however, some have recommended dosing based on ideal body weight (IBW) in obese patients (Playfor 2007).
Rapid sequence intubation: Children and Adolescents: IV: 0.9 to 1.2 mg/kg; Note: Lower doses of 0.6 mg/kg have been reported in the literature; however, some studies found this dosing resulted in prolonged time to onset, shortened duration of neuromuscular blockade and less favorable intubating conditions (Cheng 2002; Fuchs-Buder 1996; Mazurek 1998; Naguib 1997)
Tracheal intubation, surgical: Infants, Children, and Adolescents: Note: Inhaled anesthetic agents prolong the duration of action of rocuronium; use lower end of the dosing range; dosing interval guided by monitoring with a peripheral nerve stimulator.
Initial:
IV: 0.45 to 0.6 mg/kg
IM (Kaplan 1999): Limited data available: Note: Due to the prolonged time to onset in some patients, IM dosing may not be ideal for rapid sequence intubation for the general population and should be reserved to clinical scenarios when alternative agents are not appropriate.
Infants ≥3 months: 1 mg/kg administered as a single dose
Children 1 to 6 years: 1.8 mg/kg administered as a single dose
Maintenance for continued surgical relaxation:
Intermittent IV dosing: Infants, Children, and Adolescents: 0.075 to 0.15 mg/kg; repeat as needed
Continuous IV infusion: Infants, Children, and Adolescents: 7 to 12 mcg/kg/minute (0.42 to 0.72 mg/kg/hour); the manufacturer recommends using the lower end of the dosing range for infants and the upper end for children >2 to ≤11 years of age; higher doses have been reported with prolonged infusions (Tobias 1996)
Dosing: Obesity
Refer to indication-specific dosing for obesity-related information (may not be available for all indications). Ideal body weight or adjusted body weight is generally recommended when calculating dose for obese patients (SCCM [Murray 2016]).
Reconstitution
May be diluted in D5NS, D5W, LR or NS at concentrations up to 5 mg/mL; use within 24 hours of preparation.
Administration
IV: May be administered as a bolus injection (undiluted) or via a continuous infusion.
Storage
Store unopened/undiluted vials under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze. When stored at room temperature (25°C [77°F]), it is stable for 60 days; once opened, use within 30 days. Dilutions up to 5 mg/mL in 0.9% sodium chloride, dextrose 5% in water, 5% dextrose in sodium chloride 0.9%, or lactated Ringer's are stable for up to 24 hours at room temperature.
Drug Interactions
Acetylcholinesterase Inhibitors: May diminish the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Monitor therapy
Aminoglycosides: May enhance the respiratory depressant effect of Neuromuscular-Blocking Agents. Monitor therapy
Bacitracin (Systemic): May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
Botulinum Toxin-Containing Products: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
Bromperidol: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
Calcium Channel Blockers: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Monitor therapy
Capreomycin: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
CarBAMazepine: May decrease the serum concentration of Neuromuscular-Blocking Agents (Nondepolarizing). Monitor therapy
Cardiac Glycosides: Neuromuscular-Blocking Agents may enhance the arrhythmogenic effect of Cardiac Glycosides. Monitor therapy
Clindamycin (Topical): May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
Colistimethate: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Consider therapy modification
Corticosteroids (Systemic): Neuromuscular-Blocking Agents (Nondepolarizing) may enhance the adverse neuromuscular effect of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur. Consider therapy modification
CycloSPORINE (Systemic): May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
EPHEDrine (Systemic): May enhance the therapeutic effect of Rocuronium. Monitor therapy
Fosphenytoin-Phenytoin: May diminish the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Fosphenytoin-Phenytoin may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Fosphenytoin-Phenytoin may decrease the serum concentration of Neuromuscular-Blocking Agents (Nondepolarizing). Monitor therapy
Inhalational Anesthetics: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Monitor therapy
Ketorolac (Nasal): May enhance the adverse/toxic effect of Neuromuscular-Blocking Agents (Nondepolarizing). Specifically, episodes of apnea have been reported in patients using this combination. Monitor therapy
Ketorolac (Systemic): May enhance the adverse/toxic effect of Neuromuscular-Blocking Agents (Nondepolarizing). Specifically, episodes of apnea have been reported in patients using this combination. Monitor therapy
Lincosamide Antibiotics: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
Lithium: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
Local Anesthetics: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Exceptions: Benzocaine; Benzydamine; Cocaine (Topical); Dibucaine; Dyclonine; Ethyl Chloride; Hexylresorcinol; Lidocaine (Ophthalmic); Lidocaine (Topical); Pramoxine; Proparacaine; Tetracaine (Ophthalmic); Tetracaine (Topical). Monitor therapy
Loop Diuretics: May diminish the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Loop Diuretics may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
Magnesium Salts: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
Minocycline (Systemic): May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
Pholcodine: May enhance the adverse/toxic effect of Neuromuscular-Blocking Agents. Specifically, anaphylaxis has been reported. Monitor therapy
Polymyxin B: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Consider therapy modification
Procainamide: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
QuiNIDine: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
QuiNINE: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Avoid combination
Spironolactone: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Monitor therapy
Tetracyclines: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
Thiazide and Thiazide-Like Diuretics: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Monitor therapy
Trimebutine: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Monitor therapy
Vancomycin: May enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
Adverse Reactions
Frequency not always defined.
Cardiovascular: Increased peripheral vascular resistance (abdominal aortic surgery: 24%, frequency not defined during other procedures), tachycardia (≤5%; incidence greater in children), hypertension, transient hypotension
Hypersensitivity: Anaphylaxis
<1%, postmarketing, and/or case reports: Anaphylactoid reaction, asthma, cardiac arrhythmia, ECG abnormality, edema at insertion site, hiccups, nausea, pruritus, skin rash, vomiting
Warnings/Precautions
Concerns related to adverse effects:
- Anaphylactoid/hypersensitivity reactions: Have been reported; immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during use.
- Neuromuscular cross-sensitivity: Cross-sensitivity with other neuromuscular-blocking agents may occur; use is contraindicated in patients with previous anaphylactic reactions to other neuromuscular blockers.
- Prolonged paralysis: Some patients may experience prolonged recovery of neuromuscular function after administration (especially after prolonged use). Patients should be adequately recovered prior to extubation. Other factors associated with prolonged recovery should be considered (eg, corticosteroid use, patient condition).
Disease-related concerns:
- Burn injury: Resistance may occur in burn patients (≥20% of total body surface area), usually several days after the injury, and may persist for several months after wound healing (Han 2009).
- Cardiovascular disease: Use with caution in patients with cardiovascular disease (eg, heart failure); onset of action may be delayed and duration of action may be prolonged.
- Conditions that may antagonize neuromuscular blockade (decreased paralysis): Respiratory alkalosis, hypercalcemia, demyelinating lesions, peripheral neuropathies, denervation, and muscle trauma may result in antagonism of neuromuscular blockade (ACCM/SCCM/ASHP [Murray 2002]; Greenberg 2013; Miller 2010; Naguib 2002).
- Conditions that may potentiate neuromuscular blockade (increased paralysis): Electrolyte abnormalities (eg, severe hypocalcemia, severe hypokalemia, hypermagnesemia), cachexia, neuromuscular diseases, metabolic acidosis, respiratory acidosis, Eaton-Lambert syndrome, and myasthenia gravis may result in potentiation of neuromuscular blockade (Greenberg 2013; Miller 2010; Naguib 2002).
- Hepatic impairment: Use with caution in patients with hepatic impairment; clinical duration may be prolonged.
- Pulmonary hypertension: Use with caution in patients with pulmonary hypertension; use may increase pulmonary vascular resistance worsening symptoms of right heart failure.
- Respiratory disease: Use with caution in patients with respiratory disease.
- Valvular heart disease: Use with caution in patients with valvular heart disease; use may increase pulmonary vascular resistance.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Special populations:
- Elderly: Use with caution in the elderly, effects and duration are more variable.
- Immobilized patients: Resistance may occur in patients who are immobilized.
- Pediatric: Not recommended by the manufacturer for rapid sequence intubation in pediatric patients; however, it has been used successfully in clinical trials for this indication (Cheng 2002; Fuchs-Buder 1996; Mazurek 1998; Naguib 1997).
Other warnings/precautions:
- Appropriate use: Maintenance of an adequate airway and respiratory support is critical. Tolerance to rocuronium may develop. All patients should receive eye care including liberal use of lubricating drops, gel, or ointment and eyelids should remain closed during continuous neuromuscular blockade to protect against damage to the cornea (ulceration and drying).
- Experienced personnel: Should be administered by adequately trained individuals familiar with its use.
- Extravasation: If extravasation occurs, local irritation may ensue; discontinue administration immediately and restart in another vein.
- Risk of medication errors: Accidental administration may be fatal. Confirm proper selection of intended product, store vial so the cap and ferrule are intact and the possibility of selecting the wrong product is minimized, and ensure that the intended dose is clearly labeled and communicated, when applicable.
Monitoring Parameters
Vital signs (heart rate, blood pressure, respiratory rate); degree of muscle paralysis (eg, presence of spontaneous movement, ventilator asynchrony, shivering, and consider use of a peripheral nerve stimulator with train of four monitoring along with clinical assessments)
In the ICU setting, prolonged paralysis and generalized myopathy, following discontinuation of agent, may be minimized by appropriately monitoring degree of blockade.
Pregnancy
Pregnancy Considerations
Adverse events were not observed in animal reproduction studies. Rocuronium crosses the placenta; umbilical venous plasma levels are ~18% of the maternal concentration following a maternal dose of 0.6 mg/kg (Abouleish 1994). The manufacturer does not recommend use for rapid sequence induction during cesarean section.
Patient Education
What is this drug used for?
- It is used to calm muscles during surgery.
- It is used to calm muscles while on a breathing machine.
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Severe injection site pain
- Burning
- Edema
- Irritation
- Arrhythmia
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
