Rocuronium

Generic name
Rocuronium
Brand name
ATC Code
M03AC09
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Rocuronium

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The pharmacokinetics of rocuronium bromide in pediatric patients (n=146) aged 0 - 17 years was analyzed by population analysis of the pooled pharmacokinetic datasets from two clinical trials in which anesthesia was induced with sevoflurane and maintained with isoflurane/nitrous oxide. All pharmacokinetic parameters were found to be linearly proportional to body weight, demonstrated by similar CL. The Vd and T1/2 decreased with age (years). The pharmacokinetic parameters of the characteristic pediatric patient within each age group are summarized in table 1 (SmpC Esmeron; Wierda 1997; Vuksanaj 1995).

Table 1. Estimated PK parameters (mean) of rocuronium bromide in characteristic pediatric patients during sevoflurane and nitrous oxide (induction) and isoflurane/ nitrous oxide (maintenance anesthesia) (SmpC Esmeron; Wierda 1997; Vuksanaj 1995).

  Cl (l/kg/hour) Vd (l/kg) t½ (hours)
0-27 days 0.31 0.42 1.1
1-2 months 0.3 0.31 0.9
3-23 months 0.33 0.23 0.8
2-11 yrs 0.35 0.18 0.7
12-17 yrs 0.29 0.18 0.8

The mean time before onset of action is slightly shorter in infants, toddlers, and children than in neonates, adolescents, and adults. A good intubation condition is independent of the onset time, which varies based on dose and patient-related factors. The duration of action and time to recovery are usually shorter in children than in infants and adults. In neonates and infants, the duration of action of the single intubation dose will be longer than in older childre

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Neuromuscular blockade
  • Intravenous
    • 1 month up to 18 years
      • Initial dose: Rocuronium bromide: 0.3 - 0.6 mg/kg/dose, once only.
        •  In case of emergency, a rapid sequence intubation of 0.9 - 1.2 mg/kg/dose, bolus can be considered.
        • When rocuronium is used only for intubation, the starting dose is sufficient.
        .
      • Maintenance dose: 0.3 - 1 mg/kg/hour, continuous infusion.
        • For each dose increase, give a loading dose of 0,6 mg/kg, bolus.
        • In exceptional cases, doses up to 2,2 mg/kg/hr have been described.
        • Titrate maintenance dose based on the Train of Four (TOF) test.
        • To prevent overdose in intensive care unit, stop the administration regularly (e.g. 1/day) to monitor the positive effect of relaxation and to estimate the degree of sedation.
        Alternative maintenance during surgery: 0,1 - 0,2 mg/kg/dose, bolus. Repeated doses if indicated based on the Train of Four (TOF) test. For prolonged inhalation anesthesia reduce dose to 0.075 - 0.1 mg/kg/dose, bolus.  .
    • Term neonate
      • Initial dose: Rocuronium bromide: 0.3 - 0.6 mg/kg/dose, once only.
        •  In case of emergency, a rapid sequence intubation of 0.9 - 1.2 mg/kg/dose, bolus can be considered.
        • When rocuronium is used only for intubation, the starting dose (bolus)is sufficient.
        .
      • Maintenance dose: 0.3 - 1 mg/kg/hour, continuous infusion.
        • For each dose increase, give a loading dose of 0,6 mg/kg, bolus.
        • In exceptional cases, doses up to 2,2 mg/kg/hr have been described.
        • Titrate maintenance dose based on the Train of Four (TOF) test.
        • To prevent overdose in intensive care unit, stop the administration regularly (e.g. 1/day) to monitor the positive effect of relaxation and to estimate the degree of sedation.
        Alternative maintenance during surgery: 0,1 - 0,2 mg/kg/dose, bolus. Repeated doses if indicated based on the Train of Four (TOF) test. For prolonged inhalation anesthesia reduce dose to 0.075 - 0.1 mg/kg/dose, bolus.  .
    • Gestational age < 37 weeks
      • Initial dose: 0.3 - 0.6 mg/kg/dose, bolus. (for intubation only the starting dose (bolus) is required).
      • Maintenance dose: (maintenance during surgery) 0.1 - 0.2 mg/kg/dose, bolus Repeat and or titrate doses if indicated based on the Train of Four (TOF) test.. For prolonged inhalation anesthesia reduce dose to 0.075 - 0.1 mg/kg/dose, bolus..

      • To prevent overdose in intensive care unit, stop the administration regularly (e.g. 1/day) to monitor the positive effect of relaxation and to estimate the degree of sedation in

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2:  In renal impairment, the duration of action is prolonged. For emergency induction, an initial dose of 0.6 mg/kg and a maintenance dose of 0.075-0.1 mg/kg is recommended, regardless of the method of anesthesia. When administered as a continuous infusion, the recommended maintenance dose is 0.3-0.4 mg/kg per hour (KNMP-IM).
GFR <10 ml/min/1.73m2: a general recommendation cannot be given.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Tachycardia in 1,4% of patients [SmPC]

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Monitor neuromuscular function. The duration of action for muscle relaxants is so variable that relaxation measurement should be considered before extubation and antagonized if necessary. 

In children with obesity, ideal-body weight or adjust body weight in calculating the dose of rocuronium is recommended instead of use of total body weight (Ross 2015; NHS 2021).

Cross hypersensitivity - including from other groups - is possible. This may be based on the excipients but also on the active ingredient. Advice is to consult a pediatric allergist in case of a suspected allergic reaction to a muscle relaxant and to also test for safety of alternative muscle relaxants.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

MUSCLE RELAXANTS, PERIPHERALLY ACTING AGENTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Choline derivatives
M03AB01
Other quaternary ammonium compounds
M03AC04
M03AC11
M03AC10
M03AC01
M03AC03
Other muscle relaxants, peripherally acting agents
M03AX01

References

  1. NV Organon, SPC Esmeron (RVG 16946) 07-08-2014, www.geneesmiddeleninformatiebank.nl
  2. Cheng CA et al, Comparison of rocuronium and suxamethonium for rapid tracheal intubation in children, Paediatr Anaesth, 2002, Feb;12(2), 140-5
  3. Lemson J et al., The effect of neuromuscular blockade on oxygen consumption in sedated and mechanically ventilated pediatric patients after cardiac surgery., Intensive Care Med., 2008, Dec;34(12), 2268-72
  4. Mazurek AJ et al, Rocuronium versus succinylcholine: are they equally effective during rapid-sequence induction of anesthesia?, Anesth Analg., 1998, Dec;87(6), 1259-62
  5. Tobias JD et al, Continuous infusion of rocuronium in a paediatric intensive care unit., Can J Anaesth., 1996, Apr;43(4), 353-7
  6. Woolf RL et al, Dose-response of rocuronium bromide in children anesthetized with propofol: a comparison with succinylcholine., Anesthesiology., 1997, Dec;87(6), 1368-72
  7. Merck Sharp & Dohme B.V.,, SmPC Esmeron (RVG 16946) 19-12-22, www.geneesmiddeleninformatiebank.nl
  8. Vuksanaj D, et al, Pharmacokinetics of rocuronium in children aged 4-11 years, Anesthesiology, 1995, 82(5), 1104-10
  9. Wierda JM, et al, Pharmacokinetics and pharmacokinetic-dynamic modelling of rocuronium in infants and children. , Br J Anaesth, 1997, 78(6), 690-5
  10. National Health Service (NHS)., How should medicines be dosed in children who are obese? , Available from: https://www.sps.nhs.uk/articles/how-should-medicines-be-dosed-in-children-who-are-obese/, 2021
  11. Ross EL, et al., Development of recommendations for dosing of commonly prescribed medications in critically ill obese children, Am J Health Syst Pharm, 2015, 72(7), 542-56
  12. Working group Neonatal pharmacology, Expert opnion on the use of rocuronium - 04-03-2024
  13. Wu L, et al., Effect of neuromuscular block on surgical conditions during laparoscopic surgery in neonates and small infants: A randomised controlled trial., Eur J Anaesthesiol, 2023, 40(12), 928-35
  14. Rapp HJ, et al., Neuromuscular recovery following rocuronium bromide single dose in infants., Paediatr Anaesth., 2004, 14(4), 329-35
  15. Wierda JM, et al, Pharmacokinetics and pharmacokinetic-dynamic modelling of rocuronium in infants and children., Br J Anaesth, 1997, 78(6), 690-5
  16. National Health Service (NHS)., How should medicines be dosed in children who are obese?, Available from: https://www.sps.nhs.uk/articles/how-should-medicines-be-dosed-in-children-who-are-obese/, 2021

Changes

Therapeutic Drug Monitoring


Overdose