Rocuronium bromide parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of rocuronium bromide.
Drugs List
Therapeutic Indications
Uses
Neuromuscular blockade to aid intubation and mechanical ventilation in ITU
Neuromuscular blockade to facilitate intubation during surgery
Indicated in adults and children as an adjunct to general anaesthesia to enable tracheal intubation during routine induction and to provide skeletal muscle relaxation during surgery.
Indicated in adults to enable tracheal intubation during rapid sequence induction and as an adjunct in the intensive care unit for short term use.
Dosage
Dosage should be individualised based on the anaesthetic method used, the expected duration of surgery, possible interactions with concurrent medications, and the condition of the patient.
Inhalational anaesthetics potentiate the neuromuscular blocking effects of rocuronium bromide. Adjustments to the rocuronium bromide dose should therefore be made by administering smaller maintenance doses at less frequent intervals or by using lower infusion rates of rocuronium bromide during long lasting procedures (exceeding 1 hour) under inhalational anaesthesia.
Adults
The following dosage recommendations serve as a general guideline.
Surgical Procedures
Tracheal intubation during routine anaesthesia
600micrograms/kg rocuronium bromide. Following which adequate intubation conditions are established within 60 seconds in nearly all patients.
Tracheal intubation during rapid sequence induction of anaesthesia
1mg/kg rocuronium bromide. Following which adequate intubation conditions are established within 60 seconds in nearly all patients.
If a dose of 600micrograms/kg rocuronium bromide is used for rapid sequence induction of anaesthesia, it is recommended to intubate the patient 90 seconds after administration of rocuronium bromide.
Higher doses
There is no indication that the use of initial doses up to 2mg/kg is associated with an increased frequency or severity of cardiovascular effects.
The use of higher doses of rocuronium bromide decreases the onset time and increases the duration of action.
Maintenance dosing by intravenous injection
The recommended maintenance dose is 150micrograms/kg rocuronium bromide.
This should be reduced to 75micrograms/kg to 100micrograms/kg rocuronium bromide when long term inhalation anaesthesia is used.
Administer maintenance doses when twitch height has recovered to 25% of control twitch height, or when 2 to 3 responses to train of four (TOF) stimulation are present.
Maintenance dosing by continuous infusion
Loading dose of 600micrograms/kg rocuronium bromide is recommended, followed by continuous infusion when neuromuscular block starts to recover. The infusion rate should be adjusted to maintain twitch response at 10% of control twitch height or to maintain 1 to 2 responses to twitch height.
In adults under intravenous anaesthesia, the infusion rate required to maintain neuromuscular block ranges from 300 to 600micrograms/kg/hour. Under inhalational anaesthesia, the infusion rate ranges from 300 to 400micrograms/kg/hour.
Continuous monitoring of neuromuscular block is essential as infusion rate requirements vary between patients and depend on the anaesthetic method used.
Caesarean section
600micrograms/kg rocuronium bromide. Doses of 1mg/kg have not been investigated in this patient group.
The dose of rocuronium bromide should be reduced and titrated to twitch response in patients receiving magnesium salts to treat toxaemia of pregnancy.
Intensive Care Procedures
Tracheal intubation during routine anaesthesia
600micrograms/kg rocuronium bromide. Following which adequate intubation conditions are established within 60 seconds in nearly all patients.
Tracheal intubation during rapid sequence induction of anaesthesia
1mg/kg rocuronium bromide. Following which adequate intubation conditions are established within 60 seconds in nearly all patients.
If a dose of 600micrograms/kg rocuronium bromide is used for rapid sequence induction of anaesthesia, it is recommended to intubate the patient 90 seconds after administration of rocuronium bromide.
Facilitation of mechanical ventilation
Mechanical ventilation is not recommended in intensive care due to a lack of safety and efficacy.
Maintenance dose
Initial loading dose of 600micrograms/kg rocuronium bromide is recommended. Following which continuous infusion as soon as twitch height recovers to 10% or upon reappearance of 1 to 2 twitches.
Initial infusion rate for the maintenance of a neuromuscular block of 80-90% (1 to 2 twitches to TOF stimulation) in adult patients is 300micrograms/kg to 600micrograms/kg during the first hour of administration, which will need to be decreased during the following 6 to 12 hours, according to the individual response. Thereafter, individual dose requirements remain relatively constant.
The clinical data indicate that there is a large variability in hourly infusion rates between patients, with mean hourly infusion rates ranging from 200 to 55 micrograms/kg/hour. Therefore, to provide optimal individual patient control, monitoring of neuromuscular transmission is strongly advised.
Elderly
Surgical Procedures
Tracheal intubation during routine anaesthesia
600micrograms/kg rocuronium bromide.
Tracheal intubation during rapid sequence induction of anaesthesia
Rapid sequence induction of anaesthesia: 600micrograms/kg rocuronium bromide should be considered for patients in which a prolonged duration of action is expected.
Maintenance dose: 75micrograms/kg to 100micrograms/kg rocuronium bromide.
Infusion rate: 300 to 400micrograms/kg/hour.
Intensive Care Procedures
Facilitation of mechanical ventilation
Mechanical ventilation is not recommended in intensive care due to a lack of safety and efficacy.
Children
For intubation during routine anaesthesia and maintenance the doses are similar to those in adults(See Dosage; Adult).
The duration of action of the single intubating dose will be longer in infants aged 1 month to 3 months than in children aged 2 years to 12 years.
Maintenance dosing by continuous infusion The infusion rates, with the exception of children aged 2 to 13 years, are the same as for adults.
Children aged 2 to 13 years may require higher infusion rates. Initially infusion rates are as for adults and this should be adjusted to maintain twitch response at 10% of control twitch height or to maintain 1 or 2 responses to TOF stimulation during the procedure.
Tracheal intubation during rapid sequence indication of anaesthesia The experience with rocuronium bromide in rapid sequence induction in paediatric patients is limited. Therefore, rocuronium bromide is therefore not recommended for facilitating tracheal intubation conditions during rapid sequence induction in paediatric patients.
The following alternative dosing schedule may be suitable:
Neuromuscular blockade (intermediate duration) during surgery
Initial dose: 600 micrograms/kg by intravenous injection, then either by intravenous injection 150 micrograms/kg repeated as required or by intravenous infusion 300 to 600 micrograms/kg/hour adjusted according to response.
Assisted ventilation in intensive care (unlicensed)
Children aged 1 month to 18 years
Initial dose: 600micrograms/kg (optional) by intravenous injection, then 300 to 600micrograms/kg/hour by intravenous infusion for 1 hour, then titrate to response.
Neonates
There are insufficient data to support dose recommendations for the use of rocuronium bromide in new-born infants (0-1 month).
For intubation during routine anaesthesia and maintenance the doses are similar to those in adults(See Dosage; Adult).
The duration of action of the single intubating dose will be longer in neonates.
Maintenance dosing by continuous infusion The infusion rates are the same as for adults.
Tracheal intubation during rapid sequence indication of anaesthesia The experience with rocuronium bromide in rapid sequence induction in paediatric patients is limited. Therefore, rocuronium bromide is therefore not recommended for facilitating tracheal intubation conditions during rapid sequence induction in paediatric patients.
The following alternative dosing schedule may be suitable:
Neuromuscular blockade (intermediate duration) during surgery
Initial dose: 600 micrograms/kg by intravenous injection, then either by intravenous injection 150 micrograms/kg repeated as required or by intravenous infusion 300 to 600 micrograms/kg/hour adjusted according to response.
Patients with Renal Impairment
Surgical Procedures
Tracheal intubation during routine anaesthesia
600micrograms/kg rocuronium bromide.
Tracheal intubation during rapid sequence induction of anaesthesia
600micrograms/kg rocuronium bromide should be considered for patients in which a prolonged duration of action is expected.
Maintenance dose: 75micrograms/kg to 100micrograms/kg rocuronium bromide.
Infusion rate: 300 to 400micrograms/kg/hour.
Intensive Care Procedures
Facilitation of mechanical ventilation
Mechanical ventilation is not recommended in intensive care due to a lack of safety and efficacy.
Patients with Hepatic Impairment
Surgical Procedures
Tracheal intubation during routine anaesthesia
600micrograms/kg rocuronium bromide.
Tracheal intubation during rapid sequence induction of anaesthesia
600micrograms/kg rocuronium bromide should be considered for patients in which a prolonged duration of action is expected.
Maintenance dose: 75micrograms/kg to 100micrograms/kg rocuronium bromide.
Infusion rate: 300 to 400micrograms/kg/hour.
Intensive Care Procedures
Facilitation of mechanical ventilation
Mechanical ventilation is not recommended in intensive care due to a lack of safety and efficacy.
Additional Dosage Information
Overweight and obese patients
In overweight or obese patients (body weight of 30% or more above ideal body weight) doses should be reduced taking into account ideal body weight.
Administration
For intravenous administration as a bolus injection or as a continuous infusion.
Contraindications
None known
Precautions and Warnings
Burns
Cachexia
Elderly
Hypoproteinaemia
Hypothermia
Obesity
Oedema
Biliary tract disorder
Breastfeeding
Cardiovascular disorder
Dehydration
Hepatic impairment
Hypercapnia
Hypermagnesaemia
Hypocalcaemia
Hypokalaemia
Metabolic acidosis
Myasthenia gravis
Myasthenic Eaton-Lambert syndrome
Neuromuscular disorder
Poliomyelitis
Pregnancy
Renal impairment
Correct existing water and electrolyte disturbances before administration
Treatment to be initiated and supervised by a specialist
Ventilatory support facilities must be immediately available
Ventilatory support is mandatory until adequate respiration is restored
Monitor for malignant hyperthermia
Monitor neuromuscular function
Burns patients may require dose modification
In obese patients dosing should be based on ideal weight
Not licensed for all indications in all age groups
Driving or operating machinery not advisable following treatment
Residual neuromuscular blockade has been reported with the use of rocuronium bromide. Therefore, it is advised to extubate only after the patient has recovered sufficiently from neuromuscular blockade. After extubation, residual neuromuscular blockade could be caused by other factors in the post-operative phase (due to drug interactions or patient condition). Unless used as standard practice, the use of a reversal agent should be considered, particularly in patients in whom residual neuromuscular blockade is more likely to occur.
Neuromuscular blocking agents can cause anaphylactic reactions and these should be managed appropriately. Special care should be taken in patients with previous sensitivity to neuromuscular blocking agents as allergic cross-reactivity has been reported.
Prolonged paralysis and/or skeletal muscle weakness has been observed following long term use of neuromuscular blocking agents in the intensive care units. Continuous monitoring of neuromuscular block throughout the duration of use of rocuronium bromide may help to prevent prolonged neuromuscular block and/or overdose. Patients should also receive adequate analgesia and sedation.
Myopathy has been reported regularly after long term administration of other non-depolarising neuromuscular blocking agents in combination with corticosteroid therapy in intensive care. Therefore, the period of use of rocuronium bromide should be limited as much as possible.
If suxamethonium is used for intubation, the use of rocuronium bromide should be delayed until the patient has clinically recovered from the neuromuscular block caused by suxamethonium.
Prolonged co-administration of corticosteroids and rocuronium bromide may increase the risk of prolonged duration of neuromuscular block or myopathy.
Pregnancy and Lactation
Pregnancy
Use rocuronium bromide with caution during pregnancy.
The manufacturer advises caution if rocuronium bromide is used during pregnancy. At the time of writing there is limited published information regarding the use of rocuronium bromide during pregnancy. Animal studies do not indicate harmful effects with respect to pregnancy, embryo/foetal development, parturition or postnatal development.
Briggs (2015) concludes that neuromuscular blocking agents do not appear to represent a significant risk to an embryo or foetus. Due to the limited available data, the manufacturer advises caution.
Rocuronium is indicated for use during a Caesarean section (see Dosage; Adults). Umbilical cord samples taken during the procedure have demonstrated limited placental transfer of rocuronium and no adverse effects were observed in the newborn. A delay in the onset of lactation following combined use with other agents has been reported.
Lactation
Use rocuronium bromide with caution during breastfeeding.
The manufacturer advises only taking rocuronium bromide when the benefits outweigh the risks. The presence of rocuronium bromide in human breast milk is unknown, animal studies have shown insignificant levels of rocuronium bromide in breast milk.
Effects of exposure on a nursing infant are unknown but are considered unlikely to be clinically significant, including use following a Caesarean section (Briggs 2015, Schaeffer 2015).
Side Effects
Anaphylactic reaction
Anaphylactoid reaction
Angioneurotic oedema
Bronchospasm
Cardiovascular disturbances
Circulatory collapse
Circulatory shock
Erythematous rash
Flaccid paralysis
Flushing
Hypersensitivity reactions including anaphylaxis
Hypotension
Injection site reactions
Itching (injection site)
Muscle weakness
Myopathy
Pain on injection
Prolonged neuromuscular block
Rash
Tachycardia
Urticaria
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: August 2019
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Esmeron 10mg/ml solution for injection vials. Merck Sharp & Dohme Limited. Revised December 2021.
Summary of Product Characteristics: Rocuronium bromide 100mg/10ml solution for injection ampoules. Bowmed Ibisqus Ltd. Revised November 2018.
Summary of Product Characteristics: Rocuronium 10mg/ml solution for injection / infusion. Hameln Pharmaceuticals Ltd. Revised December 2018.
NICE Evidence Services Available at: www.nice.org.uk
Last accessed: 15 August 2019
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Last accessed: 15 August 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.