Rocuronium Bromide

Registered South African indications:

• Adjunct to general anaesthesia to facilitate tracheal intubation during routine and rapid sequence induction, and to provide skeletal muscle relaxation during surgery
• Adjunct in the intensive care unit (ICU) to facilitate intubation and mechanical ventilation for up to 3 days in adults 18 to 65 years

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to the to the bromide ion
• Inadequate data to support the use of rocuronium bromide in neonates (0 to 1 month)
• Rocuronium bromide is not recommended for the facilitation of mechanical ventilation in the intensive care in paediatric and elderly patients due to a lack of data on safety and efficacy

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Overweight or obese
• High doses
• Prolonged use
• Cardiovascular disease
• Oedema
• Neuromuscular disease
• Poliomyelitis
• Myasthenia gravis
• Eaton-Lambert syndrome
• Hypothermia
• Burns
• Hypokalaemia
• Hypermagnesaemia
• Hypocalcaemia
• Hypoproteinaemia
• Dehydration
• Acidosis
• Hypercapnia
• Cachexia

Forms avail. in SA and covered in this monograph: inj

South African registered indications and dosages

Rocuronium Bromide should be administered only by experienced doctors familiar with the use of neuromuscular blocking medicines

Adjunct to general anaesthesia to facilitate tracheal intubation during routine and rapid sequence induction, and to provide skeletal muscle relaxation during surgery

Standard intubating dose during routine anaesthesia

• IV: 0.6mg/kg body mass, resulting in adequate intubation conditions within 90 sec. in nearly all patients; Maintenance: 0.15mg/kg body mass, reduce to 0.075 to 0.1mg/kg; Maintenance doses should be given as a bolus when twitch height has recovered to 25% of control twitch height, or when 2 to 3 responses to train-of-four stimulation (TOF) are present

Tracheal intubation during rapid sequence induction of anaesthesia

• IV: 1mg/kg body mass, after which adequate intubation conditions are established within 60 sec. in nearly all patients; Maintenance: 0.15mg/kg body mass, reduce to 0.075 to 0.1mg/kg; Maintenance doses should be given as a bolus when twitch height has recovered to 25% of control twitch height, or when 2 to 3 responses to train-of-four stimulation (TOF) are present

Higer doses during surgery

• IV: Initial: 2mg/kg, which decreases the onset time and increases the duration of action; Maintenance: 0.15mg/kg body mass, reduce to 0.075 to 0.1mg/kg; Maintenance doses should be given as a bolus when twitch height has recovered to 25% of control twitch height, or when 2 to 3 responses to train-of-four stimulation (TOF) are present

Continuous infusion

• Loading dose: 0.6mg/kg body mass; When neuromuscular block starts to recover, start admin. by infusion with infusion rate adjusted to maintain twitch response at 10% of control twitch height or to maintain 1 to 2 responses to train-of-four stimulation; Maintenance of neuromuscular block: Ranges from 0.3 to 0.6mg/kg/hr; Under inhalational anaesthesia the infusion rate ranges from 0.3 to 0.4mg/kg/hr

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Continuous monitoring of the neuromuscular block is essential since infusion rate requirements vary from patient to patient and with the anaesthetic method used

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No cumulative effect (progressive increase in duration of action) with repetitive maintenance dosing at the recommended level has been observed

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Adjunct in the intensive care unit (ICU) to facilitate intubation and mechanical ventilation for up to 3 days in adults 18 to 65 years

Tracheal intubation

• As per above dosages

Maintenance dosing

• Initial: 0.6mg/kg/body mass; Followed by a continuous infusion as soon as twitch height recovers to 10% or upon reappearance of 1 to 2 twitches to train-of-four (TOF) stimulation (recommended initial infusion rate for the maintenance of a neuromuscular block of 80 to 90% (1 to 2 twitches to TOF stimulation): 0.3 to 0.6mg/kg/hr during the first hr of admin.; Then: Decreased during the following 6 to 12hrs, according to individual response; Thereafter, individual dose requirements remain relatively constant; Max duration: 3 days 

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A large interpatient variability in hourly infusion rates has been found, with mean hourly infusion rates ranging from 0.2 to 0.5mg/kg per hour depending on nature and extent of organ failure(s), concomitant medicine and individual patient characteristics. To provide optimal individual patient control, monitoring of neuromuscular transmission is strongly recommended
Safety and efficacy beyond 3 days has not been established
Following continuous infusion in the ICU, the time to recovery of the TOF ratio to 0.7 depends on the level of block at the end of the infusion. After a continuous infusion for 20 hours or more the median (range) time between return of T2 to TOF stimulation and recovery of the TOF ratio to 0.7 approximates 1.5 (1 to 5) hours in patients without multiple organ failure and 4 (1 to 25) hours in patients with multiple organ failure

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Method of administration
Administer intravenously either as a bolus injection or as a continuous infusion (refer to individual product professional information for compatible solutions. Administration should begin immediately after mixing and should be completed within 24 hours. Unused solutions should be discarded

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See Additional Prescriber Points

Forms avail. in SA and covered in this monograph: inj

South African registered indications and dosages

Rocuronium Bromide should be administered only by experienced doctors familiar with the use of neuromuscular blocking medicines

Adjunct to general anaesthesia to facilitate tracheal intubation during routine induction, and to provide skeletal muscle relaxation during surgery

Neonates (0 to 1 month)

• Contraindicated (see contraindications)

Infants (28 days to 23 months), children (2 to 14 years) and adolescents (12 to 18 years)

• See adult dosages

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For infants (28 days to 23 months), children (2 to 14 years) and adolescents (12 to 18 years) the recommended intubation dose during routine anaesthesia and maintenance dose are similar to those in adults

For continuous infusion in paediatrics the infusion rates, with exception of children, are the same as for adults

For children higher infusion rates might be necessary. For children the same initial infusion rates as for adults are recommended, and this should be adjusted to maintain twitch response at 10% of control twitch height, or to maintain 1 or 2 responses to train-of-four stimulation during the procedure

The experience with rocuronium bromide in rapid sequence induction in paediatric patients is limited. Rocuronium bromide is therefore not recommended for facilitating tracheal intubation conditions during rapid sequence induction in paediatric patients

Pregnancy

• Caution
• For rocuronium bromide, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing rocuronium bromide to pregnant women

Breastfeeding

• Caution
• It is unknown whether rocuronium bromide is excreted in human breast milk. Animal studies have shown insignificant levels of rocuronium bromide in breast milk. Insignificant levels of rocuronium bromide were found in the milk of lactating rats. There are no human data on the use of rocuronium bromide during breastfeeding. Esmeron should be given to brestfeeding women only when the attending physician decides that the benefits outweigh the risks. After the administration of a single dose, it is recommended to abstain from next breastfeeding for five elimination half-lives of rocuronium, i.e. for about 6 hours

Renal Impairment

• Caution; no dose adjustment recommended
• Dose Adjustment only required for morbidly obese patients (BMI>40) when dose must be calculated using ideal body weight

Hepatic Impairment

• Caution; no dose adjustment recommended
• Dose Adjustment only required for morbidly obese patients (BMI>40) when dose must be calculated using ideal body weight

Elderly

• Caution; no dose adjustment recommended

Overweight or obese

• Caution; dose adjustment recommended
  When used in overweight or obese patients (defined as patients with a body weight of 30% or more above ideal body mass) doses should be reduced considering a lean body mass

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Paralysis

Cardiovascular Disorders

• Tachycardia
• Hypotension
• Circulatory shock

Respiratory Disorders

• Bronchospasm
• Apnoea
• Respiratory failure

Musculoskeletal Disorders

• Skeletal muscle weakness
• Steroid myopathy

Skin and Subcutaneous Tissue Disorders

• Injection site pain
• Erythematous rash 
• Angioedema 
• Urticaria 
• Itching 
• Exanthema

Immune, Blood and Lymphatic System Disorder 

• Anaphylactic reaction
• Hypersensitivity

• Halogenated anaesthetics
• Thiopental
• Methohexital
• Ketamine
• Fentanyl
• Gammahydroxybutyrate
• Etomidate
• Propofol
• Non-depolarizing muscle relaxants
• Suxamethonium
• Corticosteroids
• Aminoglycosides
• Lincosamides
• Polypeptide anitbiotics
• Acylamino-penicillin antibiotics
• Tetracyclines
• Metronidazole
• Diuretics
• Thiamine
• Monoamine oxidase inhibitors
• Quinidine
• Quinine
• Protamine
• Adrenergic blocking agents
• Magnesium salts
• Calcium channel blocking agents
• Lithium salts
• Local anaesthetics
• Neostigmine
• Edrophonium
• Pyridostigmine
• Aminopyridine derivatives
• Corticosteroids
• Phenytoin
• Carbamazepine
• Noradrenaline
• Azathioprine
• Theophylline
• Calcium chloride
• Potassium chloride
• Protease inhibitors

None routine

Considerations

• The dosage of rocuronium bromide should be individualised in each patient. The method of anaesthesia and the expected duration of surgery, the method of sedation and the expected duration of mechanical ventilation, the possible interaction with other medicines that are administered concomitantly, and the condition of the patient should be considered when determining the dose. The use of an appropriate neuromuscular monitoring technique is recommended for the evaluation of the neuromuscular block and recovery
• Inhalation anaesthetics potentiate the neuromuscular blocking effects of rocuronium bromide. This potentiation becomes clinically relevant during the course of anaesthesia when a certain tissue concentration of the volatile medicines is reached. Consequently, adjustments should be made by administering smaller maintenance doses at less frequent intervals or by using lower infusion rates of rocuronium bromide during long lasting procedures (longer than 1 hour) under inhalational anaesthesia

Risk of medication errors

• Accidental administration of neuromuscular blocking medicines may result in serious adverse events, including fatal outcomes. Store rocuronium bromide with the cap and ferrule intact and in a manner that minimises the possibility of selecting the wrong product

Rocuronium produces neuromuscular blockade by competing with acetylcholine for cholinergic receptors at the motor endplate. It is a non-depolarizing neuromuscular blocking agent with a rapid to intermediate onset of action, depending on dose, and with an intermediate duration of action

Injection (per 5ml) 50mg

• Adco Rocuronium (Adcock)
• Erunom (Abex Pharmaceutica)
• Esmeron (Sanofi) originator
• Meraxt 10mg/ml (Kahma Biotech)
• Rocuronium Fresenius (Fresenius)
• Rocuronium 50 IV Biotech (Biotech)
• Ronia (Abex Pharmaceutica)
• Trakeze (Pharma Dynamics)