As with other neuromuscular blocking agents, 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 medicinal products that are administered concomitantly and the condition of the patient should be taken into account when determining the dose. The use of an appropriate neuromuscular monitoring technique is recommended for the evaluation of the neuromuscular block and recovery.
Inhalational 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 agents 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.
In adult patients the following dosage recommendations may serve as a general guidance for tracheal intubation and muscle relaxation for short to long lasting surgical procedures and for use in the intensive care unit.
This medicinal product is for single use only.
Surgical Procedures: Tracheal intubation: The standard intubating dose during routine anaesthesia is 0.6 mg rocuronium bromide per kg body weight, which results in adequate intubation conditions within 60 seconds in nearly all patients. A dose of 1.0 mg rocuronium bromide per kg body weight is recommended for facilitating tracheal intubation conditions during rapid sequence induction of anaesthesia, after which adequate intubation conditions are also established within 60 seconds in nearly all patients. If a dose of 0.6 mg rocuronium bromide per kg body weight is used for rapid sequence induction of anaesthesia, it is recommended to intubate the patient 90 seconds after administration of rocuronium bromide.
Maintenance dosage: The recommended maintenance dose is 0.15 mg rocuronium bromide per kg body weight. In case of long-term inhalational anaesthesia it should be reduced to 0.075 - 0.1 mg of rocuronium bromide per kg body weight.
The maintenance doses should best be given 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: If rocuronium bromide is administered by continuous infusion, it is recommended to give a loading dose of 0.6 mg rocuronium bromide per kg body weight and, when the neuromuscular block starts to recover, to start administration by infusion. The infusion rate should be adjusted to maintain twitch response at 10 % of control twitch height or to maintain 1 to 2 responses to train-of-four stimulation.
In adults under intravenous anaesthesia, the infusion rate required to maintain the neuromuscular block at this level ranges from 0.3 - 0.6 mg/kg/h. Under inhalational anaesthesia the infusion rate ranges from 0.3 - 0.4 mg/kg/h.
Continuous monitoring of the neuromuscular block is essential since infusion rate requirements vary from patient to patient and with the anaesthetic method used.
Dosage in pregnant patients: In patients undergoing Caesarean section, it is recommended to only use a dose of 0.6 mg rocuronium bromide per kg body weight, since a 1.0 mg/kg dose has not been investigated in this patient group.
Reversal of neuromuscular block induced by neuromuscular blocking agents may be inhibited or unsatisfactory in patients receiving magnesium salts for toxemia of pregnancy because magnesium salts enhance neuromuscular blockade. Therefore, in these patients the dosage of rocuronium should be reduced and be titrated to twitch response.
Paediatric population: For neonates (0-28 days), infants (28 days to ≤ 3 months), toddlers (> 3 months to ≤ 2 years), children (2-11 years), and adolescents (12 to ≤ 17 years) the recommended intubation dose during routine anaesthesia and maintenance dose are similar to those in adults. However, the duration of action of the single intubating dose will be longer in neonates and infants than in children.
For continuous infusion in pediatrics, the infusion rates, with exception of children, are the same as for adults. For children higher infusion rates might be necessary.
Thus, 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 facilitation tracheal intubation conditions during rapid sequence induction in paediatric patients.
Dosage in geriatric patients and patients with hepatic and/or biliary tract disease and/or renal failure: The standard intubation dose for geriatric patients and patients with hepatic and/or biliary tract disease and/or renal failure during routine anaesthesia is 0.6 mg rocuronium bromide per kg body weight. A dose of 0.6 mg per kg body weight should be considered for rapid sequence induction of anaesthesia in patients in which a prolonged duration of action is expected however adequate conditions for intubation may not be established for 90 seconds after administration of rocuronium bromide. Regardless of the anaesthetic technique used, the recommended maintenance dose for these patients is 0.075 - 0.1 mg rocuronium bromide per kg body weight, and the recommended infusion rate is 0.3 - 0.4 mg/kg/h (see also Continuous infusion as previously mentioned).
Dosage in overweight and obese patients: When used in overweight or obese patients (defined as patients with a body weight of 30 % or more above ideal body weight) doses should be reduced taking into account a lean body mass.
Intensive care procedures: Tracheal intubation: For tracheal intubation, the same doses should be used as previously described under Surgical Procedures.
Administration: Rocuronium bromide is administered intravenously (i.v.) either as a bolus injection or as a continuous infusion (for further information see also Pharmaceutical precautions under Cautions for Usage).