Rocuronium Bromide

Adults: Rocuronium should be given only by, or under the supervision of, experienced clinicians familiar with how neuromuscular blocking agents work and are used. The dose needs to be tailored to each patient, taking into account the anesthesia technique and expected length of surgery, the sedation method and expected duration of mechanical ventilation, possible interactions with other medicines given at the same time, and the patient's overall condition. Using an appropriate neuromuscular monitoring technique is recommended to assess the block and recovery from it. Inhalational anesthetics strengthen the neuromuscular blocking effect of Rocuronium, though this effect only becomes clinically relevant once the volatile agent has built up to the tissue concentration needed for the interaction. Because of this, during long procedures (over 1 hour) carried out under inhalational anesthesia, Rocuronium doses should be adjusted by giving smaller maintenance doses less often, or by using lower infusion rates. In adults, the following guidelines apply to tracheal intubation and muscle relaxation for surgical procedures of any length, as well as to use in the intensive care unit. Surgical procedures, tracheal intubation: The standard intubating dose for routine anesthesia is 0.6 mg of Rocuronium Bromide per kg of body weight, which achieves adequate intubation conditions within 60 seconds in nearly all patients. For rapid sequence induction of anesthesia, a dose of 1.0 mg per kg body weight is recommended, also achieving adequate intubation conditions within 60 seconds in nearly all patients. If a 0.6 mg per kg dose is used for rapid sequence induction instead, intubation should be attempted 90 seconds after the dose is given. For patients undergoing a Caesarean section, only the 0.6 mg per kg dose should be used, since the 1.0 mg per kg dose has not been studied in this group. Maintenance dosing: The recommended maintenance dose is 0.15 mg per kg body weight, reduced to 0.075 to 0.1 mg per kg for long term inhalational anesthesia. Maintenance doses are best given once twitch height has recovered to 25% of the control value, or once 2 to 3 responses to train of four stimulation appear. Continuous infusion: When Rocuronium Bromide is given by continuous infusion, a loading dose of 0.6 mg per kg body weight is recommended, with infusion starting once the neuromuscular block begins to recover. The infusion rate should be adjusted to keep twitch response at 10% of the control value, or to maintain 1 to 2 responses to train of four stimulation. In adults under intravenous anesthesia, the infusion rate needed to hold the block at this level ranges from 0.3 to 0.6 mg per kg per hour, and under inhalational anesthesia from 0.3 to 0.4 mg per kg per hour. Continuous monitoring of the neuromuscular block is recommended, since infusion requirements vary from patient to patient and depend on the anesthetic method used. Dosing in paediatric patients: Children (1 to 14 years) and infants (1 to 12 months) under halothane anesthesia show a sensitivity to Rocuronium Bromide similar to adults. Onset of action is faster in infants and children than in adults, and clinical duration is shorter in children than in adults. For continuous infusion, paediatric infusion rates are generally the same as for adults, though children may sometimes need higher rates. Children should start on the same initial infusion rate as adults, then have it adjusted to maintain twitch response at 10% of the control value, or 1 to 2 responses to train of four stimulation, throughout the procedure. There is insufficient data to support dosing recommendations in neonates (0 to 1 month). Because experience with Rocuronium Bromide for rapid sequence induction in paediatric patients is limited, it is not recommended for facilitating tracheal intubation during rapid sequence induction in this age group. Dosing in geriatric patients and patients with hepatic and/or biliary tract disease and/or renal failure: The standard intubation dose for routine anesthesia in these patients is 0.6 mg per kg body weight. A dose of 0.6 mg per kg should be considered for rapid sequence induction where a prolonged duration of action is expected. Regardless of the anesthetic technique used, the recommended maintenance dose in these patients is 0.075 to 0.1 mg per kg, with a recommended infusion rate of 0.3 to 0.4 mg per kg per hour. Dosing in overweight and obese patients: For overweight or obese patients, defined as those weighing 30% or more above ideal body weight, doses should be reduced based on ideal body weight rather than actual body weight. Intensive care procedures, tracheal intubation: The same doses described above under surgical procedures apply. Maintenance dosing: An initial loading dose of 0.6 mg per kg body weight is recommended, followed by continuous infusion once twitch height recovers to 10%, or once 1 to 2 twitches reappear on train of four stimulation. Dosage should always be titrated to the individual patient's response. The recommended initial infusion rate to maintain a neuromuscular block of 80 to 90% (1 to 2 twitches on TOF stimulation) in adults is 0.3 to 0.6 mg per kg per hour during the first hour, decreasing over the following 6 to 12 hours according to the individual's response; after that, individual dose requirements tend to remain fairly stable. Controlled clinical studies have found wide variability between patients in hourly infusion rates, with mean rates ranging from 0.2 to 0.5 mg per kg per hour depending on the nature and extent of organ failure, concomitant medication, and individual patient characteristics. To achieve optimal control for each patient, monitoring of neuromuscular transmission is strongly recommended. Administration for up to 7 days has been studied. Special populations: Rocuronium Bromide is not recommended for facilitating mechanical ventilation in intensive care for paediatric or geriatric patients, due to a lack of safety and efficacy data in these groups.