2 DOSAGE AND ADMINISTRATION To be administered only by experienced clinicians or adequately trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents.
1 ) Individualize the dose for each patient. 1 ) Peripheral nerve stimulator recommended for determination of drug response and need for additional doses, and to evaluate recovery. 1 ) Store rocuronium bromide injection with cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product.
6 mg/kg. 2 mg/kg. 3 ) Maintenance doses : Guided by response to prior dose, not administered until recovery is evident. 4 ) Continuous infusion : Initial rate of 10 to 12 mcg/kg/min. Start only after early evidence of spontaneous recovery from an intubating dose.
1 Important Dosing and Administration Information Rocuronium bromide injection is for intravenous use only. This drug should only be administered by experienced clinicians or trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics and complications of neuromuscular blocking agents.
Doses of rocuronium bromide injection should be individualized and a peripheral nerve stimulator should be used to monitor drug effect, need for additional doses, adequacy of spontaneous recovery or antagonism, and to decrease the complications of overdosage if additional doses are administered.
The dosage information which follows is derived from studies based upon units of drug per unit of body weight. It is intended to serve as an initial guide to clinicians familiar with other neuromuscular blocking agents to acquire experience with rocuronium bromide.
6 )]. Risk of Medication Errors Accidental administration of neuromuscular blocking agents may be fatal. 3 )] . 6 mg/kg. 4 to 6) minute(s) and most patients have intubation completed within 2 minutes. Maximum blockade is achieved in most patients in less than 3 minutes.
This dose may be expected to provide 31 (15 to 85) minutes of clinical relaxation under opioid/nitrous oxide/oxygen anesthesia. 3 )]. 45 mg/kg) may be used. 2) minute(s) and most patients have intubation completed within 2 minutes. Maximum blockade is achieved in most patients in less than 4 minutes.
This dose may be expected to provide 22 (12 to 31) minutes of clinical relaxation under opioid/nitrous oxide/oxygen anesthesia. 45 mg/kg who achieve less than 90% block (about 16% of these patients) may have a more rapid time to 25% recovery, 12 to 15 minutes.
2 )]. 1 )]. 2 )] . In all cases, dosing should be guided based on the clinical duration following initial dose or prior maintenance dose and not administered until recovery of neuromuscular function is evident. 2 )]. 5 Use by Continuous Infusion Infusion at an initial rate of 10 to 12 mcg/kg/min of rocuronium bromide should be initiated only after early evidence of spontaneous recovery from an intubating dose.
3 )] and the associated rapid spontaneous recovery, initiation of the infusion after substantial return of neuromuscular function (more than 10% of control T 1 ), may necessitate additional bolus doses to maintain adequate block for surgery.
Upon reaching the desired level of neuromuscular block, the infusion of rocuronium bromide must be individualized for each patient. The rate of administration should be adjusted according to the patient's twitch response as monitored with the use of a peripheral nerve stimulator.
In clinical trials, infusion rates have ranged from 4 to 16 mcg/kg/min. Inhalation anesthetics, particularly enflurane and isoflurane, may enhance the neuromuscular blocking action of nondepolarizing muscle relaxants. In the presence of steady-state concentrations of enflurane or isoflurane, it may be necessary to reduce the rate of infusion by 30% to 50%, at 45 to 60 minutes after the intubating dose.
2 )] . 7 )] . These infusion solutions should be used within 24 hours of mixing. Unused portions of infusion solutions should be discarded. 5 mg per mL)* *50 mg rocuronium bromide in 100 mL solution. 8 100 220 48 60 72 84 96 108 120 144 168 192 Table 2: Infusion Rates Using Rocuronium Bromide Injection (1 mg per mL)* *100 mg rocuronium bromide in 100 mL solution.
4 100 220 24 30 36 42 48 54 60 72 84 96 Table 3: Infusion Rates Using Rocuronium Bromide Injection (5 mg per mL)* *500 mg rocuronium bromide in 100 mL solution. 45 mg/kg may be used depending on anesthetic technique and the age of the patient.
6 mg/kg in general produce excellent to good intubating conditions within 75 seconds. 6 mg/kg dose of rocuronium bromide resulted in excellent to good intubating conditions within 60 seconds. The time to maximum block for an intubating dose was shortest in infants (28 days up to 3 months) and longest in neonates (birth to less than 28 days).
The duration of clinical relaxation following an intubating dose is shortest in children (greater than 2 years up to 11 years) and longest in infants. 15 mg/kg at reappearance of T 3 in all pediatric age groups. Maintenance dosing can also be administered at the reappearance of T 2 at a rate of 7 to 10 mcg/kg/min, with the lowest dose requirement for neonates (birth to less than 28 days) and the highest dose requirement for children (greater than 2 years up to 11 years).
25% to provide clinical relaxation for 7 to 10 minutes. Alternatively, a continuous infusion of rocuronium bromide initiated at a rate of 12 mcg/kg/min upon return of T 1 to 10% (one twitch present in train-of-four), may also be used to maintain neuromuscular blockade in pediatric patients.
2 )]. The infusion of rocuronium bromide must be individualized for each patient. The rate of administration should be adjusted according to the patient's twitch response as monitored with the use of a peripheral nerve stimulator. 2 )] .
Rocuronium bromide is not recommended for rapid sequence intubation in pediatric patients. 2 mg/kg, respectively. 2 )]. 5 )]. 6 mg/kg rocuronium bromide. 5 times longer in patients with hepatic disease. 3 )]. 1 )]. An analysis across all US controlled clinical studies indicates that the pharmacodynamics of rocuronium bromide are not different between obese and non-obese patients when dosed based upon their actual body weight.
Patients with Reduced Plasma Cholinesterase Activity Rocuronium metabolism does not depend on plasma cholinesterase so dosing adjustments are not needed in patients with reduced plasma cholinesterase activity. 8 )]. Patients with Drugs or Conditions Causing Potentiation of Neuromuscular Block The neuromuscular blocking action of rocuronium bromide is potentiated by isoflurane and enflurane anesthesia.
Potentiation is minimal when administration of the recommended dose of rocuronium bromide occurs prior to the administration of these potent inhalation agents. 85 mg/kg was 34, 38, and 42 minutes under opioid/nitrous oxide/oxygen, enflurane and isoflurane maintenance anesthesia, respectively.
3 )]. 9% NaCl solution sterile water for injection 5% glucose in water lactated Ringers 5% glucose in saline Rocuronium bromide is compatible in the above solutions at concentrations up to 5 mg per mL for 24 hours at room temperature in plastic bags, glass bottles, and plastic syringe pumps.
Drug Admixture Incompatibility Rocuronium bromide is physically incompatible when mixed with the following drugs: amphotericin hydrocortisone sodium succinate amoxicillin insulin azathioprine intralipid cefazolin ketorolac cloxacillin lorazepam dexamethasone methohexital diazepam methylprednisolone erythromycin thiopental famotidine trimethoprim furosemide vancomycin If rocuronium bromide is administered via the same infusion line that is also used for other drugs, it is important that this infusion line is adequately flushed between administration of rocuronium bromide and drugs for which incompatibility with rocuronium bromide has been demonstrated or for which compatibility with rocuronium bromide has not been established.
Infusion solutions should be used within 24 hours of mixing. Unused portions of infusion solutions should be discarded. 11 )]. Visual Inspection Parenteral drug products should be inspected visually for particulate matter and clarity prior to administration whenever solution and container permit.
Do not use solution if particulate matter is present.