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Higher doses will shorten the time to onset of neuromuscular block. Table 2 summarises mean pharmacodynamic data when NIMBEX was administered at doses of 0.1 to 0.4 mg/kg (body weight) to healthy adult patients during opioid (thiopentone/fentanyl/midazolam) or propofol anaesthesia. (See Table 2.)
Click on icon to see table/diagram/imageEnflurane or isoflurane anaesthesia may extend the clinically effective duration of an initial dose of NIMBEX by as much as 15%.
Maintenance: Neuromuscular block can be extended with maintenance doses of NIMBEX. A dose of 0.03 mg/kg (body weight) provides approximately 20 minutes of additional clinically effective neuromuscular block during opioid or propofol anaesthesia. Consecutive maintenance doses do not result in progressive prolongation of effect.
Spontaneous Recovery: Once spontaneous recovery from neuromuscular block is underway, the rate is independent of the NIMBEX dose administered. During opioid or propofol anaesthesia, the median times from 25 to 75% and from 5 to 95% recovery are approximately 13 and 30 minutes, respectively.
Reversal: Neuromuscular block following NIMBEX administration is readily reversible with standard doses of anticholinesterase agents. The mean times from 25 to 75% recovery and to full clinical recovery (T4:T1 ratio ≥0.7) are approximately 4 and 9 minutes respectively, following administration of the reversal agent at an average of 10% T1 recovery.
Dosage in Paediatric Patients: Tracheal Intubation: Paediatric Patients Aged 1 Month to 12 Years: As in adults, the recommended intubation dose of NIMBEX is 0.15 mg/kg (body weight) administered rapidly over 5 to 10 seconds.
This dose produces good to excellent conditions for tracheal intubation 120 seconds following injection of NIMBEX. Pharmacodynamic data for this dose are presented in the Tables 3, 4 and 5.
NIMBEX has not been studied for intubation in ASA Class III-IV paediatric patients. There are limited data on the use of NIMBEX in paediatric patients under 2 years of age undergoing prolonged or major surgery.
In paediatric patients aged 1 month to 12 years, NIMBEX has a shorter clinically effective duration and a faster spontaneous recovery profile than those observed in adults under similar anaesthetic conditions. Small differences in the pharmacodynamic profile were observed between the age ranges 1 to 11 months and 1 to 12 years which are summarised in Tables 3 and 4. (See Tables 3 and 4.)
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Click on icon to see table/diagram/imageWhen NIMBEX is not required for intubation: A dose of less than 0.15 mg/kg can be used. Pharmacodynamic data for doses of 0.08 and 0.1 mg/kg for paediatric patients aged 2 to 12 years are presented in Table 5: See Table 5.
Click on icon to see table/diagram/imageAdministration of NIMBEX following suxamethonium has not been studied in paediatric patients (see Interactions).
Halothane may be expected to extend the clinically effective duration of a dose of NIMBEX by up to 20%. No information is available on the use of NIMBEX in children during anaesthesia with other halogenated fluorocarbon anaesthetic agents, but these agents may also be expected to extend the clinically effective duration of a dose of NIMBEX.
Maintenance: Paediatric Patients Aged 2-12 Years: Neuromuscular block can be extended with maintenance doses of NIMBEX. In paediatric patients aged 2 to 12 years, a dose of 0.02 mg/kg (body weight) provides approximately 9 minutes of additional clinically effective neuromuscular block during halothane anaesthesia. Consecutive maintenance doses do not result in progressive prolongation of effect.
There are insufficient data to make a specific recommendation for maintenance dosing in paediatric patients under 2 years of age. However, very limited data from clinical studies in paediatric patients under 2 years of age suggest that a maintenance dose of 0.03 mg/kg may extend clinically effective neuromuscular block for a period of up to 25 minutes during opioid anaesthesia.
Spontaneous Recovery: Once recovery from neuromuscular block is underway, the rate is independent of the NIMBEX dose administered. During opioid or halothane anaesthesia, the median times from 25 to 75% and from 5 to 95% recovery are approximately 11 and 28 minutes, respectively.
Reversal: Neuromuscular block following NIMBEX administration is readily reversible with standard doses of anticholinesterase agents. The mean times from 25 to 75% recovery and to full clinical recovery (T4:T1 ratio ≥0.7) are approximately 2 and 5 minutes respectively, following administration of the reversal agent at an average of 13% T1 recovery.
Use by Intravenous Infusion: Dosage in Adults and Children Aged 2 to 12 Years: Maintenance of neuromuscular block may be achieved by infusion of NIMBEX. An initial infusion rate of 3 μg/kg (body weight)/min (0.18 mg/kg/h) is recommended to restore 89 to 99% T1 suppression following evidence of spontaneous recovery. After an initial period of stabilisation of neuromuscular block, a rate of 1 to 2 μg/kg (body weight)/min (0.06 to 0.12 mg/kg/h) should be adequate to maintain block in this range in most patients. Reduction of the infusion rate by up to 40% may be required when NIMBEX is administered during isoflurane or enflurane anaesthesia (see Interactions).
The infusion rate will depend upon the concentration of NIMBEX in the infusion solution, the desired degree of neuromuscular block, and the patient's weight. Table 6 provides guidelines for delivery of undiluted NIMBEX. (See Table 6.)
Click on icon to see table/diagram/imageSteady rate continuous infusion of NIMBEX is not associated with a progressive increase or decrease in neuromuscular blocking effect.
Following discontinuation of infusion of NIMBEX, spontaneous recovery from neuromuscular block proceeds at a rate comparable to that following administration of a single bolus.
Dosage in Neonates Aged Less Than 1 Month: The use of NIMBEX in neonates is not recommended as it has not been studied in this patient population.
Dosage in Elderly Patients: No dosing alterations are required in elderly patients. In these patients NIMBEX has a similar pharmacodynamic profile to that observed in young adult patients but, as with other neuromuscular blocking agents, it may have a slightly slower onset.
Dosage in Patients with Renal Impairment: No dosing alterations are required in patients with renal failure. In these patients NIMBEX has a similar pharmacodynamic profile to that observed in patients with normal renal function but it may have a slightly slower onset.
Dosage in Patients with Hepatic Impairment: No dosing alterations are required in patients with end-stage liver disease. In these patients NIMBEX has a similar pharmacodynamic profile to that observed in patients with normal hepatic function but it may have a slightly faster onset.
Dosage in Patients with Cardiovascular Disease: When administered by rapid bolus injection (over 5 to 10 seconds) to adult patients with serious cardiovascular disease (New York Heart Association Class I-III) undergoing coronary artery bypass graft (CABG) surgery, NIMBEX has not been associated with clinically significant cardiovascular effects at any dose studied (up to and including 0.4 mg/kg (8 x ED95).
However, there are limited data for doses above 0.3 mg/kg in this patient population). NIMBEX has not been studied in children undergoing cardiac surgery.
Dosage in Intensive Care Unit (ICU) Patients: NIMBEX may be administered by bolus dose and/or infusion to adult patients in the ICU. An initial infusion rate of NIMBEX of 3 μg/kg (body weight)/min (0.18 mg/kg/h) is recommended for adult ICU patients. There may be wide inter-patient variation in dosage requirements and these may increase or decrease with time. In clinical studies the average infusion rate was 3 μg/kg/min [range 0.5 to 10.2 μg/kg (body weight)/min (0.03 to 0.6 mg /kg/h)]. Table 7 provides guidelines for delivery of undiluted NIMBEX (2 mg/mL) injection.
The median time to full spontaneous recovery following long-term (up to 6 days) infusion of NIMBEX in ICU patients was approximately 50 minutes. (See Table 7.)
Click on icon to see table/diagram/imageThe recovery profile after infusions of NIMBEX to ICU patients is independent of duration of infusion.
Administration: NIMBEX is an intermediate-duration, non-depolarising neuromuscular blocking agent for intravenous (i.v.) administration.
NIMBEX should only be administered by or under the supervision of anaesthetists or other clinicians who are familiar with the use and action of neuromuscular blocking agents. Facilities for tracheal intubation, and maintenance of pulmonary ventilation and adequate arterial oxygenation have to be available.
Please note that NIMBEX should not be mixed in the same syringe or administered simultaneously through the same needle as propofol injectable emulsion, ketorolac trometamol or with alkaline solutions such as sodium thiopentone. (See Incompatibilities under Cautions for Usage).
NIMBEX contains no antimicrobial preservative and is intended for single patient use.
Monitoring Advice: As with other neuromuscular blocking agents, monitoring of neuromuscular function is recommended during the use of NIMBEX in order to individualise dosage requirements.
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