Nimbex

Nimbex Dosage/Direction for Use

cisatracurium

Manufacturer:

GlaxoSmithKline

Distributor:

Aspen
Full Prescribing Info
Dosage/Direction for Use
As with other neuromuscular blocking agents, monitoring of neuromuscular function is recommended during the use of Cisatracurium (Nimbex) in order to individualise dosage requirements.
Use by I.V. bolus injection in adults: Tracheal intubation: The recommended intubation dose of Cisatracurium (Nimbex) for adults is 0.15 mg/kg administered rapidly over 5 to 10 seconds. This dose produces good to excellent conditions for tracheal intubation 120 seconds following injection.
Higher doses will shorten the time to onset of neuromuscular block. Table 2 summarises mean pharmacodynamic data when Cisatracurium (Nimbex) injection was administered at doses of 0.1 to 0.4 mg/kg to healthy adult patients during opioid (thiopentone/fentanyl/midazolam) or propofol anaesthesia. (See Table 2.)

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Enflurane or isoflurane anaesthesia may extend the clinically effective duration of an initial dose of Cisatracurium (Nimbex) by as much as 15%.
Maintenance: Neuromuscular block can be extended with maintenance doses of Cisatracurium (Nimbex). A dose of 0.03 mg/kg 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 Cisatracurium (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 Cisatracurium (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 more than 0.7) are approximately 2 and 5 minutes, respectively, following administration of the reversal agent at an average of 13% T1 recovery.
Use by I.V. bolus injection in children (1 month to 12 years of age): Tracheal intubation: As in adults, the recommended initial intubation dose of Cisatracurium (Nimbex) is 0.15 mg/kg administered rapidly over 5 to 10 seconds.
This dose produces good to excellent conditions for tracheal intubation 120 seconds following injection of Cisatracurium (Nimbex). Pharmacodynamic data for this dose are presented in the tables 2 and 3. If a shorter clinical duration is required, pharmacodynamic data suggest that a dose of 0.1 mg/kg may produce similar intubation conditions at 120 to 150 seconds.
In paediatric patients aged 1 month to 12 years, Cisatracurium (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 as follows. (See Tables 3 and 4.)

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Halothane may be expected to extend the clinically effective duration of Cisatracurium (Nimbex) by up to 20%. No information is available on the use of Cisatracurium (Nimbex) in children during isoflurane or enflurane anaesthesia but these agents may also be expected to extend the clinically effective duration of a dose of Cisatracurium (Nimbex) by up to 20%.
Maintenance: Neuromuscular block can be extended with maintenance doses of Cisatracurium (Nimbex) injection. A dose of 0.02 mg/kg provides approximately 9 minutes of additional clinically effective neuromuscular block during halothane anaesthesia. Consecutive maintenance doses do not result in progressive prolongation of effect.
Spontaneous recovery: Once recovery from neuromuscular block is underway, the rate is independent of the Cisatracurium (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 Cisatracurium (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 more than or equal to 0.7) are approximately 2 and 5 minutes, respectively, following administration of the reversal agent at an average of 13% T1 recovery.
Use by I.V. infusion in adults and children (1 month to 12 years of age): Maintenance of neuromuscular block may be achieved by infusion of Cisatracurium (Nimbex). An initial infusion rate of 3 micrograms/kg/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 micrograms/kg/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 Cisatracurium (Nimbex) is administered during isoflurane or enflurane anaesthesia. (See Interactions).
The infusion rate will depend upon the concentration of Cisatracurium (Nimbex) in the infusion solution, the desired degree of neuromuscular block, and the patient's weight. Table 5 provides guidelines for delivery of undiluted Cisatracurium (Nimbex). (See Table 5.)

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Steady rate continuous infusion of Cisatracurium (Nimbex) is not associated with a progressive increase or decrease in neuromuscular blocking effect.
Following discontinuation of infusion of Cisatracurium (Nimbex), spontaneous recovery from neuromuscular block proceeds at a rate comparable to that following administration of a single bolus.
Although not specifically studied in paediatric patients under 2 years of age, extrapolation of pharmacodynamic data for bolus doses suggests that Cisatracurium (Nimbex) infusion rates should be similar.
Neonates aged less than 1 month: No dosage recommendation for neonates can be made as administration of Cisatracurium (Nimbex) has not been studied in this patient population.
Elderly: No dosing alterations are required in elderly patients. In these patients Cisatracurium (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.
Patients with renal impairment: No dosing alterations are required in patients with renal failure. In these patients Cisatracurium (Nimbex) has a similar pharmacodynamic profile to that observed in patients with normal renal function but it may have a slightly slower onset.
Patients with hepatic impairment: No dosing alterations are required in patients with end-stage liver disease. In these patients Cisatracurium (Nimbex) has a similar pharmacodynamic profile to that observed in patients with normal hepatic function but it may have a slightly faster onset.
Patients with cardiovascular disease: Cisatracurium (Nimbex) has been used effectively to provide neuromuscular block in patients undergoing cardiac surgery. When administered by rapid bolus injection (over 5 to 10 seconds) to patients with serious cardiovascular disease Cisatracurium (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)).
ICU patients: Cisatracurium (Nimbex) may be administered by bolus dose and/or infusion to adult patients in the ICU.
An initial infusion rate of Cisatracurium (Nimbex) of 3 micrograms/kg/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 micrograms/kg/min [range 0.5 to 10.2 micrograms/kg/min (0.03 to 0.6 mg/kg/h)]. Table 6 provides guidelines for delivery of undiluted Cisatracurium (Nimbex).
The median time to full spontaneous recovery following long-term (up to 6 days) infusion of Cisatracurium (Nimbex) in ICU patients was approximately 50 minutes. (See Table 6.)

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The recovery profile after infusions of Cisatracurium (Nimbex) to ICU patients is independent of duration of infusion.
Patients Undergoing Hypothermic Cardiac Surgery: There have been no studies of Cisatracurium (Nimbex) in patients undergoing surgery with induced hypothermia (25°C to 28°C). As with other neuromuscular blocking agents, the rate of infusion required to maintain adequate surgical relaxation under these conditions may be expected to be significantly reduced.
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