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Use by I.V. bolus injection in adults: Tracheal intubation: The recommended intubation dose of Cissabex 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 summarizes mean pharmacodynamics data when Cissabex injection was administered at doses of 0.1 to 0.4 mg/kg to healthy adult patients during opioid (thiopentone/fentanyl/midazolam) or propofol anesthesia.(See Table 2.)
Click on icon to see table/diagram/imageEnflurane or isoflurane anesthesia may extend the clinically effective duration of an initial dose of Cissabex by as much as 15%.
Maintenance: Neuromuscular block can be extended with maintenance doses of Cissabex. A dose of 0.03 mg/kg provides approximately 20 minutes of additional clinically effective neuromuscular block during opioid or propofol anesthesia. 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 Cissabex dose administered. During opioid or propofol anesthesia, the median times from 25 to 75% and from 5 to 95% recovery are approximately 13 and 30 minutes, respectively.
Reversal: Neuromuscular block following Cissabex 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 Cissabex 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 Cissabex. Pharmacodynamic data for this dose are presented in the Tables 3 and 4. If a shorter clinical duration is required, pharmacodynamics data suggest that a dose of 0.1 mg/kg may produce similar intubation conditions at 120 to 150 seconds.
In pediatric patients aged 1 month to 12 years, Cissabex has a shorter clinically effective duration and a faster spontaneous recovery profile than those observed in adults under similar anesthetic conditions. Small differences in the pharmacodynamics profile were observed between the age ranges 1 to 11 months and 1 to 12 years which are summarized in Tables 3 and 4 as follows. (See Tables 3 and 4.)
Click on icon to see table/diagram/image
Click on icon to see table/diagram/imageHalothane may be expected to extend the clinically effective duration of Cissabex by up to 20%. No information is available on the use of Cissabex in children during isoflurane or enflurane anesthesia but these agents may also be expected to extend the clinically effective duration of a dose of Cissabex by up to 20%.
Maintenance: Neuromuscular block can be extended with maintenance doses of Cissabex injection. A dose of 0.02 mg/kg provides approximately 9 minutes of additional clinically effective neuromuscular block during halothane anesthesia. 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 Cissabex dose administered. During opioid or halothane anesthesia, the median times from 25 to 75% and from 5 to 95% recovery are approximately 11 and 28 minutes, respectively.
Reversal: Neuromuscular block following Cissabex 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 Cissabex. An initial infusion rate of 3 mcg/kg/min (0.18 mg/kg/hr) is recommended to restore 89 to 99% T1 suppression following evidence of spontaneous recovery. After an initial period of stabilization of neuromuscular block, a rate of 1 to 2 mcg/kg/min (0.06 to 0.12 mg/kg/hr) 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 Cissabex is administered during isoflurane or enflurane anesthesia.
The infusion rate will depend upon the concentration of Cissabex in the infusion solution, the desired degree of neuromuscular block, and the patient's weight. Table 5 provides guidelines for delivery of undiluted Cissabex. (See Table 5.)
Click on icon to see table/diagram/imageSteady rate continuous infusion of Cissabex is not associated with a progressive increase or decrease in neuromuscular blocking effect.
Following discontinuation of infusion of Cissabex, spontaneous recovery from neuromuscular block proceeds at a rate comparable to that following administration of a single bolus.
Although not specifically studied in pediatric patients under 2 years of age, extrapolation of pharmacodynamics data for bolus doses suggests that Cissabex infusion rates should be similar.
Neonates aged less than 1 month: No dosage recommendation for neonates can be made as administration of Cissabex has not been studied in this patient population.
Elderly: No dosing alterations are required in elderly patients. In these patients Cissabex has a similar pharmacodynamics 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 Cissabex has a similar pharmacodynamics 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 Cissabex has a similar pharmacodynamics profile to that observed in patients with normal hepatic function but it may have a slightly faster onset.
Patients with cardiovascular disease: Cissabex 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 Cissabex 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: Cissabex may be administered by bolus dose and/or infusion to adult patients in the ICU.
An initial infusion rate of Cissabex of 3 mcg/kg/min (0.18 mg/kg/hr) 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 mcg/kg/min [range 0.5 to 10.2 mcg/kg/min (0.03 to 0.6 mg/kg/hr)]. Table 6 provides guidelines for delivery of undiluted Cissabex.
The median time to full spontaneous recovery following long-term (up to 6 days) infusion of Cissabex in ICU patients was approximately 50 minutes. (See Table 6.)
Click on icon to see table/diagram/imageThe recovery profile after infusions of Cissabex to ICU patients is independent of duration of infusion.
Patients undergoing hypothermic cardiac surgery: There have been no studies of Cissabex 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.
