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Use by intravenous bolus injection: Dosage in adults: Endotracheal Intubation: The recommended intubation dose of cisatracurium for adults is 0.15 mg/kg (body weight). Endotracheal intubation can be accomplished 120 seconds after administration of Cisatracurium Kabi, following induction of anaesthesia with propofol.
Higher doses will shorten the time to onset of neuromuscular block.
The following table summarises mean pharmacodynamic data when cisatracurium 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 1.)
Click on icon to see table/diagram/imageEnflurane or isoflurane anaesthesia may extend the clinically effective duration of an initial dose of cisatracurium by up to 15%.
Maintenance dosage: Neuromuscular block can be extended with maintenance doses of cisatracurium. A dose of 0.03 mg/kg (body weight) provides approximately 20 minutes of additional clinically effective neuromuscular block during opioid or propofol anaesthesia.
Successive supplementary dosing does not produce accumulation in neuromuscular blocking effect.
Spontaneous Recovery: Once evidence of spontaneous recovery from neuromuscular block is present, the duration until complete reversal is independent of the cisatracurium dose administered. During opioid or propofol anaesthesia, the mean duration for recovery from 25 to 75% and from 5 to 95% is approximately 13 and 30 minutes, respectively.
Reversal: Neuromuscular block following cisatracurium administration is readily reversible with standard doses of anticholinesterase agents. The mean duration of recovery from 25 to 75% and to full clinical recovery (T4:T1 ratio ≥ 0.7) is approximately 4 and 9 minutes, respectively, following administration of the reversal agent at an average T1 recovery of 10%.
Dosage in paediatric population: Endotracheal Intubation (paediatric patients aged 1 month to 12 years): As in adults, the recommended intubation dose of cisatracurium is 0.15 mg/kg (body weight) administered rapidly over 5 to 10 seconds. Endotracheal intubation can be accomplished 120 seconds after administration of cisatracurium.
Pharmacodynamic data for this dose are presented in the following tables.
Cisatracurium has not been studied for intubation in ASA Class III-IV paediatric patients. There are limited data on the use of cisatracurium in paediatric patients under 2 years of age undergoing prolonged or major surgery.
In paediatric patients aged 1 month to 12 years, cisatracurium 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 the following tables. (See Tables 2 and 3.)
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Click on icon to see table/diagram/imageWhen cisatracurium 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 the following table: See Table 4.
Click on icon to see table/diagram/imageAdministration of cisatracurium following suxamethonium has not been studied in paediatric patients (see Interactions).
Halothane may extend the clinically effective duration of a dose of cisatracurium by up to 20%.
No information is available on the use of cisatracurium in children during anaesthesia with other halogenated fluorocarbon anaesthetic agents. Nevertheless, these agents may also be expected to extend the clinically effective duration of a cisatracurium dose.
Maintenance (paediatric patients aged 2-12 years): Neuromuscular block can be extended with maintenance doses of cisatracurium. 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.
Successive supplementary dosing does not produce accumulation in neuromuscular blocking effect.
There are insufficient data available for recommendation of 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 evidence of spontaneous recovery from neuromuscular block is present, the duration until complete reversal is independent of the cisatracurium dose administered. During opioid or halothane anaesthesia, the mean duration for recovery from 25 to 75% and from 5 to 95% are approximately 11 and 28 minutes, respectively.
Reversal: Neuromuscular block following cisatracurium administration is readily reversible with standard doses of anti-cholinesterase agents. The mean duration of recovery from 25 to 75% 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 T1 recovery of 13%.
Use by intravenous infusion: Dosage in adults and children aged 2 to 12 years: Maintenance of neuromuscular block is achieved by infusion of Cisatracurium Kabi. Following evidence of spontaneous recovery, an initial infusion rate of 3 μg/kg/min (0.18 mg/kg/h) is recommended to restore 89 to 99% T1 suppression. After a primary stabilisation period of the neuromuscular block, an infusion rate of 1 to 2 μg/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 is administered during isoflurane or enflurane anaesthesia (see Interactions).
The infusion rate depends on the concentration of cisatracurium in the infusion solution, the desired degree of neuromuscular block, and the patient's body weight. The following table provides guidelines for infusion of undiluted Cisatracurium Kabi. (See Table 5.)
Click on icon to see table/diagram/imageSteady rate continuous infusion is not associated with a progressive increase or decrease in neuromuscular blocking effect.
Following termination of infusion, spontaneous recovery from neuromuscular block proceeds at a rate comparable to that following administration of a single bolus injection.
Use by intravenous bolus injection and/or by intravenous infusion: Dosage in adults: Intensive Care Unit (ICU) patients: Cisatracurium Kabi may be administered by bolus dose and/or infusion to adult patients in the ICU.
An initial infusion rate of 3 μg/kg/min (0.18 mg/kg/h) is recommended for adult ICU patients. There may be wide interpatient 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)].
The mean duration to full spontaneous recovery following long-term (up to 6 days) infusion of cisatracurium in ICU patients was approximately 50 minutes.
The recovery profile after infusions of cisatracurium to ICU patients is independent of the duration of the infusion.
Special populations: Dosage in elderly patients: No dosing alterations are required in elderly patients. In these patients a pharmacodynamic profile similar to young adult patients is observed but, as with other neuromuscular blocking agents, a delayed onset might occur.
Dosage in patients with renal impairment: No dosing alterations are required in patients with renal failure.
In these patients a similar pharmacodynamic profile to that in patients with normal renal function is observed but a delayed onset might occur.
Dosage in patients with hepatic impairment: No dosing alterations are required in patients with end-stage liver disease. In these patients a similar pharmacodynamic profile to that in patients with normal hepatic function is observed but a slightly accelerated onset might occur.
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, cisatracurium has not been associated with clinically significant cardiovascular effects at any dose studied (maximal 0.4 mg/kg (8x ED95). However, there are limited data for doses above 0.3 mg/kg bw in this patient population.
Cisatracurium has not been studied in children undergoing cardiac surgery.
Paediatric population: Dosage in new-born infants (aged less than 1 month): The use of cisatracurium in new-born infants is not recommended as it has not been studied in this patient population.
Method of administration: Cisatracurium Kabi is for intravenous use.
Cisatracurium Kabi contains no antimicrobial preservative and is intended for single dose use only.
The medicinal product should be visually inspected prior to use. The solution should only be used if it is clear and colourless or almost colourless up to slightly yellow/greenish yellow, practically free from particles and if the container is undamaged. If the visual appearance has changed or if the container is damaged, the product must be discarded.
For instructions on dilution of the medicinal product before administration, see Storage.
