Cissabex Special Precautions

Cissabex paralyses the respiratory muscles as well as other skeletal muscles but has no known effect on consciousness or pain threshold. Cissabex should be only administered by or under the supervision of anesthetists of 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 should be available.
Caution should be exercised when administering cisatracurium to patients who have shown hypersensitivity to other neuromuscular blocking agents since a high rate of cross-sensitivity (greater than 50%) between neuromuscular blocking agents has been reported.
Cissabex does not have significant vagolytic or ganglion-blocking properties. Consequently, Cissabex has no clinically significant effect on heart rate and will not counteract the bradycardia produced by many anesthetic agent or by vagal stimulation during surgery.
Patients with myasthenia gravis and other forms of neuromuscular disease have shown greatly increased sensitivity to non-depolarizing blocking agents. An initial dose of not more than 0.02 mg/kg Cissabex is recommended in these patients.
Severe acid-base and/or serum electrolyte abnormalities may increase or decrease the sensitivity of patients to neuromuscular blocking agents.
Cissabex has not been studied in patients with a history of malignant hyperthermia. Studies in malignant hyperthermia-susceptible pigs indicated that Cissabex does not trigger this syndrome.
Cissabex has not been studied in patients with burns; however, as with other non-depolarizing neuromuscular blocking agents, the possibility of increased dosing requirements and shortened duration of action must be considered if Cissabex is administered to these patients.
Cissabex is hypotonic and must not be administered into the infusion line of a blood transfusion.
ICU patients: When administered to laboratory animals in high doses, laudanosine, a metabolite of cisatracurium and atracurium, has been associated with transient hypotension and, in some species, cerebral excitatory effects.
Consistent with the decreased infusion rate requirements of Cissabex, plasma laudanosine concentrations are approximately one third those following atracurium infusion.
There have been rare reports of seizure in ICU patients who have received atracurium and other agents. These patients usually had one or more medical conditions predisposing to seizures (e.g., cranial trauma, hypoxia encephalopathy, cerebral edema, viral encephalitis, uremia).
A causal relationship to laudanosine has not been established.
Effects on ability to drive and use machine: This precaution is not relevant to the use of Cissabex. Cissabex will always be used in combination with a general anesthetic and therefore the usual precautions relating to performance of tasks following general anesthesia apply.