Nimbex賽機寧

Nimbex Special Precautions

cisatracurium

Manufacturer:

Aspen Pharmacare Asia

Distributor:

Cordial Trading
/
Primal
Full Prescribing Info
Special Precautions
NIMBEX paralyses the respiratory muscles as well as other skeletal muscles but has no known effect on consciousness or pain threshold. NIMBEX should be only 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.
Caution should be exercised when administering NIMBEX to patients who have shown hypersensitivity to other neuromuscular blocking agents since a high rate cross-sensitivity (greater than 50%) between neuromuscular blocking agents has been reported (see Contraindications).
NIMBEX does not have significant vagolytic or ganglion-blocking properties. Consequently, NIMBEX has no clinically significant effect on heart rate and will not counteract the bradycardia produced by many anaesthetic agents or by vagal stimulation during surgery.
Patients with myasthenia gravis and other forms of neuromuscular disease have shown greatly increased sensitivity to non-depolarising blocking agents. An initial dose of not more than 0.02 mg/kg NIMBEX 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.
There is no information on the use of NIMBEX in neonates aged less than one month since it has not been studied in this patient population.
NIMBEX has not been studied in patients with a history of malignant hyperthermia. Studies in malignant hyperthermia-susceptible pigs indicated that NIMBEX does not trigger this syndrome.
There have been no studies of cisatracurium in patients undergoing surgery with induced hypothermia (25 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.
NIMBEX has not been studied in patients with burns; however, as with other non-depolarising neuromuscular blocking agents, the possibility of increased dosing requirements and shortened duration of action must be considered if NIMBEX is administered to these patients.
NIMBEX is hypotonic and must not be applied into the infusion line of a blood transfusion.
Intensive Care Unit (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.
In the most sensitive animal species, these effects occurred at laudanosine plasma concentrations similar to those that have been observed in some ICU patients following prolonged infusion of atracurium.
Consistent with the decreased infusion rate requirements of NIMBEX, plasma laudanosine concentrations are approximately one third those following atracurium infusion.
There have been rare reports of seizures 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, hypoxic encephalopathy, cerebral oedema, viral encephalitis, uraemia).
A causal relationship to laudanosine has not been established.
Effects on the Ability to Drive and Operate Machinery: This precaution is not relevant to the use of NIMBEX. NIMBEX will always be used in combination with a general anaesthetic and therefore the usual precautions relating to performance of tasks following general anaesthesia apply.
Fertility: Fertility studies have not been performed.
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