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5 x 25 mg / 2.5 ml
5 X 50 mg / 5 ml
Used by injection in adults: Tracrium is administered by intravenous injection. The dosage range recommended for adults is 0.3 to 0.6 mg/kg (depending on the duration of full block required) and will provide adequate relaxation for about 15 to 35 minutes. Endotracheal intubation can usually be accomplished within 90 seconds from the intravenous injection of 0.5 to 0.6 mg/kg. Full block can be prolonged with supplementary doses of 0.1 to 0.2 mg/kg as required. Successive supplementary dosing does not give rise to accumulation of neuromuscular blocking effect. Spontaneous recovery from the end of full block occurs in about 35 minutes as measured by the restoration of the tetanic response to 95% of normal neuromuscular function. The neuromuscular block produced by Tracrium can be rapidly reversed by standard doses of anticholinesterase agents, such as neostigmine and edrophonium, accompanied or preceded by atropine, with no evidence of recurarisation.
Use as an infusion in adults: After an initial bolus dose of 0.3 to 0.6 mg/kg, Tracrium can be used to maintain neuromuscular block during long surgical procedures by administration as a continuous infusion at rates of 0.3 to 0.6mg/kg/hour. to a body temperature of
Tracrium can be administered by infusion during cardiopulmonary bypass surgery at the recommended infusion rates. Induced hypothermia 25o to 26oC reduces the rate of inactivation of atracurium, therefore full neuromuscular block may be maintained by approximately half the original infusion rate at these low temperatures.
For full details see prescribing information.
As adjunct to general anesthesia to enable tracheal intubation to be performed and to relax skeletal muscles during surgery or controlled ventilation.
In common with all the other neuromuscular blocking agents, Tracrium paralyses the respiratory muscles as well as other skeletal muscles but has no effect on consciousness. Tracrium should be administered only with adequate general anaesthesia and only by or under the close supervision of an experienced anaesthetist with adequate facilities for endotracheal intubation and artificial ventilation.
The potential for histamine release exists in susceptible patients during Tracrium administration. Caution should be exercised in administering Tracrium to patients with a history suggestive of an increased sensitivity to the effects of histamine. In particular, bronchospasm may occur in patients with a history of allergy and asthma. High rates of cross-sensitivity between neuromuscular blocking agents have been reported. Therefore, where possible, before administering atracurium, hypersensitivity to other neuromuscular blocking agents should be excluded. Atracurium should only be used when absolutely essential in susceptible patients. Patients who experience a hypersensitivity reaction under general anaesthesia should be tested subsequently for hypersensitivity to other neuromuscular blockers.
Monitoring of serial creatinine phosphate (cpk) values should be considered in asthmatic patients receiving high dose corticosteroids and neuromuscular blocking agents in ICU. Tracrium does not have significant vagal or ganglionic blocking properties in the recommended dosage range. Consequently, Tracrium has no clinically significant effects on heart rate in the recommended dosage range and it will not counteract the bradycardia produced by many anaesthetic agents or by vagal stimulation during surgery. In common with other non-depolarising neuromuscular blocking agents, increased sensitivity to atracurium may be expected in patients with myasthenia gravis and other forms of neuromuscular disease. As with other neuromuscular blocking agents severe acid-base and/or serum electrolyte abnormalities may increase or decrease the sensitivity of patients to atracrium. As with other non-depolarising neuromuscular blockers hypophosphataemia may prolong recovery. Recovery may be hastened by correcting this condition. Tracrium should be administered over a period of 60 seconds to patients who may be unusually sensitive to falls in arterial blood pressure, for example those who are hypovolaemic. Tracrium is inactivated by high pH and so must not be mixed in the same syringe with thiopental or any alkaline agent. When a small vein is selected as the injection site, Tracrium should be flushed through the vein with physiological saline after injection. When other anaesthetic drugs are administered through the same in-dwelling needle or cannula as Tracrium it is important that each drug is flushed through with an adequate volume of physiological saline. Atracurium besilate is hypotonic and must not be administered into the infusion line of a blood transfusion. Studies in malignant hyperthermia in susceptible animals (swine), and clinical studies in patients susceptible to malignant hypothermia indicate that Tracrium does not trigger this syndrome. In common with other non-depolarising neuromuscular blocking agents, resistance may develop in patients suffering from burns. Such patients may require increased doses, dependent on the time elapsed since the burn injury and the extent of the burn. Intensive Care Unit (ICU) patients: When administered to laboratory animals in high doses, Laudanosine, a metabolite of atracrium has been associated with transient hypotension and, in some species, cerebral excitatory effects. Although seizures have been seen in ICU patients receiving atracurium, a causal relationship to laudanosine has not been established.
Pregnancy and lactation: Should be used in pregnancy only if the potential benefit to the mother outweighs any potential risk to the fetus. It is not known whether Tracrium is excreted in human milk.
Use in the elderly: Initial dose should be at the lower end of the range and should be administered slowly.
The most commonly reported adverse reactions during treatment are hypotension (mild, transient) and skin flushing, these events are attributed to histamine release. Very rarely, severe anaphylactoid or anaphylactic reactions have been reported in patients receiving atracurium in conjunction with one or more anaesthetic agents.
For full details see prescribing information.
Halothane, isoflurane and enflurane. Antibiotics, including aminoglycosides, polymyxins, spectinomycin, tetracyclines, lincomycin and clindamycin. Propranolol, calcium channel blockers, lignocaine, procainamide, quinidine. Frusemide, mannitol, thiazide diuretics, acetazolamide; magnesium sulphate, ketamine, lithium salts; ganglion blocking agents; trimetaphan, hexamethonium. Chronic anticonvulsant therapy, suxamethonium chloride.
Pregnancy and Lactation
Fertility: Fertility studies have not been performed
Pregnancy: Animal studies have indicated that Tracrium has no significant effects on foetal development.
In common with all neuromuscular blocking agents, Tracrium should be used during pregnancy only if the potential benefit to the mother outweighs any potential risk to the foetus. Tracrium is suitable for maintenance of muscle relaxation during Caesarean section as it does not cross the placenta in clinically significant amounts following recommended doses.
Breast-feeding: It is not known whether Tracrium is excreted in human milk.
Symptoms: Prolonged muscle paralysis and its consequences are the main signs of overdose.
Management: It is essential to maintain a patient airway together with assisted positive pressure ventilation until spontaneous respiration is adequate. Full sedation will be required since consciousness is not impaired. Recovery may be hastened by the administration of anticholinesterase agents accompanied by atropine or glycopyrrolate, once evidence of spontaneous recovery is present.