Notrixum Special Precautions

In common with all other neuromuscular-blocking agents, Notrixum paralyses the respiratory muscles as well as other skeletal muscles, but has no effect on consciousness. Notrixum should be administered only with adequate general anesthesia and only by or under the close supervision of an experienced anesthetist with adequate facilities for endotracheal intubation and artificial ventilation. In common with other neuromuscular-blocking agents, the potential for histamine release exists in susceptible patients during Notrixum administration. Caution should be exercised in administering Notrixum in patients with a history suggestive of an increased sensitivity to the effect of histamine. Notrixum does not have significant vagal or ganglionic-blocking properties in the recommended dosage range. Consequently, Notrixum has no clinically significantly effects on heart rate in the recommended dosage range and it will not counteract the bradycardia produced by many anesthetic agents or by vagal stimulation during surgery.
In common with other nondepolarising neuromuscular-blocking agents, increased sensitivity to Atracurium may be expected in patients with myasthenia gravis, other forms of neuromuscular disease and severe electrolyte imbalance.
Notrixum should be administered over a period of 60 seconds to patients who may be unusually sensitive to fall in arterial blood pressure, e.g. those who are hypovolaemic.
When a small vein is selected as the injection side, Atracurium should be flushed through the vein with physiological saline after injection. When other anesthetic drugs are administered through the same in dwelling needle or cannula as Notrixum is important that each drug is flushed through with an adequate volume of physiological saline.
Atracurium besylate is hypotonic and must not be administered into the infusion line of a blood transfusion.
Studies of malignant hyperthermia in susceptible animals (swine) and clinical studies in patients susceptible to malignant hyperthermia indicate that Notrixum, does not trigger this syndrome.
In common with other nondepolarising 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.
Carcinogenicity, Mutagenicity and Impairment of Fertility: Atracurium has been evaluated in 3 short term mutagenicity test. It was not mutagenic in either the in vitro Ames salmonella assay at concentrations up to 1000 μg/plate or in an in vivo rat bone marrow assay at doses up to those which resulted in neuromuscular blockade. In a 2nd in vitro test, the mouse lymphoma assay, mutagenicity was not observed at doses up to 60 μg/ml which killed up to 50 % of the treated cell, but it was moderately mutagenic at concentrations of 80 μg/ml in the absence of metabolizing agent and weakly mutagenic at very high concentrations (1200 μg/ml) when metabolizing enzymes were added. At both concentrations, >80 % of the cells were killed.
In view of the nature of human exposure to Atracurium, the mutagenic risk to patients undergoing surgical relaxation with Notrixum must be considered negligible. Fertility studies have not been performed.