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ATRACURIUM is a brand name for Atracurium. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Atracurium is used intravenously as an adjunct to general anaesthesia, during surgical and other procedures and in intensive care to facilitate tracheal intubation and controlled ventilation.
Verbatim from this product's MHRA label. Tap a section to expand.
Route of administration:
Intravenous injection or continuous infusion. Posology In common with all neuromuscular blocking agents, monitoring of neuromuscular function is recommended during the use of atracurium besilate injection, in order to individualise dosage requirements.
Use in anaesthesia ● In adults:
Use as an injection Atracurium besilate is administered by intravenous injection and must not be applied intramuscularly. 6 mg atracurium/kg (depending on the duration of full block required). This dose will provide adequate relaxation for about 15 to 35 minutes.
6 mg atracurium/kg. 2 mg atracurium/kg. Generally, the first maintenance dose is required 20 to 45 minutes after the initial bolus dose, then typically at 15 to 25 minutes intervals, however, the need for maintenance doses should be determined by the individual patient's requirements and responses.
Successive supplementary dosing does not produce accumulation in neuromuscular blocking effect. As measured by the restoration of the tetanic response to 95% of normal neuromuscular function, spontaneous recovery occurs about 35 minutes after a full block.
The neuromuscular block produced by atracurium besilate can be rapidly reversed by standard doses of anticholinesterase agents, such as neostigmine and edrophonium, accompanied or preceded by atropine or glycopyrrolate, with no evidence of recurarisation.
● In adults: Use as an infusion Atracurium besilate is hypotonic and must not be administered via the infusion system of a blood transfusion. In this case atracurium besilate has to be administered via a separate infusion line. 6 mg/kg/hour, can be used to maintain neuromuscular block during long surgical procedures.
Atracurium besilate can be administered by infusion during cardiopulmonary bypass surgery at the recommended infusion rates. Induced hypothermia with body temperature of 25 to 26°C reduces the rate of degradation of atracurium besilate, therefore full neuromuscular block may be maintained with approximately half the original infusion rate at these low temperatures.
• Use in paediatric population On a bodyweight basis the dosage in children over the age of 1 month is similar to that in adults. 1). In case of a necessary neuromuscular blockade also in newborn or premature newborn the dose has to be significantly lowered.
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.
Adverse reactions are listed below by system organ class and frequency.
Frequencies are defined as:
Very common (≥1/10) Common (≥1/100 to < 1/10) Uncommon (≥1/1,000 to < 1/100) Rare (≥1/10,000 to < 1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data).
Immune system disorders Very rare:
Anaphylactic and anaphylactoid reactions including shock, circulatory failure and cardiac arrest. Very rarely, severe anaphylactoid or anaphylactic reactions have been reported in patients receiving atracurium besilate in conjunction with one or more anaesthetic agents.
Nervous system disorders Very rare:
Seizures There have been reports of seizures in patients in ICUs who had been receiving atracurium besilate simultaneously with other pharmacological agents. These patients generally had one or more medical conditions which made them susceptible to seizures (such as brain injury, cerebral oedema, viral encephalitis, hypoxic encephalopathy, uraemia).
A causal relationship to laudanosine (a metabolite of atracurium besilate) has not been established. 2).
Cardiac disorders Common:
Tachycardia Vascular disorders Common: Mild transient hypotension, skin flushing Respiratory, thoracic and mediastinal disorders Common: Wheezing, bronchospasm Very rare: Laryngospasm Skin and subcutaneous tissue disorders Common: Urticaria Musculoskeletal and connective tissue disorders Very rare: Myopathy, muscle weakness.
In common with all the other neuromuscular blocking agents, atracurium besilate paralyses the respiratory muscles as well as other skeletal muscles but has no effect on consciousness. Atracurium besilate has to be administered only with adequate general anaesthesia and only by or under the close supervision of an experienced anaesthetist, with adequate facilities and staff for endotracheal intubation and artificial ventilation, as well as an antidote, immediately at hand.
Atracurium besilate must not be applied intramuscularly. 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 atracurium. As with other non-depolarising neuromuscular blockers hypophosphataemia may prolong recovery.
Recovery may be hastened by correcting this condition. As with other neuromuscular blocking agents, the potential for histamine release exists in susceptible patients during atracurium besilate administration. Caution should be exercised in administering atracurium besilate 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.
Atracurium is contraindicated in patients known to be hypersensitive to atracurium, cisatracurium or benzenesulfonic acid.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• Use in special populations Use in the elderly: Atracurium besilate may be used at standard dosage in elderly patients. It is recommended, however, that the initial dose be at the lower end of the range and that it be administered slowly.
Use in patients with reduced renal and/or hepatic function:
Atracurium besilate may be used at standard dosage at all levels of renal or hepatic function, including endstage failure.
Use in patients with cardiovascular disease:
In patients with clinically significant cardiovascular disease, the initial dose of Atracurium besilate should be administered over a period of 60 seconds. • Use in patients suffering from burns: As 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.
Use in patients in intensive care units (ICU):
When there is a need of atracurium besilate for long-term mechanical ventilation in intensive care units, the benefit to risk ratio of neuromuscular block must be considered. 78 mg/kg/h). There is, however, a great variety of dosage requirements between patients.
77 mg/kg/h). Dosage requirements may change over time. The speed of spontaneous recovery from neuromuscular block after infusion of atracurium besilate in ICU patients is independent of the duration of administration. 75 (the ratio of the peak of the fourth to the first contraction in a train of four) which occurs on average in approximately 60 minutes with a range of approximately 32 - 108 minutes (n = 6) has been observed in clinical trials.
The few findings currently available regarding long-term use of atracurium besilate indicate only minor influence of haemofiltration and haemodialysis on the plasma levels of atracurium besilate and its metabolites. The effect of the haemoperfusion on the level of Atracurium and its metabolites in plasma is not known.
Monitoring:
In common with all neuromuscular blocking agents, monitoring of neuromuscular function is recommended during the use of Atracurium besilate in order to individualise dosage requirements.
After prolonged use of atracurium besilate in severely ill ICU patients myasthenia and/or myopathy have been observed. The majority of these patients received concomitant corticosteroids. Causal connection with atracurium besilate therapy is not established.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Monitoring of cpk (Creatinphosphokinase) should be considered in asthmatic patients receiving high-dose corticosteroids and neuromuscular blocking agents in ICU. Histamine release can be minimized by slow administration or by divided doses over at least one minute.
Atracurium besilate is hypotonic and must not be administered via the infusion system of a blood transfusion, because it might cause haemolysis. 7. 2) Atracurium is inactivated by high pH and so must not be mixed in the same syringe with thiopentone or any alkaline agent.
Atracurium besilate should be administered - slowly or in partial doses - over a period of 60 - 120 seconds to patients abnormally susceptible to falls in arterial blood pressure, for example those who are hypovolaemic. Atracurium besilate does not have significant vagal or ganglionic blocking properties in the recommended dosage range.
Consequently, atracurium besilate has no significant effects on heart rate in the recommended dosage range. Bradycardia produced by other anaesthetic agents or by vagal stimulation during surgery will not be counteracted by atracurium besilate and may therefore occur at a higher severity.
After injecting atracurium besilate into a small vein, physiological saline solution should be flushed through the vein. If other anaesthetic medicinal products are administered through the same in-dwelling needle or cannula as atracurium besilate, it is important that after each medicinal product an adequate volume of water for injection or physiological saline is flushed through.
2). Such patients may require increased doses dependent on the time elapsed since the burn injury and the extent of the burn. Atracurium besilate has no direct effect on the intra-ocular pressure, which makes it suitable for use in ophthalmic surgery.
Studies in malignant hyperthermia in susceptible animals (swine) and clinical studies in patients susceptible to malignant hyperthermia indicate that atracurium besilate does not trigger this syndrome.
Intensive Care unit (ICU) Patients:
When administered to laboratory animals in high doses, laudanosine, a metabolite of atracurium, has been associated with transient hypotension and in some species, cerebral excitatory effects. 8).