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ATRACURIUM BESILATE is a brand name for Atracurium. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Atracurium besilate is a highly selective, competitive or non-depolarising neuromuscular blocking agent. It is used as an adjunct to general anaesthesia or sedation in the intensive care unit (ICU), to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation.
Verbatim from this product's MHRA label. Tap a section to expand.
Route of administration:
Intravenous injection or continuous infusion. Used by injection in adults: atracurium besilate is administered by intravenous injection. 6 mg/kg (depending on the duration of full block required) and will provide adequate relaxation for about 15 to 35 minutes.
6 mg/kg. 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 atracurium besilate 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.
6mg/kg/hour. Atracurium besilate can be administered by infusion during cardiopulmonary bypass surgery at the recommended infusion rates. Induced hypothermia to a body temperature of 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.
5 mg/ml and above, the resultant solutions will be stable in daylight for the stated periods at temperatures of up to 30oC.
Use in Children:
The dosage in children over the age of one month is similar to that in adults on a bodyweight basis. 1). 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 end stage 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. 78 mg/kg/hr). There may be wide inter-patient variability in dosage requirements and these may increase or decrease with time.
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 and < 1/10, uncommon >1/1000 and < 1/100, rare >1/10,000 and < 1/1000, very rare < 1/10,000. Very common, common and uncommon frequencies were determined from clinical trial data.
Rare and very rare frequencies were generally derived from spontaneous data. The frequency classification "Not known" has been applied to those reactions where a frequency could not be estimated from the available data. Clinical Trial Data Vascular Disorders Common Hypotension (mild, transient)#, Skin flushing# Respiratory, thoracic and mediastinal disorders Uncommon Bronchospasm# Post-Marketing Data Immune system disorders Very rare Anaphylactic reaction, anaphylactoid reaction including anaphylactic shock, circulatory failure and cardiac arrest Very rarely, severe anaphylactoid or anaphylactic reactions have been reported in patients receiving atracurium in conjunction with one or more anaesthetic agents.
Nervous system disorder Not known Seizures There have been reports of seizures in ICU patients who have been receiving atracurium concurrently with several other agents. g. cranial trauma, cerebral oedema, viral encephalitis, hypoxic encephalopathy, uraemia).
A causal relationship to laudanosine has not been established. In clinical trials, there appears to be no correlation between plasma laudanosine concentration and the occurrence of seizures. Skin and subcutaneous tissue disorders Rare Urticaria Musculoskeletal and connective tissue disorders Not known Myopathy, muscle weakness There have been some reports of muscle weakness and/or myopathy following prolonged use of muscle relaxants in severely ill patients in the ICU.
Precautions:
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 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 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.
Monitoring of serial creatinine phosphate (cpk) values should be considered in asthmatic patients receiving high dose corticosteroids and neuromuscular blocking agents in ICU. Atracurium besilate does not have significant vagal or ganglionic blocking properties in the recommended dosage range.
Consequently, atracurium besilate 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.
4, Special Warnings and Precautions for Use).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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77 mg/kg/hr) are required in some patients. The rate 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 height of the fourth to the first twitch in a train-of-four) can be expected to occur in approximately 60 minutes.
A range of 32 to 108 minutes has been observed in clinical trials.
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.
Most patients were receiving concomitant corticosteroids. These events have been seen infrequently in association with atracurium and a causal relationship has not been established. Events which have been attributed to histamine release are indicated by a hash (#) Description of selected adverse reactions Anaphylactic reaction, anaphylactoid reaction including anaphylactic shock: Very rarely, severe anaphylactoid or anaphylactic reactions including anaphylactic shock have been reported in patients receiving atracurium in conjunction with one or more anaesthetic agents.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
As with other non-depolarising neuromuscular blockers hypophosphataemia may prolong recovery. Recovery may be hastened by correcting this condition. Atracurium besilate 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.
Atracurium besilate 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, atracurium besilate 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 atracurium besilate 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 atracurium besilate 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 (see Undesirable Effects).