Active Ingredient: Atracurium besilate
Atracurium is indicated as an adjunct to general anaesthesia during surgery to relax skeletal muscles, and to facilitate endotracheal intubation and mechanical ventilation. It is also indicated to facilitate mechanical ventilation in intensive care unit (ICU) patients.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
0.3 - 0.6 mg per kg of body weight
From 0.3 To 0.6 mg per kg of body weight once every day
Atracurium should only be administered by intravenous injection. Do not give atracurium intramuscularly since this may result in tissue irritation and there are no clinical data to support this route of administration.
To avoid distress to the patient,atracurium should not be administered before unconsciousness has been induced.
Atracurium should not be mixed in the same syringe, or administered simultaneously through the same needle, with alkaline solutions (e.g. barbiturate solutions).
In common with all neuromuscular blocking agents, monitoring of neuromuscular function is recommended during the use of atracurium in order to individualise dosage requirements.
An initial atracurium besilate dose of 0.3 to 0.6 mg/kg (depending on the duration of full block required), given as an intravenous bolus injection, is recommended. This will provide adequate relaxation for about 15 to 35 minutes.
Endotracheal intubation can usually be accomplished within 90 to 120 seconds of the intravenous injection of 0.5 to 0.6 mg/kg. Maximum neuromuscular blockade is generally achieved approximately 3 to 5 minutes after administration. 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.
Intermittent IV injection: During prolonged surgical procedures neuromuscular blockade may be maintained with atracurium besilate maintenance doses of 0.1 to 0.2 mg/kg. Successive supplementary dosing does not give rise to accumulation of neuromuscular blocking effect.
Use as an infusion: After the initial atracurium bolus dose, neuromuscular blockade may be maintained during prolonged surgical procedures by administering atracurium besilate as a continuous intravenous infusion at a rate of 0.3 to 0.6 mg/kg/hour. The infusion should not be commenced until early spontaneous recovery from the initial atracurium bolus dose is evident.
Atracurium can be administered by infusion during cardiopulmonary bypass surgery at the recommended infusion rates. Induced hypothermia to a body temperature of 25 to 26°C reduces the rate of inactivation of atracurium, and therefore full neuromuscular block may be maintained with approximately half the original infusion rate at these temperatures.
The neuromuscular blockade induced by atracurium can be reversed with an anticholinesterase agent such as neostigmine or pyridostigmine, usually in conjunction with an anticholinergic agent such as atropine or glycopyrronium to prevent the adverse muscarinic effects of the anticholinesterase. Under balanced anaesthesia, reversal can usually be attempted approximately 20 to 35 minutes after the initial atracurium dose, or approximately 10 to 30 minutes after the last atracurium maintenance dose, when recovery of muscle twitch has started. Complete reversal of neuromuscular blockade is usually achieved within 8 to 10 minutes after administration of the reversing agents.
Rare instances of breathing difficulties, possibly related to incomplete reversal, have been reported following attempted pharmacological antagonism of atracurium induced neuromuscular blockade. As with other agents in this class, the tendency for residual neuromuscular block is increased if reversal is attempted at deep levels of blockade or if inadequate doses of reversal agents are employed.
After an optional initial bolus dose of 0.3 to 0.6 mg/kg, neuromuscular block may be maintained by administering a continuous atracurium besilate infusion at rates of between 11 and 13 microgram/kg/min (0.65 to 0.78 mg/kg/hr). There may be wide inter-patient variability in dosage requirements and these may increase or decrease with time. Infusion rates as low as 4.5 microgram/kg/min (0.27 mg/kg/hr) or as high as 29.5 microgram/kg/min (1.77 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.
Spontaneous recovery to a train-of-four ratio >0.75 (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.
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