ATRACURIUM

What it is

Atracurium besilate is a medicine available as a solution for injection containing 10 mg of atracurium besilate per mL. It is supplied as a sterile solution in water and appears as a clear, colourless or yellowish solution, free from visible particles. Atracurium besilate is an intermediate-duration, non-depolarising, skeletal muscle relaxant for intravenous administration. Non-depolarising agents antagonise the neurotransmitter action of acetylcholine by binding competitively with cholinergic receptor sites on the motor end-plate.

Approved indications

— Enable tracheal intubation to be performed as an adjunct to general anaesthesia. — Relax skeletal muscles during surgery or controlled ventilation. — Facilitate mechanical ventilation in Intensive Care Unit (ICU) patients.

Dosing overview

The initial dosage for adults ranges from 0.3 to 0.6 mg/kg (depending on the duration of full block required) and will provide adequate relaxation for 15 to 35 minutes. Atracurium besilate doses of 0.08 to 0.10 mg/kg are recommended for maintenance of neuromuscular blockade during prolonged surgical procedures. No atracurium besilate dosage adjustments are required for paediatric patients two years of age or older. An atracurium besilate dose of 0.4 mg/kg is recommended as the initial dose for paediatric patients aged 1 month to 2 years of age under halothane anaesthesia. Atracurium besilate may be used at standard dosage at all levels of renal or hepatic function, including end stage failure. Atracurium besilate may be used at standard dosage in elderly patients; however, it is recommended that the initial dose be at the lower end of the range and that it be administered slowly.

Key safety warnings

Atracurium paralyses the respiratory muscles as well as other skeletal muscles but has no effect on consciousness. Atracurium should be administered only with adequate anaesthesia or sedation/analgesia in the ICU and only by those skilled in the management of artificial respiration and only when facilities are instantly available for endotracheal intubation and for providing adequate ventilation of the patient, including the administration of oxygen under positive pressure and the elimination of carbon dioxide. Atracurium has the potential to cause histamine release. Anaphylactic and anaphylactoid reactions have been reported and have sometimes been life-threatening. For this reason it is essential that appropriate resuscitative equipment be immediately available. Mean arterial pressure decreases in a substantial percentage of patients with a history of cardiovascular disease even at lower doses. Atracurium may have profound effects in patients with myasthenia gravis, Eaton-Lambert syndrome, or other neuromuscular diseases in which potentiation of non-depolarising agents has been noted. A reduced dosage of atracurium besilate and the use of a peripheral nerve stimulator for assessing neuromuscular blockade is especially important in these patients.

Contraindications

Atracurium besilate is contraindicated in patients known to be hypersensitive to atracurium, cisatracurium or benzenesulfonic acid.

Regulatory history

Atracurium besilate MEDSURGE 25 mg/2.5 mL and 50 mg/5 mL solution for injection ampoules were first listed on the Australian Register of Therapeutic Goods on 20 November 2023.