TRACRIUM

What it is

TRACRIUM contains atracurium besilate. TRACRIUM injection contains 10 mg atracurium besilate in each mL, supplied as 2.5 mL glass ampoules containing 25 mg or 5 mL glass ampoules containing 50 mg. TRACRIUM injection is a sterile solution in water. TRACRIUM (atracurium besilate) is an intermediate-duration, non-depolarising, skeletal muscle relaxant for intravenous administration.

Approved indications

TRACRIUM is a highly selective, competitive or non-depolarising neuromuscular blocking agent which is used as an adjunct to general anaesthesia to enable tracheal intubation to be performed and to relax skeletal muscles during surgery or controlled ventilation, and to 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. TRACRIUM doses of 0.08 to 0.10 mg/kg are recommended for maintenance of neuromuscular blockade during prolonged surgical procedures. No TRACRIUM dosage adjustments are required for paediatric patients two years of age or older. A TRACRIUM 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. TRACRIUM may be used at standard dosage at all levels of renal or hepatic function, including end stage failure. TRACRIUM 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

TRACRIUM paralyses the respiratory muscles as well as other skeletal muscles but has no effect on consciousness and 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. The clinician must be prepared to assist or control respiration and anticholinesterase reversal agents should be immediately available. TRACRIUM 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. Caution should be exercised in administering TRACRIUM to patients with a history suggestive of an increased sensitivity to the effects of histamine. TRACRIUM is hypotonic and must not be administered into the infusion line of a blood transfusion. TRACRIUM Injection, which has an acid pH, should not be mixed with alkaline solutions (e.g. barbiturate solutions) in the same syringe or administered simultaneously during intravenous infusion through the same needle, as TRACRIUM may be inactivated and a free acid may be precipitated. TRACRIUM 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 TRACRIUM and the use of a peripheral nerve stimulator for assessing neuromuscular blockade is especially important in these patients.

Contraindications

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

Regulatory history

TRACRIUM atracurium besilate 25 mg/2.5 mL injection ampoule was first approved on 2 August 1991. TRACRIUM atracurium besilate 50 mg/5 mL injection ampoule was first approved on 12 June 1992.