ARTG Entry

CISATRACURIUM JUNO

ARTG entry for CISATRACURIUM JUNO (cisatracurium), ARTG 226859 — Product Information, dosage form, registration history. Compiled by arcimedes.

What it is

Cisatracurium besilate is an intermediate duration, non-depolarising benzylisoquinolinium skeletal muscle relaxant. Cisatracurium besilate binds to cholinergic receptors on the motor end-plate to antagonise the action of acetylcholine, resulting in a competitive block of neuromuscular transmission. Cisatracurium is available as a colourless to pale yellow or greenish solution for injection.

Approved indications

— Relaxation of skeletal muscles during surgical and other procedures and in intensive care, to facilitate tracheal intubation and mechanical ventilation, used as an adjunct to general anaesthesia or sedation in the intensive care unit.

Dosing overview

The recommended intubation dose of Cisatracurium for adults is 0.15 mg/kg bodyweight. This dose produces good to excellent conditions for tracheal intubation 120 seconds following injection. A maintenance dose of 0.03 mg/kg bodyweight provides approximately 20 minutes of additional clinically effective neuromuscular block during opioid or propofol anaesthesia. In paediatric patients aged 1 month to 12 years, the recommended intubation dose is 0.15 mg/kg bodyweight administered rapidly over 5 to 10 seconds. For maintenance by intravenous infusion in adults and paediatric patients aged 1 month to 12 years, an initial infusion rate of 3 µg/kg/min is recommended to restore 89 to 99% T1 suppression following evidence of spontaneous recovery, with a maintenance rate of 1 to 2 µg/kg/min thereafter. For adult ICU patients, an initial infusion rate of 3 µg/kg/min is recommended.

Key safety warnings

Cisatracurium besilate paralyses the respiratory muscles as well as other skeletal muscles but has no effect on consciousness or pain threshold. Cisatracurium should only be administered by, or under the supervision of, anaesthetists or other clinicians who are familiar with the use and action of neuromuscular blocking agents, and facilities for tracheal intubation and maintenance of pulmonary ventilation and adequate arterial oxygenation should be available. Little information is available on the plasma levels and clinical consequences of cisatracurium metabolites during prolonged ICU administration; laudanosine, a major biologically active metabolite, produces transient hypotension and in higher doses cerebral excitatory effects in animal studies, with plasma laudanosine concentrations approximately one third those following atracurium infusion. Patients with myasthenia gravis and other forms of neuromuscular disease have shown greatly increased sensitivity to non-depolarising blocking agents, and an initial dose of not more than 0.02 mg/kg bodyweight cisatracurium besilate is recommended in these patients. Severe acid-base and/or serum electrolyte abnormalities may increase or decrease the sensitivity of patients to neuromuscular blocking agents. Patients with burns have developed resistance to non-depolarising neuromuscular blocking agents, and although cisatracurium has not been studied in burn patients, based on its structural similarity to atracurium, the possibility of increased dosing requirements and shortened duration of action must be considered.

Contraindications

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

Regulatory history

Cisatracurium besilate was first approved on 19 March 2015. Cisatracurium variants sponsored by Medsurge Pharma were first listed on the ARTG on 11 October 2023, comprising four registered presentations: 5 mg/2.5 mL and 10 mg/5 mL injection ampoules under both the Cisatracurium Medsurge and Cisatracurium Medicianz brand names.

TGA Public Summary — ARTG 226859