DEXDOR

What it is

Dexmedetomidine hydrochloride is the active ingredient in DEXDOR. Dexmedetomidine is a relatively selective alpha 2-adrenoreceptor agonist with sedative pharmacologic properties. DEXDOR is a sterile, non-pyrogenic solution suitable for intravenous (IV) infusion.

Approved indications

— Sedation of initially intubated adult patients during treatment in an intensive care setting (Intensive Care Unit sedation). — Sedation of non-intubated adult patients prior to and/or during surgical and other procedures (procedural sedation).

Dosing overview

Dexmedetomidine should be administered only by persons skilled in anaesthetics or in the management of patients in the intensive care setting. For ICU sedation, DEXDOR may be initiated with a loading infusion of 1 microgram/kg over 10 to 20 minutes, if needed. Adult patients will generally require a maintenance infusion of 0.2 to 1 microgram/kg/h, and it is recommended that 0.4 microgram/kg/h should be the initial maintenance infusion. For procedural sedation, DEXDOR is generally initiated with a loading infusion of 1 microgram/kg over 10 to 20 minutes for sedation of non-intubated patients undergoing surgical and other procedures. Following the loading dose, maintenance dosing of DEXDOR should generally be initiated at 0.6 microgram/kg/h and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 microgram/kg/h for all procedures. A dose reduction for both the loading and maintenance infusions should be considered in patients with impaired hepatic function and in patients over 65 years of age.

Key safety warnings

Patients should be continuously monitored for early signs of hypotension, hypertension, bradycardia, respiratory depression, airway obstruction, apnoea, dyspnoea and/or oxygen desaturation while receiving dexmedetomidine hydrochloride. Continuous electrocardiogram (ECG), blood pressure, and oxygen saturation monitoring are recommended during infusion of DEXDOR. Clinical events of bradycardia and sinus arrest have been associated with dexmedetomidine administration in young, healthy adult volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration of dexmedetomidine. Reports of hypotension and bradycardia have been associated with dexmedetomidine infusion. Some of these cases have resulted in fatalities. Hypotension and/or bradycardia may be expected to be more pronounced in hypovolaemic patients and in those with diabetes mellitus, severe cardiac disease, chronic hypertension and in elderly patients. Transient hypertension has been observed primarily during the loading infusion, associated with initial peripheral vasoconstrictive effects of dexmedetomidine and relatively higher plasma concentrations achieved during the loading infusion. Following the loading infusion, the central effects of dexmedetomidine dominate and the blood pressure usually decreases. Use of dexmedetomidine greater than 24 hours has been associated with an increased mortality in critically ill adult ICU patients 65 years of age and younger compared to usual care. Dexmedetomidine should not be administered for greater than 24 hours. Dexmedetomidine may cause reduced lacrimation. Lubrication of the patient's eyes should be considered when administering dexmedetomidine to avoid corneal dryness.

Contraindications

DEXDOR is contraindicated in patients with a known hypersensitivity to dexmedetomidine or any of the excipients contained in DEXDOR.

Regulatory history

DEXDOR received initial approval on 09 December 2015. DEXDOR dexmedetomidine concentrated injection products were first listed on the ARTG on 2022-11-14 under licence category RE.