Active Ingredient: Dexmedetomidine
For sedation of non-intubated adult patients prior to and/or during dianostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
0.7 - 1.4 ug per kg of body weight
From 0.7 To 1.4 ug per kg of body weight once every day
Dexmedetomidine should be administered only by health care professionals skilled in the anaesthetic management of patients in the operating room or during diagnostic procedures. When dexmedetomidine is administered for conscious sedation, patients should be continuously monitored by persons not involved in the conduct of the diagnostic or surgical procedure. Patients should be monitored continuously for early signs of hypotension, hypertension, bradycardia, respiratory depression, airway obstruction, apnoea, dyspnoea and/or oxygen desaturation. Supplemental oxygen should be immediately available and provided when indicated. The oxygen saturation should be monitored by pulse oximetry.
Dexmedetomidine is given as a loading infusion followed by maintenance infusion. Depending on the procedure concomitant local anaesthesia or analgesia may be needed in order to achieve the desired clinical effect. Additional analgesia or sedatives (e.g. opioids, midazolam, or propofol) are recommended in case of painful procedures or if increased depth of sedation is necessary. The pharmacokinetic distribution half –life of dexmedetomidine has been estimated to be around 6 min, which can be taken into consideration, together with the effects of other administered medications, when assessing the appropriate time needed for titration to desired clinical effect of dexmedetomidine.
A loading infusion of 1.0 microgram/kg over 10 minutes. For less invasive procedures such as ophthalmic surgery, a loading infusion of 0.5 micrograms/kg given over 10 minutes may be suitable.
The maintenance infusion is generally initiated at 0.6-0.7 microgram/kg/hour and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 microgram/kg/hour. The rate of the maintenance infusion should be adjusted to achieve the targeted level ofsedation.
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