What is Dexdor - dexmedetomidine?
Dexdor is a medicine containing the active substance dexmedetomidine. It is available as a concentrate for solution for infusion (drip into a vein).
What is Dexdor - dexmedetomidine used for?
Dexdor is used to sedate (calm or sleep) adult patients in intensive care units. Dexdor is used to induce a relatively superficial level of sedation, during which the patient is able to respond to verbal stimuli (corresponding to the value from 0 to -3 of the Richmond Sedation-Agitation Scale, RASS).
The medicine can only be obtained with a prescription.
How is Dexdor - dexmedetomidine used?
Dexdor is intended for hospital use only and should be administered by healthcare professionals specializing in the management of patients who require intensive care.
Dexdor is given by intravenous infusion, using a controlled infusion device. The dose is changed until the desired level of sedation is reached. If an adequate level of sedation is not obtained with the maximum dose, it is necessary to switch to an alternative sedative.
For more information on the use of Dexdor, including posology and dose adjustment, please refer to the summary of product characteristics (included with EPAR).
How does Dexdor - dexmedetomidina work?
The active substance in Dexdor, dexmedetomidine, is a selective alpha-2 receptor agonist. It works by binding to certain brain receptors called "alpha-2 receptors" and causing a reduction in the activity of the sympathetic nervous system, which is involved in the control of anxiety, awakening and sleep, as well as blood pressure and heart rate. By reducing the activity of the sympathetic nervous system, dexmedetomidine helps to calm patients or induce sleep.
What studies have been performed on Dexdor - dexmedetomidine?
The effects of Dexdor were first tested in experimental models before being studied in humans.
Dexdor has been compared with other sedative treatments (propofol or midazolam) in two main studies involving 1 000 patients admitted to intensive care units who had to be sedated. The main efficacy parameters were the medicinal product's ability to maintain the desired sedation level and the length of time patients needed mechanical ventilation.
What benefit has Dexdor - dexmedetomidine shown during the studies?
Dexdor has shown similar efficacy to the comparator medicines in maintaining sedation. In one of the two main studies, the desired sedation level was maintained in 65% of patients treated with Dexdor, compared with 65% of subjects who received propofol. In the second study, the desired sedation level was maintained in 61% of patients treated with Dexdor, compared with 57% of subjects receiving midazolam. An additional benefit shown by Dexdor during the studies was the reduction in the duration of mechanical ventilation.
What are the risks associated with Dexdor - dexmedetomidine?
The most common side effects with Dexdor are hypotension (low blood pressure), hypertension (high blood pressure) and bradycardia (low heart rate). These undesirable effects are observed in approximately 25%, 15% and about 13% of patients, respectively. For the full list of all side effects reported with Dexdor, see the package leaflet.
Dexdor should not be used in people who may be hypersensitive (allergic) to dexmedetomidine or any of the other ingredients. It must also not be used in patients with advanced heart block (a type of heart rhythm disorder), in patients with uncontrolled hypotension and in patients suffering from conditions that compromise blood supply to the brain (such as stroke).
Why has Dexdor - dexmedetomidine been approved?
The CHMP noted that in the studies conducted Dexdor demonstrated efficacy similar to that of other sedatives and that it could be used as an alternative treatment to obtain more superficial sedation levels in suitable patients. Since dexmedetomidine has been used as a sedative agent in various countries, its risks are known and are considered manageable. Therefore, the Committee decided that Dexdor's benefits are greater than its risks and recommended that it be given marketing authorization.
Other information on Dexdor - dexmedetomidina
On 16 September 2011, the European Commission issued a marketing authorization for Dexdor, valid throughout the European Union.
For more information about treatment with Dexdor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 08-2011.
