Dexdor - dexmedetomidine

What is Dexdor - dexmedetomidine?

Dexdor is a medicine that contains the active substance dexmedetomidine. It is available as a concentrate for solution for infusion (drip into a vein).

What is Dexdor used for - dexmedetomidine?

Dexdor is used to sedate (calm or make you sleepy) adult patients in an intensive care unit. 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 on the Richmond Sedation-Agitation Scale, RASS).
The medicine can only be obtained with a prescription.

How is Dexdor used - dexmedetomidine?

Dexdor is indicated for inpatient use only and should be administered by healthcare professionals who specialize in the management of patients requiring intensive care.
Dexdor is administered by intravenous infusion, using a controlled infusion device. The dose is adjusted until the desired level of sedation is achieved. If adequate sedation is not achieved with the maximum dose, an alternative sedative should be changed.
For further information on the use of Dexdor, including the posology and how to adjust the dose, please refer to the Summary of Product Characteristics (included in the EPAR).

How does Dexdor - dexmedetomidine work?

The active substance in Dexdor, dexmedetomidine, is a selective alpha-2 receptor agonist. It works by binding to some brain receptors called "alpha-2 receptors" and causing a reduction in the activity of the sympathetic nervous system, which is involved in controlling 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 to induce sleep.

How has Dexdor - dexmedetomidine been studied?

Dexdor's effects 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 ICU patients who needed to be sedated. The main parameters of effectiveness were the ability of the drug to maintain the desired level of sedation and the length of time patients needed mechanical ventilation.

What benefit has Dexdor - dexmedetomidine shown during the studies?

Dexdor showed "comparable efficacy to comparator medicines in maintaining sedation. In one of the two main studies, the desired level of sedation was maintained in 65% of patients treated with Dexdor, compared with 65% of those administered it. propofol. In the second study, the desired level of sedation was maintained in 61% of patients treated with Dexdor, compared with 57% of subjects treated with 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 of 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 13% of patients, respectively. For the full list of side effects reported with Dexdor, see the package leaflet.
Dexdor must 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 with conditions that impair the blood supply to the brain (such as stroke).

Why has Dexdor - dexmedetomidine been approved?

The CHMP noted that in the studies conducted Dexdor demonstrated "similar efficacy to other sedatives and could be used as an alternative treatment to achieve more superficial sedation levels in suitable patients. As 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 a Marketing Authorization for the medicine.

More information about Dexdor - dexmedetomidine

On 16 September 2011, the European Commission issued a "Marketing Authorization" for Dexdor, valid throughout the European Union.
For more information about Dexdor therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 08-2011.

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