DEXDOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MICROGRAMS/ML [SIN16767P]

Product Info

DEXDOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MICROGRAMS/ML

[SIN16767P]

4.1 Therapeutic indications

For sedation of adult ICU (Intensive Care Unit) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3).

For sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.

4.2 Posology and method of administration

For sedation of adult ICU (Intensive Care Unit) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3).

For hospital use only. Dexdor should be administered by healthcare professionals skilled in the management of patients requiring intensive care.

Posology

Patients already intubated and sedated may switch to dexmedetomidine with an initial infusion rate of 0.7 micrograms/kg/h which may then be adjusted stepwise within the dose range 0.2 to 1.4 micrograms/kg/h in order to achieve the desired level of sedation, depending on the patient’s response. A lower starting infusion rate should be considered for frail patients. Dexmedetomidine is very potent and the infusion rate is given per hour. After dose adjustment, a new steady state sedation level may not be reached for up to one hour.

Maximum dose

The maximum dose of 1.4 micrograms/kg/h should not be exceeded. Patients failing to achieve an adequate level of sedation with the maximum dose of dexmedetomidine should be switched to an alternative sedative agent.

Use of a loading dose of Dexdor in ICU sedation is not recommended and is associated with increased adverse reactions. Propofol or midazolam may be administered if needed until clinical effects of dexmedetomidine are established.

Duration

There is no experience in the use of Dexdor for more than 14 days. The use of Dexdor for longer than this period should be regularly reassessed.

For sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.

Dexdor should be administered only by health care professionals skilled in the anaesthetic management of patients in the operating room or during diagnostic procedures. When Dexdor 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 (see section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Supplemental oxygen should be immediately available and provided when indicated. The oxygen saturation should be monitored by pulse oximetry.

Dexdor 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 Dexdor 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 Dexdor.

Initiation of Procedural Sedation:

• 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.

Maintenance of Procedural Sedation:

• 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 of sedation.

Special populations

Elderly

No dose adjustment is normally required for elderly patients for ICU sedation (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Patients over 65 years of age may be more prone to hypotension with the administration of dexmedetomidine, including a loading dose, for procedures. A dose reduction may be considered, but the limited data available from procedural sedation do not suggest a clear dose dependency.

Renal impairment

No dose adjustment is required for patients with renal impairment.

Hepatic impairment

Dexmedetomidine is metabolised in the liver and should be used with caution in patients with hepatic impairment. A reduced maintenance dose may be considered (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population

The safety and efficacy of Dexdor in children aged 0 to 18 years have not been established. Currently available data are described in sections 4.8, 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information but no recommendation on a posology can be made.

Method of administration

Dexdor must be administered only as a diluted intravenous infusion using a controlled infusion device. For instructions on dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Advanced heart block (grade 2 or 3) unless paced.

Uncontrolled hypotension.

Acute cerebrovascular conditions.