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Dexdor is a brand name for Dexmedetomidine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's EMA label. Tap a section to expand.
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. 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. 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. 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. 8). 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.
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.
Summary of the safety profile Sedation of adult ICU (Intensive Care Unit) patients The most frequently reported adverse reactions with dexmedetomidine in ICU setting are hypotension, hypertension and bradycardia, occurring in approximately 25%, 15% and 13% of patients respectively.
9% of randomised Intensive Care Unit (ICU) patients respectively. 8 Procedural/awake sedation The most frequently reported adverse reactions with dexmedetomidine in procedural sedation are listed below (the protocols of phase III studies contained pre-defined thresholds for reporting changes in blood pressure, respiratory rate and heart rate as AEs).
- Hypotension (55% in dexmedetomidine-group vs. 30% in placebo-group receiving rescue midazolam and fentanyl) - Respiratory depression ( 38% in dexmedetomidine-group vs. 35% in placebo-group receiving rescue midazolam and fentanyl) - Bradycardia (14% in dexmedetomidine-group vs.
4% in placebo-group receiving rescue midazolam and fentanyl) Tabulated list of adverse reactions The adverse reactions listed in Table 1 have been accumulated from pooled data of clinical trials in intensive care. Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).
Table 1. 4. In relatively healthy non-ICU subjects treated with dexmedetomidine, bradycardia has occasionally led to sinus arrest or pause. The symptoms responded to leg raising and anticholinergics such as atropine or glycopyrrolate.
In isolated cases bradycardia has progressed to periods of asystole in patients with pre-existing bradycardia. Also cases of cardiac arrest, often preceded by bradycardia or atrioventricular block, have been reported. Hypertension has been associated with the use of a loading dose and this reaction can be reduced by avoiding such a loading dose or reducing the infusion rate or size of the loading dose.
Monitoring Dexdor is intended for use in an intensive care setting, operating room and during diagnostic procedures. The use in other environments is not recommended. All patients should have continuous cardiac monitoring during Dexdor infusion.
8). The time to recovery after the use of dexmedetomidine was reported to be approximately one hour. When used in an outpatient setting close monitoring should continue for at least one hour (or longer based on the patient condition), with medical supervision continued for at least one further hour to ensure the safety of the patient.
General precautions Dexdor should not be given as a bolus dose and in the ICU a loading dose is not recommended. Users should therefore be ready to use an alternative sedative for acute control of agitation or during procedures, especially during the first few hours of treatment.
During procedural sedation a small bolus of another sedative may be used if a rapid increase in sedation level is required. Some patients receiving Dexdor have been observed to be arousable and alert when stimulated. This alone should not be considered as evidence of lack of efficacy in the absence of other clinical signs and symptoms.
5 Dexmedetomidine normally does not cause deep sedation and patients may be easily roused. Dexmedetomidine is therefore not suitable in patients who will not tolerate this profile of effects, for example those requiring continuous deep sedation.
Dexdor should not be used as a general anaesthetic induction agent for intubation or to provide sedation during muscle relaxant use. Dexmedetomidine lacks the anticonvulsant action of some other sedatives and so will not suppress underlying seizure activity.
Care should be taken if combining dexmedetomidine with other substances with sedative or cardiovascular actions as additive effects may occur. Dexdor is not recommended for patient controlled sedation. Adequate data is not available.
1. Advanced heart block (grade 2 or 3) unless paced. Uncontrolled hypotension. Acute cerebrovascular conditions.
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0 microgram/kg over 10 minutes. 5 micrograms/kg given over 10 minutes may be suitable. 2 to 1 microgram/kg/hour. The rate of the maintenance infusion should be adjusted to achieve the targeted level of sedation. 2). 4) but the limited data available from procedural sedation do not suggest a clear dose dependency.
4 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. 2). Paediatric population The safety and efficacy of Dexdor in children aged 0 to 18 years have not been established.
2 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. 6.
Paediatric population Children > 1 month post-natal, predominantly post-operative, have been evaluated for treatment up to 24 hours in the ICU and demonstrated a similar safety profile as in adults. 2 mcg/kg/h. A single case of hypothermic bradycardia in a neonate has been reported in the literature.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
When Dexdor is used in an outpatient setting patients should normally be discharged into the care of a suitable third party. g, benzodiazepines, opioids, alcohol) for a suitable period of time based on observed effects of dexmedetomidine, the procedure, concomitant medications, the age and the condition of the patient.
Caution should be exercised when administering dexmedetomidine to elderly patients. Elderly 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 should be considered. 2. Mortality in ICU patients ≤ 65 years old In the SPICE III pragmatic randomised controlled trial of 3 904 critically ill adult ICU patients dexmedetomidine was used as primary sedative and compared with usual care.
1% in both groups), but a heterogeneity of effect from age on mortality was observed. 56) compared to alternative sedatives. While the mechanism is unclear, this heterogeneity of effect on mortality from age was most prominent in patients admitted for reasons other than post-operative care, and increased with increasing APACHE II scores and with decreasing age.
These findings should be weighed against the expected clinical benefit of dexmedetomidine compared to alternative sedatives in younger patients. 1). Dexmedetomidine is therefore not suitable in patients with severe cardiovascular instability.
Caution should be exercised when administering dexmedetomidine to patients with pre-existing bradycardia. Data on the effects of Dexdor in patients with heart rate < 60 are very limited and particular care should be taken with such patients.
Bradycardia does not normally require treatment, but has commonly responded to anti-cholinergic medicine or dose reduction where needed. Patients with high physical fitness and slow resting heart rate may be particularly sensitive to bradycardic effects of alpha-2 receptor agonists and cases of transient sinus arrest have been reported.
8). 3). Hypotension does not normally require specific treatment but, where needed, users should be ready to intervene with dose reduction, fluids and/or vasoconstrictors . g. due to spinal cord injury) may have more pronounced haemodynamic changes after starting dexmedetomidine and so should be treated with care.
Transient hypertension has been observed primarily during the loading dose in association with the peripheral vasoconstrictive effects of dexmedetomidine and a loading dose is not recommended in ICU sedation. Treatment of hypertension has generally not been necessary but decreasing the continuous infusion rate may be advisable.
Local vasoconstriction at higher concentration may be of greater […]