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Dexmedetomidine parenteral

Updated 2 Feb 2023 | Dexmedetomidine

Presentation

Infusions of dexmedetomidine.

Drugs List

  • DEXDOR 1mg/10ml concentrate for solution for infusion
  • DEXDOR 200microgram/2ml concentrate for solution for infusion
  • DEXDOR 400microgram/4ml concentrate for solution for infusion
  • dexmedetomidine 1mg/10ml concentrate for solution for infusion
  • dexmedetomidine 200microgram/2ml concentrate for solution for infusion
  • dexmedetomidine 400microgram/100ml infusion bag
  • dexmedetomidine 400microgram/4ml concentrate for solution for infusion
  • Therapeutic Indications

    Uses

    Sedation for surgical and diagnostic procedures
    Sedation of patients receiving intensive care

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

    Sedation of non-intubated adult patients for diagnostic or surgical procedures.

    Dosage

    Adults

    Sedation of adult intensive care unit (ICU) patients requiring a sedation level not deeper than arousal in response to verbal stimulation
    Initial dose: 0.7 microgram/kg/hour.

    Adjusted stepwise within the dose range of 0.2 to 1.4 microgram/kg/hour to achieve the desired level of sedation, depending on the patient's response.

    The maximum dose of 1.4 micrograms/kg/hour 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.

    A lower starting infusion rate should be considered for frail patients.

    After dose adjustment, a new steady state sedation level may not be reached for up to one hour.

    Use of a loading dose of dexmedetomidine in ICU sedation is not recommended.

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

    Sedation of non-intubated adult patients for diagnostic or surgical procedures
    Initial dose: a loading dose of 1 microgram/kg over 10 minutes.

    For less invasive procedures, a loading dose of 0.5 microgram/kg over 10 minutes.

    Maintenance dose: 0.6 to 0.7 microgram/kg/hour, titrated within the dose range of 0.2 to 1 microgram/kg/hour.

    Administration

    For administration as an intravenous infusion using a controlled infusion device.

    Some formulations will require dilution before use.

    Contraindications

    Children under 18 years
    Acute cerebrovascular disorder
    Breastfeeding
    Non-paced second degree atrioventricular block
    Non-paced third degree atrioventricular block
    Severe hypotension

    Precautions and Warnings

    Elderly
    Predisposition to malignant hyperthermia
    Bradycardia
    Cardiovascular disorder
    Central nervous system surgery
    Cerebrovascular disorder
    Head trauma
    Hepatic impairment
    Hypotension
    Hypovolaemia
    Ischaemic heart disease
    Pregnancy
    Reduced respiratory reserve
    Severe neurological disorder

    Advise patient ability to drive or operate machinery may be impaired
    Some formulations contain glucose
    Administration carried out in centres with intensive care facilities
    Some formulations must be diluted before use
    Treatment to be administered under the supervision of a specialist
    Monitor blood pressure
    Monitor cardiac function
    Monitor respiratory function
    Discontinue in patients with unexplained high fever
    Withdrawal symptoms after long-term normal use on abrupt cessation
    Consider dose reduction/discontinuation if cerebral ischaemia occurs
    Consider dose reduction/discontinuation if myocardial ischaemia occurs

    Not suitable for patients requiring continuous deep sedation, as patients are normally easily roused whilst on dexmedetomidine.

    Alternative sedative treatment is required for acute control of agitation or during procedures, especially during the first few hours of treatment.

    Pregnancy and Lactation

    Pregnancy

    Use dexmedetomidine with caution during pregnancy.

    The manufacturer recommends that dexmedetomidine should not be used during pregnancy unless the clinical condition requires the use of dexmedetomidine. At the time of writing, there is limited published information data from the use of dexmedetomidine in pregnant women. Animals studies have shown reproductive toxicity.

    Lactation

    Dexmedetomidine is contraindicated during breastfeeding.

    The manufacturer recommends that either breastfeeding or dexmedetomidine therapy should be discontinued, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother. Available data have shown that dexmedetomidine is excreted in breast milk, and a risk to infants cannot be excluded.

    Side Effects

    Abdominal distension
    Agitation
    Apnoea
    Bradycardia
    Decreased cardiac output
    Dry mouth
    Dyspnoea
    First degree AV block
    Hallucinations
    Hyperglycaemia
    Hypertension
    Hyperthermia
    Hypoalbuminaemia
    Hypoglycaemia
    Hypotension
    Metabolic acidosis
    Myocardial infarction
    Myocardial ischaemia
    Nausea
    Respiratory depression
    Tachycardia
    Thirst
    Vomiting
    Withdrawal symptoms

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: September 2015

    Reference Sources

    Summary of Product Characteristics: Dexdor 100micrograms/ml concentrate for solution for infusion. Orion Pharma (UK) Limited. Revised June 2015.

    Summary of Product Characteristics: Dexmedetomidine 4 micrograms/ml solution for infusion. Altan Pharma Ltd. Revised April 2020.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 03 December 2021

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