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dexmedetomidine

Dexdor · ATC code N05CM18

Also known as: Dexmedetomidin · Brand names: Dexdor, Dexmedetomidin Altan, Dexmedetomidin B. braun, Dexmedetomidin Baxter, Dexmedetomidin Hikma, Dexmedetomidin Kabi, Dexmedetomidin Kalceks, Dexmedetomidin Noridem, Dexmedetomidine Ever Pharma, Dexmedetomidine Hameln, Dexmedetomidin Eql Pharma, Dexmedetomidin Mylan, Dexmedetomidine Ever Valinject, Dexmedetomidine Seacross, Dekstomid …

Key facts
Active substance
dexmedetomidine
Drug class
Hypnotics and sedatives
ATC code
N05CM18
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Dexdor 100 micrograms/ml concentrate for solution for infusion
Marketing authorisation holder
Orion Corporation
Information as of
2026-10-27

Key facts

Dexmedetomidine is an alpha-2 agonist used for sedation of adult ICU patients and for procedural sedation of non-intubated adults.

What it is used for

  • Sedation of adult ICU patients requiring a level not deeper than arousal to voice (RASS 0 to -3)
  • Sedation of non-intubated adults prior to and/or during diagnostic or surgical procedures

Dosing

  • Hospital use only, by skilled healthcare professionals
  • ICU: initial rate 0.7 micrograms/kg/h, adjusted within 0.2 to 1.4 micrograms/kg/h; the maximum of 1.4 micrograms/kg/h should not be exceeded
  • ICU: loading dose not recommended; no experience beyond 14 days
  • Procedural sedation: loading infusion 1.0 microgram/kg over 10 minutes, maintenance generally started at 0.6–0.7 microgram/kg/hour
  • Lower starting rate considered for frail patients; caution and possibly reduced maintenance dose in hepatic impairment

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Advanced heart block (grade 2 or 3) unless paced
  • Uncontrolled hypotension
  • Acute cerebrovascular conditions

Important warnings

  • Only in ICU, operating room or diagnostic procedures; continuous cardiac monitoring
  • Respiration monitored in non-intubated patients due to respiratory depression and apnoea
  • Not given as a bolus; an alternative sedative should be ready for acute agitation
  • Elderly patients appear to have an increased risk of hypotension

Side effects

  • ICU: most frequent are hypotension, hypertension and bradycardia
  • Procedural sedation: hypotension, respiratory depression and bradycardia
  • Hypotension and bradycardia are the most frequent serious reactions

Interactions

  • Anaesthetics, sedatives, hypnotics and opioids: enhanced sedative and cardiorespiratory effects; dose reduction may be needed
  • Possible interaction with substrates with dominant CYP2B6 metabolism

Pregnancy and breastfeeding

  • Not to be used in pregnancy unless the woman's clinical condition requires it
  • Excreted in human milk; decision between breastfeeding and therapy

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • DexdorOrion Corporation · EMEA/H/C/002268

Source: European Medicines Agency (EMA), product information

Austria

  • Dexmedetomidin AltanAltan Pharmaceuticals S.A. · 2 register entries
  • Dexmedetomidin B. braunB.Braun Melsungen Ag · 1 register entry
  • Dexmedetomidin BaxterBaxter Holding B.V. · 1 register entry
  • Dexmedetomidin HikmaHikma Farmacêutica (Portugal), S.A. · 1 register entry
  • Dexmedetomidin KabiFresenius Kabi Austria Gmbh · 1 register entry
  • Dexmedetomidin KalceksKalceks · 1 register entry
  • Dexmedetomidin NoridemNoridem Enterprises Ltd · 1 register entry
  • Dexmedetomidine Ever PharmaEver Valinject Gmbh · 1 register entry
  • Dexmedetomidine HamelnHameln Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Dexmedetomidin B. BraunB.Braun Melsungen Ag · 1 register entry
  • Dexmedetomidin BaxterBaxter Holding B.V. · 1 register entry
  • Dexmedetomidin Eql PharmaEql Pharma Ab · 1 register entry
  • Dexmedetomidin HikmaHikma Farmacêutica (Portugal), S.A. · 1 register entry
  • Dexmedetomidin KabiFresenius Kabi Deutschland Gmbh · 1 register entry
  • Dexmedetomidin KalceksKalceks · 1 register entry
  • Dexmedetomidin MylanViatris Germany Gmbh · 1 register entry
  • Dexmedetomidine Ever ValinjectEver Valinject Gmbh · 1 register entry
  • Dexmedetomidine HamelnHameln Pharma Gmbh · 1 register entry
  • Dexmedetomidine SeacrossSeacross Pharma (Europe) Ltd · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • DekstomidPOLİFARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • DinesinSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • HipnodexHAVER FARMA İLAÇ A.Ş. · 1 register entry
  • PrexodinDEVA HOLDİNG A.Ş. · 1 register entry
  • ProvenixCENTURİON İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • SedadomidKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
  • SemotidinVEM İLAÇ SAN. VE TİC. A.Ş. · 3 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 28 more European countries
Belgium
Dexmedetomidine A.Forall, Dexmedetomidine Baxter, Dexmedetomidine Ever Pharma, Dexmedetomidine Hikma, Dexmedetomidine Kabi, Dexmedetomidine Kalceks
Bulgaria
Dexmedetomidine Ever Valinject, Dexmedetomidine Kalceks
Croatia
Deksmedetomidin Kabi, Deksmedetomidin Kalceks, Dexmedetomidine Ever Pharma
Cyprus
Dexmedetomidine Baxter, Dexmedetomidine Ever Valinject, Dexmedetomidine Noridem
Czechia
Dexmedetomidine B. Braun, Dexmedetomidine Ever Pharma, Dexmedetomidine Fmk, Dexmedetomidine Hameln, Dexmedetomidine Kabi, Dexmedetomidine Kalceks
Denmark
Dexmedetomidin Kalceks, Dexmedetomidin Viatris, Dexmedetomidine B. Braun, Dexmedetomidine Baxter, Dexmedetomidine Eql Pharma, Dexmedetomidine Ever Pharma, Dexmedetomidine Ever Valinject, Dexmedetomidine Hameln, Dexmedetomidine Kabi, Dexmedetomidine Noridem
Estonia
Dexmedetomidine Auxilia, Dexmedetomidine Kabi, Dexmedetomidine Kalceks
Finland
Dexmedetomidine B. Braun, Dexmedetomidine Baxter, Dexmedetomidine Eql Pharma, Dexmedetomidine Ever Valinject, Dexmedetomidine Hameln, Dexmedetomidine Kabi, Dexmedetomidine Kalceks, Dexmedetomidine Viatris
France
Dexmedetomidine Altan, Dexmedetomidine Ever Pharma, Dexmedetomidine Hikma, Dexmedetomidine Kabi, Dexmedetomidine Kalceks, Dexmédétomidine Viatris
Greece
Dexmedetomidine /Kabi, Dexmedetomidine Ariti, Dexmedetomidine Baxter, Dexmedetomidine Ever Valinject
Hungary
Dexmedetomidin Ever Pharma, Dexmedetomidine Kabi, Dexmedetomidine Kalceks
Iceland
Dexdor, Dexmedetomidine Rph Pharma
Ireland
Dexmedetomidine As Kalceks, Dexmedetomidine B. Braun, Dexmedetomidine Baxter, Dexmedetomidine Ever Pharma, Dexmedetomidine Kabi, Dexmedetomidine Kalceks, Dexmedetomidine Noridem Enterprises
Italy
Dexmedetomidina Galenica Senese, Dexmedetomidina Hikma, Dexmedetomidina Kalceks, Dexmedetomidine Ever Pharma
Latvia
Dexmedetomidine Kalceks, Dexmedetomidine Pharmidea
Liechtenstein
Dexdor
Lithuania
Dexmedetomidine Kabi, Dexmedetomidine Kalceks
Luxembourg
Dexmedetomidine Baxter, Dexmedetomidine Kabi
Malta
Dexmedetomidine Ever Valinject
Netherlands
Dexmedetomidine Altan Pharmaceuticals S.A., Dexmedetomidine B. Braun, Dexmedetomidine Baxter, Dexmedetomidine Ever Pharma, Dexmedetomidine Hameln, Dexmedetomidine Hikma, Dexmedetomidine Kabi, Dexmedetomidine Kalceks, Dexmedetomidine Noridem, Dexmedetomidine Seacross
Norway
Dexdor, Dexmedetomidine B. Braun, Dexmedetomidine Baxter, Dexmedetomidine Eql Pharma, Dexmedetomidine Ever Pharma, Dexmedetomidine Hameln, Dexmedetomidine Kabi, Dexmedetomidine Kalceks, Dexmedetomidine Noridem, Dexmedetomidine Viatris
Poland
Dexmedetomidine Ever Pharma, Dexmedetomidine Farmak, Dexmedetomidine Kabi, Dexmedetomidine Kalceks
Portugal
Dexmedetomidina A.Forall, Dexmedetomidina Acure, Dexmedetomidina Altan, Dexmedetomidina Baxter, Dexmedetomidina Farmak, Dexmedetomidina Hikma, Dexmedetomidina Kabi, Dexmedetomidina Kalceks, Dexmedetomidina Viatris, Dexmedetomidine Ever Pharma
Romania
Dexmedetomidine Ever Valinject, Dexmedetomidină Kabi, Dexmedetomidină Kalceks
Slovakia
Dexmedetomidine B. Braun, Dexmedetomidine Ever Pharma, Dexmedetomidine Kabi, Dexmedetomidine Kalceks
Slovenia
Deksmedetomidin Kalceks, Deksmedetomidin Viatris, Dexmedetomidine Ever Pharma
Spain
Dexmedetomidina Altan, Dexmedetomidina B. Braun, Dexmedetomidina Baxter, Dexmedetomidina Hikma, Dexmedetomidina Kabi, Dexmedetomidina Kalceks, Dexmedetomidina Normon, Dexmedetomidina Rph Pharma, Dexmedetomidine Ever Pharma, Dexmedetomidine Farmak
Sweden
Dexmedetomidine B. Braun, Dexmedetomidine Baxter, Dexmedetomidine Eql Pharma, Dexmedetomidine Ever Pharma, Dexmedetomidine Hameln, Dexmedetomidine Kabi, Dexmedetomidine Kalceks, Dexmedetomidine Rph Pharma

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Dexdor – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/dexdor-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC N05CM.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.