Patient leaflet - Dexdor 100 micrograms/ml concentrate for solution for infusion
1. What Dexdor is and what it is used for 2. What you need to know before you are
given Dexdor
- 3. How to use Dexdor
- 4. Possible side effects
- 5. How to store Dexdor
- 6.
information
- 1. What Dexdor is and what it is used for
Dexdor contains an active substance called dexmedetomidine which belongs to a medicine group called sedatives. It is used to provide sedation (a state of calm, drowsiness or sleep) for adult patients in hospital intensive care settings or awake sedation during different diagnostic or surgical procedures.
2. What you need to know before you are given Dexdor
You must not be given Dexdor
if you are allergic to dexmedetomidine
or any of the other ingredients of this medicine (listed in section 6).
if you have some disorders of heart
rhythm (heart block grade 2 or 3).
if you have very low blood pressure
which does not respond to treatment.
if you have recently had a stroke or
other serious condition affecting blood supply to the brain.
Warnings and precautions
Before you have this medicine, tell your doctor or nurse if any of the following apply as Dexdor should be used cautiously: – if you have an abnormally slow heart
rate (either due to illness or high levels of physical fitness) as it may increase the risk for cardiac arrest
if you have low blood pressure – if you have low blood volume, for
example after bleeding
- if you have certain heart disorders – if you are elderly
if you have a neurological disorder (for
instance head or spinal cord injury or stroke)
if you have severe liver problems – if you have ever developed a serious
fever after some medicines, especially anaesthetics
This medicine may cause large amount of urine and excessive thirst, contact a doctor if these side effects occur. See section 4 for more information.
Other medicines and Dexdor
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
The following medicines may enhance the effect of Dexdor:
medicines that help you sleep or cause
sedation (e.g. midazolam, propofol) – strong pain medicines (e.g. opioids
such as morphine, codeine)
anaesthetic medicines (e.g. sevoflurane,
isoflurane)
If you are using medicines which lower your blood pressure and heart rate, co-administration with Dexdor may enhance this effect. Dexdor should not be used with medicines that cause temporary paralysis. Pregnancy and breast-feeding
Dexdor should not be used during pregnancy or breast-feeding unless clearly necessary.
Ask your doctor for advice before having this medicine
Driving and using machines
Dexdor has major impact on the ability to drive and use machines. After you have been given Dexdor you must not drive, operate machinery, or work in dangerous situations until the effects are completely gone. Ask your doctor when you can start doing these activities again and when you can go back to this kind of work. Excipients
Dexdor contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.
3. How to use Dexdor
Hospital intensive care
Dexdor is administered to you by a doctor or nurse in hospital intensive care. Procedural sedation/awake sedation
Dexdor is administered to you by a doctor or a nurse prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.
Your doctor will decide on a suitable dose for you. The amount of Dexdor depends on your age, size, general condition of health, the level of sedation needed and how you respond to the medicine. Your doctor may change your dose if needed and will monitor your heart and blood pressure during the treatment.
Dexdor is diluted and it is given to you as an infusion (drip) into your veins. After sedation/wake-up
The doctor will keep you under medical
supervision for some hours after the sedation to make sure that you feel well.
You should not go home
unaccompanied.
Medicines to help you sleep, cause sedation or strong painkillers may not be appropriate for some time after you have been given Dexdor. Talk to your doctor about the use of these medicines and about the use of alcohol. If you have been given more Dexdor than you should
If you are given too much Dexdor, your blood pressure may go up or down, your heartbeat may slow down, you may breathe more slowly and you may feel more drowsy. Your doctor will know how to treat you based on your condition. If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (affects more than 1 user in
10)
- slow heart rate
- low or high blood pressure
change in breathing pattern or
stopping breathing.
Common (affects 1 to 10 users in 100) – chest pain or heart attack
- fast heart rate
- low or high blood sugar
- nausea, vomiting or dry mouth – restlessness
- high temperature
- symptoms after stopping the medicine. Uncommon (affects 1 to 10 users in 1,000) – reduced heart function, cardiac arrest – swelling of the stomach
- thirst
- a condition where there is too much acid in the body
- low albumin level in blood
- shortness of breath
- hallucinations
- the medicine is not effective enough. Not known (frequency cannot be estimated from the available data) – large amount of urine and excessive thirst – may be symptoms of a hormonal disorder called diabetes insipidus. Contact a doctor if these occur.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Dexdor
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
This medicine does not require any special temperature storage conditions. Keep the ampoules or vials in the outer carton in order to protect from light.
6. Contents of the pack and other information
What Dexdor contains
The active substance is
dexmedetomidine. Each
ml of concentrate contains
dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine.
- The other ingredients are sodium chloride and water for injections. Each 2 ml ampoule contains
200 micrograms of dexmedetomidine (as hydrochloride).
Each 2 ml vial contains 200 micrograms of dexmedetomidine (as hydrochloride). Each 4 ml vial contains 400 micrograms of dexmedetomidine (as hydrochloride). Each 10 ml vial contains 1000 micrograms of dexmedetomidine (as hydrochloride). The concentration of the final solution after dilution should be either 4 micrograms/ml or 8 micrograms/ml.
What Dexdor looks like and contents of the pack
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear, colourless solution.
Containers
2 ml glass ampoules
2, 5 or 10 ml glass vials
Pack sizes
5 x 2 ml ampoules
25 x 2 ml ampoules
5 x 2 ml vials
4 x 4 ml vials
4 x 10 ml vials
Not all pack sizes may be marketed. Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma Orionintie 1
FI-02200 Espoo
Finland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Orion Pharma UK Ltd, 9th Floor, The Blade, Abbey Square, Reading, RG1 3BE Tel: +44 1635 520 300
This leaflet was last revised in January 2026
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PROOF COLOURS:
Dexdor 100 micrograms/ml concentrate for solution for infusion
Method of administration
Dexdor should be administered by healthcare professionals skilled in the management of patients requiring intensive care or in the anaesthetic management of patients in the operating room. It must be administered only as a diluted intravenous infusion using a controlled infusion device
Preparation of solution
Dexdor can be diluted in glucose 50 mg/ml (5%), Ringers, mannitol or sodium chloride 9 mg/ml (0.9%) solution for injection to achieve the required concentration of either 4 micrograms/ml or 8 micrograms/ ml prior to administration. Please see below in tabulated form the volumes needed to prepare the infusion.
In the case the required concentration is 4 micrograms/ml:
Volume of Dexdor 100 micrograms/ ml concentrate for solution for infusion | Volume of diluent | Total volume of infusion |
| 2 ml | 48 ml | 50 ml |
| 4 ml | 96 ml | 100 ml |
| 10 ml | 240 ml | 250 ml |
| 20 ml | 480 ml | 500 ml |
In the case the required concentration is 8 micrograms/ml:
| Volume of Dexdor 100 micrograms/ ml concentrate for solution for infusion | Volume of diluent | Total volume of infusion |
| 4 ml | 46 ml | 50 ml |
| 8 ml | 92 ml | 100 ml |
| 20 ml | 230 ml | 250 ml |
| 40 ml | 460 ml | 500 ml |
The solution should be shaken gently to mix well.
Dexdor should be inspected visually for particulate matter and discoloration prior to administration.
Dexdor has been shown to be compatible when administered with the following intravenous fluids and medicinal products: Lactated Ringers, 5% glucose solution, sodium chloride 9 mg/ml (0.9%) solution for injection, mannitol 200 mg/ml (20%), thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate bromide, phenylephrine HCl, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate, and a plasma-substitute.
Compatibility studies have shown potential for adsorption of dexmedetomidine to some types of natural rubber. Although dexmedetomidine is dosed to effect, it is advisable to use components with synthetic or coated natural rubber gaskets. Shelf life
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to the use are the responsibility of the user and would not normally be longer than 24 hours at 2° to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.