Consumer medicine information

1. Why am I being given DEXDOR?

DEXDOR contains the active ingredient dexmedetomidine hydrochloride. DEXDOR is used in adult patients who need to be kept calm or sleepy when either:

• on a breathing machine (ventilator) in the Intensive Care Unit (ICU), or

• unaided by a breathing machine before a surgical or other procedure.

2. What should I know before I am given DEXDOR?

Do not use if you have ever had an allergic reaction to DEXDOR or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I am given DEXDOR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with DEXDOR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is DEXDOR given?

DEXDOR is diluted with another liquid in an IV bag and given as a ‘drip’ through a vein (intravenous infusion) by a doctor or nurse. Your doctor or anaesthetist will decide how fast the infusion will be given to keep you at the right depth of sleep or calmness, and how long you need it.
More information can be found in Section 4. How is DEXDOR given? in the full CMI.

5. What should I know while being given DEXDOR?

6. Are there any side effects?

Common side effects such as dizziness, light-headedness, nausea, vomiting, fever, dry mouth, feeling thirsty, constipation, diarrhoea, agitation, confusion, tiredness, swelling, sweating more, blood sugar changes, vision changes and passing less or more urine are usually mild and short-lived. More serious side effects such as heart rate changes, breathing problems, chest pain or tightness, bruising, overheating, excessive thirst, extreme fatigue, lack of energy, restlessness, confusion, muscle twitches and seizures may require urgent medical attention.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Dexmedetomidine (as hydrochloride).

2 Qualitative and Quantitative Composition

200 microgram/2 mL. Each 2 mL ampoule of Dexdor contains 236 micrograms of dexmedetomidine hydrochloride (equivalent to 200 micrograms dexmedetomidine base).
400 microgram/4 mL. Each 4 mL vial of Dexdor contains 472 micrograms of dexmedetomidine hydrochloride (equivalent to 400 micrograms dexmedetomidine base).
1000 microgram/10 mL. Each 10 mL vial of Dexdor contains 1180 micrograms of dexmedetomidine hydrochloride (equivalent to 1000 micrograms dexmedetomidine base).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Dexdor dexmedetomidine (as hydrochloride) concentrated injection is a sterile, non-pyrogenic solution suitable for intravenous (IV) infusion.
Dexdor concentrated injection is supplied as a clear, colourless, isotonic solution with a pH of 4.5-7.0. It is presented in 2 mL ampoule, 4 mL vial or 10 mL vial, and must be diluted prior to use.

4 Clinical Particulars

4.9 Overdose

The tolerability of dexmedetomidine was noted in one study in which healthy adult subjects achieved plasma concentrations from 1.8 up to 13 times the upper boundary of the therapeutic range. The most notable effects observed in two subjects who achieved the highest plasma concentrations were 1st degree AV block and 2nd degree heart block. No haemodynamic compromise was noted with the AV block and the heart block resolved spontaneously within one minute.
Of five adult patients reported with overdose of dexmedetomidine in the Phase II/III ICU sedation studies, two had no symptoms reported; one patient received a 2 microgram/kg loading dose over 10 minutes (twice the recommended loading dose) and one patient received a maintenance infusion of 0.8 microgram/kg/hr. Two other patients who received a 2 microgram/kg loading dose over 10 minutes experienced bradycardia with or without hypotension. One patient, who received a loading bolus dose of undiluted (100 microgram/mL) dexmedetomidine (19.4 microgram/kg), had cardiac arrest from which he was successfully resuscitated.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Dexmedetomidine was not mutagenic in vitro, in either the bacterial reverse mutation assay (E. coli and Salmonella typhimurium) or the mammalian cell forward mutation assay (mouse lymphoma). In a mouse micronucleus study, dexmedetomidine was not cytotoxic to bone marrow and did not increase the numbers of micronucleated PCEs at any dose tested, both in animals maintained at room temperature and in those kept warm. In addition, dexmedetomidine did not induce chromosomal aberrations in cultured human peripheral blood lymphocytes in the absence or presence of an exogenous metabolic activation system comprised of a human S9 homogenate.
Carcinogenicity. Animal carcinogenicity studies have not been performed with dexmedetomidine.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Dexmedetomidine hydrochloride is a white or almost white powder, freely soluble in water and its pKa is 7.1. The partition coefficient in octanol: water at pH 7.4 is 2.89.
Dexdor concentrated injection is preservative-free and contains no additives or chemical stabilisers.
Chemical structure. Dexmedetomidine hydrochloride is chemically described as (+)-4-(S)-[1-(2, 3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride and has a molecular weight of 236.7 and the empirical formula is C₁₃H₁₆N₂.HCl. The structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDEXHYD.gif CAS number. 145108-58-3.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/DEXDORST.gif