Consumer medicine information

1. Why am I being given Dexmedetomidine Accord?

Dexmedetomidine Accord contains the active ingredient dexmedetomidine (as hydrochloride). Dexmedetomidine Accord belongs to a group of medicines called alpha-2-receptor agonists. It is used as a sedative (calming agent) if adults need to be calm or sleepy in the Intensive Care Unit whilst they are being ventilated (on a breathing machine). Dexmedetomidine Accord can be given to adults prior to an operation if they are not on a ventilator if it is required for the procedure or surgery that they be sleepy and calm. It works by its actions on brain chemicals.
For more information, see Section 1. Why am I using Dexmedetomidine Accord? in the full CMI.

2. What should I know before I am given Dexmedetomidine Accord?

Do not use if you have ever had an allergic reaction to any medicine containing dexmedetomidine hydrochloride 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 Dexmedetomidine Accord? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Dexmedetomidine Accord 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 will I be given Dexmedetomidine Accord?

Dexmedetomidine Accord will be given to you by a doctor or a nurse.
More instructions can be found in Section 4. How will I be given Dexmedetomidine Accord? in the full CMI.

5. What should I know while being given Dexmedetomidine Accord?

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
Some of the very serious side effects are:

• pressure, tightness or pain in your chest or arms that may spread to your neck, jaw or back

• unusual bruising

• overheating of your body that you can't control by normal cooling methods

• excessive thirst, extreme fatigue, lack of energy, confusion, muscle twitching or spasms, restlessness, seizures

1 Name of Medicine

Dexmedetomidine hydrochloride.

2 Qualitative and Quantitative Composition

Dexmedetomidine Accord concentrated injection is a sterile, non-pyrogenic solution suitable for intravenous infusion.
Each 2 mL of Dexmedetomidine Accord contains 236 micrograms of dexmedetomidine hydrochloride (equivalent to 200 micrograms dexmedetomidine base) and 18 mg of sodium chloride in water for injections.
The solution is preservative-free and contains no additives or chemical stabilisers.

3 Pharmaceutical Form

Dexmedetomidine Accord is a clear, colourless, isotonic solution with a pH of 4.5 to 7.0.
Dexmedetomidine Accord is presented in 2 mL vials 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.
The most common adverse effects reported in conjunction with overdose include bradycardia, hypotension, hypertension, over sedation, respiratory depression and cardiac arrest.
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 7.84 is 2.89.
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/DEXACCST.gif