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Details for: DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION

Company: ACCORD HEALTHCARE INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02477327DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTIONDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)100 MCG / MLSOLUTIONINTRAVENOUS
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

Dexmedetomidine Hydrochloride for Injection is used in adults:

  • for continuous sedation (to keep you calm) after you arrive at the intensive care unit after your surgery under a general anesthesia
  • for sedation when you receive certain surgical procedures under a local anesthesia or nerve block or when you receiving a breathing tube while awake
What it does

Dexmedetomidine Hydrochloride for Injection acts by activating a part of the brain which helps keep you calm.

When it should not be used

You should not be given Dexmedetomidine Hydrochloride for Injection if you:

  • are allergic to dexmedetomidine hydrochloride or to any non-medicinal ingredient in the formulation.
What the medicinal ingredient is

dexmedetomidine hydrochloride.

What the non-medicinal ingredients are

sodium chloride and water for injection. Dexmedetomidine Hydrochloride for Injection is preservative-free and contains no additives or other chemicals.

What dosage form it comes in

Dexmedetomidine Hydrochloride for Injection is available as:

  • A solution containing 100 micrograms / mL of dexmedetomidine that will be further diluted into saline and given to you by intravenous infusion. The Dexmedetomidine Hydrochloride for Injection concentrate solution is available in a 2 mL glass vial.
Warnings and precautions

Dexmedetomidine Hydrochloride for Injection should only be administered by healthcare professionals skilled in the management of patients in the intensive care unit or operating room setting.

BEFORE you are given Dexmedetomidine Hydrochloride for Injection talk to your doctor or nurse if you:

  • have heart problems, including chronic high blood pressure
  • have diabetes mellitus
  • have liver problems
  • have severe kidney problems
  • are taking any other medicines
  • are dehydrated or suffer from excessive vomiting, diarrhea, or sweating
  • are older than 65 years of age
  • are pregnant or think you might be pregnant
  • are breastfeeding
Interactions with this medication

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

Drugs that may interact with Dexmedetomidine Hydrochloride for Injection include:

  • anesthestic drugs such as: sevoflurane, isoflurane, propofol, alfentanil, and midazolam neuromuscular blockers such as rocuronium, cisatracurium
  • heart medications
Proper use of this medication

Usual Adult Dose

Dosage will be individualized and titrated to the desired clinical effect. You will be given a loading dose followed by a maintenance dose, specific for your body weight and the procedure you are undergoing. Your doctor will decide what the appropriate dose is for your specific case.

Your doctor and / or nurse will monitor blood pressure, heart rate and oxygen levels, both continuously during the infusion of Dexmedetomidine Hydrochloride for Injection and as clinically appropriate after discontinuation.

It is important that following the return of consciousness, you do not attempt to change position or rise from bed without assistance.

Overdose

If you think you have taken too much Dexmedetomidine Hydrochloride for Injection, or in case of drug overdose, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Side effects and what to do about them

You should report symptoms that may occur within 48 hours after you are given Dexmedetomidine Hydrochloride for Injection such as: dry mouth, nausea, vomiting, or fever.

Serious side effects, how often they happen and what to do about them
After exposure to Dexmedetomidine Hydrochloride for Injection, you should contact your physician or anesthesia professional if you have any of the following reactions:
Symptom / effect Talk with your doctor. Call your doctor immediately 911.
Common
Hypotension (low blood pressure): dizziness, fainting, light-headedness  
Hypertension (high blood pressure): headaches, vision disorders, nausea and vomiting  
Hyperglycemia (high blood sugar): irregular heartbeats, muscle weakness and generally feeling unwell  
Hypokalemia (low potassium blood level) : irregular heartbeats, muscle weakness and generally feeling unwell  
Bradycardia: slow heart beat  
Tachycardia: fast heart beat  
Hypoxia: blueish colouration to the skin, confusion, fast heartbeat, shortness of breath, sweating  
Uncommon
Nervousness  
Headaches  
Agitation  
Weakness  
Confusion  
Excessive sweating  
Weight loss  
Abdominal pain  
Salt cravings  
Diarrhea  
Constipation  
Dizziness/ Lightheadedness  
Anemia: fatigue, loss of energy, weakness, shortness of breath  
Respiratory difficulty  

This is not a complete list of side effects. For any unexpected effects while taking Dexmedetomidine Hydrochloride for Injection, contact your doctor or pharmacist.

How to store

Dexmedetomidine Hydrochloride for Injection (100 mcg / mL) is stored between 15 to 30°C.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about Dexmedetomidine Hydrochloride for Injection:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by calling the sponsor Accord Healthcare Inc. at 1-866-296-0354.

This leaflet was prepared by:

Accord Healthcare Inc.
3535 Boul. St. Charles Suite 704
Kirkland, Québec
H9H 5B9, Canada
Last revised: September 23, 2020

Date modified: