Details for: DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION
Company: ACCORD HEALTHCARE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02477327 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) | 100 MCG / ML | SOLUTION | INTRAVENOUS |
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.
| 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:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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