Dexmedetomidine Injection

Dexmedetomidine is used to provide short-term sedation (you are relaxed, sleepy or in some cases asleep) for adults in intensive care units that are receiving mechanical ventilation (a machine that takes over the work of breathing). It is also used to provide sedation in adults and children and infants 1 month of age and older during surgical and other procedures. Dexmedetomidine is in a class of medications called alpha₂ receptor agonists. It works by changing the activity of certain natural substances in the brain.

Dexmedetomidine comes as a solution to give intravenously (into a vein) by a specially trained healthcare provider. It is usually given by an infusion in amounts required to maintain anesthesia or sedation depending on age, health, and other factors. Your dose will be adjusted based on your response. You will be monitored carefully by your healthcare provider while you are receiving dexmedetomidine and for a period of time afterwards.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving dexmedetomidine,

• tell your doctor and pharmacist if you are allergic to dexmedetomidine, any other medications, or any of the ingredients in dexmedetomidine solution. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking dexmedetomidine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had diabetes, hypertension, or heart or liver disease.
• tell your doctor if you are pregnant or are breast-feeding. If you are breastfeeding after receiving dexmedetomidine, tell your doctor if your infant becomes irritable.
• you should know that dexmedetomidine may make you drowsy and reduce mental alertness. Do not drive a car, operate machinery, or sign legal documents until your doctor recommends you to do so.

Dexmedetomidine may cause side effects, usually within 48 hours after receiving the drug. Tell your doctor if any of these symptoms are severe or do not go away:

• dry mouth
• diarrhea
• constipation
• abdominal pain
• salt cravings

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• slow or irregular heartbeat
• lightheadedness or dizziness
• fainting
• nervousness, agitation, and headaches
• weakness or confusion
• fever, excessive sweating

Dexmedetomidine may cause other side effects. Call your doctor if you have any unusual problems after receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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