Dexmedetomidine is a sedative that is used to sedate a patient who is under intensive medical care and needs a mechanical ventilator (breathing machine).

Before a ventilator is used, a breathing tube must be inserted through the mouth and into the patient's airway, a procedure called intubation. The tube is then attached to the ventilator, which pumps air slowly into the lungs to control the patient's breathing. Sedation with dexmedetomidine can help keep the patient relaxed and comfortable while the ventilator and tube are in place.

Dexmedetomidine is also used during anesthesia to get a patient ready for a surgery or other medical procedure.

Dexmedetomidine may also be used for purposes not listed in this medication guide.

Before dexmedetomidine is given, the doctor should know about all the patient's medical conditions or allergies, and all other medicines the patient is using. Also make sure the doctor knows if the patient is pregnant or breast-feeding.

Dexmedetomidine is given as an infusion into a vein. A healthcare provider will give you this injection.

Dexmedetomidine is given using a continuous infusion device that slowly injects the medicine into the body. This type of infusion keeps the patient sedated around the clock.

The patient's breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while dexmedetomidine is given.

When dexmedetomidine is discontinued after long-term use over several days, the patient may have withdrawal symptoms. The most common withdrawal symptoms are nausea, vomiting, and agitation. The patient may also have rapid heartbeats and increased blood pressure.

Usual Adult Dose for Sedation:

Intensive Care Unit Sedation:
-Initial Dose: Loading dose of 1 mcg/kg IV infusion over 10 minutes.
-Maintenance Dose: 0.2 to 0.7 mcg/kg/hour IV infusion; adjust the infusion rate to achieve the desired clinical effect.

Procedural Sedation:
-Initial Dose (including Awake Fiberoptic Intubation): 1 mcg/kg IV infusion over 10 minutes.
-Maintenance Dose: Initiate IV infusion at 0.6 mcg/kg/hour and titrate to achieve the desired clinical effect; doses may range from 0.2 to 1 mcg/kg/hour.

Uses: Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting; sedation of non-intubated patients prior to and/or during surgical and other procedures.

Usual Geriatric Dose for Sedation:

Over Age 65 Years:
Intensive Care Unit Sedation: Dose reduction may be required; however, no specific guidelines have been suggested.

Procedural Sedation:
-Initial Dose: May be omitted or reduced (e.g., 0.5 mcg/kg IV infusion over 10 minutes).
-Maintenance Dose: Dose reduction may be required; however, no specific guidelines have been suggested.

Uses: Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting; sedation of non-intubated patients prior to and/or during surgical and other procedures.

You should not be treated with dexmedetomidine if you are allergic to it.

To make sure dexmedetomidine is safe to give, tell the doctor if the patient has:

• liver disease;

• diabetes;

• high blood pressure;

• a serious heart condition such as severe heart block, or "AV block";

• a heart rhythm disorder; or

• low blood pressure, or if the patient may be dehydrated.

It is not known whether dexmedetomidine will harm an unborn baby. Tell the doctor if the patient is pregnant or plan to become pregnant.

The patient should not breast-feed within 10 hours after receiving dexmedetomidine. If a breast pump is used during this time, any milk collected should be thrown out and not fed to a baby.

Because dexmedetomidine is given in a controlled clinical setting, a missed dose is not likely.

Since dexmedetomidine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

In the event of an overdose, medical care providers in an intensive care setting are able to quickly treat any symptoms that may occur.

Follow the doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if the patient has signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Tell the medical caregivers right away if the person receiving dexmedetomidine has:

• agitation, signs of waking up, or any change in level of consciousness;

• slow heartbeats;

• weak or shallow breathing, cough;

• feeling light-headed or short of breath;

• muscle weakness; or

• pale or blue-colored skin.

Certain side effects may occur during the first 48 hours after the patient stops receiving dexmedetomidine. Call the doctor right away if the patient has any of the following side effects:

• headache, confusion, anxiety, feeling nervous or agitated;

• weakness, feeling light-headed or short of breath;

• stomach pain, diarrhea, constipation;

• excessive sweating;

• weight loss;

• blurred vision, pounding in the neck or ears;

• severe chest pain, rapid or irregular heartbeats; or

• an unusual craving for salt.

Common side effects of dexmedetomidine may include:

• slowed breathing;

• slow or irregular heartbeats;

• anemia;

• dry mouth, nausea;

• fever; or

• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dexmedetomidine can interact with other drugs that can cause drowsiness or slowed breathing, leading to dangerous side effects or death. Ask a doctor before giving the patient a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may affect dexmedetomidine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of the patient's health care providers about all medicines in use now and any medicine the patient starts or stops using.