Dexmedetomidine (injection)

Dexmedetomidine (injection) is used in adults to begin or keep sedation in people who are on a ventilator in the intensive care unit (ICU).

Dexmedetomidine (injection) is used in adults for sedation before and during surgery or a medical procedure.

Dexmedetomidine (injection) is also used in children aged 1 month to less than 18 years for sedation before and during other medical procedures.

Dexmedetomidine (injection) may also be used for reasons not mentioned in this medication guide.

Dexmedetomidine is given as an injection into a vein by a healthcare provider.

Your breathing, heart rate, blood pressure, oxygen levels, and other vital signs will be monitored closely during and after you receive the dexmedetomidine injection.

Use only as directed. Inform your doctor if you are taking other medicines, have other medical conditions, or have allergies.

Tell your doctor if you have or have ever had:

• diabetes;
• high blood pressure;
• a serious heart condition such as "AV block" (2nd or 3rd degree);
• a heart rhythm disorder;
• low blood pressure, if you are dehydrated; or
• liver disease.

It is not known if dexmedetomidine (injection) will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are breastfeeding, tell your doctor if you notice irritability in the nursing baby.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Certain side effects may occur during the first 48 hours after receiving dexmedetomidine (injection). Tell your medical caregivers at once if you have: weakness, confusion, feeling nervous or agitated, increased sweating, weight loss, stomach pain, diarrhea, constipation, craving salty foods, dizziness, feeling light-headed, and headache.

Dexmedetomidine (injection) may cause serious side effects. Call your doctor at once if you have:

• fever with shortness of breath or rapid breathing.

Common side effects of dexmedetomidine may include:

• slow heartbeats;
• low blood pressure;
• dry mouth; or
• nausea, vomiting, and agitation.

Some side effects are more common in children receiving dexmedetomidine (injection) such as slow breathing and high blood pressure.

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.

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.

In a medical setting, it is unlikely that you will miss a dose.

In a medical setting, an overdose will be treated quickly.

Follow your doctor's instructions about any limitations on food, drinks, or activities.

Using dexmedetomidine with other drugs that make you sleepy can make this effect stronger. Talk to your doctor before taking opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may influence dexmedetomidine, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.