Dexmedetomidine

Dosage Forms & Strengths

injectable solution

• 100mcg/mL

ICU Sedation

Load: 1 mcg/kg IV over 10 minutes 

Maintenance 0.2-1.4 mcg/kg/hr IV

Titrate less frequently than q30min to prevent hypotension

Fiberoptic Intubation

Load: 1 mcg/kg IV over 10 minutes 

Maintenance 0.7 mcg/kg/hr IV

Procedural Sedation

Load: 1 mcg/kg IV over 10 minutes

Maintenance 0.6 mcg/kg/hr IV titrate to effect (usually 0.2-1 mcg/kg/hr) 

Titrate less frequently than q30min to prevent hypotension

Renal Impairment

Dose reduction may be required

Hepatic Impairment

Dose reduction may be required

Safety and efficacy not established

Load: 0.5 mcg/kg IV over 10 minutes

This is not a complete list of Dexmedetomidinedrug interactions. Ask your doctor or pharmacist for more information.

Dexmedetomidine is available in the following forms:

• Injectable Solution

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.

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

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 interact with 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.

• It is used to cause sleep during care.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Dexmedetomidine is injected into a vein through an IV. A healthcare provider will give 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.

Since this medicine 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.

Because you will receive dexmedetomidine in a clinical setting, you are not likely to miss a dose.

Applies to dexmedetomidine: parenteral injection concentrate

Side effects include:

Hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia, anemia.

Dose reduction may be required; however, no specific guidelines have been suggested.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Animal studies have not revealed teratogenicity or fertility effects; however, maternal, fetal, and reproductive toxicity have been observed. There are no controlled data in human pregnancy. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is recommended only if clearly needed and the benefit outweighs the risk. AU TGA pregnancy category: B1 US FDA pregnancy category: C Comments: Fetal exposure in humans should be expected, based on two studies (an in vitro human study and an animal study) which revealed evidence of drug placental transfer.