Dexmedetomidine

Dexamedetomidine is a prescription medication indicated for Sedation of initially intubated and mechanically ventilated patients in ICU setting and for Procedural Sedation.

• Dexamedetomidine is available under the following different brand names: Precedex

Adult dosage

Injectable solution

• 200mcg/2mL (100mcg/mL) single-dose glass vial
• Requires further dilution before administering
• Ready-to-use injectable solution
  • 80mcg/20mL 0.9% NaCl (4mcg/mL)
  • 200mcg/50mL 0.9% NaCl (4mcg/mL)
  • 400mcg/100mL 0.9% NaCl (4mcg/mL)

ICU Sedation

Adult

• Load: 1 mcg/kg IV over 10 minutes; loading dose may not be required for adults converted from other sedative therapy
• Maintenance: 0.2-0.7 mcg/kg/hr continuous IV infusion; not to exceed 24 hours

Procedural Sedation

Adult

• 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)

Pediatric

• Safety and efficacy not established

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

 

Common side effects of Dexamedetomidine include:

• slowed breathing, 
• slow or irregular heartbeats, 
• anemia, 
• dry mouth, 
• nausea, 
• fever, and
• dizziness

Serious side effects of Dexamedetomidine include:

• hives, 
• difficulty breathing, 
• swelling of face, lips, tongue, or throat, 
• agitation, 
• signs of waking up, 
• change in level of consciousness, 
• slow heartbeats, 
• weak or shallow breathing, 
• cough, 
• lightheadedness, 
• shortness of breath, 
• muscle weakness, 
• pale or blue-colored skin, 
• headache, 
• confusion, 
• anxiety, 
• nervous, 
• weakness, 
• stomach pain, 
• diarrhea, 
• constipation, 
• excessive sweating, 
• weight loss, 
• blurred vision, 
• pounding in the neck or ears, 
• severe chest pain, 
• rapid or irregular heartbeats, and
• an unusual craving for salt

Rare side effects of Dexamedetomidine include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first

• Dexamedetomidine has severe interactions with the following drug:
  • eliglustat 
• Dexamedetomidine has serious interactions with the following drugs:
  • calcium/magnesium/potassium/sodium oxybates
  • hydrocodone
  • lonafarnib
  • metoclopramide intranasal
  • ponesimoid
  • sodium oxybate
  • sufentanil SL
  • valerian 
  • vortioxetine
• Dexamedetomidine has moderate interactions with at least 195 other drugs.
• Dexamedetomidine has minor interactions with the following drugs:
  • ashwagandha
  • brimonidine
  • eucalyptus
  • nettle
  • ruxolitinib
  • sage
  • Siberian ginseng

This information does not contain all possible interactions or adverse effects.  Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• None 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Dexamedetomidine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Dexamedetomidine?”

Cautions

• Continuously monitor patients while on therapy; therapy should be administered only by persons skilled in the management of patients in the intensive care or operating room setting
• Bradycardia and sinus arrest have occurred in young healthy volunteers with high vagal tone or with different routes of administration, including rapid IV bolus administration
• Caution with advanced heart block and/or severe ventricular dysfunction; because dexmedetomidine decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension, and in older patients
• Transient hypertension reported primarily during loading dose; consider reduction in loading infusion rate
• Patients can become aroused/alert with stimulation; this alone should not be considered as lack of efficacy
• Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse events (eg, ARDS, respiratory failure, agitation)
• Use with caution in hepatic impairment; consider dose reduction
• Hypotension and bradycardia may necessitate medical intervention; may be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension, and in the elderly; use with caution in patients with advanced heart block or severe ventricular dysfunction
• Withdrawal symptoms after discontinuation reported when administered for longer than 6 hours; most common events reported include nausea, vomiting, and agitation
• Tachycardia and hypertension reported, requiring intervention 48 hours following study drug discontinuation; if tachycardia and/or hypertension occurs after discontinuation, supportive therapy is indicated
• Drug interaction overview
  • Caution if co-administered with other vasodilators or negative chronotropic agents owing to additive pharmacodynamic effects
  • Coadministration with anesthetics, sedatives, hypnotics, and opioids is likely to lead to an enhancement of pharmacodynamic effects

Pregnancy and Lactation

• There are no adequate and well-controlled studies of use in pregnant women. In an in vitro human placenta study, placental transfer of dexmedetomidine occurred 
• Unknown if excreted in human milk. Radio-labeled dexmedetomidine administered SC to lactating female rats was excreted in milk; because many drugs are excreted in human milk, caution should be exercised when administered to breastfeeding women