Generic name: dexmedetomidine
Brand names: Precedex, Igalmi
Dosage form: intravenous solution (100 mcg/mL; 4 mcg/mL-D5%; 4 mcg/mL-NaCl 0.9%)
Drug class: Miscellaneous anxiolytics, sedatives and hypnotics
Medically reviewed by A Ras MD.
What is dexmedetomidine?
Dexmedetomidine is a prescription medicine that is used to cause sleep during a procedure.
Dexmedetomidine Injection, USP is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as 4-[(S)-a,2,3-trimethylbenzyl]imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.74 and the molecular formula is C13H16N2• HCl and the structural formula is:
Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection, USP is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7.0. Each mL contains 118 mcg of dexmedetomidine hydrochloride equivalent to 100 mcg (0.1 mg) of dexmedetomidine and 9 mg of sodium chloride in water and is to be used after dilution. The solution is preservative-free and contains no additives or chemical stabilizers.
Mechanism of Action
Dexmedetomidine hydrochloride is a relatively selective alpha2-adrenergic agonist with sedative properties. Alpha2 selectivity is observed in animals following slow intravenous infusion of low and medium doses (10 to 300 mcg/kg). Both alpha1 and alpha2 activity is observed following slow intravenous infusion of high doses (≥, 1000 mcg/kg) or with rapid intravenous administration.
Before taking dexmedetomidine, tell your doctor:
- If you are allergic to dexmedetomidine; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
This medicine may interact with other drugs or health problems.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take dexmedetomidine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take dexmedetomidine?
- Tell all of your health care providers that you take dexmedetomidine. This includes your doctors, nurses, pharmacists, and dentists.
- Avoid driving and doing other tasks or actions that call for you to be alert until the effects of dexmedetomidine wear off and you feel fully awake.
- Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
- Low blood pressure and slow heartbeat have happened with dexmedetomidine. Sometimes, these have been deadly. Talk with the doctor.
- The doctor will watch blood pressure, heart rate, and oxygen levels closely. Talk with the doctor.
- If you are 65 or older, use dexmedetomidine with care. You could have more side effects.
- Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
How is dexmedetomidine best taken?
Use dexmedetomidine as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- It is given into a vein for a period of time.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
What are the side effects of dexmedetomidine that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Very bad dizziness or passing out.
- Trouble breathing, slow breathing, or shallow breathing.
- Fast, slow, or abnormal heartbeat.
- Feeling agitated.
- Feeling nervous and excitable.
- Call your doctor right away if you have any of these signs within 48 hours after getting dexmedetomidine: Change in thinking clearly and with logic, constipation, diarrhea, dizziness, salt cravings, stomach pain, sweating, weakness, or weight loss.
What are some other side effects of dexmedetomidine?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out dexmedetomidine?
- If you need to store dexmedetomidine at home, talk with your doctor, nurse, or pharmacist about how to store it.
PRINCIPAL DISPLAY PANEL
- NDC 0143-9532-25 Rx only
200 mcg per 2 mL
For Intravenous use
MUST BE DILUTED
25 x 2 mL Single Dose Vials
SRC: NLM .