Dexmedetomidine

Dexmedetomidine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

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Overview

Dexmedetomidine is a general anesthetic that is FDA approved for the {{{indicationType}}} of premedication for anesthetic procedure, nonintubated patients, sedation, intubated/mechanically ventilated ICU patients. Common adverse reactions include cardiovascular: hypertension (12% to 13% ), tachycardia (2% to 5% ), gastrointestinal: nausea (3% to 11% ), xerostomia (3% to 4% )..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Cough, Fentanyl- or sufentanil-induced: 0.1 mcg/kg, 0.25 mcg/kg, or 0.5 mcg/kg IV over 5 minutes immediately prior to sufentanil [1] and 0.5 or 1 mcg/kg IV over 10 minutes immediately prior to fentanyl [2] were used in clinical trials Cough, Fentanyl- or sufentanil-induced: (combination with midazolam) 0.6 mcg/kg IV over 10 minutes plus midazolam 0.06 mg/kg IV over 5 seconds, administered 2 minutes prior to fentanyl, was used in a clinical trial [3] Premedication for anesthetic procedure, Nonintubated patients: initial, loading infusion of 1 mcg/kg IV over 10 minutes; for less invasive procedures (ie, ophthalmic surgery), initial loading infusion of 0.5 mcg/kg IV over 10 minutes may be sufficient [4] Premedication for anesthetic procedure, Nonintubated patients: maintenance, 0.6 mcg/kg/hr IV infusion titrated to desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/hr [4] Premedication for anesthetic procedure, Nonintubated patients: (awake, fiberoptic intubation) initial loading infusion of 1 mcg/kg IV over 10 minutes, followed by maintenance infusion of 0.7 mcg/kg/hr until endotracheal tube is secured [4] Premedication for anesthetic procedure, Nonintubated patients: 1 mcg/kg INTRANASALLY, diluted in NS to a total volume of 0.8 mL and administered bilaterally (0.4 mL each nostril), provided effective sedation in a small randomized study [5] Sedation, Intubated/mechanically ventilated ICU patients: initial, loading infusion of 1 mcg/kg IV over 10 minutes; no loading dose required when converting from alternate sedative therapy [4] Sedation, Intubated/mechanically ventilated ICU patients: maintenance, 0.2 to 0.7 mcg/kg/hr continuous IV infusion titrated to desired clinical effect for a MAX of 24 hours [4]

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Anesthetics adverse reaction - ShiveringView additional information.

       Cough, Fentanyl- or sufentanil-inducedView additional information.
       General anesthesia; AdjunctView additional information.
       Sedation, During awake craniotomyView additional information.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Dexmedetomidine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

safety and efficacy not established in pediatric patients [4] Premedication for anesthetic procedure, Nonintubated patients: 2 mcg/kg IV bolus over 10 minutes, then 1 mcg/kg/hour IV until completion of nuclear medicine imaging was used in a clinical study (mean age, 5.7 years) [6] Premedication for anesthetic procedure, Nonintubated patients: 0.5 to 1 mcg/kg IV every 3 to 5 minutes (mean total dose, 2.1 mcg/kg; mean infusion rate, 1.5 mcg/kg/hr) provided sedation during EEG testing in a retrospective review (mean age, 5.6 years) [7] Premedication for anesthetic procedure, Nonintubated patients: initial, 1 to 4.5 mcg/kg IM (mean dose, 2.6 mcg/kg) provided sedation during EEG testing in a retrospective review; a second, lower dose (mean dose, 2 mcg/kg) was given if adequate sedation was not achieved 10 minutes after first dose (mean age, 3.5 years) [8] Premedication for anesthetic procedure, Nonintubated patients: 1 to 2 mcg/kg INTRANASALLY, administered bilaterally, provided effective sedation prior to anesthesia induction in 2 randomized studies (ages, 1 to 8 years) [

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Dexmedetomidine in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Dexmedetomidine in pediatric patients.

Contraindications

There is limited information regarding Dexmedetomidine Contraindications in the drug label.

Warnings

There is limited information regarding Dexmedetomidine Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Dexmedetomidine Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Dexmedetomidine Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Dexmedetomidine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Dexmedetomidine in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dexmedetomidine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Dexmedetomidine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Dexmedetomidine in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Dexmedetomidine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Dexmedetomidine in geriatric settings.

Gender

There is no FDA guidance on the use of Dexmedetomidine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Dexmedetomidine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Dexmedetomidine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Dexmedetomidine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Dexmedetomidine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Dexmedetomidine in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Dexmedetomidine Administration in the drug label.

Monitoring

There is limited information regarding Dexmedetomidine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Dexmedetomidine and IV administrations.

Overdosage

There is limited information regarding Dexmedetomidine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Dexmedetomidine Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Dexmedetomidine Mechanism of Action in the drug label.

Structure

There is limited information regarding Dexmedetomidine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Dexmedetomidine Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Dexmedetomidine Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Dexmedetomidine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Dexmedetomidine Clinical Studies in the drug label.

How Supplied

There is limited information regarding Dexmedetomidine How Supplied in the drug label.

Storage

There is limited information regarding Dexmedetomidine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Dexmedetomidine Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Dexmedetomidine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Dexmedetomidine Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Dexmedetomidine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.