Dexmedetomidine
Generic Name: dexmedetomidine
Brand Names:
Dexmedetomidine
11 DESCRIPTION Dexmedetomidine injection, USP (100 mcg/mL) is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha 2 -adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine.
Overview
11 DESCRIPTION Dexmedetomidine injection, USP (100 mcg/mL) is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha 2 -adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine.
Uses
1 INDICATIONS AND USAGE Dexmedetomidine injection is a alpha 2 -adrenergic receptor agonist indicated for: • Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine injection by continuous infusion not to exceed 24 hours. ( 1.1 ) • Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. ( 1.2 ) • Sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures. ( 1.2 ) 1.1 Intensive Care Unit Sedation Dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting.
Dosage
2 DOSAGE AND ADMINISTRATION • Individualize and titrate dexmedetomidine injection dosing to desired clinical effect. ( 2.1 ) • Administer dexmedetomidine injection using a controlled infusion device. ( 2.1 ) • Dilute the 200 mcg/2 mL (100 mcg/mL) vial contents in 0.9% sodium chloride solution to achieve required concentration (4 mcg/mL) prior to administration. ( 2.4 ) • For Adult Intensive Care Unit Sedation: Initiate at one mcg/kg over 10 minutes , followed by a maintenance infusion of 0.2 mcg/kg/ hour to 0.7 mcg/kg/ hour . ( 2.2 ) • For Adult Procedural Sedation : Initiate at one mcg/kg over 10 minutes , followed by a maintenance infusion initiated at 0.6 mcg/kg/ hour and titrated to achieve desired clinical effect with doses ranging from 0.2 mcg/kg/ hour to 1 mcg/kg/ hour .
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypotension, bradycardia and sinus arrest [see Warnings and Precautions ( 5.2 )] • Transient hypertension [see Warnings and Precautions ( 5.3 )] • The most common adverse reactions (incidence >2%) in adults are hypotension, bradycardia, and dry mouth. ( 6.1 ) • The most common adverse reactions (incidence >5%) in pediatric patients aged 1 month to less than 17 years are bradypnea, bradycardia, hypertension, and hypotension. ( 6.1 ) • Adverse reactions in adults, associated with infusions >24 hours in duration include ARDS, respiratory failure, and agitation.
Interactions
7 DRUG INTERACTIONS Anesthetics, Sedatives, Hypnotics, Opioids: Enhancement of pharmacodynamic effects. Reduction in dosage of dexmedetomidine or the concomitant medication may be required. ( 7.1 ) 7.1 Anesthetics, Sedatives, Hypnotics, Opioids Co-administration of dexmedetomidine with anesthetics, sedatives, hypnotics, and opioids is likely to lead to an enhancement of effects. Specific studies have confirmed these effects with sevoflurane, isoflurane, propofol, alfentanil, and midazolam. No pharmacokinetic interactions between dexmedetomidine and isoflurane, propofol, alfentanil and midazolam have been demonstrated.
Warnings
5 WARNINGS AND PRECAUTIONS • Monitoring : Continuously monitor patients while receiving dexmedetomidine. ( 5.1 ) • Bradycardia and Sinus Arrest : Have occurred in young healthy volunteers with high vagal tone or with different routes of administration, e.g., rapid intravenous or bolus administration. ( 5.2 ) • 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. ( 5.2 ) • Co-administration with Other Vasodilators or Negative Chronotropic Agents : Use with caution due to additive pharmacodynamic effects. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Available data from published randomized controlled trials and case reports over several decades of use with intravenously administered dexmedetomidine during pregnancy have not identified a drug-associated risk of major birth defects and miscarriage; however, the reported exposures occurred after the first trimester. Most of the available data are based on studies with exposures that occurred at the time of caesarean section delivery, and these studies have not identified an adverse effect on maternal outcomes or infant Apgar scores.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Dexmedetomidine Injection, USP 200 mcg/2 mL (100 mcg/mL) is clear and colorless. The strength is based on the dexmedetomidine base. Discard unused portion.
Frequently Asked Questions
What is Dexmedetomidine used for?▼
1 INDICATIONS AND USAGE Dexmedetomidine injection is a alpha 2 -adrenergic receptor agonist indicated for: • Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine injection by continuous infusion not to exceed 24 hours. ( 1.1 ) • Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. ( 1.2 ) • Sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures. ( 1.2 ) 1.1 Intensive Care Unit Sedation Dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting.
What are the side effects of Dexmedetomidine?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypotension, bradycardia and sinus arrest [see Warnings and Precautions ( 5.2 )] • Transient hypertension [see Warnings and Precautions ( 5.3 )] • The most common adverse reactions (incidence >2%) in adults are hypotension, bradycardia, and dry mouth. ( 6.1 ) • The most common adverse reactions (incidence >5%) in pediatric patients aged 1 month to less than 17 years are bradypnea, bradycardia, hypertension, and hypotension. ( 6.1 ) • Adverse reactions in adults, associated with infusions >24 hours in duration include ARDS, respiratory failure, and agitation.
Can I take Dexmedetomidine during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from published randomized controlled trials and case reports over several decades of use with intravenously administered dexmedetomidine during pregnancy have not identified a drug-associated risk of major birth defects and miscarriage; however, the reported exposures occurred after the first trimester. Most of the available data are based on studies with exposures that occurred at the time of caesarean section delivery, and these studies have not identified an adverse effect on maternal outcomes or infant Apgar scores.
What are the important warnings for Dexmedetomidine?▼
5 WARNINGS AND PRECAUTIONS • Monitoring : Continuously monitor patients while receiving dexmedetomidine. ( 5.1 ) • Bradycardia and Sinus Arrest : Have occurred in young healthy volunteers with high vagal tone or with different routes of administration, e.g., rapid intravenous or bolus administration. ( 5.2 ) • 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. ( 5.2 ) • Co-administration with Other Vasodilators or Negative Chronotropic Agents : Use with caution due to additive pharmacodynamic effects. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.