Dexmedetomidine

What it is and how it works

Mechanism of Action Dexmedetomidine is a relatively selective centrally acting alpha 2 -adrenergic agonist with sedative properties. Alpha 2 selectivity is observed in animals following slow intravenous infusion of low and medium doses (10 mcg/kg to 300 mcg/kg). Both alpha 1 and alpha 2 activity is observed following slow intravenous infusion of high doses (≥1,000 mcg/kg) or with rapid intravenous administration.

Indications

Dexmedetomidine hydrochloride in 0.9% sodium chloride 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 hydrochloride in 0.9% sodium chloride injection by continuous infusion not to exceed 24 hours. Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. Intensive Care Unit Sedation Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation.

Dosage and administration (summary)

Individualize and titrate dexmedetomidine hydrochloride in 0.9% sodium chloride injection dosing to desired clinical effect. Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection using a controlled infusion device. The 80 mcg per 20 mL single-dose vial, 200 mcg per 50 mL, and 400 mcg per 100 mL single-dose bottles, do not require further dilution prior to administration. 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 .

Contraindications

None. None

Warnings and precautions

Monitoring: Continuously monitor patients while receiving dexmedetomidine. 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. 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.

Pregnancy

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.

Storage and supply

Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) . Do not use if product is discolored or if precipitate matter is present. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection (4 mcg per mL) is clear and colorless. The strengths are based on the dexmedetomidine base. Discard unused portion.

Source: Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride (Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride) — US FDA prescribing information, 2025-11-04, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.