Dexmedetomidine Hydrochloride
Injection, Solution · Intravenous
Current shortage
Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-297-10) – Available (Eugia US LLC, updated Sep 17, 2026)
Check wholesalers for inventory
Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 42023-146-25) – Available (Par Health, USA LLC, updated Aug 18, 2026)
Please check wholesalers for inventory
Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 52536-126-08) – Available (Azurity Pharmaceuticals, Inc, updated Sep 16, 2026)
Distributed by Wilshire Pharmaceuticals, Inc.
Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 100 mL (NDC 70121-1389-1) – Available (Amneal Pharmaceuticals, updated Jun 17, 2026)
Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-187-10) – Unavailable (Par Health, USA LLC, updated Sep 17, 2026)
Estimated recovery: TBD; Please check wholesalers for inventory
Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 52536-125-10) – Available (Azurity Pharmaceuticals, Inc, updated Sep 16, 2026)
Distributed by Wilshire Pharmaceuticals, Inc.
Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-296-10) – Available (Eugia US LLC, updated Sep 17, 2026)
Check wholesalers for inventory
Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 72572-128-08) – Available (Azurity Pharmaceuticals, Inc, updated Sep 16, 2026)
Distributed by Civica
Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-759-04) – Available (Somerset Therapeutics, LLC, updated Sep 11, 2026)
Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-186-20) – Unavailable (Par Health, USA LLC, updated Sep 17, 2026)
Estimated recovery: TBD; Please check wholesalers for inventory
Uses
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. ( 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 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. It is not necessary to discontinue dexmedetomidine hydrochloride in 0.9% sodium chloride injection prior to extubation. 1.2 Procedural Sedation Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures. 1.1 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. It is not necessary to discontinue dexmedetomidine hydrochloride in 0.9% sodium chloride injection prior to extubation. 1.2 Procedural Sedation Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures.
Dosage and administration
Individualize and titrate dexmedetomidine hydrochloride in 0.9% sodium chloride injection dosing to desired clinical effect. ( 2.1 ) Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection using a controlled infusion device. ( 2.1 ) The 200 mcg/50 mL single-dose vials and 400 mcg/100 mL single-dose vials do not require further dilution 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 . ( 2.2 ) For Sedation of Pediatric Patients During Non-invasive Procedures : Patients 1 month to less than 2 years old initiate at 1.5 mcg/kg over 10 minutes followed by a maintenance infusion of 1.5 mcg/kg/ hour and titrated to achieve desired clinical effect with dosage ranging from 0.5 mcg/kg/ hour to 1.5 mcg/kg/ hour ; patients 2 to less than 18 years old initiate at 2 mcg/kg over 10 minutes followed by a maintenance infusion of 1.5 mcg/kg/ hour and titrated to achieve desired clinical effect with dosage ranging from 0.5 mcg/kg/ hour to 1.5 mcg/kg/ hour . ( 2.2 ) Alternative Doses : Recommended for patients over 65 years of age and awake fiberoptic intubation patients. ( 2.2 ) 2.1 Administration Instructions Dexmedetomidine hydrochloride in 0.9% sodium chloride injection dosing should be individualized and titrated to desired clinical response. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is not indicated for infusions lasting longer than 24 hours. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered using a controlled infusion device. 2.2 Recommended Dosage Table 1: Recommended Dosage in Adult Patients INDICATION DOSAGE AND ADMINISTRATION Initiation of Intensive Care Unit Sedation For adult patients: a loading infusion of one mcg/kg over 10 minutes. For adult patients being converted from alternate sedative therapy: a loading dose may not be required. For patients over 65 years of age: Consider a dose reduction [see Use in Specific Populations ( 8.5 )] . For adult patients with impaired hepatic function: Consider a dose reduction [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )]. Maintenance of Intensive Care Unit Sedation For adult patients: a maintenance infusion of 0.2 mcg/kg/hour to 0.7 mcg/kg/hour. The rate of the maintenance infusion should be adjusted to achieve the desired level of sedation. For patients over 65 years of age: Consider a dose reduction [see Use in Specific Populations ( 8.5 )] . For adult patients with impaired hepatic function: Consider a dose reduction [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )]. Initiation of Procedural Sedation For adult patients: a loading infusion of one mcg/kg over 10 minutes. For less invasive procedures such as ophthalmic surgery, a loading infusion of 0.5 mcg/kg given over 10 minutes may be suitable. For awake fiberoptic intubation in adult patients: a loading infusion of one mcg/kg over 10 minutes. For patients over 65 years of age: a loading infusion of 0.5 mcg/kg over 10 minutes [see Use in Specific Populations ( 8.5 )]. For adult patients with impaired hepatic function: Consider a dose reduction [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )]. Maintenance of Procedural Sedation For adult patients: the maintenance infusion is generally 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. Adjust the rate of the maintenance infusion to achieve the targeted level of sedation. For awake fiberoptic intubation in adult patients: a maintenance infusion of 0.7 mcg/kg/hour is recommended until the endotracheal tube is secured. For patients over 65 years of age: Consider a dose reduction [see Use in Specific Populations ( 8.5 )]. For adult patients with impaired hepatic function: Consider a dose reduction [see Use in Specific Populations (8.6), Clinical Pharmacology ( 12.3 )]. Table 2: Recommended Dosage in Pediatric Patients INDICATION DOSAGE AND ADMINISTRATION Initiation of Sedation During Non-invasive Procedures For pediatric patients:
• 1 month to less than 2 years: a loading infusion of 1.5 mcg/kg over 10 minutes.
• 2 to less than 18 years: a loading infusion of 2 mcg/kg over 10 minutes. Consider a reduction in dosage if clinically indicated. Maintenance of Sedation During Non-invasive Procedures For pediatric patients:
• 1 month to less than 18 years: the maintenance infusion is generally initiated at 1.5 mcg/kg/hour and titrated to achieve desired clinical effect with dosage ranging from 0.5 mcg/kg/hour to 1.5 mcg/kg/hour. As clinically warranted, titrate the maintenance dose to individual patient clinical response. 2.3 Dosage Adjustment Due to possible pharmacodynamic interactions, a reduction in dosage of dexmedetomidine hydrochloride in 0.9% sodium chloride injection or other concomitant anesthetics, sedatives, hypnotics or opioids may be required when co-administered [see Drug Interactions (7.1)]. Dosage reductions may need to be considered for adult patients with hepatic impairment, and geriatric patients [see Warnings and Precautions (5.9), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]. 2.4 Preparation of Solution Strict aseptic technique must always be maintained during handling of dexmedetomidine hydrochloride in 0.9% sodium chloride injection. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if product is discolored or if precipitate matter is present.
Dosage forms and strengths
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a clear and colorless solution, ready to use. It is available as: Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 200 mcg/50 mL (4 mcg/mL) single-dose glass vial. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 400 mcg/100 mL (4 mcg/mL) single-dose glass vial.
• Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 200 mcg/50 mL (4 mcg/mL) and 400 mcg/100 mL (4 mcg/mL) in single-dose glass vials. Ready to use. ( 3 )
Contraindications
None. None. ( 4 )
Warnings and precautions
Monitoring : Continuously monitor patients while receiving dexmedetomidine hydrochloride in 0.9% sodium chloride injection. (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. (5.2) Transient Hypertension : Observed primarily during the loading dose. Consider reduction in loading infusion rate. (5.3) Arousability : Patients can become aroused/alert with stimulation; this alone should not be considered as lack of efficacy. (5.4) Tolerance and Tachyphylaxis : Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse events. (5.7) 5.1 Drug Administration Dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological effects of dexmedetomidine, patients should be continuously monitored while receiving dexmedetomidine hydrochloride in 0.9% sodium chloride injection. 5.2 Hypotension, Bradycardia, and Sinus Arrest Clinically significant episodes of bradycardia and sinus arrest have been reported with dexmedetomidine administration in young, healthy adult volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration. Reports of hypotension and bradycardia have been associated with dexmedetomidine infusion. Some of these cases have resulted in fatalities. If medical intervention is required, treatment may include decreasing or stopping the infusion of dexmedetomidine hydrochloride in 0.9% sodium chloride injection, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents. Because dexmedetomidine has the potential to augment bradycardia induced by vagal stimuli, clinicians should be prepared to intervene. The intravenous administration of anticholinergic agents (e.g., glycopyrrolate, atropine) should be considered to modify vagal tone. In clinical trials, glycopyrrolate or atropine were effective in the treatment of most episodes of dexmedetomidine-induced bradycardia. However, in some patients with significant cardiovascular dysfunction, more advanced resuscitative measures were required. Caution should be exercised when administering dexmedetomidine hydrochloride in 0.9% sodium chloride injection to patients 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 elderly patients. In clinical trials where other vasodilators or negative chronotropic agents were co-administered with dexmedetomidine hydrochloride in 0.9% sodium chloride injection an additive pharmacodynamic effect was not observed. Nonetheless, caution should be used when such agents are administered concomitantly with dexmedetomidine hydrochloride in 0.9% sodium chloride injection. 5.3 Transient Hypertension Transient hypertension has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive effects of dexmedetomidine hydrochloride in 0.9% sodium chloride injection. Treatment of the transient hypertension has generally not been necessary, although reduction of the loading infusion rate may be desirable. 5.4 Arousability Some patients receiving dexmedetomidine hydrochloride in 0.9% sodium chloride injection have been observed to be arousable and alert when stimulated. This alone should not be considered as evidence of lack of efficacy in the absence of other clinical signs and symptoms. 5.5 Withdrawal Intensive Care Unit Sedation With administration up to 7 days, regardless of dose, 12 (5%) dexmedetomidine hydrochloride in 0.9% sodium chloride injection adult subjects experienced at least 1 event related to withdrawal within the first 24 hours after discontinuing study drug and 7 (3%) dexmedetomidine hydrochloride in 0.9% sodium chloride injection adult subjects experienced at least 1 event 24 to 48 hours after end of study drug. The most common events were nausea, vomiting, and agitation [see Adverse Reactions ( 6.1 )] . In adult subjects, tachycardia and hypertension requiring intervention in the 48 hours following study drug discontinuation occurred at frequencies of <5%. Procedural Sedation In adult subjects, withdrawal symptoms were not seen after discontinuation of short-term infusions of dexmedetomidine hydrochloride in 0.9% sodium chloride injection (<6 hours). In pediatric patients, mild transient withdrawal symptoms of emergence delirium or agitation were seen after discontinuation of short-term infusions of dexmedetomidine hydrochloride in 0.9% sodium chloride injection (<2 hours) [see Adverse Reactions ( 6.1 )] . 5.6 Diabetes Insipidus Cases of diabetes insipidus (DI) have been reported with use of dexmedetomidine in the setting of sedation. Signs of DI in this setting include polyuria (output >125 mL/hr), diluted urine (osmolality <300 mOsm/kg), and hypernatremia (serum sodium >145 mmol/L). If unrecognized, this condition can lead to hemodynamic instability including unstable blood pressure and increased risk of other cardiovascular sequelae.
Side effects
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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Piramal Critical Care at 1-800-414-1901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common treatment-emergent adverse reactions, occurring in greater than 2% of adult patients in both Intensive Care Unit and procedural sedation studies include hypotension, bradycardia and dry mouth. Intensive Care Unit Sedation Adverse reaction information is derived from the continuous infusion trials of dexmedetomidine for sedation in the Intensive Care Unit setting in which 1,007 adult patients received dexmedetomidine hydrochloride in 0.9% sodium chloride injection. The mean total dose was 7.4 mcg/kg (range: 0.8 to 84.1), mean dose per hour was 0.5 mcg/kg/hr (range: 0.1 to 6.0) and the mean duration of infusion of 15.9 hours (range: 0.2 to 157.2). The population was between 17 to 88 years of age, 43% ≥65 years of age, 77% male and 93% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 3. The most frequent adverse reactions were hypotension, bradycardia and dry mouth [see Warnings and Precautions ( 5.2 )] . Table 3: Adverse Reactions with an Incidence >2%-Adult Intensive Care Unit Sedation Population <24 hours* Adverse Event All Dexmedetomidine (N = 1,007) (%) Randomized Dexmedetomidine (N = 798) (%) Placebo (N = 400) (%) Propofol (N = 188) (%) Hypotension 25% 24% 12% 13% Hypertension 12% 13% 19% 4% Nausea 9% 9% 9% 11% Bradycardia 5% 5% 3% 0 Atrial Fibrillation 4% 5% 3% 7% Pyrexia 4% 4% 4% 4% Dry Mouth 4% 3% 1% 1% Vomiting 3% 3% 5% 3% Hypovolemia 3% 3% 2% 5% Atelectasis 3% 3% 3% 6% Pleural Effusion 2% 2% 1% 6% Agitation 2% 2% 3% 1% Tachycardia 2% 2% 4% 1% Anemia 2% 2% 2% 2% Hyperthermia 2% 2% 3% 0 Chills 2% 2% 3% 2% Hyperglycemia 2% 2% 2% 3% Hypoxia 2% 2% 2% 3% Post-procedural Hemorrhage 2% 2% 3% 4% Pulmonary Edema 1% 1% 1% 3% Hypocalcemia 1% 1% 0 2% Acidosis 1% 1% 1% 2% Urine Output Decreased 1% 1% 0 2% Sinus Tachycardia 1% 1% 1% 2% Ventricular Tachycardia <1% 1% 1% 5% Wheezing <1% 1% 0 2% Edema Peripheral <1% 0 1% 2% * 26 subjects in the all dexmedetomidine hydrochloride in 0.9% sodium chloride injection group and 10 subjects in the randomized dexmedetomidine hydrochloride in 0.9% sodium chloride injection group had exposure for greater than 24 hours. Adverse reaction information was also derived from the placebo-controlled, continuous infusion trials of dexmedetomidine hydrochloride in 0.9% sodium chloride injection for sedation in the surgical intensive care unit setting in which 387 adult patients received dexmedetomidine hydrochloride in 0.9% sodium chloride injection for less than 24 hours. The most frequently observed treatment-emergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia (see Table 4). Table 4: Treatment-Emergent Adverse Events Occurring in >1% of All Dexmedetomidine-Treated Adult Patients in the Randomized Placebo-Controlled Continuous Infusion <24 Hours ICU Sedation Studies Adverse Event Randomized Dexmedetomidine (N = 387) Placebo (N = 379) Hypotension 28% 13% Hypertension 16% 18% Nausea 11% 9% Bradycardia 7% 3% Fever 5% 4% Vomiting 4% 6% Atrial Fibrillation 4% 3% Hypoxia 4% 4% Tachycardia 3% 5% Hemorrhage 3% 4% Anemia 3% 2% Dry Mouth 3% 1% Rigors 2% 3% Agitation 2% 3% Hyperpyrexia 2% 3% Pain 2% 2% Hyperglycemia 2% 2% Acidosis 2% 2% Pleural Effusion 2% 1% Oliguria 2% <1% Thirst 2% <1% In a controlled clinical trial, dexmedetomidine hydrochloride in 0.9% sodium chloride injection was compared to midazolam for ICU sedation exceeding 24 hours duration in adult patients. Key treatment emergent adverse events occurring in dexmedetomidine or midazolam treated adult patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided in Table 5. The number (%) of adult subjects who had a dose-related increase in treatment-emergent adverse events by maintenance adjusted dose rate range in the dexmedetomidine hydrochloride in 0.9% sodium chloride injection group is provided in Table 6. Table 5: Key Treatment-Emergent Adverse Events Occurring in Dexmedetomidine- or Midazolam-Treated Adult Patients in the Randomized Active Comparator Continuous Infusion Long-Term Intensive Care Unit Sedation Study Adverse Event Dexmedetomidine (N = 244) Midazolam (N = 122) Hypotension 1 56% 56% Hypotension Requiring Intervention 28% 27% Bradycardia 2 42% 19% Bradycardia Requiring Intervention 5% 1% Systolic Hypertension 3 28% 42% Tachycardia 4 25% 44% Tachycardia Requiring Intervention 10% 10% Diastolic Hypertension 3 12% 15% Hypertension 3 11% 15% Hypertension Requiring Intervention † 19% 30% Hypokalemia 9% 13% Pyrexia 7% 2% Agitation 7% 6% Hyperglycemia 7% 2% Constipation 6% 6% Hypoglycemia 5% 6% Respiratory Failure 5% 3% Renal Failure Acute 2% 1% Acute Respiratory Distress Syndrome 2% 1% Generalized Edema 2% 6% Hypomagnesemia 1% 7% † Includes any type of hypertension.
Drug interactions
Anesthetics, Sedatives, Hypnotics, Opioids: Enhancement of pharmacodynamic effects. Reduction in dosage of dexmedetomidine hydrochloride in 0.9% sodium chloride injection or the concomitant medication may be required. ( 7.1 ) 7.1 Anesthetics, Sedatives, Hypnotics, Opioids Co-administration of dexmedetomidine hydrochloride in 0.9% sodium chloride injection 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. However, due to possible pharmacodynamic interactions, when co-administered with dexmedetomidine, a reduction in dosage of dexmedetomidine hydrochloride in 0.9% sodium chloride injection or the concomitant anesthetic, sedative, hypnotic or opioid may be required. 7.2 Neuromuscular Blockers In one study of 10 healthy adult volunteers, administration of dexmedetomidine hydrochloride in 0.9% sodium chloride injection for 45 minutes at a plasma concentration of one ng/mL resulted in no clinically meaningful increases in the magnitude of neuromuscular blockade associated with rocuronium administration. 7.1 Anesthetics, Sedatives, Hypnotics, Opioids Co-administration of dexmedetomidine hydrochloride in 0.9% sodium chloride injection 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. However, due to possible pharmacodynamic interactions, when co-administered with dexmedetomidine, a reduction in dosage of dexmedetomidine hydrochloride in 0.9% sodium chloride injection or the concomitant anesthetic, sedative, hypnotic or opioid may be required. 7.2 Neuromuscular Blockers In one study of 10 healthy adult volunteers, administration of dexmedetomidine hydrochloride in 0.9% sodium chloride injection for 45 minutes at a plasma concentration of one ng/mL resulted in no clinically meaningful increases in the magnitude of neuromuscular blockade associated with rocuronium administration.
Use in specific populations
Geriatric Patients: Dose reduction should be considered. ( 2.2 , 2.3 , 5.2 , 8.5 ) Hepatic Impairment: Dose reduction should be considered. ( 2.2 , 2.3 , 5.9 , 8.6 ) See 17 for PATIENT COUNSELING INFORMATION. 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. Available data indicate that dexmedetomidine crosses the placenta. In animal reproduction studies, fetal toxicity that lower fetal viability and reduced live fetuses occurred with subcutaneous administration of dexmedetomidine to pregnant rats during organogenesis at doses 1.8 times the maximum recommended human dose (MRHD) of 17.8 mcg/kg/day. Developmental toxicity (low pup weights and adult offspring weights, decreased F1 grip strength, increased early implantation loss and decreased viability of second-generation offspring) occurred when pregnant rats were subcutaneously administered dexmedetomidine at doses less than the clinical dose from late pregnancy through lactation and weaning (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Increased post-implantation losses and reduced live fetuses in the presence of maternal toxicity (i.e. decreased body weight) were noted in a rat embryo-fetal development study in which pregnant dams were administered subcutaneous doses of dexmedetomidine 200 mcg/kg/day (equivalent to 1.8 times the intravenous MRHD of 17.8 mcg/kg/day based on body surface area [BSA]) during the period of organogenesis (Gestation Day [GD] 6 to 15). No malformations were reported. No malformations or embryo-fetal toxicity were noted in a rabbit embryo-fetal development study in which pregnant does were administered dexmedetomidine intravenously at doses of up to 96 mcg/kg/day (approximately half the human exposure at the MRHD based on AUC) during the period of organogenesis (GD 6 to 18). Reduced pup and adult offspring birth weights, and grip strength were reported in a rat developmental toxicology study in which pregnant females were administered dexmedetomidine subcutaneously at doses of 8 mcg/kg/day (0.07 times the MRHD based on BSA) during late pregnancy through lactation and weaning (GD 16 to postnatal day [PND] 25). Decreased viability of second generation offspring and an increase in early implantation loss along with delayed motor development occurred in the 32 mcg/kg/day group (equivalent to less than the clinical dose based on BSA) when first generation offspring were allowed to mate. This study limited dosing to hard palate closure (GD 15 to 18) through weaning instead of dosing from implantation (GD 6 to 7) to weaning (PND 21). In a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously. 8.2 Lactation Risk Summary Available published literature reports the presence of dexmedetomidine in human milk following intravenous administration (see Data) . There is no information regarding the effects of dexmedetomidine on the breastfed infant or the effects on milk production. Advise women to monitor the breastfed infant for irritability. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dexmedetomidine and any potential adverse effects on the breastfed infant from dexmedetomidine or from the underlying condition. Data In two published clinical studies, a total of 14 women were given intravenous dexmedetomidine 6 mcg/kg/hour for 10 minutes after delivery followed by continuous infusion of 0.2 mcg/kg/hour to 0.7 mcg/kg/hour. Breast milk and maternal blood samples were collected at 0, 6, 12, and 24 hours after discontinuation of dexmedetomidine. Plasma and milk dexmedetomidine concentrations were detectable up to 6 hours in most subjects, up to 12 hours in one subject and undetectable in all at 24 hours. The milk-to-plasma ratio from single paired maternal milk and plasma concentrations at each time point ranged from 0.53 to 0.95. The relative infant dose was estimated to range from 0.02 to 0.098%. 8.4 Pediatric Use Sedation for Non-Invasive Procedures The safety and efficacy of dexmedetomidine hydrochloride in 0.9% sodium chloride injection have been established in pediatric patients 1 month to less than 18 years of age for sedation during non-invasive procedures. Use in this age group is based on one randomized double-blind, dose-ranging safety and efficacy trial in non-intubated pediatric patients 1 month to less than 17 years of age who required sedation prior to undergoing MRI scans [see Clinical Studies ( 14.2 )] . An increase in frequency of bradypnea, bradycardia, hypertension and hypotension was observed in pediatric patients treated with dexmedetomidine hydrochloride in 0.9% sodium chloride injection [see Adverse Reactions ( 6.1 )]. The overall safety profile of dexmedetomidine hydrochloride in 0.9% sodium chloride injection in pediatric patients was consistent with the known safety profile in adults [see Adverse Reactions ( 6.1 )] .
Overdosage
The tolerability of dexmedetomidine hydrochloride in 0.9% sodium chloride injection was studied in one study in which healthy adult subjects were administered doses at and above the recommended dose of 0.2 mcg/kg/hr to 0.7 mcg/kg/hr . The maximum blood concentration achieved in this study was approximately 13 times the upper boundary of the therapeutic range. The most notable effects observed in two subjects who achieved the highest doses were first degree atrioventricular block and second-degree heart block. No hemodynamic compromise was noted with the atrioventricular block and the heart block resolved spontaneously within one minute. Five adult patients received an overdose of dexmedetomidine hydrochloride in 0.9% sodium chloride injection in the intensive care unit sedation studies. Two of these patients had no symptoms reported; one patient received a 2 mcg/kg loading dose over 10 minutes (twice the recommended loading dose) and one patient received a maintenance infusion of 0.8 mcg/kg/hr. Two other patients who received a 2 mcg/kg loading dose over 10 minutes, experienced bradycardia and/or hypotension. One patient who received a loading bolus dose of undiluted dexmedetomidine (19.4 mcg/kg), had cardiac arrest from which he was successfully resuscitated.
Description
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection (4 mcg/mL) is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine. Dexmedetomidine hydrochloride chemical name is 1H-Imidazole, 4-[1-(2,3-dimethylphenyl)ethyl]-, monohydrochloride, (S). Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C 13 H 16 N 2
• HCl and the structural formula is: Dexmedetomidine hydrochloride, USP 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 hydrochloride in 0.9% sodium chloride injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride, USP (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers. Dexmedetomidine-SPL-Structure
Mechanism of action
12.1 Mechanism of Action Dexmedetomidine hydrochloride in 0.9% sodium chloride injection 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 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.
How supplied
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection (4 mcg/mL) is clear and colorless. The strength is based on the dexmedetomidine base. Discard unused portion. NDC No. Container Size Package Factor Concentration 66794-234-44 Single-dose vial 50 mL 20 Vials per Carton 200 mcg/50 mL (4 mcg/mL) 66794-235-41 Single-dose vial 100 mL 10 Vials per Carton 400 mcg/100 mL (4 mcg/mL) Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not use if product is discolored or if precipitate matter is present.
Patient information
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for short-term intravenous sedation. Dosage must be individualized and titrated to the desired clinical effect. Blood pressure, heart rate and oxygen levels will be monitored both continuously during the infusion of dexmedetomidine hydrochloride in 0.9% sodium chloride injection and as clinically appropriate after discontinuation. When dexmedetomidine hydrochloride in 0.9% sodium chloride injection is infused for more than 6 hours, patients should be informed to report nervousness, agitation, and headaches that may occur for up to 48 hours. Additionally, patients should be informed to report symptoms that may occur within 48 hours after the administration of dexmedetomidine hydrochloride in 0.9% sodium chloride injection such as: weakness, confusion, excessive sweating, weight loss, abdominal pain, salt cravings, diarrhea, constipation, dizziness or light-headedness. Advise breastfeeding mothers who were exposed to dexmedetomidine hydrochloride in 0.9% sodium chloride injection to monitor breastfed neonates for irritability [see Use in Specific Populations ( 8.2 )] . Manufactured for Piramal Critical Care Bethlehem, PA 18017, USA Product of India 1313000570-02 Revised: 05/2026
Label text from the FDA structured product label by Piramal Critical Care Inc (revised Jul 28, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Dexmedetomidine Hydrochloride in 39 products
Dexmedetomidine Hydrochloride NDC products (39)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 70121-1712 | Dexmedetomidine Hydrochloride 4 ug/mL Injection | Amneal Pharmaceuticals LLC | ANDA |
| 70121-1711 | Dexmedetomidine Hydrochloride 4 ug/mL Injection | Amneal Pharmaceuticals LLC | ANDA |
| 70121-1389 | Dexmedetomidine Hydrochloride 4 ug/mL Injection, Solution | Amneal Pharmaceuticals LLC | ANDA |
| 70121-1388 | Dexmedetomidine Hydrochloride 4 ug/mL Injection, Solution | Amneal Pharmaceuticals LLC | ANDA |
| 43066-565 | Dexmedetomidine Hydrochloride 400 ug/100mL Injection | Baxter Healthcare Company | ANDA |
| 43066-561 | Dexmedetomidine Hydrochloride 200 ug/50mL Injection | Baxter Healthcare Company | ANDA |
| 0338-9555 | Dexmedetomidine Hydrochloride 200 ug/50mL Injection | Baxter Healthcare Company | ANDA |
| 0338-9557 | Dexmedetomidine Hydrochloride 400 ug/100mL Injection | Baxter Healthcare Company | ANDA |
| 36000-262 | Dexmedetomidine Hydrochloride 100 ug/mL Injection, Solution, Concentrate | Baxter Healthcare Corporation | ANDA |
| 72572-128 | Dexmedetomidine Hydrochloride 4 ug/mL Injection | CIVICA, INC. | ANDA |
| 72572-127 | Dexmedetomidine Hydrochloride 4 ug/mL Injection | CIVICA, INC. | ANDA |
| 43598-975 | Dexmedetomidine Hydrochloride 4 ug/mL Injection, Solution | Dr.Reddy's Laboratories Inc | ANDA |
| 43598-976 | Dexmedetomidine Hydrochloride 4 ug/mL Injection, Solution | Dr.Reddy's Laboratories Inc | ANDA |
| 55150-297 | Dexmedetomidine Hydrochloride 4 ug/mL Injection, Solution | Eugia US LLC | ANDA |
| 55150-296 | Dexmedetomidine Hydrochloride 4 ug/mL Injection, Solution | Eugia US LLC | ANDA |
| 63323-421 | Dexmedetomidine Hydrochloride 100 ug/mL Injection, Solution | Fresenius Kabi USA, LLC | ANDA |
| 65219-642 | Dexmedetomidine Hydrochloride 100 ug/mL Injection, Solution | Fresenius Kabi USA, LLC | ANDA |
| 68083-657 | Dexmedetomidine Hydrochloride 4 ug/mL Injection | Gland Pharma Limited | ANDA |
| 68083-239 | Dexmedetomidine Hydrochloride 4 ug/mL Injection | Gland Pharma Limited | ANDA |
| 68083-238 | Dexmedetomidine Hydrochloride 4 ug/mL Injection | Gland Pharma Limited | ANDA |
| 0143-9525 | Dexmedetomidine Hydrochloride 4 ug/mL Injection, Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9526 | Dexmedetomidine Hydrochloride 4 ug/mL Injection, Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9198 | Dexmedetomidine Hydrochloride 4 ug/mL Injection, Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 71872-7122 | Dexmedetomidine Hydrochloride 100 ug/mL Injection, Solution | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7031 | Dexmedetomidine Hydrochloride 100 ug/mL Injection, Solution | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7030 | Dexmedetomidine Hydrochloride 100 ug/mL Injection, Solution | Medical Purchasing Solutions, LLC | ANDA |
| 67457-924 | Dexmedetomidine Hydrochloride 200 ug/50mL Injection, Solution | Mylan Institutional LLC | ANDA |
| 67457-925 | Dexmedetomidine Hydrochloride 400 ug/100mL Injection, Solution | Mylan Institutional LLC | ANDA |
| 42023-187 | Dexmedetomidine Hydrochloride 4 ug/mL Injection, Solution | Par Health USA, LLC | ANDA |
| 42023-186 | Dexmedetomidine Hydrochloride 4 ug/mL Injection, Solution | Par Health USA, LLC | ANDA |
| 42023-146 | Dexmedetomidine Hydrochloride 100 ug/mL Injection, Solution, Concentrate | Par Health USA, LLC | ANDA |
| 66794-234 | Dexmedetomidine Hydrochloride 4 ug/mL Injection | Piramal Critical Care Inc | ANDA |
| 66794-235 | Dexmedetomidine Hydrochloride 4 ug/mL Injection | Piramal Critical Care Inc | ANDA |
| 25021-617 | Dexmedetomidine Hydrochloride 4 ug/mL Injection | Sagent Pharmaceuticals | ANDA |
| 70069-758 | Dexmedetomidine Hydrochloride 100 ug/mL Injection, Solution | Somerset Therapeutics, LLC | ANDA |
| 70069-759 | Dexmedetomidine Hydrochloride 100 ug/mL Injection, Solution | Somerset Therapeutics, LLC | ANDA |
| 57664-596 | Dexmedetomidine Hydrochloride 100 ug/mL Injection, Solution | Sun Pharmaceuticals Industries, Inc. | ANDA |
| 52536-126 | Dexmedetomidine Hydrochloride 4 ug/mL Injection | Wilshire Pharmaceuticals, Inc. | ANDA |
| 52536-125 | Dexmedetomidine Hydrochloride 4 ug/mL Injection | Wilshire Pharmaceuticals, Inc. | ANDA |
Frequently asked questions
What is Dexmedetomidine Hydrochloride used for?
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. ( 1.1 ) Sedation of non-intubated…
What are the side effects of Dexmedetomidine Hydrochloride?
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… See the full label for the complete list.
Who makes Dexmedetomidine Hydrochloride?
Dexmedetomidine Hydrochloride is listed by 17 labelers in the FDA NDC directory, including Amneal Pharmaceuticals LLC, Baxter Healthcare Company, Baxter Healthcare Corporation, CIVICA, INC..