Dexmedetomidine Hydrochloride
Dexmedetomidine Hydrochloride Prescribing Information
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a alpha2-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. (
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.
• 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 adult patients prior to and/or during surgical and other procedures.
• Individualize and titrate dexmedetomidine hydrochloride in 0.9% sodium chloride injection dosing to desired clinical effect. (
• 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.
• Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection using a controlled infusion device. (
• 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.
• The 200 mcg/50mL and 400 mcg/100 mL single-dose bottles, do not require further dilution prior to administration. (
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.
Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection is supplied in glass containers containing a premixed, ready to use dexmedetomidine hydrochloride solution in 0.9% sodium chloride in water. No further dilution of these preparations is necessary.
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INDICATION | DOSAGE AND ADMINISTRATION |
Initiation of Intensive Care Unit Sedation | For adult patients : a loading infusion of one mcg/kg over 10minutes 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 ].For adult patients with impaired hepatic function : Consider a dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
Maintenance of Intensive Care Unit Sedation | For adult patients : a maintenance infusion of 0.2 to 0.7 mcg/kg/hour For patients over 65 years of age : Consider a dose reduction [see Use in Specific Populations ]. For adult patients with impaired hepatic function :Considera dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
Initiation of Procedural Sedation | For adult patients : a loading infusion of one mcg/kg over 10minutes minutes For awake fiberoptic intubation in adult patients : a loading infusion of one mcg/kg over 10minutes For patients over 65 years of age : a loading infusion of 0.5 mcg/kg over 10minutes see Use in Specific Populations ]. For adult patients with impaired hepatic function : Consider a dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
Maintenance of Procedural Sedation | For adult patients : the maintenance infusion is generally initiated at 0.6 mcg/kg/hour hour For awake fiberoptic intubation in adult patients : a maintenance infusion of 0.7 mcg/kg/hour For patients over 65 years of age : Consider a dose reduction [see Use in Specific Populations ]. For adult patients with impaired hepatic function : Consider a dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
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INDICATION | DOSAGE AND ADMINISTRATION |
Initiation of Intensive Care Unit Sedation | For adult patients : a loading infusion of one mcg/kg over 10minutes 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 ].For adult patients with impaired hepatic function : Consider a dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
Maintenance of Intensive Care Unit Sedation | For adult patients : a maintenance infusion of 0.2 to 0.7 mcg/kg/hour For patients over 65 years of age : Consider a dose reduction [see Use in Specific Populations ]. For adult patients with impaired hepatic function :Considera dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
Initiation of Procedural Sedation | For adult patients : a loading infusion of one mcg/kg over 10minutes minutes For awake fiberoptic intubation in adult patients : a loading infusion of one mcg/kg over 10minutes For patients over 65 years of age : a loading infusion of 0.5 mcg/kg over 10minutes see Use in Specific Populations ]. For adult patients with impaired hepatic function : Consider a dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
Maintenance of Procedural Sedation | For adult patients : the maintenance infusion is generally initiated at 0.6 mcg/kg/hour hour For awake fiberoptic intubation in adult patients : a maintenance infusion of 0.7 mcg/kg/hour For patients over 65 years of age : Consider a dose reduction [see Use in Specific Populations ]. For adult patients with impaired hepatic function : Consider a dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
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INDICATION | DOSAGE AND ADMINISTRATION |
Initiation of Intensive Care Unit Sedation | For adult patients : a loading infusion of one mcg/kg over 10minutes 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 ].For adult patients with impaired hepatic function : Consider a dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
Maintenance of Intensive Care Unit Sedation | For adult patients : a maintenance infusion of 0.2 to 0.7 mcg/kg/hour For patients over 65 years of age : Consider a dose reduction [see Use in Specific Populations ]. For adult patients with impaired hepatic function :Considera dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
Initiation of Procedural Sedation | For adult patients : a loading infusion of one mcg/kg over 10minutes minutes For awake fiberoptic intubation in adult patients : a loading infusion of one mcg/kg over 10minutes For patients over 65 years of age : a loading infusion of 0.5 mcg/kg over 10minutes see Use in Specific Populations ]. For adult patients with impaired hepatic function : Consider a dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
Maintenance of Procedural Sedation | For adult patients : the maintenance infusion is generally initiated at 0.6 mcg/kg/hour hour For awake fiberoptic intubation in adult patients : a maintenance infusion of 0.7 mcg/kg/hour For patients over 65 years of age : Consider a dose reduction [see Use in Specific Populations ]. For adult patients with impaired hepatic function : Consider a dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is clear 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 bottle.
Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg/100 mL (4 mcg/mL) single-dose glass bottle.
• Geriatric Patients: Dose reduction should be considered. (
INDICATION | DOSAGE AND ADMINISTRATION |
Initiation of Intensive Care Unit Sedation | For adult patients : a loading infusion of one mcg/kg over 10minutes 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 ].For adult patients with impaired hepatic function : Consider a dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
Maintenance of Intensive Care Unit Sedation | For adult patients : a maintenance infusion of 0.2 to 0.7 mcg/kg/hour For patients over 65 years of age : Consider a dose reduction [see Use in Specific Populations ]. For adult patients with impaired hepatic function :Considera dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
Initiation of Procedural Sedation | For adult patients : a loading infusion of one mcg/kg over 10minutes minutes For awake fiberoptic intubation in adult patients : a loading infusion of one mcg/kg over 10minutes For patients over 65 years of age : a loading infusion of 0.5 mcg/kg over 10minutes see Use in Specific Populations ]. For adult patients with impaired hepatic function : Consider a dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
Maintenance of Procedural Sedation | For adult patients : the maintenance infusion is generally initiated at 0.6 mcg/kg/hour hour For awake fiberoptic intubation in adult patients : a maintenance infusion of 0.7 mcg/kg/hour For patients over 65 years of age : Consider a dose reduction [see Use in Specific Populations ]. For adult patients with impaired hepatic function : Consider a dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
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 [
Dosage reductions may need to be considered for adult patients with hepatic impairment, and geriatric patients [
A total of 131 patients in the clinical studies were 65 years of age and over. A total of 47 patients were 75 years of age and over. Hypotension occurred in a higher incidence in dexmedetomidine hydrochloride in 0.9% sodium chloride injection-treated patients 65 years or older (72%) and 75 years or older (74%) as compared to patients <65 years (47%). A reduced loading dose of 0.5 mcg/kg given over 10 minutes is recommended and a reduction in the maintenance infusion should be considered for patients greater than 65 years of age.
• Hepatic Impairment: Dose reduction should be considered. (
INDICATION | DOSAGE AND ADMINISTRATION |
Initiation of Intensive Care Unit Sedation | For adult patients : a loading infusion of one mcg/kg over 10minutes 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 ].For adult patients with impaired hepatic function : Consider a dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
Maintenance of Intensive Care Unit Sedation | For adult patients : a maintenance infusion of 0.2 to 0.7 mcg/kg/hour For patients over 65 years of age : Consider a dose reduction [see Use in Specific Populations ]. For adult patients with impaired hepatic function :Considera dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
Initiation of Procedural Sedation | For adult patients : a loading infusion of one mcg/kg over 10minutes minutes For awake fiberoptic intubation in adult patients : a loading infusion of one mcg/kg over 10minutes For patients over 65 years of age : a loading infusion of 0.5 mcg/kg over 10minutes see Use in Specific Populations ]. For adult patients with impaired hepatic function : Consider a dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
Maintenance of Procedural Sedation | For adult patients : the maintenance infusion is generally initiated at 0.6 mcg/kg/hour hour For awake fiberoptic intubation in adult patients : a maintenance infusion of 0.7 mcg/kg/hour For patients over 65 years of age : Consider a dose reduction [see Use in Specific Populations ]. For adult patients with impaired hepatic function : Consider a dose reduction [see Use in Specific Populations , Clinical Pharmacology ]. |
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 [
Dosage reductions may need to be considered for adult patients with hepatic impairment, and geriatric patients [
Since dexmedetomidine hydrochloride in 0.9% sodium chloride injection clearance decreases with increasing severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [
None
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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 hydrochloride in 0.9% sodium chloride injection, patients should be continuously monitored while receiving dexmedetomidine hydrochloride in 0.9% sodium chloride injection.
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Clinically significant episodes of bradycardia and sinus arrest have been reported with dexmedetomidine hydrochloride in 0.9% sodium chloride injection 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 hydrochloride in 0.9% sodium chloride injection 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 hydrochloride in 0.9% sodium chloride injection 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 hydrochloride 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 hydrochloride in 0.9% sodium chloride injection 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.
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Clinically significant episodes of bradycardia and sinus arrest have been reported with dexmedetomidine hydrochloride in 0.9% sodium chloride injection 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 hydrochloride in 0.9% sodium chloride injection 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 hydrochloride in 0.9% sodium chloride injection 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 hydrochloride 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 hydrochloride in 0.9% sodium chloride injection 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.
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Clinically significant episodes of bradycardia and sinus arrest have been reported with dexmedetomidine hydrochloride in 0.9% sodium chloride injection 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 hydrochloride in 0.9% sodium chloride injection 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 hydrochloride in 0.9% sodium chloride injection 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 hydrochloride 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 hydrochloride in 0.9% sodium chloride injection 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.
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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.
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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.
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Use of dexmedetomidine beyond 24 hours has been associated with tolerance and tachyphylaxis and a dose-related increase in adverse reactions [