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Clinical Studies 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 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 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 ICU setting in which 1007 patients received Dexmedetomidine. 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 events occurring at an incidence of >2% are provided in Table 8. The most frequent adverse events were hypotension, bradycardia and dry mouth (see Precautions). See Table 8.
Click on icon to see table/diagram/imageAdverse reaction information was also derived from the placebo-controlled, continuous infusion trials of Dexmedetomidine for sedation in the surgical intensive care unit setting in which 387 adult patients received Dexmedetomidine 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 9).
Click on icon to see table/diagram/imageIn a controlled clinical trial, Dexmedetomidine 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 patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided in Table 9.
The number (%) of subjects who had a dose-related increase in treatment-emergent adverse events by maintenance adjusted dose rate range in the Dexmedetomidine group is provided in Table 10.
Click on icon to see table/diagram/imageThe following adverse events occurred between 2 and 5% for Dexmedetomidine hydrochloride and midazolam, respectively: renal failure acute (2.5%, 0.8%), acute respiratory distress syndrome (2.5%, 0.8%), and respiratory failure (4.5%, 3.3%). (See Table 11.)
Click on icon to see table/diagram/imageProcedural Sedation: Adverse reaction information is derived from the two trials for procedural sedation in which 318 patients received Dexmedetomidine. The mean total dose was 1.6 mcg/kg (range: 0.5 to 6.7), mean dose per hour was 1.3 mcg/kg/hr (range: 0.3 to 6.1) and the mean duration of infusion of 1.5 hours (range: 0.1 to 6.2). The population was between 18 to 93 years of age, ASA I-IV 30% ≥65 years of age, 52% male and 61% Caucasian.
Treatment-emergent adverse events occurring at an incidence of >2% are provided in Table 12. The most frequent adverse events were hypotension, bradycardia, and dry mouth (see Precautions). Pre-specified criteria for the vital signs to be reported as Adverse Events are footnoted as follows in the table.
The decrease in respiratory rate and hypoxia was similar between Dexmedetomidine and comparator groups in both studies. (See Table 12.)
Click on icon to see table/diagram/imagePost Marketing Experience: The following adverse reactions have been identified during post approval use of Dexmedetomidine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypotension and bradycardia were the most common adverse reactions associated with the use of Dexmedetomidine during post approval use of the drug. (See Table 13.)
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