Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common adverse reactions (incidence greater than 2%) in adults are hypotension, bradycardia, and dry mouth.
(6.1) Adverse reactions in adults, associated with infusions greater than 24 hours in duration include ARDS, respiratory failure, and agitation.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc.
at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 )] 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.
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) 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 greater than 2% are provided in Table 3 .
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.
Like all medications, Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: