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%) are hypotension, bradycardia, and dry mouth.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp.
at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 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.
Use of dexmedetomidine hydrochloride has been associated with the following serious adverse reactions: Hypotension, bradycardia and sinus arrest [see Warnings and Precautions (5.2 )] Transient hypertension [see Warnings and Precautions (5.3 )] Most common treatment-emergent adverse reactions, occurring in greater than 2% of patients in procedural sedation studies include hypotension, bradycardia and dry mouth.
Procedural Sedation Adverse reaction information is derived from the two trials for procedural sedation [ see Clinical Studies (14.1)] in which 318 adult patients received dexmedetomidine hydrochloride.
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 reactions occurring at an incidence of >2% are provided in Table
The most frequent adverse reactions were hypotension, bradycardia, and dry mouth [see Warnings and Precautions (5.2 )] .
Pre-specified criteria for the vital signs to be reported as adverse reactions are footnoted below the table.
5 WARNINGS AND PRECAUTIONS Monitoring: Continuously monitor patients while receiving dexmedetomidine HCl.
(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 Hcl 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: