- QT Prolongation/Torsades de Pointes have been reported at or below recommended doses. Some cases have been in patients without known risk factors for QT prolongation. Some cases have been fatal.
- Reserve for treatment in refractory disease because of serious proarrhythmic effects.
- Contraindicated in patients with known or suspected QT prolongation
- Extreme caution in patients at risk for development of prolonged QT
Other risk factors may include age over 65 years, alcohol abuse, and use of agents such as benzodiazepines, volatile anesthetics, and IV opiates. Droperidol should be initiated at a low dose and adjusted upward, with caution, as needed to achieve the desired effect.
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MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Perform baseline 12 lead ECG prior to initiation of therapy
- Do not administer if QTc > 440 msec in males or 450 msec in females.
- Baseline ECG monitoring and continued for 2-3 hrs post completion of therapy
- Risk factors for QT prolonged syndrome: CHF, bradycardia, diuretic use, cardiac hypertrophy, hypokalemia, hypomagnesemia, drugs which prolong QT interval, >65 yrs, alcohol abuse, benzodiazepines, volatile anesthestics, IV opiates.
- Initiate at low dose and titrate slowly
- Black Box Warning revised/added December 2001