(remifentanil HCl) for Injection is indicated for intravenous administration:
Important Safety Information
- As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures
- For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting
- As an analgesic component of monitored anesthesia care in adult patients
Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects (within 5 to 10 min) upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia particularly where postoperative pain is anticipated.
Vital signs and oxygenation must be continually monitored during ULTIVA administration. ULTIVA produces adverse events that are characteristic of μ-opioids, such as respiratory depression, tachycardia, bradycardia, hypotension, and skeletal muscle (including chest wall) rigidity. Because these effects are dose-dependent and can occur rapidly, continual monitoring is necessary. ULTIVA should not be used as a sole agent because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia.
ULTIVA should be used with caution in pediatric, geriatric, and morbidly obese patients due to high variability in pharmacodynamics and dose/response. Intraoperative awareness has been reported with concomitant administration with propofol infusion ≤75 mcg/kg/min.
Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing.
Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVA is also contraindicated in patients with known hypersensitivity to fentanyl analogs.
ULTIVA SHOULD BE USED IN THE CAREFULLY MONITORED SETTINGS BY SPECIFICALLY TRAINED PERSONS NOT INVOLVED IN THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION IS TO BE CONTINUOUSLY MONITORED. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE.