Rapid response and recovery in a variety of procedures
Demonstrated results in spine, ortho, ENT, cardiac, and other procedures1-10
Rapid onset in 1 to 2 minutes1
Rapid response to dose adjustment1
Rapid recovery from Remi effects in 5 to 10 minutes1
No accumulation regardless of infusion duration1
Rapid offset of Remi results in rapid dissipation of analgesic effect within 5-10 minutes of discontinuation. However, respiratory depression may occur in some patients up to 30 minutes after termination of infusion due to residual effects of concomitant anesthetics. Other analgesics should be administered prior to discontinuation where postoperative pain is anticipated.
Remi produces adverse events that are characteristic of μ-opioids, such as respiratory depression, apnea, tachycardia, bradycardia, hypotension, hypertension, and skeletal muscle (including chest wall) rigidity.
Guy J, Hindman BJ, Baker KZ, et al. Comparison of remifentanil and fentanyl in patients undergoing craniotomy for supratentorial space-occupying lesions. Anesthesiology. 1997;86(3):514-524. Supported in part by funding from Glaxo Wellcome Inc.
Imani F, Jafarian A, Hassani V, Khan ZH. Propofol-alfentanil vs propofol-remifentanil for posterior spinal fusion including wake-up test. Br J Anaesth. 2006;96(5):583-586.
Lison S, Schill M, Conzen P. Fast-track cardiac anesthesia: efficacy and safety of remifentanil versus sufentanil. J Cardiothorac Vasc Anesth. 2007;21(1):35-40. Supported by a grant from GlaxoSmithKline.
Wilhelm W, Schlaich N, Harrer J, et al. Recovery and neurological examination after remifentanil-desflurane or fentanyl-desflurane anaesthesia for carotid artery surgery. Br J Anaesth. 2001;86(1):44-49.
Eberhart LH, Folz BJ, Wulf H, Geldner G. Intravenous anesthesia provides optimal surgical conditions during microscopic and endoscopic sinus surgery. Laryngoscope. 2003;113(8):1369-1373.
De Baerdemaeker LEC, Jacobs S, Pattyn P, Mortier EP, Struys MMRF. Influence of intraoperative opioid on postoperative pain and pulmonary function after laparoscopic gastric banding: remifentanil TCI vs sufentanil TCI in morbid obesity. Br J Anaesth. 2007;99(3):404-411.
Lee JH, Koo BN, Jeong JJ, Kim HS, Lee JR. Differential effects of lidocaine and remifentanil on response to the tracheal tube during emergence from general anaesthesia. Br J Anaesth. 2011;106(3):410-415.
Twersky RS, Jamerson B, Warner DS, Fleisher LA, Hogue S. Hemodynamics and emergence profile of remifentanil versus fentanyl prospectively compared in a large population of surgical patients. J Clin Anesth. 2001;13(6):407-416. Sponsored by Glaxo Wellcome Inc.
Chung F, Mulier JP, Scholz J, et al. A comparison of anaesthesia using remifentanil combined with either isoflurane, enflurane or propofol in patients undergoing gynaecological laparoscopy, varicose vein or arthroscopic surgery. Acta Anaesthesiol Scand. 2000;44(7):790-798.
SAFETY INFORMATION
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.
Clearance of ULTIVA generally correlates with total body weight and may vary in pediatric, geriatric, and morbidly obese patients due to variation in physiology and pharmacodynamics. Respiratory depression may occur in some patients up to 30 minutes after termination of infusion due to residual effects of concomitant anesthetics. See full Prescribing Information.
Vital signs and oxygenation must be continuously monitored during ULTIVA administration. ULTIVA produces adverse events that are characteristic of μ-opioids, such as respiratory depression, apnea, tachycardia, bradycardia, hypotension, hypertension, and skeletal muscle (including chest wall) rigidity. Because these effects are dose-dependent and can occur rapidly, continuous 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.
Due to lack of drug accumulation, the duration of action of ULTIVA at a given dose does not increase with increasing duration of administration unlike other fentanyl analogs. Clearance of ULTIVA is generally correlated with total body weight and may vary in pediatric, geriatric, and morbidly obese patients due to high variability in physiology, pharmacodynamics, and dose/response. Intraoperative awareness has been reported with concomitant administration with propofol infusion ≤75 mcg/kg/min.
ULTIVA should be used with caution in pediatric, geriatric, and morbidly obese patients due to high variability in pharmacodynamics and dose/response.
The starting doses of ULTIVA should be based on ideal body weight (IBW) in obese patients (greater than 30% over their IBW). The clearance of remifentanil is reduced (approximately 25%) in the elderly (>65 years of age) compared to young adults (average 25 years of age). However, ULTIVA blood concentrations fall as rapidly after termination of administration in the elderly as in young adults.
ULTIVA has been studied as an analgesic agent for use in the maintenance of general anesthesia in outpatient and inpatient pediatric surgery for patients from birth to 12 years, but has not been studied for use as a postoperative analgesic or as an analgesic component of monitored anesthesia care for pediatric patients.
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 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.
Please see full Prescribing Information for all precautions, warnings, contraindications, and adverse events.
INDICATIONS AND IMPORTANT RISK INFORMATION
INDICATIONS
ULTIVA® (remifentanil HCl) for Injection is indicated for intravenous administration:
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
IMPORTANT RISK INFORMATION
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 continuously monitored during ULTIVA administration. ULTIVA produces adverse events that are characteristic of
μ-opioids, such as respiratory depression, apnea, tachycardia, bradycardia, hypotension, hypertension, and skeletal muscle (including chest wall) rigidity. Because these effects are dose-dependent and can occur rapidly, continuous 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 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.
Please see full Prescribing Information for all precautions, warnings, contraindications, and adverse events.
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