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Full Prescribing Information.
 
Predictable control of depth and duration of
analgesia

  • Rapid onset in 1 to 2 minutes1
  • Rapid response to dose adjustment and flexible titration1
  • Rapid offset in 5 to 10 minutes and rapid recovery1
  • Rapid offset necessitates establishment of adequate postoperative analgesia1
  • Rapid elimination with no accumulation1,3
  • Unique organ-independent metabolism allows use in patients with renal or hepatic impairment and obese patients1,3
Flexible control for specific procedures and patient
types

  • High-risk patients1
  • Neurological and evoked potential procedures1,4-6
  • Head and neck procedures7-9
  • Abdominal procedures1,10-14
  • Orthopedic procedures1,15-17
  • Cardiothoracic procedures1,18-25
*Remifentanil is commonly referred to as Remi by anesthesia providers.
  • REFERENCES
    1. ULTIVA [package insert]. Rockford, IL: Mylan Institutional LLC; 2011.
    2. Data on file. Canonsburg, PA: Mylan Institutional; 2011.
    3. Goldenberg D, Goldstein BJ. Handbook of Otolaryngology: Head and Neck Surgery. New York, NY: Thieme Medical Publishers, Inc; 2011:38.
    4. 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.
    5. Samra SK, Dy EA, Welch KB, Lovely LK, Graziano GP. Remifentanil- and fentanyl-based anesthesia for intraoperative monitoring of somatosensory evoked potentials. Anesth Analg. 2001;92(6):1510-1515.
    6. Schubert A, Deogaonkar A, Lotto M, Niezgoda J, Luciano M. Anesthesia for minimally invasive cranial and spinal surgery. J Neurosurg Anesthesiol. 2006;18(1):47-56.
    7. Prakash N, McLeod T, Gao Smith F. The effects of remifentanil on haemodynamic stability during rigid bronchoscopy. Anaesthesia. 2001;56(6):576-580.
    8. Wuesten R, Van Aken H, Glass PS, Buerkle H. Assessment of depth of anesthesia and postoperative respiratory recovery after remifentanil- versus alfentanil-based total intravenous anesthesia in patients undergoing ear-nose-throat surgery. Anesthesiology. 2001;94(2):211-217.
    9. Lee B, Lee JR, Na S. Targeting smooth emergence: the effect site concentration of remifentanil for preventing cough during emergence during propofol-remifentanil anaesthesia for thyroid surgery. Br J Anaesth. 2009;102(6):775-778.
    10. Bergland A, Gislason H, Raeder J. Fast-track surgery for bariatric laparoscopic gastric bypass with focus on anaesthesia and peri-operative care: experience with 500 cases. Acta Anaesthesiol Scand. 2008;52(10):1394-1399.
    11. Rowbotham DJ, Peacock JE, Jones RM, et al. Comparison of remifentanil in combination with isoflurane or propofol for short-stay surgical procedures. Br J Anaesth. 1998;80(6):752-755.
    12. Sneyd J, Camu F, Doenicke A, et al. Remifentanil and fentanyl during anaesthesia for major abdominal and gynaecological surgery: an open, comparative study of safety and efficacy. Eur J Anaesthesiol. 2001;18(9):605-614.
    13. Song D, Whitten CW, White PF. Remifentanil infusion facilitates early recovery for obese outpatients undergoing laparoscopic cholecystectomy. Anesth Analg. 2000;90(5):1111-1113.
    14. Lendvay V, Drægni T, Rostrup M, Kirkebøen KA. Propofol/remifentanil vs desflurane/fentanyl in open hemicolectomy surgery. J Anesth Clin Res. 2010;1:103. doi:10.4172/2155-6148.1000103.
    15. Jung JY, Han JH, Yi JW, Kang JM. Remifentanil prevents tourniquet-induced arterial pressure increase in elderly orthopedic patients under sevoflurane/N2O general anesthesia. Int J Med Sci. 2012;9(4):311-315.
    16. 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.
    17. Sacchetti A, Jachowski J, Heisler J, Cortese T. Remifentanil use in emergency department patients: initial experience. Emerg Med J. 2012;29(11):928-929.
    18. Howie MB, Cheng D, Newman MF, et al. A randomized double-blinded multicenter comparison of remifentanil versus fentanyl when combined with isoflurane/propofol for early extubation in coronary artery bypass graft surgery. Anesth Analg. 2001;92(5):1084-1093.
    19. Knapik M, Knapik P, Nadziakiewicz P, et al. Comparison of remifentanil or fentanyl administration during isoflurane anesthesia for coronary artery bypass surgery. Med Sci Monit. 2006;12(8):PI33-PI38.
    20. 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.
    21. Burlacu CL, McKeating K, McShane AJ. Remifentanil for the insertion and removal of long-term central venous access during monitored anesthesia care. J Clin Anesth. 2011;23(4):286-291.
    22. Turkoz A, Turkoz R, Gulcan O, et al. Wake-up test after carotid endarterectomy for combined carotid-coronary artery surgery: a case series. J Cardiothorac Vasc Anesth. 2007;21(4):540-546.
    23. Mandel JE, Hutchinson MD, Marchlinski FE. Remifentanil-midazolam sedation provides hemodynamic stability and comfort during epicardial ablation of ventricular tachycardia. J Cardiovasc Electrophysiol. 2011;22(4):464-466.
    24. Wilhelm W, Schlaich N, Harrer J, Kleinschmidt S, Muller M, Larsen R. Recovery and neurological examination after remifentanil-desflurane or fentanyl-desflurane anaesthesia for carotid artery surgery. Br J Anaesth. 2001;86(1):44-49.
    25. Bonfreschi V, Giuliani E, Malagnino FC, et al. Analgesia during abdominal aortic aneurysm endovascular repair: remifentanil vs fentanyl-midazolam: a randomized controlled trial. Eur J Anaesthesiol. 2009;26(9):782-787.
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.

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 THE CAREFULLY MONITORED SETTING 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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INDICATIONS AND IMPORTANT RISK INFORMATION

INDICATIONS

ULTIVA® (remifentanil HCl) for Injection is indicated for intravenous administration:


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 THE CAREFULLY MONITORED SETTING 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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