On Off

when you want it.
when you don’t.

Remi* gives you flexibility when you want predictable control of depth and duration of perioperative analgesia1

Unique organ-independent metabolism allows use in patients with renal or hepatic impairment and obese patients1

Rapid response to dose adjustment in 5 to 10 minutes of dosing change for predictable control of analgesic coverage1

Rapid onset of 1 to 2 minutes allows you to get procedures started fast1

Rapid offset and short half-life of 3 to 10 minutes gives you the speed to have your patient awake fast1

Rapid recovery and rapid elimination with no accumulation1-3

Please see Important Risk Information below and to the right.

Neurological and evoked potential procedures

Remi* gives you rapid emergence and rapid response to dose adjustment in neurological and evoked potential procedures, such as1,3-5:

  •   Craniotomy
  •   Spinal procedures
  •   Minimally invasive procedures
  •   Laminectomy

Please see Important Risk Information below and to the right.

Abdominal procedures

Remi* gives you rapid onset and rapid elimination with no accumulation over long procedures, such as1,6-11:

  •   Bariatric/gastric bypass
  •   Hernia repair
  •   Laparoscopy
  •   Hysterectomy
  •   Common bile duct
  •      exploration
  •   Cholecystectomy
  •   Colorectal resection
  •   Exploratory laparotomy
  •   Small bowel resection
  •   Endoscopy

Please see Important Risk Information below and to the right.

Head and neck procedures

Remi* gives you rapid onset, adjustable dosing for points of high stimulation, rapid offset, and rapid recovery in head and neck procedures, such as1,2,11-14:

  •   Bronchoscopy
  •   Laryngoscopy
  •   Thyroidectomy
  •   Tonsillectomy
  •   Adenoidectomy
  •   Endoscopy
  •   Ophthalmic procedures

Please see Important Risk Information below and to the right.

Orthopedic procedures

Remi* gives you rapid onset, adjustable dosing for points of high stimulation, rapid offset and recovery, and flexible use in certain high-risk patient populations for procedures such as1,15-17:

  •   Arthroplasty
  •   Arthroscopy
  •   Fracture reduction

Please see Important Risk Information below and to the right.

Cardiothoracic procedures

Remi* gives you rapid onset, rapid elimination with no accumulation, and rapid recovery in cardiothoracic procedures such as1-3,18-26:

  •   Coronary artery bypass graft (CABG)
  •   Catheterization
  •   Ablation
  •   Endarterectomy
  •   Carotid artery surgery
  •   Abdominal aortic aneurysm repair

Please see Important Risk Information below and to the right.

High-risk patients

Remi* gives you unique organ-independent metabolism for rapid elimination and no significant accumulation in adipose tissue for your high-risk patients, including1,18:

  •   Renal impairment
  •   Hepatic impairment
  •   Obese patients
  •   Elderly patients

Please see Important Risk Information below and to the right.

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 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 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.

Safety Information

Within 5-10 minutes after discontinuation, no residual analgesic activity will be present. Interruption of ULTIVA infusion will result in rapid offset of effect. Discontinuation should be preceded by establishment of adequate postoperative analgesia. Where postoperative pain is anticipated, other analgesics should be administered prior to discontinuation of ULTIVA.

Oxygen saturation should be monitored on a continuous basis. Resuscitative and intubation equipment, oxygen, and an opioid antagonist must be readily available.

Continuous infusions of ULTIVA should be administered only by an infusion device and continual monitoring is necessary. ULTIVA produces adverse events characteristic of μ-opioids, such as respiratory depression, tachycardia, bradycardia, hypotension, and skeletal (including chest wall) rigidity.

See full Prescribing Information for dosage and administration.

Safety Information

Effects and side effects are dose dependent and similar to other μ-opioids, and include hypotension, muscle rigidity, apnea, and respiratory depression. Other adverse events include bradycardia and hypertension.

ULTIVA should not be used as the sole agent for induction of anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia.

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 for dosage and administration.

Safety Information

Effects and side effects are dose dependent and similar to other μ-opioids, and include hypotension, muscle rigidity, apnea, and respiratory depression. Other adverse events include bradycardia and hypertension.

ULTIVA should not be used as the sole agent for induction of anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia.

Continuous infusions of ULTIVA should be administered only by an infusion device and continual monitoring is necessary. Interruption of infusion will result in rapid offset of effect. ULTIVA produces adverse events characteristic of μ-opioids, such as respiratory depression, tachycardia, bradycardia, hypotension, and skeletal (including chest wall) rigidity.

Within 5-10 minutes after discontinuation, no residual analgesic activity will be present. Discontinuation should be preceded by establishment of adequate postoperative analgesia. Where postoperative pain is anticipated, other analgesics should be administered prior to discontinuation of ULTIVA.

Oxygen saturation should be monitored on a continuous basis. Resuscitative and intubation equipment, oxygen, and an opioid antagonist must be readily available.

See full Prescribing Information for dosage and administration.

Safety Information

Effects and side effects are dose dependent and similar to other μ-opioids, and include hypotension, muscle rigidity, apnea, and respiratory depression. Other adverse events include bradycardia and hypertension.

ULTIVA should not be used as the sole agent for induction of anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia.

Continuous infusions of UTLIVA should be administered only by an infusion device and continual monitoring is necessary. Interruption of infusion will result in rapid offset of effect. ULTIVA produces adverse events characteristic of μ-opioids, such as respiratory depression, tachycardia, bradycardia, hypotension, and skeletal (including chest wall) rigidity.

Within 5-10 minutes after discontinuation, no residual analgesic activity will be present. Discontinuation should be preceded by establishment of adequate postoperative analgesia. Where postoperative pain is anticipated, other analgesics should be administered prior to discontinuation of ULTIVA.

Oxygen saturation should be monitored on a continuous basis. Resuscitative and intubation equipment, oxygen, and an opioid antagonist must be readily available.

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.

See full Prescribing Information for dosage and administration.

Safety Information

Effects and side effects are dose-dependent and similar to other μ-opioids, and include hypotension, muscle rigidity, apnea, and respiratory depression. Other adverse events include bradycardia and hypertension.

ULTIVA should not be used as the sole agent for induction of anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia.

Oxygen saturation should be monitored on a continuous basis. Resuscitative and intubation equipment, oxygen, and an opioid antagonist must be readily available.

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 for dosage and administration.

Safety Information

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 for dosage and administration.


INDICATIONS

ULTIVA 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 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 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.

*Remifentanil is commonly referred to as Remi by anesthesia providers.

References

  1. ULTIVA [package insert]. Lake Forest, IL: Bioniche Pharma USA LLC; 2009.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. Song D, Whitten CW, White PF. Remifentanil infusion facilitates early recovery for obese outpatients undergoing laparoscopic cholecystectomy. Anesth Analg. 2000;90(5):1111-1113.
  10. 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.
  11. Mandel JE, Tanner JW, Lichtenstein GR, et al. A randomized, controlled, double-blind trial of patient-controlled sedation with propofol/remifentanil versus midazolam/fentanyl for colonoscopy. Anesth Analg. 2008;106(2):434-439.
  12. Prakash N, McLeod T, Gao Smith F. The effects of remifentanil on haemodynamic stability during rigid bronchoscopy. Anaesthesia. 2001;56(6):576-580.
  13. 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.
  14. 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):7757-7758.
  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 [published online ahead of print August 25, 2011]. Emerg Med J. doi:10.1136/emermed-2011-200013.
  18. Goldenberg D, Goldstein BJ. Handbook of Otolaryngology: Head and Neck Surgery. New York, NY: Thieme Medical Publishers, Inc; 2011:38.
  19. 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.
  20. 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.
  21. 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.
  22. 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.
  23. 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-P138.
  24. Türköz A, Türköz R, Gülcan Ö, 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.
  25. 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.
  26. Bonfreschi V, Giuliani E, Malagnino C, 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.

ULTIVA is a registered trademark of Glaxo Group Limited. The Mylan logo is a registered trademark of Mylan Inc.

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