apart from [1:0.05 mcg/kg per minute associated with transient and reversible muscle rigidity. 1 Prior or simultaneous administration of propofol or thiopental or a neuromuscular blocking agent may attenuate the development of rigidity. 1 For excessive rigidity, consider decreasing the infusion rate or discontinuing the infusion of remifentanil or administering a neuromuscular blocking agent or naloxone. 1 (See Musculoskeletal Effects under Cautions.) Doses of 0.5 1 mcg/kg administered in conjunction with a continuous infusion of the drug and incremental increases in infusion rate of >0.05 mcg/kg per minute are associated with transient and reversible respiratory depression and apnea. 1 In spontaneously breathing patients, manage respiratory depression by reducing infusion rate of remifentanil by 50% or by temporarily discontinuing the infusion. 1 (See Respiratory Depression under Cautions.) Dosage Available as remifentanil hydrochloride; dosage expressed in terms of remifentanil. 1 Synergistic activity with other anesthetics; dosage adjustment of concomitantly administered anesthetic(s) may be needed. 1 3 (See Specific Drugs under Interactions.) Pediatric Patients General Anesthesia (General Dosage) Manufacturer makes no specific recommendations regarding use or dosage of remifentanil in adolescents 13 years of age. 1 41 Maintenance of General Anesthesia in Neonates and Infants Up to 2 Months of Age IV Infusion In conjunction with 70% nitrous oxide: Initial remifentanil infusion rate of 0.4 mcg/kg per minute. 1 Because neonatal clearance of remifentanil is variable and may average twice that observed in young adults, some neonates may require increased infusion rate to maintain adequate anesthesia; titrate dosage carefully according to individual requirements. 1 Recommended infusion rate: 0.4 1 mcg/kg per minute. 1 Rapid IV (bolus) doses of 1 mcg/kg could be administered every 2 5 minutes in response to signs of inadequate anesthesia in clinical trials in full-term neonates and infants up to 2 months of age with American Society of Anesthesiologists (ASA) physical status of I or II. 1 16 30 Individualize dosage. 1 Some neonates, including those receiving potent inhalation anesthetics or neuraxial anesthesia, those with substantial comorbidities or fluid shifts, and those who have not received atropine premedication, may require smaller bolus doses of remifentanil to avoid hypotension and/or bradycardia. 1 Maintenance of General Anesthesia in Children 1 12 Years of Age IV Infusion In conjunction with nitrous oxide plus halothane (0.3 1.5 minimum alveolar concentration [MAC]), sevoflurane (0.3 1.5 MAC), or isoflurane (0.4 1.5 MAC): Remifentanil 0.25 mcg/kg per minute in patients with ASA physical status of I, II, or III. 1 Adjust infusion rate upward by 50% or downward by 25 50% based on patient's response at intervals of 2 5 minutes. 1 Recommended infusion rate: 0.05 1.3 mcg/kg per minute. 1 May administer rapid IV (bolus) doses of 1 mcg/kg every 2 5 minutes in response to light anesthesia or transient episodes of intense surgical stress. 1 An initial dose of 1 mcg/kg may be administered over 30 60 seconds. 1 13 At remifentanil infusion rates >1 mcg/kg per minute, consider increases in dosage of concomitant anesthetic agent(s) to increase depth of anesthesia. 1 Adults General Anesthesia (General Dosage) Induction of General Anesthesia IV Infusion Remifentanil 0.5 1 mcg/kg per minute given in conjunction with a volatile anesthetic or hypnotic agent in patients with ASA physical status of I, II, or III. 1 If intubation is to occur within 8 minutes after initiation of the remifentanil infusion, an initial dose of 1 mcg/kg may be given over 30 60 seconds. 1 Maintenance of General Anesthesia IV Infusion In conjunction with 66% nitrous oxide: Remifentanil 0.4 mcg/kg per minute in patients with ASA physical status of I, II, or III. 1 Adjust infusion rate upward by 25 100% or downward by 25 50% based on patient's response at intervals of 2 5 minutes. 1 Recommended infusion rate: 0.1 2 mcg/kg per minute. 1 May administer rapid IV (bolus) doses of 1 mcg/kg every 2 5 minutes in response to light anesthesia or transient episodes of intense surgical stress. 1 In conjunction with isoflurane (0.4 1.5 MAC) or propofol (100 200 mcg/kg per minute): Remifentanil 0.25 mcg/kg per minute in patients with ASA physical status of I, II, or III. 1 Adjust infusion rate upward by 25 100% or downward by 25 50% based on patient's response at intervals of 2 5 minutes. 1 Recommended infusion rate: 0.05 2 mcg/kg per minute. 1 May administer rapid IV (bolus) doses of 1 mcg/kg every 2 5 minutes in response to light anesthesia or transient episodes of intense surgical stress. 1 At remifentanil infusion rates >1 mcg/kg per minute, consider increases in dosage of concomitant anesthetic agent(s) to increase depth of anesthesia. 1 Analgesia in the Immediate Postoperative Period IV Infusion Initial postoperative infusion rate of 0.1 mcg/kg per minute in patients with ASA physical status of I, II, or III. 1 Adjust infusion rate in increments of 0.025 mcg/kg per minute at 5-minute intervals based on level of analgesia and respiratory rate. 1 Recommended infusion rate: 0.025 0.2 mcg/kg per minute. 1 Supplemental rapid IV (bolus) doses of remifentanil are not recommended because of risk for respiratory depression and muscle rigidity. 1 Infusion rates >0.2 mcg/kg per minute associated with respiratory depression. 1 General Anesthesia for Coronary Artery Bypass Surgery Induction of Anesthesia for Coronary Artery Bypass Surgery IV Infusion Remifentanil 1 mcg/kg per minute in patients with ASA physical status of III or IV. 1 Excessive hypotension reported in clinical studies when dosage of concomitantly administered propofol exceeded 0.5 mg/kg over 1 minute followed by 10 mg every 10 seconds until loss of consciousness. 1 Maintenance of Anesthesia for Coronary Artery Bypass Surgery IV Infusion As the analgesic component of a high-dose-opiate, balanced or IV anesthetic regimen, remifentanil 1 mcg/kg per minute in patients with ASA physical status of III or IV. 1 Recommended infusion rate: 0.125 4 mcg/kg per minute. 1 Supplemental rapid IV (bolus) doses of 0.5 1 mcg/kg may be administered. 1 41 Analgesia in the Immediate Period After Coronary Artery Bypass Surgery IV Infusion Remifentanil 1 mcg/kg per minute in patients with ASA physical status of III or IV. 1 Recommended infusion rate: 0.05 1 mcg/kg per minute. 1 Monitored Anesthesia Care Supplemental oxygen strongly recommended for patients receiving remifentanil for monitored anesthesia care. 1 As Analgesic Component of Local or Regional (Nerve Block) Anesthesia IV (Single Dose) When used alone prior to local or regional anesthesia in patients with ASA physical status of I, II, or III, single remifentanil dose of 1 mcg/kg (over 30 60 seconds) administered 90 seconds before the local anesthetic. 1 When used in this manner in conjunction with midazolam 2 mg, reduce remifentanil dose to 0.5 mcg/kg (over 30 60 seconds). 1 IV Infusion When used alone in patients with ASA physical status of I, II, or III, remifentanil 0.1 mcg/kg per minute, beginning 5 minutes before the local anesthetic. 1 Because of risk of respiratory depression, reduce infusion rate to 0.05 mcg/kg per minute following nerve block placement. 1 Adjust subsequent infusion rate in increments of 0.025 mcg/kg per minute at 5-minute intervals based on level of analgesia and respiratory rate. 1 Recommended infusion rate: 0.025 0.2 mcg/kg per minute. 1 When used in conjunction with midazolam 2 mg, remifentanil 0.05 mcg/kg per minute, beginning 5 minutes before the local anesthetic. 1 Because of risk of respiratory depression, reduce infusion rate to 0.025 mcg/kg per minute following nerve block placement. 1 Adjust subsequent infusion rate in increments of 0.025 mcg/kg per minute at 5-minute intervals based on level of analgesia and respiratory rate. 1 Recommended infusion rate: 0.025 0.2 mcg/kg per minute. 1 Infusion rates >0.2 mcg/kg per minute associated with respiratory depression. 1 Administration of rapid IV (bolus) doses of remifentanil concomitantly with a continuous infusion of the drug in spontaneously breathing patients is not recommended. 1 11 Special Populations Geriatric Patients Decrease initial and, possibly, subsequent doses of remifentanil by 50% in patients >65 years of age; titrate cautiously. 1 2 9 12 (See Geriatric Use under Cautions.) Consider extending anticipated time to clinical effect by 50 100% in geriatric patients. 9 (See Absorption: Special Populations under Pharmacokinetics.) Obese Patients Base initial dosage on an estimate of ideal (lean) body weight if body weight exceeds ideal weight by >30%. 1 Base subsequent dosage reductions on an estimate of ideal body weight. 2 9 12 Cautions for Ultiva Contraindications Contains glycine; contraindicated for epidural or intrathecal administration. 1 2 3 9 Known hypersensitivity to fentanyl analogs. 1 Warnings/Precautions Warnings Shares the toxic potentials of the opiate agonists; observe the usual precautions of opiate agonist therapy. 1 2 3 Supervised Administration Remifentanil should only be administered by persons trained in the use of anesthetic drugs and the management of respiratory effects of opiates, including respiratory and cardiac resuscitation. 1 Such training must include the establishment and maintenance of a patent airway and assisted ventilation. 1 Do not use for diagnostic or therapeutic procedures outside a monitored anesthesia care setting. 1 Patients receiving the drug for monitored anesthesia care should be continuously monitored by persons not involved in the conduct of the surgical or diagnostic procedure. 1 Monitor oxygen saturation continuously and have resuscitative and intubation equipment, oxygen, and an opiate antagonist readily available. 1 Discontinuance of Therapy Clear remifentanil from the IV tubing upon drug discontinuance; failure to remove residual remifentanil associated with respiratory depression, apnea, and muscle rigidity upon administration of fluids or drugs through the same tubing. 1 Respiratory Depression Apnea and dose-dependent respiratory depression reported with remifentanil. 1 2 3 9 11 Remifentanil infusion rates of 0.05 0.1 mcg/kg per minute are associated with minimal decreases in respiratory rate; doses of 0.5 1 mcg/kg administered in conjunction with a continuous IV infusion of the drug, incremental increases in infusion rate of >0.05 mcg/kg per minute, and plasma concentrations >5 ng/mL are associated with transient and reversible respiratory depression and apnea. 1 Peak respiratory depression after rapid IV (bolus) doses generally occurs within 2.5 5 minutes. 2 8 11 Respiratory depression may occur up to 30 minutes after discontinuance of remifentanil infusion secondary to residual effects of concomitant anesthetics. 1 Monitor patients in postoperative period to ensure adequate recovery without stimulation. 1 To date, no reported cases of remifentanil-induced delayed respiratory depression occurring >30 minutes after drug discontinuance. 1 Recovery of respiratory drive after a 3-hour infusion was faster and less variable with remifentanil than with alfentanil (when dosed to produce equal levels of respiratory depression). 1 Manage respiratory depression in spontaneously breathing patients by reducing infusion rate of remifentanil by 50% or by temporarily discontinuing the infusion. 1 Spontaneous respiration occurs at plasma remifentanil concentrations of 4 5 ng/mL in the absence of other anesthetic agents. 1 In patients undergoing general anesthesia, rate of respiratory recovery is dependent upon concomitant anesthetics. 1 (See Duration under Pharmacokinetics.) Supplemental oxygen strongly recommended for patients receiving remifentanil for monitored anesthesia care. 1 Musculoskeletal Effects Dose-dependent muscle rigidity, particularly involving respiratory muscles. 1 Chest wall rigidity may occur following single remifentanil doses of >1 mcg/kg given over 30 60 seconds, with infusion rates of >0.1 mcg/kg per minute, or following single doses of]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out 2 CSA Schedule High potential for abuse Approval History Drug history at FDA Manufacturer Mylan Pharmaceuticals Inc. Drug Class Narcotic analgesics Related Drugs Anesthesia lidocaine , fentanyl , hyoscyamine , propofol , Levsin , ketamine , glycopyrrolate , Emla , Robinul , butorphanol , etomidate , succinylcholine , Nubain , Diprivan , benzocaine topical , Stadol , Levbid , rocuronium , Talwin , pentazocine , Sublimaze , sevoflurane , nalbuphine , Anaspaz , HyoMax , More... Ultiva Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } appears
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