Remifentanil

May cause hypotension; use with caution in patients with hypovolemia, cardiovascular disease (including acute MI), or drugs which may exaggerate hypotensive effects (including phenothiazines or general anesthetics). Monitor for symptoms of hypotension following initiation or dose titration.

Intraoperative awareness has been reported when used with propofol infusion rates of ≤75 mcg/kg/minute in patients • Respiratory depression: Serious, life-threatening, or fatal respiratory depression, even when used as recommended may occur. Monitor closely for respiratory depression, especially during initiation or dose escalation. Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.

Potentially life-threatening serotonin syndrome (SS) has occurred with concomitant use of remifentanil and serotonergic agents (eg, SSRIs, SNRIs, triptans, TCAs, 5-HT3 receptor antagonists, mirtazapine, trazodone, tramadol) and agents that impair metabolism of serotonin (eg, MAO inhibitors). Monitor patients closely for signs of SS such as mental status changes (eg, agitation, hallucinations, delirium, coma); autonomic instability (eg, tachycardia, labile blood pressure, diaphoresis); neuromuscular changes (eg, tremor, rigidity, myoclonus); GI symptoms (eg, nausea, vomiting, diarrhea); and/or seizures. Discontinue remifentanil if serotonin syndrome is suspected. Disease-related concerns:

May obscure diagnosis or clinical course of patients with acute abdominal conditions.

Use with caution in patients with biliary tract dysfunction, including acute pancreatitis; opioids may cause constriction of sphincter of Oddi.

Use with caution when administering to patients with bradycardia.

Use with caution in patients with delirium tremens.

Use with extreme caution in patients with head injury, intracranial lesions, or elevated intracranial pressure (ICP); exaggerated elevation of ICP may occur.

Use with caution in patients who are morbidly obese.

Use with caution in patients with prostatic hyperplasia and/or urinary stricture.

Use with caution in patients with toxic psychosis.

Use with caution and monitor for respiratory depression in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression, particularly when initiating and titrating therapy; critical respiratory depression may occur, even at therapeutic dosages.

Use with caution in patients with a history of seizure disorders; may increase risk or exacerbate preexisting seizure disorders.

Use with caution in patients with thyroid dysfunction. Concurrent drug therapy issues:

Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in hypotension, profound sedation, respiratory depression, coma, and death. Alcohol should be avoided for 24 hours after surgery.

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

Use with caution in cachectic or debilitated patients; there is a greater potential for critical respiratory depression, even at therapeutic dosages.

Use with caution in the elderly; may be more sensitive to adverse effects. Decrease initial dose. Other warnings/precautions:

Remifentanil exposes users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing remifentanil.

Inadequate clearing of IV tubing following administration has been associated with muscle rigidity, respiratory depression, and apnea when another fluid is administered through the same line. Do not administer into the same IV tubing with blood due to potential inactivation by nonspecific esterases in blood products.

Interruption of an infusion will result in offset of effect within 5 to 10 minutes; the discontinuation of an infusion should be preceded by the establishment of adequate postoperative analgesia.

Not recommended as the sole agent for induction of anesthesia, because the loss of consciousness cannot be assured.

Rapid IV infusion (single dose >1 mcg/kg over 30 to 60 seconds and infusion rates >0.1 mcg/kg/minute) should only be used during maintenance of general anesthesia; rapid infusion may result in skeletal muscle and chest wall rigidity. Chest wall rigidity may resolve by decreasing the infusion rate, discontinuing the infusion, or by administering a neuromuscular blocking agent.

Remifentanil should only be administered by health care providers specifically trained in the use of anesthetic agents. Should not be used in diagnostic or therapeutic procedures outside the monitored anesthesia setting; resuscitative and intubation equipment should be readily available.