Remifentanil Hydrochloride is indicated for intravenous (IV) use:

• As an analgesic during the induction and maintenance of general anesthesia for both inpatient and outpatient surgical procedures.
• For continued analgesia in the immediate postoperative period in adult patients under the supervision of an anesthesia specialist in a recovery unit or intensive care setting.
• As part of monitored anesthesia care to provide analgesia in adult patients.

Remifentanil is a selective µ-opioid receptor agonist characterized by a rapid onset of action, peak effect, and very short duration. Its opioid effects can be reversed by antagonists such as naloxone. Unlike most opioids, remifentanil is rapidly broken down by non-specific esterases present in blood and tissues through hydrolysis of its ester linkage. It is not dependent on plasma cholinesterase for metabolism, so even patients with atypical cholinesterase have a normal duration of drug action.

Remifentanil Hydrochloride is for IV use only. Continuous infusion of Remifentanil Hydrochloride should be administered only by an infusion device. The injection site should be close to the venous cannula and all IV tubing should be cleared at the time of discontinuation of the infusion.

Mixed agonist/antagonist and partial agonist opioid analgesics may decrease the analgesic effect of Remifentanil and can also trigger withdrawal symptoms. If such combinations are necessary, patients should be closely monitored, especially during the initiation of therapy and dose adjustments.

Remifentanil is contraindicated for epidural or intrathecal administration due to the presence of glycine in its formulation. It is also contraindicated in patients with known hypersensitivity to remifentanil (e.g., anaphylaxis).

Remifentanil Hydrochloride may cause typical µ-opioid-related adverse effects such as respiratory depression, bradycardia, hypotension, and muscle rigidity. These effects usually resolve quickly after stopping or reducing the infusion. Other side effects may include nausea, vomiting, shivering, fever, dizziness, headache, visual disturbances, itching, apnea, tachycardia, hypertension, postoperative pain, agitation, hypoxia, chills, flushing, constipation, arrhythmias, myocardial ischemia, atrial fibrillation, reduced cardiac output, bleeding complications, confusion, anxiety, edema, diarrhea, hallucinations, pneumonia, pharyngitis, dyspnea, cough, renal impairment, urinary retention, seizures, sleep disturbances, and bronchospasm.

Pregnancy Category C. It is not known whether remifentanil is excreted in human breast milk. Since similar opioids are excreted in breast milk, caution should be exercised when administering to breastfeeding women.

Remifentanil should not be used as the sole anesthetic agent because it may not ensure loss of consciousness and may cause apnea, muscle rigidity, or tachycardia. It should only be administered by trained professionals experienced in intravenous anesthesia, with proper facilities available to manage respiratory depression. Respiratory depression typically resolves within about 10 minutes after stopping the infusion. Naloxone may be used in severe cases but stopping the infusion is usually sufficient. Bolus doses should be avoided in spontaneously breathing patients receiving continuous infusion. Doses above 0.2 mcg/kg/min may lead to hypoventilation. Supplemental oxygen should always be provided. Pain relief effects disappear within 5–10 minutes after stopping the infusion, so alternative postoperative analgesia should be established beforehand. Residual drug in IV tubing should be flushed after use. Continuous monitoring of vital signs and oxygen levels is essential. Bradycardia and hypotension may occur and should be monitored.

Overdose symptoms may include apnea, chest wall rigidity, seizures, low oxygen levels, hypotension, and bradycardia.

Opioid analgesic

Store below 30°C, protect from light, and keep out of reach of children.