Remisala IV Injection

Remisala is indicated for IV 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.

Remifentanil is a µ-opioid agonist with rapid onset and peak effect, and a short duration of action. The µ-opioid the activity of Remifentanil is antagonized by opioid antagonists such as naloxone. Unlike other opioids, Remifentanil is rapidly metabolized by hydrolysis of the propanoic acid-methyl ester linkage by nonspecific blood and tissue esterases. Remifentanil is not a substrate for plasma cholinesterase (pseudocholinesterase) and, therefore, patients with atypical cholinesterase are expected to have a normal duration of 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 reduce the analgesic effect of Remisala and/or precipitate withdrawal symptoms. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment.

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

Remisala produces adverse events that are characteristic of µ-opioids, such as respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity. These adverse events dissipate within minutes of discontinuing or decreasing the infusion rate of Remisala. Other adverse events are- nausea, vomiting, shivering, fever, dizziness, visual disturbance, headache, respiratory depression, apnea, pruritus, tachycardia, postoperative pain, hypertension, agitation. hypoxia, chills, flushing, warm sensation, constipation, premature ventricular beats, myocardial ischemia, atrial fibrillation, decreased cardiac output, coagulation disorder, arrhythmia, ventricular fibrillation, postoperative complication, third degree heart block, hemorrhage, perioperative complication, involuntary movement(s), thrombocytopenia, oliguria, anemia, atrial fibrillation, confusion, ache, anxiety, diarrhea, edema, atrial flutter, hallucinations, pneumonia, pharyngitis, decreased mental acuity, dyspnea, cough, renal insufficiency, urine retention, cerebral infarction, premature ventricular beats, cerebral ischemia, paresthesia, seizure, sleep disorder, bronchospasm.

Pregnancy Category C. It is not known whether Remifentanil Hydrochloride is excreted in human milk. Because fentanyl analogs are excreted in human milk, caution should be exercised when Remifentanil Hydrochloride is administered to a nursing woman.

Remisala is not recommended as the sole agent in general anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity and tachycardia. Remisala should only be administered by clinicians specifically trained to use intravenous anesthetics. It is essential that qualified personnel and adequate facilities are available for the treatment of postoperative respiratory depression. Respiratory depression will abate approximately 10 minutes after the discontinuation of a Remisala infusion. Administration of the narcotic antagonist, naloxone, has not been shown to be more effective or more prompt in reversing respiratory depression than the discontinuation of Remisala. Naloxone can be used to manage severe respiratory depression or muscle rigidity. Bolus doses of Remisala should not be administered to patients who are spontaneously breathing and also receiving a continuous infusion of Remisala. Administration of Remisala at a rate greater than 0.2 mcg/kg/min is usually associated with hypoventilation (respiratory rate of less than 8 breaths/minute). The manufacturer strongly recommends that supplemental oxygen be supplied whenever Remisala is administered. Analgesic effects will dissipate within 5 to 10 minutes after discontinuation of Remisala. Adequate postoperative analgesia should be established prior to discontinuation of Remisala. The intravenous tubing supplying the Remisala infusion should be cleared of residual drug after the discontinuation of therapy. Vital signs and oxygenation must be continually monitored during the administration of Remisala. Bradycardia has been reported with Remisala. Hypotension has been reported with Remisala.

Expected signs and symptoms of overdoses include apnea, chest-wall rigidity, seizures, hypoxemia, hypotension, and bradycardia.

Opioid analgesics

Do not store above 30ºC. Keep away from light and out of the reach of children.