Remifentanil Hydrochloride

REMIFENTANIL HYDROCHLORIDE — remifentanil hydrochloride injection, powder, lyophilized, for solution
Fresenius Kabi USA, LLC

WARNING: ADDICTION, ABUSE, AND MISUSE

Addiction, Abuse, and Misuse

Remifentanil hydrochloride for injection exposes patients and other 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 hydrochloride for injection [ see Warnings and Precautions ( 5.1)] .

1 INDICATIONS AND USAGE

Remifentanil hydrochloride (HCl) for injection is indicated for intravenous (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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Monitor patients closely for respiratory depression when initiating therapy and following dosage increases with remifentanil HCl and adjust the dosage accordingly [see Warnings and Precautions (5.2)].

Remifentanil HCl is for intravenous use only. Continuous infusions of remifentanil HCl 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 infusion.

Remifentanil HCl should not be administered without dilution.

Consider an alternative to remifentanil HCl for patients taking mixed agonist/antagonist and partial agonist opioid analgesics due to reduced analgesic effect or potential withdrawal symptoms. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue remifentanil HCl if patient is not responding appropriately to treatment.

Discard unused portion.

2.2 General Anesthesia

Remifentanil HCl 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. Remifentanil HCl is synergistic with other anesthetics; therefore, clinicians may need to reduce doses of thiopental, propofol, isoflurane, and midazolam by up to 75% with the coadministration of remifentanil HCl. The administration of remifentanil HCl must be individualized based on the patient’s response.

Induction of Anesthesia

Remifentanil HCl should be administered at an infusion rate of 0.5 to 1 mcg/kg/min with a hypnotic or volatile agent for the induction of anesthesia. If endotracheal intubation is to occur less than 8 minutes after the start of the infusion of remifentanil HCl, then an initial dose of 1 mcg/kg may be administered over 30 to 60 seconds.

Remifentanil HCl should not be used as a 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.

Maintenance of AnesthesiaAfter endotracheal intubation, the infusion rate of remifentanil HCl should be decreased in accordance with the dosing guidelines in Tables 1 (adults, predominately ASA physical status I, II, or III) and 2 (pediatric patients).

  • Due to the fast onset and short duration of action of remifentanil HCl, the rate of administration during anesthesia can be titrated upward in 25% to 100% increments in adult patients or up to 50% increments in pediatric patients, or downward in 25% to 50% decrements every 2 to 5 minutes to attain the desired level of μ-opioid effect.
  • In response to light anesthesia or transient episodes of intense surgical stress, supplemental bolus doses of 1 mcg/kg may be administered every 2 to 5 minutes.
  • At infusion rates > 1 mcg/kg/min, increases in the concomitant anesthetic agents should be considered to increase the depth of anesthesia. [See Clinical Pharmacology: Specific Populations: Pediatric Population (12.3) and Dosage and Administration, Table 2 (2.2).]

Table 1: Dosing Guidelines in Adults – General Anesthesia and Continuing as an Analgesic into the Postoperative Care Unit or Intensive Care Settinga

Phase Continuous IV Infusion of Remifentanil HCl (mcg/kg/min) Range of Infusion Dose Remifentanil HCl (mcg/kg/min) Supplemental IV Bolus Dose of Remifentanil HCl (mcg/kg)
Induction of Anesthesia (through intubation) 0.5 – 1a
Maintenance of anesthesia with:
Nitrous oxide (66%) 0.4 0.1 – 2 1
Isoflurane (0.4 to 1.5 MAC) 0.25 0.05 – 2 1
Propofol (100 to 200 mcg/kg/min) 0.25 0.05 – 2 1
Continuation as an analgesic into the immediate postoperative period 0.1 0.025 – 0.2 not recommended

a An initial dose of 1 mcg/kg may be administered over 30 to 60 seconds.

Table 2 summarizes the recommended doses in pediatric patients, predominantly ASA physical status I, II, or III. In pediatric patients, remifentanil was administered with nitrous oxide or nitrous oxide in combination with halothane, sevoflurane, or isoflurane. The use of atropine may blunt the potential for bradycardia that can occur upon administration of remifentanil HCl.

Table 2: Dosing Guidelines in Pediatric Patients – Maintenance of Anesthesia

Phase Continuous IV Infusion of Remifentanil HCl (mcg/kg/min) Range of Infusion Dose Remifentanil HCl (mcg/kg/min) Supplemental IV Bolus Dose of Remifentanil HCl (mcg/kg)
Maintenance of anesthesia in patients aged 1 to 12 years old witha:
Halothane (0.3 to 1.5 MAC) 0.25 0.05 – 1.3 1
Sevoflurane (0.3 to 1.5 MAC) 0.25 0.05 – 1.3 1
Isoflurane (0.4 to 1.5 MAC) 0.25 0.05 – 1.3 1
Maintenance of anesthesia for patients from birth to 2 months of age with:
Nitrous oxide (70%)b 0.4 0.4 – 1.0 1c

a An initial dose of 1 mcg/kg may be administered over 30 to 60 seconds.
b The clearance rate in neonates is highly variable, on average two times higher than in the young healthy adult population. Therefore, an increased infusion rate may be necessary to maintain adequate surgical anesthesia, and additional bolus doses may be required.
The use of atropine may blunt the potential for bradycardia that can occur upon administration of remifentanil HCl. [See Clinical Pharmacology: Specific Populations: Pediatric Population (12.3) and Clinical Studies (14.4).]
c Boluses of 1 mcg/kg were studied in ASA 1 and 2, full-term patients weighing at least 2500 gm, undergoing pyloromyotomy who received pretreatment with atropine. Neonates receiving supplementation with potent inhalation agents or neuraxial anesthesia, those with significant co-morbidities or undergoing significant fluid shifts, or those who have not been pretreated with atropine, may require smaller bolus doses to avoid hypotension and/or bradycardia.

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