Remifentanil

Remifentanil
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

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Overview

Remifentanil is an analgesic opioid that is FDA approved for the {{{indicationType}}} of general anesthesia; adjunct, monitored anesthesia care sedation, analgesic component; adjunct, postoperative pain, immediate postoperative period. Common adverse reactions include cardiovascular: hypotension (19% or less ), dermatologic: pruritus (less than 1% to 18% ), gastrointestinal: nausea (less than 1% to 44% ), vomiting (less than 1% to 22% ), musculoskeletal: muscle rigidity (11% or less) , neurologic: headache (18% or less ).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Exceeding the recommended dose (greater than 1 and up to 20 mcg/kg) or exceeding the recommended infusion rate (starting dose greater than 0.1 mcg/kg/min) results in higher incidence of adverse events.
• Administering bolus doses to spontaneously breathing patients is not recommended.
• Analgesia for a mechanically ventilated patient, ICU: continuous infusion, 0.1 to 0.15 mcg/kg/min IV initially (using ideal body weight), with titration to a max dose of 0.2 to 0.4 mcg/kg/min IV (clinical studies).
• General anesthesia; adjunct: induction, 0.5 to 1 mcg/kg/min IV; 1 mcg/kg IV over 30 to 60 seconds if intubated within 8 minutes of initiation.
• General anesthesia; adjunct: maintenance, 0.25 mcg/kg/min IV (range 0.05 to 2 mcg/kg/min) plus isoflurane or propofol; supplemental bolus of 1 mcg/kg every 2 to 5 minutes if needed.
• General anesthesia; adjunct: maintenance, 0.4 mcg/kg/min IV (range 0.1 to 2 mcg/kg/min IV) plus nitrous oxide; supplemental bolus of 1 mcg/kg every 2 to 5 minutes if needed.
• General anesthesia; adjunct: CABG, during induction through intubation, 1 mcg/kg/min IV.
• General anesthesia; adjunct: CABG, during maintenance of anesthesia, 1 mcg/kg/min IV (range 0.125 to 4 mcg/kg/min); supplemental bolus of 0.5 to 1 mcg/kg if needed.
• Monitored anesthesia care sedation, Analgesic component; adjunct: single dose, used with midazolam, 0.5 mcg/kg IV injection over 30 to 60 seconds as single dose 90 seconds before administration of local anesthetic.
• Monitored anesthesia care sedation, Analgesic component; adjunct: single dose, used alone 1 mcg/kg IV injection over 30 to 60 seconds as single dose 90 seconds before administration of local anesthetic.
• Monitored anesthesia care sedation, Analgesic component; adjunct: continuous infusion, used WITH midazolam, 0.05 mcg/kg/min IV infusion 5 minutes before placement of local or regional block; after placement of block, decrease dose to 0.025 mcg/kg/min (range 0.025 to 0.2 mcg/kg/min), adjust dose in 0.025 mcg/kg/min increments at 5-minute intervals.
• Monitored anesthesia care sedation, Analgesic component; adjunct: continuous infusion, used alone, 0.1 mcg/kg/min IV infusion 5 minutes before placement of local or regional block; after placement of block, decrease dose to 0.05 mcg/kg/min (range 0.025 to 0.2 mcg/kg/min), adjust dose in 0.025 mcg/kg/min increments at 5-minute intervals.
• Postoperative pain, Immediate postoperative period: 0.1 mcg/kg/min IV, adjust infusion every 5 minutes in 0.025 mcg/kg/min increments to reach desired effect (range 0.025 to 0.2 mcg/kg/min) [1]
• Postoperative pain, Immediate postoperative period: CABG, 1 mcg/kg/min IV infusion (range 0.05 to 1 mcg/kg/min).

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• Analgesia for a mechanically ventilated patient, ICU.
• Procedural sedation.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Remifentanil in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Efficacy for use in pediatric patients during the immediate postoperative period or for use as a component of monitored anesthesia care has not been established.
• Administering bolus doses to spontaneously breathing patients is not recommended.
• Analgesia for a mechanically ventilated patient, ICU: (infants) continuous infusion, 0.075 to 0.15 mcg/kg/min IV initially, with titration to a max dose of 0.5 to 0.94 mcg/kg/min IV (clinical studies).
• Analgesia for a mechanically ventilated patient, ICU: (children) continuous infusion, 0.1 mcg/kg/min IV (clinical study) [9]
• General anesthesia; Adjunct: (age birth to 2 months) maintenance, 0.4 mcg/kg/min IV (range 0.4 to 1 mcg/kg/min) plus nitrous oxide; supplemental bolus of 1 mcg/kg every 2 to 5 minutes if needed.
• General anesthesia; Adjunct: (age 1 year to 12 years) maintenance, 0.25 mcg/kg/min IV (range 0.05 to 1.3 mcg/kg/min) plus halothane, sevoflurane, or isoflurane; supplemental bolus of 1 mcg/kg every 2 to 5 minutes if needed.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Remifentanil in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Remifentanil in pediatric patients.

Contraindications

Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVA is also contraindicated in patients with known hypersensitivity to fentanyl analogs.

Warnings

There is limited information regarding Remifentanil Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Remifentanil Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Remifentanil Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Remifentanil Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Remifentanil in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Remifentanil in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Remifentanil during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Remifentanil in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Remifentanil in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Remifentanil in geriatric settings.

Gender

There is no FDA guidance on the use of Remifentanil with respect to specific gender populations.

Race

There is no FDA guidance on the use of Remifentanil with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Remifentanil in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Remifentanil in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Remifentanil in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Remifentanil in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Remifentanil Administration in the drug label.

Monitoring

There is limited information regarding Remifentanil Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Remifentanil and IV administrations.

Overdosage

There is limited information regarding Remifentanil overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Remifentanil Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Remifentanil Mechanism of Action in the drug label.

Structure

There is limited information regarding Remifentanil Structure in the drug label.

Pharmacodynamics

There is limited information regarding Remifentanil Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Remifentanil Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Remifentanil Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Remifentanil Clinical Studies in the drug label.

How Supplied

There is limited information regarding Remifentanil How Supplied in the drug label.

Storage

There is limited information regarding Remifentanil Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Remifentanil Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Remifentanil interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Remifentanil Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Remifentanil Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.