Remifentanil
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 [1]
administering bolus doses to spontaneously breathing patients is not recommended [1] Analgesia for a mechanically ventilated patient, ICU: continuous infusion, 0.1 to 0.15 mcg/kg/min IV initially (using ideal body weight) [2][3][4][5][6], with titration to a MAX dose of 0.2 to 0.4 mcg/kg/min IV (clinical studies) [2][3][4] 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 [1] 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 [1] 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 [1] General anesthesia; Adjunct: CABG, during induction through intubation, 1 mcg/kg/min IV [1] 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 [1] 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 [1] 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 [1] 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 [1] 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 [1] 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) [1]
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Analgesia for a mechanically ventilated patient, ICUView additional information.
Procedural sedationView additional information.
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 [1] administering bolus doses to spontaneously breathing patients is not recommended [1] 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) [7][8] 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 [1] 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 [1]
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
There is limited information regarding Remifentanil Contraindications in the drug label.
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.