Sufentanil

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Sufentanil
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

Sufentanil is a analgesic opioid that is FDA approved for the {{{indicationType}}} of analgesia in labor, epidural; adjunct, general anesthesia. Common adverse reactions include cardiovascular: bradyarrhythmia (3% to 9% ), hypotension (3% to 9% ), dermatologic: pruritus (25% ), gastrointestinal: nausea (3% to 9% ), vomiting (3% to 9% ), musculoskeletal: muscle rigidity, chest wall (3% to 9% ), neurologic: somnolence (3% to 9% ).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Dosage should be individualized
  • Analgesia in labor, epidural; adjunct: (epidural use) 10-15 mcg sufentanil administered with 10 mL bupivacaine 0.125% with or without epinephrine; may repeat twice at not less than 1 hr intervals until delivery; max 3 doses
  • General anesthesia: primary anesthetic agent, 8-30 mcg/kg IV with 100% oxygen and a muscle relaxant, then 0.5-10 mcg/kg as needed in response to signs of lightening of anesthesia; max 30 mcg/kg/procedure
  • General anesthesia: analgesic adjunct to balanced general anesthesia, 1-8 mcg/kg IV (approximately 1 mcg/kg/hr of estimated surgical duration); 75% given prior to intubation, then incrementally as 10-50 mcg IV as needed in response to signs of lightening of analgesia

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

  • General anesthesia: cardiovascular surgery (age under 12 yr) 10-25 mcg/kg with 100% oxygen, additional doses up to 25-50 mcg for maintenance of anesthesia

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

  • Sufentanil is contraindicated in patients with known hypersensitivity to the drug or known intolerance to other opioid agonists.

Warnings

  • Sufentanil should be administered only by persons specifically trained in the use of intravenous and epidural anesthetics and management of the respiratory effects of potent opioids.
  • An opioid antagonist, resuscitative and intubation equipment and oxygen should be readily available.
  • Prior to catheter insertion, the physician should be familiar with patient conditions (such as infection at the injection site, bleeding diathesis, anticoagulant therapy, etc.) which call for special evaluation of the benefit versus risk potential.
Intravenous use
  • Intravenous administration or unintentional intravascular injection during epidural administration of Sufentanil may cause skeletal muscle rigidity, particularly of the truncal muscles. The incidence and severity of muscle rigidity is dose related. Administration of Sufentanil may produce muscular rigidity with a more rapid onset of action than that seen with fentanyl. Sufentanil may produce muscular rigidity that involves the skeletal muscles of the neck and extremities. As with fentanyl, muscular rigidity has been reported to occur or recur infrequently in the extended postoperative period. The incidence of muscular rigidity associated with intravenous Sufentanil can be reduced by: 1) administration of up to 1/4 of the full paralyzing dose of a non-depolarizing neuromuscular blocking agent just prior to administration of Sufentanil at dosages of up to 8 mcg/kg, 2) administration of a full paralyzing dose of a neuromuscular blocking agent following loss of consciousness when Sufentanil is used in anesthetic dosages (above 8 mcg/kg) titrated by slow intravenous infusion, or, 3) simultaneous administration of Sufentanil and a full paralyzing dose of a neuromuscular blocking agent when Sufentanil is used in rapidly administered anesthetic dosages (above 8 mcg/kg).
  • The neuromuscular blocking agents used should be compatible with the patient's cardiovascular status. Adequate facilities should be available for postoperative monitoring and ventilation of patients administered Sufentanil. It is essential that these facilities be fully equipped to handle all degrees of respiratory depression.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Precautions with Alcohol

Alcohol-Sufentanil 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 Sufentanil Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Sufentanil 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.