Sufentanil
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
SUFENTA is contraindicated in patients with known hypersensitivity to the drug or known intolerance to other opioid agonists.
Warnings
SUFENTA 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 SUFENTA may cause skeletal muscle rigidity, particularly of the truncal muscles. The incidence and severity of muscle rigidity is dose related. Administration of SUFENTA may produce muscular rigidity with a more rapid onset of action than that seen with fentanyl. SUFENTA 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 SUFENTA 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 SUFENTA 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 SUFENTA is used in anesthetic dosages (above 8 mcg/kg) titrated by slow intravenous infusion, or, 3) simultaneous administration of SUFENTA and a full paralyzing dose of a neuromuscular blocking agent when SUFENTA 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 SUFENTA. 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.