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sufentanil citrate injection, USP Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use SUFENTANIL CITRATE INJECTION, safely and effectively. See full prescribing information for SUFENTANIL CITRATE INJECTION.

Sufentanil Citrate Injection, for intravenous and epidural use, CII
Initial U.S. Approval: 1984

WARNING: ADDICTION, ABUSE, AND MISUSE

See full prescribing information for complete boxed warning.

  • Sufentanil Citrate Injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor regularly for these behaviors and conditions. (5.1)

INDICATIONS AND USAGE

Sufentanil Citrate Injection is an opioid agonist indicated (1):

  • as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated.
  • as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated.
  • for epidural administration as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery.

DOSAGE AND ADMINISTRATION

  • Sufentanil Citrate Injection should be administered only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids.
  • Ensure that an opioid antagonist, resuscitative and intubation equipment, and oxygen are readily available. (2.1)
  • Individualize dosing based on factors such as age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and the surgical procedure involved. (2.1)
  • Initiate analgesic treatment with 1 to 2 mcg/kg intravenously. (2.2)
  • Initiate epidural injection for labor and delivery at 10 to 15 mcg of sufentanil administered with 10 mL bupivacaine 0.125% with or without epinephrine. (2.3)

DOSAGE FORMS AND STRENGTHS

Solution for injection (sterile): eq. to 50 mcg/mL sufentanil base; 1 mL, 2 mL and 5 mL vials. (3)

CONTRAINDICATIONS

  • Hypersensitivity to sufentanil. (4)

WARNINGS AND PRECAUTIONS

  • Risks of Muscle Rigidity and Skeletal Muscle Movement: Manage with neuromuscular blocking agent. See full prescribing information for more detail on managing these risks. (5.4)
  • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or
    Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.2)
  • Severe Cardiovascular Depression: Monitor during dosage initiation and titration. (5.6)
  • Serotonin Syndrome: Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue Sufentanil Citrate Injection if serotonin syndrome is suspected. (5.7)
  • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, or Head Injury: Monitor for sedation and respiratory depression. (5.9)

ADVERSE REACTIONS

Most common adverse reactions were apnea, rigidity, and bradycardia. (6)


To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Concomitant Use of CNS Depressants: May decrease pulmonary arterial pressure and may cause hypotension. See FPI for management instructions. For post-operative pain, start with the lowest effective dosage and monitor for potentiation of CNS depressant effects. (5.5, 7)
  • Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Sufentanil Citrate Injection because they may reduce analgesic effect of Sufentanil Citrate Injection or precipitate withdrawal symptoms. (7)

USE IN SPECIFIC POPULATIONS

  • Pregnancy: May cause fetal harm. (8.1)
  • Lactation: Infants exposed to Sufentanil Citrate Injection through breast milk should be monitored for excess sedation and respiratory depression. (8.2)

Revised: 7/2021

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