sufentanil citrate injection, USP Highlights

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

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as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated.

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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.

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for epidural administration as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery.

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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.

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Ensure that an opioid antagonist, resuscitative and intubation equipment, and oxygen are readily available. (2.1)

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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)

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Initiate analgesic treatment with 1 to 2 mcg/kg intravenously. (2.2)

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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)

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

Hypersensitivity to sufentanil. (4)

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Risks of Muscle Rigidity and Skeletal Muscle Movement: Manage with neuromuscular blocking agent. See full prescribing information for more detail on managing these risks. (5.5)

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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)

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Severe Cardiovascular Depression: Monitor during dosage initiation and titration. (5.6)

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Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced ‎Hyperalgesia (OIH) occurs when an opioid analgesic ‎paradoxically causes an increase in pain, or an increase in ‎sensitivity to pain. If OIH is suspected, carefully consider appropriately ‎decreasing the dose of the current opioid analgesic or ‎opioid rotation. (5.7)‎

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Serotonin Syndrome: Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue Sufentanil Citrate Injection if serotonin syndrome is suspected. (5.8)

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Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, or Head Injury: Monitor for sedation and respiratory depression. (5.10)

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.

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Concomitant Use of CNS Depressants: May decrease pulmonary arterial pressure and may cause hypotension. See FPI for management instructions. For postoperative pain, start with the lowest effective dosage and monitor for potentiation of CNS depressant effects. (5.3, 7)

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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)

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Pregnancy: May cause fetal harm. (8.1)

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Lactation: Infants exposed to Sufentanil Citrate Injection through breast milk should be monitored for excess sedation and respiratory depression. (8.2)