sufentanil citrate injection, USP Highlights

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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: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF SUFENTANIL CITRATE ‎INJECTION

See full prescribing information for complete boxed warning.

Addiction, Abuse, and Misuse

Because the use of Sufentanil Citrate Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)].



Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of ‎Sufentanil Citrate Injection, ‎especially during initiation or following a dose ‎increase. To reduce the risk of respiratory depression, proper dosing ‎and ‎titration of Sufentanil Citrate Injection are essential [see Warnings and Precautions (5.2)].



Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous ‎system (CNS) depressants, including ‎alcohol, may result in profound sedation, ‎respiratory depression, coma, and death. Reserve concomitant prescribing of ‎‎Sufentanil Citrate Injection and benzodiazepines or other CNS depressants for ‎use in patients for whom ‎alternative treatment options are inadequate [see Warnings and Precautions (5.3), Drug Interactions (7)].



Cytochrome P450 3A4 Interaction

The concomitant use of Sufentanil Citrate Injection with all cytochrome P450 ‎‎3A4 inhibitors may result in an ‎increase in sufentanil plasma concentrations, ‎which could increase or prolong adverse reactions and may cause ‎potentially ‎fatal respiratory depression. In addition, discontinuation of a concomitantly used ‎cytochrome P450 3A4 ‎inducer may result in an increase in sufentanil plasma ‎concentration. Monitor patients receiving Sufentanil Citrate Injection and any ‎CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.4), Drug ‎Interactions (7), ‎Clinical Pharmacology (12.3)]‎.

RECENT MAJOR CHANGES

Boxed Warning

7/2023‎

Warnings and Precautions (5.1, 5.3, 5.7)

7/2023‎

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. (5.5)
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)
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)‎
Serotonin Syndrome: Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue Sufentanil Citrate Injection if serotonin syndrome is suspected. (5.8)
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, or Head Injury: Monitor for sedation and respiratory depression. (5.10)

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 postoperative pain, start with the lowest effective dosage and monitor for potentiation of CNS depressant effects. (5.3, 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: 12/2023

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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: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF SUFENTANIL CITRATE ‎INJECTION

See full prescribing information for complete boxed warning.

Addiction, Abuse, and Misuse

Because the use of Sufentanil Citrate Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)].



Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of ‎Sufentanil Citrate Injection, ‎especially during initiation or following a dose ‎increase. To reduce the risk of respiratory depression, proper dosing ‎and ‎titration of Sufentanil Citrate Injection are essential [see Warnings and Precautions (5.2)].



Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous ‎system (CNS) depressants, including ‎alcohol, may result in profound sedation, ‎respiratory depression, coma, and death. Reserve concomitant prescribing of ‎‎Sufentanil Citrate Injection and benzodiazepines or other CNS depressants for ‎use in patients for whom ‎alternative treatment options are inadequate [see Warnings and Precautions (5.3), Drug Interactions (7)].



Cytochrome P450 3A4 Interaction

The concomitant use of Sufentanil Citrate Injection with all cytochrome P450 ‎‎3A4 inhibitors may result in an ‎increase in sufentanil plasma concentrations, ‎which could increase or prolong adverse reactions and may cause ‎potentially ‎fatal respiratory depression. In addition, discontinuation of a concomitantly used ‎cytochrome P450 3A4 ‎inducer may result in an increase in sufentanil plasma ‎concentration. Monitor patients receiving Sufentanil Citrate Injection and any ‎CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.4), Drug ‎Interactions (7), ‎Clinical Pharmacology (12.3)]‎.

RECENT MAJOR CHANGES

Boxed Warning

7/2023‎

Warnings and Precautions (5.1, 5.3, 5.7)

7/2023‎

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. (5.5)
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)
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)‎
Serotonin Syndrome: Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue Sufentanil Citrate Injection if serotonin syndrome is suspected. (5.8)
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, or Head Injury: Monitor for sedation and respiratory depression. (5.10)

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 postoperative pain, start with the lowest effective dosage and monitor for potentiation of CNS depressant effects. (5.3, 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: 12/2023

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