fentanyl citrate injection, USP VIAL , AMPULE Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

FENTANYL CITRATE Injection, for Intravenous or Intramuscular use, CII

Initial U.S. Approval: 1968

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

See full prescribing information for complete boxed warning.

•
Fentanyl 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 reassess regularly for these behaviors and conditions. (5.1)
•
Serious, life-threatening, or fatal respiratory depression may occur with use Fentanyl Citrate Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of ‎Fentanyl Citrate Injection are essential.‎ (5.2)
•
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 for use in patients for whom alternative treatment options are inadequate. (5.3, 7).
•
Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl. (5.4, 7, 12.3)

RECENT MAJOR CHANGES

Boxed Warning

12/2023

Warnings and Precautions (5.7)

12/2023

INDICATIONS AND USAGE

Fentanyl Citrate Injection is an opioid agonist indicated for: (1)

•
analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises.
•
use as an opioid analgesic supplement in general or regional anesthesia.
•
administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
•
use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.

DOSAGE AND ADMINISTRATION

•
Fentanyl 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 the 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 treatment in adults with 50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 mL). (2.2)
•
Initiate treatment in children 2 to 12 years of age with a reduced dose as low as 2 to 3 mcg/kg. (2.2)

DOSAGE FORMS AND STRENGTHS

•
Injection: 50 mcg (0.05 mg)/mL in single-dose Fliptop vial. (3)
•
Injection: 50 mcg (0.05 mg)/mL in single-dose ampule. (3)

CONTRAINDICATIONS

•
Hypersensitivity to fentanyl. (4)

WARNINGS AND PRECAUTIONS

•
Risks of Skeletal Muscle Rigidity and Skeletal Muscle Movement: Manage with neuromuscular blocking agent. See full prescribing information for more detail on managing these risks. (5.5)
•
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 Fentanyl Citrate Injection if serotonin syndrome is suspected. (5.7)
•
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.8)
•
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. (5.10)

ADVERSE REACTIONS

Most common serious adverse reactions were respiratory depression, 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. (5.3, 7)
•
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Fentanyl Citrate Injection because they may reduce analgesic effect of Fentanyl Citrate Injection or precipitate withdrawal symptoms. (7)

USE IN SPECIFIC POPULATIONS

•
Pregnancy: May cause fetal harm. (8.1)
•
Lactation: Infants exposed to Fentanyl Citrate Injection through breast milk should be monitored for excess sedation and respiratory depression. (8.2)
•
Geriatric Patients: Titrate slowly and monitor for CNS and respiratory depression. (8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

FENTANYL CITRATE Injection, for Intravenous or Intramuscular use, CII

Initial U.S. Approval: 1968

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

See full prescribing information for complete boxed warning.

•
Fentanyl 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 reassess regularly for these behaviors and conditions. (5.1)
•
Serious, life-threatening, or fatal respiratory depression may occur with use Fentanyl Citrate Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of ‎Fentanyl Citrate Injection are essential.‎ (5.2)
•
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 for use in patients for whom alternative treatment options are inadequate. (5.3, 7).
•
Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl. (5.4, 7, 12.3)

RECENT MAJOR CHANGES

Boxed Warning

12/2023

Warnings and Precautions (5.7)

12/2023

INDICATIONS AND USAGE

Fentanyl Citrate Injection is an opioid agonist indicated for: (1)

•
analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises.
•
use as an opioid analgesic supplement in general or regional anesthesia.
•
administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
•
use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.

DOSAGE AND ADMINISTRATION

•
Fentanyl 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 the 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 treatment in adults with 50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 mL). (2.2)
•
Initiate treatment in children 2 to 12 years of age with a reduced dose as low as 2 to 3 mcg/kg. (2.2)

DOSAGE FORMS AND STRENGTHS

•
Injection: 50 mcg (0.05 mg)/mL in single-dose Fliptop vial. (3)
•
Injection: 50 mcg (0.05 mg)/mL in single-dose ampule. (3)

CONTRAINDICATIONS

•
Hypersensitivity to fentanyl. (4)

WARNINGS AND PRECAUTIONS

•
Risks of Skeletal Muscle Rigidity and Skeletal Muscle Movement: Manage with neuromuscular blocking agent. See full prescribing information for more detail on managing these risks. (5.5)
•
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 Fentanyl Citrate Injection if serotonin syndrome is suspected. (5.7)
•
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.8)
•
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. (5.10)

ADVERSE REACTIONS

Most common serious adverse reactions were respiratory depression, 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. (5.3, 7)
•
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Fentanyl Citrate Injection because they may reduce analgesic effect of Fentanyl Citrate Injection or precipitate withdrawal symptoms. (7)

USE IN SPECIFIC POPULATIONS

•
Pregnancy: May cause fetal harm. (8.1)
•
Lactation: Infants exposed to Fentanyl Citrate Injection through breast milk should be monitored for excess sedation and respiratory depression. (8.2)
•
Geriatric Patients: Titrate slowly and monitor for CNS and respiratory depression. (8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2023
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