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: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
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 monitor regularly for these behaviors and conditions. (5.1)
- Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. (5.2)
- Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl. (5.3, 7, 12.3).
- 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; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (5.4, 7)
RECENT MAJOR CHANGES
|Warnings and Precautions (5.2)||10/2019|
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)
- 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)
- 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. (5.9)
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.
- 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. (5.4, 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.