pharmacopeia
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/api/v1/drug/fentanyl

Boxed warning

SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL CITRATE INJECTION Addiction, Abuse, and Misuse Because the use of Fentanyl 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 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 [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 Fentanyl 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 )].

2D structure
N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]propanamide
SMILES CCC(=O)N(C1CCN(CC1)CCC2=CC=CC=C2)C3=CC=CC=C3
InChIKey PJMPHNIQZUBGLI-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Fentanyl Citrate Injection is an opioid agonist, whose principal actions of therapeutic value are analgesia and sedation.

Full Opioid

Indications

Sourced from openFDA
  • Fentanyl Citrate Injection is indicated for: • 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 a narcotic analgesic supplement in general or regional anesthesia.

Contraindications

Sourced from openFDA
  • Fentanyl Citrate Injection is contraindicated in patients with: • Hypersensitivity to fentanyl (e.g., anaphylaxis) [See Adverse Reactions ( 6 )] • Hypersensitivity to fentanyl ( 4 )contraindicated

Dosage & administration

Sourced from openFDA

• 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 mcg to 100 mcg. ( 2.2 ) • Initiate treatment in children 2 to 12 years of age, with a reduced dose as low as 2 mcg/kg to 3 mcg/kg. ( 2.2 ) 2.1 Important Dosage and Administration Instructions 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. • Individualize dosage 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. • Monitor vital signs routinely. As with other potent opioids, the respiratory depressant effect of fentanyl may persist longer than the measured analgesic effect. The total dose of all opioid agonists administered should be considered by the practitioner before ordering opioid analgesics during recovery from anesthesia.

Warnings & precautions

Sourced from openFDA

• 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. ( 5.8 ) • Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.9 ) • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, or Head Injury : Monitor for sedation and respiratory depression. ( 5.10 ) 5.1 Addiction, Abuse, and Misuse Fentanyl Citrate Injection contains fentanyl, a Schedule II controlled substance. As an opioid, Fentanyl Citrate Injection exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence ( 9 )] . Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use. Consider these risks when handling Fentanyl Citrate Injection.

Adverse reactions

Sourced from openFDA

The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.1 )] • Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.2 )] • Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions ( 5.3 )] • Severe Cardiovascular Depression [see Warnings and Precautions ( 5.6 )] • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions ( 5.7 )] • Serotonin Syndrome [see Warnings and Precautions ( 5.8 )] • Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.11 )] • Seizures [see Warnings and Precautions ( 5.12 )] The following adverse reactions associated with the use of fentanyl were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. As with other opioid agonists, the most common serious adverse reactions reported to occur with fentanyl are respiratory depression, apnea, rigidity and bradycardia; if these remain untreated, respiratory arrest, circulatory depression or cardiac arrest could occur. Other adverse reactions that have been reported are hypertension, hypotension, dizziness, blurred vision, nausea, emesis, laryngospasm, diaphoresis, serotonin syndrome, adrenal insufficiency, and anaphylaxis.

Use in specific populations

Sourced from openFDA

• 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 ) 8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with Fentanyl Citrate Injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes. There are adverse outcomes reported with fetal exposure to opioid analgesics (see Clinical Considerations ) . In animal reproduction studies, fentanyl administration to pregnant rats during organogenesis was embryocidal at doses within the range of the human recommended dosing. No evidence of malformations was noted in animal studies completed to date [see Data ] . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Pharmacokinetics

Sourced from openFDA
Metabolism
Fentanyl Citrate Injection is administered by the intravenous or intramuscular route. The pharmacokinetics of fentanyl can be described as a three-compartment model.

Overdosage

Sourced from openFDA

Clinical Presentation Acute overdose with fentanyl can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology ( 12.2 )] . Treatment of Overdose In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support measures. Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to fentanyl overdose, administer an opioid antagonist.

Approval history

Sourced from openFDA
  • Jul 11, 1984NDANDA019101Hikma
  • Jan 12, 1985NDANDA019115Hospira
  • Nov 4, 1998NDANDA020747Cephalon
  • Jan 28, 2005ANDAANDA076258Mylan Technologies
  • Oct 20, 2008ANDAANDA077449Difgen Pharms
  • Feb 9, 2011ANDAANDA077154Specgx Llc
  • Nov 4, 2016ANDAANDA202097Kindeva
  • May 3, 2019ANDAANDA210762Fresenius Kabi Usa

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
113,403 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Abuse12,32911%
  2. 2Overdose8,1177.2%
  3. 3Pain7,7746.9%
  4. 4Death7,4416.6%
  5. 5Toxicity To Various Agents7,2896.4%
  6. 6Drug Dependence6,4105.7%
  7. 7Drug Ineffective6,3505.6%
  8. 8Nausea5,6415.0%
  9. 9Dependence4,4013.9%
  10. 10Vomiting4,1093.6%
  11. 11Fatigue3,7723.3%
  12. 12Off Label Use3,7283.3%
  13. 13Hypotension3,3352.9%
  14. 14Dyspnoea3,2532.9%
  15. 15Drug Withdrawal Syndrome3,1992.8%

Literature

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Recent PubMed references pinned to Fentanyl as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 2,345 ClinicalTrials.gov registrations naming Fentanyl as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Fentanyl. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Frequently asked questions

How does Fentanyl work?
Fentanyl Citrate Injection is an opioid agonist, whose principal actions of therapeutic value are analgesia and sedation.
What is Fentanyl used for?
According to FDA labeling, Fentanyl carries indications including: Fentanyl Citrate Injection is indicated for: • 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 a narcotic analgesic supplement in general or regional anesthesia.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Fentanyl?
Fentanyl is classified as Opioid anesthetics, Phenylpiperidine derivatives, Opioid Agonist, Full Opioid Agonists, Analgesia, Decreased Organized Electrical Activity.
What are the brand names for Fentanyl?
Fentanyl is marketed under brand names including Abstral, Actiq, Fentora, Ionsys, Subsys.
What are the contraindications for Fentanyl?
Fentanyl labeling lists contraindications including: Fentanyl Citrate Injection is contraindicated in patients with: • Hypersensitivity to fentanyl (e.g., anaphylaxis) [See Adverse Reactions ( 6 )] • Hypersensitivity to fentanyl ( 4 ). Always consult the full prescribing information and a clinician.
Note. Data for fentanyl is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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