fentanyl citrate injection, USP VIAL , AMPULE Boxed Warning

()

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)].

Cytochrome P450 3A4 Interaction

The concomitant use of Fentanyl Citrate Injection with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl 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 fentanyl plasma concentration. Monitor patients receiving Fentanyl Citrate Injection and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.4), Drug Interactions (7), Clinical Pharmacology (12.3)].

Find fentanyl citrate injection, USP VIAL , AMPULE medical information:

Find fentanyl citrate injection, USP VIAL , AMPULE medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

fentanyl citrate injection, USP VIAL , AMPULE Quick Finder

Medication Guide

Health Professional Information

Boxed Warning

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)].

Cytochrome P450 3A4 Interaction

The concomitant use of Fentanyl Citrate Injection with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl 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 fentanyl plasma concentration. Monitor patients receiving Fentanyl Citrate Injection and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.4), Drug Interactions (7), Clinical Pharmacology (12.3)].

Prescribing Information
Download Prescribing Information

Health Professional Information

Boxed Warning

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)].

Cytochrome P450 3A4 Interaction

The concomitant use of Fentanyl Citrate Injection with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl 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 fentanyl plasma concentration. Monitor patients receiving Fentanyl Citrate Injection and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.4), Drug Interactions (7), Clinical Pharmacology (12.3)].

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Contact Medical Information.9AM-5PM ET Monday to Friday; excluding holidays.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.