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 )] 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 monitor regularly for these behaviors and conditions ( 5.1 ) • Serious, life-threatening, or fatal respiratory depression may occur with use of Fentanyl Citrate Injection, especially during initiation or following a dose 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...
Adult Dosing
USE – MicroVault ® Figure 1
FOR USE – MicroVault ® Figure 1: Outer Packaging (MicroVault ® ) and Prefilled Syringe NOTES: - Do not introduce any other fluid into the syringe at any time. - Do not dilute for IV push. - Do not re-sterilize the syringe. - Do not use this product on a sterile field. - This product is for single dose only. 1. Once removed from the bundle, inspect the outer packaging by verifying: - Integrity of the tube and the cap. - Tamper evident seal is intact (outer shrink wrap is not broken). Do not use if the outer packaging has been damaged. 2. Hold the outer packaging with both hands. To break the tamper evident seal, hold the tube and the cap close to the seal, and twist until broken. (See Figure 2) Figure 2 3.
USE – Blister Pack Figure 1
FOR USE – Blister Pack Figure 1: Outer Packaging and Prefilled Syringe NOTES: - Do not introduce any other fluid into the syringe at any time. - Do not dilute for IV push. - Do not re-sterilize the syringe. - Do not use this product on a sterile field. - This product is for single dose only. 1. Inspect the outer packaging (blister pack) to confirm the integrity of the packaging. Do not use if the blister pack or the prefilled syringe has been damaged. 2. Remove the syringe from the outer packaging. (See Figure 2) Figure 2 3. Visually inspect the syringe. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 4. Twist off the syringe tip cap.
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