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Sufenta Preservative Free (SUFENTANIL)
Sufentanil works by binding to opioid receptors in the brain, spinal cord, and other areas to produce pain relief.
Sufenta Preservative Free (Sufentanil) is a small molecule opioid agonist that targets the mu-type opioid receptor. Originally developed by AKORN and currently owned by Rising, it was FDA approved in 1984 for general anesthesia and postoperative pain. As an off-patent medication, it is available as a generic from multiple manufacturers. Sufentanil has a half-life of 14.0 hours and 0% bioavailability. It is used to manage severe pain.
At a glance
| Generic name | SUFENTANIL |
|---|---|
| Sponsor | Rising |
| Drug class | Opioid Agonist |
| Target | Mu-type opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | FDA-approved |
| First approval | 1984 |
Mechanism of action
Sufentanil is an opioid agonist. When used in balanced general anesthesia, sufentanil has been reported to be as much as 10 times as potent as fentanyl. When administered intravenously as primary anesthetic agent with 100% oxygen, sufentanil is approximately to times as potent as fentanyl.
Approved indications
- General anesthesia
- Postoperative pain
Boxed warnings
- WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF SUFENTANIL CITRATE INJECTION Addiction, Abuse, and Misuse Because the use of Sufentanil 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 Sufentanil Citrate Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Sufentanil 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 Sufentanil 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 Sufentanil Citrate Injection with all cytochrome P450 3A4 inhibitors may result in an increase in sufentanil 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 sufentanil plasma concentration. Monitor patients receiving Sufentanil 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 SUFENTANIL CITRATE INJECTION See full prescribing information for complete boxed warning. • Sufentanil 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 (5.1) . • Serious, life-threatening, or fatal respiratory depression may occur with use of Sufentanil Citrate Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Sufentanil 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 sufentanil (5.4, 7 , 12.3) .
Common side effects
- Apnea
- Rigidity
- Bradycardia
- Pruritus
- Impaired neonatal adaptation to sound and light
- Impaired neuromuscular coordination
- Serotonin syndrome
- Adrenal insufficiency
- Anaphylaxis
- Androgen deficiency
Drug interactions
- tranylcypromine
Key clinical trials
- Tegileridine Combined With Intercostal Nerve Block After Thoracoscopic Lung Resection (NA)
- Intranasal Dexmedetomidine for Prevention of Intrapartum Fever (NA)
- Intranasal Dexmedetomidine for Postpartum Depression Prevention (NA)
- Effects of Different Drugs for Glottic Atomization on Postoperative Sore Throat After Thyroid Surgery (PHASE4)
- Intercostal Nerve Cryoablation Versus Epidural Analgesia for Nuss Repair of Pectus Excavatum (NA)
- Cardiac Index and General Anesthesia Without Opioid. (PHASE2,PHASE3)
- Oliceridine Versus Sufentanil for Postoperative Nausea in Cerebellopontine Angle Surgery (NA)
- The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Laparoscopic Surgery (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |