SUFENTA PRESERVATIVE FREE (sufentanil citrate)
Sufentanil Citrate is a potent opioid agonist indicated for use in adult and pediatric patients as an analgesic adjunct in balanced general anesthesia or as a primary anesthetic agent with 100% oxygen during major surgical procedures (e.g., cardiovascular or neurosurgery). It is specifically utilized in intubated and ventilated patients to maintain myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated. Additionally, it is indicated for epidural administration in combination with low-dose bupivacaine for analgesia during labor and vaginal delivery.
How SUFENTA PRESERVATIVE FREE Works
Sufentanil is a highly potent opioid agonist. It provides analgesia and anesthesia through its action on opioid receptors in the central nervous system. When used as an adjunct in balanced general anesthesia, sufentanil is approximately 10 times as potent as fentanyl. When administered as a primary anesthetic agent with 100% oxygen, it is approximately 5 to 7 times as potent as fentanyl.
Details
- Status
- Prescription
- First Approved
- 1984-05-04
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SUFENTA PRESERVATIVE FREE Approval History
What SUFENTA PRESERVATIVE FREE Treats
1 indicationsSUFENTA PRESERVATIVE FREE is approved for 1 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Labor Pain
SUFENTA PRESERVATIVE FREE Boxed 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 Se...
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
SUFENTA PRESERVATIVE FREE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06530563 | XiangyaHMZK | Ph 4 | not yet recruiting | the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery |
| NCT05831345 | CHUB-Methadone | Ph 3 | recruiting | Intraoperative Methadone for the Prevention of Postoperative Pain |
| NCT03685188 | WCH2018086 | Ph 4 | enrolling by invitation | Oxycodone and Sufentanil for Analgesia in Hip Surgery |
| NCT00738192 CARAN | NMU-FY2008-311 NJFY0807311M | Ph 4 | completed | Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SUFENTA PRESERVATIVE FREE FDA Label Details
Indications & Usage
FDA Label (PDF)SUFENTA PRESERVATIVE FREE is indicated for the treatment of Labor Pain.
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 p...
Track SUFENTA PRESERVATIVE FREE with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.