SUBLIMAZE PRESERVATIVE FREE (fentanyl citrate) · RISING
Sublimaze is a short-acting opioid analgesic indicated for use throughout the anesthetic period, including premedication, induction, maintenance, and the immediate recovery period. It serves as a supplemental analgesic in general or regional anesthesia and may be administered alongside a neuroleptic. Additionally, it is indicated as a primary anesthetic agent with oxygen for high-risk patients undergoing complex procedures, such as open heart surgery or complicated neurological and orthopedic surgeries.
How SUBLIMAZE PRESERVATIVE FREE Works
Fentanyl citrate is an opioid agonist; its principal therapeutic actions are analgesia and sedation.
Details
- Status
- Prescription
- First Approved
- 1968-02-19
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SUBLIMAZE PRESERVATIVE FREE Approval History
What SUBLIMAZE PRESERVATIVE FREE Treats
4 indicationsSUBLIMAZE PRESERVATIVE FREE is approved for 4 conditions since its original approval in 1968. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Short-term pain during anesthesia (premedication, induction, and maintenance)
- Postoperative pain in the recovery room
- Supplement to general or regional anesthesia
- Anesthesia for high-risk surgeries (e.g., open heart, neurological, or orthopedic procedures)
SUBLIMAZE PRESERVATIVE FREE Boxed Warning
RISK OF ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; CYTOCHROME P450 3A4 INTERACTION; and RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; CYTOCHROME P450 3A4 INTERACTION; and RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning. Fentanyl Citrate Injection exposes users to risks of addiction...
WARNING: RISK OF ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; CYTOCHROME P450 3A4 INTERACTION; and RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; CYTOCHROME P450 3A4 INTERACTION; and RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS 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. Monitor closely, especially upon initiation or following a dose increase. ( 5.2 ) Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl. ( 5.3 , 7 , 12.3 ) 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; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. ( 5.4 , 7 ) Addiction, Abuse, and Misuse 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 Fentanyl Citrate Injection, and monitor 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. Monitor for respiratory depression, especially du
SUBLIMAZE PRESERVATIVE FREE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SUBLIMAZE PRESERVATIVE FREE
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05437575 PAIN | STUDY22010164 HT9425-25-F-0041 | Ph 3 | recruiting | Prehospital Analgesia INtervention Trial (PAIN) |
| NCT06051227 FORE-PAIN | FP-2023 2022-500176-63-00, U1111-1287-7486 | Ph 3 | terminated | Fentanyl OR Esketamine for Traumatic PAIN (FORE-PAIN) Trial |
| NCT04645823 | Versio4_22112020 2020-005506-26 | Ph 4 | completed | Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor |
| NCT03018756 | DMED-1921-16 | Ph 3 | completed | Nebulized Fentanyl in Patients With Mild to Moderate Interstitial Lung Disease and Chronic Dyspnea |
| NCT03405090 | DMED-1926-16 | Ph 4 | completed | Differential Mechanisms of Dyspnea Relief in Advanced COPD: Opiates vs. Bronchodilators |
| NCT06017141 | STUDY00149314 NCI-2023-05587, IIT-2022-VIVA | Ph 2 | recruiting | Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study |
| NCT03809455 FARADI | UC-0106/1607 SdS 02 FARADI | Ph 2 | withdrawn | Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients |
| NCT01516684 results posted | IRB00017079 NCI-2012-00019, CCCWFU 01211 | Ph 2 | completed | Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures |
| NCT03682211 | SCC01 2011-005161-20, ISRCTN67469672 | Ph 4 | completed | Intranasal Fentanyl Versus Intravenous Morphine in the Treatment of Severe Painful Sickle Cell Crises in Children |
| NCT01482091 results posted | 11-09-343 | Ph 4 | completed | Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis |
| NCT02576353 | INS002-15-049 | Ph 1 | completed | Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects |
| NCT01308320 | 4-2009-0111 | Ph 4 | completed | Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia |
| NCT00795314 PABADUC | NMU-2008-FY10MZ31 NJFY0811-MZ02 | Ph 4 | completed | Propofol-butorphanol Anesthesia During Uterine Curettage |
| 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.
SUBLIMAZE PRESERVATIVE FREE FDA Label Details
Indications & Usage
FDA Label (PDF)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. administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certai...
WARNING: RISK OF ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; CYTOCHROME P450 3A4 INTERACTION; and RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; CYTOCHROME P450 3A4 INT...
Track SUBLIMAZE 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.