SUBLIMAZE PRESERVATIVE FREE (fentanyl citrate)
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
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, l...
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 FR
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 | recruiting | 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)SUBLIMAZE PRESERVATIVE FREE is indicated for the treatment of 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).
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...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.