BUTORPHANOL TARTRATE PRESERVATIVE FREE (butorphanol tartrate)
BUTORPHANOL TARTRATE PRESERVATIVE FREE is indicated for the treatment of Pain.
Details
- Status
- Discontinued
- First Approved
- 1997-01-22
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
BUTORPHANOL TARTRATE PRESERVATIVE FREE Approval History
What BUTORPHANOL TARTRATE PRESERVATIVE FREE Treats
1 indicationsBUTORPHANOL TARTRATE PRESERVATIVE FREE is approved for 1 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
BUTORPHANOL TARTRATE PRESERVATIVE FREE Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTORPHANOL TARTRATE NASAL SPRAY Addiction, Abuse, and Misuse Because the use of butorphanol tartrate nasal spray 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 ]. Life-Threatening Respiratory Depression Serious, life-threat...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTORPHANOL TARTRATE NASAL SPRAY Addiction, Abuse, and Misuse Because the use of butorphanol tartrate nasal spray 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 ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of butorphanol tartrate nasal spray, especially during initiation or following a dose increase. To reduce the risk of respiratory depression, proper dosing and titration of butorphanol tartrate nasal spray are essential [see WARNINGS ]. Accidental Exposure Accidental exposure of even one dose of butorphanol tartrate nasal spray, especially in children, can result in a fatal overdose of butorphanol tartrate[see WARNINGS ]. 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 butorphanol tartrate nasal spray and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see WARNINGS , PRECAUTIONS ; Drug Interactions ]. Neonatal Opioid Withdrawal Syndrome If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see WARNINGS] . Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS): Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers
BUTORPHANOL TARTRATE PRESERVATIVE FREE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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.
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| 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.
BUTORPHANOL TARTRATE PRESERVATIVE FREE FDA Label Details
Indications & Usage
BUTORPHANOL TARTRATE PRESERVATIVE FREE is indicated for the treatment of Pain.
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTORPHANOL TARTRATE NASAL SPRAY Addiction, Abuse, and Misuse Because the use of butorphanol tartrate nasal spray exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.