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BUPIVACAINE HYDROCHLORIDE
At a glance
| Generic name | BUPIVACAINE HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1972 |
Approved indications
Boxed warnings
- WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride Injection for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% (7.5 mg/mL) concentration of Bupivacaine Hydrochloride Injection is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary [see Warnings and Precautions (5.1) ]. WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA See full prescribing information for complete boxed warning. There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride Injection for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% (7.5 mg/mL) concentration of Bupivacaine Hydrochloride Injection is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary ( 5.1 ).
Common side effects
- Convulsions
- Cardiac arrest
- Ventricular fibrillation
- Ventricular tachycardia
- Heartblock
- Bradycardia
- Hypotension
- Respiratory paralysis
- Underventilation
- Apnea
- High spinal
- Total spinal block
Key clinical trials
- Effect of Scalp Block on Intraoperative Hemodynamics and Postoperative Pain in Craniotomy Patients" (NA)
- Repeated Bilateral Greater Occipital Nerve Blockade in Chronic Migraine and Chronic Tension-Type Headache (NA)
- Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery (NA)
- Arthrosemid vs. Steroid for the Management Knee Osteoarthritis (PHASE4)
- Bilateral Cervical Plexus Block for Postoperative Pain After Thyroidectomy (NA)
- Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion (EARLY_PHASE1)
- mTLIP vs QIPB for Postoperative Analgesia in Lumbar Microdiscectomy Surgery (NA)
- Continuous Epidural With Dexmedetomidine Adjuvant in Gynecologic Laparotomy (PHASE4)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BUPIVACAINE HYDROCHLORIDE CI brief — competitive landscape report
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