Last reviewed 2026-04-20 · How we verify

Bupivacaine Hydrochloride And Epinephrine (BUPIVACAINE)

Bupivacaine Hydrochloride And Epinephrine (generic name: BUPIVACAINE) is a Amide Local Anesthetic Small molecule drug developed by Innocoll. It is currently FDA-approved (first approved 1972) for Anesthesia for cesarean section, Itching of skin, Local Anesthesia for Ophthalmologic Procedure.

Bupivacaine works by blocking nerve impulses to prevent pain signals from reaching the brain.

Bupivacaine Hydrochloride And Epinephrine (BUPIVACAINE) is a local anesthetic drug developed by HOSPIRA and currently owned by Innocoll. It works by targeting the cytochrome P450 2D6 enzyme and inhibiting sodium channels to block nerve impulses, providing pain relief. BUPIVACAINE is approved for various indications, including anesthesia for cesarean section, local anesthesia, and regional anesthesia for labor pain. It has a half-life of 3.1 hours and is administered via injection. As an off-patent drug, it is available as a generic product.

At a glance

Mechanism of action

Bupivacaine blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone.Epinephrine is vasoconstrictor added to bupivacaine to slow absorption into the general circulation and thus prolong maintenance of an active tissue concentration.

Approved indications

• Anesthesia for cesarean section
• Itching of skin
• Local Anesthesia for Ophthalmologic Procedure
• Local anesthesia
• Local anesthetic intrathecal block
• Major Nerve Block for Surgery
• Minor Skin Wound Pain
• Regional Anesthesia for Labor Pain
• Regional Anesthesia for Ophthalmologic Surgery
• Regional Anesthesia for Postoperative Pain
• Regional Anesthesia for Surgery
• Skin irritation

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

• Anaesthetic complication
• Maternal exposure during delivery
• Local anaesthetic systemic toxicity
• Chondrolysis
• Exposure during pregnancy
• Hypotension
• Cauda equina syndrome
• Bradycardia
• Premature baby
• Foetal exposure during delivery
• Drug withdrawal syndrome
• Incorrect route of product administration

Drug interactions

• propranolol

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)

Patents

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Bupivacaine Hydrochloride And Epinephrine CI brief — competitive landscape report
• Bupivacaine Hydrochloride And Epinephrine updates RSS · CI watch RSS
• Innocoll portfolio CI

Frequently asked questions about Bupivacaine Hydrochloride And Epinephrine

Related

• Drug class: All Amide Local Anesthetic drugs
• Target: All drugs targeting Cytochrome P450 2D6
• Manufacturer: Innocoll — full pipeline
• Therapeutic area: All drugs in Ophthalmology
• Indication: Drugs for Anesthesia for cesarean section
• Indication: Drugs for Itching of skin
• Indication: Drugs for Local Anesthesia for Ophthalmologic Procedure

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing