Overview
Bupivacaine is a widely used local anesthetic agent.
Indication
As an implant, bupivacaine is indicated in adults for placement into the surgical site to produce postsurgical analgesia for up to 24 hours following open inguinal hernia repair. Bupivacaine, in liposome suspension, is indicated in patients aged 6 years and older for single-dose infiltration to produce postsurgical local analgesia. In adults, it is also indicated as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Bupivacaine, in combination with meloxicam, is indicated for postsurgical analgesia in adult patients for up to 72 hours following foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. Bupivacaine, alone or in combination with epinephrine, is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations are recommended for each type of block indicated to produce local or regional anesthesia or analgesia. Finally, its use is not indicated in all blocks given clinically significant risks associated with use.
Associated Conditions
- Acute Gouty Arthritis
- Adrenocortical Insufficiency
- Alopecia Areata (AA)
- Ankylosing Spondylitis (AS)
- Berylliosis
- Bullous dermatitis herpetiformis
- Congenital Adrenal Hyperplasia (CAH)
- Congenital Hypoplastic Anemia
- Dermatomyositis (DM)
- Discoid Lupus Erythematosus (DLE)
- Edema of the cerebrum
- Epicondylitis
- Hemolytic Anemia
- Hypercalcemia caused by Cancer
- Keloids Scars
- Leukemias
- Mycosis Fungoides (MF)
- Necrobiosis lipoidica diabeticorum
- Ocular Inflammation
- Ophthalmia, Sympathetic
- Osteoarthritis (OA)
- Pain, Labor
- Polymyositis
- Postoperative pain
- Psoriatic Arthritis
- Psoriatic plaque
- Pure Red Cell Aplasia
- Regional Enteritis
- Rheumatoid Arthritis
- Secondary thrombocytopenia
- Stevens-Johnson Syndrome
- Synovitis
- Systemic Lupus Erythematosus
- Temporal Arteritis
- Trichinosis
- Tuberculous Meningitis
- Ulcerative Colitis
- Uveitis
- Acute Bursitis
- Acute Idiopathic Nephrotic Syndrome
- Acute Lupus Erythematosus
- Acute Multiple sclerosis
- Acute Rheumatic heart disease, unspecified
- Acute nonspecific tenosynovitis
- Cystic tumors of aponeurosis
- Cystic tumors of tendon
- Disseminated Pulmonary Tuberculosis (TB)
- Exfoliative erythroderma
- Inflammatory lesions of granuloma annulare
- Inflammatory lesions of lichen planus
- Inflammatory lesions of lichen simplex
- Non-suppurative Thyroiditis
- Permphigus
- Severe Allergic Reactions
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/17 | Not Applicable | Recruiting | |||
2025/07/10 | Not Applicable | Not yet recruiting | |||
2025/07/10 | Not Applicable | Completed | |||
2025/07/01 | Not Applicable | Completed | |||
2025/06/22 | Not Applicable | Completed | Usama Ahmed Elsaeed Salem, MD | ||
2025/06/17 | Phase 1 | ENROLLING_BY_INVITATION | |||
2025/06/10 | Phase 3 | ENROLLING_BY_INVITATION | Minia University | ||
2025/06/06 | Phase 4 | Completed | Alzahraa Ahmed Abbas | ||
2025/06/04 | Not Applicable | Active, not recruiting | |||
2025/05/30 | Phase 4 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Eugia US LLC | 55150-249 | INFILTRATION, PERINEURAL | 2.5 mg in 1 mL | 7/24/2023 | |
| Hospira, Inc. | 0409-1159 | EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL | 2.5 mg in 1 mL | 3/3/2023 | |
| Cantrell Drug Company | 52533-174 | EPIDURAL | 1.25 mg in 1 mL | 1/13/2015 | |
| Hospira, Inc. | 0409-1250 | INFILTRATION, PERINEURAL | 125 mg in 50 mL | 5/27/2025 | |
| Medical Purchasing Solutions, LLC | 71872-7270 | PERINEURAL | 5 mg in 1 mL | 5/2/2023 | |
| Xellia Pharmaceuticals USA LLC | 70594-120 | EPIDURAL, PERINEURAL, INTRACAUDAL | 7.5 mg in 1 mL | 6/9/2023 | |
| Fresenius Kabi USA, LLC | 63323-466 | EPIDURAL, PERINEURAL, INTRACAUDAL | 5 mg in 1 mL | 7/12/2019 | |
| Meitheal Pharmaceuticals Inc | 71288-722 | INFILTRATION, PERINEURAL, INTRACAUDAL, EPIDURAL | 2.5 mg in 1 mL | 7/21/2023 | |
| Hospira, Inc. | 0409-1749 | EPIDURAL, INTRACAUDAL, PERINEURAL | 5 mg in 1 mL | 1/14/2022 | |
| Somerset Therapeutics, LLC | 70069-752 | INFILTRATION, PERINEURAL | 2.5 mg in 1 mL | 9/19/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/16/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BUPIVACAINE-BAXTER SOLUTION FOR INJECTION 2.5 MG/ML | SIN15020P | INJECTION, SOLUTION | 2.5 mg/mL | 5/25/2016 | |
| MARCAIN INJECTION 0.5% (POLYAMP DUOFIT) | SIN05679P | INJECTION | 5 mg/ml | 4/8/1991 | |
| REGIVELL SPINAL HEAVY INJECTION 0.5% W/V | SIN16501P | INJECTION | 5 mg/ml | 5/24/2022 | |
| BUPIVACAINE-BAXTER SOLUTION FOR INJECTION 5 MG/ML | SIN15019P | INJECTION, SOLUTION | 5 mg/mL | 5/25/2016 | |
| MARCAIN SPINAL 0.5% HEAVY INJECTION | SIN05681P | INJECTION | 5 mg/ml | 4/8/1991 | |
| Marcain Injection 0.5% (4ml) | SIN13211P | INJECTION | 5mg/ml | 7/4/2006 | |
| SURGICAINE Injection | Novocol Pharmaceutical of Canada, Inc. | SIN14273P | INJECTION | 5 mg | 11/22/2012 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bupivacaine Liposome Injection | 国药准字H20223899 | 化学药品 | 注射剂 | 11/30/2022 | |
| Bupivacaine Liposome Injection | 国药准字H20247011 | 化学药品 | 注射剂 | 1/15/2024 | |
| Bupivacaine Liposome Injection | 国药准字H20244686 | 化学药品 | 注射剂 | 10/22/2024 | |
| Bupivacaine Liposome Injection | 国药准字H20244685 | 化学药品 | 注射剂 | 10/22/2024 | |
| Bupivacaine Hydrochloride Injection | 国药准字H31022839 | 化学药品 | 注射剂 | 4/15/2020 | |
| Bupivacaine Hydrochloride Injection | 国药准字H20249767 | 化学药品 | 注射剂 | 12/25/2024 | |
| Bupivacaine Hydrochloride Injection | 国药准字H20258019 | 化学药品 | 注射剂 | 2/19/2025 | |
| Bupivacaine Hydrochloride Injection | 国药准字H20253665 | 化学药品 | 注射剂 | 3/18/2025 | |
| Bupivacaine Hydrochloride Injection | 国药准字H20253664 | 化学药品 | 注射剂 | 3/18/2025 | |
| Bupivacaine Hydrochloride Injection | 国药准字H37022567 | 化学药品 | 注射剂 | 7/12/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| REGIVELL SOLUTION FOR INJECTION 20MG/4ML | N/A | N/A | N/A | 11/10/2014 | |
| BUPIVACAINE HYPERBARIC SINTETICA SOLUTION FOR INJECTION 20MG/4ML | N/A | N/A | N/A | 1/16/2025 |
TGA Drug Approvals
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