bupivacaine hydrochloride
Drug Details
- Generic Name
- bupivacaine hydrochloride
- Brand Names
- bupivacaine hydrochloride, Sensorcaine MPF, Bupivacaine Hydrochloride, Marcaine, BUPIVACAINE HYDROCHLORIDE
- Application Number
- ANDA216039
- Sponsor
- Northstar Rx LLC
- NDC Codes
- 15
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- PERINEURAL, INFILTRATION, EPIDURAL, INTRACAUDAL, RETROBULBAR
- Active Ingredients
- BUPIVACAINE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see Dosage and Administration (2.2) , Contraindications (4) , Warnings and Precautions (5.1 , 5.4 , 5.5 , 5.7 , 5.9 )] . Bupivacaine hydrochloride injection contains bupivacaine hydrochloride, an amide local anesthetic indicated in adults for the production of local or regional anesthesia or analgesia for surgery, oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. ( 1 , 2.2 ) Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use. ( 1 , 2.2 , 4 , 5.1 , 5.4 , 5.5 , 5.7 , 5.9 )