bupivacaine hydrochloride and epinephrine bitartrate
bupivacaine hydrochloride and epinephrine bitartrate is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including MARCAINE WITH EPINEPHRINE, Marcaine, Vivacaine. Available dosage form: injection, solution.
Drug Details
- Generic Name
- bupivacaine hydrochloride and epinephrine bitartrate
- Brand Names
- MARCAINE WITH EPINEPHRINE, Marcaine, Vivacaine
- Application Number
- NDA016964
- Sponsor
- Henry Schein, Inc.
- NDC Codes
- 3
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL, SUBMUCOSAL
- Active Ingredients
- BUPIVACAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE, BUPIVACAINE HYDROCHLORIDE ANHYDROUS
Indications and Usage
1 INDICATIONS AND USAGE SENSORCAINE / SENSORCAINE 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 of SENSORCAINE / SENSORCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration ( 2.2 )]. SENSORCAINE contains bupivacaine, an amide local anesthetic, and SENSORCAINE WITH EPINEPHRINE is a combination of bupivacaine, an amide local anesthetic, and epinephrine, an alpha and beta-adrenergic agonist. SENSORCAINE/ SENSORCAINE 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. 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 SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE given clinically significant risks associated with use. ( 1 , 2.2 , 4 , 5.1 , 5.4 , 5.5 , 5.7 , 5.9 ) Limitations of Use Not all blocks are indicated for use with SENSORCAINE / SENSORCAINE WITH EPINEPHRINE 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 )] .