Bupivacaine Hydrochloride and Epinephrine

FDA Drug Profile — Bupivacaine Hydrochloride and Epinephrine

Bupivacaine Hydrochloride and Epinephrine is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Bupivacaine Hydrochloride and Epinephrine. Available dosage form: injection, solution.

Drug Details

Generic Name
Bupivacaine Hydrochloride and Epinephrine
Brand Names
Bupivacaine Hydrochloride and Epinephrine
Application Number
ANDA071165
Sponsor
Henry Schein, Inc.
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL
Active Ingredients
BUPIVACAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE

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 )] .