Bupivacaine Hydrochloride and Epinephrine

FDA Drug Profile — Bupivacaine Hydrochloride and Epinephrine

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 MARCAINE / MARCAINE 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 MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ]. MARCAINE contains bupivacaine, an amide local anesthetic, and MARCAINE WITH EPINEPHRINE is a combination of bupivacaine, an amide local anesthetic, and epinephrine, an alpha and beta-adrenergic agonist. MARCAINE / MARCAINE 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 MARCAINE / MARCAINE 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 MARCAINE / MARCAINE 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) ] .