BUPIVACAINE and MELOXICAM

FDA Drug Profile — ZYNRELEF

Drug Details

Generic Name
BUPIVACAINE and MELOXICAM
Brand Names
ZYNRELEF
Application Number
NDA211988
Sponsor
Heron Therapeutics, Inc.
NDC Codes
8
Dosage Forms
SOLUTION
Routes
INFILTRATION
Active Ingredients
BUPIVACAINE, MELOXICAM

Indications and Usage

1 INDICATIONS AND USAGE ZYNRELEF is indicated in adults for postsurgical analgesia for up to 72 hours after: soft tissue surgical procedures orthopedic surgical procedures – foot and ankle procedures – other orthopedic surgical procedures (e.g., total joint arthroplasty) in which direct exposure to articular cartilage is avoided [see Warnings and Precautions (5.10) ] ZYNRELEF is indicated in adults for postsurgical analgesia for up to 72 hours after: soft tissue surgical procedures orthopedic surgical procedures – foot and ankle procedures – other orthopedic surgical procedures (e.g., total joint arthroplasty) in which direct exposure to articular cartilage is avoided [see Warnings and Precautions (5.10) ] Limitations of Use Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large 4 or more level spinal, and head and neck procedures ( 1 ). Limitations of Use Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large 4 or more level spinal, and head and neck procedures.