Posimir FDA Approval History
FDA Approved: Yes (First approved February 1, 2021)
Brand name: Posimir
Generic name: bupivacaine
Dosage form: Solution for Infiltration Use
Company: Durect Corporation
Treatment for: Post-Surgical Pain
Posimir (bupivacaine) is a sustained-release anamide local anesthetic formulation indicated for post-surgical pain reduction following arthroscopic subacromial decompression shoulder surgery.
- Posimir is administered as a single dose into the subacromial space under direct arthroscopic arthroscopic visualization (used to confirm proper placement of the needle tip).
- Post-surgical analgesia can last for up to 72 hours.
- The Posimir product label carries a boxed warning that advises the risk of potential adverse embolic effects resulting from inadvertent intravascular injection. Posimir must not be injected intravascularly.
- Common adverse reactions reported in shoulder surgery patients include dizziness, dysgeusia, dysuria, headache, hypoesthesia, paresthesia, tinnitus, and vomiting.
Development Timeline for Posimir
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