Label Changes for:

DepoDur (morphine sulfate extended-release) liposome injection

September 2009

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009

PRECAUTIONS 

General
  • revised to include statement to reinforce that DepoDur dosing will need to be adjusted in the elderly and other risk groups taking into account the patient's age, body mass, physical status, prior experience with opiate analgesics, risk factors for respiratory depression, and medications to be co-administered before or during surgery

CLINICAL PHARMACOLOGY

Drug Interactions
  • revised to include pharmacokinetic interaction with respect to DepoDur and therapeutic doses of local anesthetic bupivacaine HCI
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