Label Changes for:

Lidocaine in 5% Dextrose Injection, USP

March 2012

Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2012

 

WARNINGS

  • Anaphylactic reactions may occur following administration of lidocaine hydrochloride. In the case of severe reaction, discontinue the use of the drug.               

ADVERSE REACTIONS

Hematologic Effects: methemoglobinemia
  • Allergic reactions, including anaphylactic reactions, may occur but are infrequent.
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