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U.S. Department of Health and Human Services

Safety

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Precedex (dexmedetomidine hydrochloride) Injection for Intravenous Infusion [following dilution] October 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


 

Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Withdrawal
    • Procedural Sedation

ADVERSE REACTIONS

  • Clinical Studies Experience
    • Procedural Sedation
      • Table 3

USE IN SPECIFIC POPULATIONS

  • Geriatric Use
    • Procedural Sedation

NONCLINICAL TOXICOLOGY

  • Carcinogenesis, Mutagenesis, Impairment of Fertility

PATIENT COUNSELING INFORMATION (new)

WARNINGS AND PRECAUTIONS

Withdrawal/Procedural Sedation:

Withdrawal symptoms were not seen after discontinuation of short term infusions of Precedex (<6 hours).

 

Label approved 10/17/2008 is not available on this site