• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail
?
-

Resources for You

Rocephin (ceftriaxone sodium) for injection, 250 mg, 500 mg, 1 g and 2 g March 2009

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

 

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

 

Sections Modified

Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

  • Neonates

WARNINGS

  • Interaction with Calcium-Containing Products

ADVERSE REACTIONS

  • Postmarketing Experience
    • A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported...

CONTRAINDICATIONS

  • Neonates (section edited)
    • Rocephin is contraindicated in neonates if they require...
    • A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy...

WARNINGS

  • Interaction with Calcium-Containing Products
    • Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute Rocephin vials...