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Macrodantin (nitrofurantoin macrocrystals) capsules, 25, 50 and 100 mg 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

WARNINGS

CONTRAINDICATIONS

  • Macrodantin is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin.

WARNINGS

  • Added subheadings for readability of the following reactions:
    • Pulmonary reactions
    • Hepatoxicity
    • Neuropathy
    • Hemolytic anemia
    • Clostridium difficile-associated diarrhea