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U.S. Department of Health and Human Services

Safety

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Sular (nisoldipine) Extended Release Tablets [in new Geomatrix Formulation]


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


Summary View

Sections Modified

PRECAUTIONS

  • Information for Patients
    • ...Sular should be taken on an empty stomach (1 hour before or 2 hours after a meal)...
    • This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions...
  • Drug Interactions
    • CYP3A4 Inhibitors and Inducers
    • See highlighted label for revised text.

ADVERSE REACTIONS

  • See highlighted label for revised text.
  • See Adverse Event Table with Sular, dose bioequivalent to...

 

Label not available at this site.