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.