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U.S. Department of Health and Human Services

Safety

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Tarka (trandolopril/verapamil hydrochloride) 2/180, 1/240, 2/240, 4/240 mg ER Tablets 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

PRECAUTIONS

  • Drug Interactions (the following interactions have been added):
    • Clarithromycin
      • Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent clarithromycin.
    • Erythromycin
      • Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients
        receiving concurrent erythromycin ethylsuccinate.
    • Gold
      • Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including Tarka.

The latest label (approved 3/5/2009) is not available on this site