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Label Changes for:

Monopril HCT (fosinopril/hydrochlorothiazide) 20/12.5mg and 10/12.5mg Tablets 

February 2009

Changes have been made to the PRECAUTIONS sections of the safety label.

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

Summary View

Sections Modified


  • Drug Interaction
    • 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 MONOPRIL/ MONOPRIL HCT.

The latest label (approved 02/09/2009) is not available on this site