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. |
Sections Modified
PRECAUTIONS
- 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.
- Gold: Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and
The latest label (approved 02/09/2009) is not available on this site
