Label Changes for:
Tarka (trandolopril/verapamil hydrochloride) 2/180, 1/240, 2/240, 4/240 mg ER Tablets
March 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) -- 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. |
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.
- 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.
- Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients
- 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.
- Clarithromycin
The latest label (approved 3/5/2009) is not available on this site
