Label Changes for:
Avapro (irbesartan) Tablets
Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011
- Concomitant use of potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium.
- Impaired renal function, including cases of renal failure, has been reported.
- Cases of increased CPK and rhabdomyolysis have been reported in patients receiving angiotensin II receptor blocker.