Label Changes for:
Univasc (moexipril hydrochloride) Tablets
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) – January 2010 and August 2011
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase -2 Inhibitors (COX- 2 Inhibitors)
- In patients who are elderly, volume-depleted (including those on diuretic therapy),or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including moexipril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving moexipril and NSAID therapy. The antihypertensive effect of ACE inhibitors, including moexipril, may be attenuated by NSAIDs.
- 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 Univasc.