Label Changes for:

Atacand (candesartan cilexetil) tablets and Atacand HCT (candesartan/cilexetil hydrochlorothiazide) tablets

June 2011

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) – June 2011

 

DRUG INTERACTIONS

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 angiotensin II receptor antagonists, including candesartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving candesartan and NSAID therapy.
  • The antihypertensive effect of angiotensin II receptor antagonists, including candesartan may be attenuated by NSAIDs including selective COX-2 inhibitors.
Hide
(web5)