Label Changes for:

Azor (amlodipine/olmesartan medoxomil) Tablets

July 2013

Changes have been made to the WARNINGS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

July 2013

WARNINGS AND PRECAUTIONS

Sprue-like Enteropathy
  • Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of Benicar in cases where no other etiology is identified

ADVERSE REACTIONS

Post marketing Experience
  • sprue-like enteropathy 

 

October 2011

 

DRUG INTERACTIONS

Drug interactions with Amlodipine

added:

  • Simvastatin: Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily

 

May 2011

PRECAUTIONS

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

ADVERSE REACTIONS

Postmarketing Experience
  • Anaphylactic reactions, peripheral edema, and diarrhea

 

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