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U.S. Department of Health and Human Services

Safety

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Edarbi (azilsartan medoxomil) and Edarbyclor (azilsartan medoxomil/chlorthalidone) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2012

Summary View

 

CONTRAINDICATIONS

  • Do not co-administer aliskiren with Edarbi in patients with diabetes.
 

DRUG INTERACTIONS

Dual Blockade of the Renin-Angiotensin System (RAS)
  • Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and Edarbyclor (azilsartan medoxomil/chlorthalidone) or Edarbi (azilsartan medoxomil) tablets changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function and electrolytes in patients on Edarbi and other agents that affect the RAS.
  • Do not co-administer aliskiren with Edarbi in patients with diabetes. Avoid use of aliskiren with Edarbi/Edarbyclor in patients with renal impairment (GFR <60 ml/min).

 

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