Safety

Edarbyclor (azilsartan medoxomil and chlorthalidone) 40 mg/12.5 mg and 40/25 mg Tablets

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

April 2015

Summary View

WARNINGS AND PRECAUTIONS

HypokalemiaSerum Electrolyte Imbalances

Chlorthalidone

  • Thiazide diuretics can cause hyponatremia and hypokalemia. Drugs that inhibit the renin angiotensin system can cause hyperkalemia … Monitor serum electrolytes periodically.

 

July 2014

Summary View

PRECAUTIONS

Drug Interactions

Dual Blockade of the Renin-Angiotensin System (RAS)

  • Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors

Lithium

  • Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor. Monitor serum lithium levels during concomitant use.
     

 

April 2014

Summary View

6 ADVERSE REACTIONS  

6.2 Postmarketing Experience

The following adverse reactions have been identified during the postmarketing use of EDARBYCLOR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Nausea
  • Rash
  • Pruritus
  • Angioedema

 

Page Last Updated: 05/13/2015
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