Label Changes for:

Tekturna (Aliskiren) Tablets

November 2013

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

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

 

 

November 2013

WARNINGS AND PRECAUTIONS

Hypotension
  • Symptomatic hypotension may occur after initiation of treatment with Tekturna in patients with marked volume depletion, patients with salt depletion, or with combined use of aliskiren and other agents acting on the renin-angiotensin-aldosterone system. Thevolume or salt depletion should be corrected prior to administration of Tekturna, or the treatment should start under close medical supervision.

 

 

April 2012

 

*Concomitant use with ARBs or ACEIs in diabetes
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