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Label Changes for:

Tekturna HCT (Aliskiren and Hydrochlorothiazide) 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


  • Symptomatic hypotension may occur after initiation of treatment with Tekturna HCT 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. The volume or salt depletion should be corrected prior to administration of Tekturna HCT, or the treatment should start under close medical supervision.



April 2012


*Concomitant use with ARBs or ACEIs in diabetes