Medication Guide App

Label Changes for:

Tekturna (aliskiren) Tablets

May 2008

Changes have been made to the PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

Sections Modified

PRECAUTIONS

  • Cyclosporine
    • When aliskiren was given with cyclosporine, the blood concentrations of aliskiren were significantly increased. Concomitant use of aliskiren with cyclosporine is not recommended.

PATIENT PACKAGE INSERT

  • Tell your doctor about all the medicines you take...
    • cyclosporine (a medicine used to suppress the immune system).
    • potassium-containing medicines, potassium supplements, or salt substitutes containing potassium.

Label approved 05/19/2008 is not available on Drugs@FDA

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