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. |
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
