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U.S. Department of Health and Human Services

Safety

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Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets July 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 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 Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Serum Electrolyte Abnormalities
    • Tekturna HCT
  • Renal Artery Stenosis
  • Cyclosporine
    • Aliskiren

DRUG INTERACTIONS

  • Aliskiren
    • Effects of Other Drugs on Aliskiren
      • P-glycoprotein Effects
      • Ketoconazole
      • Cyclosporine

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

WARNINGS AND PRECAUTIONS

Serum Electrolyte Abnormalities

Tekturna HCT

...Based on experience with the use of other substances that affect the renin-angiotensin system (RAS), concomitant use of Tekturna HCT with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other drugs that increase potassium levels may lead to increases in serum potassium. If concomitant use is considered necessary, caution should be exercised.

Renal Artery Stenosis (added)

No data are available on the use of Tekturna HCT in patients with unilateral or bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.

Cyclosporine: Aliskiren (added)

When aliskiren was given with cyclosporine, the blood concentrations of aliskiren were significantly increased. Concomitant use of aliskiren with cyclosporine is not recommended [see Drug Interactions (7)].

The July 2008 label is not available at this site.