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U.S. Department of Health and Human Services

Safety

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Renin Inhibitors

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2012

 

  • Amturnide (amlodipine/aliskiren/hydrochlorothiazide) 150/5/12.5 mg, 300/5/12.5 mg, 300/5/25 mg, 300/10/12.5 mg and 300/10/25 mg Tablets
  • Tekamlo (aliskiren/amlodipine) 150 mg/5 mg, 150 mg/10 mg, 300 mg/5 mg and 300 mg/10 mg Tablets
  • Tekturna (aliskiren) 150 mg, 300 mg Tablets
  • Tekturna HCT (aliskiren/hydrochlorothiazide) 150/12.5 mg, 150/25 mg, 300/12.5 mg, and 300/25 mg Tablets
  • Valturna (aliskiren and valsartan) 150/160 mg and 300/320 mg Tablets

 

Summary View

6 ADVERSE REACTIONS

6.2 Post-Marketing Experience
  • Severe cutaneous adverse reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis

7 DRUG INTERACTIONS

Aliskiren [and xxx]
  • Non-Steroidal Anti-Inflammatory Agents(NSAIDS) including Selective Cyclooxygenase Inhibitors (COX-2 inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including COX-2 inhibitors with agents acting on the renin-angiotensin system, including aliskiren and valsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving aliskiren, valsartan, and NSAID therapy.

PATIENT INFORMATION

What should I tell my doctor before taking Tekturna?
Tell your doctor about all the medicines you take:
  • nonsteroidal anti-inflammatory drugs (like ibuprofen or naproxen)