Label Changes for:

Twynsta (telmisartan/amlodipine) tablets  

June 2011

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2011

 

Twynsta (telmisartan/amlodipine) tablets

*NSAID interaction

 

DRUG INTERACTIONS

Drug Interactions with Telmisartan

Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 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 selective COX-2 inhibitors with angiotensin II receptor antagonists, including telmisartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving telmisartan and NSAID therapy.
  • The antihypertensive effect of angiotensin II receptor antagonists, including telmisartan may be attenuated by NSAIDs including selective COX-2 inhibitors.

PATIENT INFORMATION

Tell your doctor about all the medicines you take:

  • medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs(NSAIDs), including COX-2 inhibitors
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