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U.S. Department of Health and Human Services

Safety

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Micardis (telmisartan) tablets and Micardis HCT (telmisartan/HCTZ) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009

 

Summary View

 

PRECAUTIONS

Dual Blockade of the Renin-angiotensin-aldosterone System (section added)
Drug Interactions
  • Ramipril and Ramiprilat: Co-administration of telmisartan 80 mg qd and ramipril 10 mg qd to healthy subjects increases steady-state Cmax and AUC of ramipril 2.3 and 2.1 fold, respectively, and Cmax and AUC of ramiprilat 2.4 and 1.5 fold, respectively. In contrast, Cmax and AUC of telmisartan decrease by 31% and 16%, respectively. When coadministering telmisartan and ramipril, the response may be greater because of the possibly additive pharmacodynamic effects of the combined drugs, and also because of the increased exposure to ramipril and ramiprilat in the presence of telmisartan.
  • Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Cases have also been reported with angiotensin II receptor antagonists including telmisartan. Therefore, serum lithium level monitoring is advisable during concomitant use.  
    • (Added to the Micardis HCT label only in place of last sentence: "Therefore, serum lithium level monitoring is advisable during concomitant use”) Because lithium should not be used with diuretics, the use of lithium with telmisartan and hydrochlorothiazide is not recommended.

ADVERSE REACTIONS

Post-Marketing
  • “…anemia, increased CPK, anaphylactic reaction, and tendon pain (including tendonitis, tenosynovitis)