Label Changes for:

Twynsta (telmisartan/amlodipine)

November 2011

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

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

 

November 2011

WARNINGS AND PRECAUTIONS

Drug Interactions with Amlodipine
  • Simvastatin: Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.

 

July 2010 

 

ADVERSE REACTIONS

Clinical Trials Experience
  • TWYNSTA tablets:  The adverse reactions that occurred in the placebo-controlled factorial design trial in patients treated with Twynsta and at a higher incidence in Twynsta-treated patients (n=789) than placebo-treated patients (n=46) were peripheral edema (4.8% vs 0%), dizziness (3.0% vs 2.2%), and back pain (2.2% vs 0%). Edema (other than peripheral edema), hypotension, and syncope were reported in <2% of patients treated with Twynsta tablets.
  • Amlodipine: Gastrointestinal- change of bowel habit; Psychiatric- mood change

 

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