Label Changes for:
Twynsta (telmisartan/amlodipine) Tablets
November 2012
Changes have been made to the CONTRAINDICATIONS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
November 2012
CONTRAINDICATIONS
- Do not co-administer aliskiren with TWYNSTA in patients with diabetes
DRUG INTERACTIONS
Drug Interactions with Telmisartan
- Aliskiren: Do not co-administer aliskiren with TWYNSTA in patients with diabetes. Avoid use of aliskiren with TWYNSTA in patients with renal impairment (GFR <60 ml/min).
Patient Information
Who should not take TWYNSTA?
For patients with diabetes, if you are taking TWYNSTA you should not take aliskiren.
Tell your doctor about all the medicines you take
For patients with diabetes, if you are taking TWYNSTA you should not take aliskiren.
October 2012
WARNINGS AND PRECAUTIONS
Hypotension
- Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis
- Amlodipine: Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.
