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FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent
Date:7/20/2009

tor thinks you are unlikely to achieve your goal blood pressure with a single medicine.

Important considerations

IMPORTANT WARNING:

TEKTURNA or TEKTURNA HCT may harm an unborn baby, causing injury and even death. If you get pregnant, stop taking TEKTURNA or TEKTURNA HCT and call your doctor right away. If you plan to become pregnant, talk to your doctor about other medicines to treat your high blood pressure before taking TEKTURNA or TEKTURNA HCT.

Do not take TEKTURNA or TEKTURNA HCT if you are allergic to any of its ingredients. Do not take TEKTURNA HCT if you have a history of reduced urine output, or if you have allergic reactions to certain drugs known as sulfonamides. If you are taking TEKTURNA or TEKTURNA HCT, tell your doctor about all of your medical conditions, including kidney problems. Also, tell your doctor about all medicines you take, including those to treat fungal infections, cyclosporine, potassium-containing medicines, potassium supplements, or salt substitutes containing potassium. Additionally, if you take TEKTURNA HCT, tell your doctor if you have liver problems, lupus, or if you take lithium.

Two of the most serious side effects of TEKTURNA and TEKTURNA HCT include an allergic reaction involving swelling of the face, lips, throat and/or tongue that may cause difficulty in breathing and swallowing (stop taking TEKTURNA or TEKTURNA HCT and contact your doctor immediately), and low blood pressure, especially if you take water pills, are on a low-salt diet, get dialysis treatments, have heart problems, or get sick with vomiting or diarrhea. Lie down if you feel faint or dizzy. Call your doctor right away.

In clinical studies, the most common side effect experienced by more patients taking TEKTURNA than patients taking a sugar pill was diarrhea. The most common side effects experienced by more patients taking TEKTURNA HCT than
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SOURCE Novartis Pharmaceuticals Corporation
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