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Novartis receives FDA approval of Tekamlo™, a single-pill combination of aliskiren and amlodipine to treat high blood pressure
Date:8/27/2010

gement, offering a range of innovative therapies designed to help patients with different needs achieve their blood pressure goals. Novartis is dedicated to helping physicians and patients improve cardiovascular and metabolic health through effective medicines, programs and an ongoing commitment to research.

Tekamlo is available in four strengths as once-daily tablets containing aliskiren and amlodipine:  150 mg/5 mg tablets, 150 mg/10 mg tablets, 300 mg/5 mg tablets and 300 mg/10 mg tablets.  

About TekamloTekamlo is indicated for the treatment of hypertension, alone or with other antihypertensive agents.

Use Tekamlo as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. Base the choice of Tekamlo as initial therapy on an assessment of potential benefits and risks. Individualize the decision to use a combination as initial therapy by weighing factors such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy.

Switch a patient whose blood pressure is not adequately controlled with aliskiren or amlodipine (or another dihydropyridine calcium channel blocker) alone to combination therapy with Tekamlo.

Important ConsiderationsWARNING: AVOID USE IN PREGNANCYWhen pregnancy is detected, discontinue Tekamlo as soon as possible.  Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and even death to the developing fetus. [See WARNINGS and Precautions (5.1) and Use in Special Populations (8.1) in full Prescribing Information]Angioedema of the face, extremities, lips, tongue, glottis, and/or larynx has been reported in patients treated with aliskiren and has necessitated hospitalization and intubation. This may occur at any time during treatment and has occurred in patients with and without a history of angioedema with ACE inhibitors (ACEI) or angiotensin
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