FDA Clears Triple-Comb Hypertension Pill


December 27, 2010

Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets are designed for the treatment of high blood pressure. It combines a direct renin inhibitor, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

The single-pill combination Amturnide works to lower blood pressure in three ways. The Tekturna component targets the activity of the renin angiotensin aldosterone system (RAAS), an important regulator of blood pressure. Tekturna directly binds to and inhibits renin, an enzyme produced by the kidneys that starts a process that can make blood vessels narrow and lead to high blood pressure. The calcium channel blocker amlodipine lowers blood pressure by relaxing muscles in the blood vessel walls, and the diuretic hydrochlorothiazide increases the excretion of sodium chloride and water. All three complementary medicines work to relax blood vessels and reduce blood volume, therefore lowering blood pressure.

Amturnide is indicated for the treatment of hypertension. It is not indicated for initial therapy of hypertension. It is designed for use in patients not adequately controlled with any two of the following: aliskiren, dihydropyridine calcium-channel blockers (DHP-CCB), and thiazide diuretics.

Switch a patient who experiences dose-limiting adverse reactions attributed to an individual component-while on any dual combination of components of Amturnide - to Amturnide at a lower dose of that component to achieve similar blood pressure reductions. Amturnide may be substituted for its titrated components.

Safety and efficacy of Amturnide in pediatric patients have not been established.

The combination drug was cleared by the FDA in December 2010.

For more information: www.novartis.com