Japan's Takeda Pharmaceutical has announced that its Edarbyclor (azilsartan medoxomil and chlorthalidone) is now available by prescription in US pharmacies for the treatment of hypertension to lower blood pressure in adults.
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Edarbyclor is a fixed-dose combination of two medications: azilsartan medoxomil, an angiotensin II receptor blocker (ARB), and chlorthalidone, a long-acting diuretic used in the treatment of hypertension.
In a phase 3 clinical trial, Edarbyclor (40/25 mg) was found to reduce systolic blood pressure compared to the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide at its maximum dose (40/25 mg).
In December 2011, the US Food and Drug Administration approved Edarbyclor at a recommended starting dose of 40/12.5 mg and a maximal dose of 40/25 mg.
The company said Edarbyclor may be used in patients not adequately controlled with monotherapy and as an initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals.
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