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FDA Approves EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension
Date:12/20/2011

atients with renal disease, chlorthalidone may precipitate azotemia. Consider withholding or discontinuing EDARBI or EDARBYCLOR if progressive renal impairment becomes evident.

EDARBYCLOR attenuates chlorthalidone-associated hypokalemia. Hypokalemia is a dose-dependent adverse reaction that may develop with chlorthalidone. Coadministration of digitalis may exacerbate the adverse effects of hypokalemia.

Hyperuricemia (chlorthalidone) may occur or frank gout may be precipitated in certain patients receiving chlorthalidone or other thiazide diuretics.

The most common adverse reaction that occurred more frequently with EDARBI than placebo in adults was diarrhea (2 percent versus 0.5 percent). The adverse reactions that occurred at an incidence of greater than or equal to 2 percent of EDARBYCLOR-treated patients, and greater than azilsartan medoxomil or chlorthalidone, were dizziness and fatigue. Elevations of creatinine (2 percent) were typically transient, or nonprogressive and reversible, and associated with large blood pressure reductions.

Patients receiving EDARBI or EDARBYCLOR and nonsteroidal anti-inflammatory drugs (NSAIDs) who are also elderly, volume-depleted (including those on diuretics), or who have compromised renal function due to potential reversible deterioration of renal function should have their renal function monitored periodically. NSAIDs increase risk of renal dysfunction and interfere with antihypertensive effect. Renal clearance of lithium is reduced by diuretics, such as chlorthalidone, increasing the risk of lithium toxicity.

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Please click here for complete EDARBI Prescribing Information or here'/>"/>

SOURCE Takeda Pharmaceuticals North America, Inc.
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