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EDARBYCLOR (azilsartan medoxomil and chlorthalidone) Now Available in U.S. Pharmacies for Patients with Hypertension
Date:2/6/2012

barrier and appear in cord blood and may be associated with adverse reactions, including fetal or neonatal jaundice and thrombocytopenia.

In patients with an activated renin-angiotensin-aldosterone system (RAAS), such as volume- and/or salt-depleted patients, EDARBI and EDARBYCLOR can cause excessive hypotension. Correct volume or salt depletion prior to administration of EDARBI or EDARBYCLOR.

Patients with renal impairment should be monitored for worsening renal function. In patients whose renal function may depend on the activity of the renin-angiotensin system, treatment with ACE inhibitors and ARBs has been associated with oliguria or progressive azotemia and rarely with acute renal failure and death. In patients with renal artery stenosis, EDARBI and EDARBYCLOR may cause renal failure. In patients with renal disease, chlorthalidone may precipitate azotemia. Consider withholding or discontinuing EDARBI or EDARBYCLOR if progressive renal impairment becomes evident.

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

Hyperuricemia 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 (8.9 percent) and fatigue (2.0 percent). The incidence of consecutive elevations of creatinine with EDARBYCLOR (greater than or equal to 50 percent from baseline and greater than the upper limit of normal) was 2 percent; elevations were typically transient, or nonprogressive and reve
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SOURCE Takeda Pharmaceutical Company Limited
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1. FDA Approves EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension
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