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American Journal of Medicine Publishes Hypertension Study Comparing the Fixed-Dose Combination of Azilsartan Medoxomil and Chlorthalidone versus Azilsartan Medoxomil Co-administered with Hydrochlorothiazide
Date:9/5/2012

tration of Edarbyclor.

Monitor for worsening renal function in patients with renal impairment. 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, Edarbyclor may cause renal failure. In patients with renal disease, chlorthalidone may precipitate azotemia. Consider withholding or discontinuing 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.

Adverse Reactions (AEs): AEs that occurred at an incidence of ≥2% of Edarbyclor -treated patients and greater than azilsartan medoxomil or chlorthalidone were dizziness (8.9%) and fatigue (2.0%).

Incidence of consecutive elevations of creatinine (≥50% from baseline and >ULN) was 2% and were typically transient, or nonprogressive and reversible, and associated with large blood pressure reductions.

Drug Interactions: Renal clearance of lithium is reduced by diuretics, such as chlorthalidone, increasing the risk of lithium toxicity. Monitor renal function periodically in patients receiving Edarbyclor and 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. NSAIDs may interfere with antihypertensive effect.

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SOURCE Takeda Pharmaceuticals U.S.A., Inc.
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