In patients with an activated renin-angiotensin-aldosterone system (RAAS), such as volume- and/or salt-depleted patients, EDARBI or EDARBYCLOR can cause excessive hypotension. Correct volume or salt depletion prior to administration of EDARBI or 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, EDARBI and 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. Avoid use of aliskiren with EDARBI or EDARBYCLOR in patients with renal impairment (GFR <60 mL/min).
Thiazide diuretics can cause hyponatremia and hypokalemia. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. 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. Monitor electrolytes periodically.