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EDARBI (azilsartan medoxomil), Now Available in U.S. Pharmacies for Patients With Hypertension
Date:4/14/2011

ACE inhibitors and ARBs has been associated with oliguria or progressive azotemia and rarely with acute renal failure and death. Similar results may be anticipated in patients treated with EDARBI. In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen have been reported. There has been no long-term use of EDARBI in these patients but similar results may be expected.

Monitor renal function periodically in patients receiving EDARBI 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.

Small reversible increases in serum creatinine are seen in patients receiving 80 mg of EDARBI. The increase may be larger when co-administered with chlorthalidone or hydrochlorothiazide. In addition, patients taking EDARBI who had moderate to severe renal impairment at baseline or those 75 years of age or older were more likely to report serum creatinine increases.

The most common adverse reaction that occurred more frequently with EDARBI than placebo in adults was diarrhea (two percent versus 0.5 percent).

Please click here for complete Prescribing Information, including boxed warning.

Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology, and cardiovascular treatments and seek to bring innovative products to patients thro
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SOURCE Takeda Pharmaceuticals North America, Inc.
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