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).
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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
|SOURCE Takeda Pharmaceuticals North America, Inc.|
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