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Patients with mild to moderate renal impairment generally do not require dose adjustment, but closer monitoring may be warranted, particularly for signs of gastrointestinal adverse effects that could lead to dehydration and worsening renal function

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The FDA's 2003 guidance on pharmacokinetics in patients with impaired hepatic function acknowledges that drugs primarily cleared by non-hepatic mechanisms may not require dedicated hepatic impairment studies [5]