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The systemic safety of fexofenadine HCl


Dr J Mason Hoechst Marion Roussel, 10236 Marion Park Drive, PO Box 9627, Kansas City, MO 64134-1405, USA.


Fexofenadine is a highly specific, H1-receptor antagonist with a safety profile similar to placebo. In placebo-controlled trials of seasonal allergic rhinitis (SAR) and chronic idiopathic urticaria (CIU), the type and incidence of adverse events were comparable in fexofenadine and placebo recipients. Fexofenadine does not impair performance in tests of driving or psychomotor performance and has been shown to improve quality of life in patients with SAR. Fexofenadine has a high margin of safety and is also well tolerated in subjects with renal or hepatic impairment, in children and the elderly. No clinically significant drug interactions have been identified. Fexofenadine is not associated with cardiotoxicity. Unlike some other antihistamines, such as loratidine or cetirizine [1, 2], fexofenadine is truly non-sedating, showing no dose-related increase in sedation, even at high doses [3, 4]. Fexofenadine is formulated and marketed as the hydrochloride salt. The recommended dose of fexofenadine HC1 is 120 mg daily for SAR (either as 120 mg once daily or 60 mg twice daily) or 180 mg once daily for CIU.