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Detailed information

In dogs (30 mgkg orally twice daily for 5 days) and rabbits (10 mgkg intravenously over 1 hour), fexofenadine hydrochloride did not prolong QT c at plasma concentrations that were at least 7 and 15 times, respectively, the therapeutic plasma concentrations in man (based on a 180 mg once daily fexofenadine hydrochloride dose when administered as Allegra-D 24 Hour). No effect was observed on calcium channel current, delayed K channel current, or action potential duration in guinea pig myocytes, Na current in rat neonatal myocytes, or on the delayed rectifier K channel cloned from human heart at concentrations up to 1 times; 10 minus;5 M of fexofenadine. This concentration was at least 8 times the therapeutic plasma concentration in man (based on a 180 mg once daily fexofenadine hydrochloride dose). No statistically significant increase in mean QT c interval compared to placebo was observed in 714 subjects with seasonal allergic rhinitis given fexofenadine hydrochloride capsules in doses of 60 mg to 240 mg twice daily for 2 weeks or in 40 healthy volunteers given fexofenadine hydrochloride as an oral solution at doses up to 400 mg twice daily for 6 days.

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