Allegra

[Fexofenadine]

No statistically significant increase in mean QTc interval compared to placebo was observed in 714 seasonal allergic rhinitis patients given fexofenadine hydrochloride capsules in doses of 60 to 240 mg twice daily for two weeks. Pediatric patients from two placebo controlled trials (n=855) treated with up to 60 mg fexofenadine hydrochloride twice daily demonstrated no significant treatment or dose-related increases in QTc. In addition, no statistically significant increase in mean QTc interval compared to placebo was observed in 40 healthy volunteers given fexofenadine hydrochloride as an oral solution at doses up to 400 mg twice daily for 6 days, or in 231 healthy volunteers given fexofenadine hydrochloride 240 mg once daily for 1 year.

Clinical Studies Seasonal Allergic Rhinitis:

Adults.

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In three, 2-week, multicenter, randomized, double-blind, placebo-controlled trials in patients 12 to 68 years of age with seasonal allergic rhinitis (n=1634), fexofenadine hydrochloride 60 mg twice daily significantly reduced total symptom scores (the sum of the individual scores for sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes) compared to placebo. Statistically significant reductions in symptom scores were observed following the first 60 mg dose, with the effect maintained throughout the 12-hour interval.

In these studies, there was no additional reduction in total symptom scores with higher doses of fexofenadine hydrochloride up to 240 mg twice daily. In one 2-week, multicenter, randomized, double-blind clinical trial in patients 12 to 65 years of age with seasonal allergic rhinitis (n=863), fexofenadine hydrochloride 180 mg once daily significantly reduced total symptom scores (the sum of the individual scores for sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes) compared to placebo. Although the number of patients in some of the subgroups was small, there were no significant differences in the effect of fexofenadine hydrochloride across subgroups of patients defined by gender, age, and race.

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