Fexofenadine hydrochloride inhibited antigen-induced bronchospasm in sensitized guinea pigs and histamine release from peritoneal mast cells in rats.
Two 4-week multicenter, randomized, double-blind, placebo-controlled clinical trials compared four different doses of fexofenadine hydrochloride tablet (20, 60, 120, and 240 mg twice daily) to placebo in subjects aged 12 to 70 years with chronic idiopathic urticaria (n=726).
These studies indicate that ketoconazole or erythromycin co-administration enhances fexofenadine gastrointestinal absorption. Improvement was demonstrated within 1 day of treatment with fexofenadine hydrochloride 180 mg and was maintained over the entire 4- week treatment period.
After administration of a single 60 mg capsule to healthy subjects, the mean maximum plasma concentration (Cmax) was 131 ng/mL. Fexofenadine hydrochloride is a white to off-white crystalline powder.
Administration of a 30 mg dose to pediatric subjects 2 to 11 years of age produced exposures comparable to those seen with a dose of 60 mg administered to adults. Both enantiomers of fexofenadine hydrochloride displayed approximately equipotent antihistaminic effects. Although the number of subjects in some of the subgroups was small, there were no significant differences in the effect of fexofenadine hydrochloride across subgroups of subjects defined by gender, age, and race.
The tablet formulations are bioequivalent to the capsule when administered at equal doses.
Radiolabeled tissue distribution studies in rats indicated that fexofenadine does not cross the blood-brain barrier. In 1 of these 2 studies, conducted in 411 pediatric subjects, all 3 doses of fexofenadine hydrochloride 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, however, a dose-response relationship was not seen. There were no significant differences in the effect of fexofenadine hydrochloride across subgroups of subjects defined by gender, age, and race. Following single dose oral administrations of either the 60 and 180
Where Buy Allegra D tablet to healthy adult male subjects, mean Cmax were 142 and 494 ng/mL, respectively.
In these studies, there was no additional reduction in total symptom scores with higher doses of
Allegra 12 Hour hydrochloride up to 240 mg twice daily. The clinical significance of these findings is unknown.
Two 2-week multicenter, randomized, placebo-controlled, double-blind trials in 877 pediatric subjects 6 to 11 years of age with seasonal allergic rhinitis were conducted at doses of 15, 30, and 60 mg twice daily.