There were no significant differences in the effect of fexofenadine hydrochloride across subgroups of subjects defined by gender, age, and race.
Administration of a 30 mg dose to pediatric subjects 2 to 11 years of age
Allegra D Product exposures comparable to those seen with a dose of 60 mg administered to adults. 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. After administration of a single 60 mg capsule to healthy subjects, the mean maximum plasma concentration (Cmax) was 131 ng/mL. Following single dose oral administrations of either the 60 and 180 mg tablet to healthy adult male subjects, mean Cmax were 142 and 494 ng/mL, respectively.
Pharmacokinetics in renally and hepatically impaired subjects and geriatric subjects, obtained after a single dose of 80 mg fexofenadine hydrochloride, were compared to those from healthy subjects in a separate study of similar design. There were no significant differences in the effect of fexofenadine hydrochloride across subgroups of subjects defined by gender, age, weight, and race. It is freely soluble in methanol and ethanol, slightly soluble in chloroform and water, and insoluble in hexane. Improvement was demonstrated within 1 day of treatment with fexofenadine hydrochloride 180 mg and was maintained over the entire 4- week treatment period. Efficacy was demonstrated by a significant reduction in mean pruritus scores (MPS), mean number of wheals (MNW), and mean total symptom Allegra Claritin Zyrtec (MTSS, the sum of the MPS and MNW score). However, no additional benefit of the 120 or 240 mg fexofenadine hydrochloride twice daily dose was seen over the 60 mg twice daily dose in reducing symptom scores.
The clinical significance of these findings is unknown. ALLEGRA is formulated as a tablet for oral administration. Although the number of subjects in some of the subgroups was small, there were Allegra Claritin Zyrtec significant differences in the effect of fexofenadine hydrochloride across subgroups of subjects defined by gender, age, and race.
In one 4-week, multicenter, randomized, double-blind, placebo-controlled clinical trial in subjects 12 years of age and older with chronic idiopathic urticaria (n=259), fexofenadine hydrochloride 180 mg once daily significantly reduced the mean number of wheals (MNW), the mean pruritus score (MPS), and the mean total symptom score (MTSS, the sum of the MPS and MNW scores). Human mass balance studies documented
Allegra D Information recovery of approximately 80% and 11% of the [14C] fexofenadine hydrochloride dose in the feces and urine, respectively. 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. This observed increase in the bioavailability of fexofenadine may be due to transport-related effects, such as p-glycoprotein.