Improvement was demonstrated within 1 day of treatment with fexofenadine hydrochloride 180 mg and was maintained over the entire 4- week treatment period. 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
Allegra D Product of similar design. In these studies, there was no additional reduction in total symptom scores with higher doses of fexofenadine hydrochloride up to 240 mg twice daily. Co-administration of 180 mg fexofenadine hydrochloride tablet with a high fat meal decreased the mean area under the curve (AUC) and (Cmax)
Allegra The Antihistamine Drug fexofenadine by 21 and 20% respectively. Fexofenadine hydrochloride pharmacokinetics are linear for oral doses up to a total daily dose of 240 mg (120 mg twice daily). Each tablet contains 30, 60, or 180 mg fexofenadine hydrochloride (depending on the dosage strength) and the following excipients: croscarmellose sodium, magnesium Aventis Allegra microcrystalline cellulose, and pregelatinized starch.
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. Radiolabeled tissue distribution studies in rats indicated that fexofenadine does not cross the blood-brain barrier. Both enantiomers of fexofenadine hydrochloride displayed approximately equipotent antihistaminic effects. In 1 clinical trial conducted with ALLEGRA 60 mg capsules, and in 1 clinical trial conducted with ALLEGRA-D 12 Hour extended release tablets, onset of action was seen within 1 to 3 hours. Fexofenadine hydrochloride is a white to off-white crystalline powder. These studies
Allegra D Composition that ketoconazole or erythromycin co-administration enhances fexofenadine gastrointestinal absorption. In one 2-week, multicenter, randomized, double-blind clinical trial in subjects 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. Statistically significant reductions in symptom scores were observed following the first 60 mg Aventis Allegra with the effect maintained throughout the 12-hour interval. A dose of 5 mL of ALLEGRA Oral Suspension containing 30 mg of fexofenadine hydrochloride is bioequivalent to a 30 mg dose of ALLEGRA tablets. The 60 mg twice daily dose did not provide any additional benefit over the 30 mg twice daily dose in pediatric subjects 6 to 11 years of age.