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) of fexofenadine by 21 and 20% respectively.
These studies indicate that ketoconazole or erythromycin co-administration enhances fexofenadine gastrointestinal absorption. Each tablet contains 30, 60, or 180 mg fexofenadine hydrochloride (depending on the dosage strength) and the following excipients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Although all 4 doses were significantly superior to placebo, symptom reduction was greater and efficacy was maintained over the entire 4-week treatment period with fexofenadine hydrochloride doses of 60 mg twice daily. ALLEGRA is formulated as a tablet for oral administration. Radiolabeled tissue distribution studies in rats indicated that fexofenadine does not cross the blood-brain barrier. Similar reductions were observed for mean number of wheals and mean pruritus score at the end of the 24-hour dosing interval. Administration of a 30 mg dose to pediatric Allegra D 12 Hour 2 to 11 years of age produced exposures comparable to those seen with a dose of 60 mg administered to adults. Human mass balance studies documented a recovery of approximately 80% and 11% of the [14C] fexofenadine hydrochloride dose in the feces and urine, respectively. 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. There were no significant differences in the effect of fexofenadine hydrochloride across subgroups of subjects defined by gender, age, and race. 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. Following single dose oral administrations of either the 60 and 180 mg tablet to healthy adult male Allegra And Price mean Cmax were 142 and Allegra And Price ng/mL, respectively. In laboratory animals, no anticholinergic or alpha1-adrenergic blocking effects Allegra And Price observed. Efficacy was demonstrated by a significant reduction in mean pruritus scores (MPS), mean number of wheals (MNW), and mean total symptom scores (MTSS, the sum of the MPS and MNW score). Fexofenadine hydrochloride was rapidly absorbed following oral administration of a single dose of two 60 mg capsules to healthy male subjects with a mean time to maximum plasma concentration occurring at 2.6 hours post-dose.