Improvement was demonstrated within 1 day of treatment with fexofenadine hydrochloride 180 mg and was maintained over the entire 4- week treatment period. These studies indicate that ketoconazole or erythromycin co-administration enhances fexofenadine gastrointestinal absorption. Statistically significant reductions in symptom scores were observed following the first 60 mg dose, with the effect maintained throughout the 12-hour interval. It is freely soluble in methanol and ethanol, slightly soluble in chloroform and water, and insoluble in hexane. 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). ALLEGRA is formulated as a tablet for oral administration. ALLEGRA Oral Suspension, a white uniform suspension, contains 6 mg fexofenadine hydrochloride per mL and the following excipients: propylene glycol, edetate disodium, propylparaben, butylparaben, xanthan gum, poloxamer 407, titanium dioxide, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, artificial raspberry cream flavor, sucrose, xylitol and purified water.
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. 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). This observed increase in the bioavailability of fexofenadine may be due to transport-related effects, such as p-glycoprotein. Both enantiomers of fexofenadine hydrochloride displayed approximately equipotent antihistaminic effects.
Allegra D Price in renally and hepatically impaired subjects Allegra D Price geriatric subjects, obtained after a single dose of 80 mg fexofenadine hydrochloride, were compared to those from healthy Allegra D Price 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. Because the absolute bioavailability of fexofenadine hydrochloride has not been established, it is unknown if the fecal component represents primarily unabsorbed drug or the result of biliary excretion.
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. 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. Fexofenadine hydrochloride, the major active metabolite of terfenadine, is an antihistamine with selective peripheral H1-receptor antagonist activity.