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Because the absolute bioavailability of fexofenadine hydrochloride has not been established, it is unknown if the fecal component is unabsorbed drug or the result of biliary excretion. The pharmacokinetics of fexofenadine hydrochloride in seasonal allergic rhinitis patients were similar to those in healthy subjects. Peak fexofenadine plasma concentrations were similar between adolescent (12-16 years of age) and adult patients. Fexofenadine is 60% to 70% bound to plasma proteins, primarily albumin and 1-acid glycoprotein. Pseudoephedrine has been shown to have a mean elimination half-life of 4-6 hours which is dependent on urine pH. The elimination half-life is decreased at urine pH lower than 6 and may be increased at urine pH higher than 8. The bioavailability of fexofenadine hydrochloride and pseudoephedrine hydrochloride from ALLEGRA-D Extended-Release Tablets is similar to that achieved with separate administration of the components. Coadministration of fexofenadine and pseudoephedrine does not significantly affect the bioavailability of either component. Text Continues Below
Fexofenadine hydrochloride was rapidly absorbed following single-dose administration of the 60 mg fexofenadine hydrochloride/120 mg pseudoephedrine hydrochloride tablet with median time to mean maximum fexofenadine plasma concentration of 191 ng/mL occurring 2 hours postdose. Pseudoephedrine hydrochloride produced a mean single-dose pseudoephedrine peak plasma concentration of 206 ng/mL which occurred 6 hours postdose. Following multiple dosing to steady-state, a fexofenadine peak concentration of 255 ng/mL was observed 2 hours postdose. Following multiple dosing to steady-state, a pseudoephedrine peak concentration of 411 ng/mL was observed 5 hours postdose. Coadministration of ALLEGRA-D with a high-fat meal decreased fexofenadine plasma concentrations Cmax (-46%) and AUC (-42%). Time to maximum concentration (Tmax) was delayed by 50%. The rate or extent of pseudoephedrine absorption was not affected by food. It is recommended that the administration of ALLEGRA-D with food should be avoided. (See DOSAGE AND ADMINISTRATION). Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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