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Patients should be told that this product should be used in pregnancy or lactation only if the potential benefit justifies the potential risk to the fetus or nursing infant. Patients should be cautioned not to break or chew the tablet. Patients should be directed to swallow the tablet whole. Patients should be instructed not to take the tablet with food. Patients should also be instructed to store the medication in a tightly closed container in a cool, dry place, away from children. Drug Interactions Fexofenadine hydrochloride and pseudoephedrine hydrochloride do not influence the pharmacokinetics of each other when administered concomitantly. Text Continues Below
Fexofenadine has been shown to exhibit minimal (ca. 5%) metabolism. However, co-administration of fexofenadine with ketoconazole and erythromycin led to increased plasma levels of fexofenadine. Fexofenadine had no effect on the pharmacokinetics of erythromycin and ketoconazole. In two separate studies, fexofenadine HCl 120 mg BID (twice the recommended dose) was co-administered with erythromycin 500 mg every 8 hours or ketoconazole 400 mg once daily under steady-state conditions to normal, healthy volunteers (n=24, each study). No differences in adverse events or QTc interval were observed when subjects were administered fexofenadine HCl alone or in combination with erythromycin or ketoconazole. The findings of these studies are summarized in the following table. Effects on Steady-State Fexofenadine Pharmacokinetics After 7 Days of Co-Administration with Fexofenadine Hydrochloride 120 mg Every 12 Hours (twice recommended dose) in Normal Volunteers (n=24) Concomitant DrugCmax SS (Peak plasma concentration) AUCSS(0-12h) (Extent of systemic exposure)Erythromycin (500 mg every 8 hrs)+82%+109%Ketoconazole (400 mg once daily)+135%+164%The changes in plasma levels were within the range of plasma levels achieved in adequate and well-controlled clinical trials. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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