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Metabolism: Approximately 5% of the total oral dose was metabolized. Special Populations: Text Continues Below
Special population pharmacokinetics (for geriatric subjects, renal and hepatic impairment), obtained after a single dose of 80 mg fexofenadine hydrochloride, were compared to those for normal subjects from a separate study of similar design. While subject weights were relatively uniform between studies, these adult special population patients were substantially older than the healthy, young volunteers. Thus, an age effect may be confounding the pharmacokinetic differences observed in some of the special populations. Seasonal allergic rhinitis (SAR) and chronic idiopathic urticaria (CIU) patients. The pharmacokinetics of fexofenadine hydrochloride in seasonal allergic rhinitis and chronic idiopathic urticaria patients were similar to those in healthy subjects. Geriatric Subjects. In older subjects (>65 years old), peak plasma levels of fexofenadine were 99% greater than those observed in normal volunteers (<65 years old). Mean elimination half-lives were similar to those observed in normal volunteers. Pediatric Patients. Cross study comparisons indicated that fexofenadine hydrochloride area under the curve (AUC) following oral administration of a 60 mg dose to 7-12 year old pediatric allergic rhinitis patients was 56% greater compared to healthy adult subjects given the same dose. Plasma exposure in pediatric patients given 30 mg fexofenadine hydrochloride is comparable to adults given 60 mg. Renal Impairment. In patients with mild to moderate (creatinine clearance 41-80 mL/min) and severe (creatinine clearance 11-40 mL/min) renal impairment, peak plasma levels of fexofenadine were 87% and 111% greater, respectively, and mean elimination half-lives were 59% and 72% longer, respectively, than observed in normal volunteers. Peak plasma levels in patients on dialysis (creatinine clearance <10 mL/min) were 82% greater and half-life was 31% longer than observed in normal volunteers. Based on increases in bioavailability and half-life, a dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function. (See DOSAGE AND ADMINISTRATION). Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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