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Special Populations: Geriatric: In older subjects ( . 65 years old; n= 17) following multiple-dose administra-tion of CLARINEX Tablets, the mean Cmax and AUC values for desloratadine were 20% greater than in younger subjects (< 65 years old). The oral total body clearance (CL/ F) when normalized for body weight was similar between the two age groups. The mean plasma elimination half-life of desloratadine was 33.7 hr in subjects . 65 years old. The pharmacokinetics for 3-hydroxydesloratadine appeared unchanged in older versus younger subjects. These age-related differences are unlikely to be clinically relevant and no dosage adjustment is recom-mended in elderly subjects. Text Continues Below
Renally Impaired: Desloratadine pharmacokinetics following a single dose of 7.5 mg were characterized in patients with mild (n= 7; creatinine clearance 51-69 mL/ min/ 1.73 m 2 ), moderate (n= 6; creatinine clearance 34-43 mL/ min/ 1.73 m 2 ), and severe (n= 6; creatinine clearance 5-29 mL/ min/ 1.73 m 2 ) renal impairment or hemodialysis dependent (n= 6) patients. In patients with mild and moderate renal impairment, median Cmax and AUC values increased by approximately 1.2-and 1.9-fold, respectively, relative to subjects with normal renal function. In patients with severe renal impairment or who were hemodialysis dependent, Cmax and AUC values increased by approximately 1.7-and 2.5-fold, respectively. Minimal changes in 3-hydroxydesloratadine concentrations were observed. Desloratadine and 3-hydroxydesloratadine were poorly removed by hemo-dialysis. Plasma protein binding of desloratadine and 3-hydroxydesloratadine was unaltered by renal impairment. Dosage adjustment for patients with renal impairment is recommended (see DOSAGE AND ADMINISTRATION section). Hepatically Impaired: Desloratadine pharmacokinetics were characterized following a single oral dose in patients with mild (n= 4), moderate (n= 4), and severe (n= 4) hepatic impairment as defined by the Child-Pugh classification of hepatic function and 8 subjects with normal hepatic function. Page: << Prev | 1 | 2 | 3 | 4 | Next >>
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