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Elimination Based on the results of the aforementioned radio labeled study, following a single oral dose of pimecrolimus ~81% of the administered radio activity was recovered, primarily in the feces (78.4%) as metabolites. Less than 1% of the radioactivity found in the feces was due to unchanged pimecrolimus. Special Populations Text Continues Below
Pediatrics The systemic exposure to pimecrolimus from Elidel ® (pimecrolimus) Cream 1% was investigated in 26 pediatric patients with atopic dermatitis (20%-69% BSA involvement) between the ages of 2-14 yrs. Following twice daily application for three weeks, blood concentrations of pimecrolimus were consistently low (< 3 ng/mL), with the majority of the blood samples being below the limit of quantification (0.5 ng/mL). However, the children (20 children out of the total 23 children investigated) had at least one detectable blood level as compared to the adults (13 adults out of the total 25 adults investigated) over a 3-week treatment period. Due to the low and erratic nature of the blood levels observed, no correlation could be made between amount of cream, degree of BSA involvement, and blood concentrations. In general, the blood concentrations measured in adult atopic dermatitis patients were comparable to those seen in the pediatric population. In a second group of 22 pediatric patients aged 3- 23 months with 10%-92% BSA involvement, a higher proportion of detectable blood levels was seen ranging from 0.1 ng/mL to 2.6 ng/mL (limit of quantification 0.1 ng/mL). This increase in the absolute number of positive blood levels may be due to the larger surface area to body mass ratio seen in these younger subjects. In addition, a higher incidence of upper respiratory symptoms/infections was also seen relative to the older age group in the PK studies. At this time a causal relationship between these findings and Elidel us e cannot be ruled out. Use of Elidel in this population is not recommended (see Pediatric Use). Page: << Prev | 1 | 2 | 3 | 4 | Next >>
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