n patients aged 6 to 11 years was similar to that seen with the 20 mg dose in adults and adolescents aged 12 to 17 years. The total exposure for the 10 mg dose in patients aged 1 to 5 years was approximately 30% higher than the 10 mg dose in patients aged 6 to 11 years. The total exposure for the 20 mg dose in patients aged 6 to 11 years was higher than that observed with the 20 mg dose in 12 to 17 year-olds and adults, but lower than that observed with the 40 mg dose in 12 to 17 year-olds and adults.
Table 5
Summary of PK Parameters in 1 to 11 Year Olds with GERD Following 5 Days of Once-Daily Oral Esomeprazole Treatment *
Geometric mean;
†
arithmetic mean
1 to 5 Year Olds
6 to 11 Year Olds
Parameter
10 mg (N=8)
10 mg (N=7)
20 mg (N=6)
AUC (μmol*h/L)*
4.83
3.70
6.28
Cmax (μmol/L)*
2.98
1.77
3.73
tmax (h)†
1.44
1.79
1.75
t½λz (h)*
0.74
0.88
0.73
Cl/F (L/h)*
5.99
7.84
9.22
Geometric mean;
†
arithmetic mean
1 to 5 Year Olds
6 to 11 Year Olds
Parameter
10 mg (N=8)
10 mg (N=7)
20 mg (N=6)
AUC (μmol*h/L)*
4.83
3.70
6.28
Cmax (μmol/L)*
2.98
1.77
3.73
tmax (h)†
1.44
1.79
1.75
t½λz (h)*
0.74
0.88
0.73
Cl/F (L/h)*
5.99
7.84
9.22
12 to 17 Years of Age
The pharmacokinetics of NEXIUM were studied in 28 adolescent patients with GERD aged 12 to 17 years inclusive, in a single center study. Patients were randomized to receive NEXIUM 20 mg or 40 mg once daily for 8 days. Mean Cmax and AUC values of esomeprazole were not affected by body weight or age; and more than dose-proportional increases in mean Cmax and AUC values were observed between the two dose groups in the study. Overall, NEXIUM pharmacokinetics in adolescent patients aged 12 to 17 years were similar to those observed in adult patients with symptomatic GERD.
Table 6
Comparison of PK Parameters in 12 to 17 Year Olds with GERD and Adults with Symptomatic GERD Following the Repeated Daily Oral Dose Administration of Esomeprazole* *
Duration of treatment for 12 to 17 year olds and adults were 8 days and 5 days, respectively. Data were obtained from two independent studies.
12 to 17 Year Olds (N=28)
Adults (N=36)
Parameter
20 mg
40 mg
20 mg
40 mg
AUC (μmol*h/L)
3.65
13.86
4.2
12.6
Cmax (μmol/L)
1.45
5.13
2.1
4.7
tmax (h)
2.00
1.75
1.6
1.6
t½λz (h)
0.82
1.22
1.2
1.5
Data presented are geometric means for AUC, Cmax and t½λz, and median value for tmax.
Duration of treatment for 12 to 17 year olds and adults were 8 days and 5 days, respectively. Data were obtained from two independent studies.
12 to 17 Year Olds (N=28)
Adults (N=36)
