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Nexium
Clinical Pharmacology
Nexium
The pharmacokinetic parameters for clarithromycin and amoxicillin were similar during triple combination therapy and administration of each drug alone. However, the mean AUC and Cmax for 14-hydroxyclarithromycin increased by 19% and 22%, respectively, during triple combination therapy compared to treatment with clarithromycin alone. This increase in exposure to 14-hydroxyclarithromycin is not considered to be clinically significant.
Special Populations
Geriatric
The AUC and Cmax values were slightly higher (25% and 18%, respectively) in the elderly as compared to younger subjects at steady state. Dosage adjustment based on age is not necessary.
Pediatric
1 to 11 Years of Age
The pharmacokinetics of esomeprazole were studied in pediatric patients with GERD aged 1 to 11 years.
Following once daily dosing for 5 days, the total exposure (AUC) for the 10 mg dose in 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
| Parameter | 1 to 5 Year Olds | 6 to 11 Year Olds | |
| 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 | |||
12 to 17 Years of Age
The pharmacokinetics of esomeprazole were studied in 28 adolescent patients with GERD aged 12 to 17 years inclusive, in a single center study. Patients were randomized to receive esomeprazole 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, esomeprazole 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*
| Parameter | 12 to 17 Year Olds (N=28) | Adults (N=36) | ||
| 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 |
| t½lz (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. |
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Gender
Generic Name: Esomeprazole Magnesium
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