Prilosec Clinical Pharmacology

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Prilosec - Clinical Pharmacology [Omeprazole]

The pharmacokinetics of omeprazole have been investigated in pediatric patients of different ages. Pharmacokinetic Parameters of Omeprazole Following Single and Repeated Oral Administration in Pediatric Populations Compared to Adults Single or Repeated
Oral Dosing /Parameter
Children * < 20 kg

2-5 years 10 mg
Children * > 20 kg
6-16 years 20 mg
Adults * (mean 76 kg)
23-29 years (n= 12)
Single Dosing Cmax*
(ng/ mL) 288 (n= 10) 495 (n= 49) 668 AUC*
(ng h/ mL) 511 (n= 7) 1140 (n= 32) 1220 Repeated Dosing
Cmax* (ng/ mL) 539 (n= 4) 851 (n= 32) 1458
AUC* (ng h/ mL) 1179 (n= 2) 2276 (n= 23) 3352

Note: * = plasma concentration adjusted to an oral dose of 1 mg/ kg. *
Data from single and repeated dose studies * Data from a single and repeated dose study

Doses of 10, 20 and 40 mg Omeprazole as Enteric-Coated Granules
Following comparable mg/ kg doses of omeprazole, younger children (2-5 years) have lower AUCs than children 6 ? 16 years or adults; AUCs of the
latter two groups did not differ. (See DOSAGE AND ADMINISTRATION ? Pediatric Patients.)

Pharmacokinetics:

Combination Therapy with Antimicrobials

Omeprazole 40 mg daily was given in combination with clarithromycin 500 mg every 8 hours to healthy adult male subjects. The steady state plasma concentrations of omeprazole were increased (Cmax, AUC0-24, and T1/ 2 increases of 30%, 89% and 34% respectively) by the concomitant administration of clarithromycin. The observed increases in omeprazole plasma concentration were associated with the following pharmacological effects. The mean 24-hour gastric pH value was 5.2 when omeprazole was administered alone and 5.7 when co-administered with clarithromycin. The plasma levels of clarithromycin and 14-hydroxy-clarithromycin were increased by the concomitant administration of omeprazole.

For clarithromycin, the mean Cmax was 10% greater, the mean Cmin was 27% greater, and the mean AUC0-8 was 15% greater when clarithromycin was administered with omeprazole than when clarithromycin was administered alone. Similar results were seen for 14-hydroxy-clarithromycin, the mean Cmax was 45% greater, the mean Cmin was 57% greater, and the mean AUC0-8 was 45% greater. Clarithromycin concentrations in the gastric tissue and mucus were also increased by concomitant administration of omeprazole.