Prevacid

[Lansoprazole]

Elimination

Following single-dose oral administration of lansoprazole, virtually no unchanged lansoprazole was excreted in the urine. In one study, after a single oral dose of 14 C-lansoprazole, approximately one-third of the administered radiation was excreted in the urine and two-thirds was recovered in the feces. This implies a significant biliary excretion of the metabolites of lansoprazole.

Special Populations

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Geriatric

The clearance of lansoprazole is decreased in the elderly, with elimination half-life increased approximately 50% to 100%. Because the mean half-life in the elderly remains between 1. 9 to 2. 9 hours, repeated once daily dosing does not result in accumulation of lansoprazole. Peak plasma levels were not increased in the elderly. No dosage adjustment is necessary in the elderly.

Pediatric

The pharmacokinetics of lansoprazole were studied in pediatric patients with GERD aged 1 to 11 years, with lansoprazole doses of 15 mg q. d. for subjects weighing < 30 kg and 30 mg q. d. for subjects weighing > 30 kg. Lansoprazole pharmacokinetics in these pediatric patients were similar to that observed in healthy adult subjects. The mean Cmax and AUC values were similar between the two dose groups and were not affected by weight or age within each weight-adjusted dose group used in this study.

Gender

In a study comparing 12 male and 6 female human subjects, no gender differences were found in pharmacokinetics and intragastric pH results. (Also see Use in Women.)

Renal Insufficiency

In patients with severe renal insufficiency, plasma protein binding decreased by 1. 0%-1. 5% after administration of 60 mg of lansoprazole. Patients with renal insufficiency had a shortened elimination half-life and decreased total AUC (free and bound). AUC for free lansoprazole in plasma, however, was not related to the degree of renal impairment, and Cmax and Tmax were not different from subjects with healthy kidneys. No dosage adjustment is necessary in patients with renal insufficiency.

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