Nexium

[Esomeprazole]

Following administration of equimolar doses, the S-and R-isomers are metabolized differently by the liver, resulting in higher plasma levels of the S-than of the R-isomer.

Excretion

The plasma elimination half-life of esomeprazole is approximately 1Ð 1.5 hours. Less than 1% of parent drug is excreted in the urine. Approximately 80% of an oral dose of esomeprazole is excreted as inactive metabolites in the urine, and the remainder is found as inac-tive metabolites in the feces.

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Special Populations

Geriatric

The AUC and Cmax values were slightly higher (25% and 18%, respec-tively) in the elderly as compared to younger subjects at steady state. Dosage adjustment based on age is not necessary.

Pediatric

The pharmacokinetics of esomeprazole have not been studied in patients <18 years of age. Gender The AUC and Cmax values were slightly higher (13%) in females than in males at steady state. Dosage adjustment based on gender is not necessary.

Hepatic Insufficiency

The steady state pharmacokinetics of esomeprazole obtained after administration of 40 mg once daily to 4 patients each with mild (Child Pugh A), moderate (Child Pugh Class B), and severe (Child Pugh Class C) liver insufficiency were compared to those obtained in 36 male and female GERD patients with normal liver function. In patients with mild and moderate hepatic insufficiency, the AUCs were within the range that could be expected in patients with normal liver function.

In patients with severe hepatic insufficiency the AUCs were 2 to 3 times higher than in the patients with normal liver function. No dosage adjustment is recommended for patients with mild to moderate hepatic insufficiency (Child Pugh Classes A and B).

However, in patients with severe hepatic insufficiency (Child Pugh Class C) a dose of 20 mg once daily should not be exceeded (See DOSAGE AND ADMINISTRATION).

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