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021153s022lbl.pdf
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Summary

NEXIUM (esomeprazole magnesium) Delayed-Release Capsules contain the active ingredient bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole and inhibits gastric acid secretion. The empirical formula is (C17H18N3O3S)2Mg x 3 H2O with a molecular weight of 767.2. NEXIUM is supplied as Delayed-Release Capsules for oral administration, containing 20 mg or 40 mg of esomeprazole.

The pharmacokinetics of esomeprazole were studied in patients with symptomatic gastroesophageal reflux disease. Peak plasma levels occur at approximately 1.5 hours, and the Cmax increases proportionally with dose. The systemic bioavailability is approximately 90% at repeated once-daily dosing with 40 mg.

Esomeprazole is extensively metabolized in the liver by the cytochrome P450 enzyme system, primarily by CYP2C19, and to a lesser extent by CYP3A4. The plasma elimination half-life is approximately 1-1.5 hours, and less than 1% of the parent drug is excreted in the urine.

In special populations, the AUC and Cmax values were slightly higher in the elderly and females, but dosage adjustment based on age or gender is not necessary. In patients with mild to moderate hepatic insufficiency, no dosage adjustment is recommended, but in patients with severe hepatic insufficiency, a dose of 20 mg once daily should not be exceeded. The pharmacokinetics of esomeprazole in patients with renal impairment are not expected to be altered.

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NEXIUM (esomeprazole magnesium) Delayed-Release Capsules contain the active ingredient...

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