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Reproduction studies have been performed with esomeprazole magnesium in rats at oral doses up to 280 mg/kg/dayabout 68 times an oral human dose , . of 40 mg on a body surface area basisand in rabbits at oral doses up to 86 mg/kg/dayabout 41 times an oral human dose of 40 mg on a body surface area basisand have revealed no evidence of impaired fertility or harm to the fetus due to esomeprazole magnesium.

Please refer to amoxicillin and clarithromycin prescribing information for ContraindicationsWarningsand dosing in elderly and renally-impaired patients.

Please refer to amoxicillin and clarithromycin prescribing information for ContraindicationsWarningsand dosing in elderly and renally-impaired patients.

The following serious adverse reactions are described below and elsewhere in labeling:

In patients with mild to moderate liver impairmentChild Pugh Classes A and Bno dosage adjustment is necessaryFor patients with severe liver impairmentChild Pugh Class Ca dose of 20 mg of NEXIUM should not be exceededsee CLINICAL PHARMACOLOGY

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