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The effect of NEXIUM on intragastric pH was determined in patients with symptomatic gastroesophageal reflux disease in two separate studiesIn the first study of 36 patientsNEXIUM 40 mg and 20 mg capsules were administered over 5 daysThe results are shown in the Table 3:

Effects on maternal bone were observed in pregnant and lactating rats in a preand postnatal toxicity study when esomeprazole magnesium was administered at oral doses of 14 to 280 mg/kg/dayabout 3.4 to 68 times an oral human dose of 40 mg on a body surface area basisWhen rats were dosed from gestational day 7 through weaning on postnatal day 21a statistically significant decrease in maternal femur weight of up to 14as compared to placebo treatmentwas observed at doses equal to or greater than 138 mg/kg/dayabout 34 times an oral human dose of 40 mg on a body surface area basis

The safety and effectiveness of NEXIUM in neonates have not been established.

The effect of NEXIUM on intragastric pH was determined in patients with symptomatic gastroesophageal reflux disease in two separate studiesIn the first study of 36 patientsNEXIUM 40 mg and 20 mg capsules were administered over 5 daysThe results are shown in the Table 3:

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

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Esomeprazole was negative in the Ames mutation testin the in vivo rat bone marrow cell chromosome aberration testand the in vivo mouse micronucleus testEsomeprazolehoweverwas positive in the in vitro human lymphocyte chromosome aberration testOmeprazole was positive in the in vitro human lymphocyte chromosome aberration testthe in vivo mouse bone marrow cell chromosome aberration testand the in vivo mouse micronucleus test.

A population-based retrospective cohort study covering all live births in Denmark from 1996-2009reported on 1,800 live births whose mothers used omeprazole during the first trimester of pregnancy and 837,317 live births whose mothers did not use any proton pump inhibitorThe overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole was 2.9and 2.6in infants born to mothers not exposed to any proton pump inhibitor during the first trimester.

You may be more likely to have a broken bone while taking this medicine long term or more than once per day.

Tell your doctor about all your current medicinesMany drugs can affect esomeprazoleespecially:

Each packet of NEXIUM For Delayed-Release Oral Suspension contains 2.5 mg5 mg10 mg20 mgor 40 mg of esomeprazolein the form of the same enteric-coated granules used in NEXIUM DelayedRelease Capsulesand also inactive granulesThe inactive granules are composed of the following ingredientsdextrosexanthan gumcrospovidonecitric acidiron oxideand hydroxypropyl celluloseThe esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oralnasogastricor gastric administration.

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if you are taking the delayed-release tablets, you should also tell your doctor if you are taking an h 2 blocker such as cimetidine, famotidine pepcid , nizatidine axid , and ranitidine zantac or a proton pump inhibitor such as esomeprazole nexium, in vimovo , lansoprazole prevacid , omeprazole prilosec, zegerid , pantoprazole protonix , and rabeprazole aciphex .

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