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Information about Nexium.
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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