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Omeprazole in the treatment of Zollinger-Ellison syndrome: a 4-year international study.
The relevance of these animal findings to humans has not been established.
Curtis Rosebraugh, MD, MPH, director, Office of Drug Evaluation II, Center for Drug Evaluation and Research, FDA.
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Only slight to moderate increases in Pantoprazole AUC (43%) and C max (26%) were found in elderly volunteers (64 to 76 years of age) after repeated oral administration, compared with younger subjects.
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Among 300 cases of drug induced liver disease in the US collected between 2004 and 2008, 2 were attributed to ranitidine, none to cimetidine or the proton pump inhibitors).
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2 More than 80 of uncomplicated UTIs are caused by uropathogenic Escherichia coli UPEC, 5 to 15 by Staphylococcus saprophyticus, and the remaining few cases by Enterococcus and Klebsiella species and Proteus mirabilis.
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If your doctor instructs you to use this medication regularly for a long time, laboratory and medical tests (such as a magnesium blood test, vitamin B-12 levels) may be performed periodically to monitor your progress or check for side effects.
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The use of cyclooxygenase-2 inhibitors has been shown to reduce the risk of ulcer hemorrhage, although only when not combined with aspirin therapy.
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Before oral drug administration additionally blood samples for blood chemistry, hematology and urine for urinalysis will be collected.
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The safety and efficacy of pantoprazole administration for the treatment of erosive esophagitis beyond 16-weeks has not been established.
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Pantoprazole is a proton pump inhibitor (PPI) and a potent inhibitor of gastric acidity which is widely used in the therapy of gastroesophageal reflux and peptic ulcer disease.
NEXIUM is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis.
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