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Pathological Hypersecretory Conditions Including Zollinger-Ellis On Syndrome.

Nexium may also be given to prevent gastric ulcer caused by infection with Helicobacter pylori (H. pylori).or by the use of nonsteroidal anti-inflammatory drugs (NSAIDs).

Some conditions are treated with a combination of esomeprazole and antibiotics. Use all medications as directed.

Nexium (esomeprazole magnesium) is a proton pump inhibitor that decreases the amount of acid produced in the stomach.

allergic reactions dark urine chest or back pain acne changes in heart rhythm fever yellow coloration of the eyes or skin.known as jaundice extreme fatigue and muscle weakness unusual bleeding or bruising paresthesia.a tingling or prickly sensation persistent sore throat severe stomach pain muscle spasms and shaking diarrhea and watery stools seizures.

Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose. see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite.possibly leading to methotrexate toxicities. In high-dose methotrexate administration a temporary withdrawal of the PPI may be considered in some patients [see DRUG INTERACTIONS ].

NEXIUM For Delayed-Release Oral Suspension should be administered as follows.

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Get emergency medical help if you have any of these signs of an allergic reactionhivesdifficulty breathingswelling of your facelipstongueor throat.

Erosive Esophagitis Due To Acid-Mediated Gerd In Infants 1 Month To Less Than One Year of Age.

The capsule can be given through a nasogastricNGfeeding tubeRead and carefully follow any Instructions for Use provided with your medicineAsk your doctor or pharmacist if you do not understand these instructions.

NEXIUM is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulationHypersensitivity reactions may include anaphylaxisanaphylactic shockangioedemabronchospasmacute interstitial nephritisand urticariasee ADVERSE REACTIONS

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Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole magnesium in rats and rabbits with doses about 68 times and 42 timesrespectivelyan oral human dose of 40 mgbased on a body surface area basis for a 60 kg personHoweverchanges in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mgsee Animal DataBecause of the observed effect at high doses of esomeprazole magnesium on developing bone in rat studiesNEXIUM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The carcinogenic potential of NEXIUM was assessed using studies of omeprazoleof which esomeprazole is an enantiomerIn two 24-month oral carcinogenicity studies in ratsomeprazole at daily doses of 1.73.413.844and 140.8 mg/kg/dayabout 0.4 to 34 times the human dose of 40 mg/day expressed on a body surface area basisproduced gastric ECL cell carcinoids in a dose-related manner in both male and female ratsthe incidence of this effect was markedly higher in female ratswhich had higher blood levels of omeprazoleGastric carcinoids seldom occur in the untreated ratIn additionECL cell hyperplasia was present in all treated groups of both sexesIn one of these studiesfemale rats were treated with 13.8 mg omeprazole/kg/dayabout 3.4 times the human dose of 40 mg/day on a body surface area basisfor 1 yearthen followed for an additional year without the drugNo carcinoids were seen in these ratsAn increased incidence of treatment-related ECL cell hyperplasia was observed at the end of 1 year94treated vs10controlsBy the second year the difference between treated and control rats was much smaller46vs26but still showed more hyperplasia in the treated groupGastric adenocarcinoma was seen in one rat2No similar tumor was seen in male or female rats treated for 2 yearsFor this strain of rat no similar tumor has been noted historicallybut a finding involving only one tumor is difficult to interpretA 78-week mouse carcinogenicity study of omeprazole did not show increased tumor occurrencebut the study was not conclusive.

Hypersensitivity Reactionssee CONTRAINDICATIONSAcute Interstitial Nephritissee WARNINGS AND PRECAUTIONSClostridium difficile Associated Diarrheasee WARNINGS AND PRECAUTIONSBone Fracturesee WARNINGS AND PRECAUTIONSCutaneous and Systemic Lupus Erythematosussee WARNINGS AND PRECAUTIONSCyanocobalaminVitamin B-12Deficiencysee WARNINGS AND PRECAUTIONSHypomagnesemiasee WARNINGS AND PRECAUTIONSDrug Interactions Advise patients to let you know if they are takingor begin takingother medicationsbecause NEXIUM can interfere with antiretroviral drugs and drugs that are affected by gastric pH changessee DRUG INTERACTIONS

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Some conditions are treated with a combination of esomeprazole and antibioticsUse all medications as directed.

Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole magnesium in rats and rabbits with doses about 68 times and 42 timesrespectivelyan oral human dose of 40 mgbased on a body surface area basis for a 60 kg personHoweverchanges in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mgsee Animal DataBecause of the observed effect at high doses of esomeprazole magnesium on developing bone in rat studiesNEXIUM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The symptoms described in connection with deliberate NEXIUM overdoselimited experience of doses in excess of 240 mg/dayare transientSingle doses of 80 mg of esomeprazole were uneventfulReports of overdosage with omeprazole in humans may also be relevantDoses ranged up to 2,400 mg120 times the usual recommended clinical doseManifestations were variablebut included confusiondrowsinessblurred visiontachycardianauseadiaphoresisflushingheadachedry mouthand other adverse reactions similar to those seen in normal clinical experiencesee omeprazole package insertAdverse ReactionsNo specific antidote for esomeprazole is knownSince esomeprazole is extensively protein boundit is not expected to be removed by dialysisIn the event of overdosagetreatment should be symptomatic and supportive.

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