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1、HIGHLIGHTSOFPRESCRIBINGINFORMATION•HypomagnesemiahasbeenreportedrarelywithprolongedtreatmentwithPPIs(5.4)Thesehighlightsdonotincludealltheinformationneededtouse•AvoidconcomitantuseofNEXIUMwithStJohn’sWortorrifampinduetoNEXIUMI.V.safelyandeffectively.Seefullprescribinginformationfo
2、rthepotentialreductioninesomeprazolelevels(5.5)(7.2)NEXIUMI.V.•InteractionswithdiagnosticinvestigationsforNeuroendocrineTumors:NEXIUM®I.V.(esomeprazolesodium)forInjection,forintravenoususeIncreasesinintragastricpHmayresultinhypergastrinemiaandInitialU.S.Approval:2005enterochromaff
3、in-likecellhyperplasiaandincreasedchromograninAlevelswhichmayinterferewithdiagnosticinvestigationsforneuroendocrineRECENTMAJORCHANGEStumors.(5.6,12.2)DosageandAdministration,GERD,withEE(2.1)04/2011DosageandAdministration,PreparationsforUse(2.2)04/2011ADVERSEREACTIONSWarningsandPre
4、cautions,Hypomagnesemia(5.4)06/2011Mostcommonadversereactions(>1%):StJohn'sWortorRifampin(5.5)06/2011•Headache,flatulence,nausea,abdominalpain,injectionsitereaction,WarningsandPrecautions,InteractionswithInvestigationsfordiarrhea,drymouth,dizziness/vertigo,constipationandpruritus(
5、6.1)NeuroendocrineTumors(5.6)06/2011WarningsandPrecautions,ConcomitantuseofNEXIUMwithMethotrexateToreportSUSPECTEDADVERSEREACTIONS,contactAstraZeneca(5.7)01/2012at1-800-236-9933orFDAat1-800-FDA-1088orwww.fda.gov/medwatch.INDICATIONSANDUSAGEToreportSUSPECTEDADVERSEREACTIONS,contact
6、atorFDAatNEXIUMI.V.isaprotonpumpinhibitorindicatedforthetreatmentof1-800-FDA-1088orwww.fda.gov/medwatchGastroesophagealRefluxDisease(GERD)witherosiveesophagitis(EE)inadultsandpediatricpatientsgreaterthanonemonthofage,whenoraltherapyDRUGINTERACTIONSisnotpossibleorappropriate.(1.1)•
7、NEXIUMI.V.inhibitsgastricacidsecretionandmayinterferewiththeabsorptionofdrugswheregastricpHisanimportantdeterminantofDOSAGEANDADMINISTRATIONbioavailability(e.g.ketoconazole,ironsaltsanddigoxin).PatientstreatedGERD–withErosiveEsophagitiswithNEXIUManddigoxinmayneedtobemonitoredfordi
8、goxintoxicity.•Adults:Doseiseithe
