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1、CENTERFORDRUGEVALUATIONANDRESEARCHAPPLICATIONNUMBER:022271Orig1s000LABELINGHIGHLIGHTSOFPRESCRIBINGINFORMATION-----------------------WARNINGSANDPRECAUTIONS-------------------ThesehighlightsdonotincludealltheinformationneededtouseNESINAsafelyandeffectively.Seefullprescribinginformation
2、?Acutepancreatitis:TherehavebeenpostmarketingreportsofforNESINA.acutepancreatitis.Ifpancreatitisissuspected,promptlydiscontinueNESINA.(5.1)NESINA(alogliptin)tablets?Hypersensitivity:TherehavebeenpostmarketingreportsofInitialU.S.Approval:2013serioushypersensitivityreactionsinpatientst
3、reatedwithNESINAsuchasanaphylaxis,angioedemaandseverecutaneousadverse----------------------------INDICATIONSANDUSAGE----------------------------reactions.Insuchcases,promptlydiscontinueNESINA,assessNESINAisadipeptidylpeptidase-4(DPP-4)inhbitorindicatedasanforotherpotentialcauses,inst
4、ituteappropriatemonitoringandadjuncttodietandexercisetoimproveglycemiccontrolinadultswithtreatment,andinitiatealternativetreatmentfordiabetes.(5.2)type2diabetesmellitus.(1.1,14)?Hepaticeffects:Postmarketingreportsofhepaticfailure,sometimesfatal.Causalitycannotbeexcluded.Ifliverinjury
5、isLimitationofUse:Notfortreatmentoftype1diabetesordiabeticdetected,promptlyinterruptNESINAandassesspatientforketoacidosis.(1.2)probablecause,thentreatcauseifpossible,toresolutionorstabilization.DonotrestartNESINAifliverinjuryisconfirmed------------------------DOSAGEANDADMINISTRATION-
6、----------------------andnoalternativeetiologycanbefound.(5.3)?Therecommendeddoseinpatientswithnormalrenalfunctionor?Hypoglycemia:Whenaninsulinsecretagogue(e.g.sulfonylurea)mildrenalimpairmentis25mgoncedaily.(2.1)orinsulinisusedincombinationwithNESINA,alowerdoseofthe?Canbetakenwithor
7、withoutfood.(2.1)insulinsecretagogueorinsulinmayberequiredtominimizetheriskofhypoglycemia.(5.4)?Adjustdoseifmoderateorsevererenalimpairmentorend-stagerenaldisease(ESRD).(2.2)?Macrovascularoutcomes:Therehavebeennoclinicalstudiesestablishingconclusiveevidenceofmacrovascularriskreductio
8、nwithNESINAo
