阿格列汀FDA说明书(英文).pdf

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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