阿哌沙班片-美国说明书

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1、HIGHLIGHTSOFPRESCRIBINGINFORMATION------------------------DOSAGEANDADMINISTRATION---------------------Thesehighlightsdonotincludealltheinformationneededtouse•ReductioninriskofstrokeandsystemicembolisminnonvalvularatrialELIQUISsafelyandeffectively.Seefullprescribinginf

2、ormationforfibrillation:ELIQUIS.•Therecommendeddoseis5mgorallytwicedaily.(2.1)•Inpatientswithatleast2ofthefollowingcharacteristics:age≥80ELIQUIS(apixaban)tabletsfororaluseyears,bodyweight≤60kg,orserumcreatinine≥1.5mg/dL,theInitialU.S.Approval:2012recommendeddoseis2.5

3、mgorallytwicedaily.(2.2)•ProphylaxisofDVTfollowinghiporkneereplacementsurgery:WARNING:(A)PREMATUREDISCONTINUATIONOFELIQUIS•Therecommendeddoseis2.5mgorallytwicedaily.(2.1)INCREASESTHERISKOFTHROMBOTICEVENTS----------------------DOSAGEFORMSANDSTRENGTHS-------------------

4、-(B)SPINAL/EPIDURALHEMATOMA•Tablets:2.5mgand5mg(3)Seefullprescribinginformationforcompleteboxedwarning.------------------------------CONTRAINDICATIONS------------------------------(A)PREMATUREDISCONTINUATIONOFELIQUISINCREASESTHERISKOFTHROMBOTICEVENTS:Prematuredisconti

5、nuation•Activepathologicalbleeding(4)ofanyoralanticoagulant,includingELIQUIS,increasestheriskof•SeverehypersensitivitytoELIQUIS(4)thromboticevents.Toreducethisrisk,considercoveragewithanother------------------------WARNINGSANDPRECAUTIONS----------------------anticoagu

6、lantifELIQUISisdiscontinuedforareasonotherthan•ELIQUIScancauseserious,potentiallyfatalbleeding.Promptlyevaluatepathologicalbleedingorcompletionofacourseoftherapy.(2.5,5.1,signsandsymptomsofbloodloss.(5.2)14.1)•Prostheticheartvalves:ELIQUISusenotrecommended.(5.4)(B)SPI

7、NAL/EPIDURALHEMATOMA:ELIQUISuseinpatientsundergoingspinalepiduralanesthesiaorspinalpunctureincreasesthe-------------------------------ADVERSEREACTIONS-----------------------------riskofepiduralorspinalhematomawhichmaycauselong-termorMostcommonadversereactions(>1%)arer

8、elatedtobleeding.(6.1)permanentparalysis.Monitorpatientsfrequentlyforsignsandsymptomsofneurologicimpairmentandifobserved,tre