左乙拉西坦缓释片英文说明书

_______________________________________________________________________________________________________________________________________KEPPRAXRNDA022285/S-020FDAApprovedLabelingTextAug2014HIGHLIGHTSOFPRESCRIBINGINFORMATIONThesehighlightsdonotincludealltheinformationneededtouseKEPPRAXR®safelyandeffectively.SeefullprescribinginformationforKEPPRAXR.KEPPRAXR(levetiracetam)extended-releasetablets,fororaluseInitialU.S.Approval:1999----------------------------RECENTMAJORCHANGES-------------------------­IndicationsandUsage(1)[xx/2014]WarningsandPrecautions(5.1,5.3,5.7)[xx/2014]----------------------------INDICATIONSANDUSAGE--------------------------­KEPPRAXRisanantiepilepticdrugindicatedforadjunctivetherapyinthetreatmentofpartialonsetseizuresinpatients≥12yearsofagewithepilepsy(1)----------------------DOSAGEANDADMINISTRATION----------------------­KEPPRAXRisadministeredoncedaily;treatmentshouldbeinitiatedwithadoseof1000mgoncedaily;thedosagemaybeadjustedinincrementsof1000mgevery2weeks,toamaximumrecommendeddoseof3000mgoncedaily(2.1)KEPPRAXRdosingmustbeindividualizedaccordingtorenalfunctionstatus(2.2)---------------------DOSAGEFORMSANDSTRENGTHS---------------------­• 500mgwhite,film-coatedextended-releasetablet(3)• 750mgwhite,film-coatedextended-releasetablet(3)-------------------------------CONTRAINDICATIONS-----------------------------­• None(4)-----------------------WARNINGSANDPRECAUTIONS-----------------------­• PsychiatricReactions:Monitorpatientsforbehavioralabnormalitiesincludingpsychoticsymptoms,suicidalideation,irritability,andaggressivebehavior(5.1)• SuicidalBehaviorandIdeation:Monitorpatientsforneworworseningdepression,suicidalthoughts/behavior,and/orunusualchangesinmoodorbehavior(5.2)• SomnolenceandFatigue:MonitorpatientsforthesesymptomsandadvisepatientsnottodriveoroperatemachineryuntiltheyhavegainedsufficientexperienceonKEPPRAXR(5.3)• WithdrawalSeizures:KEPPRAXRmustbewithdrawngradually(5.6)------------------------------ADVERSEREACTIONS------------------------------­• Mostcommonadversereactions(incidenceinKEPPRAXR-treatedpatientsis≥5%morethaninplacebo-treatedpatients)includesomnolenceandirritability(6.1)ToreportSUSPECTEDADVERSEREACTIONS,contactUCB,Inc.at866-822-0068orFDAat1-800-FDA-1088or­• Pregnancy:Plasmalevelsoflevetiracetammaybedecreasedandthereforeneedtobemonitoredcloselyduringpregnancy.Basedonanimaldata,maycausefetalharm(5.8,8.1)See17forPATIENTCOUNSELINGINFORMATIONandMedicationGuideRevised:[08/2014]FULLPRESCRIBINGINFORMATION:CONTENTS*1INDICATIONSANDUSAGE2DOSAGEANDADMINISTRATION2.1GeneralDosingRecommendations2.2AdultPatientswithImpairedRenalFunction3DOSAGEFORMSANDSTRENGTHS4CONTRAINDICATIONS5WARNINGSANDPRECAUTIONS5.1 PsychiatricReactions5.2 SuicidalBehaviorandIdeation5.3 SomnolenceandFatigue5.4 SeriousDermatologicalReactions5.5 CoordinationDifficulties5.6 WithdrawalSeizures5.7 HematologicAbnormalities5.8 SeizureControlDuringPregnancy6 ADVERSEREACTIONS6.1 ClinicalTrialsExperience6.2 PostmarketingExperience7DRUGINTERACTIONS8USEINSPECIFICPOPULATIONS8.1 Pregnancy8.2 LaborandDelivery8.3 NursingMothers8.4 PediatricUse8.5 GeriatricUse8.6 UseinPatientswithImpairedRenalFunction10 OVERDOSAGE10.1Signs,SymptomsandLaboratoryFindingsofAcuteOverdosageinHumans10.2 ManagementofOverdose10.3 Hemodialysis11DESCRIPTION12CLINICALPHARMACOLOGY12.1MechanismofAction12.2Pharmacodynamics12.3Pharmacokinetics13 NONCLINICALTOXICOLOGY13.1Carcinogenesis,Mutagenesis,ImpairmentofFertility14 CLINICALSTUDIES14.1KEPPRAXRinAdults14.2Immediate-releaseKEPPRAinAdults14.3Immediate-releaseKEPPRAinPediatricPatients16 HOWSUPPLIED/STORAGEANDHANDLING16.1HowSupplied16.2Storage17 PATIENTCOUNSELINGINFORMATION*SectionsorsubsectionsomittedfromtheFullPrescribingInformationarenotlisted.ReferenceID:3605315KEPPRAXRNDA022285/S-020FDAApprovedLabelingTextAug20141INDICATIONSANDUSAGEKEPPRAXR®isindicatedasadjunctivetherapyinthetreatmentofpartialonsetseizuresinpatients≥12yearsofagewithepilepsy.2DOSAGEANDADMINISTRATION2.1GeneralDosingRecommendationsKEPPRAXRisadministeredoncedaily.Treatmentshouldbeinitiatedwithadoseof1000mgoncedaily.Theoncedailydosagemaybeadjustedinincrementsof1000mgevery2weekstoamaximumrecommendedoncedailydoseof3000mg.2.2AdultPatientswithImpairedRenalFunctionKEPPRAXRdosingmustbeindividualizedaccordingtothepatient'srenalfunctionstatus.RecommendeddosesandadjustmentfordoseforadultsareshowninTable1.Inordertocalculatethedoserecommendedforpatientswithrenalimpairment,creatinineclearanceadjustedforbodysurfaceareamustbecalculated.Todothis,anestimateofthepatient'screatinineclearance(CLcr)inmL/minmustfirstbecalculatedusingthefollowingformula:[140-age(years)]xweight(kg)(x0.85for-----------------------------------------femaleCLcr=72xserumcreatinine(mg/dL)patients)ThenCLcrisadjustedforbodysurfacearea(BSA)asfollows:CLcr(mL/min)CLcr(mL/min/1.73m2)=----------------------------x1.73BSAsubject(m2)Table1:DosingAdjustmentRegimenForAdultPatientsWithImpairedRenalFunctionGroupCreatinin