欧兰宁奥氮平片说明书

本文格式为Word版，下载可任意编辑——欧兰宁奥氮平片说明书1•EfficacywasestablishedwithSymbyax(olanzapineandHIGHLIGHTSOFPRESCRIBINGINATIONfluoxetineincombination)inadults;refertotheproductlabelThesehighlightsdonotincludealltheinationneededtouseforSymbyax.ZYPREXAsafelyandeffectively.SeefullprescribinginationforZYPREXA.DOSAGEANDADMINISTRATIONZYPREXA(olanzapine)TabletforOraluseZYPREXAZYDIS(olanzapine)Tablet,OrallyDisintegratingforOraluseZYPREXAIntraMuscular(olanzapine)Injection,Powder,ForSolutionforIntramuscularuseInitialU.S.Approval:1996WARNING:INCREASEDMORTALITYINELDERLYPATIENTSWITHDEMENTIA-RELATEDPSYCHOSISSeefullprescribinginationforcompleteboxedwarning.•Elderlypatientswithdementia-relatedpsychosistreatedwithantipsychoticdrugsareatanincreasedriskofdeath.ZYPREXAisnotapprovedforthetreatmentofpatientswithdementia-relatedpsychosis.(5.1,5.12,17.2)WhenusingZYPREXAandfluoxetineincombination,alsorefertotheBoxedWarningsectionofthepackageinsertforSymbyax.RECENTMAJORCHANGESWarningsandPrecautions:MetabolicChanges(5.4)12/2022OrthostaticHypotension(5.6)MM/YYYYHyperprolactinemia(5.13)12/2022INDICATIONSANDUSAGEZYPREXA®(olanzapine)isanatypicalantipsychoticindicated:Asoralulationforthe:•Treatmentofschizophrenia.(1.1)•Adults:Efficacywasestablishedinthreeclinicaltrialsinpatientswithschizophrenia:two6-weektrialsandonemaintenancetrial.(14.1)•Adolescents(ages13-17):Efficacywasestablishedinone6­weektrialinpatientswithschizophrenia(14.1).Theincreasedpotential(inadolescentscomparedwithadults)forweightgainanddyslipidemiamayleadclinicianstoconsiderprescribingotherdrugsfirstinadolescents.(1.1)•AcutetreatmentofmanicormixedepisodesassociatedwithbipolarIdisorderandmaintenancetreatmentofbipolarIdisorder.(1.2)•Adults:EfficacywasestablishedinthreeclinicaltrialsinpatientswithmanicormixedepisodesofbipolarIdisorder:two3-to4-weektrialsandonemaintenancetrial.(14.2)•Adolescents(ages13-17):Efficacywasestablishedinone3­weektrialinpatientswithmanicormixedepisodesassociatedwithbipolarIdisorder(14.2).Theincreasedpotential(inadolescentscomparedwithadults)forweightgainanddyslipidemiamayleadclinicianstoconsiderprescribingotherdrugsfirstinadolescents.(1.2)•MedicationtherapyforpediatricpatientswithschizophreniaorbipolarIdisordershouldbeundertakenonlyafterathoroughdiagnosticuationandwithcarefulconsiderationofthepotentialrisks.(1.3)•AdjuncttovalproateorlithiuminthetreatmentofmanicormixedepisodesassociatedwithbipolarIdisorder.(1.2)•Efficacywasestablishedintwo6-weekclinicaltrialsinadults(14.2).Maintenanceefficacyhasnotbeensystematicallyuated.AsZYPREXAIntraMuscularforthe:•TreatmentofacuteagitationassociatedwithschizophreniaandbipolarImania.(1.4)•Efficacywasestablishedinthree1-daytrialsinadults.(14.3)AsZYPREXAandFluoxetineinCombinationforthe:•TreatmentofdepressiveepisodesassociatedwithbipolarIdisorder.(1.5)•EfficacywasestablishedwithSymbyax(olanzapineandfluoxetineincombination);refertotheproductlabelforSymbyax.•Treatmentoftreatmentresistantdepression.(1.6)Schizophreniainadults(2.1)Oral:Startat5-10mgoncedaily;Target:10mg/daywithinseveraldaysSchizophreniainadolescents(2.1)Oral:Startat2.5-5mgoncedaily;Target:10mg/dayBipolarIDisorder(manicormixedepisodes)inadults(2.2)Oral:Startat10or15mgoncedailyBipolarIDisorder(manicormixedepisodes)inadolescents(2.2)Oral:Startat2.5-5mgoncedaily;Target:10mg/dayBipolarIDisorder(manicormixedepisodes)withlithiumorvalproateinadults(2.2)Oral:Startat10mgoncedailyAgitationassociatedwithSchizophreniaandBipolarIManiainadults(2.4)IM:10mg(5mgor7.5mgwhenclinicallywarranted)Assessfororthostatichypotensionpriortosubsequentdosing(max.3doses2-4hrsapart)DepressiveEpisodesassociatedwithBipolarIDisorderinadults(2.5)Oralincombinationwithfluoxetine:Startat5mgoforalolanzapineand20mgoffluoxetineoncedailyDepressiveEpisodesassociatedwithBipolarIDisorderinchildrenandadolescents(2.5)Oralincombinationwithfluoxetine:Startat2.5mgoforalolanzapineand20mgoffluoxetineoncedailyTreatmentResistantDepressioninadults(2.6)Oralincombina