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1、®ZOLOFT(sertralinehydrochloride)TabletsandOralConcentrateSuicidalityandAntidepressantDrugsAntidepressantsincreasedtheriskcomparedtoplaceboofsuicidalthinkingandbehavior(suicidality)inchildren,adolescents,andyoungadultsinshort-termstudiesofmajordepressivedisorder(MDD)andotherps
2、ychiatricdisorders.AnyoneconsideringtheuseofZoloftoranyotherantidepressantinachild,adolescent,oryoungadultmustbalancethisriskwiththeclinicalneed.Short-termstudiesdidnotshowanincreaseintheriskofsuicidalitywithantidepressantscomparedtoplaceboinadultsbeyondage24;therewasareducti
3、oninriskwithantidepressantscomparedtoplaceboinadultsaged65andolder.Depressionandcertainotherpsychiatricdisordersarethemselvesassociatedwithincreasesintheriskofsuicide.Patientsofallageswhoarestartedonantidepressanttherapyshouldbemonitoredappropriatelyandobservedcloselyforclini
4、calworsening,suicidality,orunusualchangesinbehavior.Familiesandcaregiversshouldbeadvisedoftheneedforcloseobservationandcommunicationwiththeprescriber.Zoloftisnotapprovedforuseinpediatricpatientsexceptforpatientswithobsessivecompulsivedisorder(OCD).(SeeWarnings:ClinicalWorseni
5、ngandSuicideRisk,Precautions:InformationforPatients,andPrecautions:PediatricUse)DESCRIPTION®ZOLOFT(sertralinehydrochloride)isaselectiveserotoninreuptakeinhibitor(SSRI)fororaladministration.Ithasamolecularweightof342.7.Sertralinehydrochloridehasthefollowingchemicalname:(1S-cis
6、)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenaminehydrochloride.TheempiricalformulaC17H17NCl2•HClisrepresentedbythefollowingstructuralformula:1NHCH3HClClClSertralinehydrochlorideisawhitecrystallinepowderthatisslightlysolubleinwaterandisopropylalcohol,andsp
7、aringlysolubleinethanol.ZOLOFTissuppliedfororaladministrationasscoredtabletscontainingsertralinehydrochlorideequivalentto25,50and100mgofsertralineandthefollowinginactiveingredients:dibasiccalciumphosphatedihydrate,D&CYellow#10aluminumlake(in25mgtablet),FD&CBlue#1aluminumlake(
8、in25mgtablet),FD&CRed#40aluminumlake(in25mgtablet),FD&CBlue#2aluminu
