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1、奥思平(盐酸度洛西汀肠溶片)药品说明书（AusiPing(DuloxetineHydrochlorideEnteric-coatedTablets)druginstructions）DruginstructionsDrugnameDuloxetineHydrochlorideEnteric-coatedTabletsItemname:DuloxetineHydrochlorideEntericCapsuleChinesePinyin:YanSuanDuLuoXiDingChangRongJiaoNangDosageform,C
2、hinesePharmacopoeia,dosageform,capsuleThecontentofthisproductiswhiteorsmallwhitelikepellets.Themainingredientsofduloxetinehydrochloridechemicalname:(+)-(S)-N-methylgamma(1-naphthyloxygen)-2-thiophenepropanolaminehydrochloridemolecularformula:C18H19NOSmolecularweight
3、:333.88HCL.Indicationsforthetreatmentofdepression.Specifications20mg*20granuleTheadversereactionofMDDinthetreatmentofacutephaseoftheplacebo-controlledstudy,receivingduloxetinetreatedpatients,theadversereactionratewashigherthan2%andhigherthanintheplacebogroup.Oneofth
4、emostcommonadversereactions(incidenceoflessthan5%,whichisatleasttwotimeshigherthantheplacebogrouptheincidenceof)includingnausea,drymouthandconstipation,lossofappetite,fatigue,lethargy,increasedsweating(pleaseconsultaspecialist)-theurgencyofduloxetineisknowntoinfluen
5、cethedrugresistanceofurethra.Iftheuseofduloxetineinthecourseofthetreatmentofurinaryurgency,shouldconsiderthepossibilityofdrug-induced.Laboratorychanges-9weeksMDDor13weeksDPNPplacebo-controlledstudy,comparedwithbaseline,afterduloxetinetreatment,ALT,AST,CPKandalkaline
6、phosphatase(vinegar)enzymeincreasedslightly.Comparedwiththeplacebogroup,theseabnormalitiesoccurredinpatientstreatedwithduloxetineasepisodic,intermediate,andtransientabnormalities(seenote).Changesofvitalsignsin9weeksMDDplacebo-controlledstudy,duloxetinedoseof40-120mg
7、/day,leadstoincreasedbloodpressure,comparedwithplacebo,theaveragesystolicbloodpressureincreaseddiastolicbloodpressureincreasedbyanaverageof2mrnHg,0.5mmHg,systolicbloodpressureincreasedincidenceofmorethan140mmHg.Inthe9weekMDDand13weekDPNcadavericplacebo-controlledstu
8、dy,duloxetineresultedinamildincreaseinheartrate,withanincreaseofabout2/minutecomparedwithplacebo.Dosage1.initialtreatment.Thestartingdoseo
