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1、1HIGHLIGHTSOFPRESCRIBINGINFORMATION42•DrugInteractions:UsewithstrongcytochromeP4502Thesehighlightsdonotincludealltheinformationneeded43enzymeinducers(e.g.rifampicin,phenobarbital,3touseDALIRESPsafelyandeffectively.Seefull44carbamazepine,phenytoin)isnotrecomm
2、ended.(5.4)4prescribinginformationforDALIRESP.45546-----------------------------ADVERSEREACTIONS----------------------®6DALIRESP(roflumilast)tablets47Mostcommonadversereactions(≥2%)arediarrhea,weight7InitialU.S.Approval:20XX48decrease,nausea,headache,backpai
3、n,influenza,insomnia,849dizzinessanddecreasedappetite.(6.1)9------------------------INDICATIONSANDUSAGE----------------------5010DALIRESPisindicatedasatreatmenttoreducetheriskof51ToreportSUSPECTEDADVERSEREACTIONS,Contact11COPDexacerbationsinpatientswithsever
4、eCOPDassociated52ForestLaboratories,Inc.at1-800-678-1605orFDAat1-80012withchronicbronchitisandahistoryofexacerbations.(1,14)53FDA-1088orwww.fda.gov/medwatch.135414LimitationsofUse:DALIRESPisnotabronchodilatorandisnot55----------------------DRUGINTERACTIONS--
5、----------------------------15indicatedforthereliefofacutebronchospasm.(1,14)56•UsewithinhibitorsofCYP3A4ordualinhibitorsof1657CYP3A4andCYP1A2(e.g,erythromycin,ketoconazole,17----------------DOSAGEANDADMINISTRATION--------------------58fluvoxamine,enoxacin,c
6、imetidine)willincreaseroflumilast18TherecommendeddosageforpatientswithCOPDisone50059systemicexposureandmayresultinincreasedadverse19mcgtabletperday,withorwithoutfood.(2)60reactions.Theriskofsuchconcurrentuseshouldbe2061weighedcarefullyagainstbenefit.(7.2)21-
7、-----------------DOSAGEFORMSANDSTRENGTHS---------------6222Tablets:500mcg(3)63---------------------USEINSPECIFICPOPULATIONS----------------2364•NursingMothers:DALIRESPshouldnotbeusedby24----------------------CONTRAINDICATIONS----------------------------65wom
8、enwhoarenursingasexcretionofroflumilastand/or25•Moderatetosevereliverimpairment(Child-PughBorC)66itsmetabolitesintohumanmilkisprobableandthereare26(4)67nohumanstudiesthathaveinvestigatedeffectso
