富马酸福莫特罗吸入溶液说明书

HIGHLIGHTSOFPRESCRIBINGINFORMATIONDOSAGEFORMSANDSTRENGTHSThesehighlightsdonotincludealltheinformationneededtouseInhalationSolution(unitdosevialfornebulization);20mcg/2mLsolution(3)PERFOROMISTsafelyandeffectively.SeefullprescribinginformationforPERFOROMIST.CONTRAINDICATIONS•AllLABA,includingPERFOROMIST,arecontraindicatedinpatientswithThesehighlightsdonotincludealltheinformationneededtouseasthmawithoutuseofalong-termasthmacontrolmedication.(4)PERFOROMISTInhalationSolutionsafelyandeffectively.SeefullprescribinginformationforPERFOROMISTInhalationSolution.WARNINGSANDPRECAUTIONS•DonotinitiatePERFOROMISTInhalationSolutioninacutelydeterioratingpatients.(5.2)PERFOROMIST®(formoterolfumarate)InhalationSolution•Donotuseforreliefofacutesymptoms.Concomitantshort-actingbeta­InitialU.S.Approval:20012agonistscanbeusedasneededforacuterelief.(5.2)WARNING:ASTHMA-RELATEDDEATH•Donotexceedtherecommendeddose.ExcessiveuseofPERFOROMISTSeefullprescribinginformationforcompleteboxedwarningInhalationSolution,oruseinconjunctionwithothermedicationscontaininglong-actingbeta2-agonists,canresultinclinicallysignificantcardiovascular•Long-actingbeta2-adrenergicagonists(LABA)increasetheriskofeffects,andmaybefatal.(5.3,5.5)asthma-relateddeath.(5.1)•Life-threateningparadoxicalbronchospasmcanoccur.Discontinue•Aplacebo-controlledstudywithanotherlong-actingbeta2-adrenergicPERFOROMISTInhalationSolutionimmediately.(5.4)agonist(salmeterol)showedanincreaseinasthma-relateddeathsin•Usewithcautioninpatientswithcardiovascularorconvulsivedisorders,patientsreceivingsalmeterol.(5.1)thyrotoxicosis,orwithsensitivitytosympathomimeticdrugs.(5.6,5.7)•Thefindingofanincreasedriskofasthma-relateddeathwithADVERSEREACTIONSsalmeterolisconsideredaclasseffectofLABA,includingformoterol,Mostcommonadversereactions(>2%andmorecommonthanplacebo)theactiveingredientinPERFOROMIST.Thesafetyandefficacyofarediarrhea,nausea,nasopharyngitis,drymouth,vomiting,dizziness,andPERFOROMISTinpatientswithasthmahavenotbeenestablished.insomnia(6.2)AllLABA,includingPERFOROMIST,arecontraindicatedinpatientswithasthmawithoutuseofalong-termasthmacontrolmedication.(4,ToreportSUSPECTEDADVERSEREACTIONS,contactDeyPharma,5.1)L.P.at1-800-429-7751orFDAat1-800-FDA-1088orwww.fda.gov/INDICATIONSANDUSAGEmedwatch.PERFOROMISTInhalationSolutionisalong-actingbeta-adrenergicagonist2ToreportSUSPECTEDADVERSEREACTIONS,contactDeyPharma,(beta2-agonist)indicatedfor:LPatorFDAat1-800-FDA-1088orwww.fda.gov/medwatch•Long-term,twicedaily(morningandevening)administrationinthemaintenancetreatmentofbronchoconstrictioninpatientswithchronicDRUGINTERACTIONSobstructivepulmonarydisease(COPD),includingchronicbronchitisand•Otheradrenergicdrugsmaypotentiateeffect.Usewithcaution.(5.3,7.1)emphysema.(1.1)•Xanthinederivatives,steroids,diuretics,ornon-potassiumsparingdiureticsmaypotentiatehypokalemiaorECGchanges.Usewithcaution.(5.7,7.2,Importantlimitationsofuse:7.3)•PERFOROMISTInhalationSolutionisnotindicatedtotreatacute•MAOinhibitors,tricyclicantidepressantsanddrugsthatprolongQTcdeteriorationsofchronicobstructivepulmonarydisease.(1.2,5.2)intervalmaypotentiateeffectonthecardiovascularsystem.Usewith•PERFOROMISTInhalationSolutionisnotindicatedtotreatasthma.(1.2)extremecaution.(7.4)•Beta-blockersmaydecreaseeffectiveness.UsewithcautionandonlywhenDOSAGEANDADMINISTRATIONmedicallynecessary.(7.5)Fororalinhalationonly.•One20mcg/2mLvialevery12hours(2)See17forPATIENTCOUNSELINGINFORMATIONandtheFDA-•Forusewithastandardjetnebulizer(withafacemaskormouthpiece)approvedMedicationGuideconnectedtoanaircompressor(2)Revised:05/2010ReferenceID:3069227FULLPRESCRIBINGINFORMATION:CONTENTS*WARNING:ASTHMA-RELATEDDEATH7.3Non-potassiumSparingDiuretics1INDICATIONSANDUSAGE7.4MAOInhibitors,TricyclicAntidepressants,QTcProlongingDrugs1.1MaintenanceTreatmentofCOPD7.5Beta-blockers1.2ImportantLimitationsofUse8USEINSPECIFICPOPULATIONS2DOSAGEANDADMINISTRATION8.1Pregnancy3DOSAGEFORMSANDSTRENGTHS8.2LaborandDelivery4CONTRAINDICATIONS8.3NursingMothers5WARNINGSANDPRECAUTIONS8.4PediatricUse5.1Asthma-RelatedDeaths8.5GeriatricUse5.2DeteriorationofDiseaseandAcuteEpisodes10OVERDOSAGE5.3ExcessiveUseandUsewithOtherLong-ActingBeta2-Agonists11DESCRIPTION5.4ParadoxicalBronchospasm12CLINICALPHARMACOLOGY5.5CardiovascularEffects12.1MechanismofAction5.6CoexistingConditions12.2Pharmacodynamics5.7HypokalemiaandHyperglycemia12.3Pharmacokinetics5.8ImmediateHypersensitivityReactions13NONCLINICALTOXICOLOGY6ADVERSEREACTIONS13.1Carcinogenesis,Mutagenesis,ImpairmentofFertility6.1Beta2-AgonistAdverseReactionProfile13.2AnimalPharmacology6.2ClinicalTrialsExperience14CLINICALSTUDIES6.3PostmarketingExperience14.1AdultCOPDTrial7DRUGINTERACTIONS16HOWSUPPLIED/STORAGEANDHANDLING7.1AdrenergicDrugs17PATIENTCOUNSELINGINFORMATION7.2XanthineDerivatives,Steroids,orDiuretics*SectionsorsubsectionsomittedfromthefullprescribinginformationarenotlistedFULLPRESCRIBINGINFORMATIONWARNING:ASTHMA-RELATEDDEATHLong-actingbeta2-adrenergicagonists(LABA)increasetheriskofasthma-relateddeath.Datafromalargeplacebo-controlledUSstudythatcomparedthesafetyofanotherlong-actingbeta2-adrenergicagonist(salmeterol)orplaceboaddedtousualasthmatherapyshowedanincreaseinasthma-relateddeathsinpatientsreceivingsalmeterol.ThisfindingwithsalmeterolisconsideredaclasseffectofLABA,includingformoterol,theactiveingredientinPERFOROMISTInhalationSolution.ThesafetyandefficacyofPERFOROMISTinpatientswithasthmahavenotbeenestablished.AllLABA,includingPERFOROMIST,arecontraindicatedinpatientswithasthmawithoutuseofalong-termasthmacontrolmedication[seeCONTRAINDICATION(4),WARNINGSANDPRECAUTIONS(5.1)].1INDICATIONSANDUSAGE1.1MaintenanceTreatmentofCOPDPERFOROMIST(formoterolfumarate)InhalationSolutionisindicatedforthelong-term,twicedaily(morningandevening)administrationinthemaintenancetreatmentofbronchoconstrictioninpatientswithchronicobstructivepulmonarydisease(COPD),includingchronicbronchitisandemphysema.1.2ImportantLimitationsofUsePERFOROMISTInhalationSolutionisnotindicatedtotreatacutedeteriorationsofchronicobstructivepulmonarydisease[seeWARNINGSANDPRECAUTIONS(5.2)].PERFOROMISTInhalationSolutionisnotindicatedtotreatasthma.ThesafetyandeffectivenessofPERFOROMISTInhalationSolutioninasthmahavenotbeenestablished.2DOSAGEANDADMINISTRATIONTherecommendeddoseofPERFOROMIST(formoterolfumarate)InhalationSolutionisone20mcgunit-dosevialadministeredtwicedaily(morningandevening)bynebulization.Atotaldailydosegreaterthan40mcgisnotrecommended.PERFOROMISTInhalationSolutionshouldbeadministeredbytheorallyinhaledrouteviaastandardjetnebulizerconnectedtoanaircompressor.ThesafetyandefficacyofPERFOROMISTInhalationSolutionhavebeenestablishedinclinicaltrialswhenadministeredusingthePARI-LCPlus®nebulizer(withafacemaskormouthpiece)andthePRONEB®Ultracompressor.ThesafetyandefficacyofPERFOROMISTInhalationSolutiondeliveredfromnon-compressorbasednebulizersystemshavenotbeenestablished.PERFOROMISTInhalationSolutionshouldalwaysbestoredinthefoilpouch,andonlyremovedIMMEDIATELYBEFOREUSE.Contentsofanypartiallyusedcontainershouldbediscarded.ReferenceID:3069227page2of17Iftherecommendedmaintenancetreatmentregimenfailstoprovidetheusualresponse,medicaladviceshouldbesoughtimmediately,asthisisoftenasignofdestabilizationofCOPD.Underthesecircumstances,thetherapeuticregimenshouldbere-evaluatedandadditionaltherapeuticoptionsshouldbeconsidered.Thedrugcompatibility(physicalandchemical),efficacy,andsafetyofPERFOROMISTInhalationSolutionwhenmixedwithotherdrugsinanebulizerhavenotbeenestablished.3DOSAGEFORMSANDSTRENGTHSPERFOROMIST(formoterolfumarate)InhalationSolutionissuppliedasasterilesolutionfornebulizationinlow-densitypolyethyleneunit-dosevials.Eachvialcontainsformoterolfumaratedihydrate,USPequivalentto20mcg/2mLofformoterolfumarate.4CONTRAINDICATIONSAllLABA,includingPERFOROMIST,arecontraindicatedinpatientswithasthmawithoutuseofalong-termasthmacontrolmedication.[seeWARNINGSandPRECAUTIONS(5.1)].5WARNINGSANDPRECAUTIONS5.1Asthma-RelatedDeaths[SeeBOXEDWARNING]Datafromalargeplacebo-controlledstudyinasthmapatientsshowedthatlong-actingbeta2-adrenergicagonistsmayincreasetheriskofasthma-relateddeath.DataarenotavailabletodeterminewhethertherateofdeathinpatientswithCOPDisincreasedbylong-actingbeta2-adrenergicagonists.A28-week,placebo-controlledUSstudycomparingthesafetyofsalmeterolwithplacebo,eachaddedtousualasthmatherapy,showedanincreaseinasthma-relateddeathsinpatientsreceivingsalmeterol(13/13,176inpatientstreatedwithsalmeterolvs.3/13,179inpatientstreatedwithplacebo;RR4.37,95%CI1.25,15.34).Theincreasedriskofasthma-relateddeathisconsideredaclasseffectofthelong-actingbeta2-adrenergicagonists,includingPERFOROMISTInhalationSolution.NostudyadequatetodeterminewhethertherateofasthmarelateddeathisincreasedinpatientstreatedwithPERFOROMISTInhalationSolutionhasbeenconducted.ThesafetyandefficacyofPERFOROMISTinpatientswithasthmahavenotbeenestablished.AllLABA,includingPERFOROMIST,arecontraindicatedinpatientswithasthmawithoutuseofalong-termasthmacontrolmedication.[seeCONTRAINDICATIONS(4)].Clinicalstudieswithformoterolfumarateadministeredasadrypowderinhalersuggestedahigherincidenceofseriousasthmaexacerbationsinpatientswhoreceivedformoterolthaninthosewhoreceivedplacebo.Thesizesofthesestudieswerenotadequatetopreciselyquantifythedifferencesinseriousasthmaexacerbationratesbetweentreatmentgroups.5.2DeteriorationofDiseaseandAcuteEpisodesPERFOROMISTInhalationSolutionshouldnotbeinitiatedinpatientswithacutelydeterioratingCOPD,whichmaybealife-threateningcondition.PERFOROMISTInhalationSolutionhasnotbeenstudiedinpatientswithacutelydeterioratingCOPD.TheuseofPERFOROMISTInhalationSolutioninthissettingisinappropriate.PERFOROMISTInhalationSolutionshouldnotbeusedforthereliefofacutesymptoms,i.e.,asrescuetherapyforthetreatmentofacuteepisodesofbronchospasm.PERFOROMISTInhalationSolutionhasnotbeenstudiedinthereliefofacutesymptomsandextradosesshouldnotbeusedforthatpurpose.Acutesymptomsshouldbetreatedwithaninhaledshort-actingbeta2-agonist.WhenbeginningPERFOROMISTInhalationSolution,patientswhohavebeentakinginhaled,short-actingbeta2-agonistsonaregularbasis(e.g.,fourtimesaday)shouldbeinstructedtodiscontinuetheregularuseofthesedrugsandusethemonlyforsymptomaticreliefofacuterespiratorysymptoms.WhenprescribingPERFOROMISTInhalationSolution,thehealthcareprovidershouldalsoprescribeaninhaled,short-actingbeta2-agonistandinstructthepatienthowitshouldbeused.Increasinginhaledbeta2-agonistuseisasignalofdeterioratingdiseaseforwhichpromptmedicalattentionisindicated.COPDmaydeteriorateacutelyoveraperiodofhoursorchronicallyoverseveraldaysorlonger.IfPERFOROMISTInhalationSolutionnolongercontrolsthesymptomsofbronchoconstriction,orthepatient’sinhaled,short-actingbeta2-agonistbecomeslesseffectiveorthepatientneedsmoreinhalationofshort-actingbeta2-agonistthanusual,thesemaybemarkersofdeteriorationofdisease.Inthissetting,are-evaluationofthepatientandtheCOPDtreatmentregimenshouldbeundertakenatonce.IncreasingthedailydosageofPERFOROMISTInhalationSolutionbeyondtherecommended20mcgtwicedailydoseisnotappropriateinthissituation.5.3ExcessiveUseandUsewithOtherLong-ActingBeta2-AgonistsAswithotherinhaledbeta2-adrenergicdrugs,PERFOROMISTInhalationSolutionshouldnotbeusedmoreoften,athigherdosesthanrecommended,orinconjunctionwithothermedicationscontaininglong-actingbeta2-agonists,asanoverdosemayresult.Clinicallysignificantcardiovasculareffectsandfatalitieshavebeenreportedinassociationwithexcessiveuseofinhaledsympathomimeticdrugs.ReferenceID:3069227page3of175.4ParadoxicalBronchospasmAswithotherinhaledbeta2-agonists,PERFOROMISTInhalationSolutioncanproduceparadoxicalbronchospasmthatmaybelife-threatening.Ifparadoxicalbronchospasmoccurs,PERFOROMISTInhalationSolutionshouldbediscontinuedimmediatelyandalternativetherapyinstituted.5.5CardiovascularEffectsPERFOROMISTInhalationSolution,likeotherbeta2-agonists,canproduceaclinicallysignificantcardiovasculareffectinsomepatientsasmeasuredbyincreasesinpulserate,systolicand/ordiastolicbloodpressure,and/orsymptoms.Ifsucheffectsoccur,PERFOROMISTInhalationSolutionmayneedtobediscontinued.Inaddition,beta-agonistshavebeenreportedtoproduceECGchanges,suchasflatteningoftheTwave,prolongationoftheQTcinterval,andSTsegmentdepression.Theclinicalsignificanceofthesefindingsisunknown.Therefore,PERFOROMISTInhalationSolution,likeothersympathomimeticamines,shouldbeusedwithcautioninpatientswithcardiovasculardisorders,especiallycoronaryinsufficiency,cardiacarrhythmias,andhypertension.5.6CoexistingConditionsPERFOROMISTInhalationSolution,likeothersympathomimeticamines,shouldbeusedwithcautioninpatientswithconvulsivedisordersorthyrotoxicosis,andinpatientswhoareunusuallyresponsivetosympathomimeticamines.Dosesoftherelatedbeta2­agonistalbuterol,whenadministeredintravenously,havebeenreportedtoaggravatepreexistingdiabetesmellitusandketoacidosis.5.7HypokalemiaandHyperglycemiaBeta-agonistmedicationsmayproducesignificanthypokalemiainsomepatients,possiblythroughintracellularshunting,whichhasthepotentialtoproduceadversecardiovasculareffects[seeCLINICALPHARMACOLOGY(12.2)].Thedecreaseinserumpotassiumisusuallytransient,notrequiringsupplementation.Beta-agonistmedicationsmayproducetransienthyperglycemiainsomepatients.Clinicallysignificantchangesinserumpotassiumandbloodglucosewereinfrequentduringclinicalstudieswithlong-termadministrationofPERFOROMISTInhalationSolutionattherecommendeddose.5.8ImmediateHypersensitivityReactionsImmediatehypersensitivityreactionsmayoccurafteradministrationofPERFOROMISTInhalationSolution,asdemonstratedbycasesofanaphylacticreactions,urticaria,angiodema,rash,andbronchospasm.6ADVERSEREACTIONSLongactingbeta2-adrenergicagonistssuchasformoterolincreasetheriskofasthma-relateddeath[SeeBOXEDWARNINGandWARNINGSANDPRECAUTIONS(5.1)].6.1Beta2-AgonistAdverseReactionProfileAdversereactionstoPERFOROMISTInhalationSolutionareexpectedtobesimilarinnaturetootherbeta2-adrenergicreceptoragonistsincluding:angina,hypertensionorhypotension,tachycardia,arrhythmias,nervousness,headache,tremor,drymouth,musclecramps,palpitations,nausea,dizziness,fatigue,malaise,insomnia,hypokalemia,hyperglycemia,andmetabolicacidosis.6.2ClinicalTrialsExperienceBecauseclinicaltrialsareconductedunderwidelyvaryingconditions,adversereactionratesobservedintheclinicaltrialsofadrugcannotbedirectlycomparedtoratesintheclinicaltrialsofanotherdrugandmaynotreflecttheratesobservedinpractice.AdultswithCOPDThedatadescribedbelowreflectexposuretoPERFOROMISTInhalationSolution20mcgtwicedailybyoralinhalationin586patients,including232exposedfor6monthsand155exposedforatleast1year.PERFOROMISTInhalationSolutionwasstudiedina12-week,placebo-andactive-controlledtrial(123subjectstreatedwithPERFOROMISTInhalationSolution)anda52-week,active-controlledtrial(463subjectstreatedwithPERFOROMISTInhalationSolution).PatientsweremostlyCaucasians(88%)between40-90yearsold(mean,64yearsold)andhadCOPD,withameanFEV1of1.33L.Patientswithsignificantconcurrentcardiacandothermedicaldiseaseswereexcludedfromthetrials.Table1showsadversereactionsfromthe12-week,double-blind,placebo-controlledtrialwherethefrequencywasgreaterthanorequalto2%inthePERFOROMISTInhalationSolutiongroupandwheretherateinthePERFOROMISTInhalationSolutiongroupexceededtherateintheplacebogroup.Inthistrial,thefrequencyofpatientsexperiencingcardiovascularadverseeventswas4.1%forPERFOROMISTInhalationSolutionand4.4%forplacebo.TherewerenofrequentlyoccurringspecificcardiovascularadverseeventsforPERFOROMISTInhalationSolution(frequencygreaterthanorequalto1%andgreaterthanplacebo).TherateofCOPDexacerbationswas4.1%forPERFOROMISTInhalationSolutionand7.9%forplacebo.TABLE1Numberofpatientswithadversereactionsinthe12-weekmultiple-dosecontrolledclinicaltrialAdverseReactionPERFOROMISTPlaceboReferenceID:3069227page4of17InhalationSolution20mcgn(%)n(%)TotalPatients123(100)114(100)Diarrhea6(4.9)4(3.5)Nausea6(4.9)3(2.6)Nasopharyngitis4(3.3)2(1.8)DryMouth4(3.3)2(1.8)Vomiting3(2.4)2(1.8)Dizziness3(2.4)1(0.9)Insomnia3(2.4)00PatientstreatedwithPERFOROMISTInhalationSolution20mcgtwicedailyinthe52-weekopen-labeltrialdidnotexperienceanincreaseinspecificclinicallysignificantadverseeventsabovethenumberexpectedbasedonthemedicalconditionandageofthepatients.6.3PostmarketingExperienceThefollowingadversereactionshavebeenreportedduringpost-approvaluseofPERFOROMIST.Becausethesereactionsarereportedvoluntarilyfromapopulationofuncertainsize,itisnotalwayspossibletoreliablyestimatetheirfrequencyorestablishacausalrelationshiptodrugexposure.Anaphylacticreactions,urticaria,angioedema(presentingasface,lip,tongue,eye,pharyngeal,ormouthedema),rash,andbronchospasm.7DRUGINTERACTIONS7.1AdrenergicDrugsIfadditionaladrenergicdrugsaretobeadministeredbyanyroute,theyshouldbeusedwithcautionbecausethesympatheticeffectsofformoterolmaybepotentiated[seeWARNINGSANDPRECAUTIONS(5.3,5.5,5.6,5.7)].7.2XanthineDerivatives,Steroids,orDiureticsConcomitanttreatmentwithxanthinederivatives,steroids,ordiureticsmaypotentiateanyhypokalemiceffectofadrenergicagonists[seeWARNINGSANDPRECAUTIONS(5.7)].7.3Non-potassiumSparingDiureticsTheECGchangesand/orhypokalemiathatmayresultfromtheadministrationofnon-potassiumsparingdiuretics(suchaslooporthiazidediuretics)canbeacutelyworsenedbybeta-agonists,especiallywhentherecommendeddoseofthebeta-agonistisexceeded.Althoughtheclinicalsignificanceoftheseeffectsisnotknown,cautionisadvisedintheco-administrationofbeta-agonistswithnon-potassiumsparingdiuretics.7.4MAOInhibitors,TricyclicAntidepressants,QTcProlongingDrugsFormoterol,aswithotherbeta2-agonists,shouldbeadministeredwithextremecautiontopatientsbeingtreatedwithmonoamineoxidaseinhibitors,tricyclicantidepressants,ordrugsknowntoprolongtheQTcintervalbecausetheeffectofadrenergicagonistsonthecardiovascularsystemmaybepotentiatedbytheseagents.DrugsthatareknowntoprolongtheQTcintervalhaveanincreasedriskofventriculararrhythmias.7.5Beta-blockersBeta-adrenergicreceptorantagonists(beta-blockers)andformoterolmayinhibittheeffectofeachotherwhenadministeredconcurrently.Beta-blockersnotonlyblockthetherapeuticeffectsofbeta-agonists,butmayproduceseverebronchospasminCOPDpatients.Therefore,patientswithCOPDshouldnotnormallybetreatedwithbeta-blockers.However,undercertaincircumstances,e.g.,asprophylaxisaftermyocardialinfarction,theremaybenoacceptablealternativestotheuseofbeta-blockersinpatientswithCOPD.Inthissetting,cardioselectivebeta-blockerscouldbeconsidered,althoughtheyshouldbeadministeredwithcaution.ReferenceID:3069227page5of178USEINSPECIFICPOPULATIONS8.1PregnancyTeratogenicEffects:PregnancyCategoryCFormoterolfumarateadministeredthroughoutorganogenesisdidnotcausemalformationsinratsorrabbitsfollowingoraladministration.However,formoterolfumaratewasfoundtobeteratogenicinratsandrabbitsinothertestinglaboratories.Whengiventoratsthroughoutorganogenesis,oraldosesof0.2mg/kg(approximately40timesthemaximumrecommendeddailyinhalationdoseinhumansonamg/m2basis)andabovedelayedossificationofthefetus,anddosesof6mg/kg(approximately1200timesthemaximumrecommendeddailyinhalationdoseinhumansonamg/m2basis)andabovedecreasedfetalweight.Formoterolfumaratehasbeenshowntocausestillbirthandneonatalmortalityatoraldosesof6mg/kgandaboveinratsreceivingthedrugduringthelatestageofpregnancy.Theseeffects,however,werenotproducedatadoseof0.2mg/kg.Becausetherearenoadequateandwell-controlledstudiesinpregnantwomen,PERFOROMISTInhalationSolutionshouldbeusedduringpregnancyonlyifthepotentialbenefitjustifiesthepotentialrisktothefetus.WomenshouldbeadvisedtocontacttheirphysicianiftheybecomepregnantwhiletakingPERFOROMISTInhalationSolution.8.2LaborandDeliveryTherearenoadequateandwell-controlledhumanstudiesthathaveinvestigatedtheeffectsofPERFOROMISTInhalationSolutionduringlaboranddelivery.Becausebeta-agonistsmaypotentiallyinterferewithuterinecontractility,PERFOROMISTInhalationSolutionshouldbeusedduringlaboronlyifthepotentialbenefitjustifiesthepotentialrisk.8.3NursingMothersInreproductivestudiesinrats,formoterolwasexcretedinthemilk.Itisnotknownwhetherformoterolisexcretedinhumanmilk,butbecausemanydrugsareexcretedinhumanmilk,cautionshouldbeexercisedifPERFOROMISTInhalationSolutionisadministeredtonursingwomen.Therearenowell-controlledhumanstudiesoftheuseofPERFOROMISTInhalationSolutioninnursingmothers.Womenshouldbeadvisedtocontactt