奥普力农注射液药品说明书(英文)

EisaiCo.,Ltd.1Revised:July2008(7thversion)StandardCommodityClassificationNo.ofJapan872119-Agentforacuteheartfailure-CoretecInjection5mgOlprinonehydrochloridehydratepreparationDesignateddrugandPrescriptiondrugCaution:Useonlyasdirectedbyaphysician.CONTRAINDICATIONS(CORETECiscontraindicatedinthefollowingpatients.)1.Patientswithhypertrophicobstructivecardiomyopathy[CORETECmayaggravateoutflowtractstenosisoftheleftventricle.]2.Pregnantwomenorwomensuspectedofbeingpregnant[See“UseduringPregnancy,DeliveryorLactation”sec-tion.]DESCRIPTIONCORETECInjectionisacolorless,clearinjectioncontainingthefollowingingredients,andcontainedincolorlessampules(one-point-cuttype).ComponentContentperampule(5mL)ActiveingredientOlprinonehydro-chloridehydrate5mgCitricacidhydrate2.1mgSodiumhydroxideq.s.InactiveingredientsD-Sorbitol250mgDescriptionCORETECInjectionisacolorless,clearliquid.pH3.0-5.0Osmoticpressureratioabout1(ratiorelativetoisotonicsodiumchlo-ridesolution)INDICATIONSThefollowingconditionwhentheeffectofotherdrugsisinsufficient:AcuteheartfailureDOSAGEANDADMINISTRATIONUsuallyforadults,CORETECInjectionisundilutedordilutedwithisotonicsodiumchloridesolution,glucoseinjectionorotherdiluent,andadministeredintravenouslyatadoseof10µg/kgofolprinonehydrochloridehydrate,graduallyover5min,andthendrip-infusedintravenouslyatarateof0.1-0.3µg/kg/min.Thedosagefordripinfusionshouldbevariedac-cordingtothepatient’sconditionand,ifnecessary,maybein-creasedupto0.4µg/kg/min.PRECAUTIONS1.CarefulAdministration(CORETECshouldbeadminis-teredwithcareinthefollowingpatients.)(1)Patientswithserioustachyarrhythmia[SinceCORETEChasapositivechronotropicactionandtriggersthebaroreceptorreflexduetoitsvasodila-tiveactions,arrythmiamaybeaggravated.](2)Patientswithseriouscoronaryarterialdisease[SinceCORETEChasapositiveinotropicaction,coronaryarterialdiseasemaybeaggravated.](3)Patientswithrenalfunctiondisorders[Theeliminationhalf-lifeofCORETECmaybepro-longedduetoimpairedrenalfunction.Renalfunctionmayalsobeimpaired.](4)Patientswithseverehypotension[SinceCORETEChasavasodilativeaction,itmayfurtherdecreasebloodpressure.](5)Elderlypatients[See“UseintheElderly”section.]2.ImportantPrecautions(1)TheuseofCORETECshouldbeconsideredwhentheeffectsofotherdrugsareinsufficient.(2)PriortotheuseofCORETEC,measures,suchascor-rectionofdecreasedbodyfluidsandelectrolytes,orrespirationcontrol,shouldbetakenasnecessary.(3)CORETECshouldbeadministeredwhilemonitoringthepatient’scondition,suchasbloodpressure,heartrate,ECG,urinevolume,bodyfluidsandelectrolytes,and,wherepossible,pulmonarycapillarywedgepres-sure,cardiacoutputandbloodgas.(4)Ifthereisnoimprovementwithin120minofinitiatingtreatmentwithCORETEC,treatmentshouldbediscon-tinuedandappropriatemeasurestaken.StorageCORETECshouldbestoredatroomtemperature.ExpirationdateCORETECshouldbeusedbeforetheexpirationdateindicatedonthepackageorlabel.ApprovalNo.8AM-77DateoflistingintheNHIreimbursementpriceApr1996DateofinitialmarketinginJapanApr1996DateoflatestreexaminationJun2008InternationalbirthdateJan19962EisaiCo.,Ltd.(5)Althoughtherehasnotbeenmuchexperienceinad-ministeringCORETECforalongterm,theincidenceofadversereactionstendstoincreasewhenthedurationofadministrationexceeds3hr.Therefore,cautionshouldbeexercisedwhenadministeringitformorethan3hr.(see“ClinicalStudies”section.)(6)Whenclinicalsymptomshaveimprovedandthepa-tient’sconditionhasstabilized(thepatienthaspassedthroughtheacutephaseofthecondition)afteradmini-strationofCORETEC,itshouldbechangedforothertherapies.AcumulativedailydoseofCORETECshouldnotexceeded0.6mg/kg(equivalentto24hrofadministrationatarateof0.4µg/kg/min).(7)AnexcessiveincreaseinheartrateordecreaseinbloodpressureduringthecourseoftreatmentwithCORE-TECcouldmeanoverdosage.Ifsuchmarkedchangesoccur,appropriatemeasures,suchasreductionindos-ageordiscontinuationofthemedication,shouldbetaken.(8)CORETECmaynotimprovetheconditionofpatientswithsevereaorticstenosis,mitralstenosis,etc.(9)Theeliminationhalf-lifeofCORETECisexpectedtobeprolongedinpatientswithrenalfunctiondisorders.Therefore,itshouldbeadministeredwithcautiontosuchpatients,monitoringthepatient’scondition,suchasbloodpressure,heartrate,ECG,urinevolume,bodyfluidsandelectrolytes,and,wherepossible,pulmonarycapillarywedgepressure,cardiacoutputandbloodgas.Theintravenousdripinfusionshouldbestartedatarateof0.1µg/kg/mintoavoidoverdosage.(10)Cautionshouldbeexercisedthatpatientsreceivingdiu-reticsathighdosesmaynotrespondwelltoCORETEC.(11)SinceCORETECmaycauseexcessivediuresisandhypokalemia,cautionshouldbeexercisedwithpatientsondigitalization.(12)Arrythmiamayoccurinpatientswithacuteheartfail-ure.SincetheuseofCORETECmayincreasetheriskofarrhythmia,cautionshouldbeexercisedwithsuchpatients.3.DrugInteractionsPrecautionsforcoadministration(CORETECshouldbeadministeredwithcarewhencoadministeredwiththefollowingdrugs.)Signs,Symptoms,andTreatmentMechanismandRiskFactorsCardiotonicsofthecatecholaminetype:Dopaminehydro-chlorideDobutaminehy-drochloride,etc.Adenylcyclaseacti-vatorColforsindaropatehydrochlorideWhencoadminister