MSDS:EphedrineSulfateInjection,USP,50mg/mL

Manufacturer: AkornIncorporated 150S.WycklesRoad Decatur,IL62522 18009325676 customer.service@akorn.com

Telephone: Email: Section 1IDENTIFICATION TRADENAME: EphedrineSulfateInjection,USP,50mg/mL Description: EphedrineSulfateInjection,USPisindicatedinthetreatmentofallergic disorders,suchasbronchialasthma.Thedrughaslongbeenusedasapressor agent,particularlyduringspinalanesthesiawhenhypotensionfrequently occurs.Itisindicatedasacentralnervoussystemstimulantinnarcolepsyand depressivestates.Alsousedinmyastheniagravis. Composition CAS# TLV(mg/m) PEL(mg/m) %Content EphedrineSulfate 134725Unknown Unknown5.0 EphedrineSulfateInjection,USPisasterilesolutionof50mgephedrinesulfateinwaterforinjectionfor intramuscular,intravenous,orsubcutaneoususe. Commonnameofactiveingredients:EphedrineSulfate,USP ChemicalFormula(s): (C10H15NO)2H2SO4 MolecularWeight: 428.54g/mole LegalCategory: PrescriptionOnly Section 2HAZARDOUSINGREDIENTS PrincipalHazardousIngredients: EphedrineSulfate Carcinogenicity: NE Mutagenicity: NE Teratogenicity: NE DevelopmentalToxicity: NE Appearance/PhysicalState: Clear,colorlesssolution Section 3 PHYSICAL CHARACTERISTICS Boiling Point: AND CHEMICAL Water(Approximate) Melting/FreezingPoint: Water(Approximate) VaporPressure(mmHg): NE Appearance/PhysicalState: Clear,colorlesssolution BoilingPoint: Water(approximate) NE EvaporationRate: NE VaporDensity: Solubility: Aqueoussolution SpecificGravity: Approximately1.01 Viscosity: Water(Approximate) ReactivityinWater: None pH: 4.5to7.0 LatexFree: Yes
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MSDS:EphedrineSulfateInjection,USP,50mg/mL
Section4FIREANDEXPLOSIONHAZARDDATA
Nonflammable NA ND ND ND Waterspray,carbondioxide,drychemical,orfoamas appropriateforsurroundingfireandmaterials NE Method: NE Wearprotectiveclothingandselfcontainedbreathing apparatus. NE FlashPoint: FlashPointMethod: LowerExplosiveLimit(%): UpperExplosiveLimit(%): AutoignitionTemperature: ExtinguisherMedia:

AutoIgnitionTemperature: SpecialFirefightingProcedures:

SpecificHazards: CONDITIONSTOAVOID Incompatibility: HazardousDecompositionProducts: HazardousPolymerization: Section5REACTIVITYDATA ChemicalStability: ConditionstoAvoid:

Concentratedacidsorbases Whenheatedtodecompositionitemitsverytoxic fumessuchasNOx,SOxandH2SO4. ND

Stable NA

Section6HEALTHHAZARDS

EmergencyOverview:Inclinicaluse,thematerialisusedasabronchodilatorandtotreatshock.The activematerialstimulatesthesympatheticnervoussystem.Itistoxicbyingestion,andcanexert changesontheheart,lungs,cardiovascularsystemandcentralnervoussystem TargetOrgans:Sympatheticnervoussystem,respiratorysystem,centralnervoussystem,heart, cardiovascularsystem. MedicalconditionsAggravatedbyExposure:Datasuggestspreexistingcardiovascular,kidney, nervoussystemorocularailments. Overdosage: Manifestations:Theprincipalmanifestationofephedrinesulfatepoisoningisconvulsions.Inacute poisoningthefollowingsignsandsymptomsmayoccur:nausea,vomiting,chills,cyanosis,irritability, nervousness,fever,suicidalbehavior,tachycardia,dilatedpupils,blurredvision,opisthotonos,spasms, convulsions,pulmonaryedema,gaspingrespirations,comaandrespiratoryfailure.Initiallythepatient mayhavehypertension,followedlaterbyhypotensionaccompaniedbyanuria. Treatment:Ifrespirationsareshalloworcyanosisispresent,artificialrespirationshouldbe administered.Vasopressorsarecontraindicated.Incardiovascularcollapsebloodpressureshouldbe maintained. ChemicalListedasCarcinogenorPotentialCarcinogen: NationalToxicologyProgram:Yes_____ No__x___
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MSDS:EphedrineSulfateInjection,USP,50mg/mL
I.A.R.C.Monographs: Yes_____ No__x___ OSHA: Yes_____ No___x___ AGGIHThresholdLimitValue: NA OtherExposureLimitUsed: NA EmergencyandFirstAidProcedures: Inhalation: Removefromsourceofexposure.Ifsignsoftoxicityoccur,seekmedical attention.Providesymptomatic/supportivecare,monitoring cardiovascularandrespiratoryfunction,asnecessary. Eyes: Removefromsourceofexposure.Flushwithcopiousamountofwater. Ifirritationpersistsorsignsoftoxicityoccur,seekmedicalattention. Providesymptomatic/supportivecare,monitoringcardiovascularand respiratoryfunction,asnecessary. Skin: Removefromsourceofexposure.Flushwithcopiousamountsofwater. Ifirritationpersistsorsignsoftoxicityoccur,seekmedicalattention. Providesymptomatic/supportivecare,monitoringcardiovascularand respiratoryfunction,asnecessary. Ingestion: Removefromsourceofexposure.Ifsignsoftoxicityoccur,seekmedical attention.Providesymptomatic/supportivecare,monitoring cardiovascularandrespiratoryfunction,asnecessary. Notetophysicians: Treatsymptomaticallyandsupportively Section7PROTECTIONINFORMATION Nospecialprovisionsarerequiredundernormaluseconditions. EngineeringControls: RespiratoryProtection: Respiratoryprotectionisnotneededduringnormalproductuse. SkinProtection: Ifskincontactislikely,imperviousglovesarerecommended. EyeProtection: Eyeprotectionisnotrequiredduringtypicalproductuseconditions.Eye protectionisrecommendedifcontactislikely. Section 8SPECIALPRECAUTIONSANDSPILL/LEAKPROCEDURES Nospecialhandlingrequired Handling: Storage: Storeatcontrolledroomtemperatureof1525C.Protectfromlight. Stepstobetakenincasematerialisreleasedorspilled:Absorbwithsuitablematerial,and containerizepriortodisposalinaccordancewithlocal,state,andfederalregulations.Usepersonal protectiveequipmentrecommendedinsection7. WasteDisposalMethods:Disposeofinaccordancewithcounty,regional,federal,state,andlocal regulations.
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MSDS:EphedrineSulfateInjection,USP,50mg/mL
Section 9DISPOSALCONSIDERATIONS
WasteDisposalMethods: Observeallfederal,state,andlocalenvironmentalregulationsfordisposalguidelines. AppropriateMethodofDisposalofProduct,Preparation,Packaging: Disposalmustbemadeaccordingtoofficialregulations.Consultstate,localandnationalgovernmental requirements. Section10TOXICOLOGY INFORMATION OralToxicity: LD50equaltoorgreaterthan75to1072mg/kginmice,rats,and rabbits.EstimatedoralMLDof2000mginadultsforephedrinesulfate (toxic). DermalToxicity: ND InhalationToxicity: ND Corrosiveness: ND DermalIrritation: ND OcularIrritation: Ephedrinesulfateproducesdilatedpupils(mydriasis)uponlocal applicationtotheeyes. Sensitizationresponsesreportedfromapplicationofaformulation DermalSensitization: containing1%ephedrineinoliveoil. SpecialTargetOrganEffects: Inclinicaluse,ephedrinestimulatesthesympatheticnervoussystem.It relaxessmoothmuscleinthebronchiofthelungs,affectstheheart, increasesbloodpressureandconstrictssomebloodvesselswhile dilatingothers.Chronicnasalusecanleadtochronicnasalcongestion andpersonalitychangesinemotionallyunstablepeople. CarcinogenicityInformation: EphedrinesulfatewasnegativeinNTPstudiesinratsandmiceatdiet concentrationsupto250ppm. Section11REGULATORYandECOLOGICALINFORMATION Ecotoxicity: ND NA BOD5andCOD: OtherInformation: Legend: NA=NotApplicable ND=NotDetermined NE=NotEstablished
Disclaimer:Thisdocumentisgeneratedtodistributehealth,safetyandenvironmentaldata.Itisnotaspecificationsheetandnoneofthedisplayeddatashouldbeconstruedasaspecification. InformationonthisMSDSsheetwasobtainedfromsourceswhichwebelievearereliable,andwebelievethattheinformationiscompleteandaccurate.However,theinformationisprovided without any warranty, express or implied, regarding its correctness. Some of the information presented and conclusions drawn are from sources other than direct test data of the substance. Theconditionsormethodsofhandling,storage,useanddisposaloftheproductarebeyondourcontrolandmayalsobebeyondourknowledge.Itistheusersresponsibilitytodeterminethe suitability of any material for a specific purpose and to adopt such safety precautions as may be necessary. If the product is used as a component in another product, this MSDS information may notbe applicable. For these reasons, we donot assume any responsibility and expressly disclaim liability for any loss,damage orexpense arising out ofor inany way connected with the handling,storage,useordisposalofthisproduct.

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