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MSDS:EphedrineSulfateInjection,USP,50mg/mL
1of4 Rev.1111
Manufacturer: AkornIncorporated
150S.WycklesRoad
Decatur,IL 62522
Telephone: 18009325676
Email: [email protected]
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 134725 Unknown Unknown 5.0
EphedrineSulfateInjection,USPisasterilesolutionof50mgephedrinesulfateinwaterforinjectionfor
intramuscular,intravenous,orsubcutaneoususe.
Commonnameofactiveingredients: EphedrineSulfate,USP
ChemicalFormula(s): (C10H15NO)2H2SO4
MolecularWeight: 428.54g/mole
LegalCategory: PrescriptionOnly
PrincipalHazardousIngredients: EphedrineSulfate
Carcinogenicity: NE
Mutagenicity: NE
Teratogenicity: NE
DevelopmentalToxicity: NE
Appearance/PhysicalState: Clear,colorlesssolutionBoilingPoint:
Water(Approximate)
Melting/FreezingPoint: Water(Approximate) VaporPressure(mmHg):
NE
Appearance/PhysicalState: Clear,colorlesssolution
BoilingPoint: Water(approximate)
VaporDensity: NE EvaporationRate: NE
Solubility: Aqueoussolution
SpecificGravity: Approximately1.01
Viscosity: Water(Approximate) ReactivityinWater: None
pH: 4.5to7.0 LatexFree: Yes
Section1 IDENTIFICATION
Section2
HAZARDOUS
INGREDIENTS
Section3 PHYSICALANDCHEMICALCHARACTERISTICS
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MSDS:EphedrineSulfateInjection,USP,50mg/mL
2of4 Rev.1111
FlashPoint: Nonflammable
FlashPointMethod: NA
LowerExplosiveLimit(%): ND
UpperExplosiveLimit(%): NDAutoignitionTemperature: ND
ExtinguisherMedia:
Waterspray,carbondioxide,drychemical,orfoamas
appropriateforsurroundingfireandmaterials
AutoIgnitionTemperature: NE Method: NE
SpecialFirefightingProcedures:
Wearprotectiveclothingandselfcontainedbreathing
apparatus.
SpecificHazards: NE
CONDITIONSTOAVOID
Incompatibility: Concentratedacidsorbases
HazardousDecomposition
Products:
Whenheatedtodecompositionitemitsverytoxic
fumessuchasNOx,SOxandH2SO4.
HazardousPolymerization: ND
ChemicalStability: Stable
ConditionstoAvoid: NA
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___
Section4 FIREANDEXPLOSIONHAZARDDATA
Section5 REACTIVITYDATA
Section6 HEALTHHAZARDS
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MSDS:EphedrineSulfateInjection,USP,50mg/mL
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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
EngineeringControls:
Nospecialprovisionsarerequiredundernormaluseconditions.
RespiratoryProtection:
Respiratoryprotectionisnotneededduringnormalproductuse.
SkinProtection:
Ifskincontactislikely,imperviousglovesarerecommended.
Eye
Protection:
Eye
protection
is
not
required
during
typical
product
use
conditions.
Eye
protectionisrecommendedifcontactislikely.
Handling: Nospecialhandlingrequired
Storage:
Storeatcontrolledroomtemperatureof1525C.Protectfromlight.
Stepstobetakenincasematerialisreleasedorspilled:
Absorbwithsuitablematerial,and
containerizepriortodisposalinaccordancewithlocal,state,andfederalregulations.Usepersonal
protectiveequipmentrecommendedinsection7.
WasteDisposalMethods:
Disposeofinaccordancewithcounty,regional,federal,state,andlocal
regulations.
Section7 PROTECTIONINFORMATION
Section8 SPECIALPRECAUTIONSANDSPILL/LEAKPROCEDURES
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MSDS:EphedrineSulfateInjection,USP,50mg/mL
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WasteDisposalMethods:
Observeallfederal,state,andlocalenvironmentalregulationsfordisposalguidelines.
AppropriateMethodofDisposalofProduct,Preparation,Packaging:
Disposalmustbemadeaccordingtoofficialregulations.
Consultstate,localandnationalgovernmental
requirements.
OralToxicity:
LD50equaltoorgreaterthan75to1072mg/kginmice,rats,and
rabbits.EstimatedoralMLDof2000mginadultsforephedrinesulfate
(toxic).
DermalToxicity: ND
InhalationToxicity: ND
Corrosiveness: ND
DermalIrritation: ND
OcularIrritation:
Ephedrinesulfateproducesdilatedpupils(mydriasis)uponlocal
applicationtotheeyes.
DermalSensitization:
Sensitizationresponsesreportedfromapplicationofaformulation
containing1%ephedrineinoliveoil.
SpecialTargetOrganEffects:
Inclinicaluse,ephedrinestimulatesthesympatheticnervoussystem.It
relaxessmoothmuscleinthebronchiofthelungs,affectstheheart,
increasesbloodpressureandconstrictssomebloodvesselswhile
dilatingothers.Chronicnasalusecanleadtochronicnasalcongestion
andpersonalitychangesinemotionallyunstablepeople.
Carcinogenicity
Information:
Ephedrine
sulfate
was
negative
in
NTP
studies
in
rats
and
mice
at
diet
concentrationsupto250ppm.
Ecotoxicity: ND
BOD5andCOD: NA
OtherInformation:
Legend: NA=NotApplicable
ND=NotDetermined
NE=NotEstablished
Disclaimer:Thisdocumentisgeneratedtodistributehealth,safetyandenvironmentaldata.Itisnotaspecificationsheetandnoneofthedisplayeddatashouldbeconstruedasaspecification.
InformationonthisMSDSsheetwasobtainedfromsourceswhichwebelievearereliable,andwebelievethattheinformationiscompleteandaccurate.However,theinformationisprovided
withoutanywarranty,expressorimplied,regardingitscorrectness.Someoftheinformationpresentedandconclusionsdrawnarefromsourcesotherthandirecttestdataofthesubstance.
Theconditionsormethodsofhandling,storage,useanddisposaloftheproductarebeyondourcontrolandmayalsobebeyondourknowledge.Itistheusersresponsibilitytodeterminethe
suitabilityofanymaterialforaspecificpurposeandtoadoptsuchsafetyprecautionsasmaybenecessary.Iftheproductisusedasacomponentinanotherproduct,thisMSDSinformation
maynotbeapplicable.Forthesereasons,wedonotassumeanyresponsibilityandexpresslydisclaimliabilityforanyloss,damageorexpensearisingoutoforinanywayconnectedwiththe
handling,storage,useordisposalofthisproduct.
Section10 TOXICOLOGYINFORMATION
Section11 REGULATORYandECOLOGICALINFORMATION
Section9 DISPOSALCONSIDERATIONS
