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11/1/2016

DrugSafetyInformationforHeathcareProfessionals>InformationforHealthcareProfessionals:Ceftriaxone(marketedasRocephinandgenerics)

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InformationforHealthcareProfessionals:Ceftriaxone(marketedasRocephinandgenerics)
Lastupdated:4/21/2009
ThisAlerthighlightsimportantrevisionstotheWarnings,DosageandAdministration,Contraindications,andClinicalPharmacology
sectionsofthefullprescribinginformationforceftriaxone(Rocephinanditsgenerics).ThisinformationupdatesapreviousAlertand
addressestheinteractionofceftriaxonewithcalciumcontainingproducts,basedonpreviouslyreportedfatalcasesinneonates.Atthe
requestofFDA,themanufacturerofceftriaxone(Roche)conductedtwoinvitrostudiestoassessthepotentialforprecipitationof
ceftriaxonecalciumwhenceftriaxoneandcalciumcontainingproductsaremixedinvialsandininfusionlines.Thesetwoinvitrostudies
wereconductedinneonatalandadultplasmatoassessthepotentialforprecipitationofceftriaxonecalciumusingvaryingceftriaxone
andcalciumconcentrations,includingconcentrationsinexcessofthoseachievedinvivo.*Basedontheresultsfromthesestudies,FDA
hasthefollowingupdatedrecommendations:
Concomitantuseofceftriaxoneandintravenouscalciumcontainingproductsiscontraindicatedinneonates(<28daysofage).Ceftriaxoneshould
notbeusedinneonates(<28daysofage)iftheyarereceiving(orareexpectedtoreceive)calciumcontainingintravenousproducts.
Inpatients>28daysofage,ceftriaxoneandcalciumcontainingproductsmaybeadministeredsequentially,providedtheinfusionlinesare
thoroughlyflushedbetweeninfusionswithacompatiblefluid.
CeftriaxonemustnotbeadministeredsimultaneouslywithintravenouscalciumcontainingsolutionsviaaYsiteinanyagegroup.
FDAnowrecommendsthatceftriaxoneandcalciumcontainingproductsmaybeusedconcomitantlyinpatients>28daysofage,usingthe
precautionarystepsabovebecausetheriskofprecipitationislowinthispopulation.FDAhadpreviouslyrecommended,butnolonger
recommends,thatinallagegroupsceftriaxoneandcalciumcontainingproductsshouldnotbeadministeredwithin48hoursofoneanother.
Inaddition,FDAisreiteratingthreeofthepreviousrecommendationsorconsiderationsfromSeptember2007:
Donotreconstituteormixceftriaxonewithacalciumcontainingproduct,suchasRingersorHartmannssolutionorparenteralnutritioncontaining
calcium,becauseparticulateformationcanresult.
Therearenodataoninteractionsbetweenintravenousceftriaxoneandoralcalciumcontainingproductsorbetweenintramuscularceftriaxoneand
intravenousororalcalciumcontainingproducts.
ReportpatientswhohaveadverseeventsfollowingceftriaxoneadministrationtotheFDAsMedWatchprogram(seereportinginformationatthe
bottomofthispage).
*Twoinvitrostudies,oneusingadultplasmaandtheotherneonatalplasmafromumbilicalcordbloodhavebeencarriedouttoassessinteractionof
ceftriaxoneandcalcium.Ceftriaxoneconcentrationsupto1mM(inexcessofconcentrationsachievedinvivofollowingadministrationof2grams
ceftriaxoneinfusedover30minutes)wereusedincombinationwithcalciumconcentrationsupto12mM(48mg/dL).Recoveryofceftriaxonefromplasma
wasreducedwithcalciumconcentrationsof6mM(24mg/dL)orhigherinadultplasmaor4mM(16mg/dL)orhigherinneonatalplasma.Thismaybe
reflectiveofceftriaxonecalciumprecipitation.

ThisinformationreflectsFDA'scurrentanalysisofdataavailabletoFDAconcerningthisdrug.FDAintendstoupdatethiswhenadditionalinformationor
analysesbecomeavailable.
Toreportanyunexpectedadverseorseriouseventsassociatedwiththeuseofthisdrug,pleasecontacttheFDAMedWatchprogram,usingthecontact
informationatthebottomofthispage.
ThepriorFDAAlertfromSeptember2007onthetopicoftheinteractionofceftriaxonewithcalciumcontainingproductsisshownbelow.ThisAlertis
nowupdatedabove:
FDAALERT[9/2007]:ThisAlerthighlightsimportantrevisionstotheCONTRAINDICATIONS,WARNINGS,andDOSAGEand
ADMINISTRATIONsectionsofthefullprescribinginformationforRocephin.Thisnewinformationaddressestheinteractionofceftriaxone
withcalciumcontainingproductsbasedonreportsoffatalcasesinneonates.Althoughtherearenoreportedcasesofceftriaxone
calciumprecipitatesinpatientsotherthanneonates,thepotentialforthisinteractionexistsinpatientsofanyage.Generally,fatalities
havebeenassociatedwithsimultaneousadministrationofceftriaxoneandcalciumcontainingproducts.However,administrationofthe
twoproductsatdifferenttimesandviadifferentinfusionlineshasalsobeenfatal.Therefore,ceftriaxoneshouldnotbemixedwith
calciumcontainingproductsandnotadministeredinthesameordifferentinfusionlinesorsitesinanypatientwithin48hoursofeach
other.TheinformationintheAugust2007ceftriaxonelabelclarifiestheceftriaxonelabelingrevisioninMay2007thatfirstincluded
informationonthisinteraction.

Theceftriaxonefullprescribinginformation1includesnewinformationintheCONTRAINDICATIONS,WARNINGS,andDOSAGEandADMINISTRATION
sectionsabouttheinteractionofceftriaxonewithcalciumcontainingproductsandtheresultingpotentialriskoflifethreateningandfatal.
Recommendationsandconsiderationsforhealthcareprofessionals:
Donotreconstituteormixceftriaxonewithacalciumcontainingproduct,suchasRingersorHartmannssolutionorparenteralnutritioncontaining
calcium,becauseparticulateformationcanresult.
Therearenodataoninteractionsbetweenintravenousceftriaxoneandoralcalciumcontainingproductsorbetweenintramuscularceftriaxoneand
intravenousororalcalciumcontainingproducts.
ReportpatientswhohaveadverseeventsfollowingceftriaxoneadministrationtotheFDAsMedWatchprogram(seereportinginformationatthe
bottomofthispage)
Informationforthepatient:Physicianswhoareprescribingceftriaxoneshoulddiscusswiththeirpatientsortheircaregivers:
Ceftriaxoneandcalciumcontainingproductscaninteractwitheachotherandcauselifethreateningreactions.
Tellyourhealthcareprovideraboutallmedicinesthathavebeengiventoyou,especiallythosegiventoyouthroughyourveinsinthepasttwo
days.

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084263.

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11/1/2016

DrugSafetyInformationforHeathcareProfessionals>InformationforHealthcareProfessionals:Ceftriaxone(marketedasRocephinandgenerics)

BackgroundInformationandData
TheRocephinfullprescribinginformationwasupdatedinMay2007toaddnewinformationabouttheinteractionbetweenceftriaxoneandcalcium
containingproductsbasedonpostmarketingreportsinneonates.InAugust2007,thefullprescribinginformationwasmodifiedtofurtherclarifythisissue.
Roche,themanufacturerofceftriaxone,hadprovidedtoFDApostmarketingreportsoffiveneonataldeathsrelatedtotheinteractionbetweenceftriaxone
andcalciumcontainingproducts.Accordingtothereports,thedeathsoccurredsuddenly.Infourneonates,ceftriaxonewascoadministeredwithcalcium
containingfluidsusingthesameinfusionlineandinthefifthneonateceftriaxoneandcalciumgluconatewereadministeredbydifferentroutesandat
differenttimes(theexacttimedifferencewasnotreported).Twoautopsiesfoundevidenceofcrystallinematerialintherenalandpulmonaryvasculature.
Inathirdneonatetherewasevidenceofaprecipitateintheintravenoustubingandtheneonatesdeathoccurredsoonafterthecrystallinematerialwas
injected.
InadditiontothefivepostmarketingreportsprovidedbyRoche,FDAhasreceivedfouradditionalpostmarketingreportsofinteractionsbetween
ceftriaxoneandcalciumcontainingproductsinpatientsuptooneyearofagesinceFDAfirstapprovedRocephinin1984.Threeoftheinteractionsresulted
indeathinoneinstancethepatientwasreceivingparenteralnutrition.Anautopsyinonepatientrevealedevidenceofcrystalsinthelungs.
AlthoughFDAisnotawareofanycasesofceftriaxonecalciuminteractionsinadultsthereisatheoreticalpossibilitythatthisinteractionmayoccurbased
onthephysicalincompatibilityofceftriaxoneandcalciumcontainingsolutions.Ceftriaxonecalciumincompatibilitieshavebeenreportedinthe
literature.1,2Precipitatescanbeobservedwhenceftriaxoneisreconstitutedormixedwithacalciumcontainingproduct.
Therearenodataoninteractionsbetweenintravenousceftriaxoneandoralcalciumcontainingproductsorbetweenintramuscularceftriaxoneand
intravenousororalcalciumcontainingproducts.
References
1.BurkiewiczJS.IncompatibilityofceftriaxonesodiumwithlactatedRingersinjection.AmJHealthSystPharm199956:384.
2.TrisselL.A.Handbookoninjectabledrugs.14thed.Bethesda:AmericanSocietyofHealthSystemPharmacists2007.

HealthcareProviderInformation
Ceftriaxone(marketedasRocephin)Information2
InformationforHealthcareProfessionals:Ceftriaxone(marketedasRocephin)9/20073 [ARCHIVED]
FDAAlert(9/2007)
Ceftriaxone(marketedasRocephin)PrescribingInformation(labeling)4PrescribingInformation(labeling)fromDailyMed

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2./Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm
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