CEFUROXIME

Main information

  • Trade name:
  • CEFUROXIME Pdr for Soln for Infusion 3 Grams
  • Dosage:
  • 3 Grams
  • Pharmaceutical form:
  • Pdr for Soln for Infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEFUROXIME Pdr for Soln for Infusion 3 Grams
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0437/045/005
  • Authorization date:
  • 23-06-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cefuroxime3gPowderforInfusion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachvialcontains3gcefuroxime(assodiumsalt).

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Powderforsolutionforinfusion

Vialscontainingawhitepowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthemanagementofsystemicinfectionsduetomicro-organismssusceptibletothisanti-infective,includinggram

positiveandgramnegativeorganismsandsuchconditionsasrespiratoryandurinarytractinfections,gonorrhoea,

septicaemia,meningitis.

Prophylaxisagainstinfectioninabdominal,orthopaedicandothersurgicalprocedures,wherethereisincreasedrisk

frominfection.

4.2Posologyandmethodofadministration

Cefuroxime1.5gPowderforInjectionisforintravenoususeonly.Dosageinstructionsforintramuscularuseare

providedbelow;otherproductpresentationsareavailableforintramuscularadministration.

Cefuroxime3gPowderforInfusionmustbeusedforIntravenousInfusiononly.

Forshortintravenousinfusion(e.g.upto30minutes),solutionscontaining3gcefuroximein100mlWaterfor

Injectionsmaybeused.Thesesolutionsmaybegivendirectlyintotheveinorintroducedintothetubingofthegiving

setifthepatientisreceivingparenteralfluids.

Parenteralcefuroximedosagerecommendations(whereintramuscularuseisrecommended,presentationsof

CefuroximePowderforInjectionlicensedforsuchuseshouldbeadministered):

Adults:Theusualdoseis750mgt.d.s.(threetimesaday)byintravenousinjection.

Thetotaldailydosageisintherangeof1500mgto6000mgindivideddoses.

InfantsandChildren:Dosesof30to100mg/kg/daygivenasthreeorfourdivideddoses.Adoseof60mg/kg/daywill

beappropriateformostinfections.

Neonates:Dosesof30to100mg/kg/daygivenastwoorthreedivideddoses.Inthefirstweeksoflifetheserumhalf-

lifeofcefuroximecanbethreetofivetimesthatinadults.

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Otherrecommendations:

Gonorrhoea:1.5gintramuscularinjectionshouldbegivenasasingledose.Thismaybegivenas2x750mg

injectionsintodifferentsites,e.g.eachbuttock.

Meningitis:Cefuroximeissuitableforsoletherapyofbacterialmeningitisduetosensitivestrains.Thefollowing

dosagesarerecommended:

Adults:3gintravenouslyeveryeighthours.Dataarenotyetsufficienttorecommendadoseforintrathecal

administration.

Infantsandchildren:200to240mg/kg/dayintravenouslyinthreeorfourdivideddoses.Thisdosagemaybereduced

to100mg/kg/dayintravenouslyafterthreedaysorwhenclinicalimprovementoccurs.

Neonates:Theinitialdoseshouldbe100mg/kg/dayintravenously.Areductionto50mg/kg/dayintravenouslymaybe

madewhenclinicallyindicated.

Prophylaxis:Theusualdoseis1.5gintravenouslywithinductionofanaesthesiaforabdominal,pelvicandorthopaedic

operations,butmaybesupplementedwithtwo750mgintramusculardoseseightandsixteenhourslater.Incardiac,

pulmonary,oesophagealandvascularoperations,theusualdoseis1.5gintravenouslywithinductionofanaesthesia

continuingwith750mgintramuscularlyt.d.s.forafurther24to48hours.

Intotaljointreplacement,1.5gcefuroximepowdermaybemixeddrywitheachpackofmethylmethacrylatecement

polymerbeforeaddingtheliquidmonomer.

Dosageinimpairedrenalfunction:Cefuroximeisexcretedbythekidneys.Therefore,aswithallsuchantibiotics,in

patientswithmarkedlyimpairedrenalfunctionitisrecommendedthatthedosageofcefuroximeshouldbereducedto

compensateforitsslowerexcretion.However,itisnotnecessarytoreducethedoseuntilthecreatinineclearancefalls

below20ml/min.Inadultswithmarkedimpairment(creatinineclearance10-20ml/min)750mgb.d.(twicedaily)is

recommendedandwithsevereimpairment(creatinineclearance<10ml/min)750mgoncedailyisadequate.For

patientsonhaemodialysisafurther750mgdoseshouldbegivenattheendofeachdialysis.Whencontinuous

peritonealdialysisisbeingused,asuitabledosageisusually750mgtwicedaily.

Forpatientsinrenalfailureoncontinuousarteriovenoushaemodialysisofhigh-fluxhaemofiltrationinintensive

therapyunitsasuitabledosageis750mgtwicedaily.Forlow-fluxhaemofiltrationfollowthedosagerecommended

underimpairedrenalfunction.

4.3Contraindications

Hypersensitivitytocephalosporinantibiotics.

Useinpatientswithhepaticdysfunction.

4.4Specialwarningsandprecautionsforuse

Useofcefuroximeshouldbereservedformoderatelyseriousorsevereinfections.

Cephalosporinantibioticsmayingeneralbegivensafelytopatientswhoarehypersensitivetopenicillins,although

cross-reactionshavebeenreported.Specialcareisindicatedinpatientswhohaveexperiencedananaphylacticreaction

topenicillin.

Asaprecaution,renalfunctionshouldbemonitoredintheelderly,inpatientstakingconcurrentpotentdiureticsor

aminoglycosides,andinpatientswithpre-existingrenalimpairment.

Prolongeduseofananti-infectivemayresultinthedevelopmentofsuperinfectionduetoorganismsresistanttothat

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Theremaybesomevariationontheresultsofbiochemicaltestsofrenalfunction,butthesedonotappeartobeof

clinicalimportance.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Cephalosporinantibioticsathighdosageshouldbegivenwithcautiontopatientsreceivingconcurrenttreatmentwith

potentdiureticssuchasfrusemideandaminoglycosides,asthesecombinationsaresuspectedofadverselyaffecting

renalfunction.Clinicalexperiencewithcefuroximehasshownthatthisisnotlikelytobeaproblematthe

recommendeddoselevels.

Cefuroximedoesnotinterfereinenzyme-basedtestsforglycosuria.Slightinterferencewithcopperreductionmethods

(Benedict’s,Fehling’s,Clinitest)maybeobserved.However,thisshouldnotleadtofalse-positiveresults,asmaybe

experiencedwithsomeothercephalosporins.

Itisrecommendedthateithertheglucoseoxidaseorhexokinasemethodsareusedtodetermineblood/plasmaglucose

levelsinpatientsreceivingcefuroxime.Thisantibioticdoesnotinterfereinthealkalinepicrateassayforcreatinine.

4.6Pregnancyandlactation

Studiesinanimalsdonotsuggestanyadverseeffectsonreproduction.Thereisnoexperienceofuseduringpregnancy

inhumanbeings.Cefuroximeshouldnotbeusedduringpregnancyorlactationinbreastfeedingwomenunless

consideredessentialbythephysician.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Hypersensitivityreactionshavebeenreported;theseincludeskinrashes(maculopapularandurticarial),interstitial

nephritis,drugfeverandrarelyanaphylaxis.Aswithothercephalosporinstherehavebeenrarereportsoferythema

multiforme,Stevens-Johnsonsyndromeandtoxicepidermalnecrolysis.

Aswithotherantibiotics,prolongedusemayresultintheovergrowthofnon-susceptibleorganisms,e.g.candida.There

havebeenreportsofheadache,gastrointestinaldisturbances,includingnauseaanddiarrhoea.Veryrarely,

pseudomembranouscolitismayoccurduringoraftertreatment.

Theprincipalchangesinhaematologicalparametersseeninsomepatientshavebeenofdecreasedhaemoglobin

concentrationandofeosinophilia,leukopeniaandneutropenia.

ApositiveCoombs’testhasbeenfoundinsomepatientstreatedwithcefuroxime–thisphenomenoncaninterferewith

thecross-matchingofblood.

Althoughtherearesometimestransientrisesinserumliverenzymesorserumbilirubin,particularlyinpatientswith

pre-existingliverdisease,thereisnoevidenceofhepaticinvolvement.

Elevationsinserumcreatinineand/orbloodureanitrogenandadecreasedcreatinineclearancehavebeenobserved.

Transientpainmaybeexperiencedatthesiteofintramuscularinjection.Thisismorelikelytooccurwithhigherdoses.

However,itisunlikelytobeacausefordiscontinuationoftreatment.Occasionally,thrombophlebitismayfollow

intravenousinjection.

Aswithothercephalosporins,therehavebeenveryrarereportsofthrombocytopenia.

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inafewpaediatricpatientstreatedwithcefuroxime.

4.9Overdose

Overdosageofcephalosporinscancausecerebralirritationleadingtoconvulsions.Serumlevelsofcefuroximecanbe

reducedbyhaemodialysisorperitonealdialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCcodeJ01DA06.

Cefuroximeisabactericidalcephalosporinantibioticwhichisresistanttomost-lactamasesandisactiveagainstawide

rangeofGram-positiveandGram-negativeorganisms.

ItishighlyactiveagainstStaphylococcusaureusincludingstrainswhichareresistanttopenicillin(butnottherare

methicillin-resistantstrains),Staph.epidermidis,Haemophilusinfluenzae,Klebsiellaspp,Enterobacterspp,

Streptococcuspyogenes,Escherichiacoli,Str.mitis(viridansgroup),Clostridiumspp,Proteusmirabilis,Pr.rettgeri,

Salmonellatyphi,S.typhimuriumandotherSalmonellaspp,Shigellaspp,Neisseriaspp(includingbeta-lactamase

producingstrainsofN.gonorrhoea)andBordetellapertussis.ItisalsomoderatelyactiveagainststrainsofPr.

vulgaris,Morganellamorganii(formerlyProteusmorganii)andBacteroidesfragilis.

Thefollowingorganismsarenotsusceptibletocefuroxime:Clostridiumdifficile,Pseudomonasspp,Campylobacter

spp,Acinetobactercalcoaceticus,Legionellasppandmethicillin-resistantstrainsofStaph.aureusandStaph.

epidermidis.Somestrainsofthefollowinggenerahavealsobeenfoundnottobesusceptibletocefuroxime:Strep.

faecalis,Morganellamorganii,Proteusvulgaris,Enterobacterspp.Citrobacterspp,SerratiasppandBacteroides

fragilis.

Invitrotheactivitiesofcefuroximeandaminoglycosideantibioticsincombinationhavebeenshowntobeatleast

additivewithoccasionalevidenceofsynergy.

5.2Pharmacokineticproperties

Peaklevelsofcefuroximeareachievedwithin30to45minutesafterintramuscularadministration.Theserumhalf-life

aftereitherintramuscularorintravenousinjectionisapproximately70minutes.Concurrentadministrationof

probenecidprolongstheexcretionoftheantibioticandproducesanelevatedpeakserumlevel.Thereisalmost

completerecoveryofunchangedcefuroximeintheurinewithin24hoursofadministration,themajorpartbeing

eliminatedinthefirstsixhours.Approximately50%isexcretedthroughtherenaltubulesandapproximately50%by

glomerularfiltration.Concentrationsofcefuroximeinexcessoftheminimuminhibitorylevelsforcommonpathogens

canbeachievedinbone,synovialfluidandaqueoushumor.Cefuroximepassestheblood-brainbarrierwhenthe

meningesareinflamed.

5.3Preclinicalsafetydata

Therearenopreclinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSummaryofProductCharacteristics.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

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6.2Incompatibilities

Incompatiblewithsodiumbicarbonate.

Cefuroximeshouldnotbemixedinthesyringewithaminoglycosideantibiotics.

6.3ShelfLife

Aspackagedforsale:30months.

Inuse:Followingreconstitutionanddilutiontoafinalconcentrationof30mg/mlinsodiumchloride0.9%,dextrose

10%,M/6sodiumlactateinjection,LactatedRingersinjectionandRinger’sinjection,chemicalandphysicalin-use

stabilityhasbeendemonstratedfor48hoursat2-8ºC.Fromamicrobiologicalpointofview,theproductshouldbe

usedimmediately.Ifnotusedimmediately,in-usestoragetimesandconditionspriortousearetheresponsibilityofthe

userandwouldnormallynotbelongerthan24hoursat2-8ºC,unlessreconstitution/dilutionhastakenplacein

controlledandvalidatedasepticconditions.

6.4Specialprecautionsforstorage

Aspackagedforsale:Donotstoreabove25 o

Keepthevialintheoutercarton.

Inuse:see6.3.

6.5Natureandcontentsofcontainer

3g(forintravenousinfusion)–TypeIIIuncolouredglassvialswithrubberstoppersinpacksof1,10or50.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Containsnopreservative.Forsingleuse.Discardanyunusedcontents.

Maybeaddedtomostintravenousfluidsandelectrolytesolutions,e.g.WaterforInjections,sodiumchloride0.9%,

glucose5%,sodiumchloride0.18%withglucose4%.

7MARKETINGAUTHORISATIONHOLDER

MaynePharmaPlc

Queensway

RoyalLeamingtonSpa

WarwickshireCV313RW

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA437/45/5

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:23June2000

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10DATEOFREVISIONOFTHETEXT

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