CEFUROXIME

Main information

  • Trade name:
  • CEFUROXIME Powder for suspension for injection 250 Milligram
  • Dosage:
  • 250 Milligram
  • Pharmaceutical form:
  • Powder for suspension for injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEFUROXIME Powder for suspension for injection 250 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0437/045/001
  • Authorization date:
  • 23-06-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cefuroxime250mgPowderforInjection

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachvialcontains250mgcefuroxime(assodiumsalt).

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Powderforsuspensionforinjection/Powderforsolutionforinjection

Vialscontainingawhitepowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthemanagementofsystemicinfectionsduetomicro-organismssusceptibletothisanti-infective,includinggram

positiveandgramnegativeorganismsandsuchconditionsasrespiratoryandurinarytractinfections,gonorrhoea,

septicaemia,meningitis.

Prophylaxisagainstinfectioninabdominal,orthopaedicandothersurgicalprocedures,wherethereisincreasedrisk

forminfection.

4.2Posologyandmethodofadministration

Intramuscular:Add1mlWaterforInjectionsto250mgcefuroxime.Shakegentlytoproduceanopaquesuspension.

Intravenous:Dissolve250mgcefuroximeinatleast2mlWaterforInjections.

Adults:Theusualdoseis750mgt.d.s.(3timesaday)byintramuscularorintravenousinjection.Thetotaldailydosage

isintherangeof1500mgto6000mgindivideddoses.

InfantsandChildren:Dosesof30to100mg/kg/daygivenasthreeorfourdivideddoses.Adoseof60-mg/kg/daywill

beappropriateformostinfections.

Neonates:Dosesof30to100mg/kg/daygivenastwoorthreedivideddoses.Inthefirstweeksoflifetheserumhalf-

lifeofcefuroximecanbethreetofivetimethatinadults.

Elderly:Seedosageinadults.

Otherrecommendations:

Gonorrhoea:1.5gintramuscularinjectionshouldbegivenasasingledose.Thismaybegivenas2×750mg

injectionsintodifferentsites,e.g.eachbuttock.

Meningitis:Cefuroximeissuitableforsoletherapyofbacterialmeningitisduetosensitivestrains.Thefollowing

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Adults:3gintravenouslyeveryeighthours.Dataarenotyetsufficienttorecommendadoseforintrathecal

administration.

Infantsandchildren:200to240mg/kg/dayintravenouslyinthreeorfourdivideddoses.Thisdosagemaybereduced

to100mg/kg/dayintravenouslyafterthreedaysorwhenclinicalimprovementoccurs.

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

madewhenclinicallyindicated.

Prophylaxis:Theusualdoseis1.5gintravenouslywithinductionofanaesthesiaforabdominal,pelvicandorthopaedic

operationsbutmaybesupplementedwithtwo750mgintramusculardoseseightandsixteenhourslater.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-reactionhavebeenreported.Specialcareisindicatedinpatientswhohaveexperiencedananaphylacticreaction

topenicillin.

Asaprecaution,renalfunctionshouldbemonitoredintheelderly,inpatientstakingconcurrentpotentdiureticsor

aminoglycosides,andinpatientswithpre-existingrenalimpairment.

Prolongeduseofananti-infectivemayresultinthedevelopmentofsuperinfectionduetoorganismsresistanttothat

anti-infective.

Theremaybesomevariationontheresultsofbiochemicaltestsofrenalfunction,butthesedonotappeartobeof

clinicalimportance.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Cephalosporinantibioticsathighdosageshouldbegivenwithcautiontopatientsreceivingconcurrenttreatmentwith

potentdiureticssuchasfrusemideandaminoglycosides,asthesecombinationsaresuspectedofadverselyaffecting

renalfunction.Clinicalexperiencewithcefuroximehasshownthatthisisnotlikelytobeaproblematthe

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Cefuroximedoesnotinterfereinenzyme-basedtestsforglycosuria.Slightinterferencewithcopperreductionmethods

(Benedict’sFehling’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.

Aswithotherantibioticsprolongedusemayresultintheovergrowthofnon-susceptibleorganisms,e.g.candida.There

havebeenreportsofheadachegastrointestinaldisturbances,includingnauseaanddiarrhoea.Veryrarely,

pseudomembranouscolitismayoccurduringoraftertreatment.

Theprincipalchangesinhaematologicalparametersseeninsomepatientshavebeenofdecreasedhaemoglobin

concentrationandofeosinophilia,leukopeniaandneutropenia.

ApositiveCoombs’testhasbeenfoundinsomepatientstreatedwithcefuroxime–thisphenomenoncaninterferewith

thecrossmatchingofblood.

Althoughtherearesometimestransientrisesinserumliverenzymesorserumbilirubin,particularlyinpatientswith

pre-existingliverdisease,thereisnoevidenceofhepaticinvolvement.

Elevationsinserumcreatinineand/orbloodureanitrogenandadecreasedcreatinineclearancehavebeenobserved.

Transientpainmaybeexperiencedatthesiteofintramuscularinjection.Thisismorelikelytooccurwithhigherdoses.

However,itisunlikelytobeacausefordiscontinuationoftreatment.Occasionally,thrombophlebitisanyfollow

intravenousinjection.

Aswithothercephalosporins,therehavebeenveryrarereportsofthrombocytopenia.

Aswithothertherapeuticregimensusedinthetreatmentofmeningitis,mildtomoderatehearinglosshasbeenreported

inafewpaediatricpatientstreatedwithcefuroxime.

4.9Overdose

Overdosageofcephalosporinscancausecerebralirritationleadingtoconvulsions.Serumlevelsofcefuroximecanbe

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCcodeJ01DA06.

Cefuroximeisabactericidalcephalosporinantibiotic,whichisresistanttomostbeta-lactamasesandisactiveagainsta

widerangeofGram-positiveandGram-negativeorganisms.

ItishighlyactiveagainstStaphylococcusaureusincludingstrainswhichareresistanttopenicillin(butnottherare

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

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

Salmonellatyphi,S.typhimuriumandotherSamonellaspp,Shigellaspp,Neisseriaspp(includingbeta-lactamases

producingstrainsofPr.vulgaris,Morganellamorganii(formerlyProteusmorganiiandBacteroidesfragilis.

Thefollowingorganismsarenotsusceptibletocefuroxime:Clostridiumdifficile,Peudomoasspp,Campylobacterspp,

Acinetobactercalcoaceticus,Legionellasppandmethicillin-resistantstrainsofStaph.aureusandStaph.epidermidis.

Somestrainsofthefollowinggenerahavealsobeenfoundnottobesusceptibletocefuroxime:Strep.Faecalis,

Morganellamorganii,Proteusvulgaris,Enterobacterspp.Citrobacterspp,SerratiasppandBacterodoidesfragilis.

Invitrotheactivitiesofcefuroximeandaminoglycosidesantibioticsincombinationhavebeenshowntobeatleast

additivewithoccasionalevidenceofsynergy.

5.2Pharmacokineticproperties

Peaklevelsofcefuroximeareachievedwithin30to45minutesafterintramuscularadministration.Theserumhalf-life

aftereitherintramuscularorintravenousinjectionisapproximately70minutes.Concurrentadministrationof

probenecidprolongstheexcretionoftheantibioticandproducesanelevatedpeakserumlevel.Thereisalmost

completerecoveryofunchangedcefuroximeintheurinewithin24hoursofadministration,themajorpartbeing

eliminatedinthefirstsixhours.Approximately50%isexcretedthroughtherenaltubulesandapproximately50%by

glomerularfiltration.Concentrationsofcefuroximeinexcessoftheminimuminhibitorylevelsforcommonpathogens

canbeachievedinbone,synovialfluidanaqueoushumor.Cefuroximepassestheblood-brainbarrierwhenthe

meningesareinflamed.

5.3Preclinicalsafetydata

Therearenopreclinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSummaryofProductCharacteristic.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

None.

6.2Incompatibilities

Incompatiblewithsodiumbicarbonate.

Cefuroximeshouldnotbemixedinthesyringewithaminoglycosideantibiotics.

6.3ShelfLife

Aspackagedforsale:30months.

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demonstratedfor48hoursat2-8ºC.Fromamicrobiologicalpointofview,theproductshouldbeusedimmediately.If

notusedimmediately,in-usestoragetimesandconditionspriortousearetheresponsibilityoftheuserandwould

normallynotbelongerthan24hoursat2-8ºC,unlessreconstitution/dilutionhastakenplaceincontrolledandvalidated

asepticconditions.

6.4Specialprecautionsforstorage

Aspackagedforsale:

Donotstoreabove25 o

Keepthevialintheoutercarton.

Inuse:seesection6.3.

6.5Natureandcontentsofcontainer

250mg(forintramuscular/intravenousinjection)–TypeIIIuncolouredglassvialswithrubberstoppersinpacksof5,

10or50.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Containsnopreservative.Forsingleuse.Discardanyunusedcontents.

7MARKETINGAUTHORISATIONHOLDER

MaynePharmaPlc

Queensway

RoyalLeamingtonSpa

WarwickshireCV313RW

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA437/45/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:23June2000

Dateoflastrenewal:23June2005

10DATEOFREVISIONOFTHETEXT

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