CEFUROXIME AUROBINDO 125 Milligram Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
CEFUROXIME AXETIL
Available from:
Milpharm Limited
ATC code:
J01DC02
INN (International Name):
CEFUROXIME AXETIL
Dosage:
125 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Second-generation cephalosporins
Authorization status:
Authorised
Authorization number:
PA1050/021/001
Authorization date:
2012-08-03

Packageleaflet:Informationfortheuser

CefuroximeAurobindo125mgtablets

CefuroximeAurobindo250mgtablets

CefuroximeAurobindo500mgtablets

Cefuroxime

Aurobindo P150

Cefuroxime Aurobindo

P150

Readallofthisleafletcarefullybeforeyoustarttakingthis

medicine,becauseitcontainsimportantinformationforyou..

Keepthisleaflet.Youmayneedtoreaditagain.

Ifyouhaveanyfurtherquestions,askyourdoctoror

pharmacist.

Thismedicinehasbeenprescribedforyouonly.Donotpassit

ontoothers.Itmayharmthem,eveniftheirsignsofillnessare

thesameasyours.

Ifyougetanysideeffects,talktoyourdoctororpharmacistor

nurse.Thisincludesanypossiblesideeffectsnotlistedinthis

leaflet.Seesection4

Whatisinthisleaflet:

WhatCefuroximeAurobindoisandwhatitisusedfor

WhatyouneedtoknowbeforeyoutakeCefuroximeAurobindo

HowtotakeCefuroximeAurobindo

Possiblesideeffects

HowtostoreCefuroximeAurobindo

Contentsofthepackandotherfurtherinformation

CefuroximeAurobindoisanantibioticusedinadultsandchildren.It

worksbykillingbacteriathatcauseinfections.Itbelongstoagroup

ofmedicinescalledcephalosporins.

CefuroximeAurobindoisusedtotreatinfectionsof:

thethroat

sinus

middleear

thelungsorchest

theurinarytract

theskinandsofttissues.

CefuroximeAurobindocanalsobeused:

totreatLymedisease(aninfectionspreadbyparasitescalled

ticks).

DoNOTtakeCefuroximeAurobindo:

ifyouareallergic(hypersensitive)toanycephalosporin

antibioticsoranyoftheotheringredientsofthismedicine(listed

insection6).

ifyouhaveeverhadasevereallergic(hypersensitive)reaction

toanyothertypeofbetalactamantibiotic(penicillins,

monobactamsandcarbapenems).

Ifyouthinkthisappliestoyou,don'ttakeCefuroximeAurobindo

untilyouhavecheckedwithyourdoctor.

Warningsandprecautions

CefuroximeAurobindoisnotrecommendedforchildrenaged

under3months,asthesafetyandeffectivenessarenotknownin

thisagegroup.

Youmustlookoutforcertainsymptoms,suchasallergicreactions,

fungalinfections(suchascandida)andseverediahorrea

(pseudomembranouscolitis)whileyouaretakingCefuroxime

Aurobindo.Thiswillreducetheriskofanyproblems.See

Conditionsyouneedtolookoutfor'inSection4.

Ifyouneedabloodtest

CefuroximeAurobindocanaffecttheresultsofatestforblood

sugarlevels,orabloodscreencalledtheCoombstest.Ifyouneed

abloodtest:

Tellthepersontakingthesamplethatyouaretaking

CefuroximeAurobindo.

OthermedicinesandCefuroximeAurobindo

Tellyourdoctororpharmacistifyouaretakinganyother

medicines.

Medicinesusedtoreducetheamountofacidinyourstomach

(e.g.antacidsusedtotreatheartburn)canaffecthowCefuroxime

1.WhatCefuroximeAurobindoisandwhatitisusedfor

2.WhatyouneedtoknowbeforeyoutakeCefuroxime

Probenecid

Oralanticoagulants

ifyouaretakinganymedicine

likethis.

Contraceptivepills

CefuroximeAurobindomayreducetheeffectivenessofthe

contraceptivepill.Ifyouaretakingthecontraceptivepillwhileyou

arebeingtreatedwithCefuroximeAurobindoyoualsoneedtouse

abarriermethodofcontraception(suchascondoms).Askyour

doctorforadvice.

Pregnancyandbreast-feedingandfertility

TellyourdoctorbeforeyoutakeCefuroximeAurobindo:

ifyouarepregnant,thinkyoumightbepregnantorareplanningto

becomepregnant

ifyouarebreastfeeding.

YourdoctorwillconsiderthebenefitoftreatingyouwithCefuroxime

Aurobindoagainsttherisktoyourbaby

Drivingandusingmachines

CefuroximeAurobindocanmakeyoudizzyandhaveotherside

effectsthatmakeyoulessalert.

Don'tdriveorusemachinesifyoudonotfeelwell

Alwaystakethismedicineexactlyasyourdoctoror

pharmacisthastoldyouto.Checkwithyourdoctororpharmacist

ifyouarenotsure.

TakeCefuroximeAurobindoafterfood.Thiswillhelptomake

thetreatmentmoreeffective.

SwallowCefuroximeAurobindotabletswholewithsomewater.

Don'tchew,crushorsplitthetablets—thismaymakethe

treatmentlesseffective.

Therecommendeddose

Adults

TheusualdoseofCefuroximeAurobindois250mgto500mg

twicedailydependingontheseverityandtypeofinfection.

Children

TheusualdoseofCefuroximeAurobindois10mg/kg(toa

maximumof125mg)to15mg/kg(toamaximumof250mg)twice

dailydependingon:

theseverityandtypeofinfection

CefuroximeAurobindoisnotrecommendedforchildrenaged

under3months,asthesafetyandeffectivenessarenotknownin

thisagegroup.

Dependingontheillnessorhowyouoryourchildrespondsto

treatment,theinitialdosemaybechangedormorethanone

courseoftreatmentmaybeneeded.

Patientswithkidneyproblems

Ifyouhaveakidneyproblem,yourdoctormaychangeyourdose.

Talktoyourdoctorifthisappliestoyou.

IfyoutakemoreCefuroximeAurobindothanyoushould

IfyoutaketoomuchCefuroximeAurobindoyoumayhave

neurologicaldisorders,inparticularyoumaybemorelikelytohave

fits(seizures).

Don'tdelay.Contactyourdoctororyournearesthospital

emergencydepartmentimmediately.Ifpossible,showthem

theCefuroximeAurobindopack

IfyouforgettotakeCefuroximeAurobindo

Don'ttakeanextradosetomakeupforamisseddose.Just

takeyournextdoseattheusualtime.

IfyoustoptakingCefuroximeAurobindo

ItisimportantthatyoutakethefullcourseofCefuroxime

Aurobindo.Don'tstopunlessyourdoctoradvisesyouto–evenif

youarefeelingbetter.Ifyoudon'tcompletethefullcourseof

treatment,theinfectionmaycomeback

Ifyouhaveanyfurtherquestionsontheuseofthismedicine,ask

Tellyourdoctororpharmacist

3.HowtotakeCefuroximeAurobindo

Black

Likeallmedicines,thismedicinecancausesideeffects,although

noteverybodygetsthem.

Conditionsyouneedtolookoutfor

AsmallnumberofpeopletakingCefuroximeAurobindogetan

allergicreactionorpotentiallyseriousskinreaction.Symptomsof

thesereactionsinclude:

severeallergicreaction.Signsincluderaisedanditchyrash,

swelling,sometimesofthefaceormouthcausingdifficultyin

breathing.

skinrash,whichmayblister,andlookslikesmalltargets

(centraldarkspotsurroundedbyapalerarea,withadarkring

aroundtheedge).

awidespreadrashwithblistersandpeelingskin.(These

maybesignsofStevens-Johnsonsyndromeortoxicepidermal

necrolysis).

fungalinfections.MedicineslikeCefuroximeAurobindocan

causeanovergrowthofyeast(Candida)inthebodywhichcan

leadtofungalinfections(suchasthrush).Thissideeffectis

morelikelyifyoutakeCefuroximeAurobindoforalongtime.

severediarrhoea(Pseudomembranouscolitis).Medicines

likeCefuroximeAurobindocancauseinflammationofthecolon

(largeintestine),causingseverediarrhoea,usuallywithblood

andmucus,stomachpain,fever

Jarisch-Herxheimerreaction.Somepatientsmaygetahigh

temperature(fever),chills,headache,musclepainandskin

rashwhilebeingtreatedwithCefuroximeAurobindoforLyme

disease.ThisisknownastheJarisch-Herxheimerreaction.

Symptomsusuallylastafewhoursoruptooneday.

Contactadoctorornurseimmediatelyifyougetanyof

thesesymptoms.

Commonsideeffects

Thesemayaffectupto1in10people:

fungalinfections(suchasCandida)

headache

dizziness

diarrhoea

feelingsick

stomachpain.

Commonsideeffectsthatmayshowupinbloodtests:

anincreaseinatypeofwhitebloodcell(eosinophilia)

anincreaseinliverenzymes.

Uncommonsideeffects

Thesemayaffectupto1in100people:

beingsick

skinrashes.

Uncommonsideeffectsthatmayshowupinbloodtests:

adecreaseinthenumberofbloodplatelets(cellsthathelp

bloodtoclot)

adecreaseinthenumberofwhitebloodcells

positiveCoomb'stest.

Othersideeffects

Othersideeffectshaveoccurredinaverysmallnumberofpeople,

buttheirexactfrequencyisunknown:

severediarrhoea(pseudomembranouscolitis)

allergicreactions

skinreactions(includingsevere)

hightemperature(fever)

yellowingofthewhitesoftheeyesorskin

inflammationoftheliver(hepatitis).

Sideeffectsthatmayshowupinbloodtests:

redbloodcellsdestroyedtooquickly(haemolyticanaemia).

Reportingofsideeffects

Ifyougetanysideeffects,talktoyourdoctororpharmacist.This

includesanypossiblesideeffectsnotlistedinthisleaflet.Youcan

alsoreportsideeffectsdirectlyviathenationalreportingsystem

listedinAppendixV*.Byreportingsideeffectsyoucanhelp

4. Possiblesideeffects

Keepthismedicineoutofthesightandreachofchildren

Donotusethismedicineaftertheexpirydatewhichisstatedon

thecartonandblisterafterEXP.Theexpirydatereferstothelast

dayofthatmonth.

Thismedicinalproductdoesnotrequireanyspecialtemperature

storageconditions.

Storeintheoriginalpackageinordertoprotectfromlight.

Don'tthrowawayanymedicinesviawastewaterorhousehold

waste.Askyourpharmacisthowtothrowawaymedicinesyouno

longeruse.Thesemeasureswillhelptoprotecttheenvironment

WhatCefuroximeAurobindocontains

TheactivesubstanceisCefuroxime.

Eachtabletcontains150.36mgcefuroximeaxetilequivalentto

125mgcefuroxime.

Eachtabletcontains300.72mgcefuroximeaxetilequivalentto

250mgcefuroxime.

Eachtabletcontains601.44mgcefuroximeaxetilequivalentto

500mgcefuroxime.

Theotheringredientsaremicrocrystallinecellulose,

croscarmellosesodium,sodiumlaurilsulfate,cottonseedoil,

hydrogenatedandcolloidalanhydroussilica.

WhatCefuroximeAurobindolookslikeandcontentsofthe

pack

Tablet

CefuroximeAurobindo125mg:

Whitetooff-white,capsuleshapedtabletswith'A32'debossedon

onesideandplainontheotherside.

Thesizeis12.5mmX5.0mm.

CefuroximeAurobindo250mg:

Whitetooff-white,capsuleshapedtabletswith'A33'debossedonone

sideandplainontheotherside.Thesizeis16.0mmX6.5mm

CefuroximeAurobindo500mg:

Whitetooff-white,capsuleshapedtabletswith'A34'debossedonone

sideandplainontheotherside.Thesizeis20.0mmX8.5mm

Polyamide/Aluminium/PVC/Aluminiumblister.

Packsizes:6.8,10,12,14,15,16,20,24,50,100or500tablets.

Notallpacksizesmaybemarketed.

MarketingAuthorisationHolder

MilpharmLimited

Ares,OdysseyBusinessPark

WestEndRoad

SouthRuislipHA46QD

UnitedKingdom

Manufacturer

APLSwiftServices(Malta)Limited

HF26,HalFarIndustrialEstate,HalFar

Birzebbugia,BBG3000

Malta

ThismedicinalproductisauthorisedintheMemberStatesof

theEEAunderthefollowingnames:

Germany: CefuroximAurobindo125mg,250mg,500mg

Tabletten

Ireland: CefuroximeAurobindo125mg,250mg,500mg

tablets

Italy: CefuroximaAurobindo250mg,500mgcompresse

Poland: CefuroximAurobindo

Portugal: CefuroximaAurobindo

Romania: CefuroximeAurobindo125mg,250mg,500mg

comprimate

Spain: CefuroximaAurobindo125mg,250mg,500mg

comprimidos

5.HowtostoreCefuroximeAurobindo

6.Contentsofthepackandotherinformation

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CefuroximeAurobindo125mgtablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains150.36mgcefuroximeaxetilequivalentto125mgcefuroxime.

Forthefulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet.

Whitetooff-white,capsuleshapedtabletswith‘A32’debossedononesideandplainontheotherside.Thesizeis12.5

mmX5.0mm.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CefuroximeAurobindoisindicatedforthetreatmentoftheinfectionslistedbelowinadultsandchildrenfromtheage

of3months(seesections4.4and5.1).

Acutestreptococcaltonsillitisandpharyngitis.

Acutebacterialsinusitis.

Acuteotitismedia.

Acuteexacerbationsofchronicbronchitis.

Cystitis.

Pyelonephritis.

Uncomplicatedskinandsofttissueinfections.

TreatmentofearlyLymedisease.

Considerationshouldbegiventoofficialguidanceontheappropriateuseofantibacterialagents.

4.2Posologyandmethodofadministration

Posology

Theusualcourseoftherapyissevendays(mayrangefromfivetotendays).

Table1.Adultsandchildren(40kg)

Indication Dosage

Acutetonsillitisandpharyngitis,acute

bacterialsinusitis 250mgtwicedaily

Acuteotitismedia 500mgtwicedaily

Acuteexacerbationsofchronicbronchitis 500mgtwicedaily

Cystitis 250mgtwicedaily

Pyelonephritis 250mgtwicedaily

Uncomplicatedskinandsofttissueinfections 250mgtwicedaily

Lymedisease 500mgtwicedailyfor14days

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Table2.Children(<40kg)

ThereisnoexperienceofusingCefuroximeAurobindoinchildrenundertheageof3months.

Cefuroximeaxetiltabletsandcefuroximeaxetilgranulesfororalsuspensionarenotbioequivalentandarenot

substitutableonamilligram-per-milligrambasis(seesection5.2).

Renalimpairment

Thesafetyandefficacyofcefuroximeaxetilinpatientswithrenalfailurehavenotbeenestablished.

Cefuroximeisprimarilyexcretedbythekidneys.Inpatientswithmarkedlyimpairedrenalfunctionitisrecommended

thatthedosageofcefuroximeshouldbereducedtocompensateforitsslowerexcretion.Cefuroximeiseffectively

removedbydialysis.

Table5.RecommendeddosesforCefuroximeAurobindoinrenalimpairment

Hepaticimpairment

Therearenodataavailableforpatientswithhepaticimpairment.Sincecefuroximeisprimarilyeliminatedbythe

kidney,thepresenceofhepaticdysfunctionisexpectedtohavenoeffectonthepharmacokineticsofcefuroxime.

Methodofadministration

Oraluse

CefuroximeAurobindotabletsshouldbetakenafterfoodforoptimumabsorption.

CefuroximeAurobindotabletsshouldnotbecrushedandarethereforeunsuitablefortreatmentofpatientswhocannot

Indication Dosage

Acutetonsillitisandpharyngitis,acute

bacterialsinusitis 10mg/kgtwicedailytoamaximum

of125mgtwicedaily

Childrenagedtwoyearsorolderwithotitis

mediaor,whereappropriate,withmoresevere

infections 15mg/kgtwicedailytoamaximum

of250mgtwicedaily

Cystitis 15mg/kgtwicedailytoamaximum

of250mgtwicedaily

Pyelonephritis 15mg/kgtwicedailytoamaximum

of250mgtwicedailyfor10to14

days

Uncomplicatedskinandsofttissueinfections 15mg/kgtwicedailytoamaximum

of250mgtwicedaily

Lymedisease 15mg/kgtwicedailytoamaximum

of250mgtwicedailyfor14days

(10to21days)

Creatinineclearance T

1/2 (hrs) Recommendeddosage

30mL/min/1.73m 2 1.4–2.4 nodoseadjustmentnecessary

(standarddoseof125mgto500

mggiventwicedaily)

10-29mL/min/1.73m 2 4.6 standardindividualdosegiven

every24hours

<10mL/min/1.73m 2 16.8 standardindividualdosegiven

every48hours

Patientsonhaemodialysis 2-4 afurtherstandardindividual

doseshouldbegivenattheend

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4.3Contraindications

Hypersensitivitytocefuroximeortoanyoftheexcipientslistedinsection6.1.

Patientswithknownhypersensitivitytocephalosporinantibiotics.

Historyofseverehypersensitivity(e.g.anaphylacticreaction)toanyothertypeofbetalactamantibacterialagent

(penicillins,monobactamsandcarbapenems).

4.4Specialwarningsandprecautionsforuse

Hypersensitivityreactions

Specialcareisindicatedinpatientswhohaveexperiencedanallergicreactiontopenicillinsorotherbeta-lactam

antibioticsbecausethereisariskofcross-sensitivity.Aswithallbeta-lactamantibacterialagents,seriousand

occasionallyfatalhypersensitivityreactionshavebeenreported.Incaseofseverehypersensitivityreactions,treatment

withcefuroximemustbediscontinuedimmediatelyandadequateemergencymeasuresmustbeinitiated.

Beforebeginningtreatment,itshouldbeestablishedwhetherthepatienthasahistoryofseverehypersensitivity

reactionstocefuroxime,toothercephalosporinsortoanyothertypeofbeta-lactamagent.Cautionshouldbeusedif

cefuroximeisgiventopatientswithahistoryofnon-severehypersensitivitytootherbeta-lactamagents.

Jarisch-Herxheimerreaction

TheJarisch-HerxheimerreactionhasbeenseenfollowingcefuroximeaxetiltreatmentofLymedisease.Itresults

directlyfromthebactericidalactivityofcefuroximeaxetilonthecausativebacteriaofLymedisease,thespirochaete

Borreliaburgdorferi.Patientsshouldbereassuredthatthisisacommonandusuallyself-limitingconsequenceof

antibiotictreatmentofLymedisease(seesection4.8).

Overgrowthofnon-susceptiblemicroorganisms

Aswithotherantibiotics,useofcefuroximeaxetilmayresultintheovergrowthofCandida.Prolongedusemayalso

resultintheovergrowthofothernon-susceptiblemicroorganisms(e.g.enterococciandClostridiumdifficile),which

mayrequireinterruptionoftreatment(seesection4.8).

Antibacterialagent–associatedpseudomembranouscolitishavebeenreportedwithnearlyallantibacterialagents,

includingcefuroximeandmayrangeinseverityfrommildtolifethreatening.Thisdiagnosisshouldbeconsideredin

patientswithdiarrhoeaduringorsubsequenttotheadministrationofcefuroxime(seesection4.8).Discontinuationof

therapywithcefuroximeandtheadministrationofspecifictreatmentforClostridiumdifficileshouldbeconsidered.

Medicinalproductsthatinhibitperistalsisshouldnotbegiven(seesection4.8).

Interferencewithdiagnostictests

ThedevelopmentofapositiveCoomb’sTestassociatedwiththeuseofcefuroximemayinterferewithcrossmatching

ofblood(seesection4.8).

Asafalsenegativeresultmayoccurintheferricyanidetest,itisrecommendedthateithertheglucoseoxidaseor

hexokinasemethodsareusedtodetermineblood/plasmaglucoselevelsinpatientsreceivingcefuroximeaxetil.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Drugswhichreducegastricaciditymayresultinalowerbioavailabilityofcefuroximeaxetilcomparedwiththatofthe

fastingstateandtendtocanceltheeffectofenhancedabsorptionafterfood.

Cefuroximeaxetilmayaffectthegutflora,leadingtoloweroestrogenreabsorptionandreducedefficacyofcombined

oralcontraceptives.

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recommended.Concurrentadministrationofprobenecidsignificantlyincreasesthepeakconcentration,areaunderthe

serumconcentrationtimecurveandeliminationhalf-lifeofcefuroxime.

ConcomitantusewithoralanticoagulantsmaygiverisetoincreasedINR.

4.6Fertility,pregnancyandlactation

Pregnancy

Therearelimiteddatafromtheuseofcefuroximeinpregnantwomen.Studiesinanimalshaveshownnoharmful

effectsonpregnancy,embryonalorfoetaldevelopment,parturitionorpostnataldevelopment.CefuroximeAurobindo

shouldbeprescribedtopregnantwomenonlyifthebenefitoutweighstherisk.

Breastfeeding

Cefuroximeisexcretedinhumanmilkinsmallquantities.Adverseeffectsattherapeuticdosesarenotexpected,

althoughariskofdiarrhoeaandfungusinfectionofthemucousmembranescannotbeexcluded.Breastfeedingmight

havetobediscontinuedduetotheseeffects.Thepossibilityofsensitisationshouldbetakenintoaccount.Cefuroxime

shouldonlybeusedduringbreastfeedingafterbenefit/riskassessmentbythephysicianincharge.

Fertility:

Therearenodataontheeffectsofcefuroximeaxetilonfertilityinhumans.Reproductivestudiesinanimalshave

shownnoeffectsonfertility.

4.7Effectsonabilitytodriveandusemachines

Nostudiesontheeffectsontheabilitytodriveandusemachineshavebeenperformed.However,asthismedicinemay

causedizziness,patientsshouldbewarnedtobecautiouswhendrivingoroperatingmachinery.

4.8Undesirableeffects

ThemostcommonadversereactionsareCandidaovergrowth,eosinophilia,headache,dizziness,gastrointestinal

disturbancesandtransientriseinliverenzymes.

Thefrequencycategoriesassignedtotheadversereactionsbelowareestimates,asformostreactionssuitabledata(for

examplefromplacebo-controlledstudies)forcalculatingincidencewerenotavailable.Inadditiontheincidenceof

adversereactionsassociatedwithcefuroximeaxetilmayvaryaccordingtotheindication.

Datafromlargeclinicalstudieswereusedtodeterminethefrequencyofverycommontorareundesirableeffects.The

frequenciesassignedtoallotherundesirableeffects(i.e.thoseoccurringat<1/10,000)weremainlydeterminedusing

post-marketingdataandrefertoareportingrateratherthantruefrequency.Placebo-controlledtrialdatawerenot

available.Whereincidenceshavebeencalculatedfromclinicaltrialdata,thesewerebasedondrug-related(investigator

assessed)data.Withineachfrequencygrouping,undesirableeffectsarepresentedinorderofdecreasingseriousness.

Treatmentrelatedadversereactions,allgrades,arelistedbelowbyMedDRAbodysystemorganclass,frequencyand

gradeofseverity.Thefollowingconventionhasbeenutilisedfortheclassificationoffrequency:verycommon 1/10;

common 1/100to<1/10,uncommon 1/1,000to<1/100;rare 1/10,000to<1/1,000;veryrare<1/10,000andnot

known(cannotbeestimatedfromtheavailabledata).

Systemorganclass Common Uncommon Notknown

Infectionsand

infestations Candida

overgrowth Clostridiumdifficileovergrowth

Bloodand

lymphaticsystem

disorders eosinophilia positiveCoomb’stest,

thrombocytopenia,

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Paediatricpopulation

Thesafetyprofileforcefuroximeaxetilinchildrenisconsistentwiththeprofileinadults.

Reportingofsuspectedadversereactions

Reportingsuspectedadversereactionsafterauthorisationofthemedicinalproductisimportant.Itallowscontinued

monitoringofthebenefit/riskbalanceofthemedicinalproduct.Healthcareprofessionalsareaskedtoreportany

suspectedadversereactionsviaHPRAPharmacovigilance,EarlsfortTerrace,IRL-Dublin2;Tel:+35316764971;

Fax:+35316762517.Website:www.hpra.ie;E-mail:medsafety@hpra.ie.

4.9Overdose

Overdosecanleadtoneurologicalsequelaeincludingencephalopathy,convulsionsandcoma.Symptomsofoverdose

canoccurifthedoseisnotreducedappropriatelyinpatientswithrenalimpairment(seesections4.2and4.4).

Serumlevelsofcefuroximecanbereducedbyhaemodialysisandperitonealdialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:antibacterialsforsystemicuse,second-generationcephalosporins,ATCcode:J01DC02

Mechanismofaction

Cefuroximeaxetilundergoeshydrolysisbyesteraseenzymestotheactiveantibiotic,cefuroxime.

Cefuroximeinhibitsbacterialcellwallsynthesisfollowingattachmenttopenicillinbindingproteins(PBPs).This

resultsintheinterruptionofcellwall(peptidoglycan)biosynthesis,whichleadstobacterialcelllysisanddeath.

Mechanismofresistance

Bacterialresistancetocefuroximemaybeduetooneormoreofthefollowingmechanisms:

hydrolysisbybeta-lactamases;including(butnotlimitedto)byextended-spectrumbeta-lactamases(ESBLs),and

AmpCenzymesthatmaybeinducedorstablyderepressedincertainaerobicGram-negativebacteriaspecies;

reducedaffinityofpenicillin-bindingproteinsforcefuroxime;

outermembraneimpermeability,whichrestrictsaccessofcefuroximetopenicillinbindingproteinsinGram-

negativebacteria;

profound)

Immunesystem

disorders drugfever,serumsickness,anaphylaxis,Jarisch-

Herxheimerreaction

Nervoussystem

disorders headache,

dizziness

Gastrointestinal

disorders diarrhoea,nausea,

abdominalpain vomiting pseudomembranouscolitis

Hepatobiliary

disorders transientincreases

ofhepaticenzyme

levels jaundice(predominantlycholestatic),hepatitis

Skinand

subcutaneoustissue

disorders skinrashes urticaria,pruritus,erythemamultiforme,Stevens-

Johnsonsyndrome,toxicepidermalnecrolysis

(exanthematicnecrolysis)(seeImmunesystem

disorders),angioneuroticoedema

Descriptionofselectedadversereactions

Cephalosporinsasaclasstendtobeabsorbedontothesurfaceofredcellsmembranesandreactwithantibodiesdirected

againstthedrugtoproduceapositiveCoombs’test(whichcaninterferewithcross-matchingofblood)andveryrarely

haemolyticanaemia.

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Organismsthathaveacquiredresistancetootherinjectablecephalosporinsareexpectedtoberesistanttocefuroxime.

Dependingonthemechanismofresistance,organismswithacquiredresistancetopenicillinsmaydemonstratereduced

susceptibilityorresistancetocefuroxime.

Cefuroximeaxetilbreakpoints

Minimuminhibitoryconcentration(MIC)breakpointsestablishedbytheEuropeanCommitteeonAntimicrobial

SusceptibilityTesting(EUCAST)areasfollows:

S=susceptible,R=resistant

Microbiologicalsusceptibility

Theprevalenceofacquiredresistancemayvarygeographicallyandwithtimeforselectedspeciesandlocalinformation

onresistanceisdesirable,particularlywhentreatingsevereinfections.Asnecessary,

expertadviceshouldbesoughtwhenthelocalprevalenceofresistanceissuchthattheutilityofcefuroximeaxetilinat

leastsometypesofinfectionsisquestionable.

Microorganism Breakpoints(mg/L)

Enterobacteriaceae 1,2 8 >8

Staphylococcusspp.

Note 3

Note 3

StreptococcusA,B,CandG

Note 4

Note 4

Streptococcuspneumoniae 0.25 >0.5

Moraxellacatarrhalis 0.125 >4

Haemophilusinfluenzae 0.125 >1

Non-speciesrelatedbreakpoints 1

ThecephalosporinbreakpointsforEnterobacteriaceaewilldetectallclinicallyimportant

resistancemechanisms(includingESBLandplasmidmediatedAmpC).Somestrainsthatproduce

beta-lactamasesaresusceptibleorintermediateto3rdor4thgenerationcephalosporinswiththese

breakpointsandshouldbereportedasfound,i.e.thepresenceorabsenceofanESBLdoesnotin

itselfinfluencethecategorizationofsusceptibility.Inmanyareas,ESBLdetectionand

characterizationisrecommendedormandatoryforinfectioncontrolpurposes.

UncomplicatedUTI(cystitis)only(seesection4.1).

Susceptibilityofstaphylococcitocephalosporinsisinferredfromthemethicillinsusceptibility

exceptforceftazidmeandcefiximeandceftibuten,whichdonothavebreakpointsandshouldnot

beusedforstaphylococcalinfections.

Thebeta-lactamsusceptabilityofbeta-haemolyticstreptococcigroupsA,B,CandGisinferred

fromthepenicillinsusceptibility.

insufficientevidencethatthespeciesinquestionisagoodtargetfortherapywiththedrug.An

MICwithacommentbutwithoutanaccompanyingSorR-categorizationmaybereported.

Commonlysusceptiblespecies

Gram-positiveaerobes:

Staphylococcusaureus(methicillinsusceptible)*

Streptococcuspyogenes

Streptococcusagalactiae

Gram-negativeaerobes:

Haemophilusinfluenzae

Haemophilusparainfluenzae

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Spirochaetes:

Borreliaburgdorferi

Microorganismsforwhichacquiredresistancemaybeaproblem

Gram-positiveaerobes:

Streptococcuspneumoniae

Gram-negativeaerobes:

Citrobacterfreundii

Enterobacteraerogenes

Enterobactercloacae

Escherichiacoli

Klebsiellapneumoniae

Proteusmirabilis

Proteusspp.(otherthanP.vulgaris)

Providenciaspp.

Gram-positiveanaerobes:

Peptostreptococcusspp.

Propionibacteriumspp.

Gram-negativeanaerobes:

Fusobacteriumspp.

Bacteroidesspp.

Inherentlyresistantmicroorganisms

Gram-positiveaerobes:

Enterococcusfaecalis

Enterococcusfaecium

Gram-negativeaerobes:

Acinetobacterspp.

Campylobacterspp.

Morganellamorganii

Proteusvulgaris

Pseudomonasaeruginosa

Serratiamarcescens

Gram-negativeanaerobes:

Bacteroidesfragilis

Others:

Chlamydiaspp.

Mycoplasmaspp.

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5.2Pharmacokineticproperties

Absorption

Afteroraladministrationcefuroximeaxetilisabsorbedfromthegastrointestinaltractandrapidlyhydrolysedinthe

intestinalmucosaandbloodtoreleasecefuroximeintothecirculation.Optimumabsorptionoccurswhenitis

administeredshortlyafterameal.

Followingadministrationofcefuroximeaxetiltabletspeakserumlevels(2.9µg/mLfora125mgdose,4.4µg/mLfora

250mgdose,7.7µg/mLfora500mgdoseand13.6µg/mLfora1000mgdose)occurapproximately2.4hoursafter

dosingwhentakenwithfood.Therateofabsorptionofcefuroximefromthesuspensionisreducedcomparedwiththe

tablets,leadingtolater,lowerpeakserumlevelsandreducedsystemicbioavailability(4to17%less).Cefuroxime

axetiloralsuspensionwasnotbioequivalenttocefuroximeaxetiltabletswhentestedinhealthyadultsandthereforeis

notsubstitutableonamilligram-per-milligrambasis(seesection4.2).Thepharmacokineticsofcefuroximeislinear

overtheoraldosagerangeof125to1000mg.Noaccumulationofcefuroximeoccurredfollowingrepeatoraldosesof

250to500mg.

Distribution

Proteinbindinghasbeenstatedas33to50%dependingonthemethodologyused.Followingasingledoseof

cefuroximeaxetil500mgtabletto12healthyvolunteers,theapparentvolumeofdistributionwas50L(CV%=28%).

Concentrationsofcefuroximeinexcessoftheminimuminhibitorylevelsforcommonpathogenscanbeachievedinthe

tonsilla,sinustissues,bronchialmucosa,bone,pleuralfluid,jointfluid,synovialfluid,interstitialfluid,bile,sputum

andaqueoushumor.Cefuroximepassestheblood-brainbarrierwhenthemeningesareinflamed.

Biotransformation

Cefuroximeisnotmetabolised.

Elimination

Theserumhalf-lifeisbetween1and1.5hours.Cefuroximeisexcretedbyglomerularfiltrationandtubularsecretion.

Therenalclearanceisintheregionof125to148mL/min/1.73m2.

Specialpatientpopulations

Gender

Nodifferencesinthepharmacokineticsofcefuroximewereobservedbetweenmalesandfemales.

Elderly

Nospecialprecautionisnecessaryintheelderlypatientswithnormalrenalfunctionatdosagesuptothenormal

maximumof1gperday.Elderlypatientsaremorelikelytohavedecreasedrenalfunction;therefore,thedoseshould

beadjustedinaccordancewiththerenalfunctionintheelderly(seesection4.2).

Paediatrics

Inolderinfants(aged>3months)andinchildren,thepharmacokineticsofcefuroximearesimilartothatobservedin

adults.

Thereisnoclinicaltrialdataavailableontheuseofcefuroximeaxetilinchildrenundertheageof3months.

Renalimpairment

Thesafetyandefficacyofcefuroximeaxetilinpatientswithrenalfailurehavenotbeenestablished.

Cefuroximeisprimarilyexcretedbythekidneys.Therefore,aswithallsuchantibiotics,inpatientswithmarkedly

impairedrenalfunction(i.e.C1cr<30mL/minute)itisrecommendedthatthedosageofcefuroximeshouldbereduced

tocompensateforitsslowerexcretion(seesection4.2).Cefuroximeiseffectivelyremovedbydialysis.

Hepaticimpairment

Therearenodataavailableforpatientswithhepaticimpairment.Sincecefuroximeisprimarilyeliminatedbythe

kidney,thepresenceofhepaticdysfunctionisexpectedtohavenoeffectonthepharmacokineticsofcefuroxime.

PK/PDrelationship

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beenshowntobethepercentageofthedosinginterval(%T)thattheunboundconcentrationremainsabovethe

minimuminhibitoryconcentration(MIC)ofcefuroximeforindividualtargetspecies(i.e.%T>MIC).

5.3Preclinicalsafetydata

Non-clinicaldatarevealnospecialhazardforhumansbasedonstudiesofsafetypharmacology,repeateddosetoxicity,

genotoxicityandtoxicitytoreproductionanddevelopment.Nocarcinogenicitystudieshavebeenperformed;however,

thereisnoevidencetosuggestcarcinogenicpotential.

Gammaglutamyltranspeptidaseactivityinraturineisinhibitedbyvariouscephalosporins,howeverthelevelof

inhibitionislesswithcefuroxime.Thismayhavesignificanceintheinterferenceinclinicallaboratorytestsinhumans.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Microcrystallinecellulose(E460)

Croscarmellosesodium

Sodiumlaurilsulfate

Cottonseedoil,hydrogenated

Colloidalanhydroussilica

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialtemperaturestorageconditions.

Storeintheoriginalpackageinordertoprotectfromlight.

6.5Natureandcontentsofcontainer

Polyamide/Aluminium/PVC/Aluminiumblister

Packsizes:6.8,10,12,14,15,16,20,24,50,100or500tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

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7MARKETINGAUTHORISATIONHOLDER

MilpharmLimited

Ares,OdysseyBusinessPark

WestEndRoad

SouthRuislipHA46QD

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA1050/021/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:30thSeptember2011

DateofLastRenewal:30thApril2015

10DATEOFREVISIONOFTHETEXT

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