CEFODOX PAEDIATRIC 40MG/ 5ML GRANULES FOR ORAL SUSP

Main information

  • Trade name:
  • CEFODOX PAEDIATRIC 40MG/ 5ML GRANULES FOR ORAL SUSP
  • Dosage:
  • 40 Base mg/ 5ml
  • Pharmaceutical form:
  • Granules for Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEFODOX PAEDIATRIC 40MG/5ML GRANULES FOR ORAL SUSP
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0540/033/001
  • Authorization date:
  • 21-07-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CefodoxPaediatric40mg/5mlGranulesforOralSuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Whenreconstitutedeach5mlvolumecontains40mgofcefpodoxime,ascefpodoximeproxetil.

Excipients:containsper5ml:

Aspartame(E951)20mg

Lactosemonohydrateq.s.

Sucrose601.33mg

Potassium2.17mg

Sulphites0.72micrograms

Glucose322.2mg

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Granulesfororalsuspension

Paleyellowgranules.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Cefodoxisabactericidalcephalosporinantibioticactiveagainstinvitroawiderangeofgram-negativeandgram-

positiveorganisms.Itisindicatedforthetreatmentofthefollowinginfections.

Indicationsinclude:

Upperrespiratorytractinfectionscausedbyorganismssensitivetocefpodoxime,includingacuteotitismedia,

sinusitis,tonsillitisandpharyngitis.

Cefodoxshouldbereservedforrecurrentorchronicinfections.

Lowerrespiratorytractinfectionscausedbyorganismssensitivetocefpodoxime.

Upperandlowerurinarytractinfectionscausedbyorganismssensitivetocefpodoximeincludingcystitisandacute

pyelonephritis.

Skinandsofttissueinfectionscausedbyorganismssensitivetocefpodoximesuchasabscesses,cellulitis,infected

wounds,folliculitis,paronychia,carbuncles,burnsandulcers.

4.2Posologyandmethodofadministration

Routeofadministration:Oral.

Adults&Elderly:

Notapplicableforthisproduct.

Children:

Therecommendedmeandosageforchildrenis8mg/kg/dayadministeredintwodivideddosesat12hourintervals.

Thefollowingdosageregimenisproposedasaguidetoprescribing:

Below6months: 8mg/kg/dayin2divideddoses.

6months-2years: 5.0mltwicedaily.

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Cefodoxshouldnotbeusedininfantslessthan15daysold,asnoexperienceyetexistsinthisagegroup.

Ameasuringspoon(5ml)isprovidedwiththebottletoaidcorrectdosing.Onemeasuringspoon(5ml)containsthe

equivalentof40mgcefpodoxime.

Theproductshouldbetakenduringmealsforoptimalabsorption.

RenalImpairment:

ThedosageofCefodoxdoesnotrequiremodificationifcreatinineclearance(CLcr)exceeds40ml.min/1.73m.

Belowthisvalue,pharmacokineticstudiesindicateanincreaseinplasmaeliminationhalf-lifeandthemaximumplasma

concentrations,andhencethedosageshouldbeadjustedappropriately.

CLcr10-39ml.Min¯¹/1.73m²=unitdoseevery24hours.

CLcr<10ml.Min¯¹/1.73m²=unitdoseevery48hours.

Haemodialysispatients=unitdoseaftereachdialysissession.

HepaticImpairment:

Thedosagedoesnotrequiremodificationincasesofhepaticimpairment.

InstructionsforReconstitution:

Beforepreparingthesuspensionthesilicageldesiccantcontainedinacapsuleinsidethecapmustberemovedand

disposedof.Thesuspensionispreparedbyaddingwatertothebottleuptothecalibratedmarkandshakingthoroughly

toobtainanevenlydispersedsuspension.

4.3Contraindications

Patientswithhypersensitivitytocephalosporinantibiotics,oranyoftheexcipients(seesection6.1).

Patientswithphenylketonuriasincetheproductcontainsaspartame.

4.4Specialwarningsandprecautionsforuse

Preliminaryenquiryaboutallergytopenicillinisnecessarybeforeprescribingcephalosporinssincecrossallergyto

penicillinsoccursin5-10%ofcases.

Particularcarewillbeneededinpatientssensitivetopenicillin:strictmedicalsurveillanceisnecessaryfromthevery

firstadministration.Wherethereisdoubt,medicalassistanceshouldbeavailableattheinitialadministration,inorder

totreatanyanaphylacticepisode.

Inpatientswhoareallergictoothercephalosporins,thepossibilityofcrossallergytoCefodoxshouldbeborneinmind.

Cefodoxshouldnotbegiventothosepatientswithaprevioushistoryofimmediatetypehypersensitivityto

cephalosporins.

Hypersensitivityreactions(anaphylaxis)observedwithbetalactamantibioticscanbeseriousandoccasionallyfatal.

Theonsetofanymanifestationofhypersensitivityindicatesthattreatmentshouldbestopped.

Cefodoxisnotthepreferredantibioticforthetreatmentofstaphylococcalpneumoniaandshouldnotbeusedinthe

treatmentofatypicalpneumoniacausedbyorganismssuchasLegionella,MycoplasmaandChlamydia.

Incasesofsevererenalinsufficiencyitmaybenecessarytoreducethedosageregimendependentonthecreatinine

Above9years: 12.5mltwicedailyor100mgtablettwicedaily.

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Antibioticsshouldalwaysbeprescribedwithcautioninpatientswithahistoryofgastrointestinaldisease,particularly

colitis.Cefodoxmayinducediarrhoea,antibioticassociatedcolitisandpseudomembranouscolitis.Theseside-effects,

whichmayoccurmorefrequentlyinpatientsreceivinghigherdosesforprolongedperiods,shouldbeconsideredas

potentiallyserious.ThepresenceofC.Difficileshouldbeinvestigated.Inallpotentialcasesofcolitis,thetreatment

shouldbestoppedimmediately.Thediagnosisshouldbeconfirmedbysigmoidoscopyandspecificantibiotictherapy

vancomycinsubstitutedifconsideredclinicallynecessary.Theadministrationofproductswhichcausefaecalstasis

mustbeavoided.Althoughanyantibioticmaycausepseudomembranouscolitis,theriskmaybehigherwithbroad-

spectrumdrugs,suchasthecephalosporins.

Theproductshouldnotbeusedininfantslessthan15daysoldasnoclinicaltrialdatainthisagegroupyetexists.

Changesinrenalfunctionhavebeenobservedwithantibioticsofthesameclass,particularlywhengivenconcurrently

withpotentiallynephrotoxicdrugssuchasaminoglycosidesand/orpotentdiuretics.Insuchcases,renalfunctionshould

bemonitored.

Aswithallbeta-lactamantibiotics,neutropeniaandmorerarelyagranulocytosismaydevelopparticularlyduring

extendedtreatments.Forcasesoftreatmentlastinglongerthan10days,bloodcountshouldthereforebemonitoredand

treatmentdiscontinuedifneutropeniaisfound.

Aswithotherantibiotics,theprolongeduseofcephalosporinsmayresultintheovergrowthofnon-susceptible

organisms.Withoralantibioticsthenormalcolonicfloramaybealtered,allowingovergrowthbyClostridiawith

consequentpseudomembranouscolitis.Repeatedevaluationofthepatientisessentialandifsuperinfectionoccurs

duringtherapy,appropriatemeasuresshouldbetaken.

Cephalosporinsmaybeabsorbedontothesurfaceofredcellmembranesandreactwithantibioticsdirectedagainstthe

drug.ThiscanproduceapositiveCoomb’stestandveryrarely,haemolyticanaemia.Cross-reactivitymayoccurwith

penicillinsforthisreaction.

Patientswithrarehereditaryproblemsofgalactoseintolerance,fructoseintolerance,theLapplactasedeficiency,

glucose-galactosemalabsorptionorsucrose-isomaltaseinsufficiencyshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noclinicallysignificantdruginteractionshavebeenreportedduringthecourseofclinicalstudies.

HistamineH2-antagonistsandantacidsreducethebioavailabilityofcefpodoxime.Probenecidreducestheexcretionof

cephalosporins.Cephalosporinspotentiallyenhancetheanticoagulanteffectofcoumarinsandreducethecontraceptive

effectofoestrogens.

Studieshaveshownthatbioavailabilityisdecreasedbyapproximately30%whenCefodoxisadministeredwithdrugs

whichneutralisegastricpHorinhibitacidsecretions.Therefore,suchdrugsasantacidsofthemineraltypeand

Hblockerssuchasranitidine,whichcauseanincreaseingastricpH,shouldbetaken2or3hoursafterCefodox

administration.

Incontrast,drugsthatdecreasegastricpHsuchaspentagastrinwillincreasebioavailability.Theclinicalconsequences

remaintobeestablished.

Changeinrenalfunctionhasbeenobservedwithantibioticsofthesameclass,particularlywhengivenconcurrently

withpotentiallynephrotoxicdrugssuchasaminoglycosidesand/orpotentdiuretics.Insuchcases,renalfunction

shouldbemonitored(seesection4.4SpecialWarningandPrecautionsforUse).

Thebioavailabilityincreasesiftheproductisadministeredduringmeals.

Aswithothercephalosporins,isolatedcasesshowingdevelopmentofapositiveCoomb’stesthavebeenreported.(See

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AfalsepositivereactionforglucoseintheurinemayoccurwithBenedict’sorFehling’ssolutionsorwithcopper

sulphatetesttablets,butnotwithtestsbasedonenzymaticglucoseoxidasereactions.

4.6Fertility,pregnancyandlactation

Pregnancy

Studiescarriedoutinseveralanimalspecieshavenotrevealedanyteratogenicorfoetotoxiceffects.However,the

safetyofcefpodoximeproxetilinpregnantwomenhasnotbeenestablished;itisthereforeadvisablenottoadminister

theproductduringpregnancy.

Lactation

Studieshaveshownthatcefpodoximeisexcretedinhumanmilk.Itisrecommendedthateitherbreastfeedingshouldbe

ceasedortreatmentshouldbediscontinued.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

SystemOrganClass ADRTerm Frequency

BloodandLymphaticSystemDisorders Eosinophilia rare

Thrombocytopenia rare

Neutropenia unknown

Agranulocytosis unknown

Hemolyticanaemia unknown

EarandLabyrinthDisorders Tinnitus unknown

GastrointestinalDisorders Enterocolitis rare

Diarrhoea common

Nausea common

Abdomialpain uncommon

Vomiting uncommon

Bloodinstools unknown

GeneralDisordersandAdministration

SiteConditions Malaise rare

Asthenia uncommon

HepatobiliaryDisorders Bilirubinemia rare

Liverinjury unknown

Cholestasis unknown

ImmuneSystemDisorder Shock unknown

InfectionsandInfestations Superinfections common

Pseudomembranouscolitis unknown

Overgrowthofnon-

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Renal

Slightincreasesinbloodureaandcreatininehavebeenreported.

Changesinrenalfunctionhavebeenobservedwithantibioticsfromthesamegroupascefpodoxime,particularlywhen

co-prescribedwithaminoglycosidesand/orpotentdiuretics(SeeSection4.4.SpecialWarningsandPrecautionsfor

Use).

Other

Occasionalcaseshavebeenreportedofheadaches,dizziness,tinnitus,parethesiaandasthenia.

Superinfection:aswithotherantibiotics,theuseofcefpodoximeproxetil,especiallyifprolonged,mayresultin

overgrowthofnon-susceptible

organisms.Repeatedevaluationofthepatient'sconditionisessential.Ifsuperinfectionoccursduringtherapy,

appropriatemeasuresshouldbetaken.

4.9Overdose

IntheeventofoverdosagewithCefodox,supportiveandsymptomatictherapyisindicated.

Incasesofoverdosage,particularlyinpatientswithrenalinsufficiency,encephalopathymayoccur.The

encephalopathyisusuallyreversibleoncecefpodoximeplasmalevelshavefallen.

Nospecificantidoteexists.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:J01DD01

Cefodox(Cefpodoximeproxetil)isabeta-lactamantibiotic,a3rdgenerationoralcephalosporin.Itistheprodrugof

cefpodoxime.

Followingoraladministration,Cefodoxistakenupbythegastro-intestinalwallwhereitisrapidlyhydrolysedto

cefpodoxime,abactericidalantibiotic,whichisthenabsorbedsystemically.

BACTERIOLOGY:

Investigations Increasesinliverenzymes uncommon

Changesinrenalfunction rare

NervousSystemDisorders Dizzysensations uncommon

Headache uncommon

Paraesthesia rare

SkinandSubcutaneousTissueDisorders Pruritus uncommon

Rash uncommon

Urticaria uncommon

Angioedema unknown

Purpura unknown

Stevens-Johnsonsyndrome unknown

Toxicepidermalnecrolysis unknown

Erythemamultiforme unknown

Respiratory,ThoracicandMediastinal

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beta-lactamases.

Cefpodoximehasbeenshowntopossessinvitrobactericidalactivityagainstnumerousgrampositiveandgram

negativebacteria.

Thefollowingareresistanttocefpodoxime.

Enterococci

Methicillin-resistantStaphylococci(S.AureusandS.Coagulase(negative))

StaphylococcusSaprophyticus

PseudomonasAeruginosaandPseudomonasSpp.

ClostridiumDifficile

BacteroidesFragilisandRelatedSpecies

Aswithallantibiotics,wheneverpossible,sensitivityshouldbeconfirmedbyin-vitrotesting.

5.2Pharmacokineticproperties

Cefodoxistakenupintheintestineandishydrolysedtotheactivemetabolitecefpodoxime.Whencefpodoxime

proxetilisadministeredorallytofastingsubjectsasatabletcorrespondingto100mgofcefpodoxime,51.5%is

absorbedandabsorptionisincreasedbyfoodintake.Thevolumeofdistributionis32.3landpeaklevelsof

cefpodoximeoccur2to3hrsafterdosing.Themaximumplasmaconcentrationis1.2mg/land2.5mg/lafterdosesof

100mgand200mgrespectively.Followingadministrationof100mgand200mgtwicedailyover14.5days,theplasma

pharmacokineticparametersofcefpodoximeremainunchanged.Serumproteinbindingofcefpodoxime,40%

principallytoalbumin.Thisbindingisnonsaturableintype.

Concentrationsofcefpodoximeinexcessoftheminimuminhibitorylevels(MIC)forcommonpathogenscanbe

achievedinlungparenchyma,bronchialmucosa,pleuralfluid,tonsils,interstitialfluidandprostatetissue.

Asthemajorityofcefpodoximeiseliminatedintheurine,theconcentrationishigh.(Concentrationsin0-4,4-8,8-12

hrfractionsafterasingledoseexceedMIC ofcommonurinarypathogens).Gooddiffusionofcefpodoximeisalso

seenintorenaltissue,withconcentrationsaboveMIC ofthecommonurinarypathogens,3-12hrsafteran

administrationofasingle200mgdose(0.6-3.1micrograms/g).Concentrationsofcefpodoximeinthemedullaryand

corticaltissuesissimilar.

Studiesinhealthyvolunteersshowmedianconcentrationsofcefpodoximeinthetotalejaculate6-12hrsfollowing

administrationofasingle200mgdosetobeabovetheMIC ofN.gonorrhoeae.

Themainrouteofexcretionisrenal,80%isexcretedunchangedintheurine,withaneliminationhalf-lifeofapprox2.4

hours.

CHILDREN

Inchildren,studieshaveshownthemaximumplasmaconcentrationoccursapproximately2-4hoursafterdosing.A

single5mg/kgdosein4-12yearoldsproducedamaximumconcentrationsimilartothatinadultsgivena200mgdose.

Inpatientsbelow2yearsreceivingrepeateddosesof5mg/kg12hourly,theaverageplasmaconcentrations,2hours

postdose,arebetween2.75mg/l(1-6months)and2.0mg/l(7months-2years).

Inpatientsbetween1monthand12yearsreceivingrepeateddosesof5mg/kg12hourly,theresidualplasma

concentrationatsteadystatearebetween0.2-0.3mg/l(1month-2years)and0.1mg/l(2-12years).

5.3Preclinicalsafetydata

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Anhydrouscolloidalsilica

Aspartame(E951)

Bananaflavour

Carmellosecalcium

Carmellosesodium

Citricacidmonohydrate

Hyprolose/hydroxypropylcellulose

Yellowironoxide(E172)

Lactosemonohydrate

Monosodiumglutamate

Potassiumsorbate(E202)

Sodiumchloride

Sorbitantrioleate

Sucrose

Talc

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Unreconstitutedproduct: 2years.

Reconstitutedsuspension: 10days.

6.4Specialprecautionsforstorage

Bottles:unreconstitutedproductshouldbestoredbelow25°C.

Reconstitutedsuspension:shouldbekeptrefrigerated(2-8°C)fornotmorethan10days.Donotfreeze.

Anyproductremainingafteruseshouldbediscarded.

6.5Natureandcontentsofcontainer

Calibratedamberglassbottlescontaininggranulesforthepreparationof50ml,or100mlofsuspension.

Aplasticspoonissuppliedwiththebottles.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Beforepreparingthesuspensionthesilicageldesiccantcontainedinacapsuleinsidethecapmustberemovedand

disposedof.Thesuspensionispreparedbyaddingwatertothebottleuptothecalibratedmarkandshakingthoroughly

toobtainanevenlydispersedpaleyellowsuspension.

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7MARKETINGAUTHORISATIONHOLDER

Sanofi-aventisIrelandLtd.

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA540/33/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:21July1994

Dateoflastrenewal:21July2009

10DATEOFREVISIONOFTHETEXT

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