CEFODOX

Main information

  • Trade name:
  • CEFODOX Film Coated Tablet 100 Milligram
  • Dosage:
  • 100 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEFODOX Film Coated Tablet 100 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0540/033/002
  • Authorization date:
  • 11-10-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cefodox100mgfilm-coatedtablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachCefodoxTabletcontainscefpodoximeproxetilequivalentto100mgcefpodoxime.

Excipients:eachtabletcontains220mglactosemonohydrate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet

Abiconvex,cylindrical,practicallywhitetablet,9mmindiameter,with‘208’andbeneath‘A’engravedononeside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Indicationsinclude:

Upperrespiratorytractinfectionscausedbyorganismssensitivetocefpodoxime,includingsinusitis.Intonsillitisand

pharyngitis,Cefodoxshouldbereservedforrecurrentorchronicinfections,wherethecausativeorganismisknownor

suspectedtoberesistanttocommonlyusedantibiotics.

Lowerrespiratorytractinfectionscausedbyorganismssensitivetocefpodoxime,includingacutebronchitisand

relapsesorexacerbationsofchronicbronchitis,andbacterialpneumonia,includingpatientsatriskorcompromisedby

otherunderlyingillnesses.

Upperandlowerurinarytractinfectionscausedbyorganismssensitivetocefpodoximeincludingcystitisandacute

pyelonephritis.

Skinandsofttissueinfectionscausedbyorganismssensitivetocefpodoximesuchasabscesses,cellulitis,infected

wounds,furuncles,folliculitis,paronychia,carbuncles,burnsandulcers.

Gonorrhoea,uncomplicatedgonococcalurethritis.

4.2Posologyandmethodofadministration

Adults:

UpperRespiratoryTractInfection

Sinusitis:200mgtwicedaily(morningandevening).

Pharyngitis,tonsillitis:100mgtwicedaily(morningandevening).

Otherupperrespiratorytractinfections:100mgtwicedaily.

Tabletsshouldbetakenduringmeals.

LowerRespiratoryTractInfections

Forlowerrespiratorytractinfectionscausedbyorganismssensitivetocefpodoxime,includingacutebronchitis,

relapsesorexacerbationsofchronicbronchitisandbacterialpneumonia;100-200mgtwicedaily,dependentonthe

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UncomplicatedLowerUrinaryTractInfections

100mgtobetakentwicedaily.

UncomplicatedUpperUrinaryTractInfections

200mgtobetakentwicedaily.

UncomplicatedGonococcalUrethritis

200mgtobetakenasasingledose.

SkinandSoftTissueInfections

200mgtobetakentwicedaily.

Tabletsshouldbetakenduringmealswithsomeliquid,foroptimumabsorption(morningandevening).

Elderly:

Intheelderly,providedrenalfunctionisnormal,itisnotnecessarytomodifythedosage.

Children:

CefodoxPaediatricisavailabletotreatinfants(over15daysold)andchildren.Pleaserefertoit’sseparateprescribing

informationfordetails.

RenalImpairment:

ThedosageofCefodoxdoesnotrequiremodificationifcreatinineclearanceexceeds40ml/min.Belowthisvalue,

pharmacokineticstudiesindicateanincreaseinplasmaeliminationhalflifeandmaximumplasmaconcentrations,and

hencethedosageshouldbeadjustedappropriately.

Note :Theunitdoseiseither100mgor200mgdependingonthetypeofinfection.

HepaticImpairment:

Thedosagedoesnotrequiremodificationincasesofhepaticimpairment.

4.3Contraindications

Patientswithhypersensitivitytocephalosporinantibiotics.

4.4Specialwarningsandprecautionsforuse

Preliminaryenquiryaboutallergyisnecessarybeforeprescribingcephalosporinssincecrossallergytopenicillins

occursin5to10%ofcases.

Particularcarewillbeneededinpatientssensitivetopenicillins:strictmedicalsurveillanceisnecessaryfromthevery

firstadministration.

Aswithotherantibiotics,theprolongeduseofcefpodoximeproxetilmayresultinovergrowthofnon-susceptible

organisms.Withanoralantibioticthenormalcolonicfloramaybealteredallowingtheovergrowthbyclostridiawith

CREATININECLEARANCE

(ML/MIN)

39-10 UNITDOSEADMINISTEREDASASINGLEDOSE

EVERY24HOURS(IEHALFOFTHEUSUAL

ADULTDOSE)

<10 UNITDOSEADMINISTEREDASASINGLEDOSE

EVERY48HOURS(IEQUARTEROFTHEUSUAL

ADULTDOSE)

HAEMODIALYSISPATIENTS UNITDOSEADMINISTEREDAFTEREACH

DIALYSISSESSION

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Repeatedevaluationofthepatientisessential,andifsuperinfectionoccursduringtherapy,appropriatemeasurements

shouldbetaken.

Inpatientswhoareallergictoothercephalosporins,thepossibilityofcrossallergytoCefodoxshouldbeborneinmind.

Theuseofcephalosporinsisstrictlyforbiddeninsubjectswithaprevioushistoryofimmediatetypehypersensitivityto

cephalosporins.Wherethereisanydoubt,medicalassistanceshouldbeavailableatthefirstadministration,inorderto

treatanypossibleanaphylacticreaction.

Hypersensitivityreactions(anaphylaxis)observedwiththese2typesofbeta-lactamsmaybeseriousandoccasionally

fatal.

Theonsetofanymanifestationofhypersensitivityindicatesthattreatmentshouldbestopped.Cefodoxisnotthe

preferredantibioticforthetreatmentofstaphylococcalpneumoniaandnotbeusedinthetreatmentofatypical

pneumoniacausedbyorganismsuchasLegionella,MycoplasmaandChlamydia.

Incasesofsevererenalinsufficiencyitmaybenecessarytoreducethedosageregimendependentonthecreatinine

clearance.(SeeSection4.2Posologyandmethodofadministration).

Changesinrenalfunctionhavebeenobservedwithantibioticsofthesameclassandparticularlywhengiven

concurrentlywithpotentiallynephrotoxicdrugssuchasaminoglycosidesand/orpotentdiuretics.Insuchcasesrenal

functionshouldbemonitored.

Cephalosporinsmaybeabsorbedontothesurfaceofredcellmembranesandreactwithantibioticsdirectedagainstthe

drug.ThiscanproduceapositiveCoomb’stestandveryrarely,haemolyticanaemia.Cross-reactivitymayoccurwith

penicillinforthisreaction.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiency,orglucose-galactose

malabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noclinicalsignificantdruginteractionshavebeenreportedduringthecourseofclinicalstudies.

HistamineH2-antagonistsandantacidsreducethebioavailabilityofcefpodoxime.Probenecidreducestheexcretionof

cephalosporins.Cephalosporinspotentiallyenhancetheanticoagulanteffectofcoumarinsandreducethecontraceptive

effectofoestrogens.

Studieshaveshownthatbioavailabilityisdecreasedbyapproximately30%whenCefodoxisadministeredwithdrugs

whichneutralisegastricpHorinhibitacidsecretions.Therefore,suchdrugsasmineralantacidsandhistamine

blockingH

blockers,whichcauseanincreaseingastricpH,shouldbetaken2or3hoursafterCefodox

administration.Incontrast,adecreaseingastricpH(pentagastrin)willincreasebioavailability.

Aswithothercephalosporins,isolatedcasesshowingdevelopmentofapositiveCoombstesthavebeenreported(See

Section4.4.SpecialWarningsandPrecautionsforUse).

Changesinrenalfunctionhavebeenobservedwithantibioticsofthesameclass,particularlywhengivenconcurrently

withpotentiallynephrotoxicdrugssuchasaminoglycosidesand/orpotentdiuretics.Insuchcases,renalfunctionshould

bemonitored(SeeSection4.4.SpecialWarningsandPrecautionsforUse).

AfalsepositivereactionforglucoseintheurinemayoccurwithBenedictsorFehlingssolutionsorwithcopper

sulphatetesttablets,butnotwithtestsbasedonenzymaticglucoseoxidasereactions.

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4.6Fertility,pregnancyandlactation

4.6.1 Pregnancy

Studiescarriedoutinseveralanimalspecieshavenotrevealedanyteratogenicoffoetotoxiceffects.However,the

safetyofcefpodoximeproxetilinpregnantwomenhasnotbeenestablished;itisthereforeadvisablenottoadminister

theproductduringpregnancy.

4.6.2 Lactation

Studieshaveshownthatcefpodoximeisexcretedinhumanmilk.Itisrecommendedthateitherbreastfeedingshouldbe

ceasedortreatmentshouldbediscontinued.

4.7Effectsonabilitytodriveandusemachines

Attentionshouldbedrawntotheriskofdizzysensations.

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-

susceptibleorganisms unknown

Investigations Increasesinliverenzymes uncommon

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Renal

Slightincreasesinbloodureaandcreatininehavebeenreported.

Changesinrenalfunctionhavebeenobservedwithantibioticsfromthesamegroupas

cefpodoxime,particularlywhenco-prescribedwithaminoglycosidesand/orpotentdiuretics(SeeSection4.4.Special

WarningsandPrecautionsforUse).

Other

Occasionalcaseshavebeenreportedofheadaches,dizziness,tinnitus,paresthesiaandastheniaSuperinfection:aswith

otherantibiotics,theuseofcefpodoximeproxetil,especiallyifprolonged,mayresultinovergrowthofnon-susceptible

organisms.Repeatedevaluationof

thepatient'sconditionisessential.Ifsuperinfectionoccursduringtherapy,appropriatemeasuresshouldbetaken.

4.9Overdose

IntheeventofoverdosagewithCefodox,supportiveandsymptomatictherapyisindicated.Incasesofoverdosage,

particularlyinpatientswithrenalinsufficiency,encephalopathymayoccur.Theencephalopathyisusuallyreversible

oncecefpodoximeplasmalevelshavefallen.

Nospecificantidoteexists.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:J01DD01

Cefodox(Cefpodoximeproxetil)isabeta-lactamantibiotic,a3rdgenerationoralcephalosporin.Itistheprodrugof

cefpodoxime.

Followingoraladministration,Cefodoxistakenupbythegastro-intestinalwallwhereitisrapidlyhydrolysedto

cefpodoxime,abactericidalantibiotic,whichisthenabsorbedsystemically.

BACTERIOLOGY:

Themechanismofactionofcefpodoximeisbasedoninhibitionofbacterialcellwallsynthesis.Itisstabletonumerous

beta-lactamases.

CefpodoximehasbeenshowntopossessinvitrobactericidalactivityagainstnumerousGram-positiveandGram-

negativebacteria.

ItishighlyactiveagainsttheGram-positiveorganisms:

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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StreptococciofGroupsA(S.pyogenes),B(S.agalactiae),C,FandG

Otherstreptococci(S.mitis,S.sanguisandS.salivarius)

Corynebacteriumdiphtheria

ItishighlyactiveagainsttheGram-negativeorganisms:

Haemophilusinfluenzae(beta-lactamaseandnonbeta-lactamaseproducingstrains)

Haemophiluspara-influenzae(beta-lactamaseandnonbeta-lactamaseproducingstrains)

Branhamellacatarrhalis(beta-lactamaseandnonbeta-lactamaseproducing

strains)

Neisseriameningitidis

Neisseriagonorrhoeae

Escherichiacoli

KlebsiellaSpp.(K.pneumoniae;K.oxytoca)

Proteusmirabilis

Itismoderatelyactiveagainstmeticillin-sensitivestaphylococci,penicillinaseandnon-penicillinaseproducingstrains

(S.aureusandS.epidermidis).

Inaddition,aswithmanycephalosporins,thefollowingareresistanttocefpodoxime:

enterococci,meticillin-resistantstaphylococci(S.aureusandS.epidermidis),

Staphylococcussaprophyticus,PseudomonasaeruginosaandPseudomonasSpp.,

Clostridiumdifficile,Bacteroidesfragilisandrelatedspecies.

Aswithallantibiotics,wheneverpossible,sensitivityshouldbeconfirmedbyinvitrotest

5.2Pharmacokineticproperties

Followingoraladministration,Cefodoxistakenupbythegastro-intestinalwallwhereitisrapidlyhydrolysedto

cefpodoxime,abactericidalantibiotic,whichisthenabsorbedsystemically.

Cefodoxistakenupintheintestineandishydrolysedtotheactivemetabolitecefpodoxime.Whencefpodoxime

proxetilisadministeredorallytofastingsubjectsasatabletcorrespondingto100mgofcefpodoxime,51.5%is

absorbedandabsorptionisincreasedbyfoodintake.Thevolumeofdistributionis32.3Landpeaklevelsof

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

100mgand200mgrespectively.Followingadministrationof100mgand200mgtwicedailyover14.5days,theplasma

pharmacokineticparametersofcefpodoximeremainunchanged.

Serumproteinbindingofcefpodoxime,40%principallytoalbumin.Thisbindingisnonsaturable.

Concentrationofcefpodoximeinexcessoftheminimuminhibitorylevels(MIC)forcommonpathogenscanbe

achievedinlungparenchyma,bronchialmucosa,pleuralfluid,tonsils,interstitialfluidandprostatetissue.

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

hrfractionsafterasingledoseexceedMIC ofcommonurinarypathogens).Gooddiffusionofcefpodoximeisalso

seenintorenaltissue,withconcentrationsaboveMIC ofthecommonurinarypathogens(0.6-3.1mg/g),3-12hrs

afteranadministrationofasingle200mgdose.Concentrationsofcefpodoximeinthemedullaryandcorticaltissuesare

similar.

Studiesinhealthyvolunteersshowmedianconcentrationsofcefpodoximeinthetotalejaculate6-12hrsfollowing

administrationofasingle200mgdosetobeabovetheMIC ofN.gonorrhoea.

Themainrouteofexcretionisrenal,80%isexcretedunchangedintheurine,withaneliminationhalflifeofapprox.

2.4hours.

5.3Preclinicalsafetydata

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Magnesiumstearate

Carmellosecalcium

Hydroxypropylcellulose

Sodiumlaurilsulfate

Lactosemonohydrate

Coatingcontains

Titaniumdioxide(E171)

Talc

Hypromellose

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

CefodoxtabletsaresuppliedinPVC/Aluminiumblisterpacksof2,10and20tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Sanofi-AventisIrelandLtd.T/ASANOFI

CitywestBusinessCampus

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA540/33/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:11October1991

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10DATEOFREVISIONOFTHETEXT

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