CEFALEXIN

Main information

  • Trade name:
  • CEFALEXIN Capsules Hard 500 Milligram
  • Dosage:
  • 500 Milligram
  • Pharmaceutical form:
  • Capsules Hard
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEFALEXIN Capsules Hard 500 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1380/041/002
  • Authorization date:
  • 03-04-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA1380/041/002

CaseNo:2084272

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ActavisGroupPTCehf

Reykjavikurvegi76-78,220Hafnarfjordur,Iceland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Cefalexin500mghardcapsules

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom19/08/2010until02/04/2014.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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Date Printed 19/08/2010 CRN 2084272 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cefalexin500mghardcapsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontains,asactiveingredient,cefalexinmonohydrateequivalentto500mgofcefalexinbase.

Excipients:Brilliantblue(E133)andsunsetyellow(E110).

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Capsule,hard

Greencolouredopaquecapandlightgreencolouredopaquebodysize“0”hardgelatincapsulesimprintedwithblack

“CEF”oncapand“500”onbody,filledwithwhitetooffwhitegranularpowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Cefalexinisasemi-syntheticcephalosporinantibioticfororaladministration.

Cefalexinisindicatedforthetreatmentofthefollowinginfections(seealsosections4.4and5.1).

Exacerbationofchronicbronchitis

Mildtomoderatecommunity-acquiredpneumonia

Uncomplicatedupperandlowerurinarytractinfections

Skinandsofttissueinfections

Considerationshouldbegiventoofficialguidanceontheappropriateuseofantibacterialagents.

4.2Posologyandmethodofadministration

Posology

Therecommendeddoseforadultsis1-4gdailyindivideddoses.Mostinfectionswillrespondtoadosageof500mg

every8hours.Forskinandsofttissueinfectionsandmild,uncomplicatedurinarytractinfections,theusualdosageis

250mgevery6hoursor500mgevery12hours.

Formoresevereinfectionsorthosecausedbylesssusceptibleorganisms,largerdosesmaybeneeded.Ifdailydosesof

cefalexingreaterthan4garerequired,parenteralcephalosporins,inappropriatedoses,shouldbeconsidered.

Patientswithimpairedrenalfunction

Reducedosageifrenalfunctionismarkedlyimpaired(section4.4).

Elderlypatients

Therecommendeddoseforadultsshouldbeusedinelderlypatientsexceptthosewithimpairedrenalfunction(see

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Children

Therecommendeddailydosageforchildrenis25-50mg/kgbodyweightdividedin3doses.

Insevereinfections,thedosagemaybedoubled.

Inthetreatmentofbeta-haemolyticstreptococcalinfections,atherapeuticdoseshouldbeadministeredforatleast

10days.

Methodofadministration

Cefalexinisadministeredorally.

4.3Contraindications

Hypersensitivitytothecephalosporingroupofantibioticsortoanyoftheexcipients

4.4Specialwarningsandprecautionsforuse

BeforeinstitutingtherapywithCefalexin,everyeffortshouldbemadetodeterminewhetherthepatienthashad

previoushypersensitivityreactionstothecephalosporins,penicillinsorothermedicinalproducts.Cefalexinshouldbe

givencautiouslytopenicillin-sensitivepatients.Thereissomeclinicalandlaboratoryevidenceofpartialcross-

allergenicityofthepenicillinsandcephalosporins.Patientshavehadseverereactions(includinganaphylaxis)toboth

medicinalproducts.

Pseudomembranouscolitishasbeenreportedwithvirtuallyallbroad-spectrumantibiotics,includingmacrolides,semi-

syntheticpenicillins,andcephalosporins.Itisimportant,therefore,toconsideritsdiagnosisinpatientswhodevelop

diarrhoeainassociationwiththeuseofantibiotics.Suchcolitismayrangeinseverityfrommildtolife-threatening.

Mildcasesofpseudomembranouscolitisusuallyrespondtodrugdiscontinuancealone.Inmoderatetoseverecases,

appropriatemeasuresshouldbetaken.

IfanallergicreactiontoCefalexinoccurs,thedrugshouldbediscontinuedandthepatienttreatedwiththeappropriate

agents.

ProlongeduseofCefalexinmayresultintheovergrowthofnon-susceptibleorganisms.Carefulobservationofthe

patientisessential.Ifsuperinfectionoccursduringtherapy,appropriatemeasuresshouldbetaken.

CefalexinshouldnotbeusedininfectionsinwhichHaemophilusinfluenzaeis,orislikelytobe,implicated.

Cefalexinshouldbeadministeredwithcautioninthepresenceofmarkedlyimpairedrenalfunction.Carefulclinical

andlaboratorystudiesshouldbemadebecausesafedosagemaybelowerthanthatusuallyrecommended.Ifdialysisis

requiredforrenalfailure,thedailydoseofcefalexinshouldnotexceed500mg.

PositivedirectCoombs'testshavebeenreportedduringtreatmentwiththecephalosporinantibiotics.Inhaematological

studies,orintransfusioncross-matchingprocedureswhenantiglobulintestsareperformedontheminorside,orin

Coombs'testingofnewbornswhosemothershavereceivedcephalosporinantibioticsbeforeparturition,itshouldbe

recognisedthatapositiveCoombs'testmaybeduetothemedicinalproduct.

AfalsepositivereactionforglucoseintheurinemayoccurwithBenedict'sorFehling'ssolutions,orwithcopper

sulphatetesttablets.

Cefalexincapsules,hardcontaincolouringagentsbrilliantblue(E133)andsunsetyellow(E110),whichmaycause

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Aswithotherbeta-lactammedicinalproducts,renalexcretionofCefalexinisinhibitedbyprobenecid.

Concurrentadministrationwithcertainotherdrugsubstances,suchasaminoglycosides,othercephalosporins,or

furosemide,andsimilarpotentdiuretics,mayincreasetheriskofnephrotoxicity.

Inasinglestudyof12healthysubjectsgivensingle500mgdosesofCefalexinandmetformin,plasmametforminC

andAUCincreasedbyanaverageof34%and24%,respectively,andmetforminrenalclearancedecreasedbyan

averageof14%.Nosideeffectswerereportedin12healthysubjectsinthisstudy.Noinformationisavailableabout

theinteractionofCefalexinandmetforminfollowingmultipledoseadministration.Theclinicalsignificanceofthis

studyisunclear,particularlyasnocasesof“lacticacidosis”havebeenreportedinassociationwithconcomitant

metforminandCefalexintreatment.

4.6Pregnancyandlactation

Pregnancy

Therearenoadequateandwellcontrolledstudiesinpregnantwomen.Althoughanimalstudieshaveshownno

evidenceofteratogenicity,cautionshouldbeexercisedwhenprescribingcefalexinduringpregnancy(seesection5.3).

Lactation

Cefalexinisexcretedinhumanmilk.Cautionshouldbeexercisedwhencefalexinisadministeredtoanursingwoman.

4.7Effectsonabilitytodriveandusemachines

Therearenoknowneffectsofcephalexinonapatient'sabilitytodriveorusemachinery.Howeverwhendriving

vehiclesoroperatingmachinesitshouldbetakenintoaccountthatoccasionallydizzinessorconfusionmayoccur.

4.8Undesirableeffects

Adverseeventsthathavebeenreportedincefalexintrialsarecategorisedbelow,accordingtosystemorganclassand

frequency.

Frequenciesaredefinedas:

verycommon(1/10)

common(1/100to<1/10)

uncommon(1/1,000to<1/100)

rare(1/10,000to<1/1,000)

veryrare(<1/10,000),

notknown(cannotbeestimatedfromtheavailabledata).

Undesirableeffectsforcefalexinoccuratafrequencyof3-6%.

Investigations

Uncommon: IncreaseinASATandALAT(reversible)

Frequencynotknown:PositivedirectCoombstest.Falsepositivereactiontoglucoseintheurine

Bloodandlymphaticsystemdisorders

Uncommon: Eosinophilia

Rare: Neutropenia,thrombocytopenia,haemolyticanaemia

Nervoussystemdisorders

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Gastrointestinaldisorders

Common: Diarrhoea,nausea.

Rare: Abdominalpain,vomiting,dyspepsia,pseudomembranouscolitis

Renalandurinarydisorders

Rare: Reversibleinterstitialnephritis

Skinandsubcutaneoustissuedisorders

Uncommon: Rash,urticaria,pruritus

Rare: Stevens-Johnsonsyndrome,erythemamultiforme,toxicepidermalnecrolysis(Lyell’s

syndrome),angioedema

Musculoskeletalandconnectivetissuedisorders

Frequencynotknown:Arthralgia,arthritis

Infectionsandinfestations

Rare: Genitalandanalpruritus,vaginitis

Frequencynotknown:Vaginalcandidiasis

Generaldisordersandadministrationsiteconditions

Rare: Tiredness

Frequencynotknown:Fever

Immunesystemdisorders

Rare: Anaphylacticreaction

Hepatobiliarydisorders

Rare: Hepatitis,cholestaticicterus

Psychiatricdisorders

Frequencynotknown:Hallucinations,agitation,confusion

4.9Overdose

Symptomsoforaloverdosemayincludenausea,vomiting,epigastricdistress,diarrhoea,andhaematuria.

Intheeventofsevereoverdosage,generalsupportivecareisrecommended,includingcloseclinicalandlaboratory

monitoringofhaematological,renalandhepaticfunctions,andcoagulationstatusuntilthepatientisstable.Forced

diuresis,peritonealdialysis,haemodialysis,orcharcoalhaemoperfusionhavenotbeenestablishedasbeneficialforan

overdoseofCefalexin.Itwouldbeextremelyunlikelythatoneoftheseprocedureswouldbeindicated.

Unless5to10timesthenormaltotaldailydosehasbeeningested,gastro-intestinaldecontaminationshouldnotbe

necessary.

Therehavebeenreportsofhaematuria,withoutimpairmentofrenalfunction,inchildrenaccidentallyingestingmore

than3.5gofcefalexininaday.Treatmenthasbeensupportive(fluids)andnosequelaehavebeenreported.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Firstgenerationcephalosporin,ATCcode:J01DB01.

ModeofAction

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Likeothercephalosporinscefalexinexertsantibacterialactivitybybindingtoandinhibitingtheactionofpenicillin-

bindingproteinsinvolvedinthesynthesisofbacterialcellwalls.Thisleadstobacterialcelllysisandcelldeath.

Mechanismsofresistance

Bacterialresistancetocefalexinmaybeduetooneormoreofthefollowingmechanisms:

Hydrolysisbyextended-spectrumbeta-lactamasesand/orbychromosomally-encoded(AmpC)enzymesthatmay

beinducedorde-repressedincertainaerobicgram-negativebacterialspecies.

Reducedaffinityofpenicillin-bindingproteins.

Reducedpermeabilityoftheoutermembraneofcertaingram-negativeorganismsrestrictingaccesstopenicillin-

bindingproteins

Drugeffluxpumps

Morethanoneofthesemechanismsofresistancemayco-existinasinglebacterialcell.Dependingonthemechanism

(s)present,bacteriamayexpresscross-resistancetoseveralorallotherbeta-lactamsand/orantibacterialmedicinal

productsofotherclasses.

Breakpoints

Minimuminhibitoryconcentration(MIC)breakpointsestablishedbytheBritishSocietyofAntimicrobial

Chemotherapyforbeta-haemolyticStreptococciandStreptococcuspneumoniaeare:susceptible ≤2mg/l,resistant≥

2.5mg/l.

Susceptibility

Theprevalenceofresistancemayvarygeographicallyandovertimeforselectedspeciesandlocalinformationon

resistanceisdesirable,particularlywhentreatingsevereinfections.Asnecessary,expertadviceshouldbesoughtwhen

thelocalprevalenceofresistanceissuchthattheutilityoftheagentinatleastsometypesofinfectionsisquestionable.

Commonlysusceptiblespecies

Aerobes,Grampositive:

Staphylococcusaureus(methicillinsusceptible)

Streptococcusagalactiae

Streptococcuspneumoniae

Streptococcuspyogenes

Aerobes,Gramnegative:

Escherichiacoli

Moraxellacatarrhalis

Anaerobes:

Peptostreptococcusspecies

Speciesforwhichresistancemaybeaproblem

Gram-negativeaerobes:

Citrobacterspecies

Enterobacterspecies

Morganellamorganii.

Inherentlyresistantspecies

Gram-negativeaerobes:

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5.2Pharmacokineticproperties

Cefalexinisacidstableandmaybegivenwithoutregardtomeals.Itisrapidlyabsorbedafteroraladministration.

Followingdosesof250mg,500mg,and1g,averagepeakserumlevelsofapproximately9,18,and32mg/l,

respectively,wereobtainedat1hour.Measurablelevelswerepresent6hoursafteradministration.Cefalexinis

excretedintheurinebyglomerularfiltrationandtubularsecretion.Studiesshowedthatover90%ofthemedicinal

productwasexcretedunchangedintheurinewithin8hours.Duringthisperiod,peakurineconcentrationsfollowing

the250mg,500mg,and1gdoseswereapproximately1,000,2,200,and5,000mg/l,respectively.

Cefalexinisalmostcompletelyabsorbedfromthegastro-intestinaltract,and75-100%israpidlyexcretedinactive

formintheurine.Absorptionisslightlyreducedifthedrugisadministeredwithfood.Thehalf-lifeisapproximately

60minutesinpatientswithnormalrenalfunction.Haemodialysisandperitonealdialysiswillremovecefalexinfrom

theblood.

Peakbloodlevelsareachievedonehourafteradministration,andtherapeuticlevelsaremaintainedfor6-8hours.

Approximately80%oftheactivedrugisexcretedintheurinewithin6hours.Noaccumulationisseenwithdosages

abovethetherapeuticmaximumof4g/day.

Thehalf-lifemaybeincreasedinneonatesduetotheirrenalimmaturity,butthereisnoaccumulationwhengivenatup

to50mg/kg/day.

5.3Preclinicalsafetydata

Thedailyoraladministrationofcefalexintoratsindosesof250or500mg/kgpriortoandduringpregnancy,ortorats

andmiceduringtheperiodoforganogenesisonly,hadnoadverseeffectonfertility,foetalviability,foetalweight,or

littersize.

Cefalexinshowednoenhancedtoxicityinweanlingandnewbornratsascomparedwithadultanimals.

TheoralLD

ofcefalexininratsis5,000mg/kg.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Capsulecontent

Cellulosemicrocrystalline

Croscarmellosesodium

Magnesiumstearate

Capsuleshell

Sodiumlaurilsulfate

Sunsetyellow(E110)

Brilliantblue(E133)

Titaniumdioxide(E171)

Gelatin

Blackprintingink(containingshellac,propyleneglycol,potassiumhydroxideandironoxide,black(E172))

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

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6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcontentsofcontainer

BlisterstripsconsistingofPVC/Aclar/Aluminiumblisterfilm.

Packsizes:

8,14,20,21,30,40and100capsules,hard.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

ActavisGroupPTCehf

Reykjavikurvegi76-78

220Hafnarfjordur

Iceland

8MARKETINGAUTHORISATIONNUMBER

PA1380/41/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:3rdApril2009

10DATEOFREVISIONOFTHETEXT

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