CEPOREX

Main information

  • Trade name:
  • CEPOREX Granules for Oral Suspension 125 mg/ 5ml MG/ 5ml
  • Dosage:
  • 125 mg/ 5ml MG/ 5ml
  • Pharmaceutical form:
  • Granules for Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEPOREX Granules for Oral Suspension 125 mg/5ml MG/5ml
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0044/009/004
  • Authorization date:
  • 18-11-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CeporexGranulesforOralSuspension125mg/5ml

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Whenreconstituted,each5mlcontainsCephalexinequivalentto125mgCephalexin(anhydrous).

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Granulesfororalsuspension

Paleorangegranuleswithacharacteristicodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Ceporexisindicatedinthemanagementofmoderateandseriousinfectionsduetomicro-organismssensitivetothis

anti-infective,forexamplebeta-haemolyticStreptococci,Staphylococci,Proteusmirabilisetc.

4.2Posologyandmethodofadministration

Adults:

Manyinfectionsinadultswillrespondtooraldosageof1gramto2gramsperdayindivideddoses;however,formost

infections,thefollowingsimpleschemewillbefoundsatisfactory:

Adultsandchildrenover12years:500mgt.d.s.(threetimesdaily).Toaidcompliance,especiallyinambulatory

patients,thedailydosagemaybegivenintwoequaldoses,e.g.1gtwicedailyinadultwithurinarytractinfections.

Thefollowingadditionalinformationshouldalsobeconsidered:

Forsevereordeep-seatedinfections,especiallywhenlesssensitiveorganismsareinvolved,thedosageshouldbe

increasedto1gt.d.s.or1.5gq.d.s.(fourtimesdaity).

Forprophylaxisofrecurrenturinarytractinfectionsinadults,adoseof125mgeachnightisrecommendedandmaybe

continuedforseveralmonths(the125mg/5mlsuspensionissuitableforthispurpose).

Children:

Ideally,dosageshouldbecalculatedonabody-weightbasis,particularlyininfants.Thefollowingdosage

recommendationsforchildrenarederivedfromanormaldosageof25to60mg/kg/day.Forchronic,severeordeep-

seatedinfections,thisshouldbeincreasedto100mg/kg/day(maximum4g/day).

0to1year: 25to60mg/kg/day.

1yearto2years: 62.5to125mgfourtimesdailyor125to250mgtwicedaily.

3to6years: 125to250mgfourtimesdailyor250to500mgtwicedaily.

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Formostacuteinfections,treatmentshouldcontinueforatleasttwodaysaftersignshavereturnedtonormaland

symptomshavesubsided,butinchronic,recurrentorcomplicatedurinarytractinfections,treatmentfortwoweeks

(giving500mgfourtimesdaily)isrecommended.Forgonorrhoea,asingledoseof3gwith1gprobenecidformales

or2gwith0.5gprobenecidforfemalesisusuallyeffective.Concurrentadministrationofprobeneciddelaysexcretion

ofcephalexinandraisestheserumlevelsby50-100%.

Ceporexhasnotbeenshowntohaveatoxiceffectonthekidney,butaswithotherantibioticswhichareexcreted

mainlybythekidneys,unnecessaryaccumulationmayoccurinthebodywhenrenalfunctionisbelowabouthalfof

normal.ClinicalpracticeindicatesthatinviewofthewidetherapeuticwindowofCeporex,thestandardrecommended

dosesshouldbehalvedonlyinthosepatientswithsevererenalimpairment(creatinineclearance<10ml/min).

Themaximumrecommendeddosages(i.e.adults6g/day,children4g/day)shouldbereducedby50%inmild,75%in

moderateand87.5%insevererenalfailure.

Inelderlypatients,thepossibilityofrenalimpairmentshouldbeconsidered.

Ifdialysisisrequiredforrenalfailurethedailydoseofcephalexinshouldnotexceed500mgwithoutdialysis.

Adultpatientsreceivingintermittentdialysisshouldbegivenanadditional500mgCeporexaftereachdialysis,i.e.a

totaldosageofupto1gramonthatday.Childrenshouldreceiveanadditional8mgperkg.

Inskinandsofttissueinfection,streptococcalpharyngitisanduncomplicatedurinarytractinfectionsdosagemaybe

given12hourly.

4.3Contraindications

Useinpatientshypersensitivetocephalosporins.

4.4Specialwarningsandprecautionsforuse

Aswithotherbroad-spectrumantibiotics,prolongedusemayresultintheovergrowthofnon-susceptibleorganisms

(e.g.Candida,Enterococci,Clostridiumdifficile),whichmayrequireinterruptionoftreatment.Pseudomembranous

colitisduetoclostridiahasbeenreportedwiththeuseofbroad-spectrumantibiotics,therefore,itisimportantto

consideritsdiagnosisinpatientswhodevelopseverediarrhoeaduringorafterantibioticuse.

Specialcareisindicatedinpatientswhohaveexperiencedanallergicreactiontopenicillinsorotherbeta-lactams.

Aswithotherantibioticsthatareexcretedmainlybythekidneys,whenrenalfunctionispoor,dosageofCeporex

shouldbesuitablyreduced(seedosageandadministration).

InpatientsreceivingCeporex,afalse-positivereactionforglucoseintheurinemaybegiven,withBenedict'sor

Fehling'ssolution,orwith'Clinitest'tablets,butnotwithenzyme-basedtests.

Ceporexcaninterferewiththealkalinepicrateassayforcreatinine,givingafalselyhighreading,butthedegreeof

elevationisunlikelytobeofclinicalimportance.

Cross-resistanceandcrosssensitisationmayexistbetweenpenicillinsandcephalosporins.

Useoftheanti-infectiveinthepresenceofrenaldysfunctionrequirescarefulmonitoringofserumlevelsofdrugto

avoidlevelsinexcessofthosedesired.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrenttreatmentwithhighdosesofcephalosporinsandnephrotoxicdrugssuchasaminoglycosidesorpotent

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ofnephrotoxicity.

Cephalexinmayinterferewithtestsforglucoseusingcopperreagentsandforcreatininebythealkalinepicrateassay.

4.6Pregnancyandlactation

Theproductshouldnotbeusedduringpregnancyunlessconsideredessentialbythephysician.Cephalexinisexcreted

inhumanmilkinlowconcentrationsandshouldbeusedwithcautioninnursingmothers.

4.7Effectsonabilitytodriveandusemachines

Nonereported.

4.8Undesirableeffects

Asmallproportionofpatientsreceivingcephalexinhaveexperiencedgastrointestinalsymptomsincludingnausea,

vomitinganddiarrhoea.Aswithotherbroad-spectrumantibiotics,therehavebeenrarereportsofheadache,increased

levelsofliverenzymesandpseudomembranouscolitis.

ProlongedusecanresultintheovergrowthofCandidacausingvulvo-vaginitis.

Reversibleneutropeniahasoccurredinafewpatients,butisveryrare.Drugrashes-bothurticarialandmaculopapular.

Severeskinreactionsincludingveryrarelytoxicepidermalnecrolysis(exanthematicnecrolysis)andStevens-Johnson

syndromeandhypersensitivityreactionsincludingangioedemaandanaphylaxis.

TherehavebeenreportsofpositiveCoombs’test.

Aswithothercephalosporinstherehavebeenrarereportsofreversibleinterstitialnephritis.

4.9Overdose

Serumlevelsofcephalexincanbereducedgreatlybyperitonealdialysisorhaemodialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Bacteriology:

Cephalexinisabactericidalantibioticofthecephalosporingroup,whichisactiveagainstawiderangeofGram-

positiveandGram-negativeorganisms.

Gram-positiveorganisms:

CephalexinisstabletoStaphylococcalpenicillinaseandsoisactiveagainstpenicillin-resistantStaphylococcusaureus

andotherstaphylococcalspecies(excludingmethicillin-resistantisolates).

Streptococcuspyrogenes,Streptococcuspneumoniae,Streptococcusagalactiae(GroupB),otherbeta-haemolytic

streptococciandmostviridansgroupstreptococciarealsosusceptibletocephalexin.Cephalexinhasin-vitroactivity

againstCorynebacteriumdiphtheria.

Gram-negativeorganisms:

Cephalexinhasin-vitroactivityagainstE.coli,Klebsiellaspecies,Proteusmirabilis,SalmonellaandShigellaspecies.

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5.2Pharmacokineticproperties

Absorption:Cephalexinisalmostcompletelyabsorbedintheupperportionsofthegastrointestinaltract.Followingoral

administration,absorptionisrapidandpeakserumlevels(4.5microg/mlfora125mgdose,9microg/mlfor250mg

dose,18microg/mlfor500mgdoseand32microg/mlfora1000mgdose)areusuallyreachedatonehour.Inpatients

withnormalrenalfunction,serumlevelspersistfor4to6hoursanddisappearwithin8hours.

Absorptionisdelayedwhencephalexinisgivenwithorshortlyafterfood,butthetotalamountabsorbedisnotaltered.

Absorptionofcephalexinisnotadverselyaffectedbycoeliacdisease,partialgastrectomy,achlorhydria,jaundiceor

diverticulosis(duodenalorjejunal).

Theserumhalf-lifeisnormallyaboutonehour,butislongerinthenewborn(see4.2PosologyandMethodof

Administration).Inpatientswithimpairedrenalfunction,anincreaseinserumhalf-lifeofcephalexinoccurs.Clinical

practiceindicatesthatinviewofthewidetherapeuticwindowofcephalexin,thestandardrecommendeddosesshould

behalvedonlyinthosepatientswithsevererenalimpairment(creatinineclearance<10ml/min).

Distribution:Cephalexiniswidelydistributedinbodytissuesandhighconcentrationsarefoundinallorgans,

particularlytheliverandkidneys.Cephalexinreachestherapeuticlevelsintheblood,urine,bile,synovialfluid,pus,

tonsillartissue,amnioticfluid,cordbloodandfoetalblood.

MetabolismandElimination:Cephalexinisnotmetabolisedinthebodyandisrapidlyexcretedunchangedintheurine.

Highconcentrations(80-100%)ofanorallyadministereddosearerecoverableintheurinewithin6-8hours.

Cephalexinisexcretedinhumanmilkinlowconcentrations.

ConcurrentadministrationofProbeneciddelaysexcretionofcephalexinandraisesserumlevelsby50to100%.

(see4.2PosologyandMethodofAdministration).

5.3Preclinicalsafetydata

Cephalexinisnotanticipatedtocauseanygenotoxicorcarcinogeniceffects,althoughnospecificstudieshavebeen

performedtodeterminethis.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

SodiumCalciumEdetate

Acacia

CitricAcid(Anhydrous)

SodiumCitrate(Anhydrous)

EurocertSunsetYellow311831(E110)

Orange-brambleflavourpolyaromas

Sucrose

6.2Incompatibilities

Thereconstitutedsyrupsshouldnotbedilutedwithsyrup(See6.4SpecialPrecautionsforStorage).

6.3ShelfLife

Unconstitutedgranules: 3years.

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6.4Specialprecautionsforstorage

Unconstitutedgranules:Donotstoreabove30°C.

Reconstitutedgranules:Storeat2-8°Cinarefrigerator.

6.5Natureandcontentsofcontainer

Screw-cappedamberglassbottlescontainingdrygranules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

CeporexSyruppreparedbyadding60mlofwatertothegranulestogive100mlofauniformorangesuspensionwitha

characteristicodourandcontaining125mgcephalexinineach5ml.

7MARKETINGAUTHORISATIONHOLDER

GlaxoLaboratoriesLimited

StockleyParkWest

Uxbridge

MiddlesexUB111BT

8MARKETINGAUTHORISATIONNUMBER

PA44/9/4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:18November1983

Dateoflastrenewal:18November2003

10DATEOFREVISIONOFTHETEXT

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