FLUCLOXACILLIN ORAL SOLUTION BP 125 MG/ 5ML

Main information

  • Trade name:
  • FLUCLOXACILLIN ORAL SOLUTION BP 125 MG/ 5ML
  • Dosage:
  • 125 MG/ 5ml
  • Pharmaceutical form:
  • Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLUCLOXACILLIN ORAL SOLUTION BP 125 MG/5ML
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0282/041/003
  • Authorization date:
  • 13-03-1987
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0282/041/003

CaseNo:2061679

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

NortonHealthcareLimitedT/AIVAXPharmaceuticalsUK

RegentHouse,5-7BroadhurstGardens,SwissCottages,LondonNW63RZ,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

FlucloxacillinOralSolutionBP125mg/5ml

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom19/02/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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Date Printed 19/02/2009 CRN 2061679 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FlucloxacillinOralSolutionBP125mg/5ml.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Whenreconstitutedasdirected,e ach5mlcontains125mgflucloxacillin,asflucloxacillinsodium.

Excipients:Each5mlcontains3093.65mgofSucrose.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Powderfororalsolution.

Apink,pineapple-flavouredgranularpowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofinfectionsduetopenicillinaseproducingstaphylococciandothergram-positiveorganisms

susceptibletothisanti-infective.

4.2Posologyandmethodofadministration

Thedosagedependsupontheseverityandnatureoftheinfection.

Usualadult(andchildrenover10yearsofage)dosage:

250-500mgthreetimesaday.

Usualchildren’sdosage:

2–10years: ½adultdose.

Under2years:¼adultdose.

Thedosagemaybeincreasedifnecessary.

Maximumdailydoseis8gperday.

Abnormalrenalfunction:Incommonwithotherpenicillins,flucloxacillinusageinpatientswithrenalimpairment

doesnotusuallyrequiredosagereduction.However,inthepresenceofsevererenalfailure(creatinineclearance<10

ml/min)areductionindoseorextensionofthedoseintervalshouldbeconsidered.Inhighdoseregimensthe

maximumrecommendeddoseis1gevery8to12hours.

Flucloxacillinisnotsignificantlyremovedbydialysisandhencenosupplementarydosagesneedbeadministeredeither

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4.3Contraindications

Flucloxacillinshouldnotbegiventopatientswithahistoryofhypersensitivitytobeta-lactamantibiotics(e.g.

penicillins,cephalosporins)oranyoftheexcipients.

Flucloxacilliniscontraindicatedinpatientswithaprevioushistoryofflucloxacillin-associatedjaundice/hepatic

dysfunction.

4.4Specialwarningsandprecautionsforuse

Beforeinitiatingtherapywithflucloxacillin,carefulenquiryshouldbemadeconcerningprevioushypersensitivity

reactionstobeta-lactams.Cross-sensitivitybetweenpenicillinsandcephalosporinsiswelldocumented.

Seriousandoccasionallyfatalhypersensitivityreactions(anaphylaxis)havebeenreportedinpatientsreceivingbeta-

lactamantibiotics.Althoughanaphylaxisismorefrequentfollowingparenteraltherapy,ithasoccurredinpatientson

oraltherapy.Thesereactionsaremorelikelytooccurinindividualswithahistoryofbeta-lactamhypersensitivity.Ifan

allergicreactionoccurs,flucloxacillinshouldbediscontinuedandtheappropriatetherapyinstituted.Serious

anaphylactoidreactionsmayrequireimmediateemergencytreatmentwithadrenaline.Oxygen,i.vsteroids,andairway

management,includingintubation,mayalsoberequired.

Flucloxacillinshouldbeusedwithcautioninpatientswithevidenceofhepaticdysfunction,patients ≥50yearsofage,

andthosewithseriousunderlyingdisease.Inthesepatients,hepaticeventsmaybesevere,andinextremelyrare

circumstances,deathshavebeenreported(Seesection4.8,Undesirableeffects).

Dosageshouldbeadjustedinrenalimpairment(seesection4.2,Posologyandmethodofadministration).

Specialcautionisessentialinthenewbornbecauseoftheriskofhyperbilirubinemia.Studieshaveshownthat,athigh

dosefollowingparenteraladministration,flucloxacillincandisplacebilirubinfromplasmaproteinbindingsites,and

maythereforepredisposetokernicterusinajaundicedbaby.Inaddition,specialcautionisessentialinthenewborn

becauseofthepotentialforhighserumlevelsofflucloxacillinduetoareducedrateofrenalexcretion.

Duringprolongedtreatments(e.g.osteomyelitis,endocarditis),regularmonitoringofhepaticandrenalfunctionsis

recommended.

Prolongedusemayoccasionallyresultinover-growthofnon-susceptibleorganisms.

Benzoate:FlucloxacillinOralSolutioncontainssodiumbenzoatewhichisamildirritanttotheskin,eyesandmucous

membranes.Itmaycausejaundiceinnewbornbabies.

Containssucrose.Patientswithrarehereditaryproblemsoffructoseintolerance,glucose-galactosemalabsorptionor

sucrose-isomaltaseinsufficiencyshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Probeneciddecreasestherenaltubularsecretionofflucloxacillin.Concurrentadministrationofprobeneciddelaysthe

renalexcretionofflucloxacillin.

Flucloxacillin,likeotherpenicillins,mayreducetheexcretionofmethotrexate,therebyincreasingtheriskof

methotrexatetoxicity.

Therehavebeenisolatedreportsofincreasedanticoagulanteffectswhenpenicillinsandoralanticoagulantsare

administeredconcurrently.

Incommonwithotherantibiotics,flucloxacillinmayaffectthegutflora,leadingtoloweroestrogenreabsorptionand

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Bacteriostaticdrugsmayinterferewiththebactericidalactionofflucloxacillin.

4.6Pregnancyandlactation

Pregnancy:

Animalstudieswithflucloxacillinhaveshownnoteratogeniceffects.Thedecisiontoadministeranydrugduring

pregnancyshouldbetakenwiththeutmostcare.Limitedinformationisavailableontheuseofflucloxacillininhuman

pregnancy.Thereforeflucloxacillinshouldonlybeusedinpregnancywhenthepotentialbenefitsoutweighthe

potentialrisksassociatedwithtreatment.

Lactation:

Duringlactation,tracequantitiesofpencillinscanbedetectedinbreastmilk.Flucloxacillinmaybeadministered

duringtheperiodoflactation.Withtheexceptionofriskofsensitisationtherearenootherdetrimentaleffectsforthe

breastfedinfant.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Thefollowingconventionhasbeenutilisedfortheclassificationofundesirableeffects:Verycommon(>1/10),

common(>1/100,<1/10),uncommon(>1/1000,<1/100),rare(>1/10,000,<1/1000,veryrare(<1/10,000).

Unlessotherwisestated,thefrequencyoftheadverseeffectshasbeenderivedfrommorethan30yearsofpost-

marketingreports.

Bloodandlymphaticsystemdisorders

Veryrare:

Neutropenia(includingagranulocytosis)andthrombocytopenia.Thesearereversiblewhentreatmentisdiscontinued.

Eosinophilia,haemolyticanaemia.

Immunesystemdisorders

Veryrare:

Anaphylacticshock(exceptionalwithoraladministration)(seesection4.4,Specialwarningsandprecautionsforuse),

angioneuroticoedema.

Ifanyhypersensitivityreactionoccurs,thetreatmentshouldbediscontinued.(SeealsoSkinandSubcutaneoustissue

disorders).

Nervoussystemdisorders

Veryrare:

Inpatientssufferingfromrenalfailure,neurologicaldisorderswithconvulsionsarepossiblewiththeI.V.injectionof

highdoses.

Gastrointestinaldisorders

*Common:

Minorgastrointestinaldisturbances.

Veryrare:

Pseudomembranouscolitis.

Ifpseudomembranouscolitisdevelops,flucloxacillintreatmentshouldbediscontinuedandappropriatetherapy,e.g.

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Hepato-biliarydisorders

Veryrare:

Hepatitisandcholestaticjaundice(seesection4.4,Specialwarningsandprecautionsforuse).Changesinliver

functionlaboratorytestresults(reversiblewhentreatmentisdiscontinued).

Hepatitisandcholestaticjaundicemaybedelayedforuptotwomonthspost-treatment.Insomecasesthecoursehas

beenprotractedandlastedforseveralmonths.Hepaticeventsmaybesevere,andinveryrarecircumstances,deaths

havebeenreported.Mostreportsofdeathshavebeeninpatients>50yearsofageandinpatientswithserious

underlyingdisease.

Skinandsubcutaneoustissuedisorders

*Uncommon:

Rash,urticariaandpurpura.

Veryrare:

Erythemamultiforme,Stevens-Johnsonsyndrome,andtoxicepidermalnecrolysis(SeealsoImmunesystemdisorders).

Musculoskeletalandconnectivetissuedisorders

Veryrare:

Arthralgiaandmyalgiasometimesdevelopmorethan48hoursafterthestartofthetreatment.

Renalandurinarydisorders

Veryrare:

Interstitialnephritis.

Thisisreversiblewhentreatmentisdiscontinued.

Generaldisordersandadministrationsiteconditions

Veryrare:

Feversometimesdevelopsmorethan48hoursafterthestartofthetreatment.

Investigations

Veryrare:

Liverfunctiontestsabnormal.

*TheincidenceoftheseAEswasderivedfromclinicalstudiesinvolvingatotalofapproximately929adultand

paediatricpatientstakingflucloxacillin.

4.9Overdose

Gastrointestinaleffectssuchasnausea,vomitinganddiarrhoeamaybeevidentandshouldbetreated

symptomatically.

Flucloxacillinisnotremovedfromthecirculationbyhaemodialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Flucloxacillinhasthesamespectrumofactivityastheearlierantistaphylococcalpenicillinsmethicillinandcloxacillin

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5.2Pharmacokineticproperties

Absorption

Flucloxacillinisstableinacidmediaandcanthereforebeadministeredbytheoralroute.Thepeakserumlevelsof

flucloxacillinreachedafter1hareasfollows:

After250mgbytheoralroute(infastingsubjects):approximately8.8mg/l

After500mgbytheoralroute(infastingsubjects):approximately14.5mg/l

Thetotalquantityabsorbedbytheoralrouterepresentsapproximately79%ofthequantityadministered.

Distribution

Proteinbinding:theserumproteinbindingrateis95%

Flucloxacillindiffuseswellintomosttissues

Crossingthemeningealbarrier:flucloxacillindiffusesinonlysmallproportionintothecerebrospinalfluidofsubjects

whosemeningesarenotinflamed.

Crossingintomother'smilk:flucloxacillinisexcretedinsmallquantitiesinmothersmilk.

Metabolism

Innormalsubjectsapproximately10%oftheflucloxacillinadministeredismetabolisedtopenicilloicacid.The

eliminationhalflifeofflucloxacillinisontheorderof53min.

Elimination

Excretionoccursmainlythroughthekidney.Sixtyfivepercentofthedoseadministeredorallyisrecoveredin

unalteredactiveformintheurinewithin8h.Asmallportionofthedoseadministeredisexcretedinthebile.The

excretionofflucloxacillinisslowedincasesofrenalfailure.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumbenzoate(E211)

Disodiumedetate

Saccharinsodium

Mono-ammoniumglycrrhizinate

Sodiumcitrate

Flavourmenthol(containsSulphurDioxide(E220))

Flavourpineapple(containsSulphurDioxide(E220))

Erythrosine(E127)

Sucrose

6.2Incompatibilities

Noneknown.

6.3ShelfLife

Productinunopenedstate

18monthsfromthedateofmanufacture.

Reconstitutedproduct

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6.4Specialprecautionsforstorage

Powder

Donotstoreabove25 °

Reconstitutedproduct

Storeinarefrigerator(at2-8°C).

6.5Natureandcontentsofcontainer

150mlamberglassbottleswithpolypropylenescrewcapor150mlhigh-densitypolyethylenebottleswithtamper

evidentandchildresistantclosures-Polypropylenecapswithuni-foamwad/liner-expandedpolyethyleneliner

(ExtrudedclosedcellfoamproducedfromLowdensityPolyethylene)(LDPE)notfacedwithaluminium.

Eachbottlecontainssufficientpowdertoproduce100mlFlucloxacillinOralSolutionBP125mg/5ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Toprepareadd58mlsofpotablewaterandshakeuntilallpowderisdispersed.Thisproductmaybedilutedwith

sorbitolsolutionBPorpotablewater.

Theappearanceoftheproductafterreconstitutionisaclearpinksolution.

7MARKETINGAUTHORISATIONHOLDER

NortonHealthcareLtd

T/AIVAXPharmaceuticalsUK

RegentHouse

5-7BroadhurstGardens

SwissCottage

London,NW63RZ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0282/041/003

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 13 th

March1987

Dateoflastrenewal: 13 th

March2007

10DATEOFREVISIONOFTHETEXT

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