FLUCLOXACILLIN

Main information

  • Trade name:
  • FLUCLOXACILLIN Powder for Oral Solution 250mg/5ml Milligram
  • Dosage:
  • 250mg/5ml Milligram
  • Pharmaceutical form:
  • Powder for Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLUCLOXACILLIN Powder for Oral Solution 250mg/5ml Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0298/016/004
  • Authorization date:
  • 08-10-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Flucloxacillin250mg/5mlOralSolutionBP

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Whenreconstitutedeach5mlcontains250mgflucloxacillinasflucloxacillinsodium.

Each5mldosecontainsupto3.05gsucrose.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

PowderforOralSolution.

Freeflowingpinkcolouredpowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

TreatmentofinfectionsduetosensitiveGram-positiveorganisms,includinginfectionscausedby-lactamase-

producingStaphylococci.

Typicalindicationsinclude:

Skinandsofttissueinfections:

Boils

Impetigo

Abscesses

Infectedwounds

Carbuncles

Infectedskinconditionse.g.ulcers,eczemaandacne.

Infectedburns

Furunculosis

Protectionforskingrafts

Cellulitis

Respiratorytractinfections:

Pneumonia Pharyngitis

Lungabscess Tonsillitis

Empyema Quinsy

Sinusitis

Otitismediaandexterna

OtherinfectionscausedbyFlucloxacillinsensitiveorganisms:

Osteomyelitis Septicaemia

Enteritis Meningitis

Endocarditis Urinary-tractinfection

Flucloxacillinisalsoindicatedforuseasaprophylacticduringmajorsurgicalproceduressuchascardiothoracicand

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Considerationshouldbegiventoofficiallocalguidance(e.g.nationalrecommendations)ontheappropriateuseof

antibacterialagents.

Susceptibilityofthecausativeorganismtothetreatmentshouldbetested(ifpossible),althoughtherapymaybe

initiatedbeforetheresultsareavailable.

4.2Posologyandmethodofadministration

Routeofadministration

Oral.Tobeadministered½-1hourbeforemeals.

Adults(includingtheelderly)

Oral:-250mgfourtimesdaily.

Inseriousinfections,thedosagemaybedoubled.

Children’sDose:

lessthan2years62.5mgfourtimesdaily

2-10years125mgfourtimesdaily

10-18years250mgfourtimesdaily

Dependsonage,weightandrenalfunctionofthepatient,aswellastheseverityoftheinfection.

Incasesofsevererenalimpairment(creatinineclearance<10ml/min)areductionindosagemaybenecessary.

Flucloxacillinisnotsignificantlyremovedbydialysisandhencenosupplementarydosagesneedtobeadministered

eitherduring,orattheendofthedialysisperiod.

Endocarditisorosteomyelitis

Upto8gdailyindivideddosessixtoeighthourly.

Surgicalprophylaxis

1to2gIVatinductionofanaesthesiafollowedby500mgsixhourlyIV,IMororallyforupto72hours.

4.3Contraindications

Flucloxacillinshouldnotbegiventopatientswithahistoryofhypersensitivitytobeta-lactamantibiotics(e.g.

penicillins,cephalosporins)orexcipients.

Flucloxacilliniscontra-indicatedinpatientswithaprevioushistoryofflucloxacillin-associatedjaundice/hepatic

dysfunction.

4.4Specialwarningsandprecautionsforuse

TheuseofFlucloxacillin(likeotherpenicillins)inpatientswithrenalimpairmentdoesnotusuallyrequiredosage

reduction.Inthepresenceofsevererenalfailure(creatinineclearancelessthan10ml/min),however,areductionin

doseoranextensionofdoseintervalshouldbeconsideredbecauseoftheriskofneurotoxicity.

Flucloxacillinisnotsignificantlyremovedbydialysisandsonosupplementarydosagesneedtobeadministeredeither

duringorattheendofthedialysisperiod.

Hepatitisandcholestaticjaundicehavebeenreported.Thesereactionsarerelatedneithertothedosenortotherouteof

administration.Flucloxacillinshouldbeusedwithcautioninpatientswithevidenceofhepaticdysfunction,patients

>50yearsorpatientswithunderlyingdisease.Inthesepatients,hepaticeventsmaybesevereandinextremelyrare

circumstances,deathshavebeenreported(seeAdverseReactions).

Asforotherpenicillinscontactwiththeskinshouldbeavoidedassensitisationmayoccur.

Patientswithaknownhistoryofallergyaremorelikelytodevelopahypersensitivityreaction.

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Beforeinitiatingtherapywithflucloxacillin,carefulenquiryshouldbemadeconcerningprevioushypersensitivity

reactionstobeta-lactams.Seriousandoccasionallyfatalhypersensitivityreactions(anaphylaxis)havebeenreportedin

patientsreceivingbeta-lactamantibiotics.Althoughanaphylaxisismorefrequentfollowingparentaltherapy,ithas

occurredinpatientsonoraltherapy.Thesereactionsaremorelikelytooccurinindividualswithahistoryofbeta-

lactamhypersensitivity.

Specialcautionisessentialinthenewbornbecauseoftheriskofhyperbilirubinaemia.Studieshaveshownthat,athigh

dosefollowingparenteraladministration,flucloxacillincandisplacebilirubinfromplasmaproteinbindingsites,and

maythereforepredisposetokernicterusinajaundicedbaby.Inaddition,specialcautionisessentialinthenewborn

becauseofthepotentialforhighserumlevelsofflucloxacillinduetoareducedrateofrenalexcretion.During

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

recommended.

Asthisproductcontainsupto3.05gsucroseper5mldoseitisunsuitableinhereditaryfructoseintolerance,glucose-

galactosemalabsorptionsyndrome,orsucrase-isomaltasedeficiency.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Probenecidandsulpinpyrazoneslowdowntheexcretionofflucloxacillin.

4.6Fertility,pregnancyandlactation

AnimalstudieswithFlucloxacillinhaveshownnoteratogeniceffects.Flucloxacillinpreparationshavebeeninuse

since1970andthelimitednumberofreportedcasesofuseinhumanpregnancyhaveshownnoevidenceofuntoward

effect.Flucloxacillinshouldonlybeusedinpregnancywhenthepotentialbenefitsoutweightherisksassociatedwith

treatment.

Flucloxacillinissecretedintomother’smilkandmayoccasionallycausesensitisationoftheinfant.Therefore

flucloxacillinshouldonlybeadministeredtoabreast-feedingmotherwhenthepotentialbenefitsoutweighthepotential

risksassociatedwiththetreatment.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Thefollowingconventionhasbeenutilisedfortheclassificationofundesirableeffects:-Verycommon(1/10),

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

Themostcommonadverseeffectsofflucloxacillinarehypersensitivityreactionsespeciallyskinrashes.

Unlessotherwisestated,thefrequencyoftheadverseeventshasbeenderivedfrommorethan30yearsofpost-

marketingreports.

Bloodandlymphaticsystemdisorders

Veryrare:Neutropenia(includingagranulocytosis)andthrombocytopenia.Haemolyticanaemia.Coagulation

disorders.

Immunesystemdisorders

Veryrare:Anaphylacticshock(seeSection4.4Specialwarningsandspecialprecautionsforuse),angioneurotic

oedema.

Ifanyhypersensitivityreactionoccurs,thetreatmentshouldbediscontinued.(SeealsoSkinandsubcutaneoustissue

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Gastrointestinaldisorders

Common:diarrhoea,nausea

Uncommon:Soremouthortongue,blackhairytongue

Veryrare:Pseudomembranouscolitis.

Hepato-biliarydisorders

Veryrare:Hepatitisandcholestaticjaundice.(SeeSection4.4SpecialWarningsandSpecialPrecautionsforUse).

Changesinliverfunctionlaboratorytestresults.

Thesereactionsarerelatedneithertothedosenortotherouteofadministration.Theonsetoftheseeffectsmaybe

delayedforuptotwomonthspost-treatment;inseveralcasesthecourseofthereactionshasbeenprotractedandlasted

forsomemonths.Hepaticeventsmaybesevereandinveryrarecircumstancesafataloutcomehasbeenreported.Most

reportsofdeathshavebeeninpatients50yearsandinpatientswithseriousunderlyingdisease.

Skinandsubcutaneoustissuedisorders

Uncommon:Rash,urticariaandpurpura.

Veryrare:Erythemamultiforme,Stevens-Johnsonsyndrome,serumsickness-likereactionandtoxicepidermal

necrolysis.

Musculoskeletalandconnectivetissuedisorders

Veryrare:Arthralgiaandmyalgia.

Renalandurinary

Veryrare:Interstitialnephritis.

Generaldisordersandadministrationsiteconditions

Veryrare:Fever

Nervoussystemdisorders

Veryrare:Convulsions

4.9Overdose

Withhighdoses(mainlyparenteral)neurotoxicitymaydevelop.

Gastrointestinaleffectssuchasnausea,vomitinganddiarrhoeamaybeevidentandshouldbetreatedsymptomatically.

Flucloxacillinisnotremovedfromthecirculationbyhaemodialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:J01CF05

Group–Beta-lactamaseresistantpenicillins

Properties:Flucloxacillinisanarrow-spectrumantibioticofthegroupofisoxazolylpenicillins;itisnotinactivatedby

staphylococcal-lactamases.

Activity:Flucloxacillin,byitsactiononthesynthesisofthebacterialwall,exertsabacterialeffectonstreptococci,

exceptthoseofgroupD(Enterococcusfaecalis),andstaphylococci.Itisnotactiveagainstmethicillin-resistant

staphylococci.

5.2Pharmacokineticproperties

Absorption:Flucloxacillinisstableinacidmediaandcanthereforebeadministeredeitherbytheoralorparentalroute.

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-After250mgbytheoralroute(infastingsubjects):Approximately8.8mg/l.

-After500mgbytheoralroute(infastingsubjects):Approximately14.5mg/l.

-After500mgbytheIMroute:Approximately16.5mg/l.

Thetotalquantityabsorbedbytheoralrouterepresentsapproximately79%ofthequantityadministered.

Distribution:Flucloxacillindiffuseswellintomosttissue.Specifically,activeconcentrationsofflucloxacillinhave

beenrecoveredinbones:11.6mg/l(compactbone)and15.6mg/l(spongybone),withameanserumlevelof8.9mg/l.

Crossingthemeningealbarrier:Flucloxacillindiffusesinonlysmallproportionintothecerebrospinalfluidofsubjects

whosemeningesarenotinflamed.

Crossingintomother’smilk:Flucloxacillinisexcretedinsmallquantitiesinmother’smilk.

Metabolism:Innormalsubjectsapproximately10%oftheflucloxacillinadministeredismetabolisedtopenicilloic

acid.Theeliminationhalf-lifeofflucloxacillinisintheorderof53minutes.

Excretion:Excretionoccursmainlythroughthekidney.Between65.5%(oralroute)and76.1%(parentalroute)ofthe

doseadministeredisrecoveredinunalteredactiveformintheurinewithin8hours.Asmallportionofthedose

administeredisexcretedinthebile.Theexcretionofflucloxacillinisslowedincasesofrenalfailure.

Proteinbinding:Theserumprotein-bindingrateis95%.

5.3Preclinicalsafetydata

NorelevantinformationadditionaltothatalreadycontainedelsewhereintheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumbenzoate

Disodiumedetate

Saccharinsodium

Ammoniumglycyrrhizate

Sodiumcitrate

Flavourpineapple

Flavourmenthol

Erythrosine(E127)

Sucrose

6.2Incompatibilities

Asforpenicillins,incompatibilitieswithColistinPolymyxinBsulphate. Lossofpotencyaftermixingwithstreptomycin

hasalsobeenreported.

6.3Shelflife

12monthsunopened.

Oncereconstitutedthemixtureshouldbeusedwithin7days.

6.4Specialprecautionsforstorage

Drypowder:Donotstoreabove25˚C.

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6.5Natureandcontentsofcontainer

150mlnaturalhighdensitypolyethylene(HDPE)bottlewithtamperevidentcap.

150mlnaturalhighdensitypolyethylene(HDPE)bottlewithtamperevident/childresistant(CRC)cap.

6.6Specialprecautionsfordisposalandotherhandling

Tothepharmacist:

100ml:Add58mlofpotablewaterandshakeuntilallcontentsaredissolved.

Tothepatient:

Keepcaptightlyclosed.Shakewellbeforeuse.Usewithin7daysofpreparation.

7MARKETINGAUTHORISATIONHOLDER

AthloneLaboratoriesLimited

Ballymurray

Co.Roscommon

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA298/16/4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:8thOctober2010

10DATEOFREVISIONOFTHETEXT

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