FLUCILLIN

Main information

  • Trade name:
  • FLUCILLIN Powder for Oral Solution 125 MG/ 5ml
  • Dosage:
  • 125 MG/ 5ml
  • Pharmaceutical form:
  • Powder for Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLUCILLIN Powder for Oral Solution 125 MG/5ml
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0281/031/003
  • Authorization date:
  • 19-05-1997
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Flucillin125mg/5mlPowderforOralSolution.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each5mlcontainsflucloxacillin125mgasflucloxacillinsodium.

Excipients:alsoincludessucrose3.1gper5ml,sodium0.534mmolper5mlandtraceamountsofsulphurdioxide

(E220).

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Powderfororalsolution.

Apink,pineapple-flavouredgranularpowderfororalsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Flucloxacillinisrecommendedforthetreatmentofinfectionsduetopencillinase-producingStaphylococciandother

gram-positiveorganismssusceptibletoFlucloxacillin.

4.2Posologyandmethodofadministration

Adults:

750mgto1500mgdailyindivideddoses.Thedosagemaybeincreasedifnecessary.

Children:

Agedover12years:750mgto1500mgdailyindivideddoses.Thedosagemaybeincreasedifnecessary.

Aged2–12years:

Theusualdailydoseis50mg/kgbodyweightindivideddoses.

SpecialGroups:

Inthepresenceofsevererenalfailure(creatinineclearance<10ml/min)areductionindoseorextensionofdose

intervalshouldbeconsidered.

Administration:

Oraldosesshouldbeadministeredonehourbeforemealsoronanemptystomach.

4.3Contraindications

Flucloxacillinshouldnotbegiventopatientswithahistoryofhypersensitivityto-lactamantibiotics(e.g.penicillins,

cephalosporins)oranyoftheexcipients.

Flucloxacilliniscontraindicatedinpatientswithaprevioushistoryofflucloxacillin-associatedjanudice/hepatic

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4.4Specialwarningsandprecautionsforuse

Beforeinitiatingtherapywithflucloxacillin,carefulinquiryshouldbemadeconcerningprevioushypersensitivity

reactionstobeta-lactams.Cross-sensitivitybetweenpenicillinsandcephalosporinsiswelldocumented.

Seriousandoccasionallyfatalhypersensitivityreactions(anaphylaxis)havebeenreportedinpatientsreceivingbeta-

lactamantibiotics.Althoughanaphylaxisismorefrequentfollowingparenteraltherapy,ithasoccurredinpatientson

oraltherapy.Thesereactionsaremorelikelytooccurinindivdualswithahistoryofbeta-lactamhypersensitivity.Ifan

allergicreactionoccurs,flucloxacillinshouldbediscontinuedandtheappropriatetherapyinstituted.Serious

anaphylactoidreactionsmayrequireimmediateemergencytreatmentwithadrenaline.Oxygen,i.v.steroids,andairway

management,includingintubation,mayalsoberequired.

Flucloxacillinhasbeenassociatedwithcholestaticjaundicewhichmayoccurseveralweeksafterstoppingtherapy(risk

increasedinthosetreatedforlongerthan2weeksorwhoareover55yearsofage).

Flucloxacillinisexcretedinamannersimilartothatforbenzylpenicillini.e.byglomerularfiltrationandtubular

secretion.Thisshouldbeborneinmindwhenprescribingtherapy.

Flucloxacillinshouldbeusedwithcautioninpatientswithevidenceofhepaticdysfunction,thosewithserious

underlyingdisease,andtheelderly.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.

Prolongedusemayoccasionallyresultinovergrowthofnon-susceptibleorganisms.

Containssucrose:Patientswithrarehereditaryproblemsoffructoseintolerance,glucose-galactosemalabsorptionor

sucrose-isomaltaseinsufficiencyshouldnottakethismedicine.

Sodiumcontent:Thismedicinalproductcontainsapproximately38.5mgsodiumper10ml(250mg)dose.Tobetaken

intoconsiderationbypatientsonacontrolledsodiumdiet.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Probenecidreducestheexcretionofflucloxacillin.

4.6Pregnancyandlactation

Flucloxacillinshouldnotbeusedduringpregnancyunlessthephysicianconsiderstheexpectedbenefitstothepatient

outweighthepotentialriskstothefoetus.

Flucloxacillinisexcretedinbreastmilk,presentingtheriskofcandidiasisandalsoofcentralnervoussystemtoxicity

duetoimmaturityofthebloodbrainbarrier.Thereisatheoreticalpossibilityoflatersensitisation.

4.7Effectsonabilitytodriveandusemachines

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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,thefrequencyoftheadverseeventshasbeenderivedfrommorethan30yearsofpost-

marketingreports.

Bloodandlymphaticsystemdisorders

Veryrare:Neutropenia(includingagranulcytosis)andthrombocytopenia.Thesearereversiblewhentreatmentis

discontinued.Eospinphilia,haemolyticanaemia.

Immunesystemdisorders

Veryrare:Anaphylacticshock(exceptionalwithoraladministration)(seeItem4.4Warnings),angioneuroticoedema.

Ifanyhypersensitivityreactionoccurs,thetreatmentshouldbediscontinued.(seealsoSkinandsubcutaneoustissue

disorders).

Nervoussystemdisorders

Veryrare:Inpatientssufferingfromrenalfailure,neurologicaldisorderswithconvulsionsarepossiblewiththeI.V.

injectionofhighdoses.

Gastrointestinaldisorders

*Common:Minorgastrointestinaldisturbances(suchasnauseaanddiarrhoea).

Veryrare:Pseudomembranouscolitis.

Ifpseudomembranouscolitisdevelops,flucloxacillintreatmentshouldbediscontinuedandappropriatetherapy,e.g.

oralvancomycinshouldbeinitiated.

Hepato-biliarydisorders

Veryrare:Hepatitisandcholestaticjaundice(seeWarningsandPrecautions).Changesinliverfunctionlaboratorytest

results(reversiblewhentreatmentisdiscontinued).

Hepatitisandcholestaticjaundicemaybedelayedforuptotwomonthspost-treatment.Insomecasesthecoursehas

beenprotractedandlastedforseveralmonths.Hepaticeventsmaybesevere,andinveryrarecircumstances,

deathshavebeenreported.Mostreportsofdeathshavebeeninpatients>50yearsofageandinpatientswithserious

underlyingdisease.

Skinandsubcutaneoustissuedisorders

*Uncommon:Rash,urticariaandpurpura.

Veryrare:Erythemamultiforme,Stevens-johnsonsyndrome,andtoxicepidermalnecrolysis.

(SeealsoImmunesystemdisorders).

Musculoskeletalandconnectivetissuedisorders

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Renalandurinarydisorders

Veryrare:Interstitialnephritis.

Thisisreversiblewhentreatmentisdiscontinued.

Generaldisordersandadministrationsiteconditions

Veryrare:Feversometimesdevelopsmorethan48hoursafterthestartofthetreatment.

*TheincidenceoftheseAEswasderivedfromclinicalstudiesinvolvingatotalofapproximately929adultand

paediatricpatientstalkingflucloxacillin.

4.9Overdose

Symptomatictreatmentifappropriate.Flucloxacillinisnotsignificantlyremovedbydialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Flucloxacillinisapenicillinase-resistantsemi-syntheticpenicillinresistanttogastricacid.

Flucloxacillinhasthesamespectrumofactivityastheearlierantistaphylococcalpenicillinsmethicillinandcloxacillin

againstgram-positiveorganisms,includingpenicillinase-producingstrains.

5.2Pharmacokineticproperties

Peakserumconcentrationsarereachedafteronehour,followinganoraldoseof250mgto500mginfastingsubjects.

Peakserumconcentrationsrangefrom3to27µg/mlwithameanpeakof11to15µg/ml.Therapeuticconcentrations

persistforabout4hours.

5.3Preclinicalsafetydata

Noneknown.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumbenzoate(E211)

Disodiumedetate

Saccharinsodium

Monoammoniumglycyrrhizinate

Sodiumcitrate

Flavourmenthol(containssulphurdioxideE220)

Flavourpineapple(containssulphurdioxideE220)

Sucrose

Erythrosine(E127)

6.2Incompatibilities

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6.3ShelfLife

Powder:18months.

Reconstitutedsolution:7days.

6.4Specialprecautionsforstorage

Powder:Donotstoreabove25 °

Reconstitutedoralsolution:Storeinarefrigeratorbetween2 °

C-8 °

6.5Natureandcontentsofcontainer

150mlamberglassbottlewithpolypropylenescrewcaps

Or150mlhighdensitypolyethylenebottlewithtamperevidentscrewcap.

150mlhighdensitypolyethylenebottleswithtamperevidentandchildresistantclosures-PolypropylenecapwithUni-

Foamwad/liner-Expandedpolyethyleneliner(ExtrudedclosedcellfoamproducedfromLowDensityPolyethylene)

(LDPE)notfacedwithaluminium.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Topreparesolution,add58mlofwaterandshakeuntilallpowderisdissolved.Onreconstitutiontheproductisaclear

redsolutionwithapineappleodourandflavour.

7MARKETINGAUTHORISATIONHOLDER

PinewoodLaboratoriesLimited,TradingasPinewoodHealthcare

Ballymacarbry

Clonmel

CountyTipperary

8MARKETINGAUTHORISATIONNUMBER

PA0281/031/003

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:19March1987

Dateoflastrenewal:19May2007

10DATEOFREVISIONOFTHETEXT

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