GERIFLOX ELIXIR

Main information

  • Trade name:
  • GERIFLOX ELIXIR
  • Dosage:
  • 125 Base mg/ 5ml
  • Pharmaceutical form:
  • Powder for Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GERIFLOX ELIXIR
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0577/016/001
  • Authorization date:
  • 13-12-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

GerifloxElixir125mg/5mlPowderforOralSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Whenreconstitutedasdirectedeach5mlofelixircontainsflucloxacillinsodiumequivalentto125mgflucloxacillin.

Excipients:

Sucrose 3.1g/5ml

Sulphurdioxide(E220)0.16mg/5ml

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Powderfororalsolution.

Pink,pineapple-flavouredgranularpowderforreconstitutionasanoralsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

GerifloxElixirisindicatedforthetreatmentofinfectionsduetopenicillinaseproducingstaphylococciandothergram-

positiveorganismssusceptibletothisanti-infective.

4.2Posologyandmethodofadministration

GerifloxElixirisadministeredorally.

OralformsofFlucloxacillinshouldbetakenhalftoonehourbeforemeals.

Recommendeddosageschedules:

AdultsandChildrenover10years

750mg-1500mgdailyindivideddoses(i.e.250mg-500mgthreetimesaday).Thisdosagemaybedoubledif

necessary.

Childrenaged2-10years

Theusualdailydoseis50mg/kgbodyweightindivideddoses(orhalftheadultdose).

Childrenunder2years:

Aquarterofadultdose.

Thedosagemaybeincreasedifnecessary.

Specialgroups:

GerifloxElixirusageinpatientswithrenalimpairmentdoesnotrequireddosagereduction.Inthepresenceofsevere

renalfailure(creatineclearance<10mg/min)areductionindoseorextensionofdoseintervalshouldbeconsidered.In

highdoseregimensthemaximumrecommendeddoseis1gevery8to12hours.

4.3Contraindications

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penicillins,cephalosporins)orexcipients.

GerifloxElixiriscontraindicatedinpatientswithaprevioushistoryofflucloxacillin-associatedjaundice/hepatic

dysfunction.

4.4Specialwarningsandprecautionsforuse

Seriousandoccasionallyfatalhypersensitivityreactions(anaphylaxis)havebeenreportedinpatientsreceivingbeta-

lactamantibiotics.Althoughanaphylaxisismorefrequentfollowingparenteraltherapy,ithasoccurredinpatientson

oraltherapy.Thesereactionsaremorelikelytooccurinindividualswithahistoryofbeta-lactamhypersensitivity.Ifan

allergicreactionoccurs,flucloxacillinshouldbediscontinuedandtheappropriatetherapyinstituted.Serious

anaphylactoidreactionsmayrequireimmediateemergencytreatmentwithadrenaline.Oxygen,i.vsteroids,andairway

management,includingintubation,mayalsoberequired.

Flucloxacillinshouldbeusedwithcautioninpatientswithevidenceofhepaticdysfunction,thosewithserious

underlyingdisease,andtheelderly.Inthesepatients,hepaticeventsmaybesevere,andinextremelyrare

circumstances,deathshavebeenreported.

Dosageshouldbeadjustedinrenalimpairment(SeePosologyandMethodofAdministration).

Flucloxacillinisexcretedinamannersimilartothatforbenzylpenicillin,i.e.byglomerularfiltrationandtubular

secretion.Thisshouldbeborneinmindwhendesigningtherapy.

Prolongeduseofananti-infectiveagentmayresultinthedevelopmentofsuper-infectionduetoorganismsresistantto

thatanti-infective.

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

recommended.

Specialcautionisessentialinthenewbornbecauseoftheriskofhyperbilirubinemia.Studieshaveshownthat,athigh

dosefollowingparenteraladministration,flucloxacillincandisplacebilirubinfromplasmaproteinbindingsites,and

maythereforepredisposetokernicterusinajaundicedbaby.Inaddition,specialcautionisessentialinthenewborn

becauseofthepotentialforhighserumlevelsofflucloxacillinduetoareducedrateofrenalexcretion.

Flucloxacillinhasbeenassociatedwithcholestaticjaundice,whichmayoccurseveralweeksafterstoppingtherapy

(riskincreaseinthosetreatedforlongerthan2weeksorwhoareover55yearsofage).

FlucloxacillinElixircontainssodiumbenzoatewhichisamildirritanttotheskin,eyesandmucousmembranes.Itmay

causejaundiceinnewbornbabies.

Containssucrose.Patientswithrarehereditaryproblemsoffructoseintolerance,glucosegalactosemalabsorptionor

sucrose-isomaltaseinsufficiencyshouldnottakethismedicine.

AsFlucloxacillinElixircontainssucrosepatientsshouldberemindedtobrushtheirteethregularly.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Probeneciddecreasestherenaltubularsecretionofflucloxacillin.Concurrentadministrationofprobeneciddelaysthe

renalexcretionofflucloxacillin.

Incommonwithotherantibiotics,flucloxacillinmayaffectthegutflora,leadingtoloweroestrogenreabsorptionand

reducedefficacyofcombinedoralcontraceptives.

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4.6Fertility,pregnancyandlactation

GerifloxElixirshouldnotbeusedduringpregnancyunlessconsideredessentialbythephysician.Theproductis

excretedinbreastmilk,presentingriskofcandidiasisandalsoofcentralnervoussystemtoxicityduetoprematurityof

thebloodbrainbarrier.Thereisatheoreticalpossibilityoflatersensitisation.

4.7Effectsonabilitytodriveandusemachines

Notrelevant.

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.

Bloodandlymphaticsystemsdisorders

Veryrare:Neutropenia(includingagranulocytosis)andthrombocytopenia.Thesearereversiblewhentreatmentis

discontinued.Eosinophilia.Haemolyticanaemia.

Immunesystemdisorders

Veryrare:Anaphylaticshock(exceptionalwithoraladministration)(seesection4.4),angioneuroticoedema.

Ifanyhypersensitivityreactionoccurs,thetreatmentshouldbediscontinued.(SeealsoSkinandsubcutaneoustissue

disorders).

Nervoussystemdisorders

Veryrare:Inpatientssufferingfromrenalfailure,neurologicaldisorderswithconvulsionsarepossiblewiththeLV.

injectionofhighdose.

Gastrointestinaldisorders

*Common:Minorgastrointestinaldisturbances

Veryrare:Pseudomembranouscolitis

Ifpseudomembranouscolitisdevelops,flucloxacillinshouldbediscontinuedandappropriatetherapy,e.g.oral

vancomycinshouldbeinitiated.

Hepato-biliarydisorders

Veryrare:Hepatitisandcholestaticjaundice(seesection4.4).Changesinliverfunctionlaboratorytestresults

(reversiblewhentreatmentisdiscontinued).

HepatitisandcholestaticJaundicemaybedelayedforuptotwomonthspost-treatment.Insomecasesthecoursehas

beenprotractedandlastedforseveralmonths.Hepaticeventsmaybesevere,andinveryrarecircumstances,deaths

havebeenreported.Mostreportsofdeathshavebeeninpatients 50yearsofageinpatientswithseriousunderlying

disease.

Skinandsubcutaneoustissuedisorders

*Uncommon:Rash,urticariaandpurpura.

Veryrare:Erythemamultiforme,StevensJohnsonsyndrome,andtoxicepidermalnecrolysis.

(seealsoImmunesystemdisorders).

Musculoskeletalandconnectivetissuedisorders

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Renalandurinarydisorders

Veryrare:Interstitialnephritis.

Thisisreversiblewhentreatmentisdiscontinued.

Generaldisordersandadministrationsiteconditions

Veryrare:Feversometimesdevelopsmorethan48hoursafterthestartofthetreatment.

*Theincidenceoftheseadverseevents(Aes)wasderivedfromclinicalstudiesinvolvingatotalofapproximately929

adultandpaediatricpatientstakingflucloxacillin.

4.9Overdose

Thereisnospecificantidoteforflucloxacillin.Gastriclavageandgeneralsupportivemeasuresareadvised.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmatherapeuticgroup:Betalactamaseresistantpenicillins

ATCCode:J01CF05

Flucloxacillinisapenicillinase-resistantsemi-syntheticpenicillinresistanttogastricacid.

5.2Pharmacokineticproperties

Peakserumconcentrationsarereachedafteronehourfollowinganoraldoseof250-500mginfastingsubjects.The

totalquantityabsorbedbytheoralrouterepresentsapproximately79%ofthequantityadministered.

Peakserumconcentrationsrangefrom3-27micrograms/mlwithameanpeakof1115micrograms/ml.Therapeutic

concentrationspersistforabout4hours.

Proteinbinding:theserumproteinbindingrateis95%.Flucloxacillindiffuseswellintomosttissues.

Crossingthemeningealbarrier:flucloxacillindiffusesinonlysmallproportionintothecerebrospinalfluidofsubjects

whosemeningesarenotinflamed.

Innormalsubjectsapproximately10%oftheflucloxacillinadministeredismetabolisedtopenicilloicacid.The

eliminationhalflifeofflucloxacillinisontheorderof53min.

Excretionoccursmainlythroughthekidney.65%ofthedoseadministeredorallyisrecoveredinunalteredactiveform

intheurinewithin8hours.Asmallportionofthedoseadministeredisexcretedinthebile.Theexcretionof

flucloxacillinisslowedincasesofrenalfailure.

5.3Preclinicalsafetydata

Nofurtherinformationavailable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumbenzoate(E2II)

Disodiumedetate

Saccharinsodium

Ammoniumglycyrrhizate

Sodiumcitrate(E331)

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Pineappleflavour(containingsulphurdioxide(E220))

Sucrose

Erythrosine(E127)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Unreconstituted: 18months

Reconstituted: 7days

6.4Specialprecautionsforstorage

Unreconstituted: Donotstoreabove25 o

C.Keepthebottletightlyclosed.

Reconstituted: Storeinarefrigerator(2 o

Cto8 o

C).Keepthebottletightlyclosed.

6.5Natureandcontentsofcontainer

150mlamberglassbottleswithpolypropylenescrewcapor150mlhigh-densitypolyethylenebottleswithtamper

evidentandchildresistantclosures-Polypropylenecapswithuni-foamwad/liner-expandedpolyethyleneliner

(ExtrudedclosedcellfoamproducedfromLowdensityPolyethylene)(LDPE)notfacedwithaluminium.

Eachbottlecontainssufficientpowdertoproduce100mlFlucloxacillinElixir125mg/5ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Pharmacist: Toprepare,add58mlofpotablewaterandshakeuntilallpowderisdissolved.

Patient: Shakewellbeforeeachuse.Usewithinsevendaysofpreparationanddiscardanyunusedelixir.Keep

thebottletightlyclosedandstoreinarefrigerator(2 o

7MARKETINGAUTHORISATIONHOLDER

McDermottLaboratoriesLtd.,

Tradingas:

GerardLaboratories

35/36BaldoyleIndustrialEstate,

GrangeRoad,

Dublin13

8MARKETINGAUTHORISATIONNUMBER

PA577/16/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:13 th

December1996

Dateoflastrenewal: 13 th

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10DATEOFREVISIONOFTHETEXT

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