FUCIDIN FOR IV INFUSION

Main information

  • Trade name:
  • FUCIDIN FOR IV INFUSION
  • Dosage:
  • 500 Milligram
  • Pharmaceutical form:
  • Pdr+Solv for soln for Inf
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FUCIDIN FOR IV INFUSION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0046/004/015
  • Authorization date:
  • 27-02-1991
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Fucidin500mgPowderandSolventforConcentrateforSolutionforI.V.Infusion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachvialofpowdercontains500mgofSodiumFusidate.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Powderandsolventforconcentrateforsolutionforinfusion

Awhitetooff-whitecrystallinepowderaccompaniedbyaclearandcolourlessbuffersolutionassolventfor

reconstitution.Thereconstitutedproductisfurtherdilutedwiththeappropriateinfusionfluidpriortoadministrationby

intravenousinfusion.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthetreatmentofsystemicinfectionsduetomicro-organismssensitivetothisanti-infective.

4.2Posologyandmethodofadministration

Adultsonly:

(Weighingmorethan50kg)

Theusualtotaldailydoseis1,500-2,000mgindivideddoses,i.e.giventhreetofourtimesdaily.Addthe

fusidate/buffersolutionto500mlofinfusionandinfuseslowlyoveraperiodofatleast2to4hoursintoawidebore

veinwithgoodbloodflow.Ifasuperficialveinisemployedamoreprolongedperiodofatleast6hoursisadvisable.

SinceFucidinisexcretedinthebile,nodosagemodificationsareneededinrenalimpairment.

ThedosageinpatientsundergoinghaemodialysisneedsnoadjustmentasFucidinisnotsignificantlydialysed.

Children

(andadultsweighinglessthan50kg).

Theusualtotaldailydoseis20mg/kgbodyweightdailydividedinto3equaldoses.

Eachdosecorrespondsto0.13mlofthefusidatebuffersolutionperkgbodyweight.Thisvolumeshouldbefurther

dilutedatleasttenfoldwiththeappropriateinfusionfluid.

4.3Contraindications

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Useinpatientswithbiliarytractobstruction.

4.4Specialwarningsandprecautionsforuse

Regularmonitoringofliverfunctionshouldbecarriedoutinpatientsonhighdosageoffusidate.

Prolongedadministrationofananti-infectivemayresultinthedevelopmentofsuperinfectionwithorganismsresistant

tothatanti-infective.

Fucidinshouldbeusedwithcautioninpatientswithimpairedliverfunctionorthoseconcurrentlyonpotentially

hepatotoxicdrugs.

Cautionshouldbeexercisedwithotherantibioticswhichhavesimilarbiliaryexcretionpathwayse.g.lincomycinand

rifampicin.

AbilirubindisplacingeffectofFucidinhasbeendemonstratedinvitro.Althoughkernicterushasnotbeenobservedin

new-bornsreceivingFucidin,thiseffectshouldbeborneinmindwhengivingFucidintoinfants,especiallyicteric,

prematurelybornacidoticorveryillneonates.

Whenreconstituted1vialcontains3.1mMolsodium.Thesodiumcontentshouldbetakenintoconsiderationfor

patientsonacontrolledsodiumdiet.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Fucidinadministeredsystemicallyandconcomitantlywithoralanticoagulantssuchascoumarinderivativesor

anticoagulantswithsimilaractionmayincreasetheplasmaconcentrationoftheseagentsenhancingtheanticoagulant

effect.Adjustmentoftheoralanticoagulantdosemaybenecessaryinordertomaintainthedesiredlevelof

anticoagulation.Themechanismofthissuspectedinteractionremainsunknown.

SpecificpathwaysofFucidinmetabolismintheliverarenotknown,however,aninteractionbetweenFucidinand

drugsbeingCYP-3A4biotransformedcanbesuspected.Themechanismofthisinteractionispresumedtobeamutual

inhibitionofmetabolism.TheuseofFucidinsystemicallyshouldbeavoidedinpatientstreatedwithCYP-3A4

biotransformeddrugs.

Co-administrationofFucidinsystemicallyandHMG-CoAreductaseinhibitorssuchasstatinscausesincreasedplasma

concentrationsofbothagentsresultinginanelevationofcreatinekinaselevel(rhabdomyolysis),muscleweaknessand

pain.

Co-administrationofFucidinsystemicallyandHIVproteaseinhibitorssuchasRitonavirandSaquinavircauses

increasedplasmaconcentrationsofbothagentswhichmayresultinhepatotoxicity.

Co-administrationofFucidinsystemicallyandCiclosporinhasbeenreportedtocauseincreasedplasmaconcentration

ofCiclosporin.

4.6Pregnancyandlactation

Thereisinadequateevidenceofsafetyinhumanpregnancy.Howeveranimalstudiesandmanyyearsofclinical

experiencesuggestthatFucidinisdevoidofteratogeniceffects.

Fucidincrossestheplacentaandshouldbeavoidedduringthethirdtrimesterduetothetheoreticalriskofkernicterus.

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4.7Effectsonabilitytodriveandusemachines

Presumedtobesafeorunlikelytoproduceaneffect.

4.8Undesirableeffects

Sideeffectsincluderash,reversiblejaundiceandrarelythrombophlebitis.Rarelyhaematologicaldisordershavebeen

reportedincludingbonemarrowdepression,thrombocytopeniaandneutropenia.Acuterenalfailurehasbeendescribed

inpatientswithjaundice,particularlyinthepresenceofotherfactorspredisposingtorenalfailure.

4.9Overdose

TherehasbeennoexperienceofoverdosagewithFucidin.Treatmentshouldberestrictedtosymptomaticand

supportivemeasures.Dialysisisofnobenefit,sincethedrugisnotsignificantlydialysed.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Fucidinexertspowerfulactivityagainstanumberofgram-positiveorganisms.Staphylococciincludingthestrains

resistanttopenicillinandotherantibioticsareparticularlysusceptibletoFucidin.Concentrationsof0.03-0.12mcg/ml

inhibitnearlyallstrainsofStaphylococcusaureus.

5.2Pharmacokineticproperties

Fucidinreadilypenetratestissue.Bactericidallevelshavebeenassayedinboneandnecrotictissue.Bloodlevelsare

cumulative,reachingconcentrationsof50-100mcg/mlafteroraladministrationof1.5gdailyforthreetofourdays.

Fucidinisexcretedmainlyinthebile,littleornonebeingexcretedintheurine.

5.3Preclinicalsafetydata

Noadditionaldata.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Diluent

Disodiumedetate

DisodiumPhosphateDihydrate(E339)

CitricacidMonohydrate

Waterforinjections

6.2Incompatibilities

SodiumFusidatereconstitutedat50mg/mlinbuffersolutionisphysicallyincompatiblewithinfusionfluidscontaining

lipidinfusionsandperitonealdialysisfluids.Highconcentrationsofdextrose(20%)areincompatible.

GenerallyprecipitationmayoccurindilutionswhichresultinapHoflessthan7.4.

Immediateandpersistentprecipitationoccurreduponmixingofsodiumfusidatewithvancomycin(25mg/ml)and

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6.3ShelfLife

Drypowderandbuffersolution:3years

Reconstitutedsolution:Thereconstitutedsolutionshouldbeaddedtotheinfusionsolutionimmediately.Theinfusion

solutionshouldthenbeusedwithin24hrs.Unusedportionsinthevialmustbediscarded.

Fromamicrobiologicalpointofview,theproductshouldbeusedimmediately.Ifnotusedimmediately,in-usestorage

timesandconditionspriortousearetheresponsibilityoftheuserandreconstitution/dilutionshouldbecarriedout

undercontrolledandvalidatedasepticconditions.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

Thedrysubstanceiscontainedin12mlglass(Type1)vialsclosedwithabutylrubberstopper,securedwithametal

ring.

Thebuffersolutioniscontainedin12mlglass(Type1)vialsclosedwithanethylenepropylenerubberstopper,

securedwithametalring.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Forsingleuseonly:Discardanyunusedcontents.

Recommendedprocedure:

Reconstitution:Addthe10mlofsterilebufferprovidedtothevialcontaining500mgsodiumfusidate,todissolvethe

powder.Thepowdershouldbecompletelydissolvedandthereconstitutedconcentratewillbeclear.Thereconstituted

concentratemustbefurtherdilutedbeforeinfusion(seebelowforcompatibleinfusionfluids).

InvitrocompatibilitystudiesofFucidinforIntravenousInfusionwithcommonlyusedinfusionsolutionshavebeen

carriedout.Theresultsshowedthatsodiumfusidatereconstitutedat50mg/mlinbuffersolutionisphysicallyand

chemicallycompatiblefor24hoursatroomtemperaturewiththefollowinginfusionsolutions(thefigureinparenthesis

showstheconcentrationofsodiumfusidateinthefinaladmixture):

SodiumChlorideIntravenousInfusionBP0.9%(1-2mg/ml)

DextroseIntravenousInfusionBP5%(1-2mg/ml)

CompoundSodiumLactateIntravenousInfusion(“Ringer-LactateSolution”)(1mg/ml)

SodiumLactateIntravenousInfusionBP(1mg/ml)

SodiumChloride(0.18%)andDextrose(4%)IntravenousInfusionBP

(1mg/ml).

PotassiumChloride(0.3%)andDextrose(5%)IntravenousInfusionBP

(1mg/ml).

Ifadditionalantibacterialtherapyistobeemployed,itisgenerallyrecommendedthatforparenteraladministrations,

separateinfusionfluidsbeused.HoweverFucidinIVisphysicallyandchemicallycompatiblefor24hoursatroom

temperatureinthefollowingadmixtures:

Cefotaxime(2.5mg/ml)+sodiumfusidate(0.5mg/ml)inDextrose-SalineIntravenousInfusion(glassbottles).

Erythromycin(5mg/ml)+sodiumfusidate(1mg/ml)inDextrose-SalineIntravenousInfusion(PVC-bags).

Flucloxacillin(2.5mg/ml)+sodiumfusidate(0.5mg/ml)inDextrose-SalineIntravenousInfusion(glassbottles)

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bags).

Cefotaxime,erythromycin,flucloxacillinandgentamicinsulphatearecompatiblewithsodiumfusidateinthelisted

admixtures,evenifminordecreasesinpotenciestakeplace.

Fromamicrobiologicalpointofview,theproductshouldbeusedimmediately.Ifnotusedimmediately,in-usestorage

timesandconditionspriortousearetheresponsibilityoftheuserandreconstitution/dilutionshouldbecarriedout

undercontrolledandvalidatedasepticconditions.

7MARKETINGAUTHORISATIONHOLDER

LEOLaboratoriesLimited

CashelRoad

Dublin12

8MARKETINGAUTHORISATIONNUMBER

PA46/4/15

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27February1991

Dateoflastrenewal:13March2005

10DATEOFREVISIONOFTHETEXT

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