FLIXONASE AQUEOUS

Main information

  • Trade name:
  • FLIXONASE AQUEOUS
  • Dosage:
  • 50 Mcg/Dose
  • Pharmaceutical form:
  • Nasal Spray Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLIXONASE AQUEOUS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1077/043/001
  • Authorization date:
  • 10-10-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA1077/043/001

CaseNo:2051318

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

GlaxoSmithKline(Ireland)Limited

StonemasonsWay,Rathfarnham,Dublin16,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

FlixonaseAqueous50microgramspermetereddose,NasalSpraySuspension

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom10/10/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 30/08/2010 CRN 2051318 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FlixonaseAqueous50microgramspermetereddose,NasalSpraySuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmeteredspraycontains50microgramsfluticasonepropionate.

Excipients:eachmeteredspraycontains20microgramsofbenzalkoniumchloride.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Nasalspraysuspension(NasalSpray)

Awhite,opaqueaqueoussuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

FluticasonePropionateAqueousNasalSprayisindicatedfortheprophylaxisandtreatmentofseasonalallergicrhinitis

includinghayfever,andperennialrhinitis.Fluticasonepropionatehaspotentanti-inflammatoryactivitybutwhenused

topicallyonthenasalmucosahasnodetectablesystemicactivity.

4.2Posologyandmethodofadministration

FluticasonePropionateAqueousNasalSprayisforadministrationbytheintranasalrouteonly.

AdultsandChildrenover12YearsofAge:

Fortheprophylaxisandtreatmentofseasonalallergicrhinitisandperennialrhinitis:

Twospraysintoeachnostrilonceaday,preferablyinthemorning.Insomecasestwospraysintoeachnostriltwice

dailymayberequired.Themaximumdailydoseshouldnotexceedfourspraysintoeachnostril.

ElderlyPatients:

Thenormaladultdosageisapplicable.

Childrenunder12yearsofage:

Fortheprophylaxisandtreatmentofseasonalallergicrhinitisandperennialrhinitisinchildrenaged4-11years:

Onesprayintoeachnostrilonceaday,preferablyinthemorning.Insomecasesonesprayintoeachnostriltwicedaily

mayberequired.Themaximumdailydoseshouldnotexceedtwospraysintoeachnostril.

Forfulltherapeuticbenefitregularusageisessential.Theabsenceofanimmediateeffectshouldbeexplainedtothe

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4.3Contraindications

FluticasonePropionateAqueousNasalSprayiscontra-indicatedinpatientswithahypersensitivitytoanyofits

ingredients.

4.4Specialwarningsandprecautionsforuse

Systemiceffectsofnasalcorticosteroidsmayoccurparticularlyathighdosesprescribedforprolongedperiods.These

effectsvarybetweenpatientsanddifferentcorticosteroids(pleaserefertoSections5.1and5.2).

Growthretardationhasbeenreportedinchildrenreceivingsomenasalcorticosteroidsatlicenseddoses.Itis

recommendedthattheheightofchildrenreceivingprolongedtreatmentwithnasalcorticosteroidsisregularly

monitored.Ifgrowthisslowed,therapyshouldbereviewedwiththeaimofreducingthedoseofnasalcorticosteroid,if

possible,tothelowestdoseatwhicheffectivecontrolofsymptomsismaintained.Inaddition,considerationshouldbe

giventoreferringthepatienttoapaediatricspecialist.

Treatmentwithhigherthanrecommendeddosesofnasalcorticosteroidsmayresultinclinicallysignificantadrenal

suppression.Ifthereisevidenceforhigherthanrecommendeddosesbeingusedthenadditionalsystemiccorticosteroid

covershouldbeconsideredduringperiodsofstressorelectivesurgery(seesection5.1fordataonintranasal

fluticasonepropionate).

Insomepatientshoarsenessorthroatirritationmayoccur.

Particularcareshouldbetakentominimiseuseoftopicalcorticosteroidsinpatientswithimmunosuppression.

Transferofpatientsfromothertherapiesforrhinitisispreferablydonewhenpatientsarereasonablystable.Following

introductionofFlixonaseitmaybepossibletoreducetheothertherapy.Particularlyinthoseonsystemic

corticosteroidsitisessentialtocarryoutsuchdecrementsslowlyandwithgreatcareinviewofthepossibilityof

inducedimpairmentofadrenocorticalfunction.

Itisimportanttobeonthelook-outforintercurrentinfectionsincludinglocalmonilialinfections,andtotreatthese

appropriately.

Extremelyrarecasesofnasalseptalperforationhavebeenreportedfollowingtheuseofintranasalaerosol

corticosteroids.Usuallyinpatientswhohavehadpreviousnasalsurgery.

Occasionallysneezingattacksmayfollowuse.

LocalInfection:Infectionsofnasalairwaysshouldbeappropriatelytreatedbutdonotconstituteaspecificcontra-

indicationtotreatmentwithFluticasonePropionateAqueousNasalSpray.

ThefullbenefitofFluticasonePropionateAqueousNasalSpraymaynotbeachieveduntiltreatmenthasbeen

administeredforseveraldays.

AlthoughFluticasonePropionateAqueousNasalSpraywillcontrolseasonalallergicrhinitisinmostcases,an

abnormallyheavychallengeofsummerallergensmayincertaininstancesnecessitateappropriateadditionaltherapy,

particularlytocontroleyesymptoms.

Duringpost-marketinguse,therehavebeenreportsofclinicallysignificantdruginteractionsinpatientsreceiving

fluticasonepropionateandritonavir,resultinginsystematiccorticosteroideffectsincludingCushing’ssyndromeand

adrenalsuppression.Therefore,concomitantuseoffluticasonepropionateandritonavirshouldbeavoided,unlessthe

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Undernormalcircumstances,lowplasmaconcentrationsoffluticasonepropionateareachievedafterintranasaldosing,

duetoextensivefirstpassmetabolismandhighsystemicclearancemediatedbycytochromeP4503A4inthegutand

liver.Hence,clinicallysignificantdruginteractionsmediatedbyfluticasonepropionateareunlikely.

Adruginteractionstudyinhealthysubjectshasshownthatritonavir(ahighlypotentcytochromeP4503A4inhibitor)

cangreatlyincreasefluticasonepropionateplasmaconcentrations,resultinginmarkedlyreducedserumcortisol

concentrations.Duringpost-marketinguse,therehavebeenreportsofclinicallysignificantdruginteractionsin

patientsreceivingintranasalorinhaledfluticasonepropionateandritonavir,resultinginsystematiccorticosteroid

effectsincludingCushing’ssyndromeandadrenalsuppression.Therefore,concomitantuseoffluticasonepropionate

andritonavirshouldbeavoided,unlessthepotentialbenefittothepatientoutweighstheriskofsystematic

corticosteroidsideeffects.

StudieshaveshownthatotherinhibitorsofcytochromeP4503A4producenegligible(erythromycin)andminor

(ketoconazole)increaseinsystemicexposuretofluticasonepropionatewithoutnotablereductionsinserumcortisol

concentrations.Nevertheless,careisadvisedwhenco-administeringpotentcytochromeP4503A4inhibitors(e.g.

ketoconazole)asthereispotentialforincreasedsystemicexposuretofluticasonepropionate.

4.6Pregnancyandlactation

Pregnancy:

Thereisinadequateevidenceofsafetyinhumanpregnancy.Inanimalreproductionstudiesadverseeffectstypicalof

potentcorticosteroidareonlyseenathighsystemicexposurelevels;directintranasalapplicationensuresminimal

systemicexposure.

However,aswithotherdrugstheuseofFluticasonePropionateAqueousNasalSprayduringhumanpregnancy

requiresthatthebenefitsbeweighedagainstthepossiblerisksassociatedwiththeproductorwithanyalternative

therapy.

Lactation:

Theexcretionoffluticasonepropionateintohumanbreastmilkhasnotbeeninvestigated.Whenmeasurableplasma

levelswereobtainedinlactatinglaboratoryratsfollowingsubcutaneousadministrationtherewasevidenceof

fluticasonepropionateinthebreastmilk.However,plasmalevelsinpatientsfollowingintranasalapplicationof

fluticasonepropionateatrecommendeddosesarelikelytobelow.

4.7Effectsonabilitytodriveandusemachines

Nonereported.

4.8Undesirableeffects

Adverseeventsarelistedbysystemorganclassandfrequency.Frequenciesaredefinedas:verycommon( ≥1/10),

common( ≥1/100and<1/10),uncommon(≥1/1000and<1/100),rare(≥1/10,000and<1/1000)andveryrare

(<1/10,000)includingisolatedreports.Verycommon,commonanduncommoneventsweregenerallydeterminedform

clinicaltrialdata.Rareandveryrareeventsweregenerallydeterminedfromspontaneousdata.Inassigningadverse

eventfrequencies,thebackgroundratesinplacebogroupswerenottakenintoaccount,sincetheseratesweregenerally

comparabletothoseintheactivetreatmentgroup.

Immunesystemdisorders:

Veryrare:Hypersensitivityreactions,anaphylaxis/anaphylacticreactions,bronchospasm,skinrash,oedemaoftheface

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Nervoussystemdisorders:

Common:Headache,unpleasanttaste,unpleasantsmell.

Aswithothernasalsprays,unpleasanttasteandsmellandheadachehavebeenreported.

Respiratory,thoracicandmediastinaldisorders:

Verycommon:Epistaxis.

Common:Nasaldryness,nasalirritation,throatdryness,throatirritation.

Veryrare:Nasalseptalperforation.

Aswithothernasalsprays,drynessandirritationofthenoseandthroat,andepistaxishavebeenreported.Nasalseptal

perforationhavealsobeenreportedfollowingtheuseofintranasalcorticosteroids.

4.9Overdose

ThereisnodataavailableontheeffectsofacuteorchronicoverdosagewithFluticasonePropionateAqueousNasal

Spray.Intranasaladministrationof2mgfluticasonepropionatetwicedailyforsevendaystohealthyhumanvolunteers

hadnoeffectonhypothalamic-pituitary-adrenalaxisfunction.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Fluticasonepropionatecauseslittleornohypothalamic-pituitary-adrenalaxissuppressionfollowingintranasalor

topical(dermal)administration,andonlycausesovertHPAaxissuppressionafterveryhighoraldoses(10mgqds-four

timesaday-i.e.40mgdailyandabove).Plasmafluticasonepropionatelevelsafterintranasaldosesofuptoand

including1mgarelow,aroundthelimitofquantitationoftheassay(0.05nanograms/ml).

Ina1-yearrandomised,doubleblind,placebo-controlledparallelgroupgrowthstudyinpre-pubescentchildrenaged3

to9years(56patientsreceivingintranasalfluticasonepropionateand52receivingplacebo,)nostatisticallysignificant

differenceingrowthvelocitywasobservedinpatientsreceivingintranasalfluticasonepropionate(200microgramsper

daynasalspray)comparedtoplacebo.Theestimatedgrowthvelocityoveroneyearoftreatmentwas6.20cm/year

(SE=0.23)intheplacebogroupand5.99cm/year(SE=0.23)inthefluticasonepropionategroup;themeandifference

betweentreatmentsingrowthvelocityafteroneyearwas0.20cm/year(SE=0.28,95%CI=-0.35,0.76).Noevidenceof

clinicallyrelevantchangesinHPAaxisfunctionorbonemineraldensitywasobservedasassessedby12-hoururinary

cortisolexcretionanddual-energyx-rayabsorptiometry,respectively.

5.2Pharmacokineticproperties

Followingoraladministration87-100%ofthedoseisexcretedinthefaeces,upto75%asunabsorbedparent

compounddependingonthedose.After6mgoral64%excretedasparent.Thereisanonactivemajormetabolite.

Followingintravenousadministrationthereishighplasmaclearancesuggestiveofextensivehepaticextraction.From

limitedearlydatatheterminalplasmahalf-lifewasestimatedat3handtheassociatedvolumeofdistribution,over3

timesbodyweight.Thisisconsistentwithrapideliminationandextensivetissuedistribution.

5.3Preclinicalsafetydata

Toxicologyhasshownonlythoseclasseffectstypicalofapotentcorticosteroid,andtheseonlyatdosesgreatlyin

excessofthoseproposedfortherapeuticuse.Nonoveleffectswereidentifiedinrepeatdosetoxicitytests,reproductive

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Fluticasonepropionateisdevoidofmutagenicactivityinvitroandinvivoandshowednotumorigenicpotentialin

rodents.Itisbothnonirritantandnonsensitisinginanimalmodels.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Dextrose(Anhydrous)

Microcrystallinecellulose&

Sodiumcarboxymethylcellulose(AvicelRC591)

Phenylethylalcohol

Benzalkoniumchloride

Polysorbate80

DiluteHydrochloricacid(forpHadjustment)

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove30 °

C.Donotrefrigerate.

6.5Natureandcontentsofcontainer

TypeIorIII(Ph.Eur.)amberglassbottlefittedwithametering,atomisingpump,nasaladapterandadustcover.

Eachbottleprovidesapproximately60or120meteredsprays,whenusedasrecommended.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Shakegentlybeforeuse.

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKline(Ireland)Limited

StonemasonsWay

Rathfarnham

Dublin16

Ireland

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:10 th

October1990

Dateoflastrenewal:10 th

October2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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