FLIXONASE

Main information

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

Documents

Localization

  • Available in:
  • FLIXONASE Nasal Spray Suspension 50 Mcg/Acutuation
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1328/012/001
  • Authorization date:
  • 25-01-2008
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Flixonase50microgramsperactuation,Aqueousnasalspray,suspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each100mgactuationcontains50microgramoffluticasonepropionate.

Excipients:Benzalkoniumchloride

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Nasalspray,suspension.

ProductimportedfromFranceandPortugal:

Awhite,opaqueaqueoussuspensionintendedforintranasaladministration.

4CLINICALPARTICULARS

4.1TherapeuticIndications

FluticasonePropionateAqueousNasalSprayisindicatedfortheprophylaxisandtreatmentofseasonalallergicrhinitis

includinghayfever,andperennialrhinitis.Fluticasonepropionatehaspotentanti-inflammatoryactivitybutwhenused

topicallyonthenasalmucosahasnodetectablesystemicactivity.

4.2Posologyandmethodofadministration

FluticasonePropionateAqueousNasalSprayisforadministrationbytheintranasalrouteonly.

Adultsandchildrenover12yearsofage:Fortheprophylaxisandtreatmentofseasonalallergicrhinitisandperennial

rhinitis:

Twospraysintoeachnostrilonceaday,preferablyinthemorning.Insomecasestwospraysintoeachnostriltwice

dailymayberequired.Themaximumdailydoseshouldnotexceedfourspraysintoeachnostril.

ElderlyPatients:

Thenormaladultdosageisapplicable.

Childrenunder12yearsofage:Fortheprophylaxisandtreatmentofseasonalallergicrhinitisandperennialrhinitisin

childrenaged4-11years:-

Onesprayintoeachnostrilonceaday,preferablyinthemorning.Insomecasesonesprayintoeachnostriltwicedaily

mayberequired.Themaximumdailydoseshouldnotexceedtwospraysintoeachnostril.

Forfulltherapeuticbenefitregularusageisessential.Theabsenceofanimmediateeffectshouldbeexplainedtothe

patientasmaximumreliefmaynotbeobtaineduntilafter3or4daysoftreatment.

4.3Contraindications

FluticasonePropionateAqueousNasalSprayiscontra-indicatedinpatientswithahypersensitivitytoanyofits

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4.4Specialwarningsandprecautionsforuse

Systemiceffectsofnasalcorticosteroidsmayoccurparticularlyathighdosesprescribedforprolongedperiods.These

effectsaremuchlesslikelytooccurthanwithoralcorticosteroidsandmayvaryinindividualpatientsandbetween

differentcorticosteroidpreparations.PotentialsystemiceffectsmayincludeCushing’ssyndrome,Cushingoidfeatures,

adrenalsuppression,growthretardationinchildrenandadolescents,cataract,glaucomaandmorerarely,arangeof

psychologicalorbehaviouraleffectsincludingpsychomotorhyperactivity,sleepdisorders,anxiety,depressionor

aggression(particularlyinchildren).

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,resultinginsystemiccorticosteroideffectsincludingCushing'ssyndromeand

adrenalsuppression.Therefore,concomitantuseoffluticasonepropionateandritonavirshouldbeavoided,unlessthe

potentialbenefittothepatientoutweighstheriskofsystemiccorticosteroidsideeffects.(SeeSection4.5)

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Undernormalcircumstances,lowplasmaconcentrationsoffluticasonepropionateareachievedafterintranasaldosing,

duetoextensivefirstpassmetabolismandhighsystemicclearancemediatedbycytochromeP4503A4inthegutand

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Adruginteractionstudyinhealthysubjectshasshownthatritonavir(ahighlypotentcytochromeP4503A4inhibitor)

cangreatlyincreasefluticasonepropionateplasmaconcentrations,resultinginmarkedlyreducedserumcortisol

concentrations.Duringpost-marketinguse,therehavebeenreportsofclinicallysignificantdruginteractionsinpatients

receivingfluticasonepropionateandritonavir,resultinginsystemiccorticosteroideffectsincludingCushing's

syndromeandadrenalsuppression.Therefore,concomitantuseoffluticasonepropionateandritonavirshouldbe

avoided,unlessthepotentialbenefittothepatientoutweighstheriskofsystemiccorticosteroidsideeffects.

StudieshaveshownthatotherinhibitorsofcytochromeP4503A4producenegligible(erythromycin)andminor

(ketoconazole)increasesinsystemicexposuretofluticasonepropionatewithoutnotablereductionsinserumcortisol

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

ketoconazole)asthereispotentialforincreasedsystemicexposuretofluticasonepropionate.

4.6Fertility,pregnancyandlactation

Pregnancy:Thereisinadequateevidenceofsafetyinhumanpregnancy.Inanimalreproductionstudies,adverseeffects

typicalofpotentcorticosteroidsareonlyseenathighsystemicexposurelevels;directintranasalapplicationensures

minimalsystemicexposure.

However,aswithotherdrugstheuseofFluticasonePropionateAqueousNasalSprayduringhumanpregnancy

requiresthatthebenefitsbeweighedagainstthepossiblerisksassociatedwiththeproductorwithanyalternative

therapy.

Lactation:Theexcretionoffluticasonepropionateintohumanbreastmilkhasnotbeeninvestigated.Whenmeasurable

plasmalevelswereobtainedinlactatinglaboratoryratsfollowingsubcutaneousadministrationtherewasevidenceof

fluticasonepropionateinthebreastmilk.However,plasmalevelsinpatientsfollowingintranasalapplicationof

fluticasonepropionateatrecommendeddosesarelikelytobelow.

4.7Effectsonabilitytodriveandusemachines

Nonereported.

4.8Undesirableeffects

Adverseeventsarelistedbelowbysystemorganclassandfrequency.Frequenciesaredefinedas:verycommon

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

rare(<1/10,000)includingisolatedreports.Verycommon,commonanduncommoneventsweregenerallydetermined

fromclinicaltrialdata.Rareandveryrareeventsweregenerallydeterminedfromspontaneousdata.Inassigning

adverseeventfrequencies,thebackgroundratesinplacebogroupswerenottakenintoaccount,sincetheserateswere

generallycomparabletothoseintheactivetreatmentgroup.

ImmuneSystemDisorders

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

ortongue.

NervousSystemDisorders

Common:Headache,unpleasanttaste,unpleasantsmell.

Aswithothernasalsprays,unpleasanttasteandsmellandheadachehavebeenreported.

Respiratory,ThoracicandMediastinalDisorders

Verycommon:Epistaxis.

Common:Nasaldryness,nasalirritation,throatdryness,throatirritation.

Veryrare:Nasalseptalperforation.

Aswithothernasalsprays,drynessandirritationofthenoseandthroat,andepistaxishavebeenreported.Nasalseptal

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4.9Overdose

ThereisnodataavailableontheeffectsofacuteorchronicoverdosagewithFluticasonePropionateAqueousNasal

Spray.Intranasaladministrationof2mgfluticasonepropionatetwicedailyforsevendaystohealthyhumanvolunteers

hadnoeffectonhypothalamic-pituitary-adrenalaxisfunction.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Fluticasonepropionatecauseslittleornohypothalmic-pituitary-adrenalaxissuppressionfollowingintranasalortopical

(dermal)administration,andonlycausesovertHPAaxissuppressionafterveryhighoraldoses(10mgqds-i.e.40mg

dailyandabove).Plasmafluticasonepropionatelevelsafterintranasaldosesofuptoandincluding1mgarelow,

aroundthelimitofquantitationoftheassay(0.05nanograms/ml).

Ina1-yearrandomised,double-blind,placebo-controlled,parallelgroupgrowthstudyinpre-pubescentchildrenaged3

to9years(56patientsreceivingintranasalfluticasonepropionateand52receivingplacebo,)nostatisticallysignificant

differenceingrowthvelocitywasobservedinpatientsreceivingintranasalfluticasonepropionate(200microgramsper

daynasalspray)comparedtoplacebo.Theestimatedgrowthvelocityoveroneyearoftreatmentwas6.20cm/year(SE

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

betweentreatmentsinthegrowthvelocityafteroneyearwas0.20cm/year(SE=0.28,95%CI=-0.35,0.76).No

evidenceofclinicallyrelevantchangesinHPAaxisfunctionorbonemineraldensitywasobservedasassessedby12-

hoururinarycortisolexcretionanddual-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

toxicologystudiesorteratologystudies.

Fluticasonepropionateisdevoidofmutagenicactivityinvitroandinvivoandshowednotumorigenicpotentialin

rodents.Itisbothnonirritantandnonsensitisinginanimalmodels.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glucose

Microcrystallinecellulose

Carmellosesodium

Phenylethylalcohol

Benzalkoniumchloride

Polysorbate80

Dilutehydrochloricacid

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6.2Incompatibilities

Notapplicable

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

Donotrefrigerateorfreeze.

6.5Natureandcontentsofcontainer

FlixonaseAqueousNasalSprayissuppliedinanopaquewhitebottlefittedwithameteringpumpandanasal

applicator.

Eachbottleprovidesapproximately120meteredsprays,whenusedasrecommended.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7PARALLELPRODUCTAUTHORISATIONHOLDER

B&SHealthcare

Unit4

BradfieldRoad

Ruislip

Middlesex

HA40NU

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1328/12/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:25thJanuary2008

10DATEOFREVISIONOFTHETEXT

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