FLIXONASE AQUEOUS

Main information

  • Trade name:
  • FLIXONASE AQUEOUS
  • Dosage:
  • 50 Microgram
  • 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:
  • PPA0465/167/001
  • Authorization date:
  • 16-12-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Flixonase50microgramspermetereddose,Aqueousnasalspray,suspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each100mgmetereddosecontains50microgramsfluticasonepropionate.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Nasalspray,suspension.

ProductimportedfromBelgium:

Awhite,opaqueaqueoussuspension.

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.Themaximumdailydoseshouldnotexceedtwosprays

4.3Contraindications

FluticasonePropionateAqueousNasalSprayiscontra-indicatedinpatientswithahypersensitivitytoanyofits

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4.4Specialwarningsandprecautionsforuse

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.

Adruginteractionstudyinhealthysubjectshasshownthatritonavir(ahighlypotentcytochromeP4503A4inhibitor)

cangreatlyincreasefluticasonepropionateplasmaconcentrations,resultinginmarkedlyreducedserumcortisol

concentrations.Duringpost-marketinguse,therehavebeenreportsofclinicallysignificantdruginteractionsinpatients

receivingfluticasonepropionateandritonavir,resultinginsystemiccorticosteroideffectsincludingCushing's

syndromeandadrenalsuppression.Therefore,concomitantuseoffluticasonepropionateandritonavirshouldbe

avoided,unlessthepotentialbenefittothepatientoutweighstheriskofsystemiccorticosteroidsideeffects.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Undernormalcircumstances,lowplasmaconcentrationsoffluticasonepropionateareachievedafterintranasaldosing,

duetoextensivefirstpassmetabolismandhighsystemicclearancemediatedbycytochromeP4503A4inthegutand

liver.Hence,clinicallysignificantdruginteractionsmediatedbyfluticasonepropionateareunlikely.

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.

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4.6Pregnancyandlactation

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)andveryrare

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

clinicaltrialdata.Rareandveryrareeventsweregenerallydeterminedfromspontaneousdata.Inassigningadverse

eventfrequencies,thebackgroundratesinplacebogroupswerenottakenintoaccount,sincetheseratesweregenerally

comparabletothoseintheactivetreatmentgroup.

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

perforationhasalsobeenreportedfollowingtheuseofintranasalcorticosteroids.

4.9Overdose

ThereisnodataavailableontheeffectsofacuteorchronicoverdosagewithFluticasonePropionateAqueousNasal

Spray.Intranasaladministrationof2mgfluticasonepropionatetwicedailyforsevendaystohealthyhumanvolunteers

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Fluticasonepropionatecauseslittleornohypothalmic-pituitary-adrenalaxissuppressionfollowingintranasalortopical

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

dailyandabove).Plasmafluticasonepropionatelevelsafterintranasaldosesofuptoandincluding1mgarelow,

aroundthelimitofquantitationoftheassay(0.05nanograms/ml).

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

Glucoseanhydrous

Microcrystallinecellulose

Carmellosesodium

Phenylethylalcohol

Benzalkoniumchloride

Polysorbate80

Dilutehydrochloricacid

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductisthedateshownonthecontainerandouterpackageoftheproductonthe

marketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

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6.5Natureandcontentsofcontainer

FluticasonePropionateAqueousNasalSprayissuppliedinanamberglassbottlefittedwithametering,atomising

pump,nasaladapterandadustcover.

Eachbottleprovidesapproximately150meteredsprays,whenusedasrecommended

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Shakegentlybeforeuse.

7ParallelProductAuthorisationHolder

PCOManufacturingLimited

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

8ParallelProductAuthorisationNumber

PPA0465/167/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:16December2005

10DATEOFREVISIONOFTHETEXT

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