BECONASE AQUEOUS

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1077/041/001
  • Authorization date:
  • 15-10-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BeconaseAqueous50microgramspermetereddoseNasalSpraySuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each100mgspraycontainsbeclometasonedipropionatemonohydrateequivalentto50microgramsofBeclometasone

Dipropionate.

Excipients:Each100mgspraycontains20microgramsofbenzalkoniumchloride.

Forafulllistofexcipients,seeSection6.1.

3PHARMACEUTICALFORM

Nasalspray,suspension(NasalSpray)

Anaqueous,white,opaquesuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Fortheprophylaxisandtreatmentofperennialandseasonalallergicandvasomotorrhinitis.

Beconasecansignificantlydelaytherecurrenceofnasalpolypsafternasalpolypectomy.Wherepolypsdorecur,

Beconasecansuppresstheirincreaseinsize.

4.2Posologyandmethodofadministration

Beconaseisfortheadministrationbytheintranasalrouteonly.

AdultsandChildrenover6yearsofage:

Twoapplicationstoeachnostriltwicedaily.Insomepatientsasingleapplicationintoeachnostrilthreeorfourtimes

dailymaybepreferred.

Thetotaldailydoseshouldnotusuallyexceed400micrograms(8sprays).

Childrenundersixyears:

Thereisinsufficientclinicaldatatorecommenduse.

BeconaseAqueousNasalSprayhasadustcapwhichprotectsthenozzleandkeepsitclean.Remembertotakethisoff

beforeusingthespray.Replacethedustcapafteruse.

Anewspray,oronewhichhasnotbeenusedforafewdays,maynotworkthefirsttime.Youmayneedto‘prime’the

bottlebypumpingthesprayafewtimesuntilafinemistisproduced.Todothis,holdthebottleasshown.Putyour

forefingerandmiddlefingereithersideofthenozzleandyourthumbunderneaththebottle.Keepingyourthumbstill,

pressdownwithyourfingerstopumpthespray.

Holdthenozzlepointingawayfromyouwhileyouaredoingthis.

Ifthespraystilldoesn’tworkandyouthinkitmaybeblocked,cleanitasfollows.NEVERtrytounblockitorenlarge

thetinysprayholewithapinorothersharpobjectbecausethiswilldestroythespraymechanism.

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Yournasalsprayshouldbecleanedatleastonceaweekormoreifitgetsblocked.

Usingthespray:

Afterusingthespray:

Wipethenozzlecarefullywithacleantissueorhandkerchief,andreplacethedustcap.

4.3Contraindications

BeconaseAqueousNasalSprayiscontra-indicatedinpatientswithahypersensitivitytoanyofitscomponents.

4.4Specialwarningsandprecautionsforuse

Theuseofbeclomethasonedipropionatelocallyinthenasopharynxmayresultinthedevelopmentoflocalmonilial

infections.

Theuseofthepreparationshouldbeavoidedinthepresenceofuntreatedinfections.

Ifpatientsareonsystemiccorticosteroidtherapy,greatcareshouldbetakenduringthetransferofthepatienttosmall

Beclomethasonetherapyincasethereisimpairmentofadrenalfunction.

Occasionallysneezingattacksmayfollowuse.

Infectionsofthenasalpassagesandparanasalsinusesshouldbeappropriatelytreatedbutdonotconstituteaspecific

contra-indicationtotreatmentwithBeconaseAqueousNasalSpray.

Ifrecommendeddosesofintranasalbeclomethasoneareexceededorifindividualsareparticularlysensitiveor

predisposedbyvirtueofrecentsystemicsteroidtherapies,systemiceffectsmayoccur,includingreductioningrowth

velocity.

AlthoughBeconaseAqueousNasalSpraywillcontrolseasonalallergicrhinitisinmostcases,anabnormallyheavy

challengeofsummerallergensmayincertaininstancesnecessitateappropriateadditionaltherapyparticularlytocontrol

eyesymptoms.

Forfulltherapeuticbenefit,regularusageisessential.

Particularcareshouldbetakentominimiseuseoftopicalcorticosteroidsinpatientswithimmunosuppression.

1.Takethedustcapoff.

2.Pressupwardsonthewhitecollartoreleasethenozzle.

3.Soakthenozzleanddustcapinwarmwaterforafewminutesandthenrinseundertherunningtap.

4.Shakeofftheexcesswaterandallowtodryinawarm,NOTHOTplace.

5.Re-fitthenozzle.

6.‘Prime’thebottleifnecessarybypumpingthesprayafewtimesuntilthefinemistisproduced.

1.Shakethebottleandremovethedustcap.

2.Blowyournosegently.

3.Closeonenostrilasshownandputthenozzleintheothernostril.Tiltyourheadforwardslightlyandkeepthe

bottleupright.Holdthebottleasshown.

4.Starttobreatheinslowlythroughyournose.WHILEYOUAREBREATHINGINsquirtasprayoffinemist

intoyournostrilbypressingdownfirmlywithyourfingers.

5.Breatheoutthroughyourmouth.Repeatstep4totakeasecondsprayinthesamenostril.

6.Removethenozzlefromthenostrilandbreatheoutthroughyourmouth.

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Particularcautionisrequiredinpatientswithahistoryof,orexistenttuberculosis.

Cataractshavebeenassociatedwithsystemicsteroidtherapy.Therehavebeenrarereportsofcataractsdevelopingin

patientswhohavebeenusingintranasalorinhaledcorticosteroidsforprolongedperiods,althoughtogethercauses,

includingexposuretosystemicsteroids,cannotbeexcluded.

Thisproductcontainsbenzalkoniumchloridewhichmaycausenasalirritation.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Notapplicable.

4.6Fertility,pregnancyandlactation

Administrationofdrugsduringpregnancyshouldonlybeconsiderediftheexpectedbenefittothemotherisgreater

thananypossiblerisktothefoetus.

Thereisinadequateevidenceofsafetyofbeclomethasonedipropionateinhumanpregnancy.Inanimalreproduction

studies,adverseeffectstypicalofpotentcorticosteroidareonlyseenathighsystemicexposurelevels;directintranasal

applicationensuresminimalsystemicexposure.

Lactation:

Nospecificstudiesexaminingthetransferenceofbeclomethasonedipropionateintothemilkoflactatinganimalshave

beenperformed.

Itisreasonabletoassumethatbeclomethasonedipropionateissecretedinmilkbutatthedosagesusedfordirect

intranasalapplication,thereislowpotentialforsignificantlevelsinbreastmilk.Theuseofbeclomethasone

dipropionateinmothers’breastfeedingtheirbabiesrequirethatthetherapeuticbenefitsofthedrugbeweighedagainst

thepotentialhazardstothemotherandbaby.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

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,commonanduncommoneventsweregenerallydeterminedfromclinicaltrialdata.Rareandveryrare

eventsweregenerallydeterminedfromspontaneousdata.Inassigningadverseeventfrequencies,thebackgroundrates

inplacebogroupswerenottakenintoaccount,sincetheseratesweregenerallycomparabletothoseintheactive

treatmentgroup.

Immunesystemdisorders

Veryrare:Hypersensitivityreactionsincludingrashes,urticaria,pruritis,erythemaandoedemaoftheeyes,face,lips

andthroatanaphylactoid/anaphylacticreactions,bronchospasm.

Nervoussystemdisorders

Common:Unpleasanttaste,unpleasantsmell.

Aswithothernasalsprays,unpleasanttasteandsmellhavebeenreported.

Eyedisorders

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Respiratory,thoracicandmediastinaldisorders

Common:Epistaxis,nasaldryness,nasalirritation,throatdryness,throatirritation.

Veryrare:nasalseptalperforation.

Aswithothernasalsprays,drynessandirritationofthenoseandthroat,andepistaxishavebeenreported.Nasalseptal

perforationhasalsobeenreportedfollowingtheuseofintranasalcorticosteroids.

4.9Overdose

Theonlyharmfuleffectthatfollowsinhalationoflargeramountsofthedrugoverashortperiodissuppressionof

hypothalamic-pituitary-adrenal(HPA)function.Nospecificemergencyactionneedbetaken.Treatmentwith

BeconaseAqueousNasalSprayshouldbecontinuedattherecommendeddose.HPAfunctionrecoversinadayortwo.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Followingtopicaladministrationbeclomethasone17,21-dipropionate(BDP)producespotentanti-inflammatoryand

vasoconstrictoreffects.

BDPisapro-drugwithweakglucocorticoidreceptorbindingaffinity.Itishydrolysedviaesteraseenzymestothe

activemetabolitebeclometasone-17-monopropionate(B-17-MP),whichhashightopicalanti-inflammatoryactivity.

Beclomethasonedipropionateoffersapreventativebackgroundtreatmentforhayfeverwhentakenpriortoallergen

challenge.Afterwhichwithregularuse,BDPcancontinuetopreventallergysymptomsfromre-appearingbyreducing

thesensitivityofnasalmembranes.

5.2Pharmacokineticproperties

Absorption

FollowingintranasaladministrationofBDPthesystemicabsorptionwasassessedbymeasuringtheplasma

concentrationsofitsactivemetaboliteB-17-MP,forwhichtheabsolutebioavailabilityfollowingintranasal

administrationis44%.

FollowingoraladministrationofBDPthesystemicabsorptionwasalsoassessedbymeasuringtheplasma

concentrationsofitsactivemetaboliteB-17-MP,forwhichtheabsolutebioavailabilityfollowingoraladministrationis

41%.

Metabolism

BDPisclearedveryrapidlyfromthecirculationandplasmaconcentrationsareundetectable(<50pg/ml)followingoral

orintranasaldosing.Metabolismismediatedviaesteraseenzymesfoundinmosttissues.Themainproductof

metabolismistheactivemetabolite(B-17-MP).Minorinactivemetabolites,beclomethasone-21-monopropionate(B-

21-MP)andbeclomethasone(BOH),arealsoformedbutthesecontributelittletosystemicexposure.

Distribution

Thetissuedistributionatsteady-stateforBDPismoderate(201)butmoreextensiveforB-17-MP(4241).Plasma

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Elimination

TheeliminationofBDPandB-17-MParecharacterisedbyhighplasmaclearance(150and1201/h)withcorresponding

terminaleliminationhalf-livesof0.5hand2.7h.FollowingoraladministrationoftritiatedBDP,approximately60%of

thedosewasexcretedinthefaeceswithin96hoursmainlyasfreeandconjugatedpolarmetabolites.Approximately

12%ofthedosewasexcretedasfreeandconjugatedpolarmetabolitesintheurine.TherenalclearanceofBDPandits

metabolitesisnegligible.

5.3Preclinicalsafetydata

Thereisnotadditionalinformationofrelevancetotheprescriber.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Microcrystallinecellulose&sodiumcarboxymethylcellulose(AvicelRC591))

Glucose(Anhydrous)

Benzalkoniumchloride(addedasBenzalkoniumchloridesolution)

Phenylethylalcohol

Polysorbate80

Dilutehydrochloricacid

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

Discard3monthsafterfirstusingspray.

6.4Specialprecautionsforstorage

Donotstoreabove30 °

C.Donotrefrigerate.Keepthebottleintheoutercartoninordertoprotectfromlight.

6.5Natureandcontentsofcontainer

A30mlTypeIamberglassorplasticbottlefittedwithameteringatomisingpump(ValoisVP3/9318PH).

Combinednasaladaptor/actuatorcoveredwithadustcapisfittedonthepump.Eachbottledelivers200sprays.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Shakegentlybeforeuse.

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKline(Ireland)Limited

StonemasonsWay

Rathfarnham

Dublin16

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8MARKETINGAUTHORISATIONNUMBER

PA1077/41/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:15October1990

Dateoflastrenewal:15October2010

10DATEOFREVISIONOFTHETEXT

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