BECONASE AQUEOUS

Main information

  • Trade name:
  • BECONASE AQUEOUS
  • Dosage:
  • 50 Microgram
  • 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:
  • PPA1328/019/001
  • Authorization date:
  • 14-08-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Beconase50microgramsAqueousNasalSpray,suspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachspraycontainsbeclomethasonedipropionatemonohydrateequivalentto50microgramsofbeclomethasone

dipropionate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Nasalspray,suspension

ProductimportedfromtheUK:

Anaqueous,white,opaquesuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Fortheprophylaxisandtreatmentofperennialandseasonalallergicandvasomotorrhinitis.

Beconasecansignificantlydelaytherecurrenceofnasalpolypsafternasalpolypectomy.Wherepolypsdorecur,

Beconasecansuppresstheirincreaseinsize.

4.2Posologyandmethodofadministration

Beconaseisforadministrationbytheintranasalrouteonly.

AdultsandChildrenover6yearsofage:

Twoapplicationstoeachnostriltwicedaily.Insomepatientsasingleapplicationintoeachnostrilthreeorfourtimes

dailymaybepreferred.

Thetotaldailydoseshouldnotusuallyexceed400micrograms(8sprays).

Childrenunder6years:

Thereisinsufficientclinicaldatatorecommenduse

4.3Contraindications

BeconaseAqueousNasalSprayiscontraindicatedinpatientswithahypersensitivitytoanyofitscomponents.

4.4Specialwarningsandprecautionsforuse

Systemiceffectsofnasalcorticosteroidsmayoccurparticularlyathighdosesprescribedforprolongedperiods.These

effectsaremuchlesslikelytooccurthanwithoralcorticosteroidsandmayvaryinindividualpatientsandbetween

differentcorticosteroidpreparations.PotentialsystemiceffectsmayincludeCushing’ssyndrome,Cushingoidfeatures,

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/03/2011 CRN 2069878 page number: 1

psychologicalorbehaviouraleffectsincludingpsychomotorhyperactivity,sleepdisorders,anxiety,depressionor

aggression(particularlyinchildren).

Theuseofbeclomethasonedipropionatelocallyinthenasopharynxmayresultinthedevelopmentoflocalmonilial

infections.

Theuseofthepreparationshouldbeavoidedinthepresenceofuntreatedinfections.

Ifpatientsareonsystemiccorticosteroidtherapy,greatcareshouldbetakenduringthetransferofthepatienttosmall

beclomethasonetherapyincasethereisimpairmentofadrenalfunction.

Occasionallysneezingattacksmayfollowuse.

Infectionsofthenasalpassagesandparanasalsinusesshouldbeappropriatelytreatedbutdonotconstituteaspecific

contra-indicationtotreatmentwithBeconaseAqueousNasalSpray.

Ifrecommendeddosesofintranasalbeclomethasoneareexceededorifindividualsareparticularlysensitiveor

predisposedbyvirtueofrecentsystemicsteroidtherapies,systemiceffectsmayoccur,includingreductioningrowth

velocity.

AlthoughBeconaseAqueousNasalSpraywillcontrolseasonalallergicrhinitisinmostcases,anabnormallyheavy

challengeofsummerallergensmayincertaininstancesnecessitateappropriateadditionaltherapyparticularlytocontrol

eyesymptoms.

Forfulltherapeuticbenefit,regularusageisessential.

Particularcareshouldbetakentominimiseuseoftopicalcorticosteroidsinpatientswithimmunosuppression.

Experienceofthesafetyoflong-termuseoftopicalcorticosteroidsisnotyetestablished.

Particularcautionisrequiredinpatientswithahistoryof,orexistenttuberculosis.

Cataractshavebeenassociatedwithsystemicsteroidtherapy.Therehavebeenrarereportsofcataractsdevelopingin

patientswhohavebeenusingintranasalorinhaledcorticosteroidsforprolongedperiods,althoughtogethercauses,

includingexposuretosystemicsteroids,cannotbeexcluded.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Notapplicable

4.6Fertility,pregnancyandlactation

Administrationofdrugsduringpregnancyshouldonlybeconsiderediftheexpectedbenefittothemotherisgreater

thananypossiblerisktothefoetus.

Thereisinadequateevidenceofsafetyofbeclomethasonedipropionateinhumanpregnancy.Inanimalreproduction

studies,adverseeffectstypicalofpotentcorticosteroidsareonlyseenathighsystemicexposurelevels;directintranasal

applicationensuresminimalsystemicexposure.

Lactation:

Nospecificstudiesexaminingthetransferenceofbeclomethasonedipropionateintothemilkoflactatinganimalshave

beenperformed.

Itisreasonabletoassumethatbeclomethasonedipropionateissecretedinmilkbutatthedosagesusedfordirect

intranasalapplication,thereislowpotentialforsignificantlevelsinbreastmilk.Theuseofbeclomethasone

dipropionateinmothersbreast-feedingtheirbabiesrequirethatthetherapeuticbenefitsofthedrugbeweighedagainst

thepotentialhazardstothemotherandbaby.

4.7Effectsonabilitytodriveandusemachines

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/03/2011 CRN 2069878 page number: 2

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

andthroat,anaphylactoid/anaphylacticreactions,bronchospasm.

Nervoussystemdisorders

Common:Unpleasanttaste,unpleasantsmell.

Aswithothernasalsprays,unpleasanttasteandsmellhavebeenreported.

Eyedisorders

Veryrare:Glaucoma,raisedintraocularpressure,cataract.

Respiratory,thoracicandmediastinaldisorders

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

Veryrare:Nasalseptalperforation.

Aswithothernasalsprays,drynessandirritationofthenoseandthroat,andepistaxishavebeenreported.Nasalseptal

perforationhasalsobeenreportedfollowingtheuseofintranasalcorticosteroids.

4.9Overdose

Theonlyharmfuleffectthatfollowsinhalationoflargeramountsofthedrugoverashortperiodissuppressionof

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

AqueousNasalSprayshouldbecontinuedattherecommendeddose.HPAfunctionrecoversinadayortwo.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Followingtopicaladministrationbeclomethasone17,21-dipropionate(BDP)producespotentanti-inflammatoryand

vaso-constrictoreffects.

BDPisapro-drugwithweakglucocorticoidreceptorbindingaffinity.Itishydrolysedviaesteraseenzymestothe

activemetabolitebeclomethasone-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)following

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/03/2011 CRN 2069878 page number: 3

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

21-MP)andbeclomethasone(BOH),arealsoformedbutthesecontributelittletosystemicexposure.

Distribution

Thetissuedistributionatsteady-stateforBDPismoderate(20l)butmoreextensiveforB-17-MP(424l).Plasma

proteinbindingismoderatelyhigh(87%).

Elimination

TheeliminationofBDPandB-17-MParecharacterisedbyhighplasmaclearance(150and120l/h)withcorresponding

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

thedosewasexcretedinthefaeceswithin96hoursmainlyasfreeandconjugatedpolarmetabolites.Approximately

12%ofthedosewasexcretedasfreeandconjugatedpolarmetabolitesintheurine.TherenalclearanceofBDPandits

metabolitesisnegligible.

5.3Preclinicalsafetydata

Thereisnoadditionalinformationofrelevancetotheprescriber.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Microcrystallinecellulose&carmellosesodium(AvicelRC591)

Glucose(Anhydrous)

Benzalkoniumchloride

Phenylethylalcohol

Polysorbate80

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelflifeexpirydateofthisproductisthedateshownonthecontainerandoutercartonoftheproductasmarketed

inthecountryoforigin.

Discard3monthsafterfirstusingthespray.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.Donotrefrigerate.Keepthebottleintheoutercarton.

6.5Natureandcontentsofcontainer

A30mlpolypropylenebottlefittedwithameteringatomisingpump.

Packsize:200meteredsprays.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Aboutyournasalspray

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/03/2011 CRN 2069878 page number: 4

thisoffbeforeusingthespray.Replacethedustcapafteruse.

Anewspray,oronewhichhasnotbeenusedforafewdays,maynotworkthefirsttime.

Youmayneedto‘prime’thebottlebypumpingthesprayafewtimesuntilafinemistisproduced.Putyourforefinger

andmiddlefingereithersideofthenozzleandyourthumbunderneaththebottle.Keepingyourthumbstill,pressdown

withyourfingerstopumpthespray.

Holdthenozzlepointingawayfromyouwhileyouaredoingthis.

Ifthespraystilldoesn’tworkandyouthinkitmaybeblocked,cleanitasfollows.NEVERtrytounblockitorenlarge

thetinysprayholewithapinorothersharpobjectbecausethiswilldestroythespraymechanism.

Tocleanthespray:

Takethedustcapoff.

Pressupwardsonthewhitecollartoreleasethenozzle.

Soakthenozzleanddustcapinwarmwaterforafewminutesandtherinseunderarunningtap.

Shakeofftheexcesswaterandallowtodryinawarm,NOTHOTplace.

Re-fitthenozzle.

‘Prime’thebottleifnecessarybypumpingthesprayafewtimesuntilthefinemistisproduced.

Yournasalsprayshouldbecleanedatleastonceaweekormoreifitgetsblocked.

Usingthespray:

Shakethebottleandremovethedustcap.

Blowyournosegently.

Closeonenostrilasshownandputthenozzleintheothernostril.Tiltyourheadforwardslightlyandkeepthe

bottleupright.

Starttobreatheinslowlythroughyournose.WHILEYOUAREBREATHINGINsquirtasprayoffinemist

intoyournostrilbypressingdownfirmlywithyourfingers.

Breatheoutthroughyourmouth.Repeatstep4totakeasecondsprayinthesamenostril.

Removethenozzlefromthisnostrilandbreatheoutthroughyourmouth.

Repeatsteps3to6fortheothernostril.

Afterusingthespray:

Wipethenozzlecarefullywithacleantissueorhandkerchief,andreplacethedustcap.

7PARALLELPRODUCTAUTHORISATIONHOLDER

B&SHealthcare

Unit4

BradfieldRoad

Ruislip

Middlesex

HA40NU

UnitedKingdom

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1328/19/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/03/2011 CRN 2069878 page number: 5

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/03/2011 CRN 2069878 page number: 6