DEXA-RHINASPRAY DUO

Main information

  • Trade name:
  • DEXA-RHINASPRAY DUO
  • Dosage:
  • 120/20 Microgram
  • Pharmaceutical form:
  • Nasal Spray Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DEXA-RHINASPRAY DUO
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0007/053/001
  • Authorization date:
  • 04-03-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dexa-RhinasprayDuo120micrograms/20micrograms,NasalSpray,Suspension.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Tramazolinehydrochloride120micrograms/metereddoseanddexamethasoneisonicotinate20micrograms/metered

dose.

Alsocontains150micrograms/mlbenzalkoniumchloride.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Nasalspray,suspension.

Awhite,homogenoussuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofallergicrhinitis.

4.2Posologyandmethodofadministration

Adults(includingtheelderly)

1metereddoseintoeachnostriluptosixtimesin24hours,although2or3applicationsadayareusuallysufficient.

Children

5-12years:1metereddoseintoeachnostriluptotwicedaily.

Under5years:Notrecommended.

Thedoseshouldbetitratedtothelowestdoseatwhicheffectivecontrolofsymptomsismaintained.

Eachcourseoftreatmentshouldnotexceed14days.

Nospecificinformationontheuseofthisproductintheelderlyisavailable.Noadversereactionsspecifictothisage

grouphavebeenreportedwithtramazolineanddexamethasone.

Administration

FordetailedinformationoninstructionsforusepleaserefertothePatientInformationLeaflet.

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AvoidsprayingDexa-RhinasprayDuoinoraroundtheeye.Shouldthisoccur,immediatelyflushyoureyewithcold

tapwaterforseveralminutes.

Ifthenasaltipbecomesclogged,removetheclearplasticdustcap.Holdthenasaltipunderrunningwarmtapwaterfor

aboutaminute.Drythenasaltip,re-primethenasalpumpsprayandreplacetheplasticdustcap.

4.3Contraindications

Dexa-RhinasprayDuoshouldnotbeusedinpatientswith:

Untreatedinfectionsinthenose,mouth,eye,andupperrespiratorytract(e.g.herpes,vaccinia,varicella,

(chickenpox),nasalmycosis,etc

Pulmonarytuberculosis

Rhinitissicca

Glaucoma(includingnarrow-angleglaucoma)

Knownhypersensitivitytotramazolinehydrocholorideorbenzalkoniumchlorideoranyothercomponentofthe

product.

Dexa-RhinasprayDuoshouldnotbeusedaftercranialsurgeryviathenose.

DexaRhinasprayDuoisnotsuitableforchildrenunder5yearsofage.

TheuseofDexa-RhinasprayDuoiscontraindicatedduringpregnancyandlactation.

4.4Specialwarningsandprecautionsforuse

Careshouldbeusedtoavoidcontactwiththeeyesasconjunctivalirritationmayoccur.TheuseofDexa-Rhinaspray

Duoforprolongedperiodsisnotrecommended.

Thepossibilityofside-effectsfromthesystemicabsorptionofdexamethasoneshouldbeborneinmind.

Systemiceffectsofnasalcorticosteroidsmayoccur,particularlyathighdosesprescribedforprolongedperiods.

Growthretardationhasbeenreportedinchildrenreceivingnasalcorticosteroidsatlicenseddoses.

Itisrecommendedthattheheightofchildrenreceivingprolongedtreatmentwithnasalcorticosteroidsisregularly

monitored.Ifgrowthisslowed,therapyshouldbereviewedwiththeaimofreducingthedoseofnasalcorticosteroidif

possible,tothelowestdoseatwhicheffectivecontrolofsymptomsismaintained.Inaddition,considerationshouldbe

giventoreferringthepatienttoapaediatricspecialist.

Treatmentwithhigherthanrecommendeddosesofnasalcorticosteroidsmayresultinclinicallysignificantadrenal

suppression.Ifthereisevidenceofhigherthanrecommendeddosesbeingusedthenadditionalsystemiccorticosteroid

covershouldbeconsideredduringperiodsofstressorelectivesurgery.

Dexa-RhinasprayDuoshouldbeusedwithcautionandundermedicaladviceinpatientswithprostatehypertrophyand

congenitalpophyria.

Possibilityofadrenalinsufficiencywhenchangingfromsystemictolocalsteroids,alsoallergiesmayworsen.

Higherriskofinfection(e.g.TB,certainviralinfections(e.g.zoster,herpessimplex,vaccinia)),opportunistic

infections.

Cautioninpatientswithdiabetesmellitusorosteoporosisduetocorticosteroid.

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Prolongeduseofvasoconstrictorsisnotrecommendedandmayleadtochronicinflammation(andthustoablocked

nose)andatrophyofthenasalmucousmembrane.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Incertainanti-depressant(MAOinhibitorsortricyclicanti-depressants)orvasopressordrugsaregivensimultaneously,

effectsonthecardiovascularsystemcanleadtoanincreaseinbloodpressure.Combinedusewithtricyclicanti-

depressantscanalsoleadtotachyarrhythmia.

Usedincombinationwithbeta2sympathomimeticmayresultinanincreasedbeta2agonistresponse.

CYP3A4inhibitors:serumleveland/ortoxicityofsteroidcomponentmaybeincreased(e.g.ketoconazole,itaconazole,

clotrimazole,ritonavir,ciclosporin,ethinylestradiol,troleandromycin,clarithomycin,cimetidine,diltiazem,idinavir).

CYP3A4inducers:serumleveland/ortoxicityofsteroidcomponentmaybedecreased(e.g.carbamazepine,phenytoin,

Phenobarbital,rifampin).

Cautionwhencombinedwithanti-hypertensivedrugs.

4.6Pregnancyandlactation

UseofDexa-RhinasprayDuoduringpregnancyandlactationiscontraindicatedduetopossiblesystemicabsorption.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Systemiceffectsofnasalcorticosteroidsmayoccur,particularlywhenprescribedathighdosesforprolongedperiods.

Thefollowingsideeffectshavebeenlistedbasedonthepossibleclasseffectsofthetwocomponentstramazolineand

dexamethasone.Frequenciesarenotknownastheycannotbeestimatedfromtheavailabledata.

Immunesystemdisorders

Hypersensitivityreactions

Maskingoflocalsignsofinfectioninear,noseandthroat.

Endocrinedisorders

Hypercortisolims.

Psychiatricdisorders

Hallucinations

Nervoussystemdisorders

Headache

Dizziness

Insomnia

Somnolence

Sedation

Restlessness

Disturbanceinsenseoftaste

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Eyedisorders

IncreasedIntraocularpressure

Cardiacdisorders

Palpitations

Tachycardia

Cardiacarrhythmias

Bloodpressureincrease

Respiratory,ThoracicandMediastinalDisorders

Burningofnasalmucosa

Drynessofnasalmucosa

Throatirritation

Sneezing

Nasalseptalulceration

Nasalseptalperforation

Epistaxis

Mucosalswelling(reboundcongestion).

Gastro-intestinalDisorders

Nausea

SkinandsubcutaneousDisorders

Rash

Pruritus

Sweating

Urticaria

4.9Overdose

Inanalogywithotheralpha-sympathomimeticstheclinicalpictureofanintoxicationwithDexa-RhinasprayDuomay

beconfusing,becausephasesofstimulationanddepressionoftheCNSandcardiovascularsystemmayalternate.

EspeciallyinchildrenintoxicationsresultinCNSeffectswithseizuresandcoma,bradycardia,respiratorydepression

aswellasanincreaseinbloodpressure.SymptomsofstimulationoftheCNSareanxiety,agitation,hallucinationsand

seizures.SymptomsofdepressionoftheCNSaredecreaseofbodytemperature,lethargy,somnolenceandcoma.

Inadditionthefollowingsymptomsmayoccur:sweating,apprehension,nausea,mydriasis,miosis,swelling,fever,

pallor,cyanosisofthelips,cardiovasculardysfunction(tachycardia,cardiacarrhythmias,bradycardia,cardiacarrest,

hypertonia,shocklikedropinbloodpressure)respiratorydysfunction(respiratoryfailure,respiratoryarrest)

psychologicalalterations.

Dexamethasone

Chronicabuseandoverdosesupressionofadrenal/HPaxis,hypercortisolism,growthretardationinchildren.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Tramazolinehydrochlorideisasympathomimeticwithlocalvasoconstrictoractivity.Ithasaquick-acting,longlasting

decongestanteffectonthenasalmucosa.

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5.2Pharmacokineticproperties

Pharmacokineticstudieswithtramozolineinhumanshavenotbeencarriedout.ThePharmacokineticsoftramazoline

hasbeeninvestigatedintherat,rabbitandprimates.Ithasbeendemonstratedthat50-80%ofthedoseisabsorbedafter

oralorintranasaladministration.

Tramazolineanditsmetabolitesaredistributedinalltheinternalorgans,withthehighestconcentrationbeing

invariablyfoundintheliver.Elimination,withaterminalhalf-lifeof5-7hours,isprimarilyrenal.

Sofarnopharmacokineticdataareavailableafternasalapplicationofdexamethasoneisonicontinate.Afterinhalation

approximately18mgofdexamethasoneisonicotinate,maximumplasmalevelsofaround20nanograms/mlare

obtained.Byextrapolation,aplasmalevelofaround0.02nanograms/mlfromanasalspraycontaining0.02mgcanbe

expected.

Foracomparablecorticosteroidbeclomethasonedipropionateithasbeenreportedthattotalsystemicbioavailability

afternasalapplicationwasevenlowercomparedwithinhalation(44vs.62%).Thiswasmainlyduetoabsorptionof

theorallyswallowedfractionandnotbyabsorptionviathenasalmucosa.

Pharmacokineticdataontheuseofdexamethasone-21-isonicotinateinlaboratoryanimalsarenotavailable.Inhumans,

dexamethasone-21-isonicotinateisslowlyabsorbedbythelungsandafterwardsslowlyeliminated.

Dexamethasoneisreadilyabsorbedfromthegastrointestinaltract.Itsbiologicalhalf-lifeinplasmaisabout190

minutes.Bindingofdexamethasonetoplasmaproteinsisabout77%whichislessthanformostothercorticosteroids.

Upto65%ofadoseisexcretedinurinewithin24hours.Clearanceinprematureneonatesisreportedtobe

proportionaltogestationalage,withareducedeliminationrateinthemostpremature.Itreadilycrossestheplacenta

withminimalinactivation.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzalkoniumchloride

Sodiumchloride

Polyoxyethylene-sorbitanmonooleate(Polysorbate80)

Glycerol85%

Purifiedwater

Sodiumhydroxide

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

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6.4Specialprecautionsforstorage

Donotstoreabove25 o

6.5Natureandcontentsofcontainer

Ambercolouredglass(TypeI)bottlefittedwith0.07mlmeteringpumpandwhitenasaladaptorandaprotectivecap.

Nominalcontents10mlequivalenttonotlessthan110doses.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

BoehringerIngelheimLimited

EllesfieldAvenue

Bracknell

Berkshire

RG128YS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0007/053/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:4 th

March1999

Dateoflastrenewal:19 th

January2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 16/10/2007 CRN 2039175 page number: 6