DECADRON 500 MICROGRAM TABLETS

Main information

  • Trade name:
  • DECADRON 500 MICROGRAM TABLETS
  • Dosage:
  • 0.5 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DECADRON 500 MICROGRAM TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0035/016/001
  • Authorization date:
  • 01-04-1978
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Decadron500microgramTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletof‘Decadron’contains500microgramsDexamethasone.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Tablet

Round,white,half-scoredtablet,marked‘MSD41’.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Corticosteroid.

AllergicStates

Severeorincapacitatingallergiesunresponsivetoconventionaltreatment:seasonalorperennialallergicrhinitis,

bronchialasthma,contactdermatitis,atopicdermatitis,serumsickness,drughypersensitivityreactions.

Rheumaticdisorders

Asadjunctivetherapyforshort-termadministrationduringanacuteepisodeorexacerbationof:psoriaticarthritis,

rheumatoidarthritisincludingjuvenilerheumatoidarthritis(selectedcasesmayrequirelow-dosagemaintenance

therapy),ankylosingspondylitis,acuteandsubacutebursitis,acutenon-specifictenosynovitis,acutegoutyarthritis,

post-traumaticosteoarthritis,synovitisofosteoarthritis,epicondylitis.

Dermatologicaldiseases

Pemphigus,bullousdermatitisherpetiformis,severeerythemamultiforme(Stevens-Johnsonsyndrome),exfoliative

dermatitis,mycosisfungoides,severepsoriasis,severeseborrhoeicdermatitis.

Ophthalmicdiseases

Severe,acuteandchronicallergicandinflammatoryprocessesinvolvingtheeyeanditsadnexa,suchas:allergic

conjunctivitis,keratitis,allergiccornealmarginalulcers,herpeszosterophthalmicus,iritis,iridocyclitis,chorioretinitis,

diffuseposterioruveitisandchoroiditis,opticneuritis,sympatheticophthalmia,anteriorsegmentinflammation.

Endocrinedisorders

Primaryorsecondaryadrenocorticalinsufficiency(thefirstchoiceishydrocortisoneorcortisone,butsynthetic

analoguesmaybeusedwithmineralocorticoidswhereapplicable;ininfancy,mineralocorticoidsupplementationis

particularlyimportant),congenitaladrenalhyperplasia,non-suppurativethyroiditis,hypercalcaemiaassociatedwith

cancer.

Respiratorydiseases

Symptomaticsarcoidosis,Loffler’ssyndromenotmanageablebyothermeans,berylliosis,fulminatingordisseminated

pulmonarytuberculosis(whenaccompaniedbyappropriateconcurrentantituberculouschemotherapy),aspiration

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Haematologicaldisorders

Idiopathicthrombocytopenicpurpurainadultsandsecondarythrombocytopeniainadults,acquired(auto-immune)

haemolyticanaemia,redbloodcellanaemia,congenitalhypoplasticanaemia.

Neoplasticdiseases

Palliativemanagementofleukaemiasandlymphomasinadults,andofacuteleukaemiainchildren.

Oedematousstates

Toinduceadiuresisorremissionofproteinuriainthenephroticsyndrome,withouturaemia,oftheidiopathictypedue

tolupuserythematosus.

Cerebraloedema

Incerebraloedemaassociatedwithprimaryormetastaticbraintumours;inthepre-operativepreparationofpatients

withincreasedintracranialpressuresecondarytobraintumours;forthepalliationofsymptomsinpatientswith

inoperableorrecurrentbrainneoplasm;andinthemanagementofcerebraloedemaassociatedwithneurosurgery.Some

patientswithcerebraloedemaduetoheadinjuryorwithbenignintracranialhypertension(pseudotumourcerebri)may

benefitfromtherapywith‘Decadron’Tablets.Itshouldbeusedasanadjunctto,andnotareplacementfor,definitive

managementsuchasneurosurgeryorotherspecifictherapy.

Gastro-intestinaldiseases

Duringacriticalperiodofthediseasein:ulcerativecolitis,regionalenteritis.

Otherindications

Tuberculousmeningitiswithsubarachnoidblockorimpendingblock,usedconcurrentlywithappropriate

antituberculouschemotherapy;trichinosiswithneurologicalormyocardialinvolvement;duringanexacerbationoras

maintenancetherapyinsomecasesofsystemiclupuserythematosusandacuterheumaticcarditis;fordiagnostictesting

ofadrenocorticalhyperfunction.

4.2Posologyandmethodofadministration

Generalconsiderations

Therapyisgovernedbythefollowingprinciples:

Dosageshouldbeadjustedaccordingtotheseverity,prognosisandexpecteddurationofthediseaseandthe

responseoftheindividualpatient.Forinfantsandchildren,therecommendeddosageswillusuallyhavetobe

reduced,butdosageshouldbegovernedbytheseverityoftheconditionratherthanbyageorbodyweight.

Hormonetherapyisanadjuncttoconventionaltherapyanddoesnotreplaceit.Appropriateconventional

therapyshouldbeinstitutedasindicated.

Iftherapyiscontinuedformorethanafewdays,anydecreaseindosagemustbegradual.

Continuedsupervisionofthepatientaftercessationofcorticosteroidtherapyisessential,sincetheremaybea

suddenreappearanceofseveremanifestationsofthediseaseforwhichthepatientwasbeingtreated.

Inacuteconditionswherepromptreliefisurgent,highdosagesarepermissibleandmaybemandatoryforashorttime.

Inchronicconditionsrequiringlong-termtherapy,thelowestdosagewhichprovidesadequate(butnotnecessarily

complete)reliefshouldbeused.Ifahighdosageisconsideredessentialforprolongedperiods,patientsshouldbe

closelyobservedforanysignsthatmightindicatethatareductionindosageordiscontinuationofcorticosteroidtherapy

isnecessary.Chronicconditionsaresubjecttoperiodsofspontaneousremission.Whensuchperiodsoccur,

corticosteroidsshouldbegraduallydiscontinued.Routineinvestigations,suchasurineanalysis,two-hourpost-prandial

bloodsugar,determinationofbloodpressureandbodyweight,andachestX-rayshouldbecarriedoutatregular

intervalsiftherapyisprolonged.Periodicdeterminationsofserumpotassiumareadvisableifhighdosagesarebeing

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UppergastrointestinaltractX-raysshouldbetakenwhentreatmentisprolonged,inpatientswithahistoryofulcer,or

whenthereisgastricdistress.Patientsmaybetransferredto‘Decadron’fromotherglucocorticoidswithproper

adjustmentindosage.Milligramformilligram,dexamethasoneisapproximatelyequivalenttobethamethasone,4to6

timesmorepotentthanmethylprednisoloneandtriamcinolone,6to8timesmorepotentthanprednisoneand

prednisolone,25to30timesmorepotentthanhydrocortisone,andabout35timesmorepotentthancortisone.

Atequipotentanti-inflammatorydoses,dexamethasonealmostcompletelylacksthesodium-retainingpropertyof

hydrocortisoneanditscloselyrelatedderivatives.

Specificdosagerecommendations:

Inchronic,usuallynon-fataldiseases(e.g.endocrineandchronicrheumaticdisorders,oedematousstates,respiratory

andgastro-intestinaldiseases,somedermatologicaldiseasesandhaematologicaldisorders),therapyshouldbeinitiated

withalowdosage(0.5-1mgaday)whichisgraduallyincreasedtothesmallestamountthatgivesthedesireddegree

ofsymptomaticrelief.

Whenadequatesuppressionofsymptomsisachieved,dosageshouldbemaintainedattheminimumamountcapableof

providingsufficientreliefwithoutexcessivehormonaleffects.Dosagemaybeadministeredtwo,three,orfourtimesa

day.Regardlessoftheinitialdailyschedule,therapyisoftensuccessfulonatwice-dailyregimenaftertheoptimal

maintenancedosagehasbeenestablished.

Incongenitaladrenalhyperplasiatheusualdailydoseis0.5-1.5mg.

Inacute,non-fataldiseases(e.g.allergicstates,ophthalmicdiseases,acuteandsubacuterheumaticdisorders),theusual

dosageisbetween2mgand3mgaday,butinsomepatients,higherdosagesarenecessary.Sincetheseconditionsare

self-limitingprolongedmaintenancetherapyisnotusuallynecessary.

Dualtherapy

Inacute,self-limitingallergicdisordersoracuteexacerbationsofchronicallergicdisorders(e.g.acuteallergic

rhinitis,acuteattacksofseasonalallergicbronchialasthma,urticariamedicamentosa,andcontactdermatoses),the

followingdosageschedule,whichcombinesparenteralandoraltherapyissuggested:

Inchronic,potentiallyfataldiseases:suchassystemiclupuserythematosus,pemphigus,symptomaticsarcoidosis,the

recommendedinitialdosageisfrom2mgto4.5mgaday;higherdosagesarenecessaryinsomepatients.Assoonas

adequatereliefisobtained,thedosageshouldbegraduallyreducedtotheminimumamountthatwillproducethe

desiredtherapeuticeffect.

Inacuteandlife-threateningdiseases:(e.g.acuterheumaticcarditis,crisisofsystemiclupuserythematosus,severe

allergicreactions,pemphigusneoplasticdiseases),theinitialdosageisbetween4mgand10mgaday,administeredin

atleast4divideddoses.Insomepatients,thisdosagemayhavetobeincreased.Assoonascontrolisattained,the

dosageshouldbegraduallyreducedtotheminimumthatwillmaintainrelief.Whenanextremelyrapidonsetofaction

isdesired,‘Decadron’Injectionmaybeadministeredintravenouslyforthefirst2or3doses.Insevereallergic

reactions,thetherapyoffirstchoiceisadrenaline.‘Decadron’isusefulasconcurrentorsupplementarytherapy.

Firstday ‘Decadron’Injection,4mgor8mg(1mlor2ml)intramuscularly

Secondday Two0.5mg‘Decadron’Tabletstwiceaday

Thirdday Two0.5mg‘Decadron’Tabletstwiceaday

Fourthday One0.5mg‘Decadron’Tablettwiceaday

Fifthday One0.5mg‘Decadron’Tablettwiceaday

Sixthday One0.5mg‘Decadron’Tablet

Seventhday One0.5mg‘Decadron’Tablet

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isrequired,thisshouldbechangedto‘Decadron’Tabletsassoonaspossible.Forthepalliativemanagementof

patientswithrecurrentorinoperablebraintumours,maintenancedosageshouldbecalculatedindividuallyusing

‘Decadron’Injection,or‘Decadron’Tabletswhenoraltherapyisfeasible.Adosageof2mgtwoorthreetimesaday

maybeeffective.Thesmallestdosagenecessarytocontrolsymptomsshouldalwaysbeused.

Intheadrenogenitalsyndrome:dailydosageof0.5-1.5mgmaykeepchildreninremissionandpreventtherecurrence

ofabnormalexcretionof17-ketosteroids.

Asmassivetherapyincertainconditions:(e.g.acuteleukaemia,thenephroticsyndromeandpemphigus),the

recommendeddosageis10-15mgaday.Patientsreceivingsuchahighdosageshouldbeobservedverycloselyfor

theappearanceofseverereactions.

Dexamethasonesuppressiontests

1.TestsforCushing’ssyndrome:

Twomilligrams‘Decadron’isgivenorallyat11p.m.,thenbloodisdrawnforplasmacortisoldeterminationat8a.m.

thefollowingmorning.

Forgreateraccuracy,500microgram‘Decadron’isgivenorallyevery6hoursfor48hours.Twenty-four-hoururine

collectionsaremadefordeterminationof17-hydroxycorticosteroidexcretion.

2.TesttodistinguishCushing’ssyndromecausedbypituitaryACTHexcessfromthesyndromeinducedbyother

causes:

Twomilligrams‘Decadron’isgivenorallyevery6hoursfor48hours.Twenty-four-hoururinecollectionsaremadefor

determinationof17-hydroxycorticosteroidexcretion.

Useinchildren:Dosageshouldbelimitedtoasingledoseonalternatedaystolessenretardationofgrowthand

minimisesuppressionofhypothalamo-pituitary-adrenalaxis.

Useintheelderly:Treatmentofelderlypatients,particularlyiflongterm,shouldbeplannedbearinginmindthemore

seriousconsequencesofthecommonsideeffectsofcorticosteroidsinoldage,especiallyosteoporosis,diabetes,

hypertension,hypokalaemia,susceptibilitytoinfectionandthinningoftheskin.Closeclinicalsupervisionisrequired

toavoidlife-threateningreactions(see‘Undesirableeffects’).

4.3Contraindications

Systemicfungalinfections;systemicinfectionunlessspecificanti-infectivetherapyisemployed;hypersensitivityto

anycomponentofthedrug.Administrationoflivevirusvaccines(see‘Specialwarningsandspecialprecautionsfor

use’).

4.4Specialwarningsandprecautionsforuse

Thelowestdosagethatwillcontroltheconditionundertreatmentshouldbeused.Anyreductionindosageshouldbe

madegradually.

Corticosteroidsmayexacerbatesystemicfungalinfectionsandshouldnotbeusedinthepresenceofsuchinfections

unlesstheyareneededtocontrollife-threateningdrugreactionsduetoamphotericin.Moreover,therehavebeencases

reportedinwhichconcomitantuseofamphotericinandhydrocortisonewasfollowedbycardiacenlargementandheart

failure.

Reportsintheliteraturesuggestanapparentassociationbetweenuseofcorticosteroidsandleft-ventricularfree-wall

ruptureafterarecentmyocardialinfarction;therefore,corticosteroidsshouldbeusedwithgreatcautioninthese

patients.

Incerebralmalaria,theuseofcorticosteroidsisassociatedwithaprolongedcomaandanincreasedincidenceof

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Averageandlargedosesofhydrocortisoneorcortisonecancauseelevationofbloodpressure,retentionofsaltand

water,andincreasedexcretionofpotassium,buttheseeffectsarelesslikelytooccurwithsyntheticderivatives,except

whenusedinlargedoses.Dietarysaltrestrictionandpotassiumsupplementationmaybenecessary.Allcorticosteroids

increasecalciumexcretion.

Inpatientsoncorticosteroidtherapysubjectedtounusualstress(e.g.intercurrentillness,trauma,orsurgicalprocedure),

dosageshouldbeincreasedbefore,duringandafterthestressfulsituation.Drug-inducedsecondaryadrenocortical

insufficiencymayresultfromtoorapidwithdrawalofcorticosteroidsandmaybeminimisedbygradualdosage

reduction,beingtaperedoffoverweeksand/ormonthsdependingonthedoseanddurationoftreatment,butmay

persistforuptoayearafterdiscontinuationoftherapy.Inanystressfulsituationduringthatperiod,therefore,

corticosteroidtherapyshouldbereinstated.

Ifthepatientisalreadyreceivingcorticosteroids,thecurrentdosagemayhavetobetemporarilyincreased.Saltand/ora

mineralocorticoidshouldbegivenconcurrently,sincemineralocorticoidsecretionmaybeimpaired.

Followingprolongedtherapy,withdrawalofcorticosteroidsmayresultinacuteadrenocorticalinsufficiencyandin

withdrawalsymptomsincludingfever,myalgia,arthralgia,andmalaise.Thismayoccurinpatientsevenwithout

evidenceofadrenalinsufficiency.

Patientsshouldcarry‘steroidtreatment’cards,whichgiveclearguidanceontheprecautionstobetakento

minimiserisk,andwhichprovidedetailsofprescriber,drug,dosage,andthedurationoftreatment.

Administrationoflivevirusvaccinesiscontra-indicatedinindividualsreceivingimmunosuppressivedosesof

corticosteroids.Ifinactivatedviralorbacterialvaccinesareadministeredtoindividualsreceivingimmunosuppressive

dosesofcorticosteroids,theexpectedserumantibodyresponsemaynotbeobtained.However,patientswhoare

receivingcorticosteroidsasreplacementtherapy,e.g.forAddison’sdiseasemaybeimmunised.

Theuseof‘Decadron’Tabletsinactivetuberculosisshouldberestrictedtothosecasesoffulminatingordisseminated

tuberculosisinwhichthecorticosteroidisusedforthemanagementofthediseaseinconjunctionwithanappropriate

antituberculousregimen.Ifcorticosteroidsareindicatedinpatientswithlatenttuberculosisortuberculinreactivity,

closeobservationofthediseaseisnecessaryasreactivationmayoccur.Duringprolongedcorticosteroidtherapy,these

patientsshouldreceiveprophylacticchemotherapy.

Thereisanenhancedeffectofcorticosteroidsinpatientswithhypothyroidismandinthosewithcirrhosis.

Corticosteroidsmaymasksomesignsofinfection,andnewinfectionsmayappearduringtheiruse.Theclinical

presentationmayoftenbeatypical,andseriousinfectionssuchassepticaemiaandtuberculosismaybemaskedand

reachanadvancedstagebeforebeingrecognised.Theremaybedecreasedresistanceandinabilitytolocaliseinfection

inpatientsoncorticosteroids.

Chickenpoxisofparticularconcern,sincethisnormallyminorillnessmaybefatalinimmunosuppressed

patients.Patients(orparentsofchildren)withoutadefinitehistoryofchickenpoxshouldbeadvisedtoavoidclose

personalcontactwithchickenpoxorherpeszoster,andifexposedtheyshouldseekurgentmedicalattention.Passive

immunisationwithvaricella/zosterimmunoglobulin(VZIG)isneededbyexposednon-immunepatientswhoare

receivingsystemiccorticosteroidsorwhohaveusedthemwithinthepreviousthreemonths;thisshouldbegivenwithin

tendaysofexposuretochickenpox.Ifadiagnosisofchickenpoxisconfirmed,theillnesswarrantsspecialistcare

andurgenttreatment.Corticosteroidsshouldnotbestoppedandthedosemayneedtobeincreased.

Measlescanhaveamoreseriousorevenfatalcourseinimmunosuppressedpatients.Insuchchildrenoradults

particularcareshouldbetakentoavoidexposuretomeasles.Ifexposed,prophylaxiswithintramuscularpooled

immunoglobulin(IG)maybeindicated.Exposedpatientsshouldbeadvisedtoseekmedicaladvicewithoutdelay.

Corticosteroidsmayactivatelatentamoebiasisorstrongyloidiasisorexacerbateactivedisease.Therefore,itis

recommendedthatlatentoractiveamoebiasisandstrongyloidiasisberuledoutbeforeinitiatingcorticosteroidtherapy

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Prolongeduseofcorticosteroidsmayproducesubcapsularcataracts,glaucomawithpossibledamagetotheoptic

nerves,andmayenhancetheestablishmentofsecondaryocularinfectionsduetofungiorviruses.Steroidsmay

increaseordecreasethemotilityandnumberofspermatozoainsomepatients.

Particularcareisrequiredwhenconsideringtheuseofsystemiccorticosteroidsinpatientswiththefollowing

conditions,andfrequentpatientmonitoringisnecessary:non-specificulcerativecolitis,ifthereisaprobabilityof

impendingperforationabscessorotherpyogenicinfection,diverticulitis,freshintestinalanastomoses;activeorlatent

pepticulcer;renalinsufficiency;hypertension;osteoporosis;diabetes,orinthosewithafamilyhistoryofdiabetes;

congestiveheartfailure;previoussteroidmyopathy;glaucoma(orfamilyhistoryofglaucoma);existingorprevious

historyofsevereaffectivedisorders(especiallyprevioussteroidpsychoses)liverfailure;epilepsy;andmyasthenia

gravis.Signsofperitonealirritationfollowinggastro-intestinalperforationinpatientsreceivinglargedosesof

corticosteroidsmaybeminimalorabsent.Fatembolismhasbeenreportedasapossiblecomplicationof

hypercortisonism.

Corticosteroidsshouldbeusedcautiouslyinpatientswithocularherpessimplex,becauseofpossiblecorneal

perforation.

Children:Corticosteroidscausegrowthretardationininfancy,childhoodandadolescence,whichmaybeirreversible.

Treatmentshouldbelimitedtotheminimumdosagefortheshortestpossibletime.Inordertominimisesuppressionof

thehypothalamo-pituitary-adrenalaxisandgrowthretardation,treatmentshouldbelimited,wherepossible,toasingle

doseonalternatedays.

Growthanddevelopmentofinfantsandchildrenonprolongedcorticosteroidtherapyshouldbecarefullyscrutinised.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

‘Decadron’shouldbeusedwithcautionwiththalidomide,astoxicepidermalnecrolysishasbeenreportedwith

concomitantuseofthesetwodrugs.

Aspirinshouldbeusedcautiouslyinconjunctionwithcorticosteroidsinhypoprothrombinaemia.

Therenalclearanceofsalicylatesisincreasedbycorticosteroidsand,therefore,salicylatedosageshouldbereduced

alongwithsteroidwithdrawal.

DexamethasoneismetabolisedbycytochromeP4503A4(CYP3A4).Concomitantadministrationofdexamethasone

withcytochromeP4503A4enzymeinducers(e.g.phenytoin,barbiturates,rifabutin,carbamazepineandrifampicin)

mayenhancethemetabolicclearanceofcorticosteroids,resultingindecreasedbloodlevelsandreducedphysiological

activity.Thismaynecessitateadjustmentofcorticosteroiddosage.Inaddition,thecocomitantadminstrationof

dexamethasonewithknowninhibitorsofCYP3A4,(e.g.ketoconazole,macrolideantibioticssuchaserythromycin)has

thepotentialtoresultinincreasedplasmaconcentrationsofdexamethasone.Effectsofotherdrugsonthemetabolism

ofdexamethasonemayinterferewithdexamethasonesuppressiontests,whichshouldbeinterpretedwithcaution

duringadministrationofsuchdrugs.

DexamethasoneisamoderateinducerofCYP3A4.Co-administrationwithotherdrugsthataremetabolisedbyCYP

3A4(e.g.indinavir,erythromycin)mayincreasetheirclearance,resultingindecreasedplasmaconcentrations.

Inpost-marketingexperience,therehavebeenreportsofbothincreasesanddecreasesinphenytoinlevelswith

dexamethasoneco-administration,leadingtoalterationsinseizurecontrol.

AlthoughketoconazolemayincreasedexamethasoneplasmaconcentrationsthroughinhibitionofCYP3A4,

ketoconazolealonecaninhibitadrenalcorticosteroidsynthesisandmaycauseadrenalinsufficiencyduring

corticosteroidwithdrawal.

Aminoglutethimideandephedrinemayenhancemetabolicclearanceofcorticosteroidsandanincreaseincorticosteroid

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Theprothrombintimeshouldbecheckedfrequentlyinpatientswhoarereceivingcorticosteroidsandcoumarin

anticoagulantsatthesametime,becauseofreportsthatcorticosteroidshavealteredtheresponsetothese

anticoagulants.Studieshaveshownthattheusualeffectproducedbyaddingcorticosteroidsisinhibitionofresponseto

coumarins,althoughtherehavebeensomeconflictingreportsofpotentiationnotsubstantiatedbystudies.

Thedesiredeffectsofhypoglycaemicagents(includinginsulin)areantagonisedbycorticosteroids.

False-negativeresultsinthedexamethasonesuppressiontestinpatientsbeingtreatedwithindomethacinhavebeen

reported.

Corticosteroidsmayaffectthenitrobluetetrazoliumtestforbacterialinfectionandproducefalse-negativeresults.

Whencorticosteroidsareadministeredconcomitantlywithpotassium-depletingdiuretics,patientsshouldbeobserved

closelyfordevelopmentofhypokalaemia.

4.6Pregnancyandlactation

Sinceadequatehumanreproductionstudieshavenotbeendonewithcorticosteroids,theiruseinpregnancy,breast-

feedingmothers,orwomenofchild-bearingpotentialrequiresthatthepotentialbenefitsbeweighedagainstpossible

hazardstothemotherandfoetusorchild.Infantsbornofmotherswhohavereceivedsubstantialdosesof

corticosteroidsduringpregnancyshouldbecarefullyobservedforsignsofhypoadrenalism.

Whencorticosteroidsareessential,however,patientswithnormalpregnanciesmaybetreatedasthoughtheywerein

thenon-gravidstate.Patientswithpre-eclampsiaorfluidretentionrequireclosemonitoring.

Corticosteroidsappearinbreastmilkandcouldsuppressgrowth,interferewithendogenouscorticosteroidproduction,

orcauseotherunwantedeffects.Motherstakingpharmacologicaldosesofcorticosteroidsshouldbeadvisednotto

breast-feed.

4.7Effectsonabilitytodriveandusemachines

Therearesomesideeffectsassociatedwiththisproductthatmayaffectsomepatients’abilitytodriveoroperate

machinery(see4.8‘Undesirableeffects’).

4.8Undesirableeffects

Theincidenceofpredictableundesirableeffects,includinghypothalamic-pituitary-adrenalsuppression,correlateswith

therelativepotencyofthedrug,dosage,timingofadministrationandthedurationoftreatment(see‘Specialwarnings

andspecialprecautionsforuse’).

Fluidandelectrolytedisturbances:Sodiumretention,fluidretention,congestiveheartfailureinsusceptiblepatients,

potassiumloss,hypokalaemicalkalosis,hypertension,increasedcalciumexcretion(see‘Specialwarningsandspecial

precautionsforuse’).

Musculoskeletaleffects:Muscleweakness,steroidmyopathy,lossofmusclemass,osteoporosis,vertebralcompression

fractures,asepticnecrosisoffemoralandhumeralheads,pathologicalfractureoflongbones,tendonrupture.

Gastro-intestinal:Pepticulcerwithpossibleperforationandhaemorrhage,perforationofthesmallandlargebowel

particularlyinpatientswithinflammatoryboweldisease,pancreatitis,abdominaldistension,ulcerativeoesophagitis,

dyspepsia,oesophagealcandidiasis.

Dermatological:Impairedwoundhealing,thinfragileskin,petechiaeandecchymoses,erythema,striae,telangiectasia,

acne,increasedsweating,suppressedreactiontoskintests,othercutaneousreactionssuchasallergicdermatitis,

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Neurological:Convulsions,vertigo,headache.Increasedintracranialpressurewithpapilloedema(pseudotumour

cerebri)mayoccurusuallyaftertreatment,psychicdisturbances(e.g.euphoria,psychologicaldependence,depression,

insomnia).

Endocrine:Menstrualirregularities,amenorrhoea,developmentofCushingoidstate,suppressionofgrowthinchildren

andadolescents,secondaryadrenocorticalandpituitaryunresponsiveness(particularlyintimesofstressasintrauma,

surgeryorillness),decreasedcarbohydratetolerance,manifestationsoflatentdiabetesmellitus,hyperglycaemia,

increasedrequirementsforinsulinororalhypoglycaemicagentsindiabetics,hirsutism.

Anti-inflammatoryandimmunosuppressiveeffects:Increasedsusceptibilityandseverityofinfectionswithsuppression

ofclinicalsymptomsandsigns.Opportunisticinfections,recurrenceofdormanttuberculosis(see‘Specialwarnings

andspecialprecautionsforuse’).

Ophthalmic:Posteriorsubcapsularcataracts,increasedintra-ocularpressure,papilloedema,cornealorscleralthinning,

exacerbationofophthalmicviraldisease,glaucoma,exophthalmos.

Metabolic:Negativenitrogenbalanceduetoproteincatabolism.Negativecalciumbalance.

Cardiovascular:Myocardialrupturefollowingrecentmyocardialinfarction(see‘Specialwarningsandspecial

precautionsforuse’).

Other:Hypersensitivity,thrombo-embolism,weightgain,increasedappetite,nausea,malaise,hiccups.

Withdrawalsymptomsandsigns:Toorapidareductionofcorticosteroiddosagefollowingprolongedtreatmentcan

leadtoacuteadrenalinsufficiency,hypotension,anddeath(see‘Specialwarningsandspecialprecautionsforuse’).

Insomeinstances,withdrawalsymptomsmaysimulateaclinicalrelapseofthediseaseforwhichthepatienthasbeen

undergoingtreatment.

4.9Overdose

Anaphylacticandhypersensitivityreactionsmaybetreatedwithepinephrine(adrenaline),positive-pressureartificial

respirationandaminophylline.Thepatientshouldbekeptwarmandquiet.Treatmentisprobablynotindicatedfor

reactionsduetochronicpoisoningunlessthepatienthasaconditionthatwouldrenderhimunusuallysusceptibletoill

effectsfromcorticosteroids.Inthiscase,thestomachshouldbeemptiedandsymptomatictreatmentshouldbe

institutedasnecessary.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Dexamethasoneisaglucocorticoid.Itpossessestheactionsandeffectsofotherbasicglucocorticoids,andisamongthe

mostactivemembers.Glucocorticoidsareadrenocorticalsteroids,bothnaturallyoccurringandsynthetic,whichare

readilyabsorbedfromthegastro-intestinaltract.Theycauseprofoundandvariedmetaboliceffectsandinadditionthey

modifythebody’simmuneresponsestodiversestimuli.

Naturallyoccurringglucocorticoids(hydrocortisoneandcortisone),whichalsohavesalt-retainingproperties,areused

asreplacementtherapyinadrenocorticaldeficiencystates.Theirsyntheticanalogs,includingdexamethasone,areused

primarilyfortheirpotentanti-inflammatoryeffectsindisordersofmanyorgansystems.

5.2Pharmacokineticproperties

Dexamethasoneisreadilyabsorbedfromthegastro-intestinaltract.

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Bindingofdexamethasonetoplasmaproteinsislessthanformostothercorticosteroidsandisestimatedtobeabout

77%.

Upto65%ofadoseisexcretedintheurinein24hours,therateofexcretionbeingincreasedfollowingconcomitant

administrationofphenytoin.

Themorepotenthalogenatedcorticosteroidssuchasdexamethasone,appeartocrosstheplacentalbarrierwithminimal

inactivation.

Dexamethasonehaspredominantglucocorticoidactivitywithlittlepropensitytopromoterenalretentionofsodiumand

water.Therefore,itdoesnotoffercompletereplacementtherapy,andmustbesupplementedwithsaltand/or

deoxycorticosterone.Cortisoneandhydrocortisonealsoactpredominatelyasglucocorticoids,althoughtheir

mineralocorticoidactionisgreaterthanthatofdexamethasone.Theiruseinpatientswithtotaladrenocortical

insufficiencyalsomayrequiresupplementalsalt,deoxycortisone,orboth.

5.3Preclinicalsafetydata

Norelevantinformation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

CalciumhydrogenphosphateE341

Lactose

MagnesiumstearateE572

MaizeStarch

PurifiedWater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

1year.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

OpaquePVCblisterliddedwithaluminiumfoil,containing30tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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Date Printed 10/01/2007 CRN 2031797 page number: 9

7MARKETINGAUTHORISATIONHOLDER

MerckSharp&DohmeLimited

HertfordRoad

Hoddesdon

HertfordshireEN119BU

England

8MARKETINGAUTHORISATIONNUMBER

PA35/16/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1April1978

Dateoflastrenewal:1April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 10/01/2007 CRN 2031797 page number: 10