DELTACORTRIL ENTERIC

Main information

  • Trade name:
  • DELTACORTRIL ENTERIC
  • Dosage:
  • 5 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DELTACORTRIL ENTERIC
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA0465/179/002
  • Authorization date:
  • 07-07-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DeltacortrilEntericCoatedTablets5mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcoatedtabletcontains5mgprednisolone.

Excipients:Lactose

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Gastro-resistanttablet.

ProductimportedfromUK:

Round,biconvex,coated,maroon-colouredtablets

4CLINICALPARTICULARS

4.1TherapeuticIndications

Allergyandanaphylaxis:bronchialasthma,drughypersensitivityreactions,serumsickness,angioneuroticoedema,

anaphylaxis.

Arteritis/collagenosis:giantcellarteritis/polymyalgiarheumatica,mixedconnectivetissuedisease,polyarteritis

nodosa,polymyositis.

Blooddisorders:haemolyticanaemia(auto-immune),leukaemia(acuteandchroniclymphocytic),lymphoma,multiple

myeloma,idiopathicthrombocytopenicpurpura.

Cardiovasculardisorders:post-myocardialinfarctionsyndrome,rheumaticfeverwithseverecarditis.

Endocrinedisorders:primaryandsecondaryadrenalinsufficiency,congenitaladrenalhyperplasia.

Gastro-intestinaldisorders:Crohn'sdisease,ulcerativecolitis,persistentcoeliacsyndrome(coeliacdisease

unresponsivetoglutenwithdrawal),auto-immunechronicactivehepatitis,multisystemdiseaseaffectingliver,biliary

peritonitis.

Hypercalcaemia:sarcoidosis,vitaminDexcess.

Infections(withappropriatechemotherapy):helminthicinfestations,Herxheimerreaction,infectiousmononucleosis,

miliarytuberculosis,mumpsorchitis(adult),tuberculousmeningitis,rickettsialdisease.

Musculardisorders:polymyositis,dermatomyositis.

Neurologicaldisorders:infantilespasms,Shy-Dragersyndrome,sub-acutedemyelinatingpolyneuropathy.

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ophthalmicGravesdisease.

Renaldisorders:lupusnephritis,acuteinterstitialnephritis,minimalchangeglomerulonephritis.

Respiratorydisease:allergicpneumonitis,asthma,occupationalasthma,pulmonaryaspergillosis,pulmonaryfibrosis,

pulmonaryalveolitis,aspirationofforeignbody,aspirationofstomachcontents,pulmonarysarcoid,druginducedlung

disease,adultrespiratorydistresssyndrome,spasmodiccroup.

Rheumaticdisorders:rheumatoidarthritis,polymyalgiarheumatica,juvenilechronicarthritis,systemiclupus

erythematosus,dermatomyositis,mixedconnectivetissuedisease.

Skindisorders:pemphigusvulgaris,bullouspemphigoid,systemiclupuserythematosus,pyodermagangrenosum.

Miscellaneous:sarcoidosis,hyperpyrexia,Behçetsdisease,immunosuppressioninorgantransplantation.

4.2Posologyandmethodofadministration

TheinitialdosageofDeltacortrilEntericmayvaryfrom5mgto60mgdailydependingonthedisorderbeingtreated.

Divideddailydosageisusuallyused.

Thefollowingtherapeuticguidelinesshouldbekeptinmindforalltherapywithcorticosteroids:

Corticosteroidsarepalliative,symptomatictreatmentbyvirtueoftheiranti-inflammatoryeffects;theyarenever

curative.

Theappropriateindividualdosemustbedeterminedbytrialanderrorandmustbere-evaluatedregularlyaccordingto

activityofthedisease.

Ascorticosteroidtherapybecomesprolongedandasthedoseisincreased,theincidenceofdisablingside-effects

increases.

Ingeneral,initialdosageshallbemaintainedoradjusteduntiltheanticipatedresponseisobserved.Thedoseshouldbe

graduallyreduceduntilthelowestdosewhichwillmaintainanadequateclinicalresponseisreached.Useofthelowest

effectivedosemayalsominimiseside-effects(see'Specialwarningsandspecialprecautionsforuse').

Inpatientswhohavereceivedmorethanphysiologicaldoseforsystemiccorticosterodids(approximately7.5mg

prednisoloneorequivalent)forgreaterthan3weeks,withdrawalshouldnotbeabrupt.Howdosereductionshouldbe

carriedoutdependslargelyonwhetherthediseaseislikelytorelapseasthedoseofsystemiccorticosteroidsisreduced.

Clinicalassessmentofdiseaseactivitymaybeneededduringwithdrawal.Ifthediseaseisunlikelytorelapseon

withdrawalofsystemiccorticosteroidsbutthereisuncertaintyabouthypothalamic-pituitary-adrenal(HPA)

suppression,thedoseofcorticosteroidmaybereducedrapidlytophysiologicaldoses.Onceadailydoseequivalentto

7.5mgofprednisoloneisreached,dosereductionshouldbeslowertoallowtheHPA-axistorecover.

Abruptwithdrawalofsystemiccorticosteroidtreatment,whichhascontinuedupto3weeksisappropriateifitis

consideredthatthediseaseisunlikelytorelapse.Abruptwithdrawalofdosesofupto40mgdailyofprednisolone,or

equivalentfor3weeksisunlikelytoleadtoclinicallyrelevantHPA-axissuppression,inthemajorityofpatients.Inthe

followingpatientgroups,gradualwithdrawalofsystemiccorticosteroidtherapyshouldbeconsideredevenafter

courseslasting3weeksorless:

patientswhohavehadrepeatedcoursesofsystemiccorticosteroids,particularlyiftakenforgreaterthan3weeks.

whenashortcoursehasbeenprescribedwithinoneyearofcessationoflong-termtherapy(monthsoryears).

patientswhomayhavereasonsforadrenocorticalinsufficiencyotherthanexogenouscorticosteroidtherapy.

patientsreceivingdosesofsystemiccorticosteroidgreaterthan40mgdailyofprednisolone(orequivalent).

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(See'Specialwarningsandspecialprecautionsforuse'and'Undesirableeffects')

Duringprolongedtherapy,dosagemayneedtobetemporarilyincreasedduringperiodsofstressorduring

exacerbationsofthedisease(see'Specialwarningsandspecialprecautionsforuse')

IfthereislackofasatisfactoryclinicalresponsetoDeltacortrilEnteric,thedrugshouldbegraduallydiscontinuedand

thepatienttransferredtoalternativetherapy.

IntermittentdosageregimenAsingledoseofDeltacortrilEntericinthemorningonalternatedaysoratlonger

intervalsisacceptabletherapyforsomepatients.Whenthisregimenispractical,thedegreeofpituitary-adrenal

suppressioncanbeminimised.

SpecificdosageguidelinesThefollowingrecommendationsforsomecorticosteroid-responsivedisordersarefor

guidanceonly.Acuteorseverediseasemayrequireinitialhighdosetherapywithreductiontothelowesteffective

maintenancedoseassoonaspossible.Dosagereductionsshouldnotexceed5-7.5mgdailyduringchronictreatment.

AllergicandskindisordersInitialdosesof5-15mgdailyarecommonlyadequate.

CollagenosisInitialdosesof20-30mgdailyarefrequentlyeffective.Thosewithmoreseveresymptomsmayrequire

higherdoses.

RheumatoidarthritisTheusualinitialdoseis10-15mgdaily.Thelowestdailymaintenancedosecompatiblewith

tolerablesymptomaticreliefisrecommended.

BlooddisordersandlymphomaAninitialdailydoseof15-60mgisoftennecessarywithreductionafteranadequate

clinicalorhaematologicalresponse.Higherdosesmaybenecessarytoinduceremissioninacuteleukaemia.

UseinchildrenAlthoughappropriatefractionsoftheactualdosemaybeused,dosagewillusuallybedeterminedby

clinicalresponseasinadults(seealso'Specialwarningsandspecialprecautionsforuse').Alternatedaydosageis

preferablewherepossible.

UseinelderlyTreatmentofelderlypatients,particularlyiflong-term,shouldbeplannedbearinginmindthemore

seriousconsequencesofthecommonside-effectsofcorticosteroidsinoldage(seealso'Specialwarningsandspecial

precautionsforuse').

4.3Contraindications

Systemicinfectionsunlessspecificanti-infectivetherapyisemployed.Hypersensitivitytoanyingredient.Ocular

herpessimplexbecauseofpossibleperforation

4.4Specialwarningsandprecautionsforuse

Cautionisnecessarywhenoralcorticosteroids,includingDeltacortrilEnteric,areprescribedinpatientswiththe

followingconditions,andfrequentpatientmonitoringisnecessary:

Tuberculosis:Thosewithaprevioushistoryof,orX-raychangescharacteristicof,tuberculosis.Theemergenceof

activetuberculosiscan,however,bepreventedbytheprophylacticuseofanti-tuberculosistherapy.

Hypertension.

Congestiveheartfailure.

Liverfailure.

Renalinsufficiency.

Diabetesmellitusorinthosewithafamilyhistoryofdiabetes.

Osteoporosis:Thisisofspecialimportanceinpost-menopausalfemaleswhoareatparticularrisk.

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inducedpsychoses..

Also,existingemotionalinstabilityorpsychotictendenciesmaybeaggravatedbycorticosteroidsincluding

prednisolone

Epilepsy,and/orseizuredisorders

Pepticulceration.

Previoussteroidmyopathy.

Glucocorticoidsshouldbeusedcautiouslyinpatientswithmyastheniagravisreceivinganticholinesterasetherapy.

○Becausecortisonehasbeenreportedrarelytoincreasebloodcoagulabilityandtoprecipitateintravascular

thrombosis,thromboembolism,andthrombophlebitis,corticosteroidsshouldbeusedwithcautioninpatientswith

thromboembolicdisorders.

APatientInformationLeafletissuppliedwiththisproduct.

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheminimumperiodandbyadministering

thedailyrequirementasasinglemorningdoseonalternatedays.Frequentpatientreviewisrequiredtotitratethedose

appropriatelyagainstdiseaseactivity(see'Posologyandmethodofadministration').

AdrenocorticalInsufficiencyPharmacologicdosesofcorticosteroidsadministeredforprolongedperiodsmayresultin

hypothalamic-pituitary-adrenal(HPA)suppression(secondaryadrenocorticalinsufficiency).Thedegreeandduration

ofadrenocorticalinsufficiencyproducedisvariableamongpatientsanddependsonthedose,frequency,timeof

administration,anddurationofglucocorticoidtherapy.

Inaddition,acuteadrenalinsufficiencyleadingtoafataloutcomemayoccurifglucocorticoidsarewithdrawnabruptly.

Drug-inducedsecondaryadrenocorticalinsufficiencymaythereforebeminimizedbygradualreductionofdosage.This

typeofrelativeinsufficiencymaypersistformonthsafterdiscontinuationoftherapy;therefore,inanysituationof

stressoccurringduringthatperiod,hormonetherapyshouldbereinstituted.Sincemineralocorticoidsecretionmaybe

impaired,saltand/oramineralocorticoidshouldbeadministeredconcurrently.Duringprolongedtherapyany

intercurrentillness,trauma,orsurgicalprocedurewillrequireatemporaryincreaseindosage;ifcorticosteroidshave

beenstoppedfollowingprolongedtherapytheymayneedtobetemporarilyre-introduced.

Patientsshouldcarry“Steroidtreatment”cardswhichgiveclearguidanceontheprecautionstobetakentominimise

riskandwhichprovidedetailsofprescriber,drug,dosageandthedurationoftreatment.

Anti-inflammatory/ImmunosuppressiveeffectsandInfection

Suppressionoftheinflammatoryresponseandimmunefunctionincreasesthesusceptibilitytoinfectionsandtheir

severity.Theclinicalpresentationmayoftenbeatypicalandseriousinfectionsuchassepticaemiaandtuberculosismay

bemaskedandmayreachanadvancedstagebeforebeingrecognisedwhencorticosteroidsincludingprednisoloneare

used.Theimmunosuppressiveeffectsofglucocorticoidsmayresultinactivationoflatentinfectionorexacerbationof

intercurrentinfections.

ChickenpoxChickenpoxisofparticularconcernsincethisnormallyminorillnessmaybefatalinimmunosuppressed

patients.Patients(orparentsofchildren)withoutadefinitehistoryofchickenpoxshouldbeadvisedtoavoidclose

personalcontactwithchickenpoxorherpeszosterandifexposedtheyshouldseekurgentmedicalattention.Passive

immunisationwithvaricella-zosterimmunoglobulin(VZIG)isneededbyexposednon-immunepatientswhoare

receivingsystemiccorticosteroidsorwhohaveusedthemwithintheprevious3months;thisshouldbegivenwithin10

daysofexposuretochickenpox.Ifadiagnosisofchickenpoxisconfirmed,theillnesswarrantsspecialistcareand

urgenttreatment.Corticosteroidsshouldnotbestoppedandthedosemayneedtobeincreased.Theeffectof

corticosteroidsmaybeenhancedinpatientswithhypothyroidismandinthosewithchronicliverdiseasewithimpaired

hepaticfunction.

MeaslesPatientsshouldbeadvisedtotakeparticularcaretoavoidexposuretomeasles,andtoseekimmediatemedical

adviceifexposureoccurs.Prophylaxiswithintramuscularnormalimmunoglobulinmaybeneeded.

AdministrationofLiveVaccinesLivevaccinesshouldnotbegiventoindividualsonhighdosesofcorticosteroids,due

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therapy.(Seealsosection4.5Interactions.)

OcularEffectsProlongeduseofcorticosteroidsmayproduceposteriorsubcapsularcataractsandnuclearcataracts

(particularlyinchildren),exophthalmos,orincreasedintraocularpressure,whichmayresultinglaucomawithpossible

damagetotheopticnerves.Establishmentofsecondaryfungalandviralinfectionsoftheeyemayalsobeenhancedin

patientsreceivingglucocorticoids.

Corticosteroidsshouldbeusedcautiouslyinpatientswithocularherpessimplexbecauseofpossibleperforation.

Cushing'sdiseaseBecauseglucocorticoidscanproduceoraggravateCushing'ssyndrome,glucocorticoidsshouldbe

avoidedinpatientswithCushing'sdisease.

Thereisanenhancedeffectofcorticosteroidsinpatientswithhypothyroidismandinthosewithcirrhosis.

Psychicderangementsmayappearwhencorticosteroids,includingprednisolone,areused,rangingfromeuphoria,

insomnia,moodswings,personalitychanges,andseveredepression,tofrankpsychoticmanifestations.

UseinchildrenCorticosteroidscausegrowthretardationininfancy,childhoodandadolescence,whichmaybe

irreversible,andthereforelong-termadministrationofpharmacologicaldosesshouldbeavoided.Ifprolongedtherapy

isnecessary,treatmentshouldbelimitedtotheminimumsuppressionofthehypothalamo-pituitaryadrenalaxisand

growthretardation.Thegrowthanddevelopmentofinfantsandchildrenshouldbecloselymonitored.Treatment

shouldbeadministeredwherepossibleasasingledoseonalternatedays

UseintheelderlyTreatmentofelderlypatients,particularlyiflongterm,shouldbeplannedbearinginmindthemore

seriousconsequencesofthecommonside-effectsofcorticosteroidsinoldage,especiallyosteoporosis,diabetes,

hypertension,hypokalaemia,susceptibilitytoinfectionandthinningoftheskin.Closeclinicalsupervisionisrequired

toavoidlifethreateningreactions.

ExcipientsPatientswithrarehereditaryproblemofgalactoseintolerancethelapplactosedeficiencyorglucose–

galactosemalabsorption.Shouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

HepaticmicrosomalenzymeinducersDrugsthatinducehepaticenzymecytochromeP-450(CYP)isoenzyme3A4

suchasphenobarbital,phenytoin,rifampicin,rifabutin,carbamazepine,primidoneandaminoglutethimidemayreduce

thetherapeuticefficacyofcorticosteroidsbyincreasingtherateofmetabolism.Lackofexpectedresponsemaybe

observedanddosageofDeltacortrilEntericmayneedtobeincreased.

HepaticmicrosomalenzymeinhibitorsDrugsthatinhibithepaticenzymecytochromeP-450(CYP)isoenzyme3A4

(e.g.ketoconazole,troleandomycin)maydecreaseglucocorticoidclearance.Dosagesofglucocorticoidsgivenin

combinationwithsuchdrugsmayneedtobedecreasedtoavoidpotentialadverseeffects.

AntidiabeticagentsGlucocorticoidsmayincreasebloodglucoselevels.Patientswithdiabetesmellitusreceiving

concurrentinsulinand/ororalhypoglycemicagentsmayrequiredosageadjustmentsofsuchtherapy.

Non-steroidalanti-inflammatorydrugsConcomitantadministrationofulcerogenicdrugssuchasindomethacinduring

corticosteroidtherapymayincreasetheriskofGIulceration.Aspirinshouldbeusedcautiouslyinconjunctionwith

glucocorticoidsinpatientswithhypoprothrombinaemia.Althoughconcomitanttherapywithsalicylateand

corticosteroidsdoesnotappeartoincreasetheincidenceorseverityofGIulceration,thepossibilityofthiseffect

shouldbeconsidered.

Serumsalicylateconcentrationsmaydecreasewhencorticosteroidsareadministeredconcomitantly.Therenal

clearanceofsalicylatesisincreasedbycorticosteroidsandsteroidwithdrawalmayresultinsalicylateintoxication.

Salicylatesandcorticosteroidsshouldbeusedconcurrentlywithcaution.Patientsreceivingbothdrugsshouldbe

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AntibacterialsRifamycinsacceleratemetabolismofcorticosteroidsandthusmayreducetheireffect.Erythromycin

inhibitsmetabolismofmethylprednisoloneandpossiblyothercorticosteroids.

AnticoagulantsResponsetoanticoagulantsmaybereducedor,lessoften,enhancedbycorticosteroids.Close

monitoringoftheINRorprothrombintimeisrequiredtoavoidspontaneousbleeding.

AntiepilepticsCarbamazepine,phenobarbital,phenytoin,andprimidoneacceleratemetabolismofcorticosteroidsand

mayreducetheireffect.

AntifungalsRiskofhypokalaemiamaybeincreasedwithamphotericin,thereforeconcomitantusewithcorticosteroids

shouldbeavoidedunlesscorticosteroidsarerequiredtocontrolreactions;ketoconazoleinhibitsmetabolismof

methylprednisoloneandpossiblyothercorticosteroids.

AntiviralsRitonavirpossiblyincreasesplasmaconcentrationsofprednisoloneandothercorticosteroids.

CardiacGlycosidesIncreasedtoxicityifhypokalaemiaoccurswithcorticosteroids.

CiclosporinConcomitantadministrationofprednisoloneandciclosporinmayresultindecreasedplasmaclearanceof

prednisolone(i.e.increasedplasmaconcentrationofprednisolone).Theneedforappropriatedosageadjustmentshould

beconsideredwhenthesedrugsareadministeredconcomitantly.

CytotoxicsIncreasedriskofhaematologicaltoxicitywithmethotrexate.

MifepristoneEffectofcorticosteroidsmaybereducedfor3-4daysaftermifepristone.

VaccinesLivevaccinesshouldnotbegiventoindividualswithimpairedimmuneresponsiveness.Theantibody

responsetoothervaccinesmaybediminished.

OestrogensOestrogensmaypotentiatetheeffectsofglucocorticoidsanddosageadjustmentsmayberequiredif

oestrogensareaddedtoorwithdrawnfromastabledosageregimen.

SomatropinGrowthpromotingeffectmaybeinhibited.

SympathomimeticsIncreasedriskofhypokalaemiaifhighdosesofcorticosteroidsgivenwithhighdosesof

bambuterol,fenoteral,formoteral,ritodrine,salbutamol,salmeterolandterbutaline.

OtherThedesiredeffectsofantihypertensivesanddiureticsareantagonisedbycorticosteroids;andthehypokalaemic

effectofacetazolamide,loopdiuretics,thiazidediuretics,carbenoxoloneandtheophyllineareenhanced.

4.6Pregnancyandlactation

Useinpregnancy

Theabilityofcorticosteroidstocrosstheplacentavariesbetweenindividualdrugs,however,88%ofprednisoloneis

inactivatedasitcrossestheplacenta.Administrationofcorticosteroidstopregnantanimalscancauseabnormalitiesof

foetaldevelopmentincludingcleftpalate,intra-uterinegrowthretardationandeffectsonbraingrowthand

development.Thereisnoevidencethatcorticosteroidsresultinanincreasedincidenceofcongenitalabnormalities,

suchascleftpalate/lipinman.However,whenadministeredforprolongedperiodsorrepeatedlyduringpregnancy,

corticosteroidsmayincreasetheriskofintra-uterinegrowthretardation.Hypoadrenalismmay,intheory,occurinthe

neonatefollowingprenatalexposuretocorticosteroidsbutusuallyresolvesspontaneouslyfollowingbirthandisrarely

clinicallyimportant.

Cataractshavebeenobservedininfantsborntomotherstreatedwithlong-termprednisoloneduringpregnancy.Aswith

alldrugs,corticosteroidsshouldonlybeprescribedwhenthebenefitstothemotherandchildoutweightherisks.When

corticosteroidsareessentialhowever,patientswithnormalpregnanciesmaybetreatedasthoughtheywereinthenon-

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Patientswithpre-eclampsiaorfluidretentionrequireclosemonitoring.

Useinlactation

Corticosteroidsareexcretedinsmallamountsinbreastmilk.Corticosteroidsdistributedintobreastmilkmaysuppress

growthandinterferewithendogenousglucocorticoidproductioninnursinginfants.Sinceadequatereproductivestudies

havenotbeenperformedinhumanswithglucocorticoids,thesedrugsshouldbeadministeredtonursingmothersonly

ifthebenefitsoftherapyarejudgedtooutweighthepotentialriskstotheinfant.

4.7Effectsonabilitytodriveandusemachines

TheeffectofDeltacortrilEntericontheabilitytodriveorusemachineryhasnotbeenevaluated.Thereisnoevidence

tosuggestthatprednisolonemayaffecttheseabilities.

4.8Undesirableeffects

Theincidenceofpredictableundesirableeffects,includinghypothalamic-pituitaryadrenalsuppressioncorrelateswith

therelativepotencyofthedrug,dosage,timingofadministrationandthedurationoftreatment(see'Specialwarnings

andspecialprecautionsforuse').

BodyasaWholeLeucocytosis,hypersensitivityincludinganaphylaxis,thromboembolism,fatigue,malaise.

Cardiovascularcongestiveheartfailureinsusceptiblepatients,hypertension

Gastro-intestinalDyspepsia,nausea,pepticulcerationwithperforationandhaemorrhage,abdominaldistension,

abdominalpain,increasedappetitewhichmayresultinweightgain,diarrhoea,oesophagealulceration,oesophageal

candidiasis,acutepancreatitis.

Musculo-skeletalProximalmyopathy,osteoporosis,vertebralandlongbonefractures,avascularosteonecrosis,tendon

rupture,myalgia..

Metabolic/NutritionalSodiumandwaterretention,hypokalaemicalkalosis,potassiumloss,negativenitrogenand

calciumbalance.

Skin/AppendagesImpairedhealing,hirsutism,skinatrophy,bruising,striae,telangiectasia,acne,increasedsweating,

maysuppressreactionstoskintests,pruritis,rash,urticaria.

EndocrineSuppressionofthehypothalamo-pituitaryadrenalaxisparticularlyintimesofstress,asintrauma,surgery

orillness,growthsuppressionininfancy,childhoodandadolescence,menstrualirregularityandamenorrhoea.

Cushingoidfacies,weightgain,impairedcarbohydratetolerancewithincreasedrequirementforantidiabetictherapy,

manifestationoflatentdiabetesmellitus,Increasedappetite.

CentralandPeripheralNervousSystemEuphoria,psychologicaldependence,depression,insomnia,dizziness,

headache,vertigo.Raisedintracranialpressurewithpapilloedema(pseudotumorcerebri)inchildren,usuallyafter

treatmentwithdrawal.Aggravationofschizophrenia.Aggravationofepilepsy.

VisionIncreasedintra-ocularpressure,glaucoma,papilloedema,posteriorsubcapsularcataractsexophthalmos,corneal

orscleralthinning,exacerbationofophthalmicviralorfungaldisease.

Anti-inflammatoryandimmunosuppressiveeffectsIncreasessusceptibilityto,andseverityofinfectionswith

suppressionofclinicalsymptomsandsigns,opportunisticinfections,recurrenceofdormanttuberculosis(see'Special

warningsandspecialprecautionsforuse').

WithdrawalsymptomsToorapidareductionofcorticosteroiddosagefollowingprolongedtreatmentcanleadtoacute

adrenalinsufficiency,hypotensionanddeath(see'Specialwarningsandspecialprecautionsforuse'and'Posologyand

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Asteroid“withdrawalsyndrome”seeminglyunrelatedtoadrenocorticalinsufficiencymayalsooccurfollowingabrupt

discontinuanceofglucocorticoids.Thissyndromeincludessymptomssuchas:anorexia,nausea,vomiting,lethargy,

headache,fever,jointpain,desquamation,myalgia,arthralgia,rhinitis,conjunctivitis,painfulitchyskinnodulesweight

loss,and/orhypotension.Theseeffectsarethoughttobeduetothesuddenchangeinglucocorticoidconcentration

ratherthantolowcorticosteroidlevels.

4.9Overdose

Reportsofacutetoxicityand/ordeathfollowingoverdosageofglucocorticoidsarerare.Nospecificantidoteis

available;treatmentissupportiveandsymptomatic.Serumelectrolytesshouldbemonitored.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Naturallyoccurringglucocorticoids(hydrocortisoneandcortisone),whichalsohavesalt-retainingproperties,areused

asreplacementtherapyinadrenocorticaldeficiencystates.Theirsyntheticanalogsareprimarilyusedfortheirpotent

anti-inflammatoryeffectsindisordersofmanyorgansystems.

Glucocorticoidscauseprofoundandvariedmetaboliceffects.Inaddition,theymodifythebody'simmuneresponsesto

diversestimuli.

5.2Pharmacokineticproperties

Prednisoloneisrapidlyandapparentlyalmostcompletelyabsorbedafteroraladministration;itreachespeakplasma

concentrationsafter1-3hours.Thereishoweverwideinter-subjectvariationsuggestingimpairedabsorptioninsome

individuals.Plasmahalf-lifeisabout3hoursinadultsandsomewhatlessinchildren.Itsinitialabsorption,butnotits

overallbioavailability,isaffectedbyfood.Prednisolonehasabiologicalhalf-lifelastingseveralhours,makingit

suitableforalternate-dayadministrationregimens.

AlthoughpeakplasmaprednisolonelevelsaresomewhatlowerafteradministrationofDeltacortrilEntericand

absorptionisdelayed,totalabsorptionandbioavailabilityarethesameasafterplainprednisolone.Prednisoloneshows

dosedependentpharmacokinetics,withanincreaseindoseleadingtoanincreaseinvolumeofdistributionandplasma

clearance.Thedegreeofplasmaproteinbindingdeterminesthedistributionandclearanceoffree,pharmacologically

activedrug.Reduceddosesarenecessaryinpatientswithhypoalbuminaemia.Prednisoloneismetabolisedprimarilyin

thelivertoabiologicallyinactivecompound.Liverdiseaseprolongsthehalf-lifeofprednisoloneand,ifthepatienthas

hypoalbuminaemia,alsoincreasestheproportionofunbounddrugandmaytherebyincreaseadverseeffects.

Prednisoloneisexcretedintheurineasfreeandconjugatedmetabolites,togetherwithsmallamountsofunchanged

prednisolone.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tabletcore:

Calciumcarbonate

Lactose

Magnesiumstearate

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Coating:

Polyvinylalcohol

Titaniumdioxide(E171)

Purifiedtalc

Lecithin

Xanthangum(E415)

Polyvinylacetatephthalate

Macrogol

Sodiumhydrogencarbonate

Triethylcitrate

Purifiedstearicacid

Sodiumalginate(E401)

Colloidalanhydroussilica

Lactose

Beeswax(E901)

Carnaubawax(E903)

Polysorbate20(E432)

Sorbicacid(E200)

Methylcellulose(E461)

Carmellosesodium

Carmine(E120)

Indigocarminealuminiumlake(E132)

PrintingInk:

Titaniumdioxide(E171)

Shellac

Propyleneglycol

Indigocarminealuminiumlake(E132)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductisthedateshownonthecontainerandouterpackageoftheproductonthe

marketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

6.5Natureandcontentsofcontainer

PolypropylenecontainerwithHDPEChild-Resistantscrewcapcontaining100tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7PARALLELPRODUCTAUTHORISATIONHOLDER

PCOManufacturingLtd.

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA0465/179/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:07July2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 04/05/2010 CRN 2082173 page number: 10