Dexamethasone

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Dexamethasone 1 mg
Available from:
Douglas Pharmaceuticals Limited
INN (International Name):
Dexamethasone 1 mg
Dosage:
1 mg
Pharmaceutical form:
Tablet
Composition:
Active: Dexamethasone 1 mg Excipient: Lactose monohydrate Magnesium stearate Maize starch Polyvidone 30 Purified talc Sodium starch glycolate
Units in package:
Bottle, plastic, 1x100, 100 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Pharmacia & Upjohn Company LLC
Product summary:
Package - Contents - Shelf Life: Bottle, plastic, - 100 tablets - 24 months from date of manufacture stored at or below 30°C
Authorization number:
TT50-2096
Authorization date:
1972-11-16

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INFORMATIONFOR

CONSUMERS

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Information

Dexamethasone

dexamethasone1mgand4mgtablets

Whatisinthisleaflet

Thisleafletanswerssomecommonquestionsaboutdexamethasone.

Itdoesnotcontainalltheavailableinformation

Itdoesnottaketheplaceoftalkingtoyourdoctororpharmacist

Keepthisleafletwiththemedicine,youmayneedtoreaditagain.

Whatisitusedfor

Dexamethasonebelongstoagroupofmedicinescalled corticosteroids.Itmaybeusedtotreat

symptomssuchasinflammation,certainimmunedisordersandinreplacementtherapyofaninactiveor

underactiveadrenalgland.

Yourdoctormayprescribedexamethasoneforskinallergies,asthma,leukaemia,blooddisorders,

selectedrheumaticdisorders(paininthejoints,musclesorconnectivetissue),gastrointestinaldisorders

(suchasinflammatoryboweldisease),skinproblems,certainabnormalgrowths(cancers)andexcessive

calciumintheblood.

Yourdoctormayhaveprescribeddexamethasoneforanotherreason.

Ifyouhaveanyconcernsabouttakingthismedicineorwouldliketoknowwhydexamethasonehas

beenprescribedforyou,askyourdoctor.

Beforeyoutakeit

Whenyoumustnottakeit

Donottakeifyouhaveanallergytodexamethasone(orrelatedsteroids)

Donottakeifyouhaveanallergytodexamethasone(orrelatedsteroids)

Donottakeifyouhaveanallergytoanyotheringredientslistedattheendofthisleaflet.

Symptomsofanallergicreactionmayincludeskinrash,difficultybreathing,hayfeverand

swelling.

Donottakeifyouhaveaninternalfungalorviralinfection

Donottakeifyouhavebeengivenalivevaccinesuchassmallpoxorpolio

Itispermissibleifyouarebeinggivendexamethasoneforreplacementtherapy

Donottakeifyouhaveapepticulcer(ulcerofthestomach)

Donottakeifyouhaveosteoporosis(bonethinning)

Donottakeifyousufferfrompsychosis(abnormalthoughtseg.delusions,hallucinations,or

illusions)

Donotuseitaftertheexpirydate(EXP)printedonthepack

Itmaynotbeeffectiveorproduceentirelyunexpectedeffects

Donotuseifthepackagingisdamagedorshowssignsoftampering

Donotusetotreatothercomplaintsunlessyourdoctorsaysitissafeto.

Beforeyoustarttotakeit

Tellyourdoctororpharmacistifyouhaveanyallergiesto:

anyothermedicines

anyothersubstancessuchasfoods,preservativesordyes

Tellyourdoctorifyouhaveorhavehadanyofthefollowingconditions:

Diabetes(disorderofsugarmetabolism/control)

aninfection

heartfailure

kidneyfailure

inflammationofthebowelwall

highbloodpressure

eyediseaseseg.grittyeye,cataracts,glaucoma(highpressureintheeye),ocularherpes.

epilepsy(fits)

weakorbrittlebones(osteoporosis)

intestinaldisease

tuberculosis(TB)

adrenalglandproblems

hypothyroidism(lowoutputfromthyroidgland)

cirrhosis(liverdisease)

ulcersofthestomach,duodenum(partofdigestivetractthatimmediatelyfollowsthestomach)

andlargeintestine

Tellyourdoctorifyouhavebeengivenanyvaccinesrecently

Tellyourdoctorifyouarepregnant/intendtobecomepregnantorbreast-feeding

dexamethasoneisgenerallynotrecommendedforuseduringpregnancyasthereisinadequate

informationontheeffectsofdexamethasoneonthedevelopingchild.Yourdoctorwillweighthe

risksandbenefitsoftakingthismedicinewhileyouarepregnant.

Dexamethasonemaypassintobreastmilkandaffectthebaby.Breastfeedingisnotrecommended

whiletakingdexamethasone.

whiletakingdexamethasone.

Tellyourdoctorifyouareplanningtofatherachild

dexamethasonemayincreaseordecreasethemovementandnumberofspermatozoa

Tellyourdoctorifyouhavespenttimeinthetropicsorhaveunexplaineddiarrhoea

dexamethasonemayactivatelatentparasites

Tellyourdoctorifyousufferfrompsychosis(abnormalthoughts)

Tellyourdoctorordentistifyouplantohavesurgerythatneedsageneralanaesthetic

youmayneedsupplementarycorticosteroidstoovercomethisstressfultime

Ifyouhavenottoldyourdoctororpharmacistaboutanyoftheabove,tellthembeforeyoustarttaking

dexamethasone

Takingothermedicines

Tellyourdoctororpharmacistifyouaretakinganyothermedicinesincludinganythatyoubuywithout

aprescriptionfromyourpharmacy,supermarketorhealthfoodshop.

Somemedicinesanddexamethasoneinterferewitheachother.Theseinclude:

barbituratesorphenytoin-agroupofmedicinesusedtotreatepilepsy

phenylbutazone-anon-steroidalanti-inflammatorymedicine

rifampicin-usedtotreatinfections

anticoagulants-medicinestopreventbloodclots

diuretics-medicineswhichcauseincreasedvolumeofurineeg.thiazidesorfrusemide

vaccinations

Yourdoctorandpharmacistmayhavemoremedicinestobecarefulwithoravoid.

Otherthingstoconsiderbeforetakingit

Aswithothercorticosteroidmedicines,dexamethasonemaycausedizzinessinsomepeople.

Becarefuldrivingoroperatingmachineryuntilyouknowhowitaffectsyou.

Dexamethasoneisnotaddictive.

Longtermtreatmentshouldnotbeabruptlydiscontinuedasthismayresultinsymptomsof

corticosteroidwithdrawalsyndrome.

Ifyouhavebeengivendexamethasoneforapainfulorinflamedjoint,youshouldbecarefulnotto

overusethejointaslongastheinflammationisstillpresent

Howtotakeit

Followalldirectionsgiventoyoubyyourdoctorandpharmacistcarefully.Ifyoudonotunderstandthe

instructionsaskyourpharmacistordoctor.

Donotgivethismedicinetoanyoneelseeveniftheyhavethesameorasimilarconditiontoyou

Howmuchtotake

Yourdoctororpharmacistwilltellyouhowmanytabletsyouwillneedtotakeeachday.Thisdepends

onyourconditionandwhetherornotyouaretakinganyothermedicines.Thedosemaybealteredfrom

timetotime.

Donottakemoreorlessdexamethasonetabletsthanyourdoctorhasprescribed.Ifyouthinkthedoseis

tooweakortoostrong,talktoyourdoctor.

Howtotakeit

Swallowthetabletswithaglassofwater.

Whentotakeit

Howoftendependsonyourcondition.

Donotstoptakingthemedicineevenifyoufeelbetter.

Itdoesnotmatterifyoutakeitbeforeorafterfood

Howlongtotakeit

Howlongdependsonyourconditionandresponsetothetreatment.

Donotstoptakingitsuddenlyasyoursymptomsmayworsen,returnorincasesoflongtermuse,

withdrawalsymptomsmaybeexperienced(corticosteroidwithdrawalsyndrome).

Ifyouforgettotakeit

Ifyoumissadose,whetherornotyoushouldtakethemisseddoseornotwilldependonhowmay

timesadayyourdoctorhastoldyoutotakedexamethasone.

Donottakeadoubledosetomakeupforanymisseddose

Thismayincreasethechanceofgettinganunwantedsideeffect

Askyourdoctororpharmacistwhattodo.

Ifyouhavetroublerememberingtotakeyourmedicinetakeyourmedicineataboutthesametimeeach

dayoraskyourpharmacistforsomehints.

Whileyouaretakingit

Tellyourdoctorifyougetaninfectionorinjury

Symptomsofinfectionsmaybehiddenbytheanti-inflammatoryactionofdexamethasone.

Tellanyotherdoctors,dentistsandpharmacistswhoaretreatingyouthatyouaretaking

dexamethasone.

Ifyouareabouttobestartedonanewmedicinetellyourdoctor,dentistandpharmacistthatyouare

takingdexamethasone.

Ifyoubecomepregnant,tellyourdoctororpharmacist.

Donothaveanyimmunisations

Thevaccinemayinterferewithdexamethasoneornotworkatall.

Avoidclosecontactwithanyonewhohasacontagiousdiseasesuchaschickenpoxormeasles

Sideeffects

Tellyourdoctorassoonaspossibleifyoudonotfeelwellwhileyouaretakingdexamethasone.

Allmedicineshavesideeffects.Sometimestheyareserious,mostofthetimetheyarenot.

Ifyouareover65yearsofage,youmayhaveanincreasedchanceofexperiencingsideeffects.

Thefollowingisalistofpossiblesideeffects.

Donotbealarmedbythislist.

Youmaynotexperienceanyofthem.

Tellyourdoctorifyounoticeanyofthefollowingsymptoms:

slowedgrowthinchildren

bloatingorroundingoftheface

crampsorweaknessinthemusclesofthearmsandlegs

waterretentionleadingtoswollenlegsandfeet

irregularheartbeatorbreathlessness

weightgain

headache

tiredness

irregularmenstrualperiods

legpains

tinglinginhandsandfeet

painfuljoints

Changesinyourimmunesystem:

anincreasedfrequencyofinfections

Changesinyourgastrointestinalsystem

nausea

vomiting

vomiting

indigestion(burningsensation)

weightloss

Mentaleffects

moodswings

euphoria

personalitychanges

severedepression

insomnia(inabilitytosleep)

abnormalthoughts

headaches

fits

Changestoyourskin

impairedwoundhealing

itchyrash

redskin

patchesofskinwhicharepaleorredcomparedtosurroundingskin

thinfragileskin

Changestotheeyes

decreasedorblurredvision

protrudingeyeballs

TellyourdoctorimmediatelyorgototheAccidentandEmergencyatyournearesthospitalifyounotice:

severestomachorintestinalpain

suddenchangesinvision

fits

chestpainorirregularheartbeat

dizziness/faintingorfeelingfaint

difficultybreathingandswellingoftheface

Thesesideeffectsareveryserious

Whendexamethasoneistakenforlongperiodsoftime,itisimportanttovisityourdoctor

regularlyforcheckups.

Somesideeffectscanonlybedetectedbyyourdoctor.Itisimportantthatchangesinthe

followingaredetected:

strengthofbones(osteoporosis)

bloodsugarlevels(diabetes)

eyepressure(glaucoma)

spermcount

bloodpressure(hypertension)

bloodcellchanges(canalerttocancersandotherconditions)

bloodcellchanges(canalerttocancersandotherconditions)

heartbeat

nervefunction

Othersideeffectsnotlistedabovemayoccurinsomepatients.Tellyourdoctororpharmacist

aboutanyundesirablesideeffectsnotmentionedinthisleaflet.

Incaseofoverdose

Adverseeffectsrelatedtodexamethasonenormallydeveloponlyafterprolongeduse.

Ifyoutaketoomanytablets,immediatelytelephoneyourdoctororpharmacistorthePoisons

InformationCentre(telephone0800POISONor0800764766)orgototheAccidentand

Emergencydepartmentatyournearesthospital,ifyouthinkthatyouoranyoneelsemayhave

takentoomuchdexamethasone.Dothiseveniftherearenosignsofdiscomfitorpoisoning.

Storageconditions

Keepyourtabletsintheoriginalcontaineruntilitistimetotakethem.

Ifyoutakethetabletsoutoftheoriginalcontainertheywillnotkeepwell.

Keepyourtabletsinacooldryplaceawayfromlightwherethetemperaturestaysbelow30°C.

Donotstoreyourtabletsinthebathroomornearasink.

Donotleaveitinthecaroronawindowsill.

Heatanddampnesscandestroymedicines.

Keepyourtabletswherechildrencannotreachthem.

Aswithallmedicines,youshouldstoreyourtabletsoutofthereachofchildren.Alockedcupboardat

leastone-and-a-halfmetresabovethegroundisagoodplacetostoremedicines.

Disposal

Ifyourdoctortellsyoutostoptakingthismedicineorthetabletshavepassedtheirexpirydate,

askyourpharmacistwhattodowithanythatareleftover.

Productdescription

Whatitlookslike

Dexamethasone1mgand4mgtabletscomeinpacksof100tablets

Dexamethasone1mgtabletsareroundwhitetabletswiththeDPlogoononefaceandtwobisecting

scoresatrightanglestoeachotherontheoppositeface.

Dexamethasone4mgtabletsareroundwhitetabletswithabreak-lineononefaceand"4"ontheother.

Ingredients

Active:dexamethasone

Other:magnesiumstearate,talc,lactose,maizecornflour,povidone,andsodiumstarchglycolate.

Supplier

DouglasPharmaceuticalsLtd

POBox45-027

Auckland8

Dateofpreparation:19December2003

DataSheet

DEXAMETHASONE

Dexamethasone1mgand4mgtablets

Presentation

Dexamethasone1mgtablets:Biconvex,circular,whitetabletsof7.94mm

diameterwiththeDPlogoononefaceandtwobisectingscoresatright

anglestoeachotherontheoppositeface.

Dexamethasone4mgtablets:Biconvex,circular,whitetabletsof7.94mmwith

abreak-lineononefaceand"4"ontheother.

Uses

Actions

Dexamethasoneisasyntheticcorticosteroidexhibitingbothanti-inflammatory

andimmuno-suppressantproperties.Theanti-inflammatorypotencyof

dexamethasonehasbeenestimatedas25xthatofhydrocortisone.Ithaslittle

mineralocorticoidactivity.

Pharmacokinetics

Dexamethasoneisreadilyabsorbedafteroraladministrationachievingpeak

plasmaconcentrationsafteronehour.Bindingtoplasmaproteinsislessthan

formostothercorticosteroids.

Thebiologicalhalf-lifeisapproximately190minutes.Dexamethasone

penetratestissueandcerebrospinalfluid.

Eliminationoccursviametabolismandrenalexcretion.

Indications

Dexamethasoneisindicatedforreplacementtherapyinsecondaryadrenal

insufficiencyarisingfrominsufficientcorticotrophinsecretion.Itisnotindicated

forprimaryadrenalinsufficiencystates,suchasAddisonsdiseaseorafter

adrenalectomy.Insuchcaseshydrocortisoneandfludrocortisonein

combinationismoreappropriate.

Dexamethasoneisalsoindicatedforallergicdisorderssuchasbronchial

asthmaandallergicskinreactions,blooddisorderssuchasleukaemia,

thrombocytopoeniaandhaemolyticanaemias,selectedcollagenand

rheumaticdisorders(onlyrarelyinrheumatoidarthritis),gastrointestinal

disorderssuchasinflammatoryboweldisease,connectivetissuedisorders

suchasarteritis,systemiclupuserythematosus(butnotscleroderma),some

skindiseasessuchaspemphigus,oedema,someeyedisorders,certain

neoplasticdisorderssuchascerebralneoplasm,secondaryhypercalcaemia,

andacuteleukaemiainchildren.Itmayalsobeusedtopreventneonatal

respiratorydistresssyndromeandinthediagnosisofCushing'ssyndrome.

Dosageandadministration

Thedoseofdexamethasonevariesaccordingtotheconditionbeingtreated.

Thetabletsarefororaladministrationinadoseof4mg-20mgdaily.

Thedurationoftherapyisdependentontheclinicalresponseofthepatient

andassoonasimprovementisindicated,thedosageshouldbeadjustedto

theminimumrequiredtomaintainthedesiredresponse.Withdrawalof

dexamethasoneatcompletionoftreatmentshouldbegradual.

Contraindications

Hypersensitivitytoanyingredient

Systemicinfectionsunlessspecificanti-infectivetherapyisgiven

Livevirusimmunisation

Warningsandprecautions

GeneralPrecautions

Cautionisnecessarywhenoralcorticosteroidsareusedinpatientswiththe

followingconditionsandfrequentmonitoringisnecessary:

Hypertension

Hypothyroidism

CongestiveHeartfailureorrecentmyocardialinfarction

Liverfailure

Renalinsufficiency

Diabetesmellitusorinthosewithafamilyhistoryofdiabetes

Osteoporosis

Glaucoma

Patientswithahistoryofsevereaffectivedisordersparticularlyof

steroidinducedpsychoses

Epilepsyand/orseizuredisorder

Pepticulceration

Previoussteroidmyopathy

Tuberculosis

Patientswithmyastheniagravisreceivinganticholinesterasetherapy

sincecorticosteroidusemaydecreaseplasmaanticholinesterase

activity

Patientswiththromboembolicdisorders

PatientswithDuchenne’smusculardystrophysincetransient

rhabdomyolysisandmyoblobinuriahavebeenreportedfollowing

strenuousphysicalactivity

PatientswithCushing’sdisease

AdrenocorticalInsufficiency

Pharmacologicdosesofcorticosteroidsadministeredforprolongedperiods

mayresultinhypothalamic-pituitary-adrenal(HPA)suppression(secondary

adrenocorticalinsufficiency).Thedegreeanddurationofadrenocortical

insufficiencyproducedisvariableamongpatientsanddependsonthedose,

frequency,timeofadministrationanddurationoftherapy.

Symptomsofadrenalinsufficiencyinclude:malaise,muscleweakness,mental

changes,muscleandjointpain,desquamationoftheskin,dyspnoea,

anorexia,nauseaandvomiting,fever,hypoglycaemia,hypotensionand

dehydration.

Duringprolongedcoursesofcorticosteroidtherapysodiumintakemayneedto

bereducedandcalciumandpotassiumsupplementsmaybenecessary.

Monitoringoffluidintakeandoutputanddailyweightrecordsmaygivean

earlywarningoffluidretention.

Acuteadrenalinsufficiencyleadingtoafataloutcomemayoccurif

glucocorticoidsarewithdrawnabruptly,thereforewithdrawalofcorticosteroids

shouldalwaysbegradual.Adegreeofadrenalinsufficiencymaypersistfor6

to12months;thereforeinanysituationofstressoccurringduringthatperiod

steroidtherapymayneedtobereinstituted.Sincemineralocorticoidsecretion

maybeimpairedtreatmentwithsaltand/oramineralocorticoidmayalsobe

needed.

Duringprolongedtherapy,anyintercurrentillness,traumaorsurgical

procedurewillrequireatemporaryincreaseindosage.

Anti-inflammatory/ImmunosuppressiveeffectsandInfection

Suppressionoftheinflammatoryresponseandimmunefunctionincreases

susceptibilitytoinfectionsandtheirseverity.Theclinicalpresentationmay

oftenbeatypicalandseriousinfectionssuchassepticaemiaandtuberculosis

maybemaskedandmayreachanadvancedstagebeforebeingrecognized

whencorticosteroidsareused.Theimmunosuppressiveeffectsof

glucocorticoidsmayresultinactivationoflatentinfectionorexacerbationof

intercurrentinfections.

Chickenpoxisofparticularconcernsincethismaybefatalin

immunosuppressedpatients.Patientswithoutadefinitehistoryofchickenpox

shouldbeadvisedtoavoidclosepersonalcontactwithchickenpoxorherpes

zosterandifexposedtheyshouldseekurgentmedicalattention.Passive

immunizationisrecommendedfornon-immunepatientswhodocomeinto

contactwithchickenpox.Ifadiagnosisofchickenpoxisconfirmedtheillness

warrantsspecialistcareandurgenttreatment.

Livevaccinesarecontraindicatedinindividualsonhighdosesof

corticosteroidsandshouldbepostponeduntilatleast3monthsafterstopping

corticosteroidtherapy.

OcularEffects

Prolongeduseofcorticosteroidsmayproducesubcapsularcataractsand

nuclearcataracts(particularlyinchildren),exophthalmosorincreased

intraocularpressure,whichmayresultinglaucomawithpossibledamageto

theopticnerves.

Corticosteroidsshouldonlybeinitiatedinpatientswithocularherpessimplex

withappropriateviralcoverbyophthalmologistsbecauseoftheriskofcorneal

scaringlossofvisionandcornealperforation.

Psychiatriceffects

Patientsand/orcareersshouldbewarnedthatpotentiallyseverepsychiatric

reactionsmayoccur.Symptomstypicallyemergewithinafewdaysorweeks

ofstartingtreatment.Mostreactionsrecoveraftereitherdosereductionor

withdrawal,althoughspecifictreatmentmaybenecessary.Patientsand/or

carersshouldbeencouragedtoseekmedicaladviceisworrying

psychologicalsymptomsdevelop,especiallyifdepressedmoodorsuicidal

ideationissuspected.

Particularcareisrequiredwhenconsideringtheuseofcorticosteroidsin

patientswithexistingorprevioushistoryofsevereaffectivedisorders.

Psychicderangementsrangefromeuphoria,insomnia,moodswings,

personalitychangesandseveredepressiontofrankpsychoticmanifestations.

UseinChildren

Corticosteroidscausegrowthretardationininfancy,childhoodand

adolescence,whichmaybeirreversibleandthereforelong-term

administrationofpharmacologicaldosesshouldbeavoided.Ifprolonged

therapyisnecessary,treatmentshouldbelimitedtotheminimumsuppression

ofthehypothalamo-pituitaryadrenalaxisandgrowthretardation,thegrowth

anddevelopmentofinfantsandchildrenshouldbecloselymonitored.

Treatmentshouldbeadministeredwherepossibleasasingledoseon

alternatedays.

Childrenareatspecialriskfromraisedintracranialpressure.

Useintheelderly

Long-termuseintheelderlyshouldbeplannedbearinginmindthemore

seriousconsequencesofthecommonside-effectsofcorticosteroidsinold

age,especiallyosteoporosis,diabetes,hypertension,hypokalaemia,

susceptibilitytoinfectionandthinningoftheskin.Closemedicalsupervisionis

requiredtoavoidlifethreateningreactions.

Adverseeffects

Bodyasawhole:

Leucocytosis,hypersensitivityincludinganaphylaxis,thromboembolism,

fatigue,malaise

Cardiovascular:

Congestiveheartfailureinsusceptiblepatients,hypertension

Gastro-intestinal:

Dyspepsia,nausea,pepticulcerationwithperforationandhaemorrhage,

abdominaldistension,abdominalpain,increasedappetitewhichmayresultin

weightgain,diarrhoea,oesophagealulceration,oesophagealcandidiasis,

acutepancreatitis

Musculoskeletal:

Proximalmyopathy,osteoporosis,vertebralandlongbonefractures,

avascularosteonecrosis,tendonrupture,myalgia

Metabolic/Nutritional:

Sodiumandwaterretention,hypokalaemicalkalosis,potassiumloss,negative

nitrogenandcalciumbalance

Skin:

Impairedhealing,hirsutism,skinatrophy,bruising,striae,telangiectasia,acne,

increasedsweating,maysuppressreactionstoskintests,pruritis,rash,

urticaria

Endocrine:

Suppressionofthehypothalamo-pituitaryadrenalaxisparticularlyintimesof

stressasintraumasurgeryorillness,growthsuppressionininfancy,

childhoodandadolescence,menstrualirregularityandamenorrhoea.

Cushingoidfacies,weightgain,impairedcarbohydratetolerancewith

increasedrequirementforantidiabetictherapy,manifestationoflatent

diabetesmellitus,increasedappetite.

Nervoussystem:

Euphoria,psychologicaldependence,depression,insomnia,dizziness,

headache,vertigo,raisedintracranialpressurewithpapilloedemainchildren,

usuallyaftertreatmentwithdrawal.Aggravationofschizophrenia,Aggravation

ofepilepsysuicidalideation,mania,delusions,hallucinations,irritability

anxiety,insomniaandcognitivedysfunction.Inadultsthefrequencyofsevere

psychiatricreactionshasbeenestimatedtobe5-6%.

Eyedisorders:

Increased intra-ocular pressure, glaucoma, papilloedema, posterior

subcapsular cataracts, exophthalmos, corneal or scleral thinning,

exacerbationofophthalmicviralorfungaldisease

Anti-inflammatoryandImmunosuppressiveeffects:

Increasedsusceptibilitytoandseverityofinfectionswithsuppressionof

clinicalsymptomsandsigns.Opportunisticinfections,recurrenceofdormant

tuberculosis.

Withdrawalsymptoms:

Toorapidareductionofcorticosteroidsfollowingprolongedtreatmentcan

leadtoacuteadrenalinsufficiency,hypotensionanddeath.Asteroid

withdrawalsyndromeseeminglyunrelatedtoadrenocorticalinsufficiencymay

alsooccurandincludesymptomssuchasanorexia,nausea,vomiting,

lethargy,headache,fever,weightloss,and/orhypotension.

Druginteractions

Hepaticmicrosomalenzymeinducers

MedicinesthatinducehepaticenzymecytochromeP-450isozyme3A4such

asPhenobarbital,phenytoin,rifampicin,rifabutin,carbamazepine,primidone

andaminogluethimidemayreducethetherapeuticefficacyofcorticosteroids

byincreasingtherateofmetabolism.

Hepaticmicrosomalenzymeinhibitors

MedicinesthatinhibithepaticenzymecytochromeP-450isozyme3A4such

asketoconazole,ciclosporinorritonavirmaydecreaseglucocortiocoid

clearance.Areductionincoritcosteroiddosemaybeneededtoreducethe

riskofadverseeffects.

AntidiabeticAgents

Corticosteroidsmayincreasebloodglucoselevels.Patientsmayneeddosage

adjustmentofanyconcurrentantidiabetictherapy.

Non-steroidalanti-inflammatorydrugs(NSAIDs)

ConcomitantadministrationmayincreasetheriskofGIulceration.Aspirin

shouldbeusedcautiouslyinconjunctionwithconticosteroidsinpatientswith

hypothrombinaemia.Therenalclearanceofsalicylatesisincreasedby

corticosteroidsandsteroidwithdrawalmayresultinsalicylateintoxication.

Patientsshouldbeobservedcloselyforadverseeffectsofeithermedicine.

Anticoagulants

Responsetoanticoagulantsmaybereducedorlessoftenenhancedby

corticosteroids.ClosemonitoringoftheINRorprothrombintimeis

recommended.

Antifungals

Theriskofhypokalaemiamaybeincreasedwithamphoteracin.

Cardiacglycosides

Thereisariskoftoxicityifhypokalaemiaoccursduetocorticosteroid

treatment.

Mifepristone

Theeffectofcorticosteroidsmaybereducedfor3-4daysaftermifepristone.

Vaccines

Livevaccinesshouldnotbegiventoindividualswithimpairedimmune

responsiveness.Theantibodyresponsetoothervaccinesmaybediminished.

Oestrogens

Oestrogensmaypotentiatetheeffectsofglucocorticoids.Thedoseof

corticosteoidmayneedtobeadjustedifoestrogentherapyiscommencedor

stopped.

Somatropin

Thegrowthpromotingeffectmaybeinhibited.

Sympathomimetics

Thereisanincreasedriskofhypokalaemiaifhighdosesofcorticosteroidsare

givenwithhighdosesofsalbutamol,salmeterol,terbutalineorformoteral.

Diuretics

Excessivepotassiumlossmaybeexperiencedifglucocorticoidsand

potassium-depletingdiuretics(suchasfrusemideandthiazides)orcarbonic

anhydraseinhibitors(suchasacetazolamide)aregiventogether.

Antacids

Concurrentuseofantacidsmaydecreaseabsorptionofcorticosteroids–

efficacymaybedecreasedsufficientlytorequiredosageadjustmentsin

patientsreceivingsmalldosesofcorticosteroids.

Overdosage

Adverseeffectsrelatedtodexamethasonenormallydeveloponlyafter

prolongeduse.Treatmentissymptomaticandwherepossiblethe

dexamethasonedoseshouldbereducedgradually.

Pharmaceuticalprecautions

Storeatorbelow30°C,protectedfromlightandmoistureandkeptoutof

reachofchildren.

Medicineclassification

PrescriptionMedicine

Packagequantities

Dexamethasone1mgand4mgtablets:Packsof100tablets.

Furtherinformation

Dexamethasoneis(11β,16α)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-

1,4-diene-3,20-dione.ItsmolecularformulaisC

anditsmolecular

weightis392.5.

Otheringredientsofthetabletsare:MagnesiumStearate,Talc,Lactose,

MaizeCornflour,Polyvinylpyrrolidinone,andSodiumStarchGlycolate.

Nameandaddress

DouglasPharmaceuticalsLtd

POBox45-027

TeAtatuPeninsula

AUCKLAND0651

Ph:(09)835-0660

Fax:(09)835-0665

Dateofpreparation

24May2011

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