DEPO-MEDRONE WITH 40MG/ ML LIDOCAINE

Main information

  • Trade name:
  • DEPO-MEDRONE WITH 40MG/ ML LIDOCAINE
  • Dosage:
  • 10
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DEPO-MEDRONE WITH 40MG/ML LIDOCAINE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0936/077/002
  • Authorization date:
  • 28-01-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Depo-Medrone40mg/mlwithLidocaine10mg/mlSuspensionforInjection,2mlvial.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachmlcontainsMethylprednisoloneAcetate40mgandLidocaineHydrochloride10mg.

Eachvialcontains80mgMethylprednisoloneAcetateand20mgLidocaineHydrochloride.

Forafulllistofexcipients,seeSection6.1.

3PHARMACEUTICALFORM

SuspensionforInjection.

Sterilewhiteaqueoussuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Depo-MedronewithLidocaineisindicatedinconditionsrequiringaglucocorticoideffect:e.g.anti-inflammatoryor

anti-rheumatic.Itisrecommendedforlocalusewheretheaddedanaestheticeffectwouldbeconsideredadvantageous.

4.2Posologyandmethodofadministration

Depo -MedronewithLidocaineshouldnotbemixedwithanyotherpreparationasflocculationoftheproductmay

occur.Parenteraldrugproductsshouldbeinspectedvisuallyforparticulatematteranddiscolorationpriorto

administrationwheneversuspensionandcontainerpermit.

TherapywithDepo-MedronewithLidocainedoesnotobviatetheneedfortheconventionalmeasuresusually

employed.Althoughthismethodoftreatmentwillamelioratesymptoms,itisinnosenseacureandthehormonehas

noeffectonthecauseoftheinflammation.

Depo-MedronewithLidocainemaybeusedbyanyofthefollowingroutes:intra-articular,periarticular,intrabursal,

andintothetendonsheath.Itmustnotbeusedbytheintrathecalorintravenousroutes(seeSection4.3

ContraindicationsandSection4.8Undesirableeffects).

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheminimumperiod(seesection4.4

Specialwarningsandprecautionsforuse).

Depo-MedronewithLidocainevialsareintendedforsingledoseuseonly.

Intra -articular:Rheumatoidarthritis,osteo-arthritis.ThedoseofDepo-MedronewithLidocainedependsuponthe

sizeofthejointandtheseverityofthecondition.Repeatedinjections,ifneeded,maybegivenatintervalsofoneto

fiveormoreweeksdependinguponthedegreeofreliefobtainedfromtheinitialinjection.

Asuggesteddosageguideis:largejoint(knee,ankle,shoulder),20 -80mg(0.5-2ml);mediumjoint(elbow,wrist),

-40mg(0.25-1ml);smalljoint(metacarpophalangeal,interphalangeal,sternoclavicular,acromioclavicular),

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Periarticular:Epicondylitis.Infiltrate4 -30mg(0.1-0.75ml)intotheaffectedarea.

Intrabursal:Subacromialbursitis,prepatellarbursitis,olecranonbursitis.Foradministrationdirectlyintobursae,

-30mg(0.1-0.75ml).Inmostacutecases,repeatinjectionsarenotneeded.

Intothetendonsheath:Tendinitis,tenosynovitis,epicondylitis.Foradministrationdirectlyintothetendonsheath,

-30mg(0.1-0.75ml).Inrecurrentorchronicconditions,repeatinjectionsmaybenecessary.

Intra -articularinjectionsshouldbemadeusingprecise,anatomicallocalisationintothesynovialspaceofthejoint

involved.Theinjectionsiteforeachjointisdeterminedbythatlocationwherethesynovialcavityismostsuperficial

andmostfreeoflargevesselsandnerves.Suitablesitesforintra -articularinjectionaretheknee,ankle,wrist,elbow,

shoulder,phalangealandhipjoints.Thespinaljoints,unstablejointsandthosedevoidofsynovialspacearenot

suitable.Treatmentfailuresaremostfrequentlytheresultoffailuretoenterthejointspace.Intra -articularinjections

shouldbemadewithcareasfollows:ensurecorrectpositioningoftheneedleintothesynovialspaceandaspirateafew

dropsofjointfluid.TheaspiratingsyringeshouldthenbereplacedbyanothercontainingDepo -Medronewith

Lidocaine.Toensurepositionoftheneedlesynovialfluidshouldbeaspiratedandtheinjectionmade.

Afterinjectionthejointismovedslightlytoaidmixingofthesynovialfluidandthesuspension.Subsequenttotherapy

careshouldbetakenforthepatientnottooverusethejointinwhichbenefithasbeenobtained.Negligenceinthis

mattermaypermitanincreaseinjointdeteriorationthatwillmorethanoffsetthebeneficialeffectsofthesteroid.

Intrabursalinjectionsshouldbemadeasfollows:theareaaroundtheinjectionsiteispreparedinasterilewayanda

whealatthesitemadewith1%procainehydrochloridesolution.A20to24gaugeneedleattachedtoadrysyringeis

insertedintothebursaandthefluidaspirated.Theneedleisleftinplaceandtheaspiratingsyringechangedforasmall

syringecontainingthedesireddose.Afterinjection,theneedleiswithdrawnandasmalldressingapplied.

Inthetreatmentoftenosynovitisandtendinitis,careshouldbetakentoinjectDepo -MedronewithLidocaineintothe

tendonsheathratherthanintothesubstanceofthetendon.Duetotheabsenceofatruetendonsheath,theAchilles

tendonshouldnotbeinjectedwithDepo -MedronewithLidocaine.

Children:Dosageshouldbereducedforinfantsandchildren,butshouldbegovernedmorebytheseverityofthe

conditionandresponseofthepatient,thanbyageorsize(seeSection4.4Specialwarningsandprecautionsforuse).

Elderlypatients:Whenusedaccordingtoinstructions,thereisnoinformationtosuggestthatachangeindosageis

warrantedintheelderly.Treatmentofelderlypatients,however,particularlyiflong-term,shouldbeplannedbearing

inmindthemoreseriousconsequencesofthecommonside-effectsofcorticosteroidsinoldageandcloseclinical

supervisionisrequired(seeSection4.4Specialwarningsandprecautionsforuse).

4.3Contraindications

Theusualcontraindicationstothesystemicorlocaluseofcorticosteroidsshouldbeobserved.

Administrationofliveorliveattenuatedvaccinesiscontra-indicatedinpatientsreceivingimmunosuppressivedosesof

corticosteroids

Depo-MedronewithLidocaineiscontraindicatedwherethereisknownhypersensitivitytocomponentsandinsystemic

fungalinfection.

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Duetoitspotentialforneurotoxicity,Depo -MedronewithLidocainemustnotbegivenbytheintrathecalroute.In

addition,astheproductisasuspensionitmustnotbegivenbytheintravenousroute(seeSection4.8Undesirable

effects).

4.4Specialwarningsandprecautionsforuse

Specialwarnings:

1.APatientInformationLeafletisprovidedinthepackbythemanufacturer.

2.Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheminimumperiod.Frequentpatient

reviewisrequiredtoappropriatelytitratethedoseagainstdiseaseactivity(seesection4.2Posologyandmethodof

administration).

3.Depo-MedronewithLidocainevialsareintendedforsingledoseuseonly.Anymultidoseuseoftheproductmay

leadtocontamination.

4.Depo-MedronewithLidocaineshouldnotbeadministeredbyanyrouteotherthanthoselisted.Itiscriticalthat,

duringadministrationofDepo-MedronewithLidocaine,appropriatetechniquebeusedandcaretakentoassureproper

placementofdrug.

5.Administrationbyotherthanindicatedrouteshasbeenassociatedwithreportsofseriousmedicaleventsincluding:

arachnoiditis,meningitis,paraparesis/paraplegia,sensorydisturbances,bowel/bladderdysfunction,seizures,visual

impairmentincludingblindness,ocularandperiocularinflammation,andresidueorsloughatinjectionsite.

Appropriatemeasuresmustbetakentoavoidintravascularinjection.

6.Duetotheabsenceofatruetendonsheath,theAchillestendonshouldnotbeinjectedwithDepo-Medronewith

Lidocaine.

7.Whilecrystalsofadrenalsteroidsinthedermissuppressinflammatoryreactions,theirpresencemaycause

disintegrationofthecellularelementsandphysiochemicalchangesinthegroundsubstanceoftheconnectivetissue.

Theresultantinfrequentlyoccurringdermaland/orsubdermalchangesmayformdepressionsintheskinattheinjection

siteandthepossibilityofdepigmentation.Thedegreetowhichthisreactionoccurswillvarywiththeamountof

adrenalsteroidinjected.Regenerationisusuallycompletewithinafewmonthsorafterallcrystalsoftheadrenal

steroidhavebeenabsorbed.Inordertominimizetheincidenceofdermalandsubdermalatrophy,caremustbe

exercisednottoexceedrecommendeddosesininjections.Multiplesmallinjectionsintotheareaofthelesionshouldbe

madewheneverpossible.Thetechniqueofintra-articularinjectionshouldincludeprecautionsagainstinjectionor

leakageintothedermis.

8.Systemicabsorptionofmethylprednisoloneoccursfollowingintra-articularinjectionofDepo-Medronewith

Lidocaine.Systemicaswellaslocaleffectscanthereforebeexpected.

9.Intra-articularcorticosteroidsareassociatedwithasubstantiallyincreasedriskofinflammatoryresponseinthejoint,

particularlybacterialinfectionintroducedwiththeinjection.Charcot-likearthropathieshavebeenreportedparticularly

afterrepeatedinjections.Appropriateexaminationofanyjointfluidpresentisnecessarytoexcludeanybacterial

infection,priortoinjection.

10.FollowingasingledoseofDepo-MedronewithLidocaine,plasmacortisollevelsarereducedandthereisevidence

ofhypothalamic-pituitary-adrenalaxis(HPA)suppression.Thissuppressionlastsforavariableperiodofupto4

weeks.TheusualdynamictestsofHPAaxisfunctioncanbeusedtodiagnoseevidenceofimpairedactivity(e.g.

Synacthentest).

11.Adrenalcorticalatrophydevelopsduringprolongedtherapyandmaypersistformonthsafterstoppingtreatment.

Withdrawalofcorticosteroidsafterprolongedtherapymustthereforealwaysbegradualtoavoidacuterebound

exacerbationofdisease,acuteadrenalinsufficiencyorpolyarteritisbeingtaperedoffoverweeksormonthsaccording

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Duringprolongedtherapyanyintercurrentillness,trauma,anaesthesiaorsurgicalprocedurewillrequireatemporary

increaseindosage.Inpatientsoncorticosteroidtherapysubjectedtounusualstress,increaseddosageofrapidlyacting

corticosteroidsbefore,duringandafterthestressfulsituationisindicated.Ifcorticosteroidshavebeenstopped

followingprolongedtherapytheymayneedtobetemporarilyre-introduced.

12.Sincemineralocorticoidsecretionmaybeimpaired,saltand/oramineralocorticoidshouldbeadministered

concurrently.

13.Becauserareinstancesofanaphylacticreactionshaveoccurredinpatientsreceivingparenteralcorticosteroid

therapy,appropriateprecautionarymeasuresshouldbetakenpriortoadministration,especiallywhenthepatienthasa

historyofdrugallergy.

14.Corticosteroidsmaymasksomesignsofinfection,andnewinfectionsmayappearduringtheiruse.Theremaybe

decreasedresistanceandinabilitytolocalizeinfectionwhencorticosteroidsareused.Infectionswithanypathogen

includingviral,bacterial,fungal,protozoanorhelminthicinfections,inanylocationinthebody,maybeassociated

withtheuseofcorticosteroidsaloneorincombinationwithotherimmunosuppressiveagentsthataffectcellular

immunity,humoralimmunity,orneutrophilfunction.Theseinfectionsmaybemild,butcanbesevereandattimes

fatal.Withincreasingdosesofcorticosteroids,therateofoccurrenceofinfectiouscomplicationsincreases.Donotuse

intra-synovial,intrabursalorintratendinousadministrationforlocaleffectinthepresenceofacuteinfection.

15.Chickenpoxisofseriousconcernsincethisnormallyminorillnessmaybefatalinimmunosuppressedpatients.

Patients(orparentsofchildren)withoutadefinitehistoryofchickenpoxshouldbeadvisedtoavoidclosepersonal

contactwithchickenpoxorherpeszosterandifexposedtheyshouldseekurgentmedicalattention.Passive

immunizationwithvaricella/zosterimmunoglobin(VZIG)isneededbyexposednon-immunepatientswhoare

receivingsystemiccorticosteroidsorwhohaveusedthemwithintheprevious3months;thisshouldbegivenwithin10

daysofexposuretochickenpox.Ifadiagnosisofchickenpoxisconfirmed,theillnesswarrantsspecialistcareand

urgenttreatment.Corticosteroidsshouldnotbestoppedandthedosemayneedtobeincreased.

16.Measlescanhaveamoreseriousorevenfatalcourseinimmunosuppressedpatients.Insuchchildrenoradults,

particularcareshouldbetakentoavoidexposuretomeasles.Ifexposed,prophylaxiswithintramuscularpooled

immunoglobulin(IVIG)maybeindicated.Exposedpatientsshouldbeadvisedtoseekmedicaladvicewithoutdelay.

17.Livevaccinesshouldnotbegiventoindividualswithimpairedimmuneresponsiveness.Theantibodyresponseto

othervaccinesmaybediminished.

18.Ifcorticosteroidsareindicatedinpatientswithlatenttuberculosisortuberculinreactivity,closeobservationis

necessaryasreactivationofthediseasemayoccur.Duringprolongedcorticosteroidtherapy,thesepatientsshould

receivechemoprophylaxis.

19.Thisproductcontains8.7mg/mlbenzylalcohol.Benzylalcoholhasbeenreportedtobeassociatedwithafatal

"GaspingSyndrome"inprematureinfants.Benzylalcoholisalsopotentiallytoxicwhenadministeredlocallytoneural

tissue.

20.Careshouldbetakenforpatientsreceivingcardioactivedrugssuchasdigoxinbecauseofsteroidinduced

electrolytedisturbance/potassiumloss(seeSection4.8Undesirableeffects).

21.Prolongeduseofcorticosteroidsmayproduceposteriorsubcapsularcataracts,glaucomawithpossibledamageto

theopticnerveandmayenhancetheestablishmentofsecondaryocularinfectionsduetofungiorviruses.

22.Thefollowingadditionalprecautionsapplyforparenteralcorticosteroids:

Intra-synovialinjectionofacorticosteroidmayproducesystemic,aswellaslocaleffects.Noadditionalbenefitderives

fromtheintramuscularadministrationofDepo-MedronewithLidocaine.Whereparenteralcorticosteroidtherapyfor

sustainedsystemiceffectisdesired,plainDepo-Medroneshouldbeused.

Appropriateexaminationofanyjointfluidpresentisnecessarytoexcludeasepticprocess.Amarkedincreaseinpain

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Ifthiscomplicationoccursandthediagnosisofsepsisisconfirmed,appropriateantimicrobialtherapyshouldbe

instituted.

Localinjectionofasteroidintoapreviouslyinfectedjointistobeavoided.

Corticosteroidsshouldnotbeinjectedintounstablejoints.

Steriletechniqueisnecessarytopreventinfectionsorcontamination.

Sincecomplicationsoftreatmentwithglucocorticoidsaredependentonthesizeofthedoseandthedurationof

treatment,arisk/benefitdecisionmustbemadeineachindividualcaseastodoseanddurationoftreatment.

23.Kaposi'ssarcomahasbeenreportedtooccurinpatientsreceivingcorticosteroidtherapy.Discontinuationof

corticosteroidsmayresultinclinicalremission.

24.Allergicskinreactionshavebeenreportedapparentlyrelatedtotheexcipientsintheformulation.Rarelyhasskin

testingdemonstratedareactiontomethylprednisolone,perse.

Specialprecautions:

Particularcareisrequiredwhenconsideringtheuseofsystemiccorticosteroidsinpatientswiththefollowing

conditionsandfrequentpatientmonitoringisnecessary.

1.Osteoporosis(post-menopausalfemalesareparticularlyatrisk).

2.Hypertensionorcongestiveheartfailure.

3.Psychicderangementsmayappearwhencorticosteroidsareused,rangingfromeuphoria,insomnia,moodswings,

personalitychanges,andseveredepressiontofrankpsychoticmanifestations.Also,existingemotionalinstabilityor

psychotictendenciesmaybeaggravatedbycorticosteroids.

4.Diabetesmellitus(orafamilyhistoryofdiabetes).

5.Historyoftuberculosis.

6.Glaucoma(orafamilyhistoryofglaucoma).

7.Previouscorticosteroid-inducedmyopathy.

8.Liverfailureorcirrhosis.

9.Renalinsufficiency.

10.Epilepsy.

11.Activeandlatentpepticulceration.

12.Freshintestinalanastomoses.

13.Predispositiontothrombophlebitis.

14.Abscessorotherpyogenicinfections.

15.Ulcerativecolitis.

16.Diverticulitis.

17.Myastheniagravis.

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19.Hypothyroidism.

20.ExanthematousDisease

21.Cushing’sSyndrome.

22.Patientsand/orcarersshouldbewarnedthatpotentiallyseverepsychiatricadversereactionsmayoccurwith

systemicsteroids(seesection4.8).Symptomstypicallyemergewithinafewdaysorweeksofstartingtreatment.Risks

maybehigherwithhighdoses/systemicexposure(seealsosection4.5InteractionwithOtherMedicamentsandOther

FormsofInteractionthatcanincreasetheriskofsideeffects),althoughdoselevelsdonotallowpredictionoftheonset,

type,severityordurationofreactions.Mostreactionsrecoveraftereitherdosereductionorwithdrawal,although

specifictreatmentmaybenecessary.Patients/carersshouldbeencouragedtoseekmedicaladviceifworrying

psychologicalsymptomsdevelop,especiallyifdepressedmoodorsuicidalideationissuspected.Patients/carersshould

bealerttopossiblepsychiatricdisturbancesthatmayoccureitherduringorimmediatelyafterdosetapering/withdrawal

ofsystemicsteroids,althoughsuchreactionshavebeenreportedinfrequently.

Particularcareisrequiredwhenconsideringtheuseofsystemiccorticosteroidsinpatientswithexistingorprevious

historyofsevereaffectivedisordersinthemselvesorintheirfirstdegreerelatives.Thesewouldincludedepressiveor

manic-depressiveillnessandprevioussteroidpsychosis.

Useinchildren

Corticosteroidscausegrowthretardationininfancy,childhoodandadolescencewhichmaybeirreversible.Treatment

shouldbelimitedtotheminimumdosageforthemostseriousindicationsandshortestpossibletime.

Useintheelderly

Thecommonadverseeffectsofsystemiccorticosteroidsmaybeassociatedwithmoreseriousconsequencesinoldage,

especiallyosteoporosis,hypertension,hypokalaemia,diabetes,susceptibilitytoinfectionandthinningoftheskin.Close

clinicalsupervisionisrequiredtoavoidlife-threateningreactions.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Convulsionshavebeenreportedwithconcurrentuseofmethylprednisoloneandcyclosporin.Sinceconcurrent

administrationoftheseagentsresultsinamutualinhibitionofmetabolism,itispossiblethatconvulsionsand

otheradverseeffectsassociatedwiththeindividualuseofeitherdrugmaybemoreapttooccur.

Drugsthatinducehepaticenzymes,suchasrifampicin,rifabutin,carbamazepine,phenobarbitone,phenytoin,

primidone,andaminoglutethimideenhancethemetabolismofcorticosteroidsanditstherapeuticeffectsmaybe

reduced.

Drugssuchaserythromycinandketoconazolemayinhibitthemetabolismofcorticosteroidsandthusdecrease

theirclearance.Therefore,ifadministeredwiththeabovedrugs,thedoseofmethylprednisoloneshouldbe

titratedtoavoidsteroidtoxicity.

Steroidsmayreducetheeffectsofanticholinesterasesinmyastheniagravis.Thedesiredeffectsof

hypoglycaemicagents(includinginsulin),anti-hypertensivesanddiureticsareantagonisedbycorticosteroids,

andthehypokalaemiceffectsofacetazolamide,loopdiuretics,thiazidediureticsandcarbenoxoloneare

enhanced.

Theefficacyofcoumarinanticoagulantsmaybeenhancedordiminishedbyconcurrentcorticosteroidtherapy

andclosemonitoringoftheINRorprothrombintimeisrequiredtoavoidspontaneousbleeding.

Therenalclearanceofsalicylatesisincreasedbycorticosteroidsandsteroidwithdrawalmayresultinsalicylate

intoxication.Salicylatesandnon-steroidalanti-inflammatoryagentsshouldbeusedcautiouslyinconjunction

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Steroidshavebeenreportedtointeractwithneuromuscularblockingagentssuchaspancuroniumwithpartial

reversaloftheneuromuscularblock.

4.6Fertility,pregnancyandlactation

Corticosteroidscrosstheplacenta.Theremaybeaverysmallriskofcleftpalateandintra-uterinegrowthretardationin

thefoetus;thereisevidenceofharmfuleffectsonpregnancyinanimals.Adequatehumanreproductivestudieshavenot

beendonewithcorticosteroidsorlidocaine,sotheuseofDepo-MedronewithLidocaineinpregnancyshouldbecarefully

weightedagainstthepotentialrisktothemotherandembryoorfoetus.Neonatesofmotherswhoreceivedsuchtherapy

duringpregnancyshouldbeobservedforsignsofhypo-adrenalismandappropriatemeasuresinstitutedifsuchsigns

exist.Whencorticosteroidsareessentialhowever,patientswithnormalpregnanciesmaybetreatedasthoughthey

wereinthenon-gravidstate.Patientswithpre-eclampsiaorfluidretentionrequireclosemonitoring.

Methylprednisoloneisexcretedinbreastmilkandinfantsofmotherstakingpharmacologicaldosesofsteroidsshould

bemonitoredcarefullyforsignsofadrenalsuppression.

Therearenoknowneffectsofcorticosteroidsonlabouranddelivery.Theuseoflocalanaestheticssuchaslidocaine

duringlabouranddeliverymaybeassociatedwithadverseeffectsonmotherandfoetus.Lidocainereadilycrossesthe

placenta.

Itisnotknownwhetherlidocaineisexcretedinhumanbreastmilk.

4.7Effectsonabilitytodriveandusemachines

Noneknown

4.8Undesirableeffects

Theincidenceofpredictableundesirableside-effectsassociatedwiththeuseofcorticosteroids,including

hypothalamic-pituitary-adrenalsuppressioncorrelateswiththerelativepotencyofthedrug,dosage,timingof

administrationanddurationoftreatment(seesection4.4Specialwarningsandprecautionsforuse).

Side-effectsfortheDepo-Medronecomponentmaybeobservedincluding:

PARENTERALCORTICOSTEROIDTHERAPY-Anaphylacticreactionorallergicreactions,hypopigmentationor

hyperpigmentation,subcutaneousandcutaneousatrophy,sterileabscess,postinjectionflare(followingintra-articular

use),Charcot-likearthropathy.

GASTRO-INTESTINAL-Dyspepsia,pepticulcerationwithperforationandhaemorrhage,gastrichaemorrhage,

pancreatitis,oesophagitis,abdominaldistension,oesophagealulceration,oesophagealcandidiasis,acutepancreatitis,

perforationofbowel.

Increasesinalaninetransaminase(ALT,SGPT)aspartatetransaminase(AST,SGOT)andalkalinephosphatasehave

beenobservedfollowingcorticosteroidtreatment.Thesechangesareusuallysmall,notassociatedwithanyclinical

syndromeandarereversibleupondiscontinuation.

ANTI-INFLAMMATORYANDIMMUNOSUPPRESSIVEEFFECTS-Increasedsusceptibilityandseverityof

infectionswithsuppressionofclinicalsymptomsandsigns,latentinfectionsbecomingactive,opportunisticinfections,

maysuppressreactionstoskintests,recurrenceofdormanttuberculosis(seeSpecialwarningsandprecautionsforuse).

MUSCULOSKELETAL–Steroidmyopathy,osteoporosis,vertebralandlongbonefractures,pathologicalfractures,

avascularosteonecrosis,tendonruptureparticularlyoftheAchilles,asepticnecrosis,andmuscleweakness.

FLUIDANDELECTROLYTEDISTURBANCE-Sodiumandwaterretention,potassiumloss,hypertension,

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DERMATOLOGICAL-Impairedhealing,petechiaeandecchymosis,thinfragileskin,skinatrophy,bruising,striae,

telangiectasia,acne.

ENDOCRINE/METABOLIC-Suppressionofthehypothalamo-pituitary-adrenalaxis,growthsuppressionininfancy,

childhoodandadolescence,menstrualirregularityandamenorrhoea.Cushingoidfacies,hirsutism,weightgain,

manifestationoflatentdiabetesmellitus,impairedcarbohydratetolerancewithincreasedrequirementforantidiabetic

therapy,negativenitrogenandcalciumbalance,glucosemetabolism,gluconeogenesis.Increasedappetite.

NEUROPSYCHIATRIC-Awiderangeofpsychiatricreactionsincludingaffectivedisorders(suchasirritable,

euphoric,depressedandlabilemoodpsychologicaldependenceandsuicidalthoughts),psychoticreactions(including

mania,delusions,hallucinationsandaggravationofschizophrenia),behaviouraldisturbances,irritability,anxiety,sleep

disturbances,seizuresandcognitivedysfunctionincludingconfusionandamnesiahavebeenreportedforall

corticosteroids.Reactionsarecommonandmayoccurinbothadultsandchildren.Inadults,thefrequencyofsevere

reactionswasestimatedtobe5-6%.Psychologicaleffectshavebeenreportedonwithdrawalofcorticosteroids;the

frequencyisunknown.Increasedintra-cranialpressurewithpapilloedemainchildren(pseudotumourcerebri)hasbeen

reported,usuallyaftertreatmentwithdrawalofmethylprednisolone.

OPHTHALMIC-Increasedintra-ocularpressure,glaucoma,papilloedema,cataractswithpossibledamagetotheoptic

nerve,cornealorscleralthinning,exacerbationofophthalmicviralorfungaldisease,exophthalmos.

GENERAL-Leucocytosis,hypersensitivityincludinganaphylaxis,thrombo-embolism,nausea,vertigo.

WITHDRAWALSYMPTOMS-Toorapidareductionofcorticosteroiddosagefollowingprolongedtreatmentcan

leadtoacuteadrenalinsufficiency,hypotensionanddeath.However,thisismoreapplicabletocorticosteroidswithan

indicationwherecontinuoustherapyisgiven(seeSpecialwarningsandprecautionsforuse).

A'withdrawalsyndrome'mayalsooccurincluding,fever,myalgia,arthralgia,rhinitis,conjunctivitis,painfulitchyskin

nodulesandlossofweight.

Side-effectsfortheLidocainecomponentinclude:

CENTRALNERVOUSSYSTEM-Lightheadedness,nervousness,apprehension,euphoria,confusion,dizziness,

drowsiness,tinnitus,blurredordoublevision,vomiting,sensationofheat,cold,numbness,twitching,tremors,

convulsions,lossofconsciousness,respiratorydepression,respiratoryarrest.

CARDIOVASCULARSYSTEM-Bradycardia,hypotension,cardiovascularcollapse,cardiacarrest.

ALLERGICREACTIONS-Cutaneouslesions,urticaria,oedema,anaphylacticreactions.

CERTAINSIDE-EFFECTSREPORTEDWITHSOMENONRECOMMENDEDROUTESOF

ADMINISTRATION:

Intrathecal:Usualsystemiccorticoidadversereactions,headache,meningismus,meningitis,paraplegia,spinalfluid

abnormalities,nausea,vomiting,sweating,arachnoiditis,convulsions.

Extradural:Wounddehiscence,lossofsphinctercontrol.

Intranasal:Permanent/temporaryblindness,allergicreactions,rhinitis.

Ophthalmic(Subconjunctival):Rednessanditching,abscess,sloughatinjectionsite,residueatinjectionsite,increased

intra-ocularpressure,decreasedvision-blindness,infection.

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4.9Overdose

Noknownantidote.ThereisnoclinicalsyndromeofacuteoverdosagewithDepo -MedronewithLidocaine.

Followingoverdosagethepossibilityofadrenalsuppressionshouldbeguardedagainstbygradualdiminutionofdose

levelsoveraperiodoftime.Furthertraumaticepisodesduringthatperiodmayrequirespecialsupportivetherapy.

Repeatedfrequentdoses(dailyorseveraltimesperweek)overaprotractedperiodmayresultinaCushingoidstate.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Methylprednisoloneacetateisasyntheticglucocorticoidwiththeactionsanduseofnaturalcorticosteroids.However,

theslowermetabolismofthesyntheticcorticosteroids,withtheirlowerproteinbondingaffinity,mayaccountfortheir

increasedpotencycomparedwiththenaturalcorticosteroids.

Lidocainehastheactionsofalocalanaesthetic.

5.2Pharmacokineticproperties

Administrationofmethylprednisoloneacetate40mgintramuscularlyproducedmeasurableplasmaconcentrationsof

methylprednisolonefor11-17days.Theaveragepeakplasmaconcentrationwas14.8nanogramspermlandoccurred

after6-8hours.

Plasmaconcentrationsoflidocainedeclinerapidlyafteranintravenousdosewithaninitialhalf-lifeoflessthan30

minutes;theeliminationhalf-lifeis1-2hours.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogol

Sodiumchloride

Miripiriumchloride

Benzylalcohol

Waterforinjections

Sodiumhydroxide

Hydrochloricacid

6.2Incompatibilities

Noneapplicable.

6.3Shelflife

Unopened:2years

Irish Medicines Board

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Date Printed 27/10/2011 CRN 2106783 page number: 9

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Donotfreeze.Keepthevialsintheoutercarton.

6.5Natureandcontentsofcontainer

TypeIflintglassvialswithabutylrubbercap.Eachvialcontains1mlofsuspension.

Vialsarepackedinaboxof10vials.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Depo-MedronewithLidocaineshouldnotbemixedwithanyotherfluid.

Discardanyremainingsuspensionafteruse.

7MARKETINGAUTHORISATIONHOLDER

PharmaciaIreland

9Riverwalk

NationalDigitalPark

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA0936/077/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:05July1983

Dateoflastrenewal:28January2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 27/10/2011 CRN 2106783 page number: 10