DEPIXOL 200 MG/ ML SOLUTION FOR INJECTION

Main information

  • Trade name:
  • DEPIXOL 200 MG/ ML SOLUTION FOR INJECTION
  • Dosage:
  • 200 Mg/ Ml
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DEPIXOL 200 MG/ML SOLUTION FOR INJECTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0115/001/010
  • Authorization date:
  • 28-02-1992
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Depixol200mg/mlSolutionforInjection

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each1mlampoulecontains200mg(20%w/v)cis(Z)-flupentixoldecanoate.

Forafulllistofexcipientsseesection6.1.

3PHARMACEUTICALFORM

Solutionforinjection(injection).

Clearyellowishoil,practicallyfreefromparticles.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Themanagementofschizophreniaorparanoidpsychoses.

4.2Posologyandmethodofadministration

Routeofadministration

Deepintramuscularinjectionintotheupperouterbuttockorlateralthigh.Dosageanddosageintervalshouldbe

adjustedaccordingtothepatients'symptomsandresponsetotreatment.

Note:Aswithalloilbasedinjectionsitisimportanttoensure,byaspirationbeforeinjection,thatinadvertent

intravascularentrydoesnotoccur.

Adults

Thedosageshouldbeadjustedaccordingtotheseverityofthepatients'symptoms.ThedosagerangeofDepixol200

mg/mlliesbetween50mg(0.25ml)every4weeksand300mg(1.5ml)every2weeksbutsomepatientsmayrequireup

to400mg(2ml)weekly.

AdequatecontrolofseverepsychoticsymptomsbyDepixol200mg/mlInjectionisusuallyachievedwithin4to6

monthsandthismayjustifyareturntolowerdosemaintenancetreatmentwithDepixolConc.(100mg/ml)orstandard

Depixol(20mg/ml)injection.

Elderlypatients

Elderlypatientsshouldreceivedosagesinthelowerendofthedosagerange.

Reducedrenalfunction

Flupentixoldecanoatecanbegiveninusualdosestopatientswithreducedrenalfunction.

Reducedhepaticfunction

Dosereduction(relativetothedegreeofhepaticimpairment)shouldbeconsidered.Ifpossible,whereassayfacilities

existdosageshouldbeadjustedaccordingtoserumlevels.

Children

Flupentixoldecanoateisnotindicatedforchildren.

Methodofadministration

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4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipients(seesection6.1)

Circulatorycollapse,

Depressedlevelofconsciousnessduetoanycause(e.g.intoxicationwithalcohol,barbituratesoropiates)

Coma.

Useinsenileconfusionalstates

Useinchildren

4.4Specialwarningsandprecautionsforuse

Extrapyramidalreactionsintheformofacutedystonias(includingoculogyriccrisis),parkinsonianrigidity,tremor,

akinesiaandakathisiahavebeenreportedandmayoccurevenatlowerdosageinsusceptiblepatients.Sucheffects

wouldusuallybeencounteredearlyintreatment,butdelayedreactionsmayalsooccur.Antiparkinsonagentsshould

notbeprescribedroutinelybecauseofthepossibleriskofprecipitatingtoxic-confusionalstates,impairingefficacyor

causinganticholinergicside-effects.Theyshouldonlybegivenifrequiredandtheirrequirementreassessedatregular

intervals.

Tardivedyskinesiacanoccurwithneuroleptictreatment.Itismorecommonathighdosesforprolongedperiodsbut

hasbeenreportedatlowerdosageforshortperiods.Theriskseemstobegreaterintheelderly,especiallyfemales.It

hasbeenreportedthatfinevermicularmovementsofthetongueareanearlysign.Ithasbeenobservedoccasionallyin

patientsreceivingflupentixol.Theconcurrentuseofanticholinergicantiparkinsondrugsmayexacerbatethiseffect.

Thepotentialirreversibilityandseriousness,aswellastheunpredictabilityofthesyndrome,requiresespeciallycareful

assessmentoftheriskversusbenefit,andthelowestpossibledosageanddurationoftreatmentconsistentwith

therapeuticefficacy.Short-liveddyskinesiamayoccurafterabruptwithdrawalofthedrug.

Thehormonaleffectsofantipsychoticneurolepticdrugsincludehyperprolactinaemia,whichmaybeassociatedwith

galactorrhoea,gynaecomastia,oligomenorrhoeaoramenorrhoea.Sexualfunction,includingerectionandejaculation

maybeimpaired;butincreasedlibidohasalsobeenreported.

Thepossibilityofdevelopmentofneurolepticmalignantsyndromeexistswithanyneuroleptic.Theriskispossibly

greaterwiththemorepotentagents.Patientswithpre-existingorganicbrainsyndrome,mentalretardationandopiate

andalcoholabuseareover-representedamongfatalcases.RarecasesreportedasNMShavealsobeenreceivedin

associationwithflupentixol.ClinicalmanifestationsofNMSarehyperpyrexia,musclerigidity,alteredmentalstatus,

andevidenceofautonomicinstability(irregularpulseorbloodpressure,tachycardia,sweatingandcardiacarrhythmia).

Additionalsignsmayincludeelevatedcreatinine,phosphokinase,myoglubinuria( rhabdomyolysis ),andacuterenal

failure.IfapatientdevelopssignsandsymptomsindicativeofNMSorpresentswithunexplainedhighfeverwithout

additionalclinicalmanifestationsofNMS,allneurolepticmedication,includingflupentixolmustbediscontinued.

Symptomsmaypersistformorethanaweekafteroralneurolepticsarediscontinuedandsomewhatlongerwhen

associatedwiththedepotformsofthedrugs.

Likeotherneurolepticsflupentixoldecanoateshouldbeusedwithcautioninpatientswithorganicbrainsyndrome,

convulsionandadvancedhepaticdisease.

Inthelowerdosagerangeflupentixoldecanoateisnotrecommendedforexcitableoroveractivepatientssinceits

activatingeffectmayleadtoexaggerationofthesecharacteristics.

Flupentixolshouldalsobeusedwithcautioninpatientswithepilepsy(andconditionspredisposingtoepilepsye.g.alcohol

withdrawalorbraindamage),severerespiratorydiseaseandParkinson’sdisease.

Asdescribedforotherpsychotropicsflupentixoldecanoatemaymodifyinsulinandglucoseresponsescallingfor

adjustmentoftheantidiabetictherapyindiabeticpatients.

Thegeneralcautionforuseofneurolepticsinhypothyroidism,thyrotoxicosis,myastheniagravisorprostatic

hypertrophyshouldbeobserved,butthereisnoevidencetosuggestthatflupentixolgivesrisetoanyparticularproblem

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Patientsonlong-termtherapy,particularlyonhighdoses,shouldbemonitoredcarefullyandevaluatedperiodicallyto

decidewhetherthemaintenancedosagecanbelowered.

Aswithotherdrugsbelongingtothetherapeuticclassofantipsychotics,flupentixoldecanoatemaycauseQT

prolongation.PersistentlyprolongedQTintervalsmayincreasetheriskofmalignantarrhythmias.Therefore,

flupentixoldecanoateshouldbeusedwithcautioninsusceptibleindividuals(withhypokalemia,hypomagnesiaor

familyhistoryofQTprolongation)andinpatientswithahistoryofcardiovasculardisorders,e.g.QTprolongation,

significantbradycardia(<50beatsperminute),arecentacutemyocardialinfarction,uncompensatedheartfailure,or

cardiacarrhythmia.Concomitanttreatmentwithotherantipsychoticsshouldbeavoided(seesection4.5).

Casesofvenousthromboembolism(VTE)havebeenreportedwithantipsychoticdrugs.Sincepatientstreatedwith

antipsychoticsoftenpresentwithacquiredriskfactorsforVTE,allpossibleriskfactorsforVTEshouldbeidentified

beforeandduringtreatmentwithflupentixoldecanoateandpreventivemeasuresundertaken

Elderly

Careshouldalsobetakenintheelderly,particularlyiffrailoratriskofhypothermia,sedation,hypotensionor

confusion.

Cerebrovascular

Anapproximately3-foldincreasedriskofcerebrovascularadverseeventshavebeenseeninrandomisedplacebo

controlledclinicaltrialsinthedementiapopulationwithsomeatypicalantipsychotics.Themechanismforthis

increasedriskisnotknown.Anincreasedriskcannotbeexcludedforotherantipsychoticsorotherpatientpopulations.

Flupentixoldecanoateshouldbeusedwithcautioninpatientswithriskfactorsforstroke.

IncreasedMortalityinElderlypeoplewithDementia

Datafromtwolargeobservationalstudiesshowedthatelderlypeoplewithdementiawhoaretreatedwith

antipsychoticsareatasmallincreasedriskofdeathcomparedwiththosewhoarenottreated.Thereareinsufficient

datatogiveafirmestimateoftheprecisemagnitudeoftheriskandthecauseoftheincreasedriskisnotknown.

Depixolisnotlicensedforthetreatmentofdementia-relatedbehaviouraldisturbances.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Combinationsrequiringprecautionsforuse

Flupentixoldecanoatemayenhancethesedativeeffectofalcohol,theeffectsofbarbituratesandotherCNSdepressants

andmaypotentiatetheeffectsofgeneralanaesthetics.

Flupentixoldecanoatemayreducetheeffectoflevodopaandtheeffectofadrenergicdrugs.

Concomitantuseofmetoclopramideandpiperazineincreasestheriskofextrapyramidaldisorder.

Neurolepticsmayincreaseorreducetheeffectofantihypertensivedrugs;theantihypertensiveeffectofguanethidine

andsimilaractingcompoundsisreduced.

Concomitantuseofneurolepticsandlithiumincreasestheriskofneurotoxicity.

Tricyclicantidepressantsandneurolepticsmutuallyinhibitthemetabolismofeachother.

Neurolepticsmayenhancethecardiacdepressanteffectsofquinidine;theabsorptionofcorticosteroidsanddigoxin;the

hypotensiveeffectofvasodilatorantihypertensiveagentssuchashydralazineandprolongtheactionofneuromuscular

blockingagents.

Asforotheratypicalantipsychotics,cautionisadvisedinpatientstakingflupentixolinconcomitantusewithoral

anticoagulants(e.g.warfarin),andothermedicinalproductsknowntoaffectplateletfunction(e.g.phenothiazines,most

tricyclicantidepressants,acetylsalicyclicacid,andnon-steroidalanti-inflammatorymedicinalproducts(NSAIDs),

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IncreasesintheQTintervalrelatedtoantipsychotictreatmentmaybeexacerbatedbytheco -administrationofother

drugsknowntosignificantlyincreasetheQTinterval.Co-administrationofsuchdrugsshouldbeavoided.Relevant

classesinclude:

classIaandIIIantiarrhythmics(e.g.quinidine,amiodarone,sotalol,dofetilide)

someantipsychotics(e.g.thioridazine)

somemacrolides(e.g.erythromycin)

someantihistamines(e.g.terfenadine,astemizole)

somequinoloneantibiotics(e.g.gatifloxacin,moxifloxacin)

TheabovelistisnotexhaustiveandotherindividualdrugsknowntosignificantlyincreaseQTinterval(e.g.cisapride,

lithium)shouldbeavoided.

Drugsknowntocauseelectrolytedisturbancessuchasthiazidediuretics(hypokalemia)anddrugsknowntoincrease

theplasmaconcentrationofflupentixoldecanoateshouldalsobeusedwithcautionastheymayincreasetheriskofQT

prolongationandmalignantarrythmias(seesection4.4).

4.6Fertility,pregnancyandlactation

Pregnancy

Patientsshouldbeadvisedtonotifytheirphysicianiftheybecomepregnantorintendtobecomepregnantduring

treatmentwithflupentixol.

Duetoinsufficientsafetyinformationinhumans,thismedicinalproductshouldnotbeusedinpregnancyunlessthe

expectedbenefitclearlyjustifiesthepotentialrisktothefoetus.

Thenewbornofmotherstreatedwithneurolepticsinlatepregnancy,orlabour,mayshowsignsofintoxicationsuchas

lethargy,tremorandhyperexcitability,andhavealowapgarscore.

Animalreproductionstudiesonflupentixolhavenotgivenevidenceofanincreasedincidenceoffoetaldamageorother

deleteriouseffectsonthereproductionprocess.

Neonatesexposedtoantipsychotics(includingflupentixoldecanoate)duringthethirdtrimesterofpregnancyareatrisk

ofadversereactionsincludingextrapyramidaland/orwithdrawalsymptomsthatmayvaryinseverityandduration

followingdelivery.Therehavebeenreportsofagitation,hypertonia,hypotonia,tremor,somnolence,respiratory

distress,orfeedingdisorder.Consequently,newbornsshouldbemonitoredcarefully.

Lactation

Asflupentixolisfoundinbreastmilkinlowconcentrations,breast-feedingshouldnotbecontinuedduringflupentixol

decanoatetherapyunlessintheopinionofthephysiciantheexpectedbenefittothepatientoutweighsthepotentialrisk

totheinfant.

4.7Effectsonabilitytodriveandusemachines

Flupentixoldecanoateisanon-sedatingdruginthelow-moderatedosagerange(upto100mg/2ndweek).

However,patientswhoareprescribedpsychotropicmedicationmaybeexpectedtohavesomeimpairmentingeneral

attentionandconcentrationandshouldbecautionedabouttheirabilitytodriveoroperatemachinery.

4.8Undesirableeffects

Undesirableeffectsareforthemajoritydosedependent.Thefrequencyandseverityaremostpronouncedintheearly

phaseoftreatmentanddeclineduringcontinuedtreatment.

Extrapyramidalreactionsmayoccur,especiallyduringthefirstfewdaysafterinjectionandintheearlyphaseof

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antiparkinsoniandrugs.Theroutineprophylacticuseofantiparkinsoniandrugsisnotrecommended.Antiparkinsonian

drugsdonotalleviatetardivedyskinesiaandmayaggravatethem.Reductionindosageor,ifpossible,discontinuation

offlupentixoltherapyisrecommended.Inpersistentakathisia,abenzodiazepineorpropranololmaybeuseful.

Frequenciesaretakenfromtheliteratureandspontaneousreporting.Frequenciesaredefinedas:

verycommon(1/10),common(1/100to<1/10),uncommon(1/1,000to<1/100),rare(1/10,000to<1/1,000),very

rare(<1/10,000),ornotknown(cannotbeestimatedfromtheavailabledata).

Cardiacdisorders Common Tachycardia,palpitations.

Rare ElectrocardiogramQTprolonged.

Bloodandlymphatic

systemdisorders Rare Thrombocytopenia,neutropenia,

leukopenia,agranulocytosis

Nervoussystem

disorders Very

common Somnolence,akathisia,hyperkinesia,

hypokinesia.

Common Tremor,dystonia,dizziness,headache.

Uncommon

toRare Tardivedyskinesia,dyskinesia,

parkinsonism,speechdisorder,convulsion.

Veryrare Neurolepticmalignantsyndrome.

Eyedisorders Common Accommodationdisorder,visionabnormal.

Uncommon Oculogyration.

Respiratory,thoracic

andmediastinal

disorders Common Dyspnoea.

Gastrointestinal

disorders Very

common Drymouth.

Common Salivaryhypersecretion,constipation,

vomiting,dyspepsia,diarrhoea.

Uncommon Abdominalpain,nausea,flatulence.

Renalandurinary

disorders Common Micturitiondisorder,urinaryretention.

Pregnancy,

puerperiumand

perinatalconditions NotKnown Drugwithdrawalsyndrome

neonatal(see4.6).

Skinandsubcutaneous

tissuedisorders Common Hyperhidrosis,pruritus.

Uncommon Rash,photosensitivityreaction,dermatitis.

Musculoskeletaland

connectivetissue

disorder Common Myalgia.

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Localizederythema,pruritusandinjectionsitenodulearethemosttypicalinjectionsitereactions.

Aswithotherdrugsbelongingtothetherapeuticclassofantipsychotics,rarecasesofQTprolongation,ventricular

arrythmias-ventricularfibrillation,ventriculartachycardia,TorsadedePointesandsuddenunexplaineddeathhave

beenreportedforflupentixoldecanoate(seesection4.4).

Abruptdiscontinuationofflupentixoldecanoatemaybeaccompaniedbywithdrawalsymptoms.Themostcommon

symptomsarenausea,vomiting,anorexia,diarrhoea,rhinorrhoea,sweating,myalgias,paraesthesias,insomnia,

restlessness,anxiety,andagitation.Patientsmayalsoexperiencevertigo,alternatefeelingsofwarmthandcoldness,

andtremor.Symptomsgenerallybeginwithin1to4daysofwithdrawalandabatewithin7to14days.

4.9Overdose

Duetotheadministrationformoverdosesymptomsareunlikelytooccur.

Symptoms

Somnolence,coma,movementdisorders,convulsions,shock,hyperthermiaorhypothermia.

ECGchanges,QTprolongation,TorsadedePointes,cardiacarrestandventriculararrhythmiashavebeenreported

Endocrinedisorders Rare Hyperprolactinaemia.

Metabolismand

nutritiondisorders Common Increasedappetite,weightincreased.

Uncommon Decreasedappetite.

Rare Hyperglycaemia,glucosetolerance

abnormal.

Vasculardisorders Uncommon Hypotension,hotflush.

Veryrare Venousthromboembolism

Generaldisordersand

administrationsite

conditions Common Asthenia,fatigue.

Uncommon Injectionsitereaction.

Immunesystem

disorders Rare Hypersensitivity,anaphylacticreaction.

Hepatobiliarydisorders Uncommon Liverfunctiontestabnormal.

Veryrare Jaundice.

Reproductivesystem

andbreastdisorders Uncommon Ejaculationfailure,erectiledysfunction.

Rare Gynaecomastia,galactorrhoea,

amenorrhoea.

Psychiatricdisorders Common Insomnia,depression,nervousness,

agitation,libidodecreased.

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Treatment

Treatmentissymptomaticandsupportive.Measurestosupporttherespiratoryandcardiovascularsystemsshouldbe

instituted.Adrenalineshouldnotbeusedasfurtherloweringofbloodpressuremayresult.Convulsionsmaybetreated

withdiazepamandextrapyramidalsymptomswithbiperiden.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup

Neuroleptics(antipsychotics)

ATCcode:N05AF01

Mechanismofaction

Cis(Z)-flupentixolisaneurolepticofthethioxanthenegroup.

Theantipsychoticeffectofneurolepticsisrelatedtotheirdopaminereceptorblockingeffect.Itisalsopossiblethat5 -HT

(5-hydroxytryptamine)receptorblockadecontributes.

Cis(Z)-flupentixolhashighaffinityforbothdopamineD

andD

receptorsandfor

-adrenoceptorsand5-HT

receptors.

Cis(Z)-flupentixolhasnoaffinityforcholinergicmuscarinereceptors,onlyslightantihistaminergicpropertiesandno

adrenoceptorblockingactivity.

Cis(Z)-flupentixolhasproventobeapotentneurolepticinallthebehaviouralstudiesforneuroleptic(dopaminereceptor

blocking)activity.Correlationisfoundintheinvivotestmodels,theaffinityfordopamineD

bindingsitesinvitroandthe

average,dailyoralantipsychoticdoses.

Clinicalefficacy

Inclinicaluseflupentixoldecanoateisintendedforthemaintenancetreatmentofchronicpsychoticpatients.The

antipsychoticeffectincreaseswithincreasingdosages.Inlowtomoderatedosages(upto100mg/2weeks)flupentixol

decanoateisnon-sedatingwhilesomeunspecificsedationmaybeexpectedwhenhigherdosesareadministered.

Flupentixoldecanoateisparticularlyusefulinthetreatmentofapathetic,withdrawn,depressedandpoorlymotivated

patients.

Flupentixoldecanoatepermitscontinuoustreatmentespeciallyofthosepatientswhoareunreliableintakingtheoral

medicationprescribedforthem.Flupentixoldecanoatethuspreventsthefrequentrelapsesduetononcompliancein

patientsonoralmedication.

5.2Pharmacokineticproperties

Absorption

Byesterificationofcis(Z)-flupentixolwithdecanoicacidcis(Z)-flupentixolhasbeenconvertedtoahighlylipophilic

substance,cis(Z)-flupentixoldecanoate.Whendissolvedinoilandinjectedintramuscularlytheesterdiffusesrather

slowlyfromtheoiltothebodywaterphasewhereitisrapidlyhydrolysedreleasingtheactivecis(Z)-flupentixol.

Followingintramuscularinjectionmaximumserumconcentrationisgenerallyreachedoveraperiodof3-7days.With

anestimatedhalf-lifeof3weeks(reflectingthereleasefromthedepot)steadystateconditionswillbeattainedafter

about3months'repeatedadministration.

Distribution

Theapparentvolumeofdistribution(V

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Biotransformation

Themetabolismofcis(Z)-flupentixolproceedsalongthreemainroutes–sulphoxidation,sidechainN-dealkylationand

glucuronicacidconjugation.Themetabolitesaredevoidofpsychopharmacologicalactivity.Cis(Z)-flupentixol

dominatesovermetabolitesinbrainandothertissues.

Elimination

Theeliminationhalf-life(T

)ofcis(Z)-flupentixolisabout35hoursandthemeansystemicclearance(Cl

)isabout0.29

l/min.

Cis(Z)-flupentixolisexcretedmainlywithfaeces,butalsotosomedegreewiththeurine.Whentritiumlabelled

flupentixolwasadministeredtomantheexcretionpatternshowstheexcretionviafaecestobeabout4timestheurinary

excretion.

Innursingmotherscis(Z)-flupentixolisexcretedinsmallamountswiththebreastmilk.Theratiomilkconc./serum

conc.inwomenisonanaverage1.3.

Linearity

Thekineticsislinear.Themeansteadystatepre-injectionserumlevelofcis(Z)-flupentixolcorrespondingtoa40mg

doseofcis(Z)-flupentixoldecanoateeverytwoweeksisabout6nmol/l.

Elderlypatients

Pharmacokineticinvestigationshavenotbeendoneinelderlypatients.However,fortherelatedthioxanthenedrug,

zuclopenthixol,thepharmacokineticparametersarewidelyindependentoftheageofthepatients.

Reducedrenalfunction

Basedontheabovecharacteristicsforeliminationitisreasonabletoassumethatreducedkidneyfunctionislikelynot

tohavemuchinfluenceontheserumlevelsofparentdrug.

Reducedhepaticfunction

Nodataavailable.

Pharmacokinetic/Pharmacodynamicrelationship

Apre-injectionserum(plasma)concentrationof1-3ng/ml(2-8nmol/l)andamax./min.fluctuation<2.5issuggested

asaguidelineformaintenancetreatmentofschizophrenicpatientswithalow-moderatedegreeofillness.

Pharmacokineticallyadoseof40mg/2weeksofcis(Z)-flupentixoldecanoateisequivalenttoadailyoraldoseof10

mgflupentixol.

5.3Preclinicalsafetydata

Acutetoxicity

Flupentixolhaslowacutetoxicity.

Chronictoxicity

Inchronictoxicitystudiestherewerenofindingsofconcernforthetherapeuticuseofflupentixol.

Reproductiontoxicity

Flupentixolwastestedfordevelopmentaltoxicityinmice,rats,andrabbitsbytheoralrouteandcis-z-flupentixol

decanoatewastestedaftersubcutaneous(mice/rats)orintramuscularadministration(rabbits).Undertheconditionsof

thesestudiesflupentixolandcis-z-flupentixoldidnotinducemalformationsoraffectembryo-foetalviability.

Carcinogenicity

Flupentixolhasnocarcinogenicpotential.

Localtoxicity

Thelocaltolerabilityisgood.Localmuscledamageisseenafterinjectionofaqueoussolutionsofneuroleptics.After

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Cis(Z)-flupentixolhasproventobeapotentneurolepticinallthebehaviouralstudiesforneuroleptic(dopaminereceptor

blocking)activity.Correlationisfoundintheinvivotestmodels,theaffinityfordopamineD2bindingsitesinvitroand

theaverage,dailyoralantipsychoticdose.

Likemostotherneuroleptics,flupentixolincreasestheserumprolactinlevel.

Pharmacologicalstudieshaveclearlydemonstratedthatcis(Z)-flupentixoldecanoateinoilhasaprolongedneuroleptic

effectandthattheamountofdrugnecessarytomaintainacertaineffectoveralongperiodisconsiderablysmallerwith

thedepotpreparationthanwithdailyoraladministrationofflupentixol.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Triglycerides,mediumchain.

6.2Incompatibilities

Intheabsenceofcompatabilitystudies,thismedicinalproductmustnotbemixedwithothermedicinalproductsapartfrom

otherproductsintheDepixolrange.

6.3Shelflife

Unopened:2years.

Onceopen,useimmediatelyanddiscardanyunusedsolution.

6.4Specialprecautionsforstorage

Storebelow25 °

Keeptheampoulesintheoutercartoninordertoprotectfromlight.

6.5Natureandcontentsofcontainer

Colourlessglass(typeIampoulesof1ml).Packsize:5ampoulesperbox.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

LundbeckLtd.

LundbeckHouse

CaldecotteLakeBusinessPark

Caldecotte

MiltonKeynesMK78LG

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorization 28February1992

Dateoflastrenewal 21June2006

10DATEOFREVISIONOFTHETEXT

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