Vetoryl 10mg

Main information

  • Trade name:
  • VETORYL 10 MG GELULES
  • Pharmaceutical form:
  • Capsule, hard
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VETORYL 10 MG GELULES
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • trilostane
  • Therapeutic area:
  • Dogs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0215/004
  • Authorization date:
  • 03-02-2012
  • EU code:
  • UK/V/0215/004
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:January2013

AN:01395/2011

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFVETERINARYMEDICINALPRODUCT

VETORYL10mghardcapsulesfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1capsulecontains:

Activesubstance:Trilostane10mg

Excipients:

Titaniumdioxide(E171) 0.942mg

Ferricoxide(yellow)(E172) 0.035mg

Ferricoxide(black)(E172)0.532mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Hardcapsule.

Ivorybodyandblackcapwiththecapsulestrengthprintedonthebodyofthe

capsule.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Indogs:Forthetreatmentofpituitary-dependentandadrenal-dependent

hyperadrenocorticism(Cushing’sdiseaseandsyndrome).

4.3 Contraindications

Donotuseinanimalssufferingfromprimaryhepaticdiseaseand/orrenal

insufficiency.

Donotuseindogsweighinglessthan3kg.

4.4 Specialwarningsforeachtargetspecies

Anaccuratediagnosisofhyperadrenocorticismisessential.

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Wherethereisnoapparentresponsetotreatment,thediagnosisshouldbere-

evaluated.Doseincreasesmaybenecessary.

Veterinariansshouldbeawarethatdogswithhyperadrenocorticismareat

increasedriskofpancreatitis.Thisriskmaynotdiminishfollowingtreatmentwith

trilostane.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Asthemajorityofcasesofhyperadrenocorticismarediagnosedindogs

betweentheagesof10 –15years,otherpathologicalprocessesarefrequently

present.Itisparticularlyimportanttoscreencasesforprimaryhepaticdisease

andrenalinsufficiencyastheproductiscontraindicatedinthesecases.

Subsequentclosemonitoringduringtreatmentshouldbecarriedout.Particular

attentionshouldbepaidtoliverenzymes,electrolytes,ureaandcreatinine.

Thepresenceofdiabetesmellitusandhyperadrenocorticismtogetherrequires

specificmonitoring.

Ifadoghaspreviouslybeentreatedwithmitotane,itsadrenalfunctionwillhave

beenreduced.Experienceinthefieldsuggeststhatanintervalofatleastamonth

shouldelapsebetweencessationofmitotaneandtheintroductionoftrilostane.

Closemonitoringofadrenalfunctionisadvised,asdogsmaybemore

susceptibletotheeffectsoftrilostane.

Theproductshouldbeusedwithextremecautionindogswithpre-existing

anaemiaasfurtherreductionsinpacked-cellvolumeandhaemoglobinmay

occur.Regularmonitoringshouldbeundertaken.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Trilostanemaydecreasetestosteronesynthesisandhasanti-progesterone

properties.Womenwhoarepregnantorareintendingtobecomepregnant

shouldavoidhandlingthecapsules.

Washhandswithsoapandwaterfollowingaccidentalexposureandafteruse.

Thecontentofthecapsulesmaycauseskinandeyeirritationandsensitisation.

Donotdivideoropencapsules:intheeventofaccidentalbreakageofthe

capsulesandcontactofthegranuleswitheyesorskin,washimmediatelywith

plentyofwater.Ifirritationpersists,seekmedicaladvice.

Peoplewithknownhypersensitivitytotrilostaneoranyoftheexcipientsshould

avoidcontactwiththeproduct.

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Intheeventofaccidentalingestion,seekmedicaladviceimmediatelyandshow

thepackageleafletorcartontothephysician.

4.6 Adversereactions(frequencyandseriousness)

Corticosteroidwithdrawalsyndromeorhypocortisolaemiashouldbe

distinguishedfromhypoadrenocorticismbyevaluationofserumelectrolytes.

Signsassociatedwithiatrogenichypoadrenocorticism,includingweakness,

lethargy,anorexia,vomitinganddiarrhoeamayoccur,particularlyifmonitoringis

notadequate(see4.9).Signsaregenerallyreversiblewithinavariableperiod

followingwithdrawaloftreatment.AcuteAddisoniancrisis(collapse)mayalso

occur(see4.10).Lethargy,vomiting,diarrhoeaandanorexiahavebeenseenin

dogstreatedwithtrilostaneintheabsenceofevidenceofhypoadrenocorticism.

Therehavebeenoccasionalisolatedreportsofadrenalnecrosisintreateddogs

whichmayresultinhypoadrenocorticism.

Subclinicalrenaldysfunctionmaybeunmaskedbytreatmentwiththeproduct.

Treatmentmayunmaskarthritisduetoareductioninendogenouscorticosteroid

levels.

Asmallnumberofreportshavebeenreceivedofsuddendeathduringtreatment.

Othermild,rare,adverseeffectsincludeataxia,hypersalivation,bloating,muscle

tremorsandskinchanges.

4.7 Useduringpregnancy,lactationorlay

Donotuseinpregnantorlactatingbitchesorinanyanimalsintendedfor

breeding.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Thepossibilityofinteractionswithothermedicinalproductshasnotbeen

specificallystudied.Giventhathyperadrenocorticismtendstooccurinolder

dogs,manywillbereceivingconcurrentmedication.Inclinicalstudies,no

interactionswereobserved.

Theriskofhyperkalaemiadevelopingshouldbeconsiderediftrilostaneisused

inconjunctionwithpotassium-sparingdiureticsorACEinhibitors.Theconcurrent

useofsuchdrugsshouldbesubjecttoarisk-benefitanalysisbytheveterinary

surgeon,astherehavebeenafewreportsofdeaths(includingsuddendeath)in

dogswhentreatedconcurrentlywithtrilostaneandanACEinhibitor.

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4.9 Amountstobeadministeredandadministrationroute

Administerorally,oncedaily,withfood.Inclinicalstudies,anaveragestarting

doseof6mg/kgoncedailywaseffective.Thedoseshouldthenbetitrated

accordingtoindividualresponseasdeterminedbymonitoring(seebelow).

Practicalstartingdosesarerecommendedasfollows:

Bodyweight StartingDose Dosage

>3kgand<10kg 30mg 3 –10mg/kg

>10kgand<20kg 60mg 3 –6mg/kg

>20kgand<40kg 120mg 3 –6mg/kg

>40kg 120 –240mg 3 –6mg/kg

Inclinicalstudies,mostdogswereeventuallystabilisedondosesbetween2 –10

mg/kg/day.Shouldsymptomsnotbeadequatelycontrolledforanentire24hour

inter-doseperiod,considerationshouldbegiventoincreasingthedailydoseby

assmallanincrementaspossibleanddividingitbetweenmorningandevening

doses.Donotdivideoropencapsules.

Asmallnumberofanimalsmayrequiredosessignificantlyinexcessof10mg

perkgbodyweightperday.Inthesesituationsappropriateadditionalmonitoring

shouldbeimplemented.

The10mgcapsuleshouldbeusedindogsthatrequireparticularlysmalldoses

oftrilostane,andtoassistwithdosageadjustments.

Monitoring

Samplesshouldbetakenforbiochemistry(includingelectrolytes)andanACTH

stimulationtestpre-treatmentandthenat10days,4weeks,12weeks,and

thereafterevery3months,followinginitialdiagnosisandaftereachdose

adjustment.ItisimperativethatACTHstimulationtestsareperformed4 –6

hourspost-dosingtoenableaccurateinterpretationofresults.Dosinginthe

morningispreferableasthiswillallowyourveterinarysurgeontoperform

monitoringtests4-6hoursfollowingadministrationofthedose. Regular

assessmentoftheclinicalprogressofthediseaseshouldalsobemadeateach

oftheabovetimepoints.

Intheeventofanon-stimulatoryACTHstimulationtestduringmonitoring,

treatmentshouldbestoppedfor7daysandthenre-startedatalowerdose.

RepeattheACTHstimulationtestafterafurther14days.Iftheresultisstillnon-

stimulatory,stoptreatmentuntilclinicalsignsofhyperadrenocorticismrecur.

RepeattheACTHstimulationtestonemonthafterre-startingtreatment.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosemayleadtosignsofhypoadrenocorticism(lethargy,anorexia,

vomiting,diarrhoea,cardiovascularsigns,collapse).Therewerenomortalities

followingchronicadministrationat3xthemaximumrecommendeddoseto

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healthydogs,howevermortalitiesmaybeexpectedifhigherdosesare

administeredtodogswithhyperadrenocorticism.

Thereisnospecificantidotefortrilostane.Treatmentshouldbewithdrawnand

supportivetherapy,includingcorticosteroids,correctionofelectrolyteimbalances

andfluidtherapymaybeindicateddependingontheclinicalsigns.

Incasesofacuteoverdosage,inductionofemesisfollowedbyadministrationof

activatedcharcoalmaybebeneficial.

Anyiatrogenicadrenocorticalinsufficiencyisusuallyquicklyreversedfollowing

cessationoftreatment.Howeverinasmallpercentageofdogs,effectsmaybe

prolonged.Followingaoneweekwithdrawaloftrilostanetreatment,treatment

shouldbereinstatedatareduceddoserate.

4.11Withdrawalperiods

Notapplicable.

5. PHARMACOLOGICALPARTICULARS

Trilostanebelongstotheadreno-corticalsuppressantgroupofdrugs,whichact

byinhibitingthesynthesisofcortisol(Anticorticosteroids).

ATCVetCode:QH02CA01.

5.1 Pharmacodynamicproperties

Trilostaneselectivelyandreversiblyinhibitstheenzymesystem3beta

hydroxysteroidisomerase,thusblockingtheproductionofcortisol,corticosterone

andaldosterone.Whenusedtotreathyperadrenocorticism,itreducesthe

productionofglucocorticoidandmineralocorticoidsteroidsintheadrenalcortex.

Circulatingconcentrationsofthesesteroidsarethusreduced.Trilostanealso

antagonisestheactivityofexogenousadrenocorticotrophichormone(ACTH).It

hasnodirecteffectoneitherthecentralnervousorcardiovascularsystems.

5.2 Pharmacokineticproperties

Pharmacokineticdataindogshavedemonstratedlargeinter-individual

variability.Inapharmacokineticstudyinlaboratorybeagles,AUCrangedfrom52

to281micrograms/ml/mininfeddogs,andfrom16to175micrograms/ml/minin

fasteddogs.Generallytrilostaneisrapidlyremovedfromtheplasmawith

concentrationsintheplasmareachingamaximumbetween0.5to2.5hoursand

returningalmosttobaselinebysixtotwelvehoursafteradministration.The

primaryactivemetaboliteoftrilostane,ketotrilostanefollowsasimilarpattern.

Furthermore,therewasnoevidencethattrilostaneoritsmetabolites

accumulatedwithtime.Anoralbioavailabilitystudyindogsdemonstratedthat

trilostanewasabsorbedmoreextensivelywhenadministeredwithfood.

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Trilostanehasbeendemonstratedtobeexcretedprimarilyinthefaecesofthe

rat,indicatingbiliaryexcretionasthemajormetabolicpathway.Inthemonkey,

trilostaneisexcretedinequalamountsinthefaecesandurine.Resultshave

shownthattrilostaneisrapidlyandwellabsorbedfromthegastrointestinaltractin

boththeratandmonkeyandthatitaccumulatesintheadrenalglandsoftherat.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Maizestarch

Lactosemonohydrate

Magnesiumstearate

Capsuleshell:

Gelatin

Titaniumdioxide(E171)

Ferricoxide(yellow)(E172)

Ferricoxide(black)(E172)

Greyink:

Titaniumdioxide(E171)

Ferricoxide(black)(E172)

Shellac

6.2 Incompatibilities

Noneknown

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

6.4 Specialprecautionsforstorage

Donotstoreabove25°C.

Keeptheblisterpackintheoutercarton.

6.5 Natureandcontentsofimmediatepackaging

ThreePVC-PVdc/aluminiumfoilblisterstripseachcontaining10capsules.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate

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Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

DechraLimited

DechraHouse

JamageIndustrialEstate

TalkePits

Stoke-on-Trent

Staffordshire

ST71XW

UnitedKingdom

8. MARKETINGAUTHORISATIONNUMBERS

UK:Vm10434/4068

IE:VPA10955/15/4

9. DATEOFFIRSTAUTHORISATION

UK:13 th

July2007

IE:31 st

August2007

10. DATEOFANYREVISIONOFTHETEXT

January2013

Approved: 03/01/2013