Vidalta 15 mg tablets for Oral Use for Cats

Main information

  • Trade name:
  • Vidalta 15 mg tablets for Oral Use for Cats
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Vidalta 15 mg tablets for Oral Use for Cats
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • carbimazole
  • Therapeutic area:
  • Cats

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0408/002
  • Authorization date:
  • 26-10-2011
  • EU code:
  • UK/V/0408/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:January2012

AN:02007/2010

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Vidalta15mgprolonged-releasetabletsforcats

BE,NO:VidaltaVet15mgprolongedreleasetabletsforcats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachprolonged-releasetabletcontains:

Activesubstance:

Carbimazole 15,00mg

Excipients:

Redferricoxide(E172) 0.75mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Prolonged-releasetablet

Rounddarkpinktabletwithlittlespots

4. CLINICALPARTICULARS

4.1 Targetspecies

Cat

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofhyperthyroidismandhyperthyroidism-associatedclinicalsignsincats

4.3 Contraindications

Donotuseincatssufferingfromconcurrentsystemicdiseases,suchassevereprimary

liverdiseaseordiabetesmellitus.

Donotuseincatsshowingsignsofauto-immunediseasesand/oralteredredorwhite

bloodcellcounts,suchasanaemia,neutropaeniaorlymphopaenia.

Donotuseincatswithplateletdisorders(particularlythrombocytopaenia)or

coagulopathies.

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Donotuseincatswithhypersensitivitytomercaptoimidazoles(carbimazoleor

thiamazole(methimazole))Pleaserefertosection4.7.

4.4 Specialwarningsforthetargetspecies

Thiamazole(methimazole),theactivemetaboliteofcarbimazole,inhibitsthyroid

hormoneproductionandthereforecessationoftreatmentwithcarbimazolewillresultin

arapid(within48hours)returntopre-treatmentthyroidhormonelevels.Chronic

administrationisthereforenecessaryunlesssurgicalorradiation-inducedthyroidectomy

isperformed.

Asmallproportionofcatswiththyroidadenomamayfailtorespondorhaveapoor

responsetotreatment.

Thyroidcarcinomaisararecauseofhyperthyroidisminthecatandmedical

managementaloneisnotrecommendedinsuchcasesasitisnotcurative.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Treatmentshouldbeadjustedaccordingtotherisk:benefitassessmentfortheindividual

case.

Treatmentofhyperthyroidismmayresultinareductionintheglomerularfiltrationrate.

Thiscanleadtounmaskingofpre-existentrenaldysfunction.Treatmentof

hyperthyroidismmayalsoinduceanelevationofliverenzymesoraworseningofpre-

existinghepaticdisorders.Renalandliverfunctionshouldthereforebemonitored

beforeandduringtreatment

Duetoriskofleucopaeniaorhaemolyticanaemia,haematologyparametersshouldbe

monitoredonaregularbasisbeforeandduringtreatment,preferablyateachvisitofthe

doseadjustmentphaseandmaintenancephase(seesection4.9).

Anyanimalthatsuddenlyappearsunwellduringtherapy,particularlyiftheyarefebrile,

shouldhaveabloodsampletakenforroutinehaematologyandbiochemistry.

Neutropenicanimals(neutrophilcounts<2.5x10 9

/l)shouldbetreatedprophylactically

withbactericidalantibioticsandsupportivetherapy.

Dosesabove20mghaveonlybeentrialledinasmallnumberofcats.Therefore,

carefulmonitoringisrecommendedandthedoseshouldbeadjustedaccordingtothe

risk:benefitassessmentfortheindividualcase.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandswithsoapandwaterafteruseandwhenhandlinglitterusedbytreated

animals.

Donothandlethisproductifyouareallergictoantithyroidproducts.

Pregnantwomenshouldweargloveswhenhandlingtheproduct.

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Donoteat,drinkorsmokewhilehandlingthetabletorusedlitter.

Inthecaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthe

packageinsertorthelabeltothephysician.Carbimazole,asaprodrugofthiamazole

(methimazole),maycausevomiting,epigastricdistress,headache,fever,arthralgia,

pruritusandpancytopaenia.Treatmentissymptomatic.

Ascarbimazoleisasuspectedhumanteratogen,womenofchild-bearingageshould

weargloveswhenhandlinglitterorvomitoftreatedcats.

4.6Adversereactions(frequencyandseriousness)

Mostfrequentcommonadversereactionsencompassvomiting,diarrhoea,reduced

appetite,lossofcondition,lethargy,tachycardia,polydipsia,dehydration,andpolyuria.

Dermatologicalsigns(pruritus,moistdermatitis,erythema,alopecia)havealsobeen

reported.Theseclinicalsignsareusuallymild,adequatelycontrolledbysymptomatic

therapyanddonotrequiretreatmentdiscontinuation.However,ifmoresevereclinical

signsoccurthatdonotrespondtosymptomatictherapy,thedoseshouldbereducedor

treatmentstoppedaccordingtorisk:benefitevaluation.Incasesofseriousadverse

reactions,mortality,possiblyduetotheproduct,mightoccuriftreatmentisnot

discontinued.

Insomecases,signsofgastrointestinalbleedingsuchasbloodyvomit,oral

haemorrhageordarkfaecescanbeobserved.Thesesignsshouldbeconsideredas

seriousandrequireimmediateaction(dosereductionortreatmentdiscontinuation).

Weightloss,dyspnoea,aggressiveness,disorientation,ataxiaorpyrexiahavealso

beenreportedinrarecases.

Treatmentofhyperthyroidismmayresultinareductionintheglomerularfiltrationrate.

Inseverecases,whereazotaemiadevelops,temporaryorpermanenttreatment

discontinuationmayberequired.

Thetreatmentmayinduceincreaseofliverenzymes.Severecasesmayrequire

temporaryorpermanenttreatmentdiscontinuation.However,theseelevationsare

usuallyreversiblefollowingdrugdiscontinuation,althoughsymptomatictherapy

(nutritionalandfluidsupport)mayberequired.

Anaemia, increase or decrease in white blood cell count, neutrophilia,

thrombocytopaenia,eosinophiliaand/orlymphopaeniamayalsooccur,inparticular

duringthefirst4-6weeksoftreatment.Treatmentdiscontinuationmayberequiredin

caseofpersistentandmarkeddisorder.Inmostofthecases,theabnormalitywill

resolvespontaneouslywithin1monthaftertreatmentdiscontinuation.

Positiveantinuclearantibodytitreshavealsobeenreported.

Itappearsthatadversereactionsarereversibleoncessationoftreatment.

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4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandmicehaveshownevidenceofteratogenicand

embryotoxiceffectsofthiamazole.Thesafetyoftheproductwasnotassessedin

pregnantorlactatingcats.Furthermore,thiamazolecrossestheplacenta,distributes

intomilkandreachesapproximatelythesameconcentrationasinmaternalserum.

Donotuseinpregnantorlactatingfemales.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concomitanttreatmentwithphenobarbitalmayreducetheclinicalefficacyof

carbimazole.

Theconcomitantuseofbenzimidazoleanthelmintics(fenbendazoleormebendazole)

hasbeenshowntoreducethehepaticoxidationofthistherapeuticclassandmay

thereforeinduceanincreaseoftheircirculatingrates.Accordingly,co-administrationof

carbimazolewithabenzimidazoleisnotrecommended.

Thiamazolemaydisplayimmunomodulatingproperties.Thisshouldbetakeninto

accountwhenconsideringvaccinationofthecat.

4.9 Amountstobeadministeredandadministrationroute

Fororaluseonly.

Administrationwithfoodenhancesbioavailability.Thetimingoftreatmentandits

relationtofeedingshouldbekeptconsistentfromdaytoday.

DonotbreakorcrushVidaltatabletsasthiswillaffectthesustainedreleaseproperty.

Theaimoftreatmentistomaintaintotalthyroxinconcentrations(TT4)inthelowerend

ofthereferencerange.Accordingly,thefollowingdoserecommendationsfordosing

duringadjustmentandmaintenancephasesaresuggested.Howeverdosingadjustment

shouldbeprimarilybasedupontheclinicalassessmentoftheindividualcat.Monitoring

ofTT4,fullhaematologyandliverandkidneyparametersisadvisedateach

recommendedfollowupvisit(seesections4.5iand4.6).

Adjustmentphase

Thestartingdoseisasingledailyoraladministrationofonetabletof15mgcarbimazole

percat.ConsiderationcouldbegiventoastartingdoseofVidalta10mgdailywherethe

TT4concentrationisonlymildlyincreased,e.g.between50nmol/Land100nmol/L.

WiththerecommendedstartingdoseofoneVidalta15mgtabletoncedaily,total

thyroxinconcentration(TT4)maydecreasetowithintheeuthyroidrange(TT4<50

nmol/L)shortlyaftertreatmentinitiation.Adoseadjustmentmayberequiredasearlyas

10daysoftreatment.

Doseadjustmentshouldbealsoperformed3,5and8weeksafterinitiationof

treatment,dependingonbothclinicalandhormonalresponsestotreatment.

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Maintenancephase

Follow-upvisitsevery3to6monthsarerecommended.Thedoseshouldbeadjusted

individuallybasedonclinicalsignsandtotalthyroxinconcentration(TT4).Itisadvisable

tocheckTT410-14daysafterdoseadjustment.

ThetherapeuticdoseofVidaltarangesbetween10mg(one10mgtablet)and25mg

(one10mgtabletandone15mgtablet)oncedaily.

Somecatsrequiredosesoflessthan10mgcarbimazoledaily.Everyotherdaydosing

with10mgor15mgofcarbimazolemaybesufficienttocontrolthedisease.

Doseincreasesshouldnotbemadeinincrementsofgreaterthan5mg.

Dosesabove20mghaveonlybeentrialledinasmallnumberofcatsandshouldbe

usedwithcaution.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incaseofoverdosage,adverseeffectsthatmayappearinclude,butarenotlimitedto,

weightloss,inappetence,vomiting,lethargyandlessfrequentlysignsofgastrointestinal

bleedingsuchashaematemesis,oralhaemorrhageorhaemorrhageoftheintestinal

tract. Coat and skin abnormalities (erythema, alopecia), as well as

haematological/biochemical changes (eosinophilia, lymphocytosis, neutropaenia,

lymphopaenia,slightleucopaenia,agranulocytosis,thrombocytopaeniaorhaemolytic

anaemia)mayalsoappear.Hepatitisandnephritishavebeenreported.Theseadverse

effectsmaybecomesevereincaseofchronicoverdosing.Inmostcases,adverse

effectsarereversibleupontreatmentdiscontinuationandappropriateveterinarycare.

Totalthyroxinconcentrations(TT4)belowthelowerlimitofthereferencerangemaybe

observedduringtreatmentalthoughthisisrarelylinkedtoovertclinicalsigns.

DecreasingthedosewillleadtoanincreaseoftheTT4.Doseadjustmentshouldnotbe

madebasedonTT4only(seesection4.9).

Pleasealsorefertosection4.6

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Activeingredient:carbimazole

Pharmacotherapeuticgroup:sulphur-containingimidazolederivatives

ATCvetcode:QH03BB01

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5.1 Pharmacodynamicproperties

Carbimazoleistheprodrugofthiamazole(methimazole).Althoughcarbimazolehas

inherentantithyroidactivity,itisalmosttotallyconvertedtothiamazolesoonafteritsoral

administrationinvivoinhumansandcats.

Thiamazoleresultsindose-dependentinhibitionofthethyroidperoxidase-catalysed

reactionsinvolvedinthyroidhormonesynthesis,includingoxidationofiodideand

iodinationoftyrosylresiduesinthyroglobulin,therebyinhibitingneosynthesisofthyroid

hormones.Thiamazolealsointerfereswiththecouplingofiodotyrosinesto

iodothyroninesviainhibitionofthyroidperoxidaseorbybindingandalteringthe

structureofthyroglobulin,thisreactionbeingmoresensitivetoinhibitionthanthe

formationofiodotyrosines.Theinhibitoryactionofthiamazoleisreversible.

Thiamazoledoesnotinhibittheactionofthyroidhormonesalreadyformedandpresent

inthethyroidglandsorbloodstream,orinterferewiththeeffectivenessofadministered

exogenousthyroidhormone(iatrogenichyperthyroidism).Thisexplainswhythelength

ofthelatencyperioduntilnormalisationofserumconcentrationsofthyroxineand

triiodothyronine,andthustoclinicalimprovement,differsbetweenindividuals.

5.2 Pharmacokineticparticulars

Carbimazoleisrapidlyabsorbedfromthegastrointestinaltractafteroraladministration

andhydrolysedinthegastrointestinaltract(orimmediatelyafterenteringintothe

circulation)totheactivemetabolitethiamazole.Theabsolutebioavailabilityof

thiamazolefromcarbimazoleinVidalta15mgtabletsis88%.

FollowingoraladministrationofonetabletofVidalta10mgtohealthyfastedcats,

maximumthiamazoleconcentrationsareobserved3-4hoursafteradministration,witha

meanpeakconcentrationofthiamazoleof0.54-0.87µg/mL.Followingoral

administrationofonetabletofVidalta15mgtohealthyfastedcats,maximum

thiamazoleconcentrationsareobserved5-7hoursafteradministration,withamean

peakconcentrationofthiamazoleof0.72-1.13µg/mL.Forbothstrengths,the

thiamazoleconcentration/timeprofileisdevoidofpronouncedpeakandthiamazole

persistsinthecirculationatleast20and24hoursforVidalta10mgandVidalta15mg,

respectively.

Thepresenceoffoodinthegastrointestinaltractatthetimeofadministrationhasbeen

showntoincreasethebioavailabilityofthiamazole.Whentabletsareadministeredwith

food,bothC

andAUC

last maybeincreasedwhereast

isnotexpectedtochange.

Nocumulativeeffectsareobserveduponrepeatedadministration.

Thetissuedistributionofmercaptoimidazoleshasnotbeenspecificallystudiedincats

buthasbeenfullydescribedinrodents.Thiamazoleismainlyconcentratedinthe

thyroidandadrenalglands,andcanbefoundtoalesserextentinthethymus,

diaphragm,kidneys,brain,liver,colon,testes,smallintestine,stomachandplasma.

Mercaptoimidazoleshavealsobeenshowntocrosstheplacentalbarrier.

Inrats,thiamazoleisexcretedmainlyviatheurine,andtoalesserextentinthefaeces.

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6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

-Hypromellose

-Microcrystallinecellulose

-Redferricoxide(E172)

-Silica,colloidalanhydrous

-Magnesiumstearate

-Talc

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductsaspackagedforsale:

24months.

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalcontainer.

Keepthecontainertightlyclosedtoprotectfrommoisture.

Donotremovethedessicant.

6.5Natureandcompositionofimmediatepackaging

Highdensitypolyethylenecontainerof30or100tabletsclosedwithpolypropylene

tamper-evident,child-resistant,screwcapbearingadesiccant.

Packsof1or6containers.

Notallpacksizesmaybemarketed.

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6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

IntervetUKLtd

WaltonManor

Walton

MiltonKeynes

Buckinghamshire

MK77AJ

8. MARKETINGAUTHORISATIONNUMBER

Vm01708/4530

9. DATEOFFIRSTAUTHORISATION

21December2007

10. DATEOFREVISIONOFTHETEXT

January2012