Forthyron

Main information

  • Trade name:
  • Forthyron 400
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Forthyron 400
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • levothyroxine sodium
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0217/002
  • Authorization date:
  • 14-07-2010
  • EU code:
  • UK/V/0217/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:October2010

AN:01015/2009

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Forthyron400microgramtablet

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveSubstance:

400µglevothyroxinesodiumpertabletequivalentto388µglevothyroxine

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Tablet

Whitetooffwhiteroundtablets,scoredononeside

Tabletsdivisibleinto4parts

4. CLINICALPARTICULARS

4.1. Targetspecies

Dogs.

4.2. Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofhypothyroidismindogs.

4.3. Contra-indications

Donotuseindogssufferingfromuncorrectedadrenalinsufficiency.

4.4. Specialwarningsforeachtargetspecies

Thediagnosishypothyroidismshouldbeconfirmedwithappropriatetests.

4.5. Specialprecautionsforuse

Specialprecautionsforuseinanimals

Asuddenincreaseindemandforoxygendeliverytoperipheraltissues,plusthechronotropic

effectsoflevothyroxinesodium,mayplaceunduestressonapoorlyfunctioningheart,causing

decompensationandsignsofcongestiveheartfailure.Hypothyroiddogssufferingfrom

hypoadrenocorticismhaveadecreasedabilitytometaboliselevothyroxinesodiumand

thereforeanincreasedriskofthyrotoxicosis.Dogswithconcurrenthypoadrenocorticismand

hypothyroidismshouldbestabilisedwithglucocorticoidandmineralocorticoidtreatmentprior

totreatmentwithlevothyroxinesodiumtoavoidprecipitatingahypoadrenocorticalcrisis.

Afterthis,thyroidtestsshouldberepeated,thengradualintroductionoflevothyroxinetherapy,

startingwith25%ofthenormaldose,increasingby25%incrementseveryfortnightuntil

optimalstabilisationisachievedisrecommended.Gradualintroductionoftherapyisalso

recommendedfordogswithotherconcurrentillnesses;particularlydiabetesmellitusandrenal

orhepaticdysfunction.

Specialprecautionstobetakenbythepersonadministeringthemedicinalproduct

toanimals

Washhandsafteradministeringthetablets.Pregnantwomenshouldhandletheproductwith

caution.

Revised:October2010

AN:01015/2009

4.6. Adversereactions(frequencyandseriousness)

Restorationofphysicalactivitymayunmaskorintensifyotherproblems,suchas

osteoarthrosis.Adverseeffectsofthyroidhormonesaregenerallyassociatedwithexcessive

dosageandcorrespondtothesymptomsofhyperthyroidism.Seealsosection4.10.

4.7. Useduringpregnancy,lactationorlay

Thesafetyofuseoftheproductduringpregnancyhasnotbeenestablishedthroughspecial

reproductionstudies.However,levothyroxineisanendogenoussubstanceandthyroid

hormonesareessentialforthedevelopingfoetus,especiallyduringthefirstperiodof

gestation.Hypothyroidismduringpregnancymayresultinmajorcomplicationssuchasfoetal

deathandapoorperinataloutcome.Maintenancedoseoflevothyroxinesodiummayneed

adjustmentduringpregnancy.Pregnantbitchesshouldthereforebemonitoredonaregular

basefromconceptionuntilseveralweeksafterdelivery.

4.8.Interactionswithothermedicinalproductsandotherformsofinteraction

Avarietyofdrugsmayimpairplasmaortissuebindingofthethyroidhormonesoralterthyroid

hormonemetabolism(eg.barbiturates,antacids,anabolicsteroids,diazepam,furosemide,

mitotane,phenylbutazone,phenytoin,propranolol,largedosesofsalicylates,and

sulphonamides.).Whentreatingdogsthatarereceivingconcurrentmedicationtheproperties

ofthesedrugsshouldbetakenintoconsideration.

Anincreaseinthedosageofdigitalismaybenecessaryinapatientthathadpreviously

compensatedcongestiveheartfailureandthatisplacedonthyroidhormonesupplementation.

Estrogensmayincreasethyroidrequirements.

Ketaminemaycausetachycardiaandhypertensionwhenusedinpatientsreceivingthyroid

hormones.Theeffectofcatecholaminesandsympatiomimeticsisincreasedbylevothyroxine.

Followingtreatmentofhypothyroidismindogswithconcurrentdiabetes,carefulmonitoringof

diabeticcontrolisrecommended.

Mostdogsonchronichigh-dose,dailyglucocorticoidtherapywillhaveverylowor

undetectableserumT

concentrations,aswellassubnormalT

values.

4.9 Amountstobeadministeredandadministrationroute

Therecommendedstartingdosageoflevothyroxinesodiumis10µg/kgbodyweightorally

every12hour.Becauseofvariabilityinabsorptionandmetabolism,thedosagemayrequire

alterationsbeforeacompleteclinicalresponseisobserved.Theinitialdosageandfrequency

ofadministrationaremerelyastartingpoint.Therapyhastobehighlyindividualisedand

tailoredtotherequirementsoftheindividualdog.Wheninitiatingdosingofdogsweighing

lessthan5kgbodyweight,aquarterofone200μgtabletshouldbeadministeredoncedaily.

Suchcasesshouldbemonitoredcarefully.Inthedog,absorptionoflevothyroxinesodiummay

beaffectedbythepresenceoffood.Thetimingoftreatmentanditsrelationtofeedingshould

thereforebekeptconsistentfromdaytoday.Toadequatelymonitortherapy,troughvalues

(justpriortotreatment)andpeakvalues(aboutthreehoursafterdosing)ofplasmaT

canbe

measured.InadequatelydoseddogspeakplasmaconcentrationofT

shouldbeinthehigh-

normalrange(approximately30to47nmol/l)andtroughvaluesshouldbeabove

approximately19nmol/l.IfT

levelsareoutsidethisrangethelevothyroxinedosecanbe

adjustedin50to200µgincrementsuntilthepatientisclinicallyeuthyroidandserumT

is

Revised:October2010

AN:01015/2009

withinthereferencerange.PlasmaT

levelscanberetestedtwoweeksafterchangeof

dosage,butclinicalimprovementisanequallyimportantfactorindeterminingindividual

dosageandthiswilltakefourtoeightweeks.Whentheoptimumreplacementdosehasbeen

attained,clinicalandbiochemicalmonitoringmaybeperformedevery

6 –12months.

Tobreakatabletaccuratelyandeasily,placethetabletscoresideup

andapplypressurewithyourthumb.

Tobreakthetabletintwoparts;holdonehalfofthetabletdownandpressdowntheotherhalf.

4.10.Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Followingadministrationofoverdosesthyrotoxicosiscouldoccur.Thyrotoxicosisasaside

effectofmildoversupplementationisuncommonindogs,owingtothecanineabilityto

catabolizeandexcretethyroidhormones.Incaseofaccidentalintakeoflargeamountsof

Forthyrontabletsabsorptioncanbedecreasedbyinductionofvomitingandoral

administrationofbothactivatedcharcoalandmagnesiumsulphateonce.

Overdosesofthreeuptosixtimeslabelrecommendedstartingdosefor4consecutiveweeks

inhealthy,euthyroiddogsresultedinnosignificantclinicalsignsthatcouldbeattributedto

treatment.Singleoverdoseupto3-6xtherecommendeddosedoesnotposeathreattothe

dog,andnoactionsarenecessary.However,followingchronicover-supplementation,clinical

signsofhyperthyroidismsuchaspolydipsia,polyuria,panting,weightlosswithoutanorexia,

andeitherorbothtachycardiaandnervousnessmaytheoreticallyoccur.Thepresenceof

thesesignsshouldresultinevaluationofT

serumconcentrationstoconfirmthediagnosis,

andimmediatediscontinuanceofthesupplementation.Oncethesignshaveabated(daysto

weeks),thethyroiddosagehasbeenreviewed,andtheanimalhasfullyrecovered,alower

dosagemaybeinstituted,withtheanimalbeingmonitoredclosely.

4.11.Withdrawalperiods

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:syntheticthyroidhormones

ATCvetcode:QH03AA01.

Revised:October2010

AN:01015/2009

5.1. Pharmacodynamicproperties

Pharmacologicallylevothyroxineisclassifiedasahormonalpreparationthatreplaces

deficientendogenoushormones.

LevothyroxineT

isconvertedtotriiodothyronineT

actsoncellularprocessesviaspecific

ligand-receptorinteractionswiththenucleus,themitochondria,andtheplasmamembrane.

InteractionofT

withbindingsitesleadstoaugmentedtranscriptionofDNAormodulationof

RNA,thusinfluencingproteinsynthesisandenzymeaction.

Thyroidhormonesactonmanydifferentcellularprocesses.Indevelopinganimalsandhuman

beings,theyarecrucialdeterminantsofnormaldevelopment,especiallyinthecentralnervous

system.Thyroidsupplementationincreasesbasalcellularmetabolismandoxygen

consumptiontherebyaffectingthefunctionofvirtuallyallorgansystems.

5.2. Pharmacokineticparticulars

SomedogsappearedtoconsistentlyeitherabsorbL-thyroxinebetterand/oreliminateitmore

slowlythandootherdogs.Furthermoreabsorptionandeliminationrateisinfluencedbydaily

intakeoflevothyroxinesodium(highabsorption/loweliminationincaseoflowintakeandvice

versaincaseofhighintake).Thevariabilityinpharmacokineticparametersbetween

individualdogsisconsiderableand,althoughthepresenceoffoodmayaffectabsorption,itis

consideredtohaveaminoreffectontheparametersoverall.Absorptionisrelativelyslowand

incomplete:InmostcasesT

occursbetween1to5hoursafteroraladministration,mean

variesmorethan3foldbetweendogsonthesamedoses.Inadequatelydoseddogs

theplasmapeakapproachesorslightlyexceedstheupperlimitofnormalplasmaT

levels,

andbytheendof12hoursafteroraladministration,plasmaT

usuallydeclinestothelower

halfofthenormalrange.TheratesofdisappearanceofT

fromtheplasmaareslowedin

hypothyroidism.Alargepartofthethyroxineistakenupbytheliver.L-thyroxineisboundto

plasma-proteinsandplasmalipoproteins.Partofadoseofthyroxineismetabolisedtothe

morepotenttriiodothyronine(T

)bydeiodination.Theprocessofdeiodinationcontinues.

Thesefurtherdeiodinatedmetabolicproducts(otherthanT

andT

)donothavethyromimetic

activity.Otherpathwaysofthyroidhormonemetabolismincludeconjugationtoformsoluble

glucuronidesandsulphatesforbiliaryorurinaryexcretionaswellascleavageoftheether

linkageoftheiodothyroninemolecule.Inthedog,over50%oftheT

producedeachdayare

lostinthefaeces.TheextrathyroidalbodystoresofT

areeliminatedandreplacedinabout1

day.

6. PHARMACEUTICALPARTICULARS

6.1. Listofexcipients

Calciumhydrogenphosphatedihydrate,

Cellulose,Microrcrystalline,

SodiumStarchGlycolate(typeA),

Magnesiumstearate.

6.2. Incompatibilities

Notapplicable

Revised:October2010

AN:01015/2009

6.3. Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Tabletportionscanbekeptfor4daysintheblisterpack.

6.4. Specialprecautionsforstorage

Donotstoreabove25°C.

6.5. Natureandcontentsofimmediatepackaging

Blisters,consistingofaluminiumfoilandawhite,opaquePVC/PE/PVDCfoil.

10Tabletsperblister,5,25,or50blisterspercarton,50,250or500tabletspercarton.

Notallpacksizesmaybemarketed.

6.6. Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerials,derivedfromtheuseofsuchproductsifappropriate.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnational

requirements.

7. MARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.,Handelsweg25,5531AEBladel,TheNetherlands

8. MARKETINGAUTHORIZATIONNUMBER

Vm16849/4006

9. DATEOFRENEWALOFTHEAUTHORISATION

13April2010

10. DATEOFREVISIONOFTHETEXT

October2010

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10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Active substance: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine) - Transfer of orphan designation - Commission Decision (2018)3402 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/14/T/01

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Active substance: Volanesorsen sodium) - Transfer of orphan designation - Commission Decision (2018)1822 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/082/16/T/01

Europe -DG Health and Food Safety