Forthyron 200

Main information

  • Trade name:
  • FORTHYRON 200
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FORTHYRON 200
    Slovenia
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0217/001
  • Authorization date:
  • 14-07-2010
  • EU code:
  • UK/V/0217/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:October2010

AN:01014/2009

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Forthyron200microgramtablet

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveSubstance:

200µglevothyroxinesodiumpertabletequivalentto194µglevothyroxine

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:01014/2009

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.Theeffectofcatecholaminesandsympaticomimeticsisincreasedby

levothyroxine.

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.

Suchcases

shouldbemonitoredcarefully.Inthedog,absorptionoflevothyroxinesodiummaybeaffected

bythepresenceoffood.Thetimingoftreatmentanditsrelationtofeedingshouldthereforebe

keptconsistentfromdaytoday.Toadequatelymonitortherapy,troughvalues(justpriorto

treatment)andpeakvalues(aboutthreehoursafterdosing)ofplasmaT

canbemeasured.In

adequatelydoseddogspeakplasmaconcentrationofT

shouldbeinthehigh-normalrange

Revised:October2010

AN:01014/2009

(approximately30to47nmol/l)andtroughvaluesshouldbeaboveapproximately19nmol/l.If

levelsareoutsidethisrangethelevothyroxinedosecanbeadjustedin50to200µg

incrementsuntilthepatientisclinicallyeuthyroidandserumT

iswithinthereferencerange.

PlasmaT

levelscanberetestedtwoweeksafterchangeofdosage,butclinicalimprovement

isanequallyimportantfactorindeterminingindividualdosageandthiswilltakefourtoeight

weeks.Whentheoptimumreplacementdosehasbeenattained,clinicalandbiochemical

monitoringmaybeperformedevery6 –12months.

Tobreaka200µgtabletaccuratelyandeasily,placethetablet

scoresideupandapplypressurewithyourthumb.

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:01014/2009

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:01014/2009

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. MARKETINGAUTHORISATIONNUMBER

Vm16849/4005

9. DATEOFRENEWALOFTHEAUTHORISATION

13April2010

10. DATEOFREVISIONOFTHETEXT

October2010

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FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

18-4-2018

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (Active substance: Autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo) - Orphan designation - Commission Decision (2018)2405 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/246/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (Active substance: Adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1) - Orphan designation - Commission Decision (2018)2404 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/254/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Active substance: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene) - Orphan designation - Commission Decision (2018)2403 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/255/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1893 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/222/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1892 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/217/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1891 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/225/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1890 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/224/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Active substance: Recombinant modified ricin toxin A-chain subunit) - Orphan designation - Commission Decision (2018)1889 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/242/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1894 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/234/17

Europe -DG Health and Food Safety