ELTROXIN 100 MICROGRAMS TABLETS

Main information

  • Trade name:
  • ELTROXIN 100 MICROGRAMS TABLETS
  • Dosage:
  • 100mcg Microgram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ELTROXIN 100 MICROGRAMS TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA0465/120/002A
  • Authorization date:
  • 15-04-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PPA0465/120/002A

CaseNo:2078726

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

PCOManufacturingLimited

Unit10,AshbourneBusinessPark,Rath,Ashbourne,Co.Meath,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Eltroxin100microgramsTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom19/03/2010until14/04/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 21/03/2010 CRN 2078726 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Eltroxin100microgramTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains100microgramslevothyroxinesodium(thyroxinesodium).

Excipient:Lactose

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet

ProductimportedfromtheUK:

White,roundtabletswith‘ELTROXIN100’ononesideabreaklineontheotherside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Recommendedclinicalindications:Controlofhypothyroidism,congenitalhypothyroidismandjuvenilemyxoedema.

4.2Posologyandmethodofadministration

Adults:Initially50to100microgramsdaily,preferablytakenbeforebreakfast.Adjustatthreetofourweekintervals

by50microgramsuntilnormalmetabolismissteadilymaintained:thismayrequiredosesof100to200micrograms

daily.

Forpatientsover50years,itisnotadvisabletoexceed50microgramsdailyinitiallyandwherethereiscardiacdisease,

25microgramsdailyor50microgramsonalternatedaysismoresuitableinitially.Inthisconditionthedailydosemay

beincreasedby25microgramsatintervalsofperhaps4weeks.Forpatientsyoungerthan50years,andintheabsence

ofheartdisease,aserumthyroxine(T4)levelof70to160nanomolsperlitre,oraserumthyrotrophinleveloflessthan

5milli-unitsperlitreshouldbetargeted.

Forpatientsagedover50years,withorwithoutcardiacdisease,clinicalresponseisprobablyamoreacceptablecriteria

ofdosageratherthanserumlevels.

Apre-therapyECGisvaluablebecauseECGchangesduetohypothyroidismmaybeconfusedwithECGevidenceof

cardiacischaemia.Iftoorapidanincreaseinmetabolismisproduced(causingdiarrhoea,nervousness,rapidpulse,

insomnia,tremors,andsometimesanginalpainwherethereislatentcardiacischaemia),dosagemustbereduced,or

withheld,foradayortwo,andthenrestartedatalowerdoselevel.

Elderly:Asforpatientsagedover50years.

Children:Thelargestdoseconsistentwithfreedomfromtoxiceffectsshouldbegiven.Thedosageisguidedby

clinicalresponse,growthassessmentandappropriatethyroidfunctiontests.Clinically,normalpulserateandabsence

ofdiarrhoeaorconstipationarethemostusefulindicators.

Thyrotrophinlevelsmayremainelevatedduringthefirstyearoflifeinchildrenwithneonatalhypothyroidismdueto

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Forinfantswithcongenitalhypothyroidismasuitablestartingdoseis25microgramsdaily,withincrementsof25

microgramseverytwotofourweeksuntilmildtoxicsymptomsappear.Dosageisthenslightlyreduced.Thesame

appliestojuvenilemyxoedema,exceptthatthestartingdoseforchildrenolderthanoneyearmaybe2.5to5

micrograms/kg/day.

Methodofadministration:Oral

4.3Contraindications

Thyrotoxicosis.HypersensitivitytoanycomponentsofEltroxintablets.

4.4Specialwarningsandprecautionsforuse

Patientwithpanhypopituitarismorothercausespredisposingtoadrenalinsufficiencymayreacttothyroxinetreatment,

anditisadvisabletostartcorticosteroidtherapybeforegivingthyroxinetosuchpatients.

Specialcareisneededfortheelderlyandforpatientswithsymptomsofmyocardialinsufficiency,orECGevidenceof

myocardialinfarction.

Levothyroxinesodiumshouldbeusedwithcautioninpatientswithcardiovasculardisorders,includingangina,

coronaryarterydisease,andpatientswithECGevidenceofmyocardialinsufficiencyorinfarction,hypertension,andin

theelderlywhohaveagreaterlikelihoodofoccultcardiacdisease.AnECGbeforestartingtreatmentwithlevothroxine

isadvised.

Levothyroxineshouldbeintroducedverygraduallyinelderlypatientsandthosewithlongstandinghypothyroidismto

avoidanysuddenincreaseinmetabolicdemands.

Careisrequiredwhenlevothyroxineisadministeredtopatientswithknownhistoryofepilepsy.Seizureshavebeen

reportedrarelyinassociationwiththeinitiationoflevothyroxinesodiumtherapy,andmayberelatedtotheeffectof

thyroidhormoneonseizurethreshold.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactosedeficiencyorglucose-galactose

malabsorbtionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Levothyroxineincreasestheeffectofanticoagulantsanditmaybenecessarytoreducetheanticoagulationdosageif

excessive,hypoprothrombinaemiaandbleedingaretobeavoided.Phenytoinlevelsmaybeincreasedbythyroxine.

Anti-convulsants,suchascarbamazepineandphenytoin,enhancethemetabolismofthyroidhormonesandmay

displacethemfromplasmaproteins.

Initiationordiscontinuationofanti-convulsanttherapymayalterthyroxinedosagerequirements.

Ifco-administeredwithcardiacglycosidesadjustmentofdosagemaybenecessary.Theeffectofsympathomimetic

agentsareenhanced.Bloodsugarlevelsareraisedanddosageofanti-diabeticagentsmayrequireadjustment.Tricyclic

anti-depressantsresponsemaybeacceleratedbecausethyroxineincreasessensitivitytocatecholamines.

Cholestyraminereducesthegastrointestinalabsorptionoflevothyroxine.

Oralcontraceptivesmayincreasetherequirementofthyroidtherapydosage.

Otherdrugsmayaffectthyroidfunctiontestsandthismustbeconsideredwhenmonitoringapatientonthyroxine

therapy.

Absorptionoflevothyroxinemaybereducedbycimetidine,sodiumpolystyrenesulphonate,sucralfate,colestipoland

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Rifampicincanacceleratemetabolismoflevothyroxinewhichmayincreaserequirementsforlevothyroxine.

Ifyoutakeironorcalciumsupplements,thendosagesoflevothyroxineandironorcalciumneedtobeseparatedbyan

intervalofseveralhours.

4.6Pregnancyandlactation

Thesafetyoflevothyroxinetreatmentduringpregnancyisnotknown,butanypossibleriskoffoetalabnormalities

shouldbeweighedagainsttherisktothefoetusofuntreatedhypothyroidism.

Levothyroxineisexcretedinbreastmilkinlowconcentrations,anditiscontentiouswhetherthiscaninterferewith

neonatalscreening.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Side-effectsareusuallyindicativeofexcessivedosageorwithdrawaloftreatmentforafewdays.Sucheffectsinclude:

anginalpain,cardiacarrhythmias,palpitations,crampsinskeletalmuscles,tachycardia,diarrhea,vomiting,tremors,

restlessness,excitability,insomnia,headache,flushing,sweating,excessivelossofweight,andmuscularweakness.

4.9Overdose

Signsandsymptomsmaybeanexaggerationofthesideeffects,aswellasagitation,confusion,irritability,

hyperactivity,mydriasis,tachycardia,arrhythmias,tachypnoea,pyrexia,increasedbowelmovementsandconvulsions.

Theappearanceofclinicalhyperthyroidismmaybedelayedforuptofivedays.Gastriclavageoremesisisrequiredif

thepatientisseenwithinseveralhoursoftakingthedose.

Treatmentissymptomatic.Tachycardiamaybecontrolledinanadultby40mgdosesofpropranololgivenevery6

hours.Othersymptomsmaybecontrolledbydiazepamand/orchlorpromazineasappropriate.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Eltroxinisatabletcontainingthehydratedformofthyroxinesodiumwhichisusedforthetreatmentof

hypothyroidism.

Thethyroidglandisdependentupon2activeprinciplesforitsmainhormoneactivitythesearethyroxine

(tetraiodothyronine)andtri-iodothyronine(SeeGoodmanandGilman,1985).Thesecloselyrelatediodinecontaining

amino-acidsareincorporatedintotheglycoproteinthyroglobulin.

Thechiefactionofthesehormonesistoincreasetherateofcellmetabolism.

Thyroxineisdeiodinatedinperipheraltissuestoformtri-iodothyroninewhich

isthoughttobetheactivetissueformofthyroidhormone.Tri-iodothyronineiscertainlymorerapidactingandhasa

shorterdurationofactionthanthyroxine.

5.2Pharmacokineticproperties

Levothyroxinesodiumisincompletelyandvariablyabsorbedfromthegastrointestinaltract.Itisalmostcompletely

boundtoplasmaproteinsandhasahalf-lifeinthecirculationofaboutaweekinhealthysubjects,butlongerduring

pregnancyinpatientswithmyxoedema.

Alargeportionofthethyroxineleavingthecirculationistakenupbytheliver.Partofadoseofthyroxineis

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Levothyroxineisexcretedintheurineasfreedrug,deiodinatedmetabolitesandconjugates.Somelevothyroxineis

excretedinthefaeces.Thereislimitedplacentaltransferoflevothyroxine.

5.3Preclinicalsafetydata

Nofurtherdataofrelevance.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumcitrate

Lactosemonohydrate

Maizestarch

Powderedacacia

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelflifeexpirydateforthisproductisthedateshownonthecontainerandoutercartonoftheproductasmarketed

inthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

Storeintheoriginalcontainer.

6.5Natureandcontentsofcontainer

Blisterpacksof28tabletscontainedinanoutercarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7ParallelProductAuthorisationHolder

PCOManufacturingLimited

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

8ParallelProductAuthorisationNumber

Irish Medicines Board

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Date Printed 21/03/2010 CRN 2078726 page number: 5

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:15April2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 21/03/2010 CRN 2078726 page number: 6