ETHAMBUTOL

Main information

  • Trade name:
  • ETHAMBUTOL Film Coated Tablet 100 Milligram
  • Dosage:
  • 100 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ETHAMBUTOL Film Coated Tablet 100 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0037/008/001
  • Authorization date:
  • 01-04-1977
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0037/008/001

CaseNo:2039676

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

CyanamidofGreatBritain

FarehamRoad,Gosport,Hants,PO130AS,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Ethambutol100mgFilm-coatedTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom21/02/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 06/03/2008 CRN 2039676 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Ethambutol100mgFilmCoatedTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains100mgEthambutolHydrochloride.

Excipients:Eachtabletcontains32mgsucroseand5.7mgsorbitol.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet.

Smooth,yellow,biconvex,bevel-edgedfilmcoatedtablets.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Theprimarytreatmentandre-treatmentoftuberculosisandforprophylaxisincasesofinactivetuberculosisorlarge-tuberculin-

positivereaction.Ethambutolshouldonlybeusedinconjunctionwithotheranti-tuberculousdrugstowhichthepatient’s

organismsaresusceptible.

4.2Posologyandmethodofadministration

Routeofadministration:

Oral

Posology:

RecommendedDosage

Thedosageofethambutolmustbecarefullycalculatedonthebasisof

individualbodyweighttominimisetheriskoftoxicity.

Theusualdailydosageis15-25mg/kgbodyweightgivenasasingledose.

RenalInsufficiency:

Dosageshouldbereducedinpatientswithrenaldysfunction.Thefollowingguidemaybeused

GFR<50 Dosemg/kg Interval

>25ml/minute 15-25 24-36hrs

10–25 7.5-15 48hrs

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Thisdrugshouldnotbeusedasasoleanti-tuberculosisagent,butshouldbegivenwithatleastoneotheranti-

tuberculosisdrugtoavoiddevelopmentofresistantstrains.

GeriatricUse:

Doseselectionshouldbecautious,usuallystartingatthelowerendofthedosingrange,reflectingthegreaterfrequency

ofdecreasedhepatic,renal,orcardiacfunction,andofconcomitantdiseaseorotherdrugtherapy.

4.3Contraindications

KnownhypersensitivitytoethambutolortoanyofthecomponentsofEthambutolTablets.Itisalsocontra-indicatedinpatients

withknownopticneuritis,orretrobulbarneuritis,unlessclinicaljudgementdeterminesthatitmaybeused.

Ethanbutoliscontra-indicatedinpatientswhoareunabletoappreciateandreportvisualside-effectsorchangesinvision(e.gvery

youngchildren,unconsciouspatients).

4.4Specialwarningsandprecautionsforuse

Ethambutolmayproducedecreasesinvisualacquityandcolourvision,whichmayappeartobeduetooptic/retrobulbarneuritis.

Thiseffectmayberelatedtodoseanddurationoftreatment.Thiseffectisgenerallyreversiblewhenadministrationofthedrugis

discontinuedpromptly.However,irreversibleblindnesshasbeenreported.

Livertoxicitiesincludingfatalitieshavebeenreported.Baselineandperiodicassessmentofhepaticfunctions,shouldbe

performed.

Patientswithdecreasedrenalfunctionmayneedtohavethedosageadjustedasdeterminedbybloodlevelsofethambutol.

Aswithanypotentdrug,baselineandperiodicassessmentoforgansystemfunctions,includingrenal,hepatic,and

haematopoietic,shouldbeperformed.

Ethambutolmayreducetherenalclearanceofuratessuchasuricacidpossiblyleadingtohyperuricemia.Acuteattacksofgout

havebeenreported.

Becausethisdrughasauniqueeffectontheeye,itisrecommendedthatpatientsundergoafullophthalmicexaminationbefore

startingtreatment.Thisshouldincludevisualacuity,colourvision,perimetryandophthalmoscopy.Inpatientswithvisual

defectssuchascataracts,recurrentinflammatoryconditionsoftheeye,opticneuritis,anddiabeticretinopathy,theevaluationof

changesinvisualacuityismoredifficult,andcareshouldbetakentobesurethevariationsinvisionarenotduetotheunderlying

diseaseconditions.Insuchpatientsconsiderationshouldbegiventotherelationshipbetweenbenefitsexpectedandpossible

visualdeteriorationsinceevaluationofvisualchangesisdifficult.

Thechangemaybeunilateralorbilateralandhencebotheyesmustbetestedindividually.

Manyphysiciansconsiderthatroutineophthalmologicalexaminationforadultsisnotthereafternecessary,butpatientsshouldbe

informedoftheimportanceofstoppingethambutoladministrationimmediatelyiftheyexperienceanychangeinvision,and

informingtheirphysician.Routineophthalmologicalexaminationsmaybeconsidereddesirablewhentreatingyoungchildren.

Ethambutolshouldbeusedinyoungchildrenandthosewithlanguageorcommunicationdifficulties,whereappropriate,with

adviceconcerningtheneedtoreportvisualside-effectsbeinggiventoparentsorotherfamilymembers.

Thisproductshouldonlybeadministeredwithgreatcautioninpatientswithconvulsivedisorder.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Antacidscontainingaluminiumhydroxidehaveimpairedtheabsorptionofethambutol.

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4.6Pregnancyandlactation

Therearenoadequateandwell-controlledstudiesinpregnantorlactatingwomen.Ethambutolhasbeenreportedtocrossthe

placentaandisexcretedintobreastmilk.Therearereportsofophthalmicabnormalitiesoccurringininfantsborntowomenon

antituberculoustherapythatincludedethambutolhydrochloride.Ethambutolhydrochlorideshouldbeusedduringpregnancyonly

ifthebenefitjustifiesthepotentialrisktothefoetus.

4.7Effectsonabilitytodriveandusemachines

Ethambutolmayproduceauniquetypeofvisualimpairment(see4.8Undesirableeffects).Numbnessandparaesthesia

oftheextremitieshavebeenreported.Therefore,patientsshouldbecautionedabouttheirabilitytodriveacaror

operatehazardousmachineryiftheyexperienceanyifthesesymptoms.

4.8Undesirableeffects

Bloodandlymphaticsystemdisorders:

Leukopenia,neutropenia,thrombocytopenia

Immunesystemdisorders:

Hypersensitivity,anaphylactic/anaphylactoidreactions(includingshockandfatalities).Hypersensitivitysyndrome

consistingofcutaneousreaction(suchasrashorexfoliativedermatitis),eosinophilia,andoneormoreofthe

following:hepatitis,pneumonitis,nephritis,myocarditis,andpericarditis.Feverandlymphadenopathymaybe

present.

Nervoussystemdisorders:

Dizziness,hypoaesthesia,paraesthesia

Eyedisorders:

Decreasedvisualacuity,opticneuropathy,opticneuritis,retrobulbarneuritis,visualfielddefect,colourblindness,

scotoma,congenitalophthalmicabnormalities,blindness

Respiratorydisorders,thoracicandmediastinaldisorders:

Pulmonaryinfiltrateswithorwithouteosinophilia

Gastrointestinaldisorders:

Nausea,vomiting,diarrhoea,anorexia

Hepatobiliarydisorders:

Aspartateaminotransferaseincreased,alanineaminotransferaseincreased,livertoxicitiesincludingfatalities

Skinandsubcutaneoustissuedisorders:

Hypersensitivity,rash,pruritis,urticaria,Stevens-Johnsonsyndrome,photosensitivelichenoideruptions,toxicepidermal

necrolysis,bullousdermatitis

Renalandurinarydisorders:

Gout,hyperuricaemia,interstitialnephritis

Generaldisordersandadministrationsitereactions:

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4.9Overdose

Nospecificantidote,butgastriclavageshouldbeemployedifnecessary.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Ethambutolisbacteriostatic.ItiseffectiveagainstMycobacteriumtuberculosisandM.boviswithanMICof0.5-8µgperml.

WhileithasactivityagainstsomeatypicalMycobacteriaincludingM.kansasii,activityagainstothermicro-organismshasnotyet

beenreported.

Itiseffectiveagainsttuberclebacilliresistanttoothertuberculostatics.Cross-resistancehasnotyetbeenreported.Primary

resistancetoethambutolisuncommonbutresistantstrainsofM.tuberculosisarereadilyproducedifethambutolisusedalone.

5.2Pharmacokineticproperties

Ethambutolisreadilyabsorbedafteroraladministrationandthisabsorptionisnotsignificantlyimpairedbyfood.Afterasingle

doseof25mg/kgbodyweight,within4hourspeakplasmaconcentrationsofupto5µg/mlareobtained;by24hoursthe

concentrationdecreasestolessthan1µg/ml.Mostofadoseisexcretedunchangedintheurineandupto20%infaeces,within48

hours.From8-15%ofadoseappearsinurineasinactivemetabolites.

Ethambutolreadilydiffusesintoredbloodcellsandintothecerebrospinalfluidwhenthemeningesareinflamed.Ithasalsobeen

reportedtocrosstheplacenta.

5.3Preclinicalsafetydata

Ethambutolhydrochloridehadbeenshowntobeteratogenicinpregnantmiceandrabbitswhengiveninhighdoses.When

pregnantmiceorrabbitsweretreatedwithhighdosesofethambutolhydrochloride,fetalmortalitywasslightlybutnot

significantly(P>0.05)increased.Femaleratstreatedwithethambutolhydrochloridedisplayedslightbutinsignificant(>0.05)

decreasesinfertilityandlittersize.

Infoetusesbornofmicetreatedwithhighdosesofethambutolhydrochlorideduringpregnancy,alowincidenceofcleftpalate,

exencephalyandabnormalityofthevertebralcolumnwereobserved.Minorabnormalitiesofthecervicalvertebrawereseenin

thenewbornofratstreatedwithhighdoses

ofethambutolhydrochlorideduringpregnancy.Rabbitsreceivinghighdosesofethambutolhydrochlorideduringpregnancygave

birthtotwofoetuseswithmonophthalmia,onewithashortenedrightforearmaccompaniedbybilateralwrist–jointcontracture

andonewithharelipandcleftpalate.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sucrose

Gelatin

Sorbitol70%(Non-crystallizing)

Quinolineyellow(E104)

MagnesiumStearate

StearicAcid

CoatingforTablets

Confectioner’sGlazeNo.5

Shellac

Povidone

Acetylatedmonoglyceride

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6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 o C.Keepthecontainertightlyclosed.

6.5Natureandcontentsofcontainer

Polypropylenebottlewithureascrewcapcontaining56,100or500tablets.

Glassbottlewithmetalscrewcapcontaining56,100or500tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

CyanamidofGreatBritainLimited

FarehamRoad

Gosport

Hampshire

PO130AS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA37/8/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 1 st

April1977

Dateoflastrenewal: 1 st April2007

10DATEOFREVISIONOFTHETEXT

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