ETRIVEX

Main information

  • Trade name:
  • ETRIVEX Cutaneous Emulsion 500 Micrograms/g
  • Dosage:
  • 500 Micrograms/g
  • Pharmaceutical form:
  • Cutaneous Emulsion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ETRIVEX Cutaneous Emulsion 500 Micrograms/g
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0590/022/001
  • Authorization date:
  • 11-11-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA0590/022/001

CaseNo:2033593

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

Galderma(UK)Ltd

MeridienHouse,69-71ClarendonRoad,Watford,HertsWD171DS,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Etrivex500micrograms/gcutaneousemulsion

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom02/08/2007until.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 03/08/2007 CRN 2033593 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Etrivex500micrograms/gcutaneousemulsion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onegramofcutaneousemulsioncontains500microgramsofclobetasolpropionate.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cutaneousemulsion

White,fluidemulsion.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Topicaltreatmentofmoderatetosevereplaque-typepsoriasisinadults.

4.2Posologyandmethodofadministration

Forcutaneoususe.

Etrivex500micrograms/gcutaneousemulsionshouldbeappliedinthinlayerwithoutocclusiontothepsoriasis

affectedareasnotmorethantwiceperday.Itshouldberubbedingentlyuntilcompleteabsorption.

Thetreatmentdurationshouldbeadaptedtothepatient(seesection4.4)andlimitedtomaximum4weeks.Ifno

improvementisseenwithintwotofourweeks,reassessmentofthediagnosismaybenecessary.Assoonasclinical

resultsareobserved,applicationsshouldbespacedoutorreplacedbyapplicationswithadermocorticoidoflesspotent

activity.Therapyshouldbediscontinuedwhenthecontrolisachieved.

RepeatedcoursesofEtrivex500micrograms/gcutaneousemulsionmaybeusedtocontrolexacerbations.

Notmorethan50gofcutaneousemulsionshouldbeusedperweek.

ThesafetyandefficacyofEtrivex500micrograms/gcutaneousemulsionhavenotbeenevaluatedinchildren;

therefore,theuseofEtrivex500micrograms/gcutaneousemulsionisnotrecommendedinchildrenandadolescents

below18yearsofage(seesections4.3and4.4).

4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Skinareasaffectedbybacterial,viral(varicella,herpessimplex,herpeszoster),specificskindiseases(skin

tuberculosis,skindiseasescausedbylues),fungalorparasiticinfections,acnevulgaris,rosaceaorperioral

dermatitis(seesection4.8).

Etrivex500micrograms/gcutaneousemulsionmustnotbeappliedtotheeye(riskof

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Dermatosesinchildrenunder2yearsofage,includingdermatitisandnapkineruptions.

Perianalandgenitalpruritus.

4.4Specialwarningsandprecautionsforuse

Topicalcorticosteroidsshouldbeusedwithcautionforanumberofreasonsincludingposttreatmentreboundrelapses,

developmentoftolerance(tachyphylaxis)anddevelopmentoflocalorsystemictoxicity.Inrareinstances,treatmentof

psoriasiswithcorticosteroids(oritswithdrawal)isthoughttohaveprovokedgeneralisedpustularpsoriasisincaseof

intensiveandprolongedtopicaluse.

Treatmentoflargeskinareas,useoflargeamountsofcutaneousemulsion,useofocclusivedressingsortreatmentof

childrencanleadtoahigherriskofsystemiceffects.Insuchcases,medicalsupervisionshouldbeincreasedand

patientsshouldbeevaluatedperiodicallyforevidenceofHypothalamus-Pituitary-Adrenal(HPA)axissuppression.

Suchsystemiceffectsdisappearwhentreatmentisstopped.However,abruptdiscontinuationcanleadtoacuteadrenal

insufficiency,especiallyinchildren.

IfEtrivex500micrograms/gcutaneousemulsionisrequiredforuseinchildrenandadolescentsbelow18yearsofage,

itisrecommendedthatthetreatmentshouldbereviewedweekly.Itshouldbenotedthataninfant’snapkinmayactas

anocclusivedressingandthereforeEtrivex500micrograms/gcutaneousemulsionmustnotbeusedinthenapkin’s

area.

Patientswithsevereliverdysfunctionandseverediabetesmellitusshouldbetreatedwithspecialcautionandclosely

monitoredforside-effects.

Etrivex500micrograms/gcutaneousemulsionisnotrecommendedforuseintheface,eyelids,intertriginousareas

(axillaeandgenitoanalregions)andonerosiveskinsurfacesasthiscouldincreasestheriskoftopicaladverseevents

suchasatrophicchanges,telangiectasiaorcortico-induceddermatitis.

IfEtrivex500micrograms/gcutaneousemulsiondoesentertheeye,theaffectedeyeshouldberinsedwithcopious

amountsofwater.

Etrivex500micrograms/gcutaneousemulsioncontainspropyleneglycolasexcipientwhichmaycauseskinirritation.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonereported.

4.6Pregnancyandlactation

Pregnancy

Therearenoadequatedatafromtheuseoftopicalclobetasolpropionateinpregnantwomen.Studiesinanimalhave

shownreproductivetoxicity(seesection5.3).Thepotentialriskforhumansisunknown.Althoughnotdemonstratedin

allepidemiologicalstudies,apossibleassociationbetweenexposuretoglucocorticoidsduringthefirsttrimesterof

pregnancyandanincreasedriskofcleftlipwithorwithoutcleftpalateinhumanfoetuseswasshown.Intrauterine

growthretardationhasbeendescribedinhumansandanimalsforcorticoidsaftersystemicexposure.

Asaprecautionarymeasure,theuseoftopicalclobetasolpropionateshouldthereforebeavoidedduringpregnancy.If

applicationisclearlynecessaryandthepotentialbenefitjustifiesthepotentialrisktothefoetus,thedurationofuse

shouldbeasshortaspossibleandtheskin/mucosaareatreatedshouldbeassmallaspossible.

Infantsbornofmotherswhoreceivedcorticoidstowardstheendofpregnancyaretobeobservedcarefullyforsignsof

hypoadrenalism.

Lactation

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Nevertheless,astherearenoadequatedataonthepossiblemilktransferoftopicalclobetasolpropionateandits

biologicalorclinicalrepercussions,Etrivex500micrograms/gcutaneousemulsionshouldnotbeprescribedto

breastfeedingwomenunlessclearlyindicated.

4.7Effectsonabilitytodriveandusemachines

Asatopicalcorticosteroid,Etrivex500micrograms/gcutaneousemulsionhasnoornegligibleinfluenceontheability

todriveandusemachines.

4.8Undesirableeffects

Themostcommonlyreportedadversedrugreactionsare:burning/stinging,skindryness,irritation,erythema,

folliculitis,pruritus,skinatrophyandtelangiectasia.Theirincidenceisabout4%.Mostadverseeventsareratedas

mildtomoderateandtheyarenotaffectedbyraceorgender.

Noseriousdrug-relatedadverseeventswerereportedduringanyoftheclinicaltrials.Theseundesirableeffectsmay

occurmorefrequentlywiththeuseofocclusivedressings.

Ifsignsoflocalintoleranceappear,applicationshouldbesuspendeduntiltheydisappear.Ifsignsofhypersensitivity

appear,applicationshouldbestoppedimmediately.

Thetablebelowreportstheadversereactionsrelatedtotreatmentbybodysystemandbyabsolutefrequency:

Asaclassattribution,prolongeduseoftopicalcorticosteroids,treatmentofextensiveareasoruseoflargeamountscan

resultinsufficientsystemicabsorptiontoproducethefeaturesofhypercortisolism(Cushingsyndrome)orof

Hypothalamus-Pituitary-Adrenalaxissuppression.ShouldHPAaxissuppressionoccur,itislikelytobetransientwith

arapidreturntonormalvalues.Sucheffectsaremorelikelytooccurwhenocclusivedressingsareused(seesections

4.2and4.4).

Prolongedand/orintensivetreatment(e.g.onalargebodysurfacearea)withpotentcorticosteroidpreparationsmay

causelocalatrophicchanges,suchaslocalskinatrophy,striae,telangiectasia,erythema,purpura,contactdermatitis

especiallywhenocclusivedressingsareusedorwhenskinfoldsareinvolved.

Whenappliedtotheface,verypotentcorticosteroidscaninduceperioraldermatitis,skinatrophyorworsenrosacea

(seesection4.3).

Therearereportsofpigmentationchanges,acne,pustulaeruptionsandhypertrichosiswithtopicalcorticosteroids.

4.9Overdose

Acuteoverdosageisveryunlikelytooccur,however,inthecaseofchronicoverdosageormisuse,thefeaturesof

hypercortisolismmayappearandinthissituation,treatmentshouldbediscontinuedgradually.

However,becauseoftheriskofacuteadrenalsuppression,thisshouldbedoneundermedicalsupervision.

BodySystem Incidence Adversereactions

Cutaneous

manifestations Common

(>1/100,<1/10)

Uncommon

(>1/1000,<1/100) Skinatrophy,

Telangiectasia

Burning/stinging,

Skindryness,

Irritation,

Erythema,

Folliculitis,

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5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Corticosteroids,verypotent.

ATCcode:D07AD01.

Likeothertopicalcorticosteroids,clobetasolpropionatehasanti-inflammatory,antipruritic,andvasoconstrictive

properties.VasoconstrictionstudieshaveshownthatEtrivex500micrograms/gcutaneousemulsionisinthevery

potentrangeofactivityascomparedwithothertopicalcorticosteroids.Themechanismoftheanti-inflammatory

activityoftopicalcorticosteroidsingeneralisunclear.However,corticosteroidsarethoughttoactbyinductionof

phospholipaseA

inhibitoryproteins,collectivelycalledlipocortins.Itispostulatedthattheseproteinscontrolthe

biosynthesisofpotentmediatorsofinflammationsuchasprostaglandinsandleukotrienesbyinhibitingthereleaseof

theircommonprecursor,arachidonicacid.Arachidonicacidisreleasedfrommembranephospholipidsby

phospholipaseA

5.2Pharmacokineticproperties

Theextentofpercutaneousabsorptionoftopicalcorticosteroidsisdeterminedbymanyfactors,includingtheseverity

ofthedisease,thesurfacetreated,thevehicle,theintegrityoftheepidermalbarrierandocclusion.Topical

corticosteroidscanbeabsorbedfromnormalintactskin.Inflammationandotherdiseaseprocessesintheskinmay

increasepercutaneousabsorption.Therearenohumandataregardingthedistributionofcorticosteroidstobodyorgans

followingtopicalapplication.Nevertheless,onceabsorbedthroughtheskin,topicalcorticosteroidsarehandled

throughpharmacokineticpathwayssimilartosystemicallyadministeredcorticosteroids,i.e.metabolisedprimarilyby

theliverandthenexcretedbythekidneys.Clobetasolpropionatedoesnotaccumulatewhenadministeredtorats.

5.3Preclinicalsafetydata

Preclinicaldatarevealednospecialhazardforhumansbasedonconventionalstudiesofsafetypharmacology,single

andrepeateddosetoxicity.

Indevelopmentaltoxicitystudiesinboththerabbitandmouse,clobetasolpropionatewasshowntobeteratogenic

whenadministeredsubcutaneouslyatlowdoses.Inanembryotoxicitystudyperformedinratsbytopicalroute,foetal

immaturity,skeletalandvisceralmalformationswereobservedatrelativelylowdosagelevels.Therelevanceofthese

datatohumansafterdermalapplicationsofclobetasolpropionateisunknown.

Basedontheavailabledatathereisnoindicationthatclobetasolpropionatehasanygenotoxicpotential.

Long-termanimalstudieshavenotbeenperformedtoevaluatethecarcinogenicpotentialofclobetasolpropionate.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Hypromellose

Propyleneglycol

Liquidparaffin

PEG-6isostearate

Carbomercopolymer

Sodiumhydroxide

Purifiedwater

6.2Incompatibilities

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6.3ShelfLife

3years.

Shelflifeafterfirstopening:4weeks.

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageprecaution.

Afterfirstopening,donotstoreabove25°C.

6.5Natureandcontentsofcontainer

15g,30g,60gor120ginHDPEbottlesfittedwithpolypropylenecaps.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Galderma(UK)Ltd

MeridienHouse

69-71ClarendonRoad

Watford

Herts

WD171DS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA590/22/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:11November2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 03/08/2007 CRN 2033593 page number: 6