CURATODERM

Main information

  • Trade name:
  • CURATODERM Cutaneous Emulsion 4 Microgram
  • Dosage:
  • 4 Microgram
  • Pharmaceutical form:
  • Cutaneous Emulsion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CURATODERM Cutaneous Emulsion 4 Microgram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0043/027/002
  • Authorization date:
  • 02-12-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0043/027/002

CaseNo:2042784

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

CrookesHealthcareLtd

1ThaneRoadWest,Nottingham,NG23AA,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Curatoderm4Micrograms/gCutaneousEmulsion

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom18/09/2008until01/12/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 03/10/2008 CRN 2042784 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Curatoderm4micrograms/gCutaneousEmulsion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgofemulsioncontains4.17microgramstacalcitolmonohydrateequivalentto4microgramstacalcitol.

Excipients:propyleneglycol,dodecylgallate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cutaneousemulsion

White,thinemulsion.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Topicaltreatmentofmildtomoderatepsoriasis,especiallyonthescalp.

4.2Posologyandmethodofadministration

Cutaneousemulsion.

Children(<12years):TheuseofCuratodermEmulsioninchildrenunder12yearsisnotrecommended(seesection4.4).

Adultsandchildrenover12years:CuratodermEmulsionisappliedoncedailytotheaffectedareas,preferablyintheevening.

Duetolackofexperienceonpsoriaticlesionsinpalmoplantar,facial,intertriginous,genitocrurallocalizationtreatmentcannotbe

recommended.Notmorethan15%ofthebodysurfaceshouldbetreated.

Amaximumdailydoseof10mlandaweeklydoseof70mlshouldnotbeexceeded,becausehypercalcaemiaandsecondary

effectstotheorganscannotdefinitelybeexcludedathigherdoses.Thisappliesforadurationoftreatmentupto8weeksfor

treatmentofthescalp.Fortreatmentonthebodyadurationoftreatmentupto12weeksispossible.Foralongerdurationof

treatmentclinicaldataareonlyavailableforCuratodermointmentbutnotfortheemulsion.

Itisrecommendedtomonitorproteininurineinreasonablylengthyintervalsinallpatients.

4.3Contraindications

Curatoderm4micrograms/gCutaneousEmulsionshouldnotbeusedinanyofthefollowingcases:

Hypersensitivitytotheactivesubstanceortoanyoftheexcipients;

Psoriasispunctataorpsoriasispustulosa;

Patientswithseverehepatic,renalorheartdiseasesbecausethereisnoexperience;

Patientswithhypercalcaemiaorotherdisordersofcalciummetabolism.

4.4Specialwarningsandprecautionsforuse

Children(<12years):TheuseofCuratoderm4micrograms/gCutaneousEmulsionwithchildrenunder12yearsisnot

Irish Medicines Board

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Contactwiththeeyesshouldbeavoided.IfCuratoderm4micrograms/gCutaneousEmulsionaccidentallycomesinto

contactwiththeeyes,thoroughrinsingwithwaterisrecommended.

Propyleneglycolmaycauseirritationoftheskin.

Dodecylgallatemaybemildlyirritanttotheskin,theeyesandmucosemembrane.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Interactionswithothermedicinalproductsareunknown.

Thereisnoexperiencewiththeconcomitantuseofotherantipsoriatics.

Itisadvisabletomonitortheserumcalciumlevelinpatientsconcomitantlytreatedwithcalciumand/orvitaminD

preparations.

InthecaseofirradiationoftheskinwithUltra-violetlight(sunlightorartificiallightsources)Curatoderm4

micrograms/gCutaneousEmulsionshouldbeusedlater.ThereforeitisrecommendedtoapplyCuratoderm4

micrograms/gCutaneousEmulsionintheevening.

4.6Pregnancyandlactation

Pregnancy

ForCuratoderm4micrograms/gCutaneousEmulsionnoclinicaldataonexposedpregnanciesareavailable.Animal

studieshaveshownnoembryotoxiceffectsinratsandrabbits(see5.3).Thepotentialriskforhumansisunknown.

Therefore,treatmentwithCuratoderm4micrograms/gCutaneousEmulsionshouldbeavoidedduringpregnancy.

Lactation

Tacalcitolanditsmajormetaboliteareexcretedinthemilkofrats.Itisnotknownwhethertacalcitolisexcretedin

humanbreastmilk.Therefore,treatmentduringlactationisnotindicated.

4.7Effectsonabilitytodriveandusemachines

Notrelevant.

4.8Undesirableeffects

Frequencyestimate:verycommon(1/10),common(1/100to<1/10),uncommon(1/1,000to<1/100),rare(

1/10,000to<1/1,000),veryrare(<1/10,000),notknown(cannotbeestimatedfromtheavailabledata).

Skinandsubcutaneoustissuedisorders:ThetopicalapplicationofCuratodermEmulsionmaycommonlybeaccompaniedby

localskinreactions(e.g.burning,erythema)oritching.Ingeneral,localskinreactionsanditchingaremildandtransient.Inrare

casescontactdermatitisoraggravationofpsoriasishavebeenobservedwithtacalcitoltreatment.

Frequencyestimate:verycommon(1/10),common(1/100to<1/10),uncommon(1/1,000to<1/100),rare(

1/10,000to<1/1,000),veryrare(<1/10,000),notknown(cannotbeestimatedfromtheavailabledata).

Skinandsubcutaneoustissuedisorders:ThetopicalapplicationofCuratodermEmulsionmaycommonlybeaccompaniedby

localskinreactions(e.g.burning,erythema)oritching.Ingeneral,localskinreactionsanditchingaremildandtransient.Inrare

casescontactdermatitisoraggravationofpsoriasishavebeenobservedwithtacalcitoltreatment.

4.9Overdose

Itcannotbeexcludedthattopicalapplicationofexcessiveamountsmayleadtohypercalcaemia.Inthiscasetreatment

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Otherantipsoriaticsfortopicaluse.

ATCcode:D05AX04.

Tacalcitol,theactivesubstanceinCuratoderm4µg/gCutaneousEmulsion,isaVitaminD

analoguethatinhibits

epidermalhyperproliferation,promotesnormalkeratinisationandmodulatesinflammationprocesses.

ThesecharacteristicsrelateessentiallytoatargetedpharmacologicaleffectofCuratodermonpsoriasis.

5.2Pharmacokineticproperties

DataregardingpercutaneousresorptionoftacalcitolfollowingatopicalapplicationofCuratoderm4micrograms/g

CutaneousEmulsionarenotavailable.

Tacalcitoliscompletelyboundtoplasmaproteins(VitaminDbindingprotein).Themainmetabolite,1,24,25(OH)

VitaminD,isidenticaltothatofthenaturallyoccurringactivevitaminanditsVitaminDactivityis5to10times

weaker.Tacalcitolanditsmetabolitesweremostlyeliminatedinurineandfaecesinstudiesonratsanddogs.

5.3Preclinicalsafetydata

TacalcitolisavitaminD

analogue;thetoxiceffectsoftacalcitolobservedinanimalsstudieswererelatedtothe

pharmacologicaleffectsofvitaminD,i.e.hypercalcaemiaanditssequelae,e.g.calcificationofmanyorgans,bone

hyperplasia,atrophyofthethymus,spleen.Theseeffectsoccurredafterrepeatedpercutaneousdosesinratsatclinically

relevantdoses.Mutagenicitystudiesindicatenogenotoxicpotentialoftacalcitol.Thecarcinogenicpotentialof

tacalcitolhasnotbeeninvestigated.Studiesonreproduction(ratsandrabbitsinvolvingthesubcutaneousadministration

oftheactivesubstance)showednoindicationoftoxiceffectsoftacalcitolontheembryoorfoetus,post-nataleffectsin

theissueordisturbancestofertility.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Purifiedwater

Lightliquidparaffin

Medium-chaintriglycerides

Propyleneglycol

Octyldodecanol

Polyoxyethylene(21)stearylether

Diisopropyladipate

Phenoxyethanol

Disodiumphosphatedodecahydrate

Xanthangum

Potassiumdihydrogenphosphate

Disodiumedetate

Dodecylgallate

6.2Incompatibilities

Irish Medicines Board

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Date Printed 03/10/2008 CRN 2042784 page number: 4

6.3ShelfLife

3years.

Afterfirstopeningthecontainer:6months.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Plasticbottlewithnozzleandscrewcap[HDPE].

Packsizes:20ml,30ml,50ml,2x30ml,2x50mland5x50ml.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

CrookesHealthcareLimited

Nottingham

NG23AA

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA43/27/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:02December2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 03/10/2008 CRN 2042784 page number: 5