CURATODERM

Main information

  • Trade name:
  • CURATODERM Ointment 4 mcg/gr Microgram
  • Dosage:
  • 4 mcg/gr Microgram
  • Pharmaceutical form:
  • Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CURATODERM Ointment 4 mcg/gr Microgram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0043/027/001
  • Authorization date:
  • 13-11-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CuratodermOintment4 mcg/g

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Theointmentcontainstacalcitolmonohydrate4.17 mcg/g equivalentto tacalcitol

4 mcg/g.

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Ointment

Homogeneous, glossy, translucent, whiteodourlessointment.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Psoriasisvulgaris

4.2Posologyandmethodofadminstration

Adultsand Elderly:Apply sparingly, oncedaily to theaffected areas, preferablyatbedtime. Theamountapplied should

notexceed 5g ofointment/day. Normally duration oftreatmentdependson theseverity ofthelesionsandshould be

decidedby thephysician. Experienceshowsthattreatmentwillnotusually need to exceed2 periodsof12 weekseach

year.

Children:Notrecommended.Thereisno clinicalexperiencein children.

4.3Contraindications

Hypersensitivity to constituents;in patientswith hypercalcaemiaorotherknown disordersofcalciummetabolism.

4.4Special warningsandspecialprecautionsforuse

In patientsatrisk ofhypercalcaemia, albumin corrected serumcalciumlevelsshould beclosely monitored. Treatment

should bestopped ifhypercalcaemiaoccurs. Serumcalciumlevelsshould also bemonitored in patientswith renal

impairment. Curatodermisnotrecommended foruseon thescalp.

Careshould beexercised in patientswith generalised pustularorerythrodermicexfoliativepsoriasisastherisk of

hypercalcaemiamay beenhanced.

When applying to thefaceavoid contactwith theeyes. Patientsshould beadvised to wash theirhandsafterapplying

theointmentto avoid inadvertenttransferto otherpartsofthebody.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Irish Medicines Board

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Ultravioletlightincluding sunlightmay degradetacalcitol. When combining UV-treatmentwith tacalcitoltopical

therapy, UV-lightshould begiven in themorning and tacalcitolatbedtime.

When patientsarelikely to beexposed to sunlight, tacalcitolshould beapplied atbedtime.

4.6Pregnancyandlactation

Thesafety ofthismedicinalproductforusein human pregnancy hasnotbeen established. Evaluation ofexperimental

animalstudiesdoesnotindicatedirectorindirectharmfuleffectswith respectto thedevelopmentoftheembryo or

foetus, thecourseofgestation orperi-orpostnataldevelopment.

Avoid usein pregnancy unlessthereareno saferalternatives.

During lactation thebreastareashould notbetreated. Itisnotknown whethertacalcitolisexcreted in human breast

milk.

4.7Effectsonabilitytodriveandusemachines

Curatodermisunlikely to produceany effecton theability to driveand usemachines.

4.8Undesirableeffects

Localskin reactions(itching, erythema, burning, paraesthesia)havebeen reported in 1%ofthepatients. Otherlocal

reactionsmay occur.

4.9Overdose

Overdosing by ingestion ofan ointmentisvery unlikely. Itcannotbeexcluded thattopicalapplication ofexcessive

amountsmay lead to hypercalcaemia.

In thiscaseCuratodermtreatmentand otherpossiblevitamin Dorcalciumsupplementintakesmustbestopped until

serumcalciumreturnsto normal.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:D05AX02

Tacalcitolisavitamin D

derivative, which inhibitskeratinocytehyper-proliferation and inducesdifferentiation of

thesecells. Thenormalisation ofthesemechanismsisthebasisfortheefficacy in thetreatmentofpsoriasis.

In biopsiesfrompatientstreated with tacalcitolspecificindicatorsforinflammation wereimproved.

Tacalcitolbindsto thekeratinocytevitamin Dreceptorto thesameextentasnaturalactivevitamin D

.

5.2Pharmacokineticproperties

Singleorrepeated application oftacalcitolointmentin humansresultsin lessthan 0.5%ofthedrug being systemically

absorbed through psoriaticskin.

Tacalcitoliscompletely bound to plasmaproteins(vitamin Dbinding protein).

Themain metaboliteis1,24, 25 (OH)

vitamin D

, metaboliteshared with thenaturalactivevitamin, with 5-10 times

lessvitamin Dactivity. Tacalcitoland metabolitesareexcreted mainly in thefaecesin ratand dog studieswith

excretion in urinein man. Itcannotthereforebeexcluded thatifthereissufficientsystemicabsorption accumulation

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5.3Preclinical safetydata

Tacalcitoliseffectiveatvery lowconcentrations. Theno-effect-levelfollowing cutaneousapplication for12 monthsin

ratswas4 ng/kg daily. Toxicity istypically thatofthecalciferols.

Teratogenicity studiesin miceand ratsshowed no teratogeniceffectsoftacalcitol.

Theresultsofmutagenicity studies(Amestest, chromosomalaberration testand micronucleustest)indicateno

genotoxicpotential.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Whitesoftparaffin

Liquid paraffin

Di-isopropyladipate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Unopened:3 years

Opened: 6 monthsafterdateoffirstopening.

6.4Special precautionsforstorage

Do notstoreabove30°C.

6.5Natureandcontentsofcontainer

Aluminiumtubeswith internallacquer, membrane-sealed opening and plasticscrewcap, containing 20 g, 30 g, or60 g.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

CrookesHealthcareLimited,

POBox 57,

CentralPark,

Lenton Lane,

Nottingham, NG2 3AA,

United Kingdom

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:13th November1998

Dateoflastrenewal:13th November2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 03/08/2005 CRN 2012445 page number: 4