DOVONEX 50 MICROGRAMS/ G CREAM

Main information

  • Trade name:
  • DOVONEX 50 MICROGRAMS/ G CREAM
  • Dosage:
  • 50 mcg/ g Micrograms/ g
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOVONEX 50 MICROGRAMS/G CREAM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA0465/132/001A
  • Authorization date:
  • 11-06-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dovonex50micrograms/gCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramcontains50microgramscalcipotriol(asthehydrate).

Excipient:Cetostearylalcohol

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Cream.

ProductsourcedfromGreeceandtheUK:

Soft,whitecream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Dovonexcreamisindicatedforthetopicaltreatmentofplaquepsoriasis(psoriasisvulgaris).Dovonexcreammayalso

beusedincombinationwithtopicalcorticosteroids.

4.2Posologyandmethodofadministration

Adults:Thecreamshouldbeappliedtotheaffectedareaoncetotwicedaily.Twicedailyapplicationofthecreamis

oftenpreferredinitially.Applicationofthecreamcanbereducedtooncedailywhenappropriate.Maximumweekly

doseshouldnotexceed100g.Dovonexcreamincombinationwithcorticosteroids(e.g.administrationofDovonexin

themorningandsteroidintheevening)iseffectiveandwelltolerated.

Children:Over12years:Dovonexcreamshouldbeappliedtotheaffectedareatwicedaily.Maximumweeklydose

shouldnotexceed75g.

Aged6to12years:Dovonexcreamshouldbeappliedtotheaffectedareatwicedaily.Maximumweeklydoseshould

notexceed50g.

Under6years:ThereislimitedexperienceoftheuseofDovonexcreaminthisagegroup.Amaximumsafedosehas

notbeenestablished.

ThereisnoexperienceofuseofDovonexincombinationwithotherpsoriasistherapiesinchildren.

4.3Contraindications

Useinpatientswithhypersensitivitytoanyofitsconstituents.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 14/04/2011 CRN 2091269 page number: 1

4.4Specialwarningsandprecautionsforuse

Dovonexcreamshouldnotbeusedontheface.Thepatientmustbeinstructedincorrectuseoftheproducttoavoid

applicationandaccidentaltransfertotheface.Handsmustbewashedaftereachapplication.

UseofDovonexshouldbeavoidedinpatientswithsevererenalinsufficiencyorseverehepaticdisorders.

Theriskofhypercalcaemiaisminimalwhenthedosagerecommendationsarefollowed.Hypercalcaemiamayoccurif

themaximumweeklydose(100g)isexceeded.However,serumcalciumisquicklynormalisedwhentreatmentis

discontinued.

DuringDovonextreatmentphysiciansmaywishtoadvisepatientstolimitoravoidexcessiveexposuretoeithernatural

orartificialsunlight.TopicalcalcipotriolshouldbeusedwithUVradiationonlyifthephysicianandpatientconsider

thatthepotentialbenefitsoutweighthepotentialrisks(seesection5.3).

Cetostearlyalcoholmaycauselocalskinreactions.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

Safetyforuseduringhumanpregnancyhasnotyetbeenestablished,althoughstudiesinexperimentalanimalshavenot

shownteratogeniceffects.Calcipotriolshouldnotbeusedduringpregnancyandlacatationunlessclearlynecessary.

4.7Effectsonabilitytodriveandusemachines

Noornegligibleinfluence.

4.8Undesirableeffects

Verycommon>1/10

Common>1/100and<1/10

Uncommon>1/1,000and<1/100

Rare>1/10,000and<1/1,000

Veryrare<1/10,000

Themostfrequentlyreportedundesirableeffectsarevariousskinreactionsandinparticularapplicationsirereaction.

Hypercalcaemiaandallergicreactionshavebeenreportedveryrarely.

BasedonclinicaldataforDovonexcreamundesirableeffectsoccurredinapproximately25%ofthepatients.

Pruritus,skinirritation(especiallyifaccidentallytransferredtoface),burningandstingingsensation,dryskin,

erythemaandrasharecommon.Contactdermatitis,eczemaandpsoriasisaggravatedareuncommon.

Systemiceffectsaftertopicalusemayappearveryrarelycausinghypercalcaemiaorhypercalciuria,cf.section4.4.

Post-marketdataonDovonexcream,ointmentandscalpsolution.Transientchangesinskinpigmentation,transient

photosensitivityreactionsandhypersensitivityreactionsincludingurticaria,angiodema,periorbitalorfaceoedema

havebeenreportedveryrarely.Perioraldermatitismayoccurrarely.

Basedonpost-marketingdatathetotal‘reportingrate’ofundesirableeffectsisveryrarebeingapproximately1:10,000

treatmentcourses.

TheundesirableeffectsarelistedbeMedDRASOCandtheindividualundesirableeffectsarelistedstartingwiththe

mostfrequentlyreported.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 14/04/2011 CRN 2091269 page number: 2

Pruritus

Skinburningsensation

Skinstingingsensation

Skinirritation

Skindry

Erythema

Rash*

Eczema

Dermatitiscontact

Psoriasisaggravated

Skinhyperpigmentation

Skindepigmentation

Photosensitivityreaction

Urticaria

Faceoedema

Periorbitaloedema

Angiodema

*Varioustypesofrashreactionssuchasscaly,erythematous,maculo-papularandpustularhavebeenreported

Metabolismandnutritiondisorders

Hypercalcaemia

Hypercalciuria

Metabolismandnutritiondisorders

Hypercalcaemia

Hypercalciuria

4.9Overdose

Excessiveusemaycauseelevatedserumcalcium,whichrapidlysubsideswhenthetreatmentisdiscontinued.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

CalcipotriolisavitaminDderivative.Invitrodatasuggestthatcalcipotriolinducesdifferentiationandsuppresses

proliferationofkeratinocytesbutwithlesseffectoncalciummetabolism.Thisistheproposedbasisforitseffectin

psoriasis.

5.2Pharmacokineticproperties

Absorptionthroughskinappearstobelowbutthatwhichreachesthesystemiccirculationisrapidlymetabolizedto

inactivesubstances.

5.3Preclinicalsafetydata

Theeffectoncalciummetabolismisapproximately100timeslessthanthatofthehormonallyactiveformofvitamin

.Adermalcarcinogenicitystudyinmiceshowednoindicationsofincreasedcarcinogenicrisks.Calcipotriol

solutionwasappliedtopicallyforupto24monthsatdosesof3,10and30µg/kg/day(correspondingto9,30and90

µg/m 2

/day).Thehigh-dosewasconsideredtobetheMaximumToleratedDosefordermaltreatmentofmicewith

calcipotriol.Survivalwasdecreasedat10and30µg/kg/day,particularlyinthemales.Thereducedsurvivalwas

associatedwithanincreasedincidenceofobstructiveuropathy,mostprobablycausedbytreatment-relatedchangesin

theurinarycomposition.ThisisanexpectedeffectoftreatmentwithhighdosesofcalcipotriolorothervitaminD

analogues.Therewerenodermaleffectsandnodermalorsystemiccarcinogenicity.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 14/04/2011 CRN 2091269 page number: 3

calcipotriolfor40weeksatthesamedoselevelsasinthedermalcarcinogenicitystudy,areductioninthetimerequired

forUVradiationtoinducetheformationofskintumourswasobserved(statisticallysignificantinmalesonly),

suggestingthatcalcipotriolmayenhancetheeffectofUVradiationtoinduceskintumours.Theclinicalrelevanceof

thesefindingsisunknown.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogolcetostearylether

Cetostearylalcohol

Chloroallylhexaminiumchloride

Disodiumedetate

Disodiumphosphatedihydrate

Glycerol85%

Liquidparaffin

Whitesoftparaffin

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductisthedateshownonthecontainerandouterpackageoftheproductonthe

marketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Aluminiumtubewithascrewcapcontainedinanoutercardboardbox.

Packsize:30g,60gand120g

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 14/04/2011 CRN 2091269 page number: 4

7PARALLELPRODUCTAUTHORISATIONHOLDER

PCOManufacturing

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

Ireland

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA465/132/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:11June2004

Dateoflastrenewal:11June2009

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 14/04/2011 CRN 2091269 page number: 5