DOVONEX

Main information

  • Trade name:
  • DOVONEX Cream 50 5 Milligram
  • Dosage:
  • 50 5 Milligram
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOVONEX Cream 50 5 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1473/049/001
  • Authorization date:
  • 12-11-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dovonex50micrograms/gCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramcontains50microgramsofcalcipotriol(asthehydrate).

Excipients:Containscetostearylalcohol

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Cream

ProductimportedfromtheUK

Softwhitecream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

DovonexCreamisindicatedforthetopicaltreatmentofplaquepsoriasis(psoriasisvulgaris).Dovonexcreammayalso

beusedincombinationwithtopicalcorticosteroids.

4.2Posologyandmethodofadministration

Adults

Thecreamshouldbeappliedtotheaffectedareaoncetotwicedaily.Twicedailyapplicationofthecreamisoften

preferredinitially.Applicationofthecreamcanbereducedtooncedailywhenappropriate.Maximumweeklydose

shouldnotexceed100g.

DovonexCreamincombinationwithcorticosteroids(e.g.administrationofDovonexinthemorningandsteroidinthe

evening)iseffectiveandwelltolerated.

Children

Over12years

DovonexCreamshouldbeappliedtotheaffectedareatwicedaily.Maximumweeklydoseshouldnotexceed75g.

Aged6to12years

DovonexCreamshouldbeappliedtotheaffectedareatwicedaily.Maximumweeklydoseshouldnotexceed50g.

Under6years

ThereislimitedexperienceoftheuseofDovonexCreaminthisagegroup.Amaximumsafedosehasnotbeen

established.

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Date Printed 16/11/2010 CRN 2087161 page number: 1

4.3Contraindications

Knownhypersensitivitytoanyoftheingredients.Duetothecontentofcalcipotriol,Dovonexiscontraindicatedin

patientswithknowndisordersofcalciummetabolism.

4.4Specialwarningsandprecautionsforuse

Dovonexcreamshouldnotbeusedontheface.Thepatientsmustbeinstructedincorrectuseoftheproductto

avoidapplicationandaccidentaltransfertotheface.Handsmustbewashedaftereachapplication.

UseofDovonexshouldbeavoidedinpatientswithsevererenalfailureorseverehepaticdisorders.

Theriskofhypercalcaemiaisminimalwhenthedosagerecommendationsarefollowed.

Hypercalcaemiamayoccurifthemaximumweeklydose(100g)isexceeded.However,serumcalciumisquickly

normalisedwhentreatmentisdiscontinued.

DuringDovonextreatmentphysiciansmaywishtoadvisepatientstolimitoravoidexcessiveexposuretoeither

naturalorartificialsunlight.TopicalcalcipotriolshouldbeusedwithUVradiationonlyifthephysicianand

patientconsiderthatthepotentialbenefitsoutweighthepotentialrisks(Seesection5.3).

Cetostearylalcoholmaycauselocalskinreactions.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

SafetyforuseofCalcipotriolduringhumanpregnancyandlactationhasnotbeenestablished.Studiesinanimalshave

notshownteratogeniceffects.Itisnotknownwhethercalcipotriolisexcretedinbreastmilk.Calcipotriolshouldnotbe

usedduringpregnancyandlactationunlessclearlynecessary.

4.7Effectsonabilitytodriveandusemachines

Calcipotriolhasnoornegligibleinfluenceontheabilitytodriveandtousemachines.

4.8Undesirableeffects

Themostfrequentlyreportedundesirableeffectsarevariousskinreactionsandinparticularapplicationsite

reactions.Hypercalcaemiaandallergicreactionhavebeenreportedveryrarely.

BasedonclinicaldataforDovonexcreamundesirableeffectsoccurredinapproximately25%ofthepatients.

Pruritus,skinirritation,burningandstingingsensation,dryskin,erythemaandrasharecommon.Contact

dermatitis,eczemaandaggravatedpsoriasisareuncommon.Systemiceffectsaftertopicalusemayappearvery

Verycommon >1/10

Common >1/100and<1/10

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

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

Irish Medicines Board

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Date Printed 16/11/2010 CRN 2087161 page number: 2

Post-marketdataonDovonexcream,ointmentandscalpsolution

Transientchangesinskinpigmentation,transientphotosensitivityreactionandhypersensitivityreactionincluding

urticaria,angioedema,periorbitalorfacialoedemahavebeenreportedveryrarely.Perioraldermatitismayoccur

rarely.

Basedonpost-marketingdatathetotal‘reportingrate’ofundesirableeffectsisveryrarebeingapproximately

1:10,000treatmentcourses.

TheundesirableeffectsarelistedbyMedDRASOCandtheindividualundesirableeffectsarelistedstartingwith

themostfrequentlyreported.

Skinandsubcutaneoustissuedisorders:

Pruritus

Skinburningsensation

Skinstingingsensation

Skinirritation

Skindry

Erythema

Rash*

Eczema

ContactDermatitis

AggravatedPsoriasis

Skinhyperpigmentation

Skindepigmentation

Photosensitivityreaction

Urticaria

Facialoedema

Periorbitaloedema

Angioedema

*varioustypesofrashreactionsuchasscaly,erythematous,maculo-papularandpustularhavebeenreported.

Metabolismandnutritiondisorders

Hypercalcaemia

Hypercalciuria

4.9Overdose

Useabovetherecommendeddosemaycauseelevatedserumcalcium,whichquicklysubsideswhentreatmentis

discontinued.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

CalcipotriolisavitaminDderivative.Invitrodatasuggestthatcalcipotriolinducesdifferentiationandsuppresses

proliferationofkeratinocytesbutwithlesseffectoncalciummetabolism.Thisistheproposedbasisforitseffectin

psoriasis.

5.2Pharmacokineticproperties

Absorptionthroughskinappearstobelowbutthatwhichreachesthesystemiccirculationisrapidlymetabolisedto

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5.3Preclinicalsafetydata

Theeffectoncalciummetabolismisapproximately100timeslessthanthatofthehormonallyactiveformofvitamin

D.

Adermalcarcinogenicitystudyinmiceshowednoindicationsofincreasedcarcinogenicrisks.Calcipotriolsolution

wasappliedtopicallyforupto24monthsatdosesof3,10and30µg/kg/day(correspondingto9,30and90

µg/m 2

/day).Thehigh-dosewasconsideredtobetheMaximumToleratedDosefordermaltreatmentofmicewith

calcipotriol.Survivalwasdecreasedat10and30µg/kg/day,particularlyinmales.Thereducedsurvivalwas

associatedwithanincreasedincidenceofobstructiveuropathy,mostprobablycausedbytreatment-relatedchangesin

theurinarycomposition.ThisisanexpectedeffectoftreatmentwithhighdosesofcalcipotriolorothervitaminD

analogues.Therewerenodermaleffectsandnodermalorsystemiccarcinogenicity.

Inastudywherealbinohairlessmicewererepeatedlyexposedtobothultraviolet(UV)radiationandtopicallyapplied

calcipotriolfor40weeksatthesamedoselevelsasinthedermalcarcinogenicitystudy,areductioninthetimerequired

forUVradiationtoinducetheformationofskintumourswasobserved(statisticallysignificantinmalesonly),

suggestingthatcalcipotriolmayenhancetheeffectofUVradiationtoinduceskintumours.Theclinicalrelevanceof

thesefindingsisunknown.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogolcetostearylether

Cetostearylalcohol

Chloroallylhexaminiumchloride

Disodiumedetate

Disodiumphosphatedihydrate

Glycerol85%

Liquidparaffin

Whitesoftparaffin

Sodiumhydroxide

Purifiedwater

6.2Incompatibilities

Shouldnotbemixedwithothermedicinalproducts.

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductshallbethedateshownontheoverlabelledtubeandoutercartonofthe

productonthemarketinthecountryoforigin,afterEXP.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Keepthecreamawayfromheatandbrightsunlight.

6.5Natureandcontentsofcontainer

Aluminiumtubewithscrewcap.Packsizes:60gand120g.

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

McDowellPharmaceuticals

4AltonaRoad

Lisburn

N.Ireland

BT275QB

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1473/49/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:12thNovember2010

Irish Medicines Board

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Date Printed 16/11/2010 CRN 2087161 page number: 5