DOVONEX

Main information

  • Trade name:
  • DOVONEX Ointment 50 mcg/g Micrograms/g
  • Dosage:
  • 50 mcg/g Micrograms/g
  • Pharmaceutical form:
  • Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOVONEX Ointment 50 mcg/g Micrograms/g
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA0465/132/002A
  • Authorization date:
  • 11-06-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dovonex50micrograms/gOintment

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramofointmentcontains50microgramscalcipotriol.

Excipient:Propyleneglycol(E1520)

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Ointment.

ProductsourcedfromtheUKandGreece:

Afaint,translucentwhitetoyellowishointment.

4CLINICALPARTICULARS

4.1TherapeuticIndications

DovonexOintmentisindicatedforthetopicaltreatmentofplaquepsoriasis(psoriasisvulgaris).Dovonexointment

mayalsobeusedincombinationwithphototherapy,acitretin,cyclosporinortopicalcorticosteroids.

4.2Posologyandmethodofadministration

Adults:Theointmentshouldbeappliedtotheaffectedareaoncetotwicedaily.Twicedailyapplicationoftheointment

isoftenpreferredinitially.Applicationoftheointmentcanbereducedtooncedailywhenappropriate.Maximum

weeklydoseshouldnotexceed100g.

TwicedailyapplicationofDovonexincombinationwithphototherapy,cyclosporinoracitretinandoncedaily

applicationofDovonexincombinationwithcorticosteroids(e.g.administrationofDovonexinthemorningandsteroid

intheevening)iseffectiveandwelltolerated.

TheadditionofDovonextwicedailywillenhancetheefficacyandreducethedosageofcyclosporin,acitretinand

phototherapy.

Children:Over12years:DovonexOintmentshouldbeappliedtotheaffectedareatwicedaily.Maximumweeklydose

shouldnotexceed75g.

Aged6to12years:DovonexOintmentshouldbeappliedtotheaffectedareatwicedaily.Maximumweeklydose

shouldnotexceed50g.

Under6years:ThereislimitedexperienceoftheuseofDovonexOintmentinthisagegroup.Amaximumsafedose

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4.3Contraindications

Useinpatientswithhypersensitivitytoanyofitsconstituents.

DuetothecontentofcalcipotriolDovonexiscontraindictedinpatientswithknowndisordersofcalciummetabolism.

4.4Specialwarningsandprecautionsforuse

DovonexOintmentshouldnotbeusedontheface.Patientsshouldbeadvisedtowashtheirhandsafterapplyingthe

ointmentandtoavoidinadvertenttransfertotheface.Handsmustbewashedaftereachapplication.UseofDovonex

shouldbeavoidedinpatientswithsevererenalfailureorseverehepaticdisorders.

Theriskofhypercalcaemiaisminimalwhendosagerecommendationsarefollowed.Hypercalcaemiamayoccurifthe

maximumweeklydose(100g)isexceeded.However,serumcalciumisquicklynormalisedwhentreatmentis

discontinued.

DuringDovonextreatmentphysiciansmaywishtoadvisepatientstolimitoravoidexcessiveexposuretoeithernatural

orartificialsunlight.TopicalcalcipotriolshouldbeusedwithUVradiationonlyifthephysicianandpatientconsider

thatthepotentialbenefitsoutweighthepotentialrisks(seesection5.3).

Propyleneglycolmaycauseskinirritation.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

Safetyforuseduringhumanpregnancyhasnotyetbeenestablished,althoughstudiesinexperimentalanimalshavenot

shownteratogeniceffects.Avoiduseinpregnancyunlessthereisnosaferalternative.Itisnotknownwhether

calcipotriolisexcretedinbreastmilk.

4.7Effectsonabilitytodriveandusemachines

Doesnotapply.

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.

BasedonclinicaldataforDovonexointmentundesirableeffectsoccurredinapproximately15%ofthepatients.

Pruritus,skinirritation,burningandstingingsensation,dryskin,erythemaandrasharecommon.Contactdermatitis,

eczemaandpsoriasisaggravatedareuncommon.

Systemiceffectsaftertopicalusemayappearveryrarelycausinghypercalcaemiaorhypercalciuria,cf.section4.4.

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Transientchangesinskinpigmentation,transientphotosensitivityreactionsandhypersensitivityreactionsincluding

urticaria,angiodema,periorbitalorfaceoedemahavebeenreportedveryrarely.Perioraldermatitismayoccurrarely.

Basedonpost-marketingdatathetotal‘reportingrate’ofundesirableeffectsisveryrarebeingapproximately1:10,000

treatmentcourses.

TheundesirableeffectsarelistedbeMedDRASOCandtheindividualundesirableeffectsarelistedstartingwiththe

mostfrequentlyreported.

Skinandsubcutaneoustissuedisorders

Pruritus

Skinburningsensation

Skinstingingsensation

Skinirritation

Skindry

Erythema

Rash*

Eczema

Dermatitiscontact

Psoriasisaggravated

Skinhyperpigmentation

Skinpigmentation

Photosensitivityreaction

Urticaria

Faceoedema

Periorbitaloedema

Angiodema

*Varioustypesofrashreactionssuchasscaly,erythematous,maculo-papularandpustularhavebeenreported

Metabolismandnutritiondisorders

Hypercalcaemia

Hypercalciuria

4.9Overdose

Hypercalcaemiamayoccurinpatientswithplaquepsoriasiswhousemorethan100gofDovonexOintmentweeklyand

hasbeenreportedatlowerdosesinpatientswithgeneralisedpustularorerythrodermicexfoliativepsoriasis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

CalcipotriolisavitaminDderivative.Invitrodatasuggestthatcalcipotriolinducesdifferentiationandsuppresses

proliferationofkeratinocytesbutwithlesseffectoncalciummetabolism.Thisistheproposedbasisforitseffectin

psoriasis.

5.2Pharmacokineticproperties

Absorptionthroughskinappearstobelowbutthatwhichreachesthesystemiccirculationisrapidlymetabolizedto

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5.3Preclinicalsafetydata

Theeffectoncalciummetabolismisapproximately100timeslessthanthatofthehormonallyactiveformofvitamin

.Adermalcarcinogenicitystudyinmiceshowednoindicationsofincreasedcarcinogenicrisks.Calcipotriol

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

µg/m²/day).Thehigh-dosewasconsideredtobethemaximumToleratedDosefordermaltreatmentofmicewith

calcipotriol.Survivalwasdecreasedat10and30µg/kg/day,particularlyinthemales.Thereducedsurvivalwas

associatedwithanincreasedincidenceofobstructionuropathy,mostprobablycausedbytreatment-relatedchangesin

theurinarycomposition.ThisisanexpectedeffectoftreatmentwithhighdoseofcalcipotriolorothervitaminD

analogues.Therewerenodermaleffectsandnodermalorsystemiccarcinogenicity.Inastudywherealbinohairless

micewererepeatedlyexposedtobothultraviolet(UV)radiationandtopicallyappliedcalcipotriolfor40weeksatthe

samedoselevelsasinthedermalcarcinogenicitystudy,areductioninthetimerequiredforUVradiationtoinducethe

formationofskintumourswasobserved(statisticallysignificantinmalesonly),suggestingthecalcipotriolmay

enhancetheeffectofUVradiationtoinduceskintumours.Theclinicalrelevanceofthesefindingsisunknown.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Disodiumedetate

Disodiumphosphatedihydrate

DL-alpha-tocopherol

Liquidparaffin

Polyoxyethylene-(2)-stearylether/Macrogol(2)stearylether

Propyleneglycol(E1520)

Purifiedwater

Whitesoftparaffin

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Lacqueredaluminiumtubewithpolypropylenescrewcap,containedinanoutercardboardcarton.

Packsize:30gor60g.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7PARALLELPRODUCTAUTHORISATIONHOLDER

PCOManufacturingLimited

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA0465/132/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:11June2004

10DATEOFREVISIONOFTHETEXT

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