DOVONEX 50 MICROGRAMS/ML SCALP SOLUTION

Main information

  • Trade name:
  • DOVONEX 50 MICROGRAMS/ML SCALP SOLUTION
  • Dosage:
  • 50 Microgram/ML
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOVONEX 50 MICROGRAMS/ML SCALP SOLUTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA0465/132/003A
  • Authorization date:
  • 11-06-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dovonex50micrograms/mlScalpSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains50microgramscalcipotriol,(asthehydrate).

Excipient:Propyleneglycol

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cutaneousscalpsolution

ProductsourcedfromGreeceandtheUK:

Aclear,colourlessslightlyviscousscalpsolutionwithanodourofmenthol.

4CLINICALPARTICULARS

4.1TherapeuticIndications

DovonexScalpSolutionisindicatedforthetopicaltreatmentofscalppsoriasis.

4.2Posologyandmethodofadministration

Adults:DovonexScalpSolutionshouldbeappliedtwicedaily(morningandevening)totheaffectedareas.Maximum

weeklydoseshouldnotexceed60ml.WhenusedtogetherwithDovonexCreamorOintment,thetotaldoseof

calcipotriolshouldnotexceed5mginanyweek.

Children:ThereisnoexperienceoftheuseofDovonexScalpSolutioninchildren.

4.3Contraindications

Knownhypersensitivitytoanyoftheingredients.

Duetothecontentofcalcipotriol,Dovonexiscontraindictedinpatientswithknowndisordersofcalciummetabolism.

4.4Specialwarningsandprecautionsforuse

DovonexScalpSolutionshouldnotbeusedontheface.Thepatientsmustbeinstructedincorrectuseoftheproductto

avoidapplicationandaccidentaltransfertotheface.Handsmustbewashedaftereachapplication.UseofDovonex

shouldbeavoidedinpatientswithsevererenalfailureorseverehepaticdisorders.

Theriskofhypercalcaemiaisminimalwhendosagerecommendationsarefollowed.Hypercalcaemiamayoccurifthe

maximumweeklydose(60ml)isexceeded.However,serumcalciumisquicklynormalisedwhentreatmentis

discontinued.

DuringDovonex ®

treatmentphysiciansmaywishtoadvisepatientstolimitoravoidexcessiveexposuretoeither

naturalorartificialsunlight.TopicalcalcipotriolshouldbeusedwithUVradiationonlyifthephysicianandpatient

Irish Medicines Board

______________________________________________________________________________________________________________________

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

Propyleneglycolmaycauseskinirritation.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

Standardreproductionstudiesinanimalshaveshownnoevidenceofdrugrelatedabnormality.Thereisnoexperience

ofuseinhumansinpregnancyandlactation,thereforeuseshouldbelimitedtothatconsideredessentialbythe

physician.

4.7Effectsonabilitytodriveandusemachines

None.

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

Themostfrequentlyreportedundesirableeffectsarevariousskinreactionsandinparticularapplicationsitereaction.

Hypercalcaemiaandallergicreactionshavebeenreportedveryrarely.

BasedonclinicaldataforDovonexScalpSolutionundesirableeffectsoccurredinapproximately25%ofthepatients.

Burningandstingingsensationareverycommon.Pruritus,skinirritation,dryskin,erythemaandrasharecommon.

Contactdermatitis,eczemaandaggravatedpsoriasisareuncommon.

Systemiceffectsaftertopicalusemayappearveryrarelycausinghypercalcaemiaorhypercalciuria,cf.section4.4.

Post-marketdataonDovonexcream,ointmentandscalpsolution.Transientchangesinskinpigmentation,transient

photosensitivityreactionsandhypersensitivityreactionsincludingurticaria,angiodema,periorbitalorfaceoedema

havebeenreportedveryrarely.Perioraldermatitismayoccurrarely.

Basedonpost-marketingdatathetotal‘reportingrate’ofundesirableeffectsisveryrarebeingapproximately1:10,000

treatmentcourses.

TheundesirableeffectsarelistedbeMedDRASOCandtheindividualundesirableeffectsarelistedstartingwiththe

mostfrequentlyreported.

Skinandsubcutaneoustissuedisorders

Pruritus

Skinburningsensation

Skinstingingsensation

Skinirritation

Skindry

Erythema

Rash*

Eczema

Dermatitiscontact

Psoriasisaggravated

Skinhyperpigmentation

Irish Medicines Board

______________________________________________________________________________________________________________________

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

Urticaria

Faceoedema

Periorbitaloedema

Angiodema

*Varioustypesofrashreactionssuchasscaly,erythematous,maculo-papularandpustularhavebeenreported

Metabolismandnutritiondisorders

Hypercalcaemia

Hypercalciuria

4.9Overdose

Useabovetherecommendeddosemaycauseelevatedserumcalciumwhichshouldrapidlysubsidewhenthetreatment

isdiscontinued.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

CalcipotriolisavitaminDderivative.Invitrodatasuggestthatcalcipotriolinducesdifferentiationandsuppresses

proliferationofkeratinocytes.Thiseffectistheproposedbasisforitseffectinpsoriasis.

5.2Pharmacokineticproperties

Calcipotriolisonlyslightlyabsorbedfromtheskin.

5.3Preclinicalsafetydata

Theeffectonthecalciummetabolismisapproximately100timeslessthanthatofthehormonallyactiveformof

vitaminD

Adermalcarcinogenicitystudyinmiceshowednoindicationsofincreasedcarcinogenicrisks.Calcipotriol

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

µg/m2/day).Thehigh-dosewasconsideredtobetheMaximumToleratedDosefordermaltreatmentofmicewith

calcipotriol.Survivalwasdecreasedat10and30µg/kg/day,particularlyinthemales.Thereducedsurvivalwas

associatedwithanincreasedincidenceofobstructiveuropathy,mostprobablycausedbytreatment-relatedchangesin

theurinarycomposition.ThisisanexpectedeffectoftreatmentwithhighdosesofcalcipotriolorothervitaminD

analogues.Therewerenodermaleffectsandnodermalorsystemiccarcinogenicity.

Inastudywherealbinohairlessmicewererepeatedlyexposedtobothultraviolet(UV)radiationandtopicallyapplied

calcipotriolfor40weeksatthesamedoselevelsasinthedermalcarcinogenicitystudy,areductioninthetimerequired

forUVradiationtoinducetheformationofskintumourswasobserved(statisticallysignificantinmalesonly),

suggestingthatcalcipotriolmayenhancetheeffectofUVradiationtoinduceskintumours.Theclinicalrelevanceof

Irish Medicines Board

______________________________________________________________________________________________________________________

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

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Hyprolose

Isopropylalcohol

Levomenthol

Sodiumcitrate

Propyleneglycol

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductisthedateshownonthecontainerandouterpackageoftheproductonthe

marketinthecountryoforigin

6.4Specialprecautionsforstorage

Storebelow25°C.

6.5Natureandcontentsofcontainer

WhiteHDPEbottlesfittedwithanLDPEnozzleandblueHDPEscrewcap,containedinanover-labelledouter

cardboardcarton.

Packsize:30mland60ml.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Thealcoholbaseisflammable.

7PARALLELPRODUCTAUTHORISATIONHOLDER

PCOManufacturing

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

Ireland

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA465/132/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Irish Medicines Board

______________________________________________________________________________________________________________________

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

Dateoflastrenewal:11 th

June2009

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

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