BATRAFEN 10MG/G

Main information

  • Trade name:
  • BATRAFEN 10MG/G
  • Dosage:
  • 10 %v/v
  • Pharmaceutical form:
  • Shampoo
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BATRAFEN 10MG/G
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0540/032/005
  • Authorization date:
  • 26-08-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0540/032/005

CaseNo:2072051

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

sanofi-aventisIrelandLimited

CitywestBusinessCampus,Dublin24,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Batrafen10mg/gShampoo

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom05/11/2009until25/08/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 05/11/2009 CRN 2072051 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Batrafen10mg/gShampoo

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onegramshampoocontains10mgciclopirox.

Forexcipientsseesection6.1.

3PHARMACEUTICALFORM

Shampoo

Almostcolourlesstoyellowish,translucentsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Batrafen10mg/gShampooisindicatedforthetreatmentofseborrhoeicdermatitisofthescalp.

4.2Posologyandmethodofadministration

Forcutaneoususe.

FortheinitialtreatmentofthesymptomsofseborrhoeicdermatitisBatrafen10mg/gShampooisappliedonthescalp

onceortwiceaweek,dependingonseverity,forfourweeks.

Forsubsequentprophylaxisofsymptoms,thetreatmentmaybecontinuedforafurther12weeks.

Thecontentsofonesealingcup(about5ml)Batrafen10mg/gShampooareappliedtothewethairandscalpand

workedtoalather.Thisisthenthoroughlymassagedonthescalp.Ifthehairhasmorethanshoulderlength,uptotwo

capful(about10ml)areused.Batrafen10mg/gShampooislefttotakeeffectfor3minutesandisthenrinsedoffwith

water.

Theproducthasnotbeentestedinchildren.

TheuseofBatrafen10mg/gShampooislimitedtoamaximumof16-weeksofcontinuoususe.

4.3Contraindications

Batrafen10mg/gShampooshouldnotbeusedinknownhypersensitivitytociclopirox,ciclopirox-olamine,parabensor

toanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

WhenusingBatrafen10mg/gShampoo , patientsshouldbeadvisedtoavoidcontactwitheyes.Ifaccidentalcontact

occurs,rinseeyeswithcopiousamountsofwater.

ThismedicinalproductcontainsParabensandtheiresters,andcanthereforemaycauseimmediateordelayed

hypersensitivityreactions.Benzoicacidcancausemildirritationofskin,eyesandmucosae.

Incaseofirritationorsensitisationafterprolongeduseoftheproduct,thetherapyshouldbestoppedandanother

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Therearenoknownreportsofinteractionsbetweenciclopiroxandothermedicinalproducts.

4.6Pregnancyandlactation

Pregnancy:

Noclinicaldataonexposedpregnanciesareavailableforciclopirox.Animalstudiesdonotindicatedirectorindirect

harmfuleffectswithrespecttopregnancy,embryonal/foetaldevelopmentandparturition.However,thereareno

sufficientdataconcerningpossiblelongtermeffectsonpostnataldevelopment(seesection5.3).

Asaprecautionarymeasure,inventednameshouldthereforenotbeusedinpregnancy.

Lactation:

Theexcretionofciclopiroxinhumanmilkisunknown.Therefore,breast-feedingwomenshouldnotuseBatrafen

10mg/gShampoo.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

ImmuneSystemDisorders

Rare(>1/10,000and<1/1000):Allergiccontactdermatitismayoccur.

SkinAndSubcutaneousDisorders

Uncommon(>1/1000;<1/100):Hairdisorders,likemattedanddullhair,milddryhair,mildhairlossordiscoloration

andskinreactionsattheapplicationsitesuchasirritationandeczemaandsubjectivediscomfortsuchasburningand

itching.Parabensmaycausehypersensitivityreactions,includingdelayedreactions.

4.9Overdose

Noexperiencewithciclopiroxcontainingpreparationsoverdosageisavailable.HowevertoofrequentuseofBatrafen

10mg/gShampooshouldnotbeexpectedtoleadtoanymajorsystemiceffects.

Incaseofaccidentalingestion,adequatetreatmentshouldbeinitiated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:antifungalagents.

ATCcode:D01AE14(otherantifungalsfortopicaluse).

CiclopiroxisabroadspectrumN-hydroxypyridoneantifungalagentwithfungicidalactionagainstpathogenic

dermatophytes,mouldsandyeastsincludingPityrosporumovalewhichisregardedasprincipalcauseofseborrhoeic

dermatitis.

Preclinicalstudiesasteepdose-responsecurveindicatingnotonlyfungistaticbutalsofungicidalactivity,afavourable

pH-optimum,alongdurationofaction,alowinfluenceofproteinontheinhibitingconcentrations,agoodpenetration

intothedeeperlayersoftheepidermis,andanadditionalantibacterialactivityagainstGram-positiveaswellasagainst

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TheinfluenceofciclopiroxmedicinalshampooontheviabilityofPityrosporumovalewasstudiedinamodelof

excisedbackskinofpigsindicatingthattheshampooisactiveevenaftershortperiodsoftreatment.Penetration

experimentsintothestratumcorneumofexcisedpigskinshowedthatashortcontacttimeofciclopiroxmedicinal

shampooissufficienttoachieveactivedrugconcentrationsevenindeeperlayersofthestratumcorneum.

Invivoexperimentsconfirmedtheefficacyofciclopiroxusingexperimentaldermatophytosisinguineapigs.Ciclopirox

demonstratedacleardose-responseefficacyagainstinfectionswithMicrosporumcanisandTrichophyton

mentagrophytes.

Aquickonsetofactionwasobserved.

Themodeofactionisverycomplexbytargetingavarietyofmetabolicprocessesinthefungalcell.Unlikemost

antifungalagents,ciclopiroxdoesnotaffectsterolbiosynthesis.Thebasisofthemainmechanisminfungalcellsisthe

highaffinityofciclopiroxfortrivalentmetalcationssuchasFe 3+

.Thetrappingofthisessentialenzymaticco-factor

causesaninhibitoryeffectonenzymessuchascytochromes,whichareinvolvedinmitochondrialelectrontransport

processesinthecourseofenergyproduction.Inaddition,theactivityofcatalaseandperoxidase,whichareresponsible

fortheintracellulardegradationoftoxicperoxidesisstronglyreducedinthepresenceofthedrug.Asaconsequence,

ciclopiroximpairsthefungalmetabolismbyaffectingtransportmechanisms,whicharelocatedinthefunguscell

membrane.Thisparticularmodeofactionofciclopiroxsuggeststhatthereisalowriskforthedevelopmentof

resistanceandminimisestheriskofcross-resistancewithotherantimycoticagentssuchasazolesandallylamines.

Ciclopiroxhasanti-inflammatoryproperties.Invitrostudieshaveshownthatciclopiroxinhibitstheproductionof

cyclooxygenaseand5-lipoxygenaseinflammatorymediators.Ciclopiroxshowsalsoinvivoanti-inflammatoryeffects

inanimals,whichwereconfirmedinUV-erythemainhumanvolunteers.Theinflammation-inhibitingactivitycan

promotehealingincertainfungalskininfections,suchseborrhoeicdermatitis.

Atotalof1189patientswithseborrhoeicdermatitisweretreatedovera4-weekperiodinthreevehicle-controlled

double-blindstudiesusingfourdisease’ssignsandsymptoms(status,scaling,inflammation,itching)asefficacy

variableswhichwerecombinedtotwoderivedmainresponsecriteria:“effectivelytreated”and“cleared”.Afterusing

theshampoo,17.2%(applicationonceaweek)and21.3%(applicationtwiceaweek)ofthepatientsbecame

completelycleared.Clearedoreffectivelytreatedwere44.2%(applicationonceaweek),and52.5%(application

twiceaweek).

Asanextensionoftheaboveresultsfortheacutetreatmentofthedisease,aclinicalstudyhasshownthata

maintenancetreatmentonceaweekledtoare-occurrenceofthediseaseinonly16%ofthepatientscomparedto36%

ifashampoowithoutactivesubstancewasused.

Atotalof737subjectswererandomisedinadouble-blindstudycomparingtheefficacyofatwiceweeklyapplication

oftheshampoocontainingciclopirox1%toanotherwithketoconazole2%usinganalogousresponsecriteria.After

the4-weektreatmentperiod,about74%ofthepatientsrespondedintheciclopiroxgroupand78,7%inthe

ketoconazolegrouprespectively.Thesimilarresponsetobothtreatmentsgaveinthestatisticaltestfornon-inferioritya

p-valueof0.047fortheITTpopulationandp=0.061fortheVCpopulation.Whenaccountistakenofthegreater

numberofmoreseverecasesatbaselineinthe1-%ciclopiroxgroup,thep-valuesfornon-inferioritywere0.014(VC)

and0.021(ITT).

5.2Pharmacokineticproperties

Inthreeclinicaltrialsofthe1%shampooformulation,ciclopiroxserumandurineconcentrationsweremeasuredin

patientswithseborrhoeicdermatitisofthescalp.Inthefirststudy,patientsweretreatedtwiceweeklyfor4weeks.In

thesecondstudy,patientsweretreatedunderexaggerateduseconditions,i.e.thepatientswashedtheirhairwith

ciclopiroxshampooeverydayfor29days,increasingthecontacttimefrom3minto6minafter15days.

InonePhaseIIItrial,ciclopiroxserumandurinelevelsweremeasuredafter4weeksofonce-ortwice-weekly

treatmentandagainafteranadditional12weeksofprophylactictreatmentusedonceaweekoronceevery2weeks.

Afterfourweeksoftreatment,serumlevelsweredetectedin21of293patients,withmaximumserumlevelsranging

between13.2and39.0microgram/L.Afteranother12weeksofprophylactictreatment,ciclopiroxlevelsweredetected

in2of94patients(max.14.4microgram/L).

Inchronicoraltoxicitystudies,theno-toxic-effectlevelsofciclopiroxanditsmainmetaboliteswere2210–2790

microgram/Linratsand1500–3500microgramg/Lindogs,indicatinghighsafetymargins.

Whenurinaryoutputofciclopiroxwasmeasured,excretionpeakswereproducedwithinthefirst4hoursof

administrationwhichfelloffrapidlythereafter.Sincethekidneyeliminatesmorethan98%ofabsorbedciclopirox,

urinaryexcretionisareliablemeasureoftheamountofdrugabsorbedduringshampooing.Inthesestudies,themedian

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5.3Preclinicalsafetydata

Preclinicaldatarevealnoevidenceoftoxicityuptoadailyoraldoseof10mg/kgbasedonconventionalstudiesof

repeateddosetoxicity,andnoevidenceofgenotoxicityandcarcinogenicity.Areducedfertilityindexwasfoundwith

5mg/kgbwciclopiroxinrats.Noembryo/foetotoxicityorteratogenicitywasobservedinratsandrabbits.Therewasno

evidenceofperi/postnataltoxicity,howeverpossiblelong-termeffectsonoffspringhavenotbeeninvestigated.

Inacutaneoustolerancestudyinrabbits,Batrafenshampooshowednoirritanteffect.

Inamucosaltolerancestudyinrabbits,undilutedBatrafenshampooproducedocularirritation.Todate,nostudieshave

investigatedirritationafterrepeatedlocaladministration,orevaluatedsensitisation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumdodecyl-di(oxyethylene)sulphate,27%solution 1)

Disodiumdodecyl-poly(oxyethylene)-3-2-sulphosuccinate,33%solution 2)

Macrogollaurylether

Sodiumchloride

Purifiedwater

consistingof:sodiumdodecyl-di(oxyethylene)sulphate;purifiedwater;benzoicacid(E210).

consistingof:disodiumdodecylpoly(oxyethylene)-3-2-sulphosuccinate;phenoxyethanol;

isobutyl(4-hydroxybenzoate);butyl(4-hydroxybenzoate);purifiedwater;methylparahydroxybenzoate(E218);

ethylparahydroxybenzoate(E214);propylparahydroxybenzoate(E216).

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

Afterfirstopeningthebottle,theshampoomaybeusedforupto8weeks.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

6.5Natureandcontentsofcontainer

Thismedicinalproductissuppliedinlowdensitypolyethylene(LDPE)bottleswithpolypropylene(PP)hinged

closurein:

30mlbottle,boxof1.

60mlbottle,boxof1or2.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

Sanofi-AventisIrelandLtd

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA540/32/5

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:26August2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 05/11/2009 CRN 2072051 page number: 6