BATRAFEN

Main information

  • Trade name:
  • BATRAFEN Cream 1 %w/w
  • Dosage:
  • 1 %w/w
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BATRAFEN Cream 1 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0540/032/001
  • Authorization date:
  • 12-11-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Batrafen1%w/wCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Ciclopiroxolamine,1%w/w.

(10mgciclopiroxolaminein1gBatrafencream).

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cream

Whitetoalmostwhitecreamwithacharacteristicodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Batrafencreamisindicatedinthetopicaltreatmentofinfectionsduetosuperficialdermatophytes,Candidaspeciesand

otherfungisensitivetotheanti-infective.

4.2Posologyandmethodofadministration

Routeofadministration:Topical.

AdultsandChildrenover6yearsofage:Application2to3timesdailyfor2weeks.

Toavoidrelapses,treatmentshouldbecontinuedforonetotwoweeksafterdisappearanceofthesymptoms,usually

withintwoweeks.

4.3Contraindications

Batrafencreamiscontraindicatedinthefollowing:

Infantslessthanoneyearofage.

Pregnancyorinwomenbreastfeedinginfants.

Patientswithknownhypersensitivitytoanycomponent.

Batrafencreamshouldnotbeappliedtotheeyesormucosa.

Batrafencreamshouldnotbeappliedtoanopenwound.

Batrafencreamcontainsparaffinwhichcancauseleakingorbreakingoflatexcondoms.ContactbetweenBatrafen

creamandlatexcondomsmustthereforebeavoidedbecausetheprotectionaffordedbythecondomsmayotherwisebe

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4.4Specialwarningsandprecautionsforuse

Allpossiblyinfectedareasshouldbetreatedatthesametime.

Localirritationmaydevelop.Ifthisissevere,treatmentshouldbediscontinued.

Thedurationofapplicationshouldvaryaccordingtoindividualneed.

SufficientexperienceisnotyetavailableontheuseofBatrafenpowderinchildrenunder6years.

BatrafenCreamcontains10mgbenzylalcoholper10gtube.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ThereisnoinformationavailableoninteractionswithBatrafen.

4.6Fertility,pregnancyandlactation

Thereisnoinformationinuseduringpregnancyorlactation.Theproductshouldnotbeusedthereforeinthese

situations.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Inrarecases,transientlocalreactions,e.g.pruritusoraburningsensation,mayoccurasmayallergiccontact

dermatitis.

4.9Overdose

Thereisnoexperienceofoverdosewithciclopiroxpreparations.However,norelevantsystemiceffectswouldbe

expectedtooccurifBatrafenCreamwereappliedtolargeareasorusedtoofrequently.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATC:D01AE14

Ciclopiroxisabroad-spectrumN-hydroxypyridoneantimicrobialagentfortopicalusethatexertsfungistaticand

fungicidalpotencyagainstpathogenicdermatophytes,yeastsandmoulds.

Invitrostudiesshowedthatthecompoundhasahighanduniformactiononfungipathogenictohumanskin.Thedose-

responsecurveforciclopiroxis,incontrasttotheazoles,verysteep.Thisindicatesfungicidalpotentialclosetothe

MIC.Ciclopiroxexhibitsahighpenetrationintokeratinizedskin.Invivostudiesinthemodelofguinea-pig

dermatophytosisdemonstratedahighactivityandsuperioritytoknowncompounds.

Ciclopiroxhasseveralmechanismsofactionincludingchelationofpolyvalentmetalcations(e.g.FE 3+

andAl 3+

)thus

itinhibitsthemetaldependentenzymes,includingthoseresponsibleforthedegradationofperoxideswithinthe

microbialcell.Thismodeofactionofciclopiroxisuniqueandminimisestheriskofcrossresistancewithother

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5.2Pharmacokineticproperties

Onlyalimitedamountofciclopiroxappliedindifferentformulationsisabsorbedsystemically,evenwhenappliedto

inflamedskincoveringapproximately25%ofthebodysurfaceareaandincludinghighlypermeableareassuchasthe

groin.

Acomparativecross-overstudyofthepharmacokineticsofciclopiroxgel0.77%andciclopiroxolaminecream1%in

18healthymales(5gofeachproduct/25cmx30cmonintactskinontheback)indicatedthattherewerenosignificant

orclinicallyimportantdifferencesbetweenciclopiroxgelandciclopiroxolaminecreaminameanmaximumserum

levelsoftotalciclopiroxorinmeasuresofrenalexcretion.

5.3Preclinicalsafetydata

Acutetoxicity:Theacutetoxicityofciclopiroxafterasingledosewastestedinmice,ratsandrabbitsafterintravenous,

subcutaneous,intraperitonealandoraladministrationandafterdermalapplication.Generally,acutetoxicityof

ciclopiroxisratherlow.

Repeateddosetoxicity:Repeateddoseoraltoxicitystudieswithciclopiroxolaminewereperformedinratsanddogs

withoraladministrationandinrabbits,guinea-pigsanddogsusingthedermalroute.Treatmentperiodsvariedbetween

14daysand13weeks.Inrepeated-doseoraltoxicitystudiesinratsanddogs,thenoeffectlevelwas10mg/kg/day.

Dermalreactionswereseenintheskinofmostvehicle-ordrug-treatedrabbits,guineapigsanddogs(varyingdegrees

ofhyperkeratosis,parakeratosis,dermaledemaanddermalinfiltrationofmixedinflammatorycells).Thesechanges

werecompletelyreversibleafterdiscontinuationofthetreatment.Nosystemictoxicitywasobserved.

Reproductiontoxicology:Nosignificantevidenceofimpairedfertilitywasobservedinratsafteroraldosesandno

peri-/postnataltoxicitywasobservedinthisspecies.

Nofetotoxicityorteratogenicitywasshownforciclopiroxolamineinthemouse,rat,rabbitandmonkeyafteroral

dosesandalsoafterthedermalrouteofadministrationinratandrabbit.

Mutagenicity:Thefollowingbatteryofinvitrogenotoxicitytestswasconductedwithciclopiroxolamine:evaluationof

genemutationintheAmesSalmonellaandE.coliassays(negative);genemutationassaysintheHGPRTtestwithV79

Chinesehamstercells(negative);aprimaryDNAdamageassay(i.e.unscheduledDNAsynthesisassayinA549human

cells)(negative);invitrocelltransformationassayinBALB/C3T3cells(negative).

InvitrochromosomeaberrationassaysinV79Chinesehamstercellswerepositiveduetothechelatingpropertiesof

ciclopiroxolamine.However,inacorrespondingin-vivoChinesehamsterbonemarrowcytogenicassay,ciclopirox

wasnegativeforchromosomeaberrationsupto5.000mg/kganditwasdemonstratedthatciclopiroxwaspresentin

higherconcentrationsinthebonemarrow.

Additionalinvivomicronucleusanddominantlethaltestinthemousewerenegative.

Neoplasticpotential:Acarcinogenicitystudyinfemalemicedosedbythedermalroutetwiceweeklyfor50weeks

followedbya6monthdrug-freeobservationperiodpriortonecropsyrevealednoevidenceoftumorsattheapplication

site.

Toxicitiyofexcipients:Allexcipientsareaccordingtothepharmacopoeia.

Localtolerance:Primaryacutedermalirritationstudiesinrabbitsindicatedthatciclopiroxolaminecreamisnota

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzylalcohol

Octyldodecanol

Lightliquidparaffin

Stearylalcohol

Cetylalcohol

Myristylalcohol

Polysorbate60

Sorbitanstearate

(S)-Lacticacid

Purifiedwater

6.2Incompatibilities

Cosmeticscontainingmultivalentmetalions(e.g.make-up).

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Keepthetubeintheoutercartoninordertoprotectfromlight.

6.5Natureandcontentsofcontainer

Aluminiumtube(epoxyphenoicresinlined)withaHDPEscrewcap.

Eachtubecontains20gBatrafencream.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

sanofi-aventisIrelandLtd.

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA540/32/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:12November1984

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10DATEOFREVISIONOFTHETEXT

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