BATRAFEN

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0540/032/002
  • Authorization date:
  • 12-11-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Batrafen1%w/wCutaneousPowder

2QUALITATIVEANDQUANTITATIVECOMPOSITION

CiclopiroxOlamine1%w/w.

(10mgciclopiroxOlaminein1gBatrafenpowder).

Forexcipients,see6.1.

3PHARMACEUTICALFORM

CutaneousPowder

Whitetoalmostwhite,loosepowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Batrafenpowderisindicatedforuseinthetopicaltreatmentofinfectionsduetosuperficialdermatophytes,Candida

speciesandotherfungisensitivetotheanti-infective.

4.2Posologyandmethodofadministration

Routeofadministration:Topical.

AdultsandChildrenover6yearsofage:Application2to3timesdailyfor2weeks.

Toavoidrelapses,treatmentshouldbecontinuedforonetotwoweeksafterdisappearanceofthesymptoms,usually

withintwoweeks.

SufficientexperienceisnotyetavailableontheuseofBatrafenpowderinchildrenunder6years.

BatrafenPowdershouldbesprinkledontotheinfectedarea.Additionalhygienicmeasures(e.g.sprinklingpowderinto

socksorshoes)arerecommended.Theproductshouldnotbeusedonopenwounds,ontheeyesormucosalpassagesor

inconjunctionwithmakeup.

4.3Contraindications

Batrafenpowderiscontraindicatedinthefollowing:

Infantslessthanoneyearofage.

Pregnancyorinwomenbreastfeedinginfants.

Patientswithknownhypersensitivitytoanycomponent.

Batrafenpowdershouldnotbeappliedtotheeyesormucosa.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/12/2006 CRN 2030715 page number: 1

4.4Specialwarningsandprecautionsforuse

Allpossiblyinfectedareasshouldbetreatedatthesametime.

Localirritationmaydevelop.Ifthisissevere,treatmentshouldbediscontinued.

Inpatientswhoareatparticularriskoffungalinfection,prophylacticuseofBatrafenpowderisrecommended.

Thedurationofapplicationshouldvaryaccordingtoindividualneeds.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ThereisnoinformationavailableoninteractionswithBatrafen.

4.6Pregnancyandlactation

Thereisnoinformationinuseduringpregnancyorlactation.Theproductshouldnotbeusedthereforeinthese

situations.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Inrarecases,transientlocalreactions,e.g.pruritusoraburningsensation,mayoccur,asmayallergiccontact

dermatitis.Ifanyofthesereactionsaresevere,treatmentshouldbediscontinued.

4.9Overdose

Thereisnoexperienceofoverdosewithciclopiroxpreparations.However,norelevantsystemiceffectswouldbe

expectedtooccurifBatrafenpowderwereappliedtolargeareasorusedtoofrequently.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Ciclopiroxisabroad-spectrumN-hydroxypyridoneantimicrobialagentfortopicalusethatexertsfungistaticand

fungicidalpotencyagainstpathogenicdermatophytes,yeastsandmoulds.

Invitrostudiesshowedthatthecompoundhasahighanduniformactiononfungipathogenictohumanskin.Thedose-

responsecurveforciclopiroxis,incontrasttotheazoles,verysteep.

ThisindicatesfungicidalpotentialclosetotheMIC.Ciclopiroxexhibitsahighpenetrationintokeratinizedskin.Invivo

studiesinthemodelofguinea-pigdermatophytosisdemonstratedahighactivityandsuperioritytoknowncompounds.

Ciclopiroxhasseveralmechanismsofactionincludingchelationofpolyvalentmetalcations(e.g.FE 3+

andAl 3+

).It

thusinhibitsthemetaldependentenzymes,includingthoseresponsibleforthedegradationofperoxideswithinthe

microbialcell.Thismodeofactionofciclopiroxisuniqueandminimisestheriskofcross-resistancewithother

antimicrobialagents.

5.2Pharmacokineticproperties

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/12/2006 CRN 2030715 page number: 2

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-freeobservationperiodpriortonecropsyrevealednoevidenceoftumoursatthe

applicationsite.

Toxicityofexcipients:Allexcipientsareaccordingtothepharmacopoeia.

Localtolerance:Primaryacutedermalirritationstudiesinrabbitsindicatedthatciclopiroxolaminecreamisnota

primaryskinirritant.Similarlyastudyinrabbitsindicatedthatciclopiroxolaminecreamisnotaneyeirritant.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Colloidalanhydroussilica

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/12/2006 CRN 2030715 page number: 3

6.2Incompatibilities

Cosmeticscontainingmultivalentmetalions(e.g.make-up).

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Plasticsqueezebottle(HDPE)withflush-fittingdispense(LDPE)andscrewclosure(PP).Eachbottlecontains30g

BatrafenPowder.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

sanofi-aventisIrelandLtd.

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA540/32/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:12November1984

Dateoflastrenewal:12November2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/12/2006 CRN 2030715 page number: 4