CANESTEN DERMATOLOGICAL 1%w/w %w/w Cutaneous Powder

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
CLOTRIMAZOLE
Available from:
Bayer PLC
INN (International Name):
CLOTRIMAZOLE
Dosage:
1%w/w %w/w
Pharmaceutical form:
Cutaneous Powder
Authorization status:
Withdrawn
Authorization number:
PA0021/004/006
Authorization date:
2008-02-22

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0021/004/006

CaseNo:2038189

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

BayerPLC

BayerHouse,StrawberryHill,Newbury,BerkshireRG141JA,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CanestenDermatologicalPowder

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom26/07/2007until20/09/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/09/2007 CRN 2038189 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CanestenDermatologicalPowder

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Clotrimazole1%w/w.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Cutaneouspowder

White,finepowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CanestenDermatologicalPowdershouldbeusedasanadjunctinthemanagementofinfectionscausedby

microorganismssensitivetoclotrimazoleandasaprophylacticagainstre-infection.

4.2Posologyandmethodofadministration

CanestenDermatologicalPowdershouldbesprinkledontotheinfectedareastwotothreetimesdailyafterusing

CanestenCreamorCanestenDermatologicalSpray.Thepowdermayalsobedustedinsidearticlesofclothingand

footwearwhichareincontactwiththeinfectedarea.

4.3Contraindications

Hypersensitivitytoclotrimazoleortheexcipientsricestarch.

4.4Specialwarningsandprecautionsforuse

Allpossiblyinfectedareasshouldbetreatedatthesametime.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

Well-conductedepidemiologicalstudiesindicatenoadverseeffectsofclotrimazoleonpregnancyoronthehealthof

thefoetus/newbornchild.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/09/2007 CRN 2038189 page number: 2

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Rarely,patientsmayexperiencelocalmildburningorirritationimmediatelyafterapplyingthepowder.Veryrarelythe

patientmayfindthisintolerableandstoptreatment.

Otherundesirableeffects:

Bodyasawhole:allergicreaction,pain.

Skinandappendages:pruritis,rash.

4.9Overdose

Intheeventofaccidentaloralingestion,routinemeasuressuchasgastriclavageshouldbeperformedonlyifclinical

symptomsofoverdosebecomeapparent(e.g.dizziness,nauseaorvomiting).

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:D01AC01.

Clotrimazoleisanimidazolederivativewithabroadspectrumofantimycoticactivity.

MechanismofAction

Clotrimazoleactsagainstfungibyinhibitingergosterolsynthesis.Inhibitionofergosterolsynthesisleadstostructural

andfunctionalimpairmentofthecytoplasmicmembrane.

Pharmacodynamiceffects

Clotrimazolehasabroadantimycoticspectrumforactioninvitroandinvivo,whichincludesdermatophytes,yeast,

moulds,etc

Underappropriatetestconditions,theMICvaluesforthesetypesoffungiareintheregionsoflessthan0.062-4(-8)

micrograms/mlsubstrate.Themodeofactionofclotrimazoleisfungistaticorfungicidaldependingonthe

concentrationofclotrimazoleatthesiteofinfection.In-vitroactivityislimitedtoproliferatingfungalelements;fungal

sporesareonlyslightlysensitive.

Inadditiontoitsantimycoticaction,clotrimazolealsoactsonTrichomonasvaginalis,gram-positivemicroorganisms

(streptococci/staphylococci)andgram-negativemicroorganisms(Bacteroides/Gardnerellavaginalis).Ithasnoeffect

onlactobacilli.

Invitro,clotrimazoleinhibitsthemultiplicationsofcorynebacteriaandgram-positivecocci-withtheexceptionof

enterococci-inconcentrationsof0.5-10micrograms/mlsubstrateandexertsatrichomonacidalactionat100

micrograms/ml.

Primarilyresistancevariantsofsensitivefungalspeciesareveryrare;thedevelopmentofsecondaryresistanceby

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/09/2007 CRN 2038189 page number: 3

5.2Pharmacokineticproperties

Pharmacokineticinvestigationsafterdermalapplicationshaveshownthatclotrimazoleispracticallynotabsorbedfrom

theintactorinflamedskinintothehumanbloodcirculation.Theresultingpeakserumconcentrationsofclotrimazole

werebelowthedetectionlimitof0.001micrograms/ml,reflectingthatclotrimazoleappliedtopicallydoesnotleadto

measurablesystemiceffectsorsideeffects.

5.3Preclinicalsafetydata

Therearenopreclinicaldataofrelevancetotheprescriberwhichareadditionaltothosealreadyincludedinother

sectionsoftheSummaryofProductCharacteristics.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

RiceStarch

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

5years.

6.4Specialprecautionsforstorage

Nospecialstorageconditions.

6.5Natureandcontentsofcontainer

Polyethylenepowdercanisterwithaperforatedconicalplugfordustingandascrewcap.Thecanistercontains30gof

powder.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Bayerplc

BayerHouse

StrawberryHill

Newbury,Berkshire

RG141JA.

UnitedKingdom

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/09/2007 CRN 2038189 page number: 4

8MARKETINGAUTHORISATIONNUMBER

PA21/4/6

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:21September1978

Dateoflastrenewal:21September2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/09/2007 CRN 2038189 page number: 5

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