FUCIDIN H

Main information

  • Trade name:
  • FUCIDIN H
  • Pharmaceutical form:
  • Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FUCIDIN H
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0046/005/003
  • Authorization date:
  • 01-04-1977
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0046/005/003

CaseNo:2049660

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

LeoLaboratoriesLimited

CashelRoad,Dublin12,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

FucidinHOintment

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom13/05/2008until28/03/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 12/06/2008 CRN 2049660 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FucidinHOintment

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Containssodiumfusidate2%w/wandhydrocortisoneacetate1%w/w.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Ointment

Off-whiteviscousointment.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Useininflammatorydermatoseswherebacterialinfectionispresentorlikelytooccur.

4.2Posologyandmethodofadministration

Applyasmallquantitytotheaffectedareatwicedailyuntilasatisfactoryresponseisobtained.Asingletreatment

courseshouldnotnormallyexceed2weeks.

4.3Contraindications

Useinpatientshypersensitivetotheactiveingredients.

Useinthepresenceofinfectionsduetonon-sensitiveorganisms.

4.4Specialwarningsandprecautionsforuse

Prolongeduseofananti-infectivemayresultinthedevelopmentofsuperinfectionduetoorganisms,includingfungi,

resistanttothatanti-infective.

Continuoustreatmentforlongerthanthreeweeksshouldbeavoidedinpatientsundertheageofthreeyearsbecauseof

theriskofadrenocorticalsuppression.Prolongedusewithocclusivedressingsmayresultinsuppressionof

adrenocorticalfunction.

Duetothepresenceofwoolfat(lanolin)andcetylalcoholthisproductmaycauselocalallergicskinreactions(e.g.

contactdermatitis).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

None.

4.6Pregnancyandlactation

Irish Medicines Board

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Date Printed 12/06/2008 CRN 2049660 page number: 2

Topicaladministrationofcorticosteroidstopregnantanimalscancauseabnormalitiesoffoetaldevelopmentincluding

cleftpalateandintrauterinegrowthretardation.Theremay,thereforebeasmallriskofsucheffectsinthehuman

foetus.

Animalstudiesandmanyyearsofclinicalexperiencehavesuggestedthatfusidicacidisdevoidofteratogeniceffects.

Thereisevidencetosuggestthatwhengivensystemically,fusidicacidcanpenetratetheplacentalbarrier.

Safetyinnursingmothershasnotbeenestablished.

Whenfusidicacid(assodiumsalt)hasbeengivensystemically,levelshavebeendetectedinbreastmilk,butwith

topicalusethepossibleamountofdrugpresentisunlikelytoaffecttheinfant.

4.7Effectsonabilitytodriveandusemachines

Presumedtobesafeorunlikelytoproduceaneffect.

4.8Undesirableeffects

HypersensitivityhasrarelybeenencounteredwiththeuseoftopicalFucidin.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

FucidinHOintmentcombinesthepotenttopicalantibacterialactionofsodiumfusidatewiththeanti-inflammatoryand

anti-pruriticeffectsofhydrocortisone.Fusidicacidanditssaltsexhibitfatandwatersolubilitypropertieswithstrong

surfaceactivity,andshowunusualabilitytopenetrateintactskin.However,theyarepoorlysystemicallyabsorbedafter

topicaladministration.

Concentrationsof0.03-0.12µg/mlinhibitnearlyallstrainsofStaphylococcusaureus.TopicalFucidinisalsoactive

againstStreptococci,Corynebacteria,NeisseriaandcertainClostridia.

5.2Pharmacokineticproperties

TherearenodatawhichdefinethepharmacokineticsofFucidinHOintment,followingtopicaladministrationinman.

However,invitrostudiesshowthatfusidicacidanditssaltscanpenetrateintacthumanskininconcentrationswell

abovetheMIC-valuesofsusceptibleorganisms.Thedegreeofpenetrationdependsonfactorssuchasthedurationof

exposuretofusidicacid(oritssalts)andtheconditionoftheskin.Fusidicacidanditssaltsareexcretedmainlyinthe

bilewithlittleexcretedintheurine.

Hydrocortisoneisabsorbedfollowingtopicaladministration.Thedegreeofabsorptionisdependantonfactors

includingskinconditionandsiteofapplication.Absorbedhydrocortisoneisextensivelymetabolisedandrapidly

eliminatedintheurine.

5.3Preclinicalsafetydata

Therearenopreclinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

Irish Medicines Board

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Date Printed 12/06/2008 CRN 2049660 page number: 3

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Woolfat(Lanolin)

Cetylalcohol

Liquidparaffin

Whitesoftparaffin

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5Natureandcontentsofcontainer

Aluminiumtubeincartoncontaining15gor30gointment.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

LEOLaboratoriesLtd.

CashelRoad

Dublin12

8MARKETINGAUTHORISATIONNUMBER

PA46/5/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1977

Dateoflastrenewal:29March2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 12/06/2008 CRN 2049660 page number: 4