CICATRIN

Main information

  • Trade name:
  • CICATRIN Cream
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CICATRIN Cream
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1077/054/001
  • Authorization date:
  • 01-04-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA1077/054/001

CaseNo:2039664

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

GlaxoSmithKline(Ireland)Ltd

StonemasonsWay,Rathfarnham,Dublin16,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CicatrinCream

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom21/11/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/11/2007 CRN 2039664 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CicatrinCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramofcreamcontains:

NeomycinSulphate 3,300units

BacitracinZinc 250units

Glycine 10mg

L(+)Cysteine 2mg

DL-Threonine 1mg

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cream.

Atranslucentdeepyellowtobrownish-yellowcream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CicatrinCreamisbroad-spectrumbactericidalpreparationsactiveagainstpathogenscommonlyfoundininfectionsof

theskin.Theyareindicatedinthepreventionortreatmentofsuperficialskininfection.Theseinclude:

Prophylaxisinminorburns,cuts,scratchesandabrasionsandfollowingthesuturingoflacerations.

Treatmentofsuperficialinfectedulcers,cuts,scratches,andabrasions,superficialskininfectionsfollowingsurgical

procedures,minorburns,impetigoandsecondarilyinfectedskinconditions.

TheuseofCicatrinCreamdoesnotexcludeconcomitantsystemictherapywithotherantibioticswhereappropriate.

(SeeSpecialWarningsandSpecialPrecautionsforUse).

4.2Posologyandmethodofadministration

Prophylaxisandtreatment

Administrationanddosageinadults:

Beforeuse,theareaforapplicationshouldbecleanedgently.Debrissuchaspusorcrustsshouldberemovedfromthe

affectedarea.

Athinfilmofcreamshouldbeappliedoncetofourtimesdaily,dependingontheclinicalcondition.Treatmentshould

notbecontinuedformorethan7dayswithoutmedicalsupervision(seeSpecialWarningsandSpecialPrecautionsfor

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Dosageinchildren:

CicatrinCreamissuitableforuseinchildren(2yearsandover)atthesamedoseasadults.Apossibilityofincreased

absorptionexistsinveryyoungchildren,thusCicatrinCreamisnotrecommendedforuseinneonatesandinfants

(<2years)(see4.3Contra-Indicationsand4.4SpecialWarningsandSpecialPrecautionsforUse).

Dosageintheelderly:

CicatrinCreamissuitableforuseintheelderly.Cautionshouldbeexercisedincaseswhereadecreaseinrenal

functionexistsandsignificantsystemicabsorptionofneomycinsulphatemayoccur(see4.2DosageinRenal

Impairmentand4.4SpecialWarningsandSpecialPrecautionsforUse).

Dosageinpatientswithrenalimpairment:

Dosageshouldbereducedinpatientswithreducedrenalfunction(seeSpecialWarningsandSpecialPrecautionsfor

Use).

4.3Contraindications

TheuseofCicatrinCreamiscontraindicatedinpatientswhohavedemonstratedallergichypersensitivitytoany

componentofthepreparationortocross-sensitisingsubstancessuchasframycetin,kanamycin,gentamycinandother

relatedantibiotics.

TheuseofCicatrinCreamiscontraindicatedinpatientshypersensitivetopolymyxinBorneomycin.

Thepresenceofpre-existingnervedeafnessisacontraindicationtotheuseofCicatrinCreamoranytopical

aminoglycosideincircumstanceswheresignificantsystemicabsorptioncouldoccur.

TheuseofCicatrinCreamduringpregnancyandlactationcannotberecommendedincircumstanceswheresignificant

systemicabsorptionoftheactiveingredientsmayoccur(e.g.applicationtolargeareasofrawskin).

Duetotheknownototoxicandnephrotoxicpotentialofneomycinsulphate,theuseofCicatrinCreaminlarge

quantitiesoronlargeareasforprolongedperiodsoftimeisnotrecommendedincircumstanceswheresignificant

systemicabsorptionmayoccur.

Apossibilityofincreasedabsorptionexistsinveryyoungchildren,thereforeCicatrinCreamandCicatrinPowderare

notrecommendedforuseinneonatesandinfants(upto2years).Inneonatesandinfants,absorptionbyimmatureskin

maybeenhanced,andrenalfunctionmaybeimmature.

CicatrinCreamshouldnotbeappliedtotheeyes.

4.4Specialwarningsandprecautionsforuse

Cautionshouldbeexercisedsothattherecommendeddosageisnotexceeded(seePosologyandMethodof

AdministrationandContra-indications).

Followingsignificantsystemicabsorption,aminoglycosidessuchasneomycincancauseirreversibleototoxicityand

bothneomycinsulphateandbacitracinzinchavenephrotoxicpotential.

Inrenalimpairmenttheplasmaclearanceofneomycinisreduced(seeDosageinrenalimpairment).

Aswithotherantibacterialpreparations,prolongedusemayresultinovergrowthbynonsusceptibleorganisms,

includingfungi.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Followingsignificantsystemicabsorptionneomycinsulphatecanintensifyandprolongtherespiratorydepressant

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4.6Pregnancyandlactation

Teratogenicity:

Thereisinsufficientinformationavailabletodeterminewhethertheactiveingredientshaveteratogenicpotential.

Neomycinpresentinmaternalbloodcancrosstheplacentaandmaygiverisetoatheoreticalriskoffoetalototoxicity.

Fertility:

Thereisinsufficientinformationavailabletodeterminewhetheranyoftheactiveingredientscanaffectfertility.

Pregnancy:

Thereislittleinformationtodemonstratethepossibleeffectoftopicallyappliedneomycininpregnancyandlactation,

thereforeuseofCicatrinCreamisnotrecommended.

Lactation:

Noinformationisavailableregardingtheexcretionoftheactiveingredientinhumanmilk.

4.7Effectsonabilitytodriveandusemachines

Notrelevant.

4.8Undesirableeffects

Theincidenceofallergichypersensitivitytoneomycinsulphateinthegeneralpopulationislow.However,thereisan

increasedincidenceofsensitivitytoneomycinincertainselectedgroupsofpatientsindermatologicalpractice,

particularlythosewithvenousstasiseczemaandulceration.

Allergichypersensitivitytoneomycinfollowingtopicalapplicationmaymanifestitselfasareddeningandscalingof

theaffectedskin,asaneczematousexacerbationofthelesion,orasafailureofthelesiontoheal.

Allergichypersensitivityfollowingtopicalapplicationofbacitracinzinchasbeenreportedbutrare.

Anaphylacticreactionsfollowingthetopicaladministrationofbacitracinzinchavebeenreportedbutarerare.

4.9Overdose

Symptomsandsigns:

NospecificacutesymptomsorsignshavebeenidentifiedinassociationwithexcessiveuseofCicatrinCream.

However,considerationshouldbegiventoobservingadversereactionsduetosystemicabsorption.

Management:

Useoftheproductshouldbestoppedandthepatient’sgeneralstatus,hearingacuity,renalandneuromuscular

functionsshouldbemonitored.

Bloodlevelsofneomycinsulphateandbacitracinzincshouldalsobedeterminedandhaemodialysismayreducethe

serumlevelofneomycinsulphate.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

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5.2Pharmacokineticproperties

Nodata.

5.3Preclinicalsafetydata

Mutagenicity:

Thereisinsufficientinformationavailabletodeterminewhethertheactiveingredientshavemutagenicpotential.

Carcinogenicity:

Thereisinsufficientinformationavailabletodeterminewhethertheactiveingredientshavecarcinogenicpotential.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Woolalcohols

Sorbitantrioleate

Polysorbate85

Macrogollaurylether

Liquidparaffin

Hardparaffin

Whitesoftparaffin

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Aluminium,collapsibletubescontaining15gor30gofatranslucent,deepyellowtobrownish-yellowcream.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

CicatrinCreamshouldnotbediluted.

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKline(Ireland)Limited

StonemasonsWay

Rathfarnham

Dublin16

Irish Medicines Board

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8MARKETINGAUTHORISATIONNUMBER

PA1077/54/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1977

Dateoflastrenewal:01April2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 22/11/2007 CRN 2039664 page number: 6