BETNOVATE-N 0.1% / 0.5% W/W CREAM

Main information

  • Trade name:
  • BETNOVATE-N 0.1% / 0.5% W/W CREAM
  • Dosage:
  • 0.1/0.5 %w/w
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BETNOVATE-N 0.1% / 0.5% W/W CREAM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1077/003/001
  • Authorization date:
  • 09-07-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA1077/003/001

CaseNo:2076797

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

GlaxoSmithKline(Ireland)Limited

StonemasonsWay,Rathfarnham,Dublin16,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Betnovate-N0.1%/0.5%w/wCream

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom26/03/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/03/2010 CRN 2076797 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Betnovate-N0.1%/0.5%w/wCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Betamethasone0.1%w/w(asBetamethasoneValerate).

NeomycinSulphate0.5%w/w.

Alsocontainschlorocresol0.1%w/wandCetostearylAlcohol7.2%w/w

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cream

Awhite,homogenous,aqueousbasedcream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Betnovate-Nskinpreparationsareindicatedinthemanagementofcorticosteroidsensitivedermatosesactuallyor

potentiallycomplicatedbyinfectionduetomicro-organismssensitivetotheanti-infectivecontainedtherein.

Betnovate-Npreparationsareindicatedforthetreatmentofthefollowingconditionswheresecondarybacterial

infectionispresent,suspectedorlikelytooccur:eczema,includingatopic,infantile,discoideczemas;prurigo

nodularis;psoriasis(excludingwidespreadplaquepsoriasis);neurodermatoses,includinglichensimplex;lichen

planus;seborrhoeicdermatitis;contactsensitivityreactions,insectbitereactions,pricklyheat,analandgenital

intertrigo,andotitisexterna(seeContraindications).

4.2Posologyandmethodofadministration

Asmallquantityshouldbeappliedtotheaffectedareaonetothreetimesdailyuntilimprovementoccursoras

directedbyaphysician.Itmaythenbepossibletomaintainimprovementbyapplyingonceadayorevenlessoften.

Betnovate-NCreamisespeciallyappropriateformoistorweepingsurfaces,andBetnovate-Nointmentfordry,

lichenifiedorscalylesions,butthisisnotinvariablyso.

Inthemoreresistantlesions,suchasthethickenedplaquesofpsoriasisonelbowsandknees,theeffectof

Betnovate-Ncanbeenhanced,ifnecessary,byoccludingthetreatmentareawithpolythenefilm.

Overnightocclusiononlyisusuallyadequatetobringaboutasatisfactoryresponseinsuchlesions.Thereafter,

improvementcanusuallybemaintainedbyregularapplicationwithoutocclusion.

Treatmentshouldnotbecontinuedformorethan7dayswithoutmedicalsupervision.

Betnovate-Nissuitableforuseinchildren(2yearsandover)atthesamedoseasadults.Apossibilityofincreased

absorptionexistinginveryyoungchildren,thusBetnovate-Nisnotrecommendedforuseinneonatesandinfants

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/03/2010 CRN 2076797 page number: 2

Useintheelderly:

Betnovate-Nissuitableforuseintheelderly.Cautionshouldbeexercisedincaseswhereadecreaseinrenal

functionexistsandsignificantsystemicabsorptionofneomycinsulphatemayoccur.(See4.4SpecialWarningsand

SpecialPrecautionforUse).

Dosageinrenalimpairment:

Dosageshouldbereducedinpatientswithreducedrenalfunction(see4.4SpecialWarningsandSpecialPrecautions

forUse).

4.3Contraindications

Rosacea.

Acnevulgaris.

Perioraldermatitis.

Perianalandgenitalpruritus.

Primarycutaneousviralinfections(e.g.HerpesSimplex,chickenpox).

Hypersensitivitytoanycomponentofthepreparation.

UseofBetnovate-Nskinpreparationsisnotindicatedinthetreatmentofprimaryinfectedskinlesionscausedby

infectionwithfungi,orbacteria:primaryorsecondaryinfectionsduetoyeast;secondaryinfectionsdueto

PseudomonasorProteusspecies;dermatosesinchildrenundertwoyearsofage,includingdermatitisandnappy

eruptions.

Preparationscontainingneomycinshouldnotbeusedforthetreatmentofotitisexternawhentheeardrumis

perforated,becauseoftheriskofototoxicity.

Duetotheknownototoxicandnephrotoxicpotentialofneomycinsulphate,theuseofBetnovate-Ninlarge

quantitiesoronlargeareasforprolongedperiodsoftimeisnotrecommendedincircumstanceswheresignificant

systemicabsorptionmayoccur.

Apossibilityofincreasedabsorptionexistsinveryyoungchildren,thusBetnovate-Nisnotrecommendedforusein

neonatesandinfants(upto2years).Inneonatesandinfants,absorptionbyimmatureskinmaybeenhanced,and

renalfunctionmaybeimmature.

4.4Specialwarningsandprecautionsforuse

Prolongeduseofananti-infectivemayresultinthedevelopmentofsuperinfectionduetoorganisms,includingfungi,

resistanttothatanti-infective.

Long-termcontinuoustopicaltherapyshouldbeavoidedwherepossible,particularlyininfantsandchildren,as

adrenalsuppressioncanoccurevenwithoutocclusion.

Theanti-infectivepresentmaybetoxicifabsorbedfromopensurfaces.

Theface,morethanotherareasofthebody,mayexhibitatrophicchangesafterprolongedtreatmentwithpotent

topicalcorticosteroids.Thismustbeborneinmindwhentreatingsuchconditionsaspsoriasis,discoidlupus,

erythematosusandsevereeczema.

Ifappliedtotheeyelids,careisneededtoensurethatthepreparationdoesnotentertheeye,asglaucomamight

result.

Ifbacterialinfectionpersists,systemicchemotherapyisrequired.

Anyspreadofinfectionrequireswithdrawaloftopicalcorticosteroidtherapy.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/03/2010 CRN 2076797 page number: 3

Productswhichcontainantimicrobialagentsshouldbediluted.

Extensionofinfectionmayoccurduetothemaskingeffectofthesteroid.

Topicalsteroidsmaybehazardousinpsoriasisforanumberofreasons,includingreboundrelapses,developmentof

tolerance,riskofgeneralizedpustularpsoriasisanddevelopmentoflocalorsystemictoxicityduetoimpairedbarrier

functionoftheskin.Ifusedinpsoriasis,carefulpatientsupervisionisimportant.

Bacterialinfectionisencouragedbythewarm,moistconditionsinducedbyocclusivedressings,andtheskinshould

becleansedbeforeafreshdressingisapplied.

Followingsignificantsystemicabsorption,aminoglycosidessuchasneomycincancauseirreversibleototoxicity:and

neomycinhasnephrotoxicpotential.

Inrenalimpairmenttheplasmaclearanceofneomycinisreduced(See4.2DosageinRenalImpairment).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Followingsignificantsystemicabsorption,neomycinsulphatecanintensifyandprolongtherespiratorydepressant

effectsofneuromuscularblockingagents.

4.6Pregnancyandlactation

Thereislittleinformationtodemonstratethepossibleeffectoftopicallyappliedneomycininpregnancyand

lactation.However,neomycinpresentinmaternalbloodcancrosstheplacentaandmaygiverisetoatheoreticalrisk

offoetaltoxicity,thususeofBetnovate-Nisnotrecommendedinpregnancyorlactation.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Prolongedandintensivetreatmentwithhighlyactivecorticosteroidpreparationsmaycauselocalatrophicchangesin

theskinsuchasthinning,striae,anddilationofthesuperficialbloodvessels,particularlywhenocclusivedressings

areusedorwhenskinfoldsareinvolved.

Therearereportsoflocalskinburning,pruritis,pigmentationchanges,hypertrichosisandallergiccontactdermatitis

withtopicalsteroids.

Exacerbationofsymptomsmayoccur.

Aswithothertopicalcorticosteroids,prolongeduseoflargeamounts,ortreatmentofextensiveareas,canresultin

sufficientsystemicabsorptiontoproducethefeaturesofhypercortisolism.

Theeffectismorelikelytooccurininfantsandchildren,andifocclusivedressingareused.Ininfants,thenapkin

mayactasanocclusivedressing.

Inrareinstances,treatmentofpsoriasiswithcorticosteroids(oritswithdrawal)isthoughttohaveprovokedthe

putsularformofthedisease.

TheBetnovatepreparationsareusuallywelltolerated,butifsignsofhypersensitivityappear,applicationshouldstop

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/03/2010 CRN 2076797 page number: 4

4.9Overdose

Acuteoverdosageisveryunlikelytooccur.However,inthecaseofchronicoverdosageormisuse,thefeaturesof

hypercortisolismmayappearandinthissituationtopicalsteroidsshouldbediscontinuedgraduallyundermedical

supervisionbecauseoftheriskofadrenalinsufficiency.

Alsoconsiderationshouldbegiventosignificantsystemicabsorptionofneomycinsulphate(See4.4Special

WarningsandSpecialPrecautionsforUse).Ifthisissuspected,useoftheproductshouldbestoppedandthe

patient’sgeneralstatus,hearingacuity,renalandneuromuscularfunctionsshouldbemonitored.

Bloodlevelsofneomycinsulphateshouldalsobedetermined.

Haemodialysismayreducetheserumlevelofneomycinsulphate.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Betamethasonevalerateisanactivecorticosteroidthatproducesasatisfactoryresponseinthoseinflammatory

dermatosesthatarenormallyresponsivetotopicalcorticosteroidtherapy,andisofteneffectiveinthelessresponsive

conditionssuchaspsoriasis.

Neomycinsulphateisabroadspectrum,bactericidalantibioticeffectiveagainstthemajorityofbacteriacommonly

associatedwithskininfections.

5.2Pharmacokineticproperties

Theextentofpercutaneousabsorptionoftopicalcorticosteroidisdeterminedbymanyfactorsincludingthevehicle,

theintegrityoftheepidermalbarrier,andtheuseofocclusivedressings.

Topicalcorticosteroidscanbeabsorbedfromnormalintactskin.Inflammationand/orotherdiseaseprocessesinthe

skinincreasepercutaneousabsorption.Occlusivedressingssubstantiallyincreasethepercutaneousabsorptionof

topicalcorticosteroids.

Onceabsorbedthroughtheskin,topicalcorticosteroidsarehandledthroughpharmacokineticpathwayssimilarto

systematicallyadministeredcorticosteroids.Corticosteroidsareboundtoplasmaproteinsinvaryingdegrees.

Corticosteroidsaremetabolisedprimarilybytheliverandarethenexcretedbythekidneys.

5.3Preclinicalsafetydata

Noadditionaldata.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Chlorocresol

Cetomacrogol1000

CetostearylAlcohol

WhiteSoftParaffin

LiquidParaffin

SodiumDihydrogenPhosphateDihydrate

PhosphoricAcid(forpHadjustment)

SodiumHydroxide(forpHadjustment)

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/03/2010 CRN 2076797 page number: 5

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

6.5Natureandcontentsofcontainer

Betnovate-Ncreamissuppliedin30gcollapsiblealuminiumtubes.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKline(Ireland)Ltd.

StonemasonsWay

Rathfarnham

Dublin16

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA1077/3/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27October1983

Dateoflastrenewal:27October2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/03/2010 CRN 2076797 page number: 6