BETNOVATE N

Main information

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

Documents

Localization

  • Available in:
  • BETNOVATE N
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0044/023/002
  • Authorization date:
  • 27-10-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Betnovate-NOintment

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Ointment

Anoff-white,homogenousointment.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Betnovate-Nskinpreparationsareindicatedinthemanagementofcorticosteroidsensitivedermatosesactuallyor

potentiallycomplicatedbyinfectionduetomicro-organismssensitivetotheanti-infectivecontainedtherein.

Betnovate-Npreparationsareindicatedforthetreatmentofthefollowingconditionswheresecondarybacterial

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

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

seborrhoeicdermatitis;contactsensitivityreactions,insectbitereactions,pricklyheat,analandgenitalintertrigo,and

otitisexterna(seeContraindications).

4.2Posologyandmethodofadministration

Asmallquantityshouldbeappliedtotheaffectedareaonetothreetimesdailyuntilimprovementoccursorasdirected

byaphysician.Itmaythenbepossibletomaintainimprovementbyapplyingonceadayorevenlessoften.

Betnovate-NOintmentisespeciallyappropriatefordry,lichenifiedorscalylesions,butthisisnotinvariablyso.

Inthemoreresistantlesions,suchasthethickenedplaquesofpsoriasisonelbowsandknees,theeffectofBetnovate-N

canbeenhanced,ifnecessary,byoccludingthetreatmentareawithpolythenefilm.Overnightocclusiononlyisusually

adequatetobringaboutasatisfactoryresponseinsuchlesions,thereafterimprovementcanusuallybemaintainedby

regularapplicationwithoutocclusion.

Treatmentshouldnotbecontinuedformorethan7dayswithoutmedicalsupervision.

Betnovate-Nissuitableforuseinchildren(2yearsandover)atthesamedoseasinadults.Apossibilityofincreased

absorptionexistsinveryyoungchildren,thusBetnovate-Nisnotrecommendedforuseinneonatesandinfants

(<2years)(see4.3Contraindicationsand4.4SpecialWarningsandPrecautionsforUse).

Useintheelderly:

Betnovate-Nissuitableforuseintheelderly.Cautionshouldbeexercisedincaseswhereadecreaseinrenalfunction

existsandsignificantsystemicabsorptionofneomycinsulphatemayoccur(see4.4SpecialWarningsandSpecial

Betamethasone 0.1%w/w(asBetamethasoneValerate).

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/08/2006 CRN 2027083 page number: 1

Dosageinrenalimpairment:

Dosageshouldbereducedinpatientswithreducedrenalfunction(see4.4SpecialWarningsandSpecialPrecautions

forUse).

4.3Contraindications

Rosacea.

Acnevulgaris.

Perioraldermatoses.

Perianalandgenitalpruritus.

Primarycutaneousviralinfections(e.g.,herpessimplex,chickenpox).

Hypersensitivitytoanycomponentofthepreparation.

UseofBetnovate-Nskinpreparationsisnotindicatedinthetreatmentofprimaryinfectedskinlesionscausedby

infectionwithfungiorbacteria,primaryorsecondaryinfectionsduetoyeast;secondaryinfectionsduetoPseudomonas

orProteusspecies;dermatosesinchildrenundertwoyearsofage,includingdermatitisandnappyeruptions.

Preparationscontainingneomycinshouldnotbeusedforthetreatmentofotitisexternawhentheear-drumis

perforated,becauseoftheriskofototoxicity.

Duetotheknownototoxicandnephrotoxicpotentialofneomycinsulphate,theuseofBetnovate-Ninlargequantities

oronlargeareasforprolongedperiodsoftimeisnotrecommendedincircumstanceswheresignificantsystemic

absorptionmayoccur.Apossibilityexistsinveryyoungchildren,thusBetnovate-Nisnotrecommendedforusein

neonatesandinfants(upto2years).Inneonatesandinfants,absorptionbyimmatureskinmaybeenhancedandrenal

functionmaybeimmature.

4.4Specialwarningsandprecautionsforuse

Prolongeduseofananti-infectivemayresultinthedevelopmentofsuperinfectionduetoorganisms,includingfungi,

resistanttothatanti-infective.

Long-termcontinuoustopicaltherapyshouldbeavoidedwherepossible,particularlyininfantsandchildren,asadrenal

suppressioncanoccurevenwithoutocclusion.

Theanti-infectivepresentmaybetoxicifabsorbedfromopensurfaces.

Theface,morethanotherareasofthebody,mayexhibitatrophicchangesafterprolongedtreatmentwithpotenttopical

corticosteroids.Thismustbeborneinmindwhentreatingsuchconditionsaspsoriasis,discoidlupus,erythematosus

andsevereeczema.

Ifappliedtotheeyelids,careisneededtoensurethatthepreparationdoesnotentertheeye,asglaucomamightresult.

Ifbacterialinfectionpersists,systemicchemotherapyisrequired.

Anyspreadofinfectionrequireswithdrawaloftopicalcorticosteroidtherapy.

Extendedorrecurrentapplicationmayincreasetheriskofcontactsensitisation.

Productswhichcontainantimicrobialagentsshouldnotbediluted.

Extensionofinfectionmayoccurduetothemaskingeffectofthesteroid.

Topicalsteroidsmaybehazardousinpsoriasisforanumberofreasons,includingreboundrelapses,developmentof

tolerance,riskofgeneralizedpustularpsoriasisanddevelopmentoflocalorsystemictoxicityduetoimpairedbarrier

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/08/2006 CRN 2027083 page number: 2

Bacterialinfectionisencouragedbythewarm,moistconditionsinducedbyocclusivedressings,andtheskinshouldbe

cleansedbeforeafreshdressingisapplied.

Followingsignificantsystemicabsorptionaminoglycosidessuchasneomycincancauseirreversibleototoxicity:and

neomycinhasnephrotoxicpotential.

Inrenalimpairment,theplasmaclearanceofneomycinisreduced(see4.2DosageinRenalImpairment).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Followingsignificantsystemicabsorption,neomycinsulphatecanintensifyandprolongtherespiratorydepressant

effectsofneuromuscularblockingagents.

4.6Pregnancyandlactation

Thereislittleinformationtodemonstratethepossibleeffectoftopicallyappliedneomycininpregnancyandlactation.

However,neomycinpresentinmaternalbloodcancrosstheplacentaandmaygiverisetoatheoreticalriskoffoetal

toxicity,thususeofBetnovate-Nisnotrecommendedinpregnancyandlactation.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Prolongedandintensivetreatmentwithhighlyactivecorticosteroidpreparationsmaycauselocalatrophicchangesin

theskinsuchasthinning,striaeanddilatationofthesuperficialbloodvessels,particularlywhenocclusivedressingsare

usedorwhenskinfoldsareinvolved.

Therearereportsofpigmentationchangesandhypertrichosiswithtopicalsteroids.Exacerbationofsymptomsmay

occur.

Aswithothertopicalcorticosteroids,prolongeduseoflargeamountsortreatmentofextensiveareas,canresultin

sufficientsystemicabsorptiontoproducethefeaturesofhypercorticism.Thiseffectismorelikelytooccurininfants

andchildrenandifocclusivedressingareused.Ininfants,thenapkinmayactasanocclusivedressing.Inrare

instances,treatmentofpsoriasiswithcorticosteroids(oritswithdrawal)isthoughttohaveprovokedthepustularform

ofthedisease.

TheBetnovatepreparationsareusuallywelltolerated,butifsignsofhypersensitivityappear,applicationshouldstop

immediately.

4.9Overdose

Acuteoverdosageisveryunlikelytooccur.However,inthecaseofchronicoverdosageormisuse,thefeaturesof

hypercorticismmayappearandinthissituationtopicalsteroidsshouldbediscontinuedgradually.Howeverbecauseof

theriskofacuteadrenalsuppressionthisshouldbedoneundermedicalsupervision.

Alsoconsiderationshouldbegiventosignificantsystemicabsorptionofneomycinsulphate(See4.4SpecialWarnings

andSpecialPrecautionsforUse).Ifthisissuspected,useoftheproductshouldbestoppedandthepatient’sgeneral

status,hearingacuity,renalandneuromuscularfunctionsshouldbemonitored.

Bloodlevelsofneomycinsulphateshouldalsobedetermined.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/08/2006 CRN 2027083 page number: 3

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Betamethasonevalerateisanactivecorticosteroidthatproducesasatisfactoryresponseinthoseinflammatory

dermatosesthatarenormallyresponsivetotopicalcorticosteroidtherapyandisofteneffectiveinthelessresponsive

conditionssuchaspsoriasis.

Neomycinsulphateisabroadspectrum,bactericidalantibioticeffectiveagainstthemajorityofbacteriacommonly

associatedwithskininfections.

5.2Pharmacokineticproperties

Theextentofpercutaneousabsorptionoftopicalcorticosteroidisdeterminedbymanyfactorsincludingthevehicle,the

integrityoftheepidermalbarrierandtheuseofocclusivedressings.

Topicalcorticosteroidscanbeabsorbedfromnormalintactskin.Inflammationand/orotherdiseaseprocessesinthe

skinincreasepercutaneousabsorption.Occlusivedressingssubstantiallyincreasethepercutaneousabsorptionoftopical

corticosteroids.

Onceabsorbedthroughtheskin,topicalcorticosteroidsarehandledthroughpharmacokineticpathwayssimilarto

systematicallyadministeredcorticosteroids.Corticosteroidsareboundtoplasmaproteinsinvaryingdegrees.

Corticosteroidsaremetabolisedprimarilybytheliverandarethenexcretedbythekidneys.

5.3Preclinicalsafetydata

Noadditionaldata.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

WhiteSoftParaffin

LiquidParaffin

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove30ºC.

6.5Natureandcontentsofcontainer

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/08/2006 CRN 2027083 page number: 4

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

GlaxoLaboratoriesLimited

StockleyParkWest

Uxbridge

Middlesex,UB111BT

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA44/23/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27October1983

Dateoflastrenewal:27October2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/08/2006 CRN 2027083 page number: 5