BREVOXYL

Main information

  • Trade name:
  • BREVOXYL Cream 4 %w/ w
  • Dosage:
  • 4 %w/ w
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BREVOXYL Cream 4 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1077/119/001
  • Authorization date:
  • 27-05-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Brevoxyl40mg/gCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramofcreamcontains40mgofbenzoylperoxide,asthehydrate.

Thecreamalsocontainsthefollowingexcipients:

Propyleneglycolalginate2.5mg/g

Cetylalcohol15mg/g

Stearylalcohol(presentinPromulgenG)47.5mg/g

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Cream

Awhitetooff-whitecream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Brevoxylisindicatedforthetreatmentofmildtomoderateacnevulgaris.

4.2Posologyandmethodofadministration

AdolescentsandAdults

Applytothewholeoftheaffectedareaonceortwicedaily.Washwithsoapandwaterpriortoapplication.

Paediatricuse

ThesafetyandefficacyofBrevoxylhasnotbeenestablishedinchildrensinceacnevulgarisrarelypresentsinthisage

group.

Elderlypatients

Therearenospecificrecommendations.Acnevulgarisdoesnotpresentintheelderly.

Intitalapplicationoftheproductmaybevariedatthephysician'sinstructionstoreflectthepatient'sskintypeandto

avoidundesirableeffects.

Irish Medicines Board

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Date Printed 30/01/2012 CRN 2108569 page number: 1

4.3Contraindications

Patientswithknownhypersensitivitytoanyoftheingredientsshouldnotusethisproduct.

4.4Specialwarningsandprecautionsforuse

Avoidcontactwiththeeyes,mouthandothermucousmembranes.Careshouldbetakenwhenapplyingtheproductto

theneckandothersensitiveareas.Propylenegycolalginatemaycauseskinirritation.

Stearylalcoholandcetylalcoholmaycauselocalskinreaction(e.g.contactdermatitits)

Itisrecommendedthatexposuretosunorsunlampsshouldbeminimised.

Simultaneoususeofotherkeratolyticssuchasalicylatesorsulphurmayincreaseoccuranceofskinirritation.

Duringthefirstweeksoftreatment,asuddenincreaseinpeelingandreddeningwilloccurinmostpatients;thisisnot

harmfulandwillnormallysubsideinadayortwoiftreamentistemporarilydiscontinued.

Theproductmaybleachcolouredordyedfabrics.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

SimultaneousapplicationofBrevoxylandtopicalacnepreparationscontainingvitaminAderivativesshouldbe

avoided.

4.6Fertility,pregnancyandlactation

Thesafetyofbenzoylperoxideinhumanpregnancyisnotestablished.DuringpregnancyandlactationBrevoxyl

shouldbeusedonlywithspecialcautionandafterthephysician'sassessmentofbenefitandrisk.Inthelastmonthof

pregnancyBrevoxylshouldnotbeused.

ThereisnoknowledgeaboutexcretionofBrevoxylinbreastmilk.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Innormaluse,amildburningsensationwillprobablybefeltonfirstapplicationandamoderatereddeningandpeeling

oftheskinwilloccurwithinafewdays.Duringthefirstfewweeksoftreatmentasuddenincreaseinpeelingwill

occurinmostpatients;thisisnotharmfulandwillnormallysubsideinadayortwoiftreatmentistemporarily

discontinued.Thepatientmayalsoexperiencetemporarypruritus,facialoedema,dermatitisorrash.Asforother

benzoylperoxidepreparationsallergiccontactdermatitiscouldoccasionallyoccur.

4.9Overdose

Irish Medicines Board

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Date Printed 30/01/2012 CRN 2108569 page number: 2

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

BenzoylperoxidehasantibacterialactivityagainstPropionibacteriumacnes,theorganismimplicatedinacnevulgaris.

Ithaskeratolyticactivityandissebostatic,counteractingthehyperkeratinisationandexcessivesebumproduction

associatedwithacne.

5.2Pharmacokineticproperties

Aftertopicalapplication,benzoylperoxideisabsorbedinvaryingquantitiesthroughtheskinofmanandanimals.

Radio-labelledstudieshaveshownthatabsorptionofbenzoylperoxidethroughtheskincanonlyoccurfollowingits

conversiontobenzoicacid.Benzoicacidismostlyconjugatedtoformhippuricacidwhichisexcretedviathekidneys.

5.3Preclinicalsafetydata

Animaltoxicitystudiesofbenzoylperoxidehaveshownthatthecompoundisnon-toxicwhenappliedtopically.

Benzoicacid,towhichbenzoylperoxideisconvertedpriortoabsorption,hasawidemarginofsafety.Benzoicacidis

anapprovedfoodadditive.

Benzoylperoxideisafreeradicalgeneratingcompound.Thereleaseofoxygenduringitsconversiontobenzoicacid

maybeimplicatedinatumourpromotingeffectseeninmouseskin.

Benzoylperoxideathighdoses(>20timesthenormalhumandose),hasbeenshowntoincreasethetumourgrowth

initiatedbydimethylbenzanthracene(DMBA)inmice.DMBAisapowerfulchemicalcarcinogentowhichpatients

areunlikelytobeexposed.Therelevanceoftheseresultstomanislimited.Studiesinmicehavealsoshownthat

benzoylperoxidedoesnotincreasethegrowthoftumoursinitiatedbyultravioletlight.

Noreproductivetoxicologystudieshavebeenperformed.Uptodatetherearenoindicationsthatthetopicaluseof

Brevoxylcausesdamagetotheunbornchild.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Cetylalcohol

PromulgenG(whichconsistsofStearylalcoholandmacrogolcetostearylether)

Simethiconeemulsion

Propyleneglycolalginate

Dimethylisosorbide

FragranceX-23304

Purifiedwater

6.2Incompatibilities

None.

6.3Shelflife

Irish Medicines Board

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Date Printed 30/01/2012 CRN 2108569 page number: 3

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

Lacqueredaluminiumorlaminatedtubeswithwhitepolypropylenescrewcaps

Packsize:40g

and/or

Membranesealedpolyethylene/ethylenevinylalcoholco-polymer(EVOH)/polyethylenelaminatetubeswitha

polyethyleneshoulderandpolypropylenescrewcaps.

Packsizes:5g,15g,30gand50g

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKline(Ireland)Ltd

StonemasonsWay

Rathfarnham

Dublin16

Ireland

TradingasStiefel

8MARKETINGAUTHORISATIONNUMBER

PA1077/119/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 13November1995

Dateoflastrenewal: 13November2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 30/01/2012 CRN 2108569 page number: 4