ACYCLOSTAD

Main information

  • Trade name:
  • ACYCLOSTAD Cream 50 mg/g
  • Dosage:
  • 50 mg/g
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACYCLOSTAD Cream 50 mg/g
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0593/015/001
  • Authorization date:
  • 27-11-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0593/015/001

CaseNo:2041180

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

StadaArzneimittelAG

Stadastrasse2-18,D-61118BadVilbel,Germany

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Acyclostad50mg/gCream

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom05/12/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 07/12/2007 CRN 2041180 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Acyclostad50mg/gcream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Acyclostad50mg/gcreamcontains50mgofaciclovirpergramofcream.

Excipient:50mg/gcetylalcoholand150mg/gpropyleneglycol

Forafulllistofexcipients,see6.1.

3PHARMACEUTICALFORM

Cream

Whitetooff-whitecream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofimmunocompetentpatientswithskininfectionscausedbyherpessimplexvirusinparticularininitial

genitalherpes.

4.2Posologyandmethodofadministration

Acyclostad50mg/gcreamshouldbeappliedtoinfectedskinareas5timesdailyatapproximately4hourlyintervals,

omittingthenighttimeapplication.

Acyclostad50mg/gcreamshouldbeappliedtothelesionsorimpendinglesionsasearlyaspossibleafterthestartofan

infection.

Treatmentshouldbecontinuedfor5days.If,after5days,healingisnotcompletethentreatmentcanbecontinuedfor

uptoanadditional5days.

4.3Contraindications

Hypersensitivitytoacicloviroranyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Acyclostad50mg/gcreamshouldnotbeusedonmucousmembranes(e.g.mouth,vagina)toavoidlocalirritation.

Accidentaleyecontactmustalsobeprevented.

Patientswithgenitalherpesshouldabstainfromsexualactivityforaslongaslesionsarevisibletoavoidtransmission

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Theseverityofrecurrentinfectionsvariesasafunctionofthepatient'simmunestatus,episodefrequencyandduration,

sizeoftotallesionareaandpresenceorabsenceofsystemicreactions.Patient'smanagementshouldreflectthese

factorsand,therefore,mayconsisteitherofcounselingandsymptomatictreatmentorofcausaltherapy.

Severecasesofinitialgenitalherpesshouldbetreatedwiththeoraldosageform.

Thephysical,emotionalandpsychosocialproblemsthatmayresultfromherpesinfectionsdifferfrompatientto

patient.Thechoiceoftherapy,therefore,willalsodependoneachpatient'sindividualsituation.

Inseriouslyimmunocompromisedpatientsoralaciclovirtherapyshouldbeconsidered.Suchpatientsshouldbeadvised

toconsulttheirdoctoraboutthetreatmentofanyinfection.

Thismedicinalproductcontainspropyleneglycolandcetylalcohol.Itmaycauseskinirritationandlocalskinreactions

(e.g.contactdermatitis).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nodruginteractionshavebeenreportedfortopicalaciclovir.

4.6Pregnancyandlactation

Pregnancy

Safeuseofaciclovirinpregnantwomenhasnotbeenestablished.

Animalstudieshaverevealedharmfuleffectsoftheactiveingredient,aciclovir:Systemicadministrationofaciclovir

ininternationallyacceptedstandardtestsdidnotproduceembryotoxicorteratogeniceffectsinrabbits,ratsormice.In

anon-standardtestinrats,fetalabnormalitieswereobserved,butonlyfollowingsuchhighsubcutaneousdosesthat

maternaltoxicitywasproduced.

Theclinicalsignificanceofthesefindingsisuncertain.

Lactation

Theactiveingredient,aciclovir,hasbeendetectedinbreastmilkfollowingsystemicadministration.However,

pharmacokineticdatashowthat,afteralocaltreatmentwithacyclovir,itisnotpossibletodectectaciclovirintheblood

plasma.

CautionisrequiredwhenAcyclostad50mg/gcreamistobeusedbybreast-feedingwomen.

Aciclovirshouldbeusedbypregnantwomenandnursingmothersonlyonphysicians'advice.

4.7Effectsonabilitytodriveandusemachines

Nostudiesontheeffectsontheabilitytodriveandusemachineshavebeenperformed.However,anadverseeffecton

theseabilitiesisunlikely.

4.8Undesirableeffects

Adversereactionshavebeenrankedunderheadingsoffrequencyusingthefollowingconvention:Verycommon(

1/10);common(1/100,<1/10);uncommon(1/1000,<1/100);rare(1/10000,<1/1000);veryrare(<1/10000).

Immunesystemdisorders

Veryrare:Hypersensitivityreactionsoftheearlyreactiontypeincludingangioedema.

Skinandsubcutaneoustissuedisorders

Uncommon:Transientburningorstinging sensation ontheapplicationsite,mildformofdryskinorflaking,itching.

Rare:Erythema,contactdermatitisafteradministration.Theresultsofhypersensitivitytestscarriedouthaveshown

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4.9Overdose

Nountowardeffectswouldbeexpectediftheentirecontentsofaforexample10gcreamtubecontaining500mgof

aciclovirwereingestedorally.

Oraldosesof800mg5timesdailyhavebeenadministeredfor7dayswithoutadverseeffectsinthetreatmentof

shingles.Singleintravenousdosesofupto80mg/kghavebeeninadvertentlyadministeredwithoutadverseeffects.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Antibioticsandchemotherapeuticsfordermatologicaluse

ATCcode:D06BB03

Acicloviritselfisapharmacodynamicallyinactivecompound.Afterpenetratingcellsinfectedwithherpessimplex

virus(HSV),aciclovirisconvertedtoantivirally-activeaciclovirtriphosphate.Thisconversioniscatalysedbyviral

HSVthymidinekinase,anenzymeessentialforviralreplication.HSVthussynthesisesitsownantiviralagent.The

affinityofaciclovirforviralDNApolymeraseis10-20timesgreaterthanitsaffinityforcellularDNApolymerase.

Aciclovirthusselectivelyinhibitsviralenzymeactivity.ViralDNApolymeraseincorporatesaciclovirintoviralDNA.

Asaciclovirisdevoidofa3'-hydroxylgroup,nomorenucleotidescanbeaddedbytheformationof3'-5'-bonds,

causingchainterminationandhenceeffectivereductionofviralreplication.Bothherpessimplexvirustypes1and2

arehighlysensitivetoaciclovir.

Inseverelyimunnocompromisedpatients,prolongedorrepeatedaciclovirtherapymayresultintheselectionofviral

strainswithreducedsensitivity.Thesepatients,therefore,willnolongerrespondtoaciclovir.

5.2Pharmacokineticproperties

Aciclovirpenetratestheskin.Intradermallevelsarehigherthantheminimuminhibitoryconcentrationintissueat

steadystate.Ithasnotbeenpossibletodetectaciclovirinthebloodfollowingtopicalapplicationtotheskin.Thedata

reportedbelowarethereforebasedonoralorintravenousadministration.

Themainmetaboliteis9-carboxy(methoxy)methylguanine.Itaccountsforabout10-15%oftherenallyexcreteddrug.

Mostofanaciclovirdosereachingtheplasmaiseliminatedasunchangeddrugviathekidneys(bybothglomerular

filtrationandtubularexcretion).

Theplasmahalf-lifeofaciclovirinpatientswithnormalkidneyfunctionisabout3hours.Plasmaproteinbindingis

relativelylow(9-33%).Interactionsduetodisplacementfromplasmaproteinbindingsitesare,therefore,unlikely.

5.3Preclinicalsafetydata

Alargenumberofinvitrotestsshowsthat,atveryhighconcentrations,chromosomaldamagemayoccur.Duringin

vivostudies,nochromosomaldamagehasbeenobserved.Aciclovirwasnotfoundtobecarcinogenicinlong-term

studiesintheratandthemouse.Systemicadministrationofaciclovirininternationallyacceptedstandardtestsdidnot

produceembryotoxicorteratogeniceffectsinseveralspecies.Inanon-standardtestinrats,noeffectsonthefetuswere

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogolstearate,dimethicone,cetylalcohol,liquidparaffin,whitesoftparaffin,propyleneglycol,purifiedwater.

6.2Incompatibilities

Thecreammustnotbemixedwithothersubstances.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5Natureandcontentsofcontainer

Aluminiumtubewithpolyethylenecap.

Eachtubecontains2,3,5,10,15or20g.*

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

STADAArzneimittelAG

Stadastr.2-18

D-61118BadVilbel

8MARKETINGAUTHORISATIONNUMBER

PA593/15/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27 th

November1998

Dateoflastrenewal:25 th

November2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 07/12/2007 CRN 2041180 page number: 5