ACICLOVIR DISPERSIBLE BP

Main information

  • Trade name:
  • ACICLOVIR DISPERSIBLE BP
  • Dosage:
  • 800mg Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACICLOVIR DISPERSIBLE BP
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1046/004/003
  • Authorization date:
  • 07-07-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Aciclovir800mgDispersibleTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachtabletcontainsAciclovir800mg.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Dispersibletablet

WhiteovaldispersibletabletwithS95embossedononesideandscoredonthereverse.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AciclovirTabletsareindicatedforthetreatmentofvaricella(chickenpox)andherpeszoster(shingles)infections.

4.2Posologyandmethodofadministration

Treatmentofvaricellaandherpeszosterinfections

800mgaciclovirshouldbetakenfivetimesdailyatapproximatelyfour-hourlyintervals,omittingthenighttimedose.

Treatmentshouldcontinueforsevendays.

Inseverelyimmunocompromisedpatients(e.g.aftermarrowtransplant)orinpatientswithimpairedabsorptionfrom

thegutconsiderationshouldbegiventointravenousdosing.

Dosingshouldbeginasearlyaspossibleafterthestartofaninfection:Treatmentofherpeszosteryieldsbetterresultsif

initiatedassoonaspossibleaftertheonsetoftherash.Treatmentofchickenpoxinimmunocompetentpatientsshould

beginwithin24hoursafteronsetoftherash.

Children

Treatmentofvaricellainfections

6yearsandover

800mgaciclovirfourtimesdaily.

2tofiveyears

400mgaciclovirfourtimesdaily.

Under2years

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Treatmentshouldcontinueforfivedays.

Dosingmaybemoreaccuratelycalculatedas20mg/kgbodyweight(nottoexceed800mg)aciclovirfourtimesdaily.

Nospecificdataareavailableonthesuppressionofherpessimplexinfectionsorthetreatmentofherpeszoster

infectionsinimmunocompetentchildren.Whentreatmentofherpeszosterinfectionsisrequiredin

immunocompromisedchildren,intravenousdosingshouldbeconsidered.

Dosageintheelderly

Intheelderly,totalaciclovirbodyclearancedeclinesalongwithcreatinineclearance.Adequatehydrationofelderly

patientstakinghighoraldosesofaciclovirshouldbemaintained.Specialattentionshouldbegiventodosagereduction

inelderlypatientswithimpairedrenalfunction.

Dosageinrenalimpairment

Inthetreatmentofvaricellaandherpeszosterinfectionsitisrecommendedtoadjustthedosageto800mgaciclovir

twicedailyatapproximatelytwelve-hourlyintervalsforpatientswithsevererenalimpairment(creatinineclearanceless

than10ml/minute),andto800mgaciclovirthreetimesdailyatintervalsofapproximatelysixtoeighthoursforpatients

withmoderaterenalimpairment(creatinineclearanceintherange10to25ml/minute).

RouteofAdministration:Oral.

AciclovirDispersibleTabletsmaybedispersedinaminimumof50mlofwaterorswallowedwholewithalittlewater.

4.3Contraindications

Aciclovirtabletsarecontraindicatedinpatientsknowntobehypersensitivetoaciclovir.

4.4Specialwarningsandprecautionsforuse

Hydrationstatus:Careshouldbetakentomaintainadequatehydrationinpatientsreceivinghigherdoseoralregimens

e.g.forthetreatmentofherpeszosterinfection(4gdaily),inordertoavoidtheriskofpossiblerenaltoxicity.

Thedatacurrentlyavailablefromclinicalstudiesisnotsufficienttoconcludethattreatmentwithaciclovirreducesthe

incidenceofchickenpox-associatedcomplicationsinimmunocompetentpatients.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noclinicallysignificantinteractionshavebeenidentified.

Acicloviriseliminatedprimarilyunchangedintheurineviaactiverenaltubularsecretion.Anydrugsadministered

concurrentlythatcompetewiththismechanismmayincreaseaciclovirplasmaconcentrations.Probenecidand

cimetidineincreasetheAUCofaciclovirbythismechanism,andreduceaciclovirrenalclearance.Similarlyincreases

inplasmaAUCsofaciclovirandoftheinactivemetaboliteofmycophenolatemofetil,animmunosuppressantagent

usedintransplantpatientshavebeenshownwhenthedrugsareco-administered.Howevernodosageadjustmentis

necessarybecauseofthewidetherapeuticindexofaciclovir.

4.6Pregnancyandlactation

Apost-marketingaciclovirpregnancyregistryhasdocumentedpregnancyoutcomesinwomenexposedtoany

formulationofaciclovir.Thebirthdefectsdescribedamongstaciclovirexposedsubjectshavenotshownany

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Cautionshouldhoweverbeexercisedbybalancingthepotentialbenefitsoftreatmentagainstanypossiblehazard.

Followingoraladministrationof200mgaciclovirfivetimesaday,aciclovirhasbeendetectedinbreastmilkat

concentrationsrangingfrom0.6to4.1timesthecorrespondingplasmalevels.Theselevelswouldpotentiallyexpose

nursinginfantstoaciclovirdosagesofupto0.3mg/kg/day.Cautionisthereforeadvisedifacicloviristobe

administeredtonursingwomen.

4.7Effectsonabilitytodriveandusemachines

Somepatientsmayexperiencedizzinessordrowsiness.Ifaffectedpatientsshouldnotdriveoroperatemachinery.

4.8Undesirableeffects

Gastrointestinal:nausea,vomiting,diarrhoeaandabdominalpainshavebeenreportedinsomepatientsreceiving

aciclovirtablets.

Haematological:veryrarely,anaemia,leukopeniaandthrombocytopenia.

Hypersensitivityandskin:rashesincludingphotosensitivity,urticaria,pruritisandrarelydyspnoea,angioedemaand

anaphylaxis.Therasheshaveresolvedonwithdrawalofthedrug.

Kidney:rarereportsofincreasesinbloodureaandcreatinine.Acuterenalfailurehasbeenreportedonvaryrare

occasions.

Liver:rarereportsofreversiblerisesinbilirubinandliverrelatedenzymes.Hepatitisandjaundicehavebeenreported

onvaryrareoccasions.

Neurological:Reversibleneurologicalreactions,notablydizziness,confusionalstates,hallucinationssomnolence,

convulsionsandcomahaveoccasionallybeenreported,usuallyinpatientswithrenalimpairmentinwhomdosagewas

inexcessofthatrecommendedorotherpredisposingfactors.

Other:Occasionalreportsofaccelerateddiffusehairlosshavebeenreceived.Asthistypeofhairlosshasbeen

associatedwithawidevarietyofdiseaseprocessesandmedicines,therelationshipoftheeventtoaciclovirtherapyis

uncertain.

4.9Overdose

Aciclovirisonlypartlyabsorbedinthegastrointestinaltract.Itisunlikelythatserioustoxiceffectswouldoccurifa

doseofupto5gweretakenonasingleoccasion.Nodataareavailableontheconsequencesoftheingestionofhigher

doses;suchanoccurrencewarrantscloseobservationofthepatient.

Singleintravenousdosesofupto80mg/kghavebeeninadvertentlyadministeredwithoutadverseeffects.Acicloviris

dialysablebyhaemodialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Antiviralsforsystemicuse,nucleosidesandnucleotides;ATCcode:J05AB01.

Aciclovirisasyntheticpurinenucleosideanaloguestructurallyrelatedtoguanine.Itisusedforthetreatmentofviral

infectionsduetoherpessimplexvirus(types1and2)andvaricella-zostervirus(zosterandchickenpox).

Herpessimplexinfectionsincludingherpeskeratitis,herpeslabialis,andgenitalherpesrespondtoaciclovirgivenby

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besuccessfullytreated.Prolongedtreatmentcanreducetheincidenceofrecurrencewhichisimportantin

immunocompromisedpatients.However,whenprolongedtreatmentiswithdrawninfectionsmayrecur.

Acicloviralsoimprovesthehealingofzosterlesionsandreducesacutepainwhengivenintravenouslyorbymouth,

althoughstudiesindicatethatithaslittleeffectonpostherpeticneuralgia.Beneficialeffectsmaybemoremarkedin

immunocompromisedpatients.

5.2Pharmacokineticproperties

About15to30%ofadoseofaciclovirgivenbymouthisconsideredtobeabsorbedfromthegastro-intestinaltract.A

doseof200mgaciclovirevery4hoursbymouthisreportedtoproducemaximumandminimumsteady-stateplasma

concentrations0.56and0.29microgramspermlrespectively;equivalentvaluesfollowing400mgdosesare1.2and0.6

microgramsperml.Aciclovircrossestheplacentaandisexcretedinbreastmilkinconcentrationsapproximatelythree

timeshigherthanthoseinmaternalserum.

5.3Preclinicalsafetydata

Theresultsofawiderangeofmutagenicitytestsinvitroandinvivoindicatethataciclovirisunlikelytoposeagenetic

risktoman.Aciclovirwasnotfoundtobecarcinogenicinlongtermstudiesintheratandthemouse.Largely

reversibleadverseeffectsonspermatogenesisinassociationwithoveralltoxicityinratsanddogshavebeenreported

onlyatdosesofaciclovirgreatlyinexcessofthoseemployedtherapeutically.Aciclovirtabletshavebeenshownto

havenodefiniteeffectuponspermcount,morphologyormotilityinman.

ExperienceinhumansislimitedsotheuseofAciclovirTabletsshouldbeconsideredonlywhenthepotentialbenefits

outweighthepossibilityofunknownrisks.Systemicadministrationofaciclovirininternationallyacceptedstandard

testsdidnotproduceembryotoxicorteratogeniceffectsinrats,rabbitsormice.

Inanon-standardtestinrats,foetalabnormalitieswereobserved,butonlyfollowingsuchhighsubcutaneousdosesthat

maternaltoxicitywasproduced.Theclinicalrelevanceofthesefindingsisuncertain.

Thereisnoexperienceoftheeffectofaciclovirtabletsonhumanfemalefertility.Two-generationstudiesinmicedid

notrevealanyeffectofaciclovironfertility.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Colloidalanhydroussilica

Polysorbate80

Gelatin

Crospovidone

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

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6.5Natureandcontentsofcontainer

Aluminium(20µm)/PVC(250µm)stripsof35tabletsinacartonbox.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

WinthropPharmaceuticalsUKLimited

OneOnslowStreet

Guildford

Surrey

GU14YS

Tradingas

WinthropPharmaceuticals

POBox611

Guildford

SurreyGU14YS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA1046/4/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoflastauthorisation:18September1998

Dateoflastrenewal:18September2003

10DATEOFREVISIONOFTHETEXT

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