ACICLOVIR

Main information

  • Trade name:
  • ACICLOVIR Cream 5 %w/w
  • Dosage:
  • 5 %w/w
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACICLOVIR Cream 5 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0876/001/001
  • Authorization date:
  • 22-01-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AciclovirCream5%w/w

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Aciclovir:5.0%w/w(50mgperg)

Excipients:

Cetylalcohol:1.5%w/w(15mgperg)

Propyleneglycol:15.0%w/w(150mgperg)

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Cream.

Whitetooff-white,smoothcreamwithoutagglomerates,coarselumpsorcontaminationsandwithcharacteristicodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AciclovirCream5%w/wisindicatedforthetreatmentofrecurrentherpeslabialisandherpesgenitalis.

4.2Posologyandmethodofadministration

Dose:

Unlessotherwiseinstructed,applyathinlayerofcreamoverthesiteofinfectioneveryfourhours,fivetimesaday.

Lengthoftreatment:

Thecreamshouldbeappliedtothelesionordevelopinglesionassoonaspossibleafterthestartoftheinfection.

TreatmentwithAciclovirCream5%w/wisnormallycontinuedforfivedays.Ifthesituationdeterioratesor,ifafterten

daysthereisnoclinicalbenefit(crustedvesicles,healingoflesions),treatmentshouldbediscontinuedandpatients

shouldconsulttheirphysician.

Methodofadministration:

AcottonbudshouldbeusedtoapplyasufficientquantityofAciclovirCream5%w/wtocoveralllesions.Thecream

shouldbeappliedtovisiblyinfectedsites(vesicles,swelling,erythema)andtheadjoiningareas.Ifhandsareusedto

applythecream,theyshouldbethoroughlywashedbeforeandafterapplicationtopreventfurtherinfectionofthe

lesionsbybacteriaandtopreventautoinoculationofthevirustoothermucousmembraneandcutaneoussitesnotyet

infected.

4.3Contraindications

Irish Medicines Board

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4.4Specialwarningsandprecautionsforuse

AciclovirCream5%w/wshouldnotbeusedonmucousmembranes(e.g.oralcavity,eyes,vagina)sincelocal

reactionsmayoccur.

SeverelyimmunocompromisedpatientsshouldconsulttheirphysicianbeforestartingtreatmentwithAciclovirCream

5%w/w.Immunocompromisedpatientsmayrequireoraldosing.

Becauseofpossibleinfectionsofbothpartners,patientswithherpesgenitalisshouldbeadvisedtoabstainfromsexual

contactassoonasprodromalsymptomsoccuranduntilalllesionshavehealed.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nointeractionsknown.

4.6Pregnancyandlactation

Pregnancy:

Onlyabout0.1%oftheaciclovirappliedtotheskinisdetectableintheplasma.Concentrationsareminimalsothatno

systemiceffectshouldoccur.

Lactation:

Asthereisonlyminimalsystemicabsorptionofaciclovir,adverseeffectsontheinfantduringlactationareunlikely.

TheuseofAciclovirCream5%w/wduringpregnancyandlactationshouldbeconsideredonlywhenthepotential

benefitsoutweighthepossibilityofunknownrisks.

4.7Effectsonabilitytodriveandusemachines

AciclovirCream5%w/whasnoornegligibleinfluenceontheabilitytodriveandusemachines.

4.8Undesirableeffects

Withineachfrequencygrouping,undesirableeffectsarepresentedinorderofdecreasingseriousness.

Immunesystemdisorders

Veryrare( ≤1/10,000):Therehavebeenreportsofimmediatehypersensitivityreactionsincludingangioedema

withtopicalaciclovir.

Skinandsubcutaneoustissuedisorders

Common( ≥1/100to<1/10):TransientburninganditchingorstingingmayoccurafterapplicationofAciclovir

Cream5%w/w.

Erythema,dryness,pruritusanddesquamationofcutaneoussiteshavealsobeenobserved.

Rare( ≥1/10,000to≤1/1,000):ContactdermatitishasbeenreportedafteradministrationofAciclovirCream5%w/w.

Examinationshowedthatinmostcasesthecontactdermatitiswascausedbyoneoftheexcipientsratherthanbythe

activeingredientaciclovir.Thecontactdermatitisischaracterizedbytheoccurrenceofthecutaneousreactionsas

describedabove,withawidespreaddistribution.

4.9Overdose

Irish Medicines Board

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Chemotherapeuticsfortopicaluse,Antivirals

ATC-Code:D06BB03

Afterpenetratingintoacellinfectedbyherpessimplexvirus,aciclovirconvertstoaciclovirtriphosphate.Viral

replicationisselectivelyinhibitedbyviralDNApolymerase.

Aciclovirdoesnoteradicatelatentvirus.

5.2Pharmacokineticproperties

Inpatientswithnormalrenalfunctionaciclovirisrenallyeliminatedasunchangeddrug(62–91%)andas9-

carboxymethoxymethyl-guanine(10–15%).Plasmahalf-life(t

1/2ß )afterintravenousadministrationofacicloviris

2.87±0.76hoursforadultsand4.1±1.2hoursfornew-bornandinfantsundertheageofthreemonths.Thereis

glomerularfiltrationaswellastubularsecretionofaciclovir.

Inpatientssufferingfromchronicrenalinsufficiency,averageplasmahalf-lifeisabout19.5hours.Meanplasmahalf-

lifeduringhaemodialysisis5.7hours.Duringhaemodialysisadecreaseofaciclovirplasmalevelsofabout60%occurs.

Concentrationsintheplasmafollowingtopicaladministrationareminimalsothatthereshouldbenooronlyminimal

systemiceffects.

5.3Preclinicalsafetydata

Localeffects:

Aciclovircreamwasappliedtoguineapigandrabbitskin(damagedandnormal)onceadayfor21days.Amild

irritationoccurredafterrepeatedapplication.

Sincetheamountofactiveingredientabsorbedfromthecreamdoesnotleadtosignificantplasmalevels(seesection

5.2,Pharmacokineticproperties)therewerenofurtherstudiesonthisformofadministration.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerinmonostearate/poloxyethylen-30-stearate(Arlatone983S)

Dimeticone

CetylAlcohol

LiquidParaffin

Whitesoftparaffin,

PropyleneGlycol

PurifiedWater

6.2Incompatibilities

None.

6.3ShelfLife

Irish Medicines Board

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6.4Specialprecautionsforstorage

Storebelow25 °

Donotrefrigerate.

6.5Natureandcontentsofcontainer

Aluminiumtubecontaining2,5,10or15gofAciclovirCream5%w/w.

Onetubeispackedinacartontogetherwithapatientinformationleaflet.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

TADPharmaGmbH,

Heinz-Lohmann-Strae5,

27472Cuxhaven,

Germany.

8MARKETINGAUTHORISATIONNUMBER

PA0876/001/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:22January1999

Dateoflastrenewal: 22November2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 12/08/2008 CRN 2054649 page number: 4