AUGMENTIN DUO

Main information

  • Trade name:
  • AUGMENTIN DUO
  • Dosage:
  • 500/ 125 Base Milligrams
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AUGMENTIN DUO
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA0465/047/002A
  • Authorization date:
  • 27-07-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AugmentinDuo500mg/125mgFilm-coatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachfilm-coatedtabletcontainsamoxicillintrihydrateequivalentto500mgamoxicillinandpotassiumclavulanate

equivalentto125mgclavulanicacid.

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet.

ProductimportedfromtheUK:

White,oval,tablets;engraved‘AUGMENTIN’ononeside,plainontheotherside.

ProductimportedfromGreeceandSpain:

White,oval,tabletswithabreaklineononeside,‘A’ononesideofthelineand‘C’ontheotherandplainontheother

side.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AugmentinDuo,fortwicedaily(b.i.d.)dosing,isindicatedforshorttermtreatmentofbacterialinfectionsatthe

followingsiteswhenamoxycillinresistantbeta-lactamaseproducingstrainsaresuspectedasthecause.Inother

situations,amoxycillinaloneshouldbeconsidered.

UpperRespiratoryTractInfections(includingENT)inparticularsinusitis,otitismedia,recurrenttonsillitis.These

infectionsareoftencausedbyStreptococcuspneumoniae,

Haemophilusinfluenzae *

,Moraxellacatarrhalis *

andStreptococcuspyogenes.

LowerRespiratoryTractInfectionsinparticularacuteexacerbationsofchronicbronchitis(especiallyifconsidered

severe),bronchopneumonia.TheseinfectionsareoftencausedbyStreptococcuspneumoniae,Haemophilus

influenzae *

andMoraxellacatarrhalis *

.

Genito-urinaryTractandAbdominalInfectionsinparticularcystitis(especiallywhenrecurrentorcomplicated–

excludingprostatis),septicabortion,pelvicorpuerperalsepsisandintra-abdominalsepsis.Theseinfectionsare

oftencausedbyEnterobacteriaceae *

(mainlyEscherichiacoli *

),Staphylococcussaprophyticus,Enterococcus

species *

.

SkinandSoftTissueInfectionsinparticularcellulitis,animalbitesandseveredentalabscesswithspreading

cellulitis.TheseinfectionsareoftencausedbyStaphylococcusaureus *

,StreptococuspyogenesandBacteroides

species *

*Somemembersofthesespeciesofbacteriaproducebeta-lactamaserenderingtheminsensitivetoamoxycillinalone.

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Mixedinfectionscausedbyamoxycillin-susceptibleorganismsinconjunctionwith‘AugmentinDuo’-susceptiblebeta-

lactamase-producingorganismsmaybetreatedwith‘AugmentinDuo’.Theseinfectionsshouldnotrequirethe

additionofanotherantibioticresistanttobeta-lactamases.

4.2Posologyandmethodofadministration

Routeofadministration:Oral

Adultsandchildrenover12years:Formildtomoderateinfectionsone‘AugmentinDuo’Tablet625mgtwiceaday.

Therapycanbestartedparenterallyandcontinuedwithanoralpreparation.‘Augmentin-Duo’Tablets625mgarenot

recommendedinchildrenof12yearsandunder.

Renalimpairment

Adults:Inmildimpairment(creatinineclearance>30ml/min),nochangeindosageisnecessary.Inmoderate

impairment(creatinineclearance10-30ml/min),therecommendeddoseisone‘Augmentin-Duo’tablet625mg12

hourly.‘Augmentin-Duo’Tablets625mgarenotrecommendedinpatientswithseverrenalimpairment(creatinine

clearance<10ml/min)

Haemodialysis

Dosageadjustmentarebasedonthemaximumrecommendedlevelofamoxycillin.One625mgtabletevery24hours

PLUSonedoseduringdialysis,toberepeatedattheendofdialysis(asserumconcentrationsofbothamoxycillinand

clavulanicacidaredecreased).

Hepaticimpairment

Dosewithcaution,monitorhepaticfunctionatregularintervals.Thereisasyetinsufficientevidenceonwhichtobase

adosagerecommended.

Administration:Tominimisepotentialgastro-intestinalintoleranceadministeratthestartofameal.The

absorptionofco-amoxiclavisoptimisedwhentakenatthestartofameal.

Durationoftherapyshouldbeappropriatetotheindicationandshouldnotexceed14dayswithoutreview.Therapycan

bestartedparentallyandcontinuedwithanoralpreparation.

4.3Contraindications

AugmentinDuoTablets625mgshouldnotbeusedinpatientswithahistoryofhypersensitivitytobeta-lactamse.g.

penicillinsandcephalosporins,oranyexcipientsintheproduct(seesection6.1).AugmentinDuoiscontra-indicatedin

patientswithaprevioushistoryof‘co-amoxiclav’-associatedjaundice/hepaticdysfunction.

4.4Specialwarningsandprecautionsforuse

Prolongeduseofananti-infectiveagentmayoccasionallyresultinsuperinfectionbymicroorganismsincludingcandida

resistanttothatanti-infective.

Beforeinitiativetherapywith‘Augmentin-Duo’carefulenquiryshouldbemadeconcerningprevioushypersensitivity

reactionstopenicillinsandcephalosporins.

Seriousandoccasionallyfatalhypersensitivity(anaphylactoid)reactionshavebeenreportedinpatientsonpenicillin

therapy.Thesereactionsaremorelikelytooccurinindividualswithahistoryofpenicillinhypersensitivity(see

Contra-indications).

'Augmentin-Duo'shouldbeusedwithcautioninpatientswithevidenceofhepaticdysfunctionandwithcarein

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‘Augmentin-Duo’shouldbeavoidedifinfectionsmononucleosisissuspectedsincetheoccurrenceofamorbilliform

rashhasbeenassociatedwiththisconditionfollowingtheuseofamoxycillin.

'Augmentin-Duo'tablets625mgeachcontain0.63mmolofpotassium.

Inpatientswithreducedurineoutput,crystalluriahasbeenobservedveryrarely,predominantlywithparenteral

therapy.DuringtheadministrationofhighdosesofAmoxicillin,itisadvisabletomaintainadequatefluidintakeand

urinaryoutputinordertoreducethepossibilityofAmoxicillincrystalluria(seeOverdosage).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concomitantuseofprobenecidisnotrecommendedassuchusemayresultinincreasedandprolongedbloodlevelsof

amoxycillinbutnotclavulanicacid.

Prolongationofbleedingtimeandprothrombintimehavebeenreportedinsomepatientsreceiving‘co-amoxiclav’.

‘AugmentinDuo’shouldbeusedwithcareinpatientsonanti-coagulationtherapy.

Concomitantuseofallopurinolduringtreatmentwithamoxicillincanincreasethelikelihoodofallergicskinreactions.

Therearenodataontheconcomitantuseofamoxicillin-clavulanateandallopurinol.

Incommonwithotherbroad-spectrumantibiotics‘AugmentinDuo’mayreducetheefficacyoforalcontraceptivesand

patientsshouldbewarnedaccordingly.

4.6Fertility,pregnancyandlactation

Pregnancy:

Reproductivestudiesinanimals(miceandrats)withorallyandparenterallyadministrationco-amoxiclavhaveshown

noteratogeniceffects.Inasinglestudyinwomenwithpreterm,prematureruptureofthefoetalmembrane(pPROM),it

wasreportedthatprophylactictreatmentwith‘Augmentin’maybeassociatedwithanincreasedriskofnecrotising

enterocolitisinneonates.Aswithallmedicinesusshouldbeavoidedinpregnancyunlessconsideredessentialbythe

physician.

Lactation:

‘Augmentin-Duo’maybeadministeredduringtheperiodoflactation.Withtheexceptionoftheriskofsensitisation

withthetracequantitiesinbreastmilk,therearenoknowndetrimentaleffectsforthebreast-fedinfant.

4.7Effectsonabilitytodriveandusemachines

Adverseeffectsontheabilitytodriveandoperatemachineryhavenotbeenobserved.

4.8Undesirableeffects

Datafromlargeclinicaltrialswasusedtodeterminethefrequencyofverycommontorareundesirableeffects.The

frequenciesassignedtoallotherundesirableeffects(i.e.thoseoccurringat<1/10,000)weremainlydeterminedusing

post-marketingdataandrefertoareportingrateratherthanatruefrequency.

Thefollowingconventionhasbeenusedfortheclassificationoffrequency:-

Verycommon>1/10

Common>1/100and<1/10

Uncommon>1/1000and<1/100

Rare>1/10,000and<1/100

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Infectionsandinfestations

Common:MucocutaneousCandidiasis

Bloodandlymphaticsystemdisorders

Rare:Reversibleleucopenia(includingneutropenia)andthrombocytopenia.

Veryrare:Reversibleagranulocytosisandhaemolyticanaemia.

Prolongationofbleedingtimeandprothrombintime(seeSection4.4Specialwarningsandspecial

precautionsforuse)

Immunesystemdisorders

VeryRare:Angioneuroticoedema,anaphylaxis,serumsickness-likesyndrome,hypersensitivityvasculitis.

Nervoussystemsdisorders

Uncommon:Dizziness,headache

VeryRare:Reversiblehyperactivityandconvulsions.Convulsionsmayoccurinpatientswithimpairedrenalfunction

orinthosereceivinghighdoses.

Gastrointestinaldisorders

Verycommon:Diarrhoea

Common:Nausea,vomiting.

Nauseaismoreoftenassociatedwithhigheroraldosages.Ifgastrointestinalreactionsareevident,theymaybereduced

bytakingAUGMENTINatthestartofameal.

Uncommon:Indigestion

VeryRare:Antibiotic-associatedcolitis(includingpseudomembranouscolitisandhaemorrhagiccolitis).

Blackhairytongue.

Hepatobiliarydisorders

Uncommon:AmoderateriseinASTand/orALTandAlkalinePhosphataseshasbeennotedinpatientstreatedwith

beta-lactamclassantibiotics,butthesignificanceofthesefindingsisunknown.

VeryRare:Hepatitisandcholestaticjaundice.Theseeventshavebeennotedwithotherpenicillinsandcephalosporins.

Hepaticeventshavebeenreportedpredominantlyinmalesandelderlypatientsandmaybeassociatedwithprolonged

treatment.

Signsandsymptomsusuallyoccurduringorshortlyaftertreatmentbutinsomecasesmaynotbecomeapparentuntil

severalweeksaftertreatmenthasceased.Theseareusuallyreversible.Hepaticeventsmaybesevereandinextremely

rarecircumstances,deathshavebeenreported.

Skinandsubcutaneoustissuedisorders

Uncommon:Skinrash,pruritus,urticaria

Rare:Erythemamultiforme

VeryRare:Stevens-Johnsonsyndrome,toxicepidermalnecrolysis,bullonsexfoliative-dermatitis,acutegeneralised

exanthemouspustulosis(AGEP).

Ifanyhypersensitivitydermatitisreactionsoccur,treatmentshouldbediscontinued.

Renalandurinarydisorders

Veryrare:Interstitialnephritis,crystalluria(seeOverdosage).

4.9Overdose

Gastro-intestinalsymptomsanddisturbanceofthefluidandelectrolytebalancesmaybeevident.Theymaybetreated

symptomaticallywithattentiontothefluidandelectrolytebalance.Augmentinmayberemovedfromthecirculation

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Amoxicillincrystalluria,insomecasesleadingtorenalfailure,hasbeenobserved(seeSection4.4specialwarnings

andspecialprecautionsforuse).

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

AugmentinDuoisanantibioticagentwithanotablybroadspectrumofactivityagainstthecommonlyoccurring

bacterialpathogensingeneralpracticeandhospital.Thebetalactamaseinhibitoryactionofclavulanateextendsthe

spectrumofamoxycillintoembraceawiderrangeoforganisms,includingmanyresistanttootherbetalactamase

antibiotics.

Resistancetomanyantibioticsiscausedbybacterialenzymeswhichdestroytheantibioticbeforeitcanactonthe

pathogen.

Theclavulanatein‘AugmentinDuo’anticipatesthisdefencemechanismbyblockingtheb-lactamaseenzymes,thus

renderingtheorganismssensitivetoamoxycillin’srapidbactericidaleffectatconcentrationsreadilyattainableinthe

body.

Clavulanatebyitselfhaslittleantibacterialactivity;however,inassociationwithamoxycillinas‘AugmentinDuo’,it

producesanantibioticagentitextendsthespectrumofamoxycillintoembraceawiderrangeoforganisms,including

mayresistanttootherbeta-lactamantibiotics.

‘AugmentinDuo’isbactericidaltoawiderangeoforganismsincluding:

Grampositive:

Aerobes:Enterococcusfaecalis *

,Enterococcusfaecium *

,Streptococcuspneumoniae,Streptococcuspyogenes,

Streptococcusviridans,Staphylococcusaureus *

,Coagulasenegativestaphylococci *

(includingStaphylococcus

epidermidis *

),Corynebacteriumspecies,Bacillusanthracis *

,Listeriamonocytogenes.

Anaerobes:Clostridiumspecies,Peptococcusspecies,Peptostreptococcus

Gram-negative:

Aerobes:Haemophilusinfluenzae *

,Moraxellacatarrhalis *

(Branhamellacatarrhalis),Escherichiacoli *

,Proteus

mirabilis *

,Proteusvulgaris *

,Klebsiellaspecies *

,Salmonellaspecies *

,Shigellaspecies *

,Bordetellapertussis,

Brucellaspecies,Neisseriagonorrhoeae *

,Neisseriameningitidis *

,Vibriocholerae,Pasturellamultocida.

Anaerobes:Bacteroidesspecies *

includingB.fragilis.

*Somemembersofthesespeciesofbacteriaproducebeta-lactamase,renderingtheminsensitivetoamoxycillinalone.

5.2Pharmacokineticproperties

Thephaarmacokineticsofthetwocomponentsof‘Augmentin-Duo’Tablets625mgarecloselymatched.Peakserum

levelsofbothoccurabout1hourafteroraladministration.Absorptionof‘Augmenton-Duo’isoptimisedatthestartof

ameal.

Bothclavulanateandamoxycillinhavelowlevelsofserumbinding;about70%remainsfreeintheserum.Doublethe

dosageof‘Augmenton-Duo’Tablets625mgapproximatelydoubletheserumlevelsachieved.

5.3Preclinicalsafetydata

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

ExcipientspresentintheproductimportedfromTheUK:

Magnesiumstearate(E572)

Sodiumstarchglycolate

Colloidalanhydroussilica

Microcrystallinecellulose(E460)

Titaniumdioxide(E171)

Hypromellose(E464)

Macrogol

Dimeticone

Eachtabletcontains1mgofsodium.

ExcipientspresentintheproductimportedfromGreece:

Magnesiumstearate(E572)

Sodiumstarchglycolate

Microcrystallinecellulose(e460)

Colloidalanhydroussilica

Hypromellose5cps

Hypromellose15cps

Titaniumdioxide(E171)

Macrogol4000

Macrogol6000

ExcipientspresentintheproductimportedfromSpain:

Magnesiumstearate(E572)

Crospovidone

Colloidalhydratedsilica

Colloidalanhydroussilica

Hypromellose

Marcrogol4000

Marcrogol6000

Titaniumdioxide(E171)

Dimeticone.

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelflifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

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6.5Natureandcontentsofcontainer

Blisterpacksof12,20,21or50tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7PARALLELPRODUCTAUTHORISATIONHOLDER

PCOManufacturing

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA0465/047/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27July2001

Dateoflastrenewal:27July2006

10DATEOFREVISIONOFTHETEXT

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