AUGMENTIN

Main information

  • Trade name:
  • AUGMENTIN Dispersable Tablet 250/ 125 Milligram
  • Dosage:
  • 250/ 125 Milligram
  • Pharmaceutical form:
  • Dispersable Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AUGMENTIN Dispersable Tablet 250/125 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1077/093/008
  • Authorization date:
  • 06-09-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA1077/093/008

CaseNo:2043772

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

GlaxoSmithKline(Ireland)Ltd

StonemasonsWay,Rathfarnham,Dublin16,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AugmentinDispersibleTablets250mg/125mg

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom19/05/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AugmentinDispersibleTablets250mg/125mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontainsamoxicillintrihydrateequivalentto250mgamoxicillinwithpotassiumclavulanateequivalentto

125mgclavulanicacid.

Excipients:alsoincludessulphurdioxide(E220),0.00028mgpertablet.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Dispersibletablet.

Whitetooff-whiteroundtabletsengravedAugmentin.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Augmentinisindicatedforshorttermtreatmentofbacterialinfectionsatthefollowingsiteswhenamoxicillin

resistantbeta-lactamaseproducingstrainsaresuspectedasthecause.Inothersituations,amoxicillinaloneshouldbe

considered.

UpperRespiratoryTractInfections(includingENT)inparticularsinusitis,otitismedia,recurrenttonsillitis.These

infectionsareoftencausedbyStreptococcuspneumoniae,Haemophilusinfluenzae*,Moraxellacatarrhalis*and

Streptococcuspyogenes.

LowerRespiratoryTractInfectionsinparticularacuteexacerbationsofchronicbronchitis(especiallyifconsidered

severe),bronchopneumonia.TheseinfectionsareoftencausedbyStreptococcuspneumoniae,Haemophilusinfluenzae*

andMoraxellacatarrhalis*.

Genito-urinaryTractandAbdominalInfectionsinparticularcystitis(especiallywhenrecurrentorcomplicated-

excludingprostatitis),septicabortion,pelvicorpuerperalsepsisandintra-abdominalsepsis.Theseinfectionsareoften

causedbyEnterobacteriaceae*(mainlyEscherichiacoli*),Staphylococcussaprophyticus,Enterococcusspecies.*

SkinandSoftTissueInfectionsinparticularcellulitis,animalbitesandseveredentalabscesswithspreadingcellulitis.

TheseinfectionsareoftencausedbyStaphylococcusaureus*,StreptococcuspyogenesandBacteroidesspecies*.

*Somemembersofthesespeciesofbacteriaproducebeta-lactamase,renderingtheminsensitivetoamoxicillinalone.

AugmentinIntravenousisindicatedwhenparenteraltherapyisrequired.

AugmentinIntravenousisalsoindicatedforProphylaxisagainstwoundinfectionwhichmaybeassociatedwith

surgicalproceduressuchasgastrointestinal,pelvic,headandneck,cardiac,renal,jointreplacementandbiliarytract.

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Mixedinfectionscausedbyamoxicillin-susceptibleorganismsinconjunctionwithAugmentin-susceptiblebeta-

lactamase-producingorganismsmaybetreatedwithAugmentin.Theseinfectionsshouldnotrequiretheadditionof

anotherantibioticresistanttobeta-lactamases.

4.2Posologyandmethodofadministration

Usualdosagesforthetreatmentofinfection:

AdultsandChildrenover12yearsofageonly:

Theusualdailydoseis375mgthreetimesdaily.

Thedosagemaybeincreasedto750mgthreetimesdailyinthetreatmentofsevereinfections.

Renalimpairment

Inpatientswithmoderateorsevererenalimpairment,dosagesshouldbeadjustedaccordingtothedegreeof

impairment.

Haemodialysis

Dosageadjustmentsarebasedonthemaximumrecommendedlevelofamoxicillin.

2times250/125mgevery24hoursPLUSonedoseduringdialysis,toberepeatedattheendofdialysis(asserum

concentrationsofbothamoxicillinandclavulanicacidaredecreased).

Hepaticimpairment

Dosewithcaution,monitorhepaticfunctionatregularintervals.Thereareasyetinsufficientdataonwhichtobasea

dosagerecommendation.

Administration

Oral:DispersibleTablets.

Tominimisepotentialgastro-intestinalintoleranceadministeratthestartofameal.TheabsorptionofAugmentinis

optimisedwhentakenatthestartofameal.

Durationoftherapyshouldbeappropriatetotheindicationandshouldnotexceed14dayswithoutreview.

4.3Contraindications

Useinpatientswithahistoryofhypersensitivitytobeta-lactamse.g.penicillins,andcephalosporins.Augmentinis

contra-indicatedinpatientswithaprevioushistoryofAugmentin-associatedjaundice/hepaticdysfunction.

4.4Specialwarningsandprecautionsforuse

Prolongeduseofananti-infectivemayoccasionallyresultinovergrowthofnon-susceptibleorganisms.

Seriousandoccasionallyfatalhypersensitivity(anaphylactoid)reactionshavebeenreportedinpatientsonpenicillin

therapy.Thesereactionsaremorelikelytooccurinindividualswithahistoryofpenicillinhypersensitivity(see

Contraindications).

Augmentinshouldbeusedwithcautioninpatientswithevidenceofhepaticdysfunctionandwithcareinpatients

withrenaldysfunction.

CreatinineClearance Dosage Interval

ml/min mg hr

10–30 375–750dependingonseverityofinfection 12(b.i.d.,twiceaday)

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Patientswithinfectiousmononucleosisfrequentlydeveloprasheswithamoxicillintherapy.

Inpatientswithreducedurineoutput,crystalluriahasbeenobservedveryrarely,predominantlywithparenteral

therapy.DuringtheadministrationofhighdosesofAmoxicillin,itisadvisabletomaintainadequatefluidintakeand

urinaryoutputinordertoreducethepossibilityofAmoxicillincrystalluria(seeOverdosage).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concomitantuseofprobenecidisnotrecommended.Probeneciddecreasestherenaltubularsecretionofamoxicillin.

Concomitantusewithamoxicillin-clavulanatemayresultinincreasedandprolongedbloodlevelsofamoxicillin,but

notofclavulanicacid.

ProlongationofbleedingtimeandprothrombintimehavebeenreportedinsomepatientsreceivingAugmentin.

Augmentinshouldbeusedwithcareinpatientsonanti-coagulationtherapy.

Concomitantuseofallopurinolduringtreatmentwithamoxicillincanincreasethelikelihoodofallergicskinreactions.

Therearenodataontheconcomitantuseofamoxicillin–clavulanateandallopurinol.

Incommonwithotherantibiotics,amoxicillin–clavulanatemayaffectthegutflora,leadingtoloweroestrogen

reabsorptionandreducedefficacyofcombinedoralcontraceptives.

4.6Pregnancyandlactation

Thisproductshouldonlybeusedinpregnancyorlactationifconsideredessentialbythephysician.Animalstudies

haveshownnoevidenceofteratogeniceffectduetodrug,butsafetyofuseinhumanbeingsisnotestablished.Ina

singlestudyinwomenwithpreterm,prematureruptureofthefoetalmembrane(pPROM),itwasreportedthat

prophylactictreatmentwithAugmentinmaybeassociatedwithanincreasedriskofnecrotisingenterocolitisin

neonates.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

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<1/1000.

Veryrare<1/10,000.

Infectionsandinfestations

Common:Mucocutaneouscandidiasis.

Bloodandlymphaticsystemdisorders

Rare:Reversibleleucopenia(includingneutropenia)andthrombocytopenia.

Veryrare:Reversibleagranulocytosisandhaemolyticanaemia.Prolongationofbleedingtimeandprothrombintime

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Immunesystemdisorders

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

Nervoussystemdisorders

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/orALTandAlkalinePhosphateshasbeennotedinpatientstreatedwithbeta-

lactamclassantibiotics,butthesignificanceofthesefindingsisunknown.

VeryRare:Hepatitisandcholestaticjaundice.Theseeventshavebeennotedwithotherpenicillinsandcephalosporins.

Hepaticeventshavebeenreportedpredominatelyinmalesandelderlypatientsandmaybeassociatedwithprolonged

treatment.

Signsandsymptomsusuallyoccurduringorshortlyaftertreatmentbutinsomecasesmaynotbecomeapparentuntil

severalweeksaftertreatmenthasceased.Theseareusuallyreversible.Hepaticeventsmaybesevereandinextremely

rarecircumstances,deathshavebeenreported.

Skinandsubcutaneoustissuedisorders

Uncommon:Skinrash,pruritis,urticaria.

Rare:Erythemamultiforme.

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

exanthemouspustulosis(AGEP).

Ifanyhypersensitivitydermatitisreactionoccurs,treatmentshouldbediscontinued.

Renalandurinarydisorders

VeryRare:Interstitialnephritis,crystalluria(seeOverdosage).

4.9Overdose

Gastrointestinalsymptomsanddisturbanceofthefluidandelectrolytebalancesmaybeevident.Theymaybetreated

symptomaticallywithattentiontothefluidandelectrolytebalance.Augmentinmayberemovedfromthecirculationby

haemodialysis.Amoxicillincrystalluria,insomecasesleadingtorenalfailure,hasbeenobserved(seeSection4.4

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Augmentinisanantibioticagentwithanotablybroadspectrumofactivityagainstthecommonlyoccurringbacterial

pathogensingeneralpracticeandhospital.Thebetalactamaseinhibitoryactionofclavulanateextendsthespectrumof

amoxycillintoembraceawiderrangeoforganisms,includingmanyresistanttootherbetalactamaseantibiotics.

Resistancetomanyantibioticsiscausedbybacterialenzymeswhichdestroytheantibioticbeforeitcanactonthe

pathogen.TheclavulanateinAugmentinanticipatesthisdefencemechanismbyblockingthebeta-lactamaseenzymes,

thusrenderingtheorganismssensitivetoamoxicillin’srapidbactericidaleffectatconcentrationsreadilyattainablein

thebody.

Clavulanatebyitselfhaslittleantibacterialactivity;however,inassociationwithamoxicillinasAugmentin,it

producesanantibioticagentofbroadspectrumwithwideapplicationinhospitalandgeneralpractice.

Augmentinisbactericidaltoawiderangeoforganismsincluding:

Gram-positive

Aerobes:Enterococcusfaecalis*,Enterococcusfaecium*,Streptococcuspneumoniae,Streptococcuspyogenes,

Streptococcusviridans,Staphylococcusaureus*,Coagulasenegativestaphylococci*(includingStaphylococcus

epidermidis*),Corynebacteriumspecies,Bacillus

anthraci*,Listeriamonocytogenes.

Anaerobes:Clostridiumspecies,Peptococcusspecies,Peptostreptococcus.

Gram-negative

Aerobes:Haemophilusinfluenzae*,Moraxellacatarrhalis*(Branhamellacatarrhalis),Escherichiacoli*,Proteus

mirabilis*,Proteusvulgaris*,Klebsiellaspecies*,Salmonellaspecies*,Shigellaspecies*,Bordetellapertussis,

Brucellaspecies,Neisseriagonorrhoeae*,Neisseriameningitidis*,Vibriocholerae,Pasteurellamultocida.

Anaerobes:Bacteroidesspecies*includingB.fragilis.

*Somemembersofthesespeciesofbacteriaproducebeta-lactamase,renderingtheminsensitivetoamoxycillinalone.

5.2Pharmacokineticproperties

ThepharmacokineticsofthetwocomponentsofAugmentinarecloselymatched.Peakserumlevelsofbothoccur

aboutonehourafteroraladministration.AbsorptionofAugmentinisoptimisedatthestartofameal.Bothclavulanate

andamoxicillinhavelowlevelsofserumbinding;about70%remainsfreeintheserum.

DoublingthedosageofAugmentinapproximatelydoublestheserumlevelsachieved.

Aswithotherpenicillins,themajorrouteofeliminationforamoxicillinisviathekidney,whereasforclavulanateitis

bybothrenalandnon-renalmechanisms.Approximately60-70%oftheamoxicillinandapproximately40-65%ofthe

clavulanicacidareexcretedunchangedinurineduringthefirst6hoursafteradministrationofasingle250/125mgora

single500/125mgtablet.

Amoxicillinisalsopartlyexcretedintheurineastheinactivepenicilloicacidinquantitiesequivalentto10-25%ofthe

initialdose.Clavulanicacidisextensivelymetabolisedinmanto2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-

carboxylicacidand1-amino-4-hydroxy-butan-2-oneandeliminatedinurineandfaecesandascarbondioxidein

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5.3Preclinicalsafetydata

Nofurtherinformationofrelevance.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Crospovidone

Siliconedioxide

Saccharinsodium

Pineappledryflavour*

Strawberrydryflavour**

Bloodorangedryflavour***

Magnesiumstearate

Microcrystallinecellulose

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalpackage.Keepfoilblisterintheoutercarton.

6.5Natureandcontentsofcontainer

Foilwrappedincartonsof21.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Dispersibletabletsshouldbestirredintoalittlewaterbeforetaking.

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKline(Ireland)Limited

StonemasonsWay

Rathfarnham

Dublin16

Contains;acacia,natural&artificialflavoursandcitricacid.

Contains;natural&artificialflavours,maltodextrin,acacia,propyleneglycol,coumarin,andsulphurdioxide

(E220).

***Contains;naturalflavours,maltodextrin,acacia,butylatedhydroxyanisole(E320),citricacidandsulphur

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8MARKETINGAUTHORISATIONNUMBER

PA1077/93/8

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:06September1982

Dateoflastrenewal: 06September2007

10DATEOFREVISIONOFTHETEXT

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