AUGMENTIN

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1562/009/001
  • Authorization date:
  • 16-10-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PPA1562/009/001

CaseNo:2064086

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

LTTPharmaLimited

Unit18,OxleasowRoad,EastMoonMoat,Redditch,WorcestershireB980RE,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AugmentinTablets250mg/125mg

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom16/10/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AugmentinTablets250mg/125mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachtabletcontainsAmoxicillintrihydrateequivalentto250mgAmoxicillinwithpotassiumclavulanateequivalentto

125mgofclavulanicacid.

Forafulllistofexcipientsseesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablets(tablet)

ProductimportedfromtheUK

Whitetooff-white,ovalshaped,film-coatedtabletsengraved'Augmentin'ononeside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

'Augmentin'isindicatedforshorttermtreatmentofbacterialinfectionsatthefollowingsiteswhenamoxicillin

resistantbeta-lactamaseproducingstrainsaresuspectedasthecause.Inothersituations,amoxicillinaloneshouldbe

considered.

UpperRespiratoryTractInfections(includingENT)inparticularsinusitis,otitismedia,recurrenttonsillitis.These

infectionsareoftencausedbyStreptococcuspneumoniae,Haemophilusinfluenzae*,Moraxellacatarrhalis*and

Streptococcuspyogenes.

LowerRespiratoryTractInfectionsinparticularacuteexacerbationsofchronicbronchitis(especiallyifconsidered

severe),bronchopneumonia.TheseinfectionsareoftencausedbyStreptococcuspneumoniae,Haemophilus

influenzae*andMoraxellacatarrhalis*.

Genito-urinaryTractandAbdominalInfectionsinparticularcystitis(especiallywhenrecurrentorcomplicated-

excludingprostatitis),septicabortion,pelvicorpuerperalsepsisandintra-abdominalsepsis.Theseinfectionsare

oftencausedbyEnterobacteriaceae*(mainlyEscherichiacoli*),Staphylococcussaprophyticus,Enterococcus

species*.

SkinandSoftTissueInfectionsinparticularcellulitis,animalbitesandseveredentalabscesswithspreading

cellulitis.TheseinfectionsareoftencausedbyStaphylococcusaureus*,StreptococcuspyogenesandBacteroides

species*.

*Somemembersofthesespeciesofbacteriaproducebeta-lactamase,renderingtheminsensitivetoamoxicillinalone.

AugmentinIntravenousisindicatedwhenparenteraltherapyisrequired.

AugmentinIntravenousisalsoindicatedforProphylaxisagainstwoundinfectionwhichmaybeassociatedwith

surgicalproceduressuchasgastrointestinal,pelvic,headandneck,cardiac,renaljointreplacementandbiliarytract.

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Mixedinfectionscausedbyamoxicillin-susceptibleorganismsinconjunctionwith‘Augmentin’-susceptiblebeta-

lactamase-producingorganismsmaybetreatedwith‘Augmentin’.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:Tablets

Tominimisepotentialgastro-intestinalintoleranceadministeratthestartofameal.TheabsorptionofAugmentinis

optimisedwhentakenatthestartofameal.

Durationoftherapyshouldbeappropriatetotheindicationandshouldnotexceed14dayswithoutreview.

4.3Contraindications

Useinpatientswithhypersensitivitytobeta-lactamse.g.penicillinsorcephalosporins.‘Augmentin’iscontra-

indicatedinpatientswithaprevioushistoryof‘Augmentin’-associatedjaundice/hepaticdysfunction.

4.4Specialwarningsandprecautionsforuse

Prolongeduseofananti-infectivemayoccasionallyresultinovergrowthofnon-susceptibleorganisms.

Seriousandoccasionallyfatalhypersensitivity(anaphylactoid)reactionshavebeenreportedinpatientsonpenicillin

therapy.Thesereactionsaremorelikelytooccurinindividualswithahistoryofpenicillinhypersensitivity(see

section4.3,Contraindications).

‘Augmentin’shouldbeusedwithcautioninpatientswithevidenceofhepaticdysfunctionandwithcareinpatients

CreatinineClearance

ml/min Dosage

Interval

10–30 375–750depending

onseverityofinfection 12(b.i.d.)

<10 375–750depending

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Eachtabletcontains0.63mmolofpotassium.

Patientswithinfectiousmononucleosisfrequentlydeveloprasheswithamoxicillintherapy.

Inpatientswithreducedurineoutput,crystalluriahasbeenobservedveryrarely,predominantlywithparenteral

therapy.DuringtheadministrationofhighdosesofAmoxicillin,itisadvisabletomaintainadequatefluidintakeand

urinaryoutputinordertoreducethepossibilityofAmoxicillincrystalluria(seeOverdosage).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concomitantuseofprobenecidisnotrecommended.Probeneciddecreasestherenaltubularsecretionofamoxicillin.

Concomitantusewithamoxicillin-clavulanatemayresultinincreasedandprolongedbloodlevelsofamoxicillin,but

notoclavulanicacid.

Prolongationofbleedingtimeandprothrombintimehavebeenreportedinsomepatientsreceiving‘Augmentin’.

‘Augmentin’shouldbeusedwithcareinpatientsonanti-coagulationtherapy.

Concomitantuseofallopurinolduringtreatmentwithamoxicillincanincreasethelikelihoodofallergicskinreactions.

Therearenodataontheconcomitantuseofamoxicillin–clavulanateandallopurinol.

Incommonwithotherantibiotics,amoxicillin–clavulanatemayaffectthegutflora,leadingtoloweroestrogen

reabsorptionandreducedefficacyofcombinedoralcontraceptives.

4.6Pregnancyandlactation

Thisproductshouldonlybeusedinpregnancyorlactationifconsideredessentialbythephysician.Animalstudies

haveshownnoevidenceofteratogeniceffectduetodrug,butsafetyofuseinhumanbeingsisnotestablished.Ina

singlestudyinwomenwithpreterm,prematureruptureofthefoetalmembrane(pPROM),itwasreportedthat

prophylactictreatmentwith‘Augmentin’maybeassociatedwithanincreasedriskofnecrotisingenterocolitisin

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.Prolongationofbleedingtimeand

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Immunesystemdisorders

Veryrare Angioneuroticoedema,anaphylaxis,serumsickness-likesyndrome,hypersensitivityvasculitis.

Nervoussystemdisorders

Uncommon Dizziness,headache

VeryRare Reversiblehyperactivityandconvulsions.Convulsionsmayoccurinpatientswithimpairedrenal

functionorinthosereceivinghighdoses.

Gastrointestinaldisorders

Verycommon Diarrhoea

Common Nausea,vomiting

Nauseaismoreoftenassociatedwithhigheroraldoses.Ifgastrointestinalreactionsareevident,

theymaybereducedbytakingAUGMENTINatthestartofameal.

Uncommon Indigestion

VeryRare Antibiotic-associatedcolitis(includingpseudomembraneouscolitisandhaemorrhagiccolitis).

Blackhairytongue

Hepatobiliarydisorders

Uncommon AmoderateriseinASTand/orALTandAlkalinePhosphateshasbeennotedinpatientstreated

withbeta-lactamclassantibiotics,butthesignificanceofthesefindingsisunknown.

VeryRare Hepatitisandcholestaticjaundice.Theseeventshavebeennotedwithotherpenicillinsand

cephalosporins.

Hepaticeventshavebeenreportedpredominatelyinmalesandelderlypatientsandmaybeassociatedwithprolonged

treatment.

Signsandsymptomsusuallyoccurduringorshortlyaftertreatmentbutinsomecasesmaynotbecomeapparentuntil

severalweeksaftertreatmenthasceased.Theseareusuallyreversible.Hepaticeventsmaybesevereandinextremely

severerarecircumstances,deathshavebeenreported.

Skinandsubcutaneoustissuedisorders

Uncommon Skinrash,pruritis,urticaria

Rare Erythemamultiforme

VeryRare Stevens-Johnsonsyndrome,toxicepidermalnecrolysis,bullousexfoliative-dermatitis,acute

generalisedexanthemouspustulosis(AGEP).

Ifanyhypersensitivitydermatitisreactionoccurs,treatmentshouldbediscontinued.

Renalandurinarydisorders

VeryRare Interstitialnephritis,crystalluria(seesection4.9,Overdosage)

4.9Overdose

Gastrointestinalsymptomsanddisturbanceofthefluidandelectrolytebalancesmaybeevident.Theymaybetreated

symptomaticallywithattentiontothefluidandelectrolytebalance.‘Augmentin’mayberemovedfromthecirculation

byhaemodialysis.Amoxicillincrystalluria,insomecasesleadingtorenalfailure,hasbeenobserved(seeSection4.4,

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Augmentin’isanantibioticagentwithanotablybroadspectrumofactivityagainstthecommonlyoccurringbacterial

pathogensingeneralpracticeandhospital.Thebetalactamaseinhibitoryactionofclavulanateextendsthespectrum

ofamoxicillintoembraceawiderrangeoforganisms,includingmanyresistanttootherbetalactamaseantibiotics.

Resistancetomanyantibioticsiscausedbybacterialenzymeswhichdestroytheantibioticbeforeitcanactonthe

pathogen.Theclavulanatein‘Augmentin’anticipatesthisdefencemechanismbyblockingtheß-lactamaseenzymes,

thusrenderingtheorganismssensitivetoamoxicillin’srapidbactericidaleffectatconcentrationsreadilyattainablein

thebody.

Clavulanatebyitselfhaslittleantibacterialactivity;however,inassociationwithamoxicillinas‘Augmentin’,it

producesanantibioticagentofbroadspectrumwithwideapplicationinhospitalandgeneralpractice.

'Augmentin’isbactericidaltoawiderangeoforganismsincluding:

Gram-positive

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

Streptococcusviridans,Staphylococcusaureus*,Coagulasenegativestaphylococci*(includingStaphylococcus

epidermidis*),Corynebacteriumspecies,Bacillusanthraci*,Listeriamonocytogenes.

Anaerobes:Clostridiumspecies,Peptococcusspecies,Peptostreptococcus.

Gram-negative

Aerobes:Haemophilusinfluenzae*,Moraxellacatarrhalis*(Branhamellacatarrhalis),

Escherichiacoli*,Proteusmirabilis*,Proteusvulgaris*,Klebsiellaspecies*,Salmonellaspecies*,Shigellaspecies*,

Bordetellapertussis,Brucellaspecies,Neisseriagonorrhoeae*,Neisseriameningitidis*,Vibriocholerae,Pasteurella

multocida.

Anaerobes:Bacteroidesspecies*includingB.fragilis

*Somemembersofthesespeciesofbacteriaproducebeta-lactamase,renderingtheminsensitivetoamoxicillinalone.

5.2Pharmacokineticproperties

Thepharmacokineticsofthetwocomponentsof‘Augmentin’arecloselymatched.Peakserumlevelsofbothoccur

aboutonehourafteroraladministration.Absorptionof‘Augmentin’isoptimisedatthestartofameal.Both

clavulanateandamoxicillinhavelowlevelsofserumbinding;about70%remainsfreeintheserum.

Doublingthedosageof‘Augmentin’approximatelydoublestheserumlevelsachieved.

Aswithotherpenicillins,themajorrouteofeliminationforamoxicillinisviathekidney,whereasforclavulanateitis

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

clavulanicacidareexcretedunchangedinurineduringthefirst6hoursafteradministrationofasingle250/125mgora

single500/125mgtablet.

Amoxicillinisalsopartlyexcretedintheurineastheinactivepenicilloicacidinquantitiesequivalentto10-25%ofthe

initialdose.Clavulanicacidisextensivelymetabolizedinmanto2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-

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

expiredair.

5.3Preclinicalsafetydata

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

magnesiumstearate(E572)

sodiumstarchglycollate

colloidalsilica

microcrystallinecellulose(E460)

titaniumdioxide(E171)

hypromellose(E464)

polyethyleneglycol

siliconeoil

6.2Incompatibilities

Notapplicable

6.3ShelfLife

Theshelflifeexpirydateforthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C .

Storeintheoriginalpackageinordertoprotectfrommoisture.

Keepblisterintheoutercartoninordertoprotectfromlight.

6.5Natureandcontentsofcontainer

Aluminium/PVC/PVdCblisterinanaluminiumpouchwithdessicant,containing21tablets.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements

7ParallelProductAuthorisationHolder

LTTPharmaLimited

Unit18

OxleasowRoad

EastMoonsMoat

Redditch

Worcestershire

B980RE

UnitedKingdom

8ParallelProductAuthorisationNumber

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:16 th

October2009

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