AUGMENTION JUNIOR

Main information

  • Trade name:
  • AUGMENTION JUNIOR
  • Dosage:
  • 125/ 62.5 MG/ 5ml
  • Pharmaceutical form:
  • Powder for Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AUGMENTION JUNIOR
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1077/093/006
  • Authorization date:
  • 28-07-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA1077/093/006

CaseNo:2064670

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

GlaxoSmithKline(Ireland)Limited

StonemasonsWay,Rathfarnham,Dublin16,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AugmentinJunior125mg/62.5mgper5mlPowderforOralSuspension

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom08/02/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/02/2010 CRN 2064670 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AugmentinJunior125mg/62.5mgper5mlPowderforOralSuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each5mlofreconstitutedsuspensioncontainsAmoxicillinTrihydrateequivalentto125mgofamoxicillinand

potassiumclavulanateequivalentto62.5mgofclavulanicacid.

Excipient:Each5mlofreconstitutedoralsuspensioncontain12.5mgofaspartane(E951)

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Powderfororalsuspension

Whitetooff-whitepowderforreconstitutionwithwater.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Augmentinisindicatedforshorttermtreatmentofbacterialinfectionsatthefollowingsiteswhenamoxicillinresistant

beta-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.

AcomprehensivelistofsensitiveorganismsisprovidedinPharmacodynamicproperties.

Mixedinfectionscausedbyamoxicillin-susceptibleorganismsinconjunctionwithAugmentin-susceptiblebeta-

lactamase-producingorganismsmaybetreatedwithAugmentin.Theseinfectionsshouldnotrequiretheadditionof

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/02/2010 CRN 2064670 page number: 2

4.2Posologyandmethodofadministration

Usualdosagesinthetreatmentofinfection:

Children6-12years

Theusualdosageis187mg(5ml)threetimesdaily.

Insevereinfectionsthesedosesmaybedoubled.

Thisformulationisnotrecommendedforchildrenundertheageof6years.

Renalimpairment

Inpatientswithmoderateorsevererenalimpairmentdosagesshouldbeadjustedaccordingtothedegreeofimpairment.

*usingthePaediatricSuspension

Haemodialysis

Dosageadjustmentsarebasedonthemaximumrecommendedlevelofamoxicillin.15/3.75mg/kg/daygivenasasingle

dose.Oneadditionaldoseof15/3.75mg/kgshouldbeadministeredpriortohaemodialysisandagainafter

haemodialysis.

HepaticImpairment

Dosewithcaution,monitorhepaticfunctionatregularintervals.Thereareasyetinsufficientdataonwhichtobasea

dosagerecommendation.

Administration:

Oral:Suspension.

Tominimisepotentialgastro-intestinalintoleranceadministeratthestartofameal.TheabsorptionofAugmentinis

optimisedwhentakenatthestartofameal.

Durationoftherapyshouldbeappropriatetotheindicationandshouldnotexceed14dayswithoutreview.

4.3Contraindications

Useinpatientswithahistoryofhypersensitivitytobeta-lactamse.g.penicillinsandcephalosporins.Augmentinis

contra-indicatedinpatientswithaprevioushistoryofAugmentin-associatedjaundice/hepaticdysfunction.

4.4Specialwarningsandprecautionsforuse

BeforeinitiatingtherapywithAugmentincarefulenquiryshouldbemadeconcerningprevioushypersensitivity

reactionstopenicillinsorcephalosporins.Seriousandoccasionallyfatalhypersensitivity(anaphylactoid)reactions

havebeenreportedinpatientsonpenicillintherapy.Thesereactionsaremorelikelytooccurinindividualswitha

historyofpenicillinhypersensitivity(seeContra-indications).

Augmentinshouldbeusedwithcautioninpatientswithevidenceofhepaticdysfunctionandwithcareinpatients

withrenaldysfunctionwhendosageshouldbeadjusted(see4.2).

Augmentinshouldbeavoidedifinfectiousmononucleosisissuspectedsincetheoccurrenceofamorbilliformrash

Creatinineclearance

ml/min Dosage

Interval

10-30 15/3.75*mg/kg

(maximum500/125mgtwicedaily) 12(b.i.d.,twiceaday)

<10 15/3.75*mg/kg

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/02/2010 CRN 2064670 page number: 3

Prolongeduseofananti-infectiveagentmayresultinsuperinfectionbymicroorganismsincludingcandidaresistantto

thatanti-infective.

AugmentinSuspensionscontain12.5mgaspartameper5mldoseandthereforecareshouldbetakenin

phenylketonuria.Each5mldosecontains0.31mmolofpotassium(JuniorSuspension).

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

Useinpregnancy:

Reproductionstudiesinanimals(miceandrats)withorallyandparenterallyadministeredAugmentinhaveshownno

teratogeniceffects.Inasinglestudyinwomenwithpreterm,prematureruptureofthefoetalmembrane(pPROM),it

wasreportedthatprophylactictreatmentwithAugmentinmaybeassociatedwithanincreasedriskofnecrotising

enterocolitisinneonates.Aswithallmedicinesuseshouldbeavoidedinpregnancyunlessconsideredessentialbythe

physician.

Useinlactation:

Augmentinmaybeadministeredduringtheperiodoflactation.Withtheexceptionoftheriskofsensitisation

associatedwiththeexcretionoftracequantitiesinbreastmilk,therearenoknowndetrimentaleffectsforthebreast-fed

infant.

4.7Effectsonabilitytodriveandusemachines

Adverseeffectsontheabilitytodriveoroperatemachineryhavenotbeenobserved.

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.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/02/2010 CRN 2064670 page number: 4

Veryrare<1/10,000.

Infectionsandinfestations

Common:Mucocutaneouscandidiasis.

Bloodandlymphaticsystemdisorders

Rare:Reversibleleucopenia(includingneutropenia)andthrombocytopenia.

Veryrare:Reversibleagranulocytosisandhaemolyticanaemia.Prolongationofbleedingtimeandprothrombintime

(seeSection4.4Specialwarningsandspecialprecautionsforuse).

Immunesystemdisorders

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

Nervoussystemdisorders

Uncommon:Dizziness,headache.

VeryRare:Reversiblehyperactivityandconvulsions.Convulsionsmayoccurinpatientswithimpairedrenalfunction

orinthosereceivinghighdoses.

Gastrointestinaldisorders

Verycommon:Diarrhoea.

Common:Nausea,vomiting.

Nauseaisoftenassociatedwithhigheroraldoses.Ifgastrointestinalreactionsareevident,theymaybereducedby

takingAUGMENTINatthestartofameal.

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

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/02/2010 CRN 2064670 page number: 5

4.9Overdose

Gastrointestinalsymptomsanddisturbanceofthefluidandelectrolytebalancesmaybeevident.Theymaybetreated

symptomaticallywithattentiontothefluidandelectrolytebalance.Clavamelmayberemovedfromthecirculationby

haemodialysis.Amoxicillincrystalluria,insomecasesleadingtorenalfailure,hasbeenobserved(seeSection4.4

specialwarningsandspecialprecautionsforuse).

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Combinationantibacterials.

ATCcode:J01RA01.

Augmentinisanantibioticagentwithanotablybroadspectrumofactivityagainstthecommonlyoccurringbacterial

pathogensingeneralpracticeandhospital.Thebetalactamaseinhibitoryactionofclavulanateextendsthespectrum

ofamoxicillintoembraceawiderrangeoforganisms,includingmanyresistanttootherbetalactamaseantibiotics.

Resistancetomanyantibioticsiscausedbybacterialenzymeswhichdestroytheantibioticbeforeitcanactonthe

pathogen.TheclavulanateinAugmentinanticipatesthisdefencemechanismbyblockingthebeta-lactamaseenzymes,

thusrenderingtheorganismssensitivetoamoxicillinrapidbactericidaleffectatconcentrationsreadilyattainableinthe

body.

Clavulanatebyitselfhaslittleantibacterialactivity;however,inassociationwithamoxicillinasAugmentin,itproduces

anantibioticagentofbroadspectrumwithwideapplicationinhospitalandgeneralpractice.

Augmentinisbactericidaltoawiderangeoforganismsincluding:

Gram-positive:

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

Streptococcusviridans,Staphylococcusaureus*,Coagulasenegativestaphylococci*(includingStaphylococcus

epidermidis*),Corynebacteriumspecies,Bacillusanthracis*,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

ThepharmacokineticsofthetwocomponentsofAugmentinarecloselymatched.Peakserumlevelsofbothoccur

aboutonehourafteroraladministration.AbsorptionofAugmentinisoptimisedatthestartofameal.Bothclavulanate

andamoxicillinhavelowlevelsofserumbinding;about70%remainsfreeintheserum.

DoublethedosageofAugmentinapproximatelydoublestheserumlevelsachieved.

Aswithotherpenicillins,themajorrouteofeliminationforamoxicillinisviathekidney,whereasforclavulanateitis

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/02/2010 CRN 2064670 page number: 6

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

expiredair.

5.3Preclinicalsafetydata

Nofurtherinformationofrelevance.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Xanthangum,(E415)

Hypromellose,(E464)

Aspartame(E951)

Silicacolloidalanhydrous

SiliconDioxide

Succinicacid

Raspberrydryflavour

Orangedryflavour1

Orangedryflavour2

Goldensyrupdryflavour

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Drypowder:2years

Reconstitutedsuspensionaccordingtodirections:7days

Discardanyunusedsuspensionsevendaysafterreconstitution.

6.4Specialprecautionsforstorage

Drypowder:Donotstoreabove25 º C.Storeintheoriginalcontainertoprotectfrommoisture.

Reconstitutedsuspensionaccordingtodirections:Storebetween2 º Cand8 º C

Donotfreeze

6.5Natureandcontentsofcontainer

GlassbottleswithaluminiumscrewcapsofaROPP,internallylacqueredclosure,containingaflowed-inPVCliner

containingpowderforreconstitutionto100ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/02/2010 CRN 2064670 page number: 7

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKline(Ireland)Limited

StonemasonsWay

Rathfarnham

Dublin16

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA1077/93/6

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:28July1983

Dateoflastrenewal:28July2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/02/2010 CRN 2064670 page number: 8