AMOXIL

Main information

  • Trade name:
  • AMOXIL Capsule 500 mg Anhyd Milligrams
  • Dosage:
  • 500 mg Anhyd Milligrams
  • Pharmaceutical form:
  • Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMOXIL Capsule 500 mg Anhyd Milligrams
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1077/033/002
  • Authorization date:
  • 10-12-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Amoxil500mgCapsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

500mgamoxicillin(asamoxicillintrihydrate)percapsule.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Capsule,hard

Maroonandgoldcapsuleswith‘GSJVL'printedinwhiteonthecapandbody,containingawhitepowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthetreatmentofinfectionsduetoorganismssensitivetoamoxicillinandintheoralprophylaxisofendocarditis

relatedtodentalprocedures,acuteuncomplicatedgonorrhoeaanddentalabscess(asanadjuncttosurgical

management).

4.2Posologyandmethodofadministration

Routeofadministration:oral.

Theabsorptionof‘Amoxil’isvirtuallyunimpairedbythepresenceoffood.

Standardadultdosage:

Theusualdailydosageis750mgindivideddoses(i.e.250mgthreetimesdailybytheoralroute).

Incasesofsevereinfectionthedosagemaybedoubledor‘Amoxil’givenbyinjection.

Highdosagetherapy:(maximumrecommendedoraldosage6gdailyindivideddoses):Adosageof3gtwicedailyis

recommendedinappropriatecasesforthetreatmentofsevereorrecurrentpurulentinfectionoftherespiratorytract.

Shortcoursetherapy:Simpleacuteurinarytractinfection:two3gdoseswith10-12hoursbetweenthedoses.

Gonorrhoea:3gasasingledose.

DentalAbscess:two3gdoseswith8hoursbetweenthedoses.

Childrenuptotenyearsofage:

Theusualtotaldailydosageis375mgindivideddoses(i.e.125mgthreetimesdailybytheoralroute).Dosagemaybe

increasedincasesofsevereinfection.

Insevereorrecurrentacuteotitismedia,especiallywherecompliancemaybeaproblem,750mgtwiceadayfortwo

daysmaybeusedasanalternativecourseoftreatmentinchildrenagedthreetotenyears.

ProphylaxisofEndocarditis:

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2011 CRN 2095010 page number: 1

Adults: 3gdosefollowedby(6hourslater)afurther3gdose(or1gIMdoseiforaldosenottolerated),if

considerednecessary.

Children: Under10:halftheadultdose.(i.e.,1.5ggivenas60mldoseof‘Amoxil’Syrup(125mg/5ml))

Under5:quartertheadultdose.

Renalimpairment:Inpatientswithrenalimpairmenttheexcretionoftheantibioticwillbedelayedanddependingon

thedegreeofimpairmentitmaybenecessarytoreducethetotaldailydoses.

Adults:

Childrenunder40kg:

AmoxicillinPaediatricSuspensionisrecommendedforchildrenunder6monthsofage.

Inpatientsreceivingperitonealdialysis:

Oraltreatment:Max.500mg/day.

Amoxicillinmayberemovedfromthecirculationbyhaemodialysis.

4.3Contraindications

Useinpatientswithahistoryofhypersensitivitytobeta-lactamantibioticsincludingpenicillinorcephalosporins.

4.4Specialwarningsandprecautionsforuse

BeforeinitiatingtherapywithAmoxicillin,carefulenquiryshouldbemadeconcerningprevioushypersensitivity

reactionstopenicillins,cephalosporins.Cross-sensitivitybetweenpenicillinsandcephalosporinsiswelldocumented.

Seriousandoccasionallyfatalhypersensitivityreactions(anaphalaxis)havebeenreportedinpatientsreceivingbeta-

lactamantibiotics.Ifanallergicreactionoccurs,Amoxicillinshouldbediscontinuedandappropriatealternative

therapyinstituted.

Amoxicillinshouldbeavoidedifinfectionsmononucleosis(glandularfever)issuspectedsincetheoccurrenceofa

morbilliformrashhasbeenassociatedwiththisconditionfollowingtheuseofAmoxicillin.

Prolongeduseofananti-infectivemayoccasionallyresultinovergrowthofnon-susceptibleorganisms.

Abnormalprolongationofprothrombintime(increasedINR)hasbeenreportedrarelyinpatientsreceivingamoxicillin

andoralanticoagulants.Appropriatemonitoringshouldbeundertakenwhenanticoagulantsareprescribed

concurrently.Adjustmentsinthedoseoforalanticoagulantsmaybenecessarytomaintainthedesiredlevelof

Glomerularfiltrationrate Oraltreatment

>30ml/min Noadjustmentnecessary

10-30ml/min Max500mgb.i.d.

<10ml/min Max500mg/day

Glomerularfiltrationrate Oraltreatment

>30ml/min Noadjustmentnecessary

10-30ml/min 15mg/kggivenb.i.d.(Maximum

500mg/twicedaily)

<10ml/min 15mg/kggivenasasingledaydose

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2011 CRN 2095010 page number: 2

Dosageshouldbeadjustedinpatientswithrenalimpairment(seeSection4.2).

Inpatientswithreducedurineoutput,crystalluriahasbeenobservedveryrarely,predominantlywithparenteral

therapy.Duringtheadministrationofhighdosesofamoxicillin,itisadvisabletomaintainadequatefluidintakeand

urinaryoutputinordertoreducethepossibilityofamoxicillincrytalluria

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ProbeneciddecreasestherenaltubularexcretionofAmoxicillin.ConcurrentusewithAmoxicillinmayresultin

increasedandprolongedbloodlevelsofAmoxicillin.

ConcurrentadministrationofallopurinolduringtreatmentwithAmoxicillincanincreasethelikelihoodofallergicskin

reactions.

Incommonwithotherantibiotics,amoxicillinmayaffectthegutflora,leadingtoloweroestrogenreabsorptionand

reducedefficacyofcombinedoralcontraceptives

Intheliteraturetherearerarecasesofincreasedinternationalnormalisedratioinpatientsmaintainedonacenocoumarol

orwarfarinandprescribedacourseofamoxicillin.Ifco-administrationisnecessary,theprothrombintimeor

internationalnormalisedratioshouldbecarefullymonitoredwiththeadditionorwithdrawalofamoxicillin.

4.6Fertility,pregnancyandlactation

Useinpregnancy:

Animalstudieswith‘Amoxil’haveshownnoteratogeniceffects.Theproducthasbeeninextensiveclinicalusesince

1972anditssuitabilityinhumanpregnancyhasbeenwelldocumentedinclinicalstudies.Amoxicillinmaybeusedin

pregnancywhenthepotentialbenefitsoutweighthepotentialrisksassociatedwithtreatment.

Useinlactation:

Amoxicillinmaybeadministeredduringtheperiodoflactation.Withtheexceptionoftheriskofsensitisation

associatedwiththeexcretionoftracequantitiesofamoxicillininbreastmilk,therearenoknowndetrimentaleffectsfor

theinfant.

4.7Effectsonabilitytodriveandusemachines

Adverseeffectsontheabilitytodriveoroperatemachineryhavenotbeenobserved.

4.8Undesirableeffects

Thefollowingconventionhasbeenutilisedfortheclassificationofundesirableeffects:-

Verycommon(morethan1/10),common(morethan1/100,lessthan1/10),uncommon(morethan1/1000,lessthan

1/100),rare(morethan1/10,000,lessthan1/1000),veryrare(lessthan1/10,000).Themajorityoftheside-effects

listedbelowarenotuniquetoamoxicillinandmayoccurwhenusingotherpenicillins.

Unlessotherwisestated,thefrequencyofadverseevents(AEs)hasbeenderivedfrommorethan30yearsofpost-

marketingreports.

Bloodandlymphaticsystemdisorders

Veryrare: Reversibleleucopenia(includingsevereneutropeniaor

agranulocytosis),reversiblethrombocytopeniaandhaemolytic

anaemia.

Prolongationofbleedingtimeandprothrombintime.

Immunesystemdisorders

Veryrare: Aswithotherantibiotics,severeallergicreactions,including

angioneuroticoedema,anaphylaxis(seeWarningsand

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2011 CRN 2095010 page number: 3

4.9Overdose

Grossoverdosagewillproduceveryhighurinaryconcentrations,moresoafterparenteraladministration.Symptomsof

water/electrolyteimbalanceshouldbetreatedsymptomatically.Problemsareunlikelytooccurifadequatefluidintake

andurinaryoutputaremaintained;however,amoxicillincrystalluriainsomecasesleadingtorenalfailurehasbeen

observed(seeSection4.4,SpecialWarningsandSpecialPrecautionsforUse.Morespecificmeasuresmaybe

necessaryinpatientswithimpairedrenalfunction:theantibioticisremovedbyhaemodialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticclassification(Group+ATCcode):Beta-LactamAntibacterialsPenicillinsJO1CA-04.

`Amoxil`isabroad-spectrumantibioticwhichpossessesthesafetyprofileofthepenicillinsandisrapidlybactericidal

Ifahypersensitivityreactionisreported,thetreatmentmustbediscontinued.(See

alsoSkinandsubcutaneoustissuedisorders).

Nervoussystemdisorders

Veryrare: Hyperkinesia,dizzinessandconvulsions.Convulsionsmay

occurinpatientswithimpairedrenalfunctionorinthose

receivinghighdoses.

InfectionsandInfestations

Veryrare: Mucocutaneouscandidiasis

Gastrointestinaldisorders

#Common: Diarrhoeaandnausea.

#Uncommon: Vomiting.

Veryrare: Antibioticassociatedcolitis(includingpseudomembraneous

colitisandhaemorrhagiccolitis).

Blackhairytongue

Superficialtoothdiscolourationhasbeenreportedinchildren.

Goodoralhygienemayhelptopreventtoothdiscolourationas

itcanusuallyberemovedbybrushing(forsuspensionand

chewabletabletformulationsonly)

Hepato-biliarydisorders

Veryrare: Hepatitisandcholestaticjaundice.AmoderateriseinAST

and/orALT.

ThesignificanceofariseinASTand/orALTisunclear.

Skinandsubcutaneoustissuedisorders

#Common: Skinrash.

#Uncommon: Urticariaandpruritus.

Veryrare: Skinreactionssuchaserythemamultiforme,Stevens-Johnson

syndrome,toxicepidermalnecrolysis,bullousandexfoliative

dermatitisandacutegeneralisedexanthematouspustulosis

(AGEP).

(SeealsoImmunesystemdisorders).

RenalandUrinarytractdisorders

Veryrare: Interstitialnephritis,crystalluria(seeOverdosage)

#TheincidenceoftheseAEswasderivedfromclinicalstudiesinvolvingatotalof

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2011 CRN 2095010 page number: 4

5.2Pharmacokineticproperties

`Amoxil`iswellabsorbedbytheoralandparenteralroutes,peaklevelsareachievedonetotwohoursafter

administration.Oraladministrationproduceshighserumlevelsindependentofthetimeatwhichthefoodistaken.

`Amoxil`givesgoodpenetrationintothebronchialsecretionsandthehighurinaryconcentrationsofunchanged

antibiotic.Theaverageserumhalflifeis60minutes.Eliminationismainlyviatheurine.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Magnesiumstearate(E572)

Erythrosine(E127)

Indigocarmine(E132)

Titaniumdioxide(E171)

Yellowironoxide(E172)

Gelatin

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalpackageinordertoprotectfrommoisture.

6.5Natureandcontentsofcontainer

Polypropylenecontainerswithpolyethylenelidcontaining100capsules.

PVC/aluminiumfoilblisterpackscontaining21capsules.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2011 CRN 2095010 page number: 5

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKline(Ireland)Limited

StonemasonsWay

Rathfarnham

Dublin16

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA1077/33/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:08August1983

Dateoflastrenewal:08August2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2011 CRN 2095010 page number: 6