CLONAMP

Main information

  • Trade name:
  • CLONAMP Capsules Hard 500 Anhyd Milligrams
  • Dosage:
  • 500 Anhyd Milligrams
  • Pharmaceutical form:
  • Capsules Hard
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLONAMP Capsules Hard 500 Anhyd Milligrams
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0126/015/002
  • Authorization date:
  • 02-07-1981
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Clonamp500mgHardCapsules.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontainsampicillintrihydrateequivalentto500mgampicillin.

Excipients:

Forfulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Hard,Capsule.(Capsule)

Size‘0’hardgelatincapsuleswitharedbodyandagreycapmarked‘CLONAMP500’containinganoff-white

powder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Fortreatmentofinfectionsduetoorganismssensitivetoampicillin.

4.2Posologyandmethodofadministration

Adultsandchildrenover20Kgb.w.:

Theusualdoseis250mgeverysixhours.

Fortreatmentofsevereinfectionsthedosagemaybeincreasedatthediscretionofthephysician.

Childrenunder20Kgb.w.:

50to100mg/Kgperdayindivideddoses.

Routeofadministration

Oral.

4.3Contraindications

Ampicillinispenicillinandshouldnotbegiventopatientswithahistoryofhypersensitivitytobeta-lactamantibiotics

Amaranth(E123) 0.271mg

Tartrazine(E102) 0.128mg

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4.4Specialwarningsandprecautionsforuse

Prolongeduseofananti-infectivemayresultinthedevelopmentofsuperinfectionduetoorganismsresistantto

thatanti-infective.

(ii) Ampicillinshouldbeavoidedifinfectiousmononucleosisand/oracuteorchronicleukaemiaoflymphoid

originaresuspected.Theoccurrenceofaskinrashhasbeenassociatedwiththeseconditionsfollowingthe

administrationofampicillin.

(iii) Thedosageshouldbereducedinpatientswithrenalimpairment.

(iv) Seriousandoccasionallyfatalhypersensitivityreactions(anaphylaxis)havebeenreportedinpatientsreceiving

beta-lactamantibiotics.Althoughanaphylaxisismorefrequentfollowingparenteraltherapy,ithasoccurredinpatients

onoralpenicillins.Thesereactionsaremorelikelytooccurinindividualswithahistoryofbeta-lactam

hypersensitivity.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Ampicillinmaydecreasetheefficacyoforalcontraceptivesandpatientsshouldbewarnedaccordingly.

Probeneciddecreasestherenaltubularsecretionofampicillin.Concurrentusewithampicillinmayresultinincreased

andprolongedbloodlevelsofampicillin.

Concurrentadmisitrationofallopurinolduringtreatmentwithampicillincanincreasethelikelihoodofallergicskin

reactions.

Itisrecommendedthatwhentestingforthepresenceofglucoseinurineduringampicillintreatment,enzymaticglucose

oxidasemethodsshouldbeused.Duetothehighurinaryconcentrationsofampicillin,falsepositivereadingsare

commonwithchemicalmethods.

Bacteriostaticdrugsmayinterferewiththebactericidalactionofampicillin.

4.6Pregnancyandlactation

Pregnancy:

Animalstudieswithampicillinhaveshownnoteratogeniceffects.Ampicillinhasbeeninextensiveclinicalusesince

1961anditsuseinhumanpregnancyhasbeenwelldocumentedinclinicalstudies.Whenantibiotictherapyisrequired

duringpregnancy,ampicillinmaybeconsideredappropriate.

Lactation:

Duringlactation,tracequantitiesofpenicillinscanbedetectedinbreastmilk.Adequatehumanandanimaldataonuse

ofampicillinduringlactationarenotavailable.

4.7Effectsonabilitytodriveandusemachines

Adverseeffectsontheabilitytodriveoroperatemachineryhavenotbeenobserved.

4.8Undesirableeffects

Hypersensitivityreactions:

Ifanyhypersensitivityreactionoccurs,thetreatmentshouldthenbediscontinued.

Skinrash,pruritisandurticariahavebeenreportedoccasionally.Theincidenceishigherinpatientssufferingfrom

infectiousmononucleosisandacuteorchronicleukaemiaoflymphoidorigin.Purpurahasalsobeenreported.Rarely,

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reported.

Aswithotherantibiotics,anaphylaxis(seesection4.4)hasbeenreportedrarely.

Renaleffects:

Interstitialnephritiscanoccurrarely.

Gastrointestinalreactions:

Effectsincludenausea,vomitinganddiarrhoea.Pseudomembraneouscolitishasbeenreportedrarely.

Hepaticeffects:

Aswithotherbeta-lactamantibiotics,hepatitisandcholestaticjaundicehavebeenreportedrarely.Aswithmostother

antibiotics,amoderateandtransientincreaseintransaminaseshasbeenreported.

Haematologicaleffects:

Aswithotherbeta-lactams,haematologicaleffectsincludingtransientleucopenia,transientthrombocytopeniaand

haemolyticanaemiahavebeenreportedrarely.

Prolongationofbleedingtimeandprothrombinhavealsobeenreportedrarely.

4.9Overdose

Problemsofoverdosagewithampicillinareunlikelytooccur;ifencounteredtheymaybetreatedsymptomatically.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Penicillinswithextendedspectrum

ATCCode:J07CA

Ampicillinisbactericidalandhasasimilarmodeofactiontothatofbenzylpenicillin,althoughithasabroader

spectrumofactivity.ItresemblesbenzylpenicillininitsactionagainstGram-positiveorganisms,including

Streptococcuspneumoniaeandotherstreptococcibut,apartperhapsfromEnterococcusfaecalis,itisslightlyless

potentthanbenzylpenicillin.Ampicillinisanaminopenicillinwithanaminogroupsidechainattachedtothebasic

penicillinstructure,whichenablesampicillintopenetratetheoutermembraneofsomeGram-negativebacteria.

5.2Pharmacokineticproperties

Ampicillinisrelativelystableintheacidgastricsecretionandismoderatelywellabsorbedfromthegastro-intestinal

tractafteroraladministration.Peakconcentrationsinplasmaareobtainedinabout1to2hours.About20%isbound

toplasmaproteinsandtheplasmahalf-lifeisabout1to2hours,butthismaybeincreasedinneonatesandtheelderly;

inrenalfailurehalf-livesof7to20hourshavebeenreported.About20to40%ofanorallyadministereddoseis

excretedunchangedintheurinein6hours;urinaryconcentrationsrangefrom0.25to1mgpermlfollowingadoseof

500mg.

5.3Preclinicalsafetydata

Noinformationsubmitted.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

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Capsuleshell

Amaranth(E123)

Tartrazine(E102)

Brilliantblack(E151)

Titaniumdioxide(E171)

Gelatin

Erythrosine(E127)

PrintingInk

Shellac

Blackironoxide(E172)

Propyleneglycol

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Keepthecapsulecontainertightlyclosed.

Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Polypropylenetubeswithlowdensitypolyethylenecaps.

Highdensitypolyethylenefilmmaybeusedaspackingmaterial.

Packsize: 500mg:

30’s,50’s,100’s,250’sand500’s.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ClonmelHealthcareLimited

WaterfordRoad,

Clonmel,

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8MARKETINGAUTHORISATIONNUMBER

PA0126/015/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:02July1981

Dateoflastrenewal: 02July2006

10DATEOFREVISIONOFTHETEXT

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