CLONAMP

Main information

  • Trade name:
  • CLONAMP Powder for Oral Suspension 125 Anhyd mg/5ml
  • Dosage:
  • 125 Anhyd mg/5ml
  • Pharmaceutical form:
  • Powder for Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLONAMP Powder for Oral Suspension 125 Anhyd mg/5ml
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0126/015/003
  • Authorization date:
  • 02-07-1981
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Clonamp125mg/5mlPowderforOralSuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each5mlofsuspensioncontains125mgofAmpicillinasAmpicillinTrihydrate.

Excipients:

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Powderfororalsuspension

Awhitepolyethylenebottlewithachild-resistantcapcontaininganoff-whitepowdergivingapink/redsuspensionon

reconstitution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Fortreatmentofinfectionsduetoorganismssensitivetoampicillin.

4.2Posologyandmethodofadministration

Adultsandchildrenover20Kgb.w.:

Theusualdoseis250mgeverysixhours.

Fortreatmentofsevereinfectionsthedosagemaybeincreasedatthediscretionofthephysician.

Childrenunder20Kgb.w.:

50to100mg/Kgperdayindivideddoses.

Routeofadministration

Oral.

4.3Contraindications

Ampicillinispenicillinandshouldnotbegiventopatientswithahistoryofhypersensitivitytobeta-lactamantibiotics

Amaranth(E123) 0.25mg/5ml

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4.4Specialwarningsandprecautionsforuse

Prolongeduseofananti-infectivemayresultinthedevelopmentofsuperinfectionduetoorganismsresistantto

thatanti-infective.

(ii) Ampicillinshouldbeavoidedifinfectiousmononucleosisand/oracuteorchronicleukaemiaoflymphoid

originaresuspected.Theoccurrenceofaskinrashhasbeenassociatedwiththeseconditionsfollowing

theadministrationofampicillin.

(iii) Thedosageshouldbereducedinpatientswithrenalimpairment.

(iv) Seriousandoccasionallyfatalhypersensitivityreactions(anaphylaxis)havebeenreportedinpatientsreceiving

beta-lactamantibiotics.Althoughanaphylaxisismorefrequentfollowingparenteraltherapy,ithasoccurredin

patientsonoralpenicillins.Thesereactionsaremorelikelytooccurinindividualswithahistoryof

beta-lactamhypersensitivity.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Ampicillinmaydecreasetheefficacyoforalcontraceptivesandpatientsshouldbewarnedaccordingly.

Probeneciddecreasestherenaltubularsecretionofampicillin.Concurrentusewithampicillinmayresultinincreased

andprolongedbloodlevelsofampicillin.

Concurrentadministrationofallopurinolduringtreatmentwithampicillincanincreasethelikelihoodofallergicskin

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

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skinreactionssuchaserythemamultiformeandStevens-Johnsonsyndromeandtoxicepidermalnecrolysishavebeen

reported.

Aswithotherantibiotics,anaphylaxis(seesection4.4)hasbeenreportedrarely.

Renaleffects:

Interstitialnephritiscanoccurrarely.

Gastrointestinalreactions:

Effectsincludenausea,vomitinganddiarrhoea.Pseudomembranouscolitishasbeenreportedrarely.

Hepaticeffects:

Aswithotherbeta-lactamantibiotics,hepatitisandcholestaticjaundicehavebeenreportedrarely.Aswithmostother

antibiotics,amoderateandtransientincreaseintransaminaseshasbeenreported.

Haematologicaleffects:

Aswithotherbeta-lactams,haematologicaleffectsincludingtransientleucopenia,transientthrombocytopeniaand

haemolyticanaemiahavebeenreportedrarely.

Prolongationofbleedingtimeandprothrombinhavealsobeenreportedrarely.

4.9Overdose

Problemsofoverdosagewithampicillinareunlikelytooccur;ifencounteredtheymaybetreatedsymptomatically.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Penicillinswithextendedspectrum.

ATCcode:J01CA.

Ampicillinisbactericidalandhasasimilarmodeofactiontothatofbenzylpenicillin,althoughithasabroader

spectrumofactivity.ItresemblesbenzylpenicillininitsactionagainstGram-positiveorganisms,including

Streptococcuspneumoniaeandotherstreptococcibut,apartperhapsfromEnterococcusfaecalis,itisslightlyless

potentthanbenzylpenicillin.Ampicillinisanaminopenicillinwithanaminogroupsidechainattachedtothebasic

penicillinstructure,whichenablesampicillintopenetratetheoutermembraneofsomeGram-negativebacteria.

5.2Pharmacokineticproperties

Ampicillinisrelativelystableintheacidgastricsecretionandismoderatelywellabsorbedfromthegastro-intestinal

tractafteroraladministration.Peakconcentrationsinplasmaareobtainedinabout1to2hours.About20%isboundto

plasmaproteinsandtheplasmahalf-lifeisabout1to2hours,butthismaybeincreasedinneonatesandtheelderly;in

renalfailurehalf-livesof7to20hourshavebeenreported.About20to40%ofanorallyadministereddoseisexcreted

unchangedintheurinein6hours;urinaryconcentrationsrangefrom0.25to1mgpermlfollowingadoseof500mg.

5.3Preclinicalsafetydata

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Saccharinsodium

Sodiumcitrate(anhydrous)

Sodiumbenzoate(E211)

Colloidalanhydroussilica

Amaranthred(E123)

Cherryflavour(17410036)

Microcrystallinecelluloseandcarmellosesodium

Sucrose

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

Shelf-lifeuponreconstitution:7days.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Keepthebottletightlyclosed.

Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Whitepolyethylenebottleswithchildresistantcaps.

Packsizes: 125mg/5ml: 60mland100mlbottles.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Add66mlwatertoreconstitute.Loosenpowder,addabouthalfthewater,shakewell.Addremainingwater.Shaketo

completesuspension.

7MARKETINGAUTHORISATIONHOLDER

ClonmelHealthcareLtd.

WaterfordRoad

Clonmel

CountyTipperary

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:02July1981

Dateoflastrenewal:02July2006

10DATEOFREVISIONOFTHETEXT

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