AMPICILLIN ORAL SUSPENSION BP

Main information

  • Trade name:
  • AMPICILLIN ORAL SUSPENSION BP
  • Dosage:
  • 250 MG/5ml
  • Pharmaceutical form:
  • Granules for Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMPICILLIN ORAL SUSPENSION BP
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0298/002/002
  • Authorization date:
  • 04-07-1986
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AmpicillinOralSuspensionBP250mg/5ml

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each5mlofsuspensioncontainsAmpicillinTrihydrateequivalentto250mgofAmpicillin,astheactivesubstance.

Each5mlofsuspensionalsocontains7.6mgofsodium,0.2mgofPonceau4R(E124)andupto2.0gofsucrose.

Forfulllistofexcipents,seesection6.1.

3PHARMACEUTICALFORM

Granulesfororalsuspension

Alightpinkgranularpowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AmpicillinOralSuspensionBPisindicatedfortheoraltherapyofbacterialinfectionscausedbyampicillin-sensitive

organisms.Suchindicationsincludeinfectionsoftheupperandlowerrespiratorytract,genito-urinarytractandthe

gastro-intestinaltract.Specificindicationsincludeearandsofttissueinfectionsandgonorrhoea.

4.2Posologyandmethodofadministration

UsualAdult/ElderlyDosage

Theusualdosageis250mgevery6hours

Allrecommendeddosagesbelowareaguideonly.Insevereinfections,thedosagesmaybeincreasedatthedirectionof

thephysician.Dosesshouldbetakenhalftoonehourbeforemeals.

Considerationshouldbegiventoofficialguidanceontheappropriateuseofantibacterialagents.Consultlocalor

nationalprescribingguidelinesforantibioticusebeforeprescribing.Wherepossible,useonlywhereantibiotic

sensitivityisknownorsuspected.

Ear,noseandthroatinfections: 250mgfourtimesaday

Bronchitis:Routinetherapy: 250mgfourtimesdaily

Highdosetherapy: 1gfourtimesdaily

Pneumonia: 500mgfourtimesdaily

Urinarytractinfections: 500mgthreetimesdaily

Gastro-intestinalinfections: 500-750mgthreetofourtimesdaily

Entericfevers:

Acute: 1-2gfourtimesdailyfortwoweeks

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Gonorrhoea: 2gorallywith1gprobenecidasasingledose.Repeateddosesarerecommended

forthetreatmentoffemales.

Usualchildren'sdosage(undertheageof10):

Childrenmaybegivenhalftheadultdose.

RenalImpairment:

Insevererenalimpairment(i.e.,creatinineclearance<10mL/min)reductionindoseorextensionofthedoseinterval

shouldbeconsidered.Inpatientsundergoingdialysis,anadditionaldoseshouldbeadministeredafterdialysis.

4.3Contraindications

Useinpatientswithhypersensitivitytopenicillinsorampicillincephalosporinsoranyoftheexcipients.

ThisproductcontainsPonceau4R(E124).Thismaycauseallergicreactions.Italsocontainssucrose.

4.4Specialwarningsandprecautionsforuse

Beforeinitiatingtherapywithampicillin,carefulenquiryshouldbemadeconcerningprevioushypersensitivity

reactionstobeta-lactamantibiotics.

Seriousandoccasionallyfatalhypersensitivityreactions(anaphylaxis)havebeenreportedinpatientsreceivingbeta-

lactamantibiotics.Althoughanaphylaxisismorefrequentfollowingparenteraltherapy,ithasoccurredinpatientson

oralpenicillins.Thesereactionsaremorelikelytooccurinindividualswithahistoryofbeta-lactamhypersensitivity.

Prolongeduseofananti-infectivemayoccasionallyresultinthedevelopmentofsuper-infectionduetoorganisms

resistanttothatanti-infectivee.g.CandidaorPseudomonas.

Careshouldbetakenwithpatientswithrenalimpairmentanddoseadjustmentmayberequired(seesection4.2).

AmpicillinshouldbeavoidedErythematousrashesarecommoninglandularfever,cytomegalovirus(CMV),and/or

acuteandchroniclymphaticleukaemiaandpossiblyHIVaserythematousrashesaremorecommon.

CareisnecessarywhentreatingspirochaeteinfectionsparticularlySyphilis.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Ampicillinmayreducetheefficacyoforalcontraceptivesandpatientsshouldbewarnedaccordingly.

Uricosurics:excretionofpenicillinisdecreased,givinganincreasedriskoftoxicitye.g.Probenecidandsulfinpyrazon.

AllopurinolincreasesAmpicillininducedskinreactions.

Anti-coagulants:INRcanbealteredbytheadministrationofAmpicillinwhileonWarfarinandPhenindione.

Vaccines:TheefficacyofOralTyphoidVaccinemaybereducedwhenampicilliniscoadministered

Cytotoxics:theexcretionofmethotrexateisreduced.

Chloroquine:absorptionofampicillinisreducedwhentakenconcomitantlywithchloroquine.

Theremaybeinteractionbetweenotherbacteriostaticantibacterialssuchaserythromycin,chloramphenicoland

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Asprobenecidprolongsthehalf-lifeofthispenicillin,itmaybeusedtherapeuticallyforthispurpose.

Ampicillinmayinterferewithsomediagnostictestse.g.testsforurinaryglucoseusingcoppersulphate;directanti-

globulin(Coombs’test)andsometestsforurinaryorserumproteins.Testsusingbacteria,e.g.theGuthrietestfor

phenylketonuriausingBacilusSubtilisorganisms,couldalsobeaffectedwhilepatientsaretakingpenicillins.

4.6Fertility,pregnancyandlactation

Pregnancy:

Animalstudieswithampicillinhaveshownnoteratogeniceffects.Theproducthasbeeninextensiveclinicalusesince

1961anditsuseinhumanpregnancyhasbeenwelldocumentedinclinicalstudies.Whenantibiotictherapyisrequired

duringpregnancy,ampicillinmaybeconsideredappropriate.

Lactation:

Duringlactation,tracequantitiesofpenicillinscanbedetectedinbreastmilk.Adequatehumanandanimaldataonuse

ofampicillinduringlactationarenotavailable.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Sideeffectsaswithotherpenicillinsarerareandusuallyofamildortransitorynature.

Occasionally,gastro-intestinaldisturbancesnausea,vomitinganddiarrhoeaorpseudomembranouscolitismayoccur.

Erythematousmaculo-papularrashes,soremouthandsore,black,hairytonguehaveoccurred.Twotypesofrashes

havebeenobserved;anurticarialrash,whichisusuallyindicativeoftruepenicillinhypersensitivity,andan

erythematousrash,whichisgenerallyspecifictoampicillin.Thelatterisparticularlyinpatientswithinfectious

mononucleosis,cytomegalovirus,acuteandchroniclymphaticleukaemiaandpossiblyHIV.Erythemamultiforme

StevensJohnsonsyndromeandtoxicepidermalnecrolysishasbeenreported.Ifarashoccurs,treatmentshouldbe

discontinued.

Angioedemaandanaphylaxis(seesection4.4)haveoccasionallyoccurred.

Fever,jointpains,serumsickness-likesymptomshavebeenreported.

Therehavebeenreportsofhaemolyticanaemia,thrombocytopenia,leucopenia,neutropeniaandcoagulationdisorders.

Prolongationofbleedingtimeandprothrombintimehavealsobeenreportedrarely.

Particularlywithhighdosesorinrenalimpairment,CNStoxicityincludingconvulsionshaveoccurred;withprolonged

useparaesthesia.

Nephropathyandinterstitialnephritishavebeenreported.

Hepaticeffects:Aswithotherbeta-lactamantibiotics,hepatitisandcholestaticjaundicehavebeenreportedrarely.As

withmostotherantibiotics,amoderateandtransientincreaseintransaminaseshasbeenreported.

4.9Overdose

Gastrointestinaleffectssuchasnausea,vomitinganddiarrhoeamaybeevidentandshouldbetreatedsymptomatically.

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:J01CA01

Ampicillinisemployedinthetreatmentofinfectionsoftheurinarytractduetogram-negativeorganisms,especially

Escherichiacoli,Proteusmirabilisandenterococciresistanttobenzylpenicillin;itisusedfortheprophylaxisand

treatmentoftherespiratorytractsuchaschronicbronchitis,pneumoniaandbronchiectasis.

Becauseitisexcretedinhighconcentrationinthebileithasbeenusedinthetreatmentofinfectionsofthebiliaryand

intestinaltractscausedbyE.coliSalmonellaandShigellae.Becauseofitslowtoxicityandbroadantimicrobial

spectrum,ithasbeenaddedtofluidsusedforintraperitonealdialysistopreventthedevelopmentofbacterial

peritonitis.

5.2Pharmacokineticproperties

Ampicillinisrelativelystableintheacidgastricsecretionandismoderatelywellabsorbedfromthegastro-intestinal

tractafteroraladministration.Peakconcentrationsinserumareobtainedinabout1or2hoursandarereportedtorange

from0.8to8.5microgramperml.About20%isboundtoplasmaproteinsinthecirculation.Itdiffusesacrossthe

placentaandhighconcentrationsarefoundincerebrospinalfluidwhenthemeningesareinfected.About30%ofan

orallyadministereddoseisexcretedintheurinein6to8hours;urinaryconcentrationsrangefrom0.25to2.5mgper

ml.Ahighconcentrationisreachedinbile.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

ColloidalAnhydrousSilica

Sodiumbenzoate(E211)

Sodiumcitrateanhydrous

CarmelloseSodium

Ponceau4R(E124)

Cherryflavourpowder17.41.0086

Sucrose

6.2Incompatibilities

Noneknown.

6.3ShelfLife

Unopened:2years.

Afterreconstitution:7days.

6.4Specialprecautionsforstorage

DryPowder:Storebelow25 o

Keepthecontainertightlyclosedinordertoprotectfrommoisture.

ReconstitutedSuspension:Storeinarefrigerator(at2-8 o

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Storeintheoriginalcontainer.

6.5Natureandcontentsofcontainer

100mlnaturalhighdensitypolyethylenebottleswithwhiteplastictamperevidentcaps.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Toreconstitute:

(a)Add76mlsofwatertoobtain100mlsofsuspension.

Appearanceonreconstitution:Aredsyrupwithacherryodourandflavour.

Shakewellbeforeuse.

7MARKETINGAUTHORISATIONHOLDER

AthloneLaboratoriesLimited

Ballymurray

Co.Roscommon

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA298/2/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:04July1986

Dateoflastrenewal:04July2006

10DATEOFREVISIONOFTHETEXT

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