AMPICILLIN

Main information

  • Trade name:
  • AMPICILLIN Capsules Hard 250 Milligram
  • Dosage:
  • 250 Milligram
  • Pharmaceutical form:
  • Capsules Hard
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMPICILLIN Capsules Hard 250 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0298/001/001
  • Authorization date:
  • 29-05-1981
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AmpicillinCapsulesBP250mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachcapsulecontainsAmpicillinTrihydrateequivalentto250mgofAmpicillin.

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Capsule,hard(Capsule)

Anopaquecapsulewithagreycapandaredbodywith‘AMP250’printedonthecapsuleshellandcontainingawhite

tocreamygranularpowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AmpicillincapsulesBPareindicatedfortheoraltherapyofbacterialinfectionscausedbyampicillin-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: 1gfourtimesaday

Pneumonia: 500mgfourtimesdaily

Urinarytractinfections: 500mgthreetimesdaily

Gastro-intestinalinfections: 500-750mgthreetofourtimesdaily

Entericfevers:

Acute:1-2gfourtimesdailyfortwoweeks

Carriers:1-2gfourtimesdailyforfourto12weeks

Gonorrhoea:2gorallywith1gprobenecidasasingledose.Repeatdosesarerecommendedforthetreatmentof

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/11/2010 CRN 2091854 page number: 1

Usualchildren’sdosage:(Under10years)

Halfoftheadultdosage

RenalImpairment:

Insevererenalimpairment(ie,creatinineclearance<10mL/min)reductionindoseorextensionofthedoseinterval

shouldbeconsidered.Inpatientsundergoingdialysis,anadditionaldoseshouldbeadministeredafterdialysis.

Fororaladministrationonly

4.3Contraindications

Useinpatientswithhypersensitivitytopenicillins,ampicillin,cephalosporinsoranyoftheexcipients.

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)

Careshouldbetakenwhenhighdosesaregiven;renalandhaematologicalstatusshouldbemonitoredduringhigh-dose

andprolongedtherapy.

Ampicillinshouldbeavoidedinglandularfever,cytomegalovirus(CMV),and/oracuteandchroniclymphatic

leukaemiaandpossiblyHIVaserythematousrashesaremorecommon.

CareisnecessarywhentreatingspirochaeteinfectionsparticularlySyphilis.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Ampicillinmayreducetheefficacyoforalcontraceptivesandpatientsshouldbewarnedaccordingly.

Uricosurics:excretionofpenicillinisdecreased,givinganincreasedriskoftoxicitye.g.Probenecidand

sulfinpyrazone.

AllopurinolincreasesAmpicillininducedskinreactions.

Anti-coagulants:INRcanbealteredbytheadministrationofAmpicillinwhileonWarfarinandPhenindione.

Vaccines:TheefficacyofOralTyphoidVaccinemaybereducedwhenampicilliniscoadministered

Cytotoxics:theexcretionofmethotrexateisreduced.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/11/2010 CRN 2091854 page number: 2

Bacteriostaticantibacterialssuchaserythromycin,chloramphenicolandtetracyclinemayinterferewiththebactericidal

actionofampicillin

Asprobenecidprolongsthehalf-lifeofthispenicillin,itmaybeusedtherapeuticallyforthispurpose.

Ampicillinmayinterferewithsomediagnostictestseg.testsforurinaryglucoseusingcoppersulphate;directanti-

globulin(Coombs’test)andsometestsforurinaryorserumproteins.Testsusingbacteria,eg.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-intestinal

disturbances,nausea,vomitinganddiarrhoeaorhaemorrhagiccolitisorpseudomembranouscolitismayoccur.

Erythematousmaculo-papularrashes,soremouthandsore,black,hairytonguehaveoccurred.Twotypesofrashes

havebeenobserved:anurticarialrashwhichisusuallyindicativeoftruepenicillinhypersensitivityandan

erythematousrashwhichisgenerallyspecifictoampicillin.Thelatterisparticularlyseeninpatientswithinfectious

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.

Nephropathyandinterstitialnephritishasbeenreported.

Hepaticeffects:Aswithotherbeta-lactamantibiotics,hepatitisandcholestaticjaundicehavebeenreportedrarely.As

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/11/2010 CRN 2091854 page number: 3

4.9Overdose

Gastrointestinaleffectssuchasnausea,vomitinganddiarrhoeamaybeevidentandshouldbetreatedsymptomatically.

Ampicillinmayberemovedfromthecirculationbyhaemodialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:J01CA01

Ampicillinisemployedinthetreatmentofinfectionsoftheurinarytractduetogram-negativeorganisms,especially

Escherichiacoli,Proteusmirabilisandenterococciresistanttobenzylpenicillin;itisusedfortheprophylaxisand

treatmentoftherespiratorytractsuchaschronicbronchitis,pneumoniaandbronchiectasis.

Becauseitisexcretedinhighconcentrationinthebileithasbeenusedinthetreatmentofinfectionsofthebiliaryand

intestinaltractscausedbyE.Coli,SalmonellaandShigellae.Becauseofitslowtoxicityandbroadantimicrobial

spectrum,ithasbeenaddedtofluidsusedforintraperitonealdialysistopreventthedevelopmentofbacterial

peritonitis.

5.2Pharmacokineticproperties

Ampicillinisrelativelystableintheacidgastricsecretionandismoderatelywellabsorbedfromthegastro-intestinal

tractafteroraladministration.Peakconcentrationsinserumareobtainedinabout1or2hoursandarereportedto

rangefrom0.8to8.5µgperml.About20%isboundtoplasmaproteinsinthecirculation.Itdiffusesacrossthe

placentaandhighconcentrationsarefoundincerebrospinalfluidwhenthemeningesareinfected.About30%ofan

orallyadministereddoseisexcretedintheurinein6to8hours;urinaryconcentrationsrangefrom0.25to2.5mgper

ml.Ahighconcentrationisreachedinbile.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Magnesiumstearate

Capsuleshell:

Gelatin

BlackIronOxide(E172)

TitaniumDioxide(E171)

Erythrosine(E127)

PatentBlueV(E131)

QuinolineYellow(E104)

6.2Incompatibilities

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/11/2010 CRN 2091854 page number: 4

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Storebelow25°C.

Keepthecontainertightlyclosedinordertoprotectfrommoisture.

6.5Natureandcontentsofcontainer

Theproductisstoredinpolypropylenejarswithpolyethylenecapscontaining100,500and1,000capsules.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

AthloneLaboratoriesLimited

Ballymurray

Co.Roscommon

8MARKETINGAUTHORISATIONNUMBER

PA0298/001/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:29May1981

Dateoflastrenewal:29May2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/11/2010 CRN 2091854 page number: 5