AMPICILLIN

Main information

  • Trade name:
  • AMPICILLIN Syrup 125 MG/ 5ml
  • Dosage:
  • 125 MG/ 5ml
  • Pharmaceutical form:
  • Syrup
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMPICILLIN Syrup 125 MG/5ml
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0493/003/001
  • Authorization date:
  • 29-01-1991
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Ampicillin Syrup BP125 mg/5 ml

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each 5 mlspoonfulofreconstituted suspension containsampicillin trihydrateBPequivalentto 125 mg ofampicillin.

3PHARMACEUTICALFORM

Powderforsyrup 125 mg/5 ml.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofinfectionsdueto organismssensitiveto ampicillin.

4.2Posologyandmethodofadminstration

4.3Contraindications

Usein patientswith hypersensitivity to ampicillin, penicillinsorcephalosporins.

4.4Special warningsandspecialprecautionsforuse

Thisdrug should beused with caution in patientswith ahistory ofallergy.

Caremustbetaken when giving thisdrug especially in high dosageto patientswith impaired renalfunction.

Routeofadministration:Oral

Adultsand Children over20 kg b.w.

ENTinfections 1000 mg daily in divided doses

Bronchitis 1000 mg-4000 mg daily in divided doses

Pneumonia 2000 mg daily in divided doses

Urinarytractinfection 1500 mg daily in divided doses

Gastrointestinalinfections 1500 mg-3000 mg daily in divided doses

Children under20 kg b.w.

Moderatelysevereinfections 50-100 mg/kg/day in divided dosesevery 6-8 hours

Irish Medicines Board

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Ampicillin should notbemixed with blood productsorotherproteinaceousfluids(e.g. protein hydrolysates).

Ampicillin may reducetheefficacy oforalcontraceptives.

Food can interferewithabsorption ofampicillin, thereforedosesshould betaken 30 minutesto onehourbefore

meals.

4.6Pregnancyandlactation

Anti-infectivesshould notbeused during pregnancy orlactation unlessconsidered essentialby thephysician.

Thedrug hasbeen shown to crosstheplacentaand isexcreted in breastmilk.Studiesin animalsand experienceof

human useto datehaveshown no evidenceofteratogeniceffects.

4.7Effectsonabilitytodriveandusemachines

Nonereported.

4.8Undesirableeffects

Sideeffectsincludemaculopapularrashes, urticariaand otherevidenceofhypersensitivity, gastrointestinal

disturbancesand diarrhoea.Transiently raised liverenzymesoccuroccasionally and pseudomembranouscolitishas

been reported in afewcases.

Prolonged useofan anti-infectivemay resultin thedevelopmentofsuperinfection dueto organismsresistantto that

anti-infective.

4.9Overdose

Cutaneousreactionswhenthey occurmay subsidespontaneously within afewhoursordaysand can becontrolled

with theadministration ofan antihistamine. Forallergicreactions, 0.3-1.0mlofadrenalineinjection should begiven

intramuscularly followed by afurtherdoseifno improvementoccurs.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Ampicillin isabroad spectrumpenicillin forthetreatmentofawiderangeofinfectionscaused by ampicillin-sensitive

organisms.

Ampicillin isbactericidal, thisaction dependson theability to reach and bind penicillin-binding proteinslocated in

bacterialcytoplasmicmembranes.Itinhibitsbacterialseptumand cellwallsynthesis, probably by acylation ofthe

transpeptidaseenzyme. Transpeptidaseisamembranebound bacterialenzymeresponsibleforcross-linking of

peptidoglycan during thefinalstageofsynthesisofbacterialcellwalls. Hence, cross-linkageofpeptidoglycan chainsis

prevented which isnecessary forbacterialcellwallstrength and rigidity.Therefore, bacterialcelldivision and growth

areinhibited and lysisand elongation ofsusceptiblebacteriafrequently occur.

Rapidly dividing bacteriaarethosemostsusceptibleto theaction ofpenicillins. Certainmicro-organisms, during their

growth, producean enzymepenicillinasewhich inhibitstheaction ofampicillin.

Minimuminhibitory concentrationsforgram-positiveorganismshavebeen reported to rangefrom0.2 to 5 microgram

permland forgram-negativeorganismsfrom0.2 to 8 microgramperml. Itisinactiveagainstmoststrainsof

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Ampicillin isacid stableand may beadministered orally;an oraldoseof500 mg producesapeak blood levelin oneto

threehoursofabout4 mcg/mland detectableamountspersistforaboutsix hours. Itiswidely distributed in thetissues.

Within six hoursofadministration, about30%ofthedoseisexcreted forthemostpartunchanged in theurine, whilea

concentration atleastten timesin excessofplasmalevelsmay beobtained in bile.

Ampicillin crossestheintactmeningesin only minuteamounts;in bacterialmeningitishigherconcentrationsarefound

in thecerebrospinalfluid.Pregnantwomengiven ampicillin may havetherapeuticlevelsofthedrug in theamniotic

fluid in thelaterstagesofpregnancy.

5.2Pharmacokineticproperties

Ampicillin isincompletely absorbed fromthegastrointestinaltractafteroraladministration.About32-53 percentis

absorbed. Itisstablein acid gastricsecretion.Whereasabsorption efficiency appearsto beindependentofdoseup to

1,000 mg, food appearsto delay theonsetand reducethetotalamountabsorbed. Ampicillin should thereforebe

administered½-1 hourbeforemeals. Peak serumconcentration isattained in abouttwo hoursand following an oral

doseof500 mg itmay rangebetween 2-6 mcg/ml.

Protein binding ofampicillin islow, about20 percentisbound to plasmaproteinsin circulation and plasmahalf-lifeis

1-2 hours.

Itiswidely distributed in mostbody fluidsand bone;penetration into cells, theeyesand acrossnormalmeningesis

poor. Inflammation increasestheamountwhichcrossesthebloodbrain barrier.Ampicillin crossestheplacentaand

appearsin cord blood and amnioticfluid. Itdoesnotpenetrateand isnotbound to human erythrocyte.

Ampicillin serumlevelsinpregnantwomen areapproximately one-halfthosein non-pregnantwomen aftera

comparabledosebuturinary recoveriesappearsimilar. Therefore, renalclearancerateisdoubled during pregnancy.

Ampicillin levelsin theplacentaand umbilicalblood arethesameasthosein maternalserum. Serumclearancein the

newbornisaboutone-halfto two-thirdsthatofan adultwith normalkidney function. Serumhalf-lifeisabout2.2 h in

infants2-5 daysold, 3.4 h in thoseunderoneday and 1.1 h in thoseolderthan fourmonths.

About12-50 percentismetabolised by theliver. Ampicillin isexcreted by thekidneysboth asaresultoftubular

secretionand glomerularfiltration.Theamountexcreted by glomerularfiltration dependson theextentofprotein

binding.

Renalconcentration rangebetweenone-halfand twicethosein serumand appearto beuniformly distributed among the

cortex, medullaand papilla.Within six hoursofadministration, aboutthirty percentofthedoseisexcreted formost

partunchanged in theurine.Abouttwenty percentoftheoraldoseisexcreted in theurineaspenicilloicacid.Small

amountsofampicillin areexcreted in bileand breastmilk. Concomitantprobenecid administration effectively reduces

therenalclearanceofampicillin to thatoftheglomerularfiltration rate. Theneteffectisto increasemean serum

concentrationsby afactoroftwo and to decreaseurinary recovery by 18 percent. Concomitantadministration of

oxacillin orcimetidinehad no effecton ampicillin absorption, biotransformation orexcretion.

5.3Preclinical safetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumcarboxymethylcellulose(E466)

Propylhydroxybenzoate(E216)

Methylhydroxybenzoate(E218)

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Sodiumbenzoate(E211)

Sucrose(refined sugar)

Aerosil200

Amaranth 1508(E123)

Sunsetyellow(E110)

VanillaflavourIFF17.41. 0067

ApricotflavourIFF17.41. 0070

6.2Incompatibilities

None.

6.3ShelfLife

Theshelflifeexpiry dateforthisproductshallnotexceed threeyearsfromthedateofitsmanufacture.

6.4Special precautionsforstorage

Beforereconstitution: Storebelow25°C.

Afterreconstitution: Storein arefrigerator(2-8°C)and usewithin 7 days.

6.5Natureandcontentsofcontainer

Amberglassbottleswith screwcapspacked in individualcartonORpacked in unitsoftensin cardboard boxes.

Translucenthighdensitypolyethylene, round bottleswith plasticscrewcaps.

Pack sizes:86 and 100 ml.

6.6Instructionsforuseandhandling

To reconstitutethegranules, add 50 mlofwaterand shakewelluntilallthepowderisdissolved.

7MARKETINGAUTHORISATIONHOLDER

RegentLaboratoriesLimited

861 Coronation Road

Park Royal

London NW10 7PT

United Kingdom

8MARKETINGAUTHORISATIONNUMBER

PA493/3/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 29 th

January 1991

Dateoflastrenewal: 29 th

January 2001

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 16/11/2005 CRN 2016870 page number: 4