AMOXYCILLIN SACHET SUGAR FREE

Main information

  • Trade name:
  • AMOXYCILLIN SACHET SUGAR FREE
  • Dosage:
  • 125 Milligram
  • Pharmaceutical form:
  • Powder for Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMOXYCILLIN SACHET SUGAR FREE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0298/010/005
  • Authorization date:
  • 21-10-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AmoxycillinSachetSugarFree125mgPowderforOralSuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramofproductcontains125mgofamoxicillinasamoxicillintrihydrate.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Powderfororalsuspension

Alemoncoloured,dry,freeflowingpowderwithacharacteristiclemonflavourforreconstitutioninwater.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Amoxycillinisabroadspectrumantibioticindicatedforthetreatmentofcommonlyoccurringbacteriainfectionssuch

Upperrespiratoryinfections,otitismedia,acuteandchronicbronchitis,lobarandbronchopneumonia,cystitis,

urethritis,pyelonephritis,bacteriuriainpregnancy,gynaecologicalinfectionsincludingpuerperalsepsisandseptic

abortion,gonorrhoea,peritonitit,intra-abdominalsepsis,septiceamia,bacterialendocarditis,typhoidandparathphoid

fever,skinandsofttissueinfections,osteomyelitis.

Amoxycillinmaybeusedforthepreventionofbacteraemiaassociatedwithproceduressuchasdentalextractionin

patientsasriskofdevelopingbacterialendocarditis.

4.2Posologyandmethodofadministration

Dosage:TheabsorptionofAmoxycillinisvirtuallyunimpairedbythepresenceoffood.

StandardAdultDose:250mgthreetimesdailybytheoralroute.

Incasesofsevereinfectionthedosagemaybedoubled.

Children:(Upto10years).

125mgthreetimesdailybytheoralroute.

4.3Contraindications

Useinpatientswithhypersensitivitytotraditionalandsemi-syntheticpenicillinsorcephalosporins.

4.4Specialwarningsandprecautionsforuse

Aswithotherpenicillins,sideeffectsarerareandusuallyofamildandtransitorynature.Gastrointestinalsideeffects,

suchasnausea,vomitinganddiarrhoeaaresometimesobserved.

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Prolongeduseofananti-infectivemayoccasionallyresultinovergrowthofnonsusceptibleorganisms.

Inpatientswithinfectiousmononucleosisanincreasedincidenceofrashescanoccurwithamoxycillintherapy.

Eachsachetcontains1gramofsorbitol.Ifyouaretakingthestandardadultdailydoseof750mgofamoxicillinyou

willalsobetaking6gofsorbitoleachday.Incasesofsevereinfectionthedosagemaybedoubled,itisthenpossible

thatyoucouldbetakingupto12gofsorbitoleachday.Sorbitolmayhaveamildlaxativeeffect.Calorificvalue2.6

kcal/gsorbitol.

Seriousandoccasionallyfatalhypersensitivity(anaphylactoid)reactionshavebeenreportedinpatientsonpenicillin

therapy.

Althoughanaphylaxisismorefrequentfollowingparenteraltherapy,ithasoccurredinpatientsonoralpenicillins.

Thesereactionsaremorelikelytooccurinpersonswithahistoryofpenicillinhypersensitivityand/orahistoryof

sensitivitytomultipleallergens.Therehavebeenreportsofindividualswithahistoryofpenicillinhypersensitivitywho

haveexperiencedseverereactionswhentreatedwithacephalosporin.Beforeinitiatingtherapywithanypenicillin,

carefulinquiryshouldbemadeconcerningprevioushypersensitivityreactionstopenicillins,cephalosporins,orother

allergens.

Ifanallergicreactionoccurs,amoxycillinshouldbediscontinuedandappropriatetherapyshouldbeinstitutedand

discontinuanceofamoxycillintherapyconsidered.

Seriousanaphylactoidreactionsrequireimmediateemergencytreatmentwithepinephrine.Oxygen,intravenous

steroids,andairwaymanagement,includingintubation,shouldalsobeadministeredasindicated.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Whenadministeredconcurrently,thefollowingdrugsmayinteractwithamoxycillin:

Bacteriostaticantibiotics

Chloramphenicol,erythromycins,sulfonamides,ortetracyclinesmayinterferewiththebactericidaleffectsof

penicillins.Thishasbeendemonstratedinvitro;however,theclinicalsignificanceofthisinteractionisnotwell

documented.

Probencid

Probencidmaydecreaserenaltubularsecretionofamoxycillinresultinginincreasedbloodlevelsand/oramoxycillin

toxicity.

Drug/LaboratoryTestInteractions

Aftertreatmentwithamoxycillin,false-positivereactionforglucoseintheurinemayoccurwithcoppersulphatetests

(Benedict’ssolution,Fehling’ssolution,Clinitesttablets)butnotwithenzymebasedtestssuchasClinistixandTes-

Tap.

4.6Pregnancyandlactation

Asthereisinsufficientexperiencewithpregnantwomentheproductshouldnotbeusedduringpregnancyunless

consideredessentialbythephysician.

Asforotherpenicillins,duringlactation,tracequantitiesofamoxycillincanbedetectedinbreastmilk,presentingthe

riskofcandidiasisandalsoofaCNStoxicityduetoprematurityofthebloodbrainbarrier.Thereisatheoretical

possibilityoflatersensitisationinthebabyifpenicillinsareusedduringthesecondandthirdtrimestersofpregnancy.

4.7Effectsonabilitytodriveandusemachines

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4.8Undesirableeffects

Side-effects,aswithotherpenicillinsareuncommonandmainlyofamildandtransitorynature;theymayinclude

nausea,vomiting,diarrhoea,indigestionoroccasionallyarash,eitherurticarialorerthyematous.Anurticularrash

suggestspenicillin-hypersensitivityandtheerthematoustyperashmayariseifamoxycillinisadministeredtopatients

withglandularfever.Ineithercase,treatmentshouldbediscounted.Antibioticassociatedcolitishasalsobeenreported.

Asoremouthorblackhairytonguehavebeenreportedoccasionally.Hypersensitivityreactionsincludingfever,joint

pains,angioedema,anaphylaxis,serumsickness-likereactions,haemolyticanaemiaandinterstitialnephritishavebeen

documented.Neutropenia,thrombocytopenia,coagulationdisordersandcentralnervoussystemdisordershavebeen

reportedespeciallywithhighdosesorinsevererenalimpairment.

Atemporaryincreaseinliverenzymesmayoccuroccasionally.

4.9Overdose

Sinceamoxycillinisapenicillin,problemsofoverdosageareunlikelytobeencountered.

Incaseofoverdosage,discontinuemedication,treatsymtomaticallyandinstitutesupportivemeasuresasrequired.

Amoxycillincanberemovedfromthecirculationbyhaemodialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Amoxycillinisabroadspectrumantibioticwhichisbactericidalforbothgrampositiveandgramnegativebacteria.In

commonwithotherpenicillinsAmoxycillinisbactericidalbyvirtueofinhibitionofbacterialcellwallsynthesis.

Amoxycillingivesgoodpenetrationintobronchialsecretionsandhighurinaryconcentrationsofunchangedantibiotic.

Itisrapidlybactericidalandpossessesthesafetyprofileofapenicillin.

5.2Pharmacokineticproperties

Amoxycillintrihydrateisasemisyntheticantibiotic,ananalogofampicillin,withabroadspectrumofbactericidal

activityagainstmanygram-positiveandgram-negativemicro–organisms.

Amoxycillinisstableinthepresenceofgastricacidandmaybegivenwithoutregardtomeals.Itisrapidlyabsorbed

afteroraladministration.50%to90%ofadoseisabsorbedafteroraladministration.Itdiffusesreadilyintomostbody

tissuesandfluids,withtheexceptionofbrainandspinalfluid,exceptwhenmeningesareinflamed.Theserumhalflife

ofamoxycillinis1hour,whichmaybeincreasedto20hoursinthecaseofrenalfailure.Mostoftheamoxycillinis

excretedunchangedintheurine.Amoxycillinisnothighlyproteinbound.Inbloodserum,amoxycillinis

approximately15%to20%proteinboundascomparedto60%forpenicillinG.

Detectableserumlevelsareobservedupto8hoursafteranorallyadministereddoseofamoxycillin.Approximately

60%ofanorallyadministereddoseofamoxycillinisexcretedintheurinewithinsixtoeighthours.

5.3Preclinicalsafetydata

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Disodiumedetate

Sodiumcitrate

Lemonflavour

Quinolineyellow

Xanthumgum

Sorbitol

6.2Incompatibilities

Noneknown.

6.3ShelfLife

Theshelflifeexpirydateforthisproductshouldnotexceed6monthsfromthedateofitsmanufacture.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

C.Keepthesachetsintheoutercarton.

6.5Natureandcontentsofcontainer

Thepowderispresentedinindividualsachetswithdimensionsofapproximately90x45mmandcomposedofa

paper/polyethylene/aluminiumfoil/polyethylenelaminate.

Thesachetsarepackagedinoutercardboardcartonsof25or50.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Toprepareadd80mlsofpotablewaterandstirthecontentsuntilallaredispersed.

Forsingleuseonly.Discardanyunusedmedicine,immediately.

7MARKETINGAUTHORISATIONHOLDER

AthloneLaboratoriesLtd.

Ballymurray

Co.Roscommon

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA298/10/5

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:21October1993

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10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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