Nisamox Tablets 250mg

Main information

  • Trade name:
  • Nisamox Tablets 250mg
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Nisamox Tablets 250mg
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • amoxicillin and enzyme inhibitor
  • Therapeutic area:
  • Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0196/002
  • Authorization date:
  • 24-11-2011
  • EU code:
  • UK/V/0196/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:November2011

AN:01187/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Nisamox250mgTabletsforDogs(inallCMSandRMSUK,BE,FR,IT,NL,

PT,ES.)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveIngredients:

Amoxicillin(asamoxicillintrihydrate) 200mg

Clavulanicacid(asPotassiumclavulanate) 50mg

Excipients:

CarmoisineLake(E122) 1.225mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Tablet.

Roundpinkbiconvextabletwithascorelineand250embossedonopposing

faces.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofthefollowinginfectionscausedby 

lactamaseproducingstrains

ofbacteriasensitivetoamoxicillinincombinationwithclavulanicacid:

Skininfections(includingsuperficialanddeeppyodermas)causedby

susceptibleStaphylococci

UrinarytractinfectioncausedbysusceptibleStaphylococciorEscherichia

coli

RespiratoryinfectionscausedbysusceptibleStaphylococci

EnteritiscausedbysusceptibleEscherichiacoli

Itisrecommendedtocarryoutsuitabletestsforsensitivitytestingwhen

initiatingthetreatment.Thetreatmentshouldonlyproceedifsensitivityis

proventothecombination.

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AN:01187/2011

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4.3 Contraindications

Donotuseinanimalswithknowncasesofhypersensitivitytopenicillinorother

substancesofthebeta-lactamgroup.

Donotuseinrabbits,guineapigs,hamstersorgerbils.

Donotuseinanimalswithseriousdysfunctionofthekidneysaccompaniedby

anuriaandoliguria.

Donotusewhereresistancetothiscombinationisknowntooccur.

4.4 SpecialWarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteria

resistanttoamoxicillin/clavulanicacid.

Inanimalswithhepaticandrenalfailure,thedosingregimenshouldbe

carefullyevaluated.

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialpolicies.Narrowspectrum

antibacterialtherapyshouldbeusedforfirstlinetreatmentwhere

susceptibilitytestingsuggestslikelyefficacyofthisapproach.

Cautionisadvisedintheuseinsmallherbivoresotherthanthosein4.3.

Donotadministertohorsesandruminatinganimals.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)

followinginjection,inhalation,ingestionorskincontact.Hypersensitivityto

penicillinsmayleadtocross-reactionstocephalosporinsandviceversa.

Allergicreactionstothesesubstancesmayoccasionallybeserious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhave

beenadvisednottoworkwithsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure,takingall

recommendedprecautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,you

shouldseekmedicaladviceandshowthedoctorthiswarning.Swellingof

theface,lipsoreyesordifficultywithbreathingaremoreserioussymptoms

andrequireurgentmedicalattention.

Washhandsafteruse.

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4.6 Adversereactions(frequencyandseriousness)

Hypersensitivityreactionsunrelatedtodosecanoccurwiththeseagents.

Gastrointestinalsymptoms(diarrhoea,vomiting)mayoccurafteradministration

oftheproduct.

Allergicreactions(e.g.skinreactions,anaphylaxia)mayoccasionallyoccur.

Incaseofoccurrenceofallergicreaction,thetreatmentshouldbewithdrawn.

4.7 Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshavenotproducedanyevidenceofteratogenic

effects.Useonlyaccordingtothebenefit/riskassessmentbytheresponsible

veterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Chloramphenicol,macrolides,sulfonamidesandtetracyclinesmayinhibitthe

antibacterialeffectofpenicillinsbecauseoftherapidonsetofbacteriostatic

action.

Thepotentialforallergiccross-reactivitywithotherpenicillinsshouldbe

considered.

Penicillinsmayincreasetheeffectofaminoglycosides.

4.9 Amountstobeadministeredandadministrationroute

Administrationisviatheoralroute.Thedosagerateis12.5mgcombined

actives/kgbodyweighttwicedaily.Thetabletsmaybecrushedandaddedtoa

littlefood.

Thefollowingtableisintendedasaguidetodispensingtheproductatthe

standarddoserateof12.5mgofcombinedactives/kgtwicedaily.

Bodyweight(kg) Numberoftabletstwicedaily

19-20 1

21-30 1,5

31-40 2

41-50 2,5

Morethan50 3

Durationoftherapy:

Routinecasesinvolvingallindications:Themajorityofcasesrespondto

between5and7daystherapy.

Chronicorrefractorycases:Inthesecaseswherethereisconsiderabletissue

damage,alongercourseoftherapymayberequiredinthatitallowssufficient

timefordamagedtissuetorepair.

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AN:01187/2011

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4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theproductisofaloworderoftoxicityandiswelltoleratedbytheoralroute.

Inatolerancestudyatesteddoseof3timestherecommendeddoseof12.5mg

ofthecombinedactivesadministeredtwicedailyfor8daysdidnotdemonstrate

adverseeffects.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Beta-lactamantibacterials,penicillins

ATCVetCode:QJ01CR02

5.1 Pharmacodynamicproperties

Amoxicillinisabeta-lactamantibioticanditsstructurecontainsthebeta-lactam

ringandthiazolidineringcommontoallpenicillins.Amoxicillinshowsactivity

againstsusceptibleGram-positivebacteriaandGram-negativebacteria.

Beta-lactamantibioticspreventthebacterialcellwallfromformingbyinterfering

withthefinalstageofpeptidoglycansynthesis.Theyinhibittheactivityof

transpeptidaseenzymes,whichcatalysecross-linkageoftheglycopeptide

polymerunitsthatformthecellwall.Theyexertabactericidalactionbutcause

lysisofgrowingcellsonly.

Clavulanicacidisoneofthenaturallyoccurringmetabolitesofthe

streptomyceteStreptomycesclavuligerus.Ithasastructuralsimilaritytothe

penicillinnucleus,includingpossessionofabeta-lactamring.Clavulanicacidis

abeta-lactamaseinhibitoractinginitiallycompetitivelybutultimatelyirreversibly.

Clavulanicacidwillpenetratethebacterialcellwallbindingtobothextracellular

andintracellularbeta-lactamases.

Amoxicillinissusceptibletobreakdownby 

-lactamaseandtherefore

combinationwithaneffectiveß-lactamaseinhibitor(clavulanicacid)extendsthe

rangeofbacteriaagainstwhichitisactivetoinclude 

-lactamaseproducing

species.

Invitropotentiatedamoxicillinisactiveagainstawiderangeofclinically

importantaerobicandanaerobicbacteriaincluding:

Gram-positive:

Staphylococci(including 

-lactamaseproducingstrains)

Clostridia

Streptococci

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Gram-negative:

Escherichiacoli(includingmost 

-lactamaseproducingstrains)

Campylobacterspp

Pasteurellae

Proteusspp

ResistanceisshownamongEnterobacterspp,Pseudomonasaeruginosaand

methicillin-resistant Staphylococcus aureus. Dogs diagnosed with

pseudomonasinfectionsshouldnotbetreatedwiththisantibioticcombination.

AtrendinresistanceofE.coliisreported

5.2 Pharmacokineticproperties

Amoxicilliniswell-absorbedfollowingoraladministration.Indogsthesystemic

bioavailabilityis60-70%.Amoxicillin(pKa2.8)hasarelativelysmallapparent

distributionvolume,alowplasmaproteinbinding(34%indogs)andashort

terminalhalf-lifeduetoactivetubularexcretionviathekidneys.Following

absorptionthehighestconcentrationsarefoundinthekidneys(urine)andthe

bileandtheninliver,lungs,heartandspleen.Thedistributionofamoxicillinto

thecerebrospinalfluidislowunlessthemeningesareinflamed.

Clavulanicacid(pK12.7)isalsowell-absorbedfollowingoraladministration.

Thepenetrationtothecerebrospinalfluidispoor.Theplasmaproteinbindingis

approximately25%andtheeliminationhalf-lifeisshort.Clavulanicacidis

heavilyeliminatedbyrenalexcretion(unchangedinurine).

Afteroraladministrationoftherecommendeddoseof12.5mgcombined

actives/kgtodogs,thefollowingparameterswereobserved:Cmaxof6.30+/-

0.45µg/ml,Tmaxof1.98+/-0.135handAUCof23.38+/-1.39µg/ml.hfor

amoxicillinandCmaxof0.87+/-0.1µg/ml,Tmaxof1.57+/-0.177hrsandAUC

of1.56+/-0.24mg/ml.hforclavulanicacid.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

CarmosineLake(E122)

SodiumStarchGlycollate

CopovidoneK24-36

MagnesiumStearate

MicrocrystallineCellulose

CalciumCarbonate

HeavyMagnesiumcarbonate

RoastBeefFlav-o-lok

6.2 Incompatibilities

Notapplicable.

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AN:01187/2011

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6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

Blisterpacks:2years

Tubs:6months

6.4 Specialprecautionsforstorage

Donotstoreabove25

C.Storeintheoriginalpackageinordertoprotectfrom

moisture.

6.5 Natureandcompositionofimmediatepackaging

Theproductissuppliedinhigh-densitypolyethylenetubswithapolyethylene

screwcaplidcontaining100and250tablets.Asachetofdesiccantisincluded

ineachcontainer.Theproductisalsopresentedinpacksof4,10and50

blisterstrips(aluminium-aluminium)eachcontaining5tabletsperstrip.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewith

nationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

Newry

Co.Down

BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm 02000/4222

9. DATEOFFIRSTAUTHORISATION

Date:5 th August2003

10. DATEOFREVISIONOFTHETEXT

Date:November2011