Nisamox Palatable Tablets 500mg

Main information

  • Trade name:
  • Nisamox Palatable Tablets 500mg
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Nisamox Palatable Tablets 500mg
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ampicillin and enzyme inhibitor
  • Therapeutic area:
  • Dogs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0246/001
  • Authorization date:
  • 20-10-2011
  • EU code:
  • UK/V/0246/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NameoftheVeterinaryMedicinalProduct

NisamoxPalatableTablets500 mgforDogs

NisamoxTablets400mg/100mgforDogs(France)

2. QualitativeandQuantitativeComposition

Eachtabletcontains:

ActiveIngredients:

Amoxicillin(asamoxicillintrihydrate) 400 mg

Clavulanicacid(aspotassiumclavulanate) 100 mg

ColouringAgent:

CarmoisineLake(E122) 2.45 mg

Forafulllistofexcipients,seeSection6.1.

3. PharmaceuticalForm

Tablet.Pinkdivisiblecirculartabletwithscorelineononefaceandfigure

500 embossedonopposingface.Thetabletcanbedividedintoequalhalves.

4. ClinicalParticulars

4.1 TargetSpecies:

Dogs

4.2 IndicationsforUse, Specifying theTargetSpecies:

Treatmentofthefollowinginfectionscausedbybeta-lactamaseproducing

strainsofbacteriasensitiveto amoxicillinincombinationwithclavulanicacid:

-Skininfections(includingsuperficialanddeeppyodermas)causedby

susceptibleStaphylococci.

-Urinary tract infections causedbysusceptibleStaphylococcior

Escherichiacoli.

-RespiratoryinfectionscausedbysusceptibleStaphylococci.

-EnteritiscausedbysusceptibleEscherichiacoli.

Itisrecommendedtocarryoutsuitabletestsforsensitivitywheninitiatingthe

treatment.Thetreatmentshouldonlyproceedifsensitivityisproventothe

combination.

4.3 Contraindications:

Donotuseinanimalswithknowncasesofhypersensitivitytopenicillinsor

othersubstancesofthebeta-lactamgroup.

Donotuseinrabbits,guineapigs,hamstersorgerbils.

Donotuseinanimalswithseriousdysfunctionofkidneysaccompaniedby

anuriaoroliguria.

Donotusewhereresistanceto thecombinationisknownto occur

4.4 SpecialWarningsforEachTargetSpecies

None.

4.5 SpecialPrecautionsforUse:

(i)Specialprecautionsforuseinanimals:

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteria

resistanttoamoxicillin/clavulanicacid.

Inanimalswithhepaticandrenalfailure,thedosingregimenshouldbe

carefullyevaluated.

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialpolicies.Narrowspectrum

antibacterialtherapyshouldbeusedforfirstlinetreatmentwhere

susceptibilitytestingsuggestslikelyefficacyofthisapproach.

Cautionisadvisedintheuseinsmallherbivoresotherthanthosein4.3.

Donotadministerto horsesandruminatinganimals.

(ii)Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproductto animals:

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)following

injection,inhalation,ingestionorskincontact.Hypersensitivitytopenicillins

mayleadtocrossreactionstocephalosporinsandviceversa.Allergic

reactionsto thesesubstancesmayoccasionallybeserious.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommended

precautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshould

seekmedicaladviceandshowthedoctorthiswarning.Swellingoftheface,

lipsoreyesordifficultywithbreathingaremoreserioussymptomsand

requireurgentmedicalattention.

Washhandsafteruse.

4.6 AdverseReactions(frequencyand seriousness):

Hypersensitivityunrelatedtodosecanoccurwiththeseagents.

Gastrointestinal symptoms (diarrhoea, vomiting) may occur after

administrationoftheproduct.

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

Incaseofoccurrenceofallergicreaction,thetreatmentshouldbewithdrawn.

4.7 UseDuring Pregnancy, LactationorLay:

Studiesinlaboratoryanimalshavenotproducedanyevidenceofteratogenic

effects.Useonlyaccordingtotherisk/benefitassessmentbytheresponsible

veterinarian.

4.8 InteractionswithOtherMedicinalProductsandOtherFormsof

Interaction:

Phenicols,macrolides,sulfonamidesandtetracyclinesmayinhibitthe

antibacterialeffectofpenicillinbecauseoftherapidonsetofbacteriostatic

action.

Thepotentialforallergiccross-reactivitywithotherpenicillinsshouldbe

considered.

Penicillinsmayincreasetheeffectsofaminoglycoside.

4.9 Amountsto beAdministered and Administration:

Administrationisviatheoralroute.Thedosagerateis12.5mgcombined

actives/kgbodyweighttwicedaily.Thetabletsmaybecrushedandaddedtoa

littlefood.

Thefollowingtableisintendedasaguidetodispensingtheproductatthe

standarddoserateof12.5 mg/kgtwicedaily.

Bodyweight(kg) Numberoftablets(500 mg)perdosetwicedaily

20 kg ½

40 kg 1

60 kg 1½

80 kg 2

Durationoftherapy:

Routinecasesinvolvingallindications:Themajorityofcasesrespondto

between5 and7 daystherapy.

Chronicorrefractorycases:Inthesecaseswherethereisconsiderabletissue

damage,alongercourseoftherapymayberequiredinthatitallowssufficient

timefordamagedtissuetorepair.

4.10 Overdose(Symptoms,EmergencyProcedures,Antidotes)ifnecessary:

Noadverseeffectshavebeenreportedafterthedailyadministrationof3times

therecommendeddosefor8days,andafterthedailyadministrationofthe

recommendeddosefor21 days.

4.11 WithdrawalPeriod(s):

Notapplicable

5. PharmacologicalProperties

Pharmacotherapeuticgroup:Anti-infectiveforsystemicuse:amoxicillin

andenzymeinhibitor.

ATCvetcode:QJ01CR02

5.1 Pharmacodynamicproperties:

Amoxicillinisabeta-lactamantibioticanditsstructurecontainsthebeta-

lactamringandthiazolidineringcommontoallpenicillins.Amoxicillin

showsexcellentactivityagainstsusceptibleGram-positivebacteriaandGram-

negativebacteria.

Beta-lactamantibioticspreventthebacterialcellwallfromformingby

interferingwiththefinalstageofpeptidoglycansynthesis.Theyinhibitthe

activityoftranspeptidaseenzymes,whichcatalysecross-linkageofthe

glycopeptidepolymerunitsthatformthecellwall.Theyexertabactericidal

actionbutcauselysisofgrowingcellsonly.

Clavulanicacidisoneofthenaturallyoccurringmetabolitesofthe

streptomyceteStreptomycesclavuligerus.Ithasastructuralsimilaritytothe

penicillinnucleus,includingpossessionofabeta-lactamring.Clavulanicacid

isabeta-lactamaseinhibitoractinginitiallycompetitivelybutultimately

irreversibly.Clavulanicacidwillpenetratethebacterialcellwallbindingto

bothextracellularandintracellularbeta-lactamases.

Amoxicillinissusceptibletobreakdownby 

-lactamaseandtherefore

combinationwithaneffectiveß-lactamaseinhibitor(clavulanicacid)extends

therangeofbacteriaagainstwhichitisactivetoinclude 

-lactamase

producingspecies.

Invitropotentiatedamoxicillinisactiveagainstawiderangeofclinically

importantaerobicandanaerobicbacteriaincluding:

Gram-positive:Staphylococci(includingβ-lactamaseproducingstrains).

Gram-negative:Escherichiacoli(includingmostβ-lactamaseproducing

strains).

Resistanceisshownamongmethicillin-resistantStaphylococcusaureus.

DogsdiagnosedwithPseudomonasinfectionsshouldnotbetreatedwiththis

antibioticcombination.AtrendinresistanceofE. coliisreported.

5.2 PharmacokineticParticulars:

Amoxicilliniswell-absorbedfollowingoraladministration.Indogsthe

systemicbioavailabilityis60-70%.Amoxicillin(pKa2.8)hasarelatively

smallapparentdistributionvolume,alowplasmaproteinbinding(34%in

dogs)andashortterminalhalf-lifeduetoactivetubularexcretionviathe

kidneys.Followingabsorptionthehighestconcentrationsarefoundinthe

kidneys(urine)andthebileandtheninliver,lungs,heartandspleen.The

distributionofamoxicillintothecerebrospinalfluidislowunlessthe

meningesareinflamed.

Clavulanicacid(pKa2.7)isalsowell-absorbedfollowingoraladministration.

Thepenetrationtothecerebrospinalfluidispoor.Theplasmaproteinbinding

isapproximately25%andtheeliminationhalf-lifeisshort.Clavulanicacidis

heavilyeliminatedbyrenalexcretion(unchangedinurine).

Afteroraladministrationofthe50mgpresentationattherecommendeddose

of12.5mgcombinedactives/kgtodogs,thefollowingparameterswere

observed:Cmaxof6.30+/-0.45µg/ml,Tmaxof1.98+/-0.135handAUCof

23.38+/-1.39µg/ml.hforamoxicillinandCmaxof0.87+/-0.1µg/ml,Tmax

of1.57 +/-0.177hrsandAUCof1.56 +/-0.24mg/ml.hforclavulanicacid.

6. PharmaceuticalParticulars

6.1 ListofExcipient(s)

LakeCarmosine(E122)

SodiumStarchGlycolate(typeA)

Copovidone

MagnesiumStearate

Cellulose,microcrystalline

SiliconDioxide

CalciumCarbonate

MagnesiumCarbonate,heavy

RoastBeefFlavour

6.2 Incompatibilities

Notapplicable.

6.3 Shelf-Life:

Shelf-lifeofveterinaryproductaspackagedforsale:2 years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:24hours.

Anydividedtabletportionremainingafter24 hoursshouldbediscarded.

6.4 SpecialPrecautionsforStorage:

Donotstoreabove25

C.Storeinadryplace.Dividedtabletsshouldbe

storedintheblisterpack.

6.5 Natureand CompositionofImmediatePackaging:

Theproductispresentedasfollows:

Aluminium/aluminiumblisterstrips,eachcontaining5tablets.Cartonsof10,

20, 25 and100 tablets.Notallpack sizesmaybemarketed.

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinaryMedicinal

ProductsorWasteMaterialsDerivedfromtheUseofSuchProductsif

appropriate:

Anyunusedproductorwastematerialshouldbedisposedofinaccordance

withnationalrequirements.

7. MarketingAuthorisationHolder

Norbrook LaboratoriesLimited

StationWorks

CamloughRoad

Newry

Co. Down,BT356JP

NorthernIreland

8. MarketingAuthorisationNumber

Vm02000/4260

9. DateofFirstAuthorisation

June2006

10. DateofRevisionofText

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

NotApplicable