Zitac

Main information

  • Trade name:
  • Zitac vet 50 mg tablet for dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Zitac vet 50 mg tablet for dogs
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • cimetidine
  • Therapeutic area:
  • Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0119/001
  • Authorization date:
  • 29-04-2011
  • EU code:
  • NL/V/0119/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

I.B. SUMMARYOFPRODUCTCHARACTERISTICS,LABELANDPACKAGE

LEAFLET

I.B.1. SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Zitac vet50mgtabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:cimetidine50mgpertablet.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet.

Oblongtablets,scoredonbothsides.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Symptomatictreatmentforthereductionofvomitingassociatedwithchronicgastritisin

dogs.

4.3 Contraindications

None

4.4 Specialwarningsforeachtargetspecies

Treatmentwithcimetidineissymptomaticonlyanddoesnotresultinresolutionof

histopathologicalchangesassociatedwithgastritis.Itisrecommendedthatdogsshowing

persistentvomitingshouldundergoappropriateinvestigationstodiagnosetheunderlying

causebeforestartingtreatment.Thisisespeciallyimportantinolderanimals.Thereduction

ofgastricaciditycausedbycimetidinemaycontributetobacterialovergrowthandantigenic

stimulation.

4.5 Specialprecautionsforuse

i) Specialprecautionsforuseinanimals

Incaseofrenaldysfunction,adjustmentofthedosemayberequiredastheclearanceof

cimetidinemaybedecreased.Iftheresponsetotreatmentispoorwithin15days,the

diagnosisandtreatmentplanshouldbere-evaluated.

ii) Specialprecautionstobetakenbythepersonadministeringthemedicinalproducttoanimals

None.

4.6 Adversereactions(frequencyandseriousness)

Transientandself-resolvingslightswellingofmammaryglandsmaybeobservedinfemale

dogs(gynaecomastia;anti-androgenicactivity).Areductionofprostateweightwasalso

observedinmaleratsanddogs,withnoimpactonreproductiveperformances;thiseffect

wasreversible.Nootherundesirableeffectswerereported.

4.7 Useduringpregnancyandlactation

Theuseoftheproductduringpregnancyandlactationinthetargetspecieshasnotbeen

investigated.

Therefore,useoftheveterinarymedicinalproductduringpregnancyandlactationshouldbe

basedonariskbenefit-assessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

DuetoinhibitionofcytochromeP-450activitybycimetidine,themetabolismand

eliminationofsomedrugscanbereduced.Clinicallyrelevantinteractionsmayoccurwith

compoundshavinganarrowtherapeuticindex,e.g.beta-blockers,calciumchannelblockers,

benzodiazepines,barbiturates,phenytoin,theophylline,aminophylline,warfarinand

lidocaine.Dosesofsuchdrugsmayneedtobereducedwhenadministeredconcomitantly

withcimetidine.

TheincreasedgastricpHresultingfromcimetidineadministrationmayleadtoreduced

absorptionofdrugsrequiringanacidmediumforabsorption.Itisrecommendedthatatleast

2hoursshouldelapsebetweenadministrationofcimetidineandaluminiumormagnesium

hydroxide,metoclopramide,digoxinorketoconazolewhenpossible.”

4.9 Amount(s)tobeadministeredandadministrationroute

Doseandrouteofadministration:5mgofcimetidineperkgofbodyweightadministered

threetimesdailybytheoralroute(seeindicativetablebelow).Theconcomitantuseof

appropriatedietarymeasuresisstronglyrecommended.Inclinicaltrialstheefficacyof

cimetidinehasonlybeenstudiedconcomitantlywithahypoallergenicdiet.

Table:NumberofZitacvet50mgtabletstobeadministeredthreetimesdailyaccordingto

bodyweight.

Weight(kg) NumberofZitacvet

50mgtablets

0 to 5 ½

6 to 10 1

Recommendedtreatmentscheme:reductionofvomitingisachievedinabout2weeks.

Animalsshouldhoweverbetreatedforatleast2weeksaftertheremissionofclinicalsigns,

soaminimumtreatmentdurationof28daysisusuallynecessaryandtherefore

recommended.Ifconsideredsuccessful,medicationshouldbewithdrawnfor2weeks.If

vomitingoccursagain,treatmentcanbere-initiatedwithoutriskofintolerance.

Dependingontheresponse,treatmentcanbeadaptedtotheindividualanimaluntilthe

responseisconsideredtobeadequateandcontinued.Dietarymeasuresshouldalwaysbe

maintained.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

AcuteexposuretocimetidineyieldedLD

valuesabove2600mg/kg,i.e.over170timesthe

recommendeddailydosageindogs.Atargetanimalsafetystudydemonstratedthatthe

productadministeredorallyat75mgcimetidine/kg/day(fivetimestherecommendeddaily

dose)foraperiodof91dayswaswelltoleratedbydogs.

Nosignsofoverdoseareknown.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Activeingredient:cimetidine.

Pharmacotherapeuticgroup:H

-receptorantagonists,ATCvetcode:QA02BA01.

5.1 Pharmacodynamicproperties

CimetidineisanantagonistofthehistamineH

-receptorspresentinthegastricparietalcells.

StimulationofH

-receptorsbyhistamineactivatesgastricacidsecretion.Cimetidine,viaits

antagonisticpropertiestowardhistamineH

-receptors,stronglyreducesgastricacid

secretion.Thismayresultinthediminutionofgastricirritationandsubsequentvomiting

duringchronicgastritis.Noaccompanyingimprovementintheinflammatorystatusofthe

gastricmucosawasobservedindogs.

5.2 Pharmacokineticparticulars

Afteroraladministrationoftheproductatadoserateof5mg/kgbodyweighttofasteddogs,

maximalplasmalevelsofapproximately2µg/mlarereachedafter1.5hourspost-

administration.Bioavailabilityisabout95%.Theextentofabsorptionofcimetidineindogs

isdelayedandreducedbyapproximately40%inthepresenceoffood(C

maxfasted 2.94

mcg/ml,C

maxfed 1.12mcg/ml,AUC

0-∞fasted 8.23mcg.h/mlandAUC

0-∞fed 5.43mcg.h/ml).

However,thisdoesnotaffecttheefficacyoftreatment

Theplasmahalf-lifeofcimetidineisapproximately2hoursatadosageof5mg/kg.

Cimetidineisrapidlyandalmostcompletelyexcretedintotheurine.Nodrugaccumulation

occursafterrepeatedoraltreatmentat5mg/kgthreetimesdailyover30consecutivedays.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Lactosemonohydrate

Microcrystallinecellulose

Maizestarchpregelatinised

SodiumstarchglycolatetypeA

Magnesiumstearate

6.2 Incompatibilities

Notapplicable

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years

6.4 Specialprecautionsforstorage

Storetheblistersintheoriginalpackagetoprotectfromlight.Remainingtablethalves

shouldbestoredintheoriginalblisterpocketinordertoprotectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Thetabletsarepackedinpush-throughblisters(whiteopaquePVC/Aluminiumfoil)inanouter

printedcartonbox.

Authorisedpacksizes:

Cartonboxcontaining30tablets(3blisterwith10tabletsperblister)

Cartonboxcontaining100tablets(10blisterwith10tabletsperblister)

Notallpacksizesmaybemarketed

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materials,derivedfromtheuseofsuchproducts,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

IntervetInternationalBV

P.O.Box31

5830AABoxmeer

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER(S)

Tobespecifiedlater.

9. DATEOFFIRSTAUTHORISATION

Tobecompletedlocally.

10. DATEOFREVISIONOFTHETEXT

April2011

11. PROHIBITIONOFSALE,SUPPLYAND/ORUSE

None.

I.B.2. PACKAGING,LABELLINGANDPACKAGELEAFLET

LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

CartonBoxZitacvet50mgtablets

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Zitacvet50mgtabletsfordogs

Cimetidine

2. STATEMENTOFACTIVESANDOTHERSUBSTANCES

Cimetidine50mgpertablet.

3. PHARMACEUTICALFORM

Tablet.

4. PACKAGESIZE

30tablets

100tablets

5. TARGETSPECIES

Dogs.

6. INDICATION(S)

Symptomatictreatmentforthereductionofvomitingassociatedwithchronicgastritisindogs.

7. METHODANDROUTE(S)OFADMINISTRATION

Oral,5mg/kgbodyweightthreetimesdaily.

Readpackageleafletbeforeuse

8. WITHDRAWALPERIOD

Notapplicable.

9. SPECIALWARNING(S),IFNECESSARY

Readpackageleafletbeforeuse

10. EXPIRYDATE

Exp:(Month/Year)

11. SPECIALSTORAGECONDITIONS

Storetheblistersintheoriginalpackagetoprotectfromlight.Remainingtablethalvesshouldbe

storedintheoriginalblisterpocketinordertoprotectfromlight.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”,ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly–tobesuppliedonlyonveterinaryprescriptions.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

IntervetInternationalB.V.

P.O.Box31

5830AABoxmeer

TheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

MAnumber.

17. MANUFACTURER’SBATCHNUMBER

Batchnumber.

MINIMUMPARTICULARSTOAPPEARONBLISTERSORSTRIPS

BlisterZitacvet50mgtablets

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Zitacvet50mgtabletsfordogs.

Cimetidine.

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

IntervetInternationalB.V.

3. EXPIRYDATE

Exp:(Month/Year)

4. BATCHNUMBER

Batchnumber.

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly

PACKAGELEAFLETFORZitacvet50mgtabletsfordogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

IntervetInternationalB.V.

P.O.Box31

5830AABoxmeer

TheNetherlands

Manufacturerforthebatchrelease:

IntervetGesmbH

Siemensstrasse107

1210Vienna

Austria

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Zitacvet50mgtabletsfordogs.

Cimetidine

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENTS

Cimetidine50mgpertablet.

4. INDICATION(S)

Symptomatictreatmentforthereductionofvomitingassociatedwithchronicgastritisindogs.

5. CONTRAINDICATION(S)

None.

6. ADVERSEREACTIONS

Transientandself-resolvingslightswellingofmammaryglandsmaybeobservedinfemaledogs

(gynaecomastia;anti-androgenicactivity).Areductionofprostateweightwasalsoobservedin

maleratsanddogs,withnoimpactonreproductiveperformances;thiseffectwasreversible.No

otherundesirableeffectswerereported.Ifyounoticeanyseriouseffectsorothereffectsnot

mentionedinthisleaflet,pleaseinformyourveterinarysurgeon.

7. TARGETSPECIES

Dogs.

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF

ADMINISTRATION

Doseandrouteofadministration:5mgofcimetidineperkgofbodyweightadministeredthree

timesdailybytheoralroute.Theconcomitantuseofappropriatedietarymeasuresisstrongly

recommended.Inclinicaltrialstheefficacyofcimetidinehasonlybeenstudiedconcomitantlywith

ahypoallergenicdiet.

Table:NumberofZitacvet50mgtabletstobeadministeredthreetimesdailyaccordingtobody

weight.

Weight(kg) NumberofZitacvet

50mgtablets

0 to 5 ½

6 to 10 1

Recommendedtreatmentscheme:reductionofvomitingisachievedinabout2weeks.Animals

shouldhoweverbetreatedforatleast2weeksaftertheremissionofclinicalsigns,soaminimum

treatmentdurationof28daysisusuallynecessaryandthereforerecommended.Ifconsidered

successful,medicationshouldbewithdrawnfor2weeks.Ifvomitingoccursagain,treatmentcan

bere-initiatedwithoutriskofintolerance.

Dependingontheresponse,treatmentcanbeadaptedtotheindividualanimaluntiltheresponseis

consideredtobeadequateandcontinued.Dietarymeasuresshouldalwaysbemaintained.

9. ADVICEONCORRECTADMINISTRATION

None.

10. WITHDRAWALPERIOD

Notapplicable.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Storetheblistersintheoriginalpackagetoprotectfromlight.Remainingtablethalvesshouldbe

storedintheoriginalblisterpocketinordertoprotectfromlight.

Donotuseafterexpirydatewhichisstatedonthecarton

12. SPECIALWARNINGS

Treatmentwithcimetidineissymptomaticonlyanddoesnotresultinresolutionof

histopathologicalchangesassociatedwithgastritis.Itisrecommendedthatdogsshowingpersistent

vomitingshouldundergoappropriateinvestigationstodiagnosetheunderlyingcausebefore

startingtreatment.Thisisespeciallyimportantinolderanimals.Thereductionofgastricacidity

causedbycimetidinemaycontributetobacterialovergrowthandantigenicstimulation.

Iftheresponsetotreatmentispoorwithin15days,thediagnosisandtreatmentplanshouldbere-

evaluated.

Incaseofrenaldysfunction,adjustmentofthedosemayberequiredastheclearanceofcimetidine

maybedecreased.

Theuseoftheproductduringpregnancyandlactationinthetargetspecieshasnotbeen

investigated.Therefore,useoftheveterinarymedicinalproductduringpregnancyandlactation

shouldbebasedonarisk-benefit-assessmentbytheresponsibleveterinarian.

DuetoinhibitionofcytochromeP-450activitybycimetidine,themetabolismandeliminationof

somedrugscanbereduced.Clinicallyrelevantinteractionsmayoccurwithcompoundshavinga

narrowtherapeuticindex,e.g.beta-blockers,calciumchannelblockers,benzodiazepines,

barbiturates,phenytoin,theophylline,aminophylline,warfarinandlidocaine.Dosesofsuchdrugs

mayneedtobereducedwhenadministeredconcomitantlywithcimetidine.

TheincreasedgastricpHresultingfromcimetidineadministrationmayleadtoreducedabsorption

ofdrugsrequiringanacidmediumforabsorption.Itisrecommendedthatatleast2hoursshould

elapsebetweenadministrationofcimetidineandaluminiumormagnesiumhydroxide,

metoclopramide,digoxinorketoconazolewhenpossible.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

April2011

15. OTHERINFORMATION

Presentations:

Cartonboxcontaining30tablets(3blisterwith10tabletsperblister)

Cartonboxcontaining100tablets(10blisterwith10tabletsperblister)

Notallpacksizesmaybemarketed

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentative

ofthemarketingauthorisationholder.

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