Benazecare 20

Main information

  • Trade name:
  • Benazecare 20
  • Pharmaceutical form:
  • Film coated tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Benazecare 20
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • benazepril
  • Therapeutic area:
  • Dogs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0264/002
  • Authorization date:
  • 28-10-2011
  • EU code:
  • UK/V/0264/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:July2013

AN:00196/2013

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BenazecareFlavour20mgTabletsforDogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Eachtabletcontains20mgbenazeprilhydrochloride

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Beigeoblongtabletwithbreaklineonbothsides.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

Dogs:

Treatmentofcongestiveheartfailure.

4.3Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

Donotuseincasesofhypotension,hypovolaemia,hyponatraemiaoracute

renalfailure.

Donotuseincasesofcardiacoutputfailureduetoaorticorpulmonary

stenosis.

Donotuseduringpregnancyorlactation(section4.7).

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Noevidenceofrenaltoxicityoftheveterinarymedicinalproduct

hasbeenobservedindogsduringclinicaltrials,however,asis

routineincasesofchronickidneydisease,itisrecommendedto

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monitorplasmacreatinine,ureaanderythrocytecountsduring

therapy.

iiSpecialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Washhandsafteruse.

Incaseofaccidentaloralingestion,seekmedicaladvice

immediatelyandshowthelabelorthepackageleaflettothe

physician.

Pregnantwomenshouldtakespecialcaretoavoidaccidental

oralexposurebecauseangiotensinconvertingenzyme(ACE)

inhibitorshavebeenfoundtoaffecttheunbornchildduring

pregnancyinhumans.

4.6Adversereactions(frequencyandseriousness)

Indouble-blindclinicaltrialsindogswithcongestiveheartfailure,benazepril

hydrochloridewaswelltoleratedwithanincidenceofadversereactionslower

thanobservedinplacebo-treateddogs.

Asmallnumberofdogsmayexhibittransientvomiting,incoordinationorsigns

offatigue.

Indogswithchronickidneydisease,benazeprilhydrochloridemayincrease

plasmacreatinineconcentrationsatthestartoftherapy.Amoderateincreasein

plasmacreatinineconcentrationsfollowingadministrationofACEinhibitorsis

compatiblewiththereductioninglomerularhypertensioninducedbythese

agents,andisthereforenotnecessarilyareasontostoptherapyintheabsence

ofothersigns.

4.7Useduringpregnancy,lactationorlay

Donotuseduringpregnancyorlactation.Thesafetyofbenazepril

hydrochloridehasnotbeenestablishedinbreeding,pregnantorlactatingdogs.

Embryotoxiceffects(foetalurinarytractmalformation)wereseenintrialswith

laboratoryanimals(rats)atmaternallynon-toxicdoses.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Indogswithcongestiveheartfailure,benazeprilhydrochloridehasbeengiven

incombinationwithdigoxin,diuretics,pimobendanandanti-arrhythmic

veterinarymedicinalproductswithoutdemonstrableadverseinteractions.

Inhumans,thecombinationofACEinhibitorsandNon-SteroidalAnti-

InflammatoryDrugs(NSAIDs)canleadtoreducedanti-hypertensiveefficacyor

impairedrenalfunction.Thecombinationofbenazeprilhydrochlorideandother

anti-hypertensiveagents(e.g.calciumchannelblockers, β-blockersor

diuretics),anaestheticsorsedativesmayleadtoadditivehypotensiveeffects.

Therefore,concurrentuseofNSAIDsorothermedicationswithahypotensive

effectshouldbeconsideredwithcare.Renalfunctionandsignsofhypotension

(lethargy,weaknessetc)shouldbemonitoredcloselyandtreatedasnecessary.

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Interactionswithpotassiumpreservingdiureticslikespironolactone,triamterene

oramiloridecannotberuledout.Itisrecommendedtomonitorplasma

potassiumlevelswhenusingbenazeprilhydrochlorideincombinationwitha

potassiumsparingdiureticbecauseoftheriskofhyperkalaemia.

4.9Amountstobeadministeredandadministrationroute

BenazecareFlavour20mgtabletsshouldbegivenorallyoncedaily,withor

withoutfood.Thedurationoftreatmentisunlimited.

BenazecareFlavour20mgtabletsshouldbeadministeredorallyataminimum

doseof

0.25mg(range0.25-0.5)benazeprilhydrochloride/kgbodyweightoncedaily,

accordingtothefollowingtable:

BENAZECAREFLAVOUR20mg

Weightofdog

(kg) Standard

Dose Double

Dose

>20 –40

>40 –80 0.5tablet

1tablet 1tablet

2tablets

Thedosemaybedoubled,stilladministeredoncedaily,toaminimumdoseof

0.5mg/kg(range0.5-1.0),ifjudgedclinicallynecessaryandadvisedbythe

veterinarysurgeon.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Benazeprilhydrochloridereducederythrocytecountsinnormaldogswhen

dosedat150mg/kgbodyweightoncedailyfor12months,butthiseffectwas

notobservedattherecommendeddoseduringclinicaltrialsindogs.

Transientreversiblehypotensionmayoccurincasesofaccidentaloverdose.

Therapyshouldconsistofintravenousinfusionofwarmisotonicsaline.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:ACEInhibitors,plain.

ATCvetcode:QC09AA07

5.1Pharmacodynamicproperties

Benazeprilhydrochlorideisaprodrughydrolysedinvivotoitsactivemetabolite,

benazeprilat.BenazeprilatisahighlypotentandselectiveinhibitorofACE,thus

preventingtheconversionofinactiveangiotensinItoactiveangiotensinIIand

therebyalsoreducingsynthesisofaldosterone.Therefore,itblockseffects

mediatedbyangiotensinIIandaldosterone,includingvasoconstrictionofboth

arteriesand

veins,retentionofsodiumandwaterbythekidneyandremodellingeffects

(includingpathologicalcardiachypertrophyanddegenerativerenalchanges).

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Benazeprilhydrochloridecauseslong-lastinginhibitionofplasmaACEactivity,

withmorethan95%inhibitionatpeakeffectandsignificantactivity(>80%in

dogs)persisting24hoursafterdosing.

Benazeprilhydrochloridereducesthebloodpressureandvolumeloadonthe

heartindogswithcongestiveheartfailure.

5.2Pharmacokineticparticulars

Afteroraladministrationofbenazeprilhydrochloride,peaklevelsofbenazepril

areattainedrapidly(T

0.5hourindogs)anddeclinequicklyastheactive

substanceispartiallymetabolisedbyliverenzymestobenazeprilat.The

systemicbioavailabilityisincomplete(~13%indogs)duetoincomplete

absorption(38%indogs)andfirstpassmetabolism.

Indogs,peakbenazeprilatconcentrations(C

of37.6ng/mlafteradoseof

0.5mg/kgbenazeprilhydrochloride)areachievedwithaT

of1.25hours.

Benazeprilatconcentrationsdeclinebiphasically:theinitialfastphase(t

=1.7

hoursindogs)representseliminationoffreedrug,whiletheterminalphase

=19hoursindogs)reflectsthereleaseofbenazeprilatthatwasboundto

ACE,mainlyinthetissues.Benazeprilandbenazeprilatareextensivelybound

toplasmaproteins(85-90%),andintissuesarefoundmainlyintheliverand

kidney.

Thereisnosignificantdifferenceinthepharmacokineticsofbenazeprilatwhen

benazeprilhydrochlorideisadministeredtofedorfasteddogs.Repeated

administrationofbenazeprilhydrochlorideleadstoslightbioaccumulationof

benazeprilat(R=1.47indogswith0.5mg/kg),steadystatebeingachieved

withinafewdays(4daysindogs).

Benazeprilatisexcreted54%viathebiliaryand46%viatheurinaryroutein

dogs.Theclearanceofbenazeprilatisnotaffectedindogswithimpairedrenal

functionandthereforenoadjustmentofbenazeprilhydrochloridedoseis

requiredincasesofrenalinsufficiency.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Pregelatinizedstarch

Croscarmellosesodium

Castoroil,hydrogenated

Beefflavour201627

6.2Incompatibilities

Noneknown

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years

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Shelflifeafterfirstopeningtheimmediatepackaging:48hours.Anydividedtablet

portionremainingafter48hoursshouldbediscarded.

6.4Specialprecautionsforstorage

Donotstoreabove25

C.

Storeinadryplace.

Dividedtabletsshouldbestoredintheblisterpack.

Theblisterpackshouldbeinsertedbackintothecardboardbox.

6.5Natureandcompositionofimmediatepackaging

Aluminium/aluminiumblisterpackscontaining14tabletspackedinacardboard

boxwithapackageleaflet.BenazecareFlavour20mgtabletsaresuppliedin

packsof14,28,56or140tablets.Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

AnimalcareLtd

10GreatNorthWay

YorkBusinessPark

NetherPoppleton

York

YO266RB

8. MARKETINGAUTHORISATIONNUMBER

Vm 10347/4022

9. DATEOFFIRSTAUTHORISATION

Date:24August2011

10.DATEOFREVISIONOFTHETEXT

Date:July2013

Approved:26/07/2013