tempora

Main information

  • Trade name:
  • Tempora 100mg chewable tablets for dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Tempora 100mg chewable tablets for dogs
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • spironolactone
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0235/003
  • Authorization date:
  • 23-05-2012
  • EU code:
  • FR/V/0235/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

VeterinaryMedicinalProduct

TEMPORA100MGCHEWABLETABLETSFORDOGS

PARTIB

SUMMARYOFTHEPRODUCTCHARACTERISTICS

PharmaceuticalForm

ChewableTablet

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

TEMPORA100MGCHEWABLETABLETSFORDOGS

TEMPORAVET(NO)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onetabletcontains

Activesubstance:

Spironolactone............................................................100mg

Excipient(s):

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Chewabletablet

Clover-shapedscoredbeigetablet.Thetabletcanbedividedintofourequalparts

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Foruseincombinationwithstandardtherapy(includingdiureticsupport,wherenecessary)

forthetreatmentofcongestiveheartfailurecausedbydegenerativemitralvalvediseasein

dogs.

4.3 Contraindications

Donotuseinanimalsusedfororintendedforuseinbreeding.

Donotusetheproductindogssufferingfromhypoadrenocorticism,hyperkalaemiaor

hyponatraemia.

DonotadministerspironolactoneinconjunctionwithNSAIDstodogswithrenalinsufficiency.

Donotuseinthecaseofhypersensitivitytospironolactoneoranyoftheexcipients.

Seesection4.7.

4.4Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Kidneyfunctionandplasmapotassiumlevelsshouldbeevaluatedbeforeinitiatingcombined

treatmentwithspironolactoneandACEinhibitors.Unlikeinhumans,anincreasedincidence

ofhyperkalaemiawasnotobservedinclinicaltrialsperformedindogswiththiscombination.

However,indogswithrenalimpairment,regularmonitoringofrenalfunctionandplasma

potassiumlevelsisrecommendedastheremaybeanincreasedriskofhyperkalaemia.

DogstreatedconcomitantlywithspironolactoneandNSAIDsshouldbecorrectlyhydrated.

Monitoringoftheirrenalfunctionandplasmapotassiumlevelsisrecommendedbefore

initiationandduringtreatmentwithcombinedtherapy(see4.3).

Asspironolactonehasanantiandrogeniceffect,itisnotrecommendedtoadministerthe

producttogrowingdogs.

Asspironolactoneundergoesextensivehepaticbiotransformation,careshouldbetaken

whenusingtheproducttotreatdogswithhepaticdysfunction.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Maycauseskinsensitisation:personsknowntobeallergictospironolactoneorother

componentsoftheformulation,shouldnothandlethisproduct.

Handlethisproductwithgreatcaretoavoidunnecessaryexposure,takingallrecommended

precautions.

Washhandsafteruse.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedical

adviceandshowthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywith

breathingaremoreserioussymptomsandrequireurgentmedicalattention.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackage

leafletorthelabeltothephysician.

4.6Adversereactions(frequencyandseriousness)

Areversibleprostaticatrophyisoftenobservedinentiremaledogs.Vomitinganddiarrhoea

maycommonlyoccur.

4.7Useduringpregnancy,lactationorlay

Spironolactonehaddevelopmentaltoxicityinlaboratoryanimals.

Thesafetyoftheproducthasnotbeenassessedinpregnantandlactatingbitches.

Donotuseduringpregnancyandlactation

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Inclinicalstudies,theproductwasco-administeredwithACE-inhibitors,furosemideand

pimobendanwithoutevidenceofassociatedadversereactions.

Spironolactonedecreasesdigoxineliminationandhenceraisesdigoxinplasma

concentration.Asthetherapeuticindexfordigoxinisverynarrow,itisadvisabletomonitor

closelydogsreceivingbothdigoxinandspironolactone.

TheadministrationofeitherdeoxycorticosteroneorNSAIDswithspironolactonemayleadto

amoderatereductionofthenatriureticeffects(reductionofurinarysodiumexcretion)of

spironolactone.

ConcomitantadministrationofspironolactonewithACE-inhibitorsandotherpotassium-

sparingdrugs(asangiotensinreceptorblockers,ß-blockers,calciumchannelsblockers,

etc..)maypotentiallyleadtohyperkalaemia(see4.5).

SpironolactonemaycausebothinductionandinhibitionofcytochromeP450enzymesand

couldthereforeaffectthemetabolismofotherdrugsutilizingthesemetabolicpathways.

4.9 Amountstobeadministeredandadministrationroute

2mgofspironolactoneperkgofbodyweightoncedaily, i.e.1tabletper50kgofbody

weight,byoralroute.Theproductshouldbeadministeredwithmeal.

Dogweight(kg) TEMPORA100mg

Numberoftabletsperday

>6.0to12.5 ¼

>12.5to25.0 ½

>25.0to37.5 ¾

>37.5to50.0 1

>50.0to62.5 1¼

>62.5to75.0 1½

>75.0to87.0 1¾

Thetabletsareflavoured.Ifthedogdoesnotacceptthetabletfromhandorbowl,thenthe

tabletsmaybemixedwithasmallamountoffoodofferedpriortothemainmeal,or

administereddirectlyintothemouthafterfeeding.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Afteradministrationofupto5timestherecommendeddose(10mg/kg)tohealthydogs,

dose-dependentadverseeffectswerenoted,seesection4.6.

Incaseofanaccidentalmassiveingestionbyadog,thereisnospecificantidoteor

treatment.Itisthereforerecommendedtoinducevomiting,lavagethestomach(depending

onriskassessment)andmonitorelectrolytes.Symptomatictreatment,e.g.,fluidtherapy,

shouldbeprovided.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Aldosteroneantagonist.

ATCvetcode:QC03DA01

5.1 Pharmacodynamicproperties

Spironolactoneanditsactivemetabolites(including7 α-thiomethyl-spironolactoneand

canrenone)actasspecificantagonistsofaldosterone,andexerttheireffectsbybinding

competitivelytothemineralocorticoidreceptorlocatedinthekidneys,heartandblood

vessels.

Spironolactoneisanatriureticdrug(historicallydescribedasasoftdiuretic).Inthekidney,

spironolactoneinhibitsthealdosterone-inducedsodiumretentionleadingtoincreasein

sodiumandsubsequentlywaterexcretion,andpotassiumretention.Therenaleffectsof

spironolactoneanditsmetabolitesleadtoadecreaseinextracellularvolumeand

consequentlyinadecreaseofcardiacpreloadandleftatrialpressure.Theresultisan

improvementinheartfunction.

Inthecardiovascularsystem,spironolactonepreventsthedetrimentaleffectsofaldosterone.

Althoughtheprecisemechanismofactionisnotyetclearlydefined,aldosteronepromotes

myocardialfibrosis,myocardialandvascularremodellingandendothelialdysfunction.

Inexperimentalmodelsindogs,itwasshownthatlongtermtherapywithanaldosterone

antagonistpreventsprogressiveleftventricledysfunctionandattenuatesleftventricle

remodellingindogswithchronicheartfailure.

WhenusedincombinationwithACE-inhibitors,spironolactonemaycounteracttheeffectsof

“aldosteroneescape”.

Aslightincreaseinaldosteronebloodlevelsmaybeobservedinanimalsontreatment.This

isthoughttobeduetoactivationoffeedbackmechanismswithoutadverseclinical

consequence.Theremaybeadoserelatedhypertrophyoftheadrenalzonaglomerulosaat

highdoserates.

5.2Pharmacokineticparticulars

Thepharmacokineticsofspironolactonearebasedonitsmetabolites,astheparent

compoundisrapidlymetabolised.

Absorption

Indogs,oralbioavailabilityofspironolactoneasmeasuredbycanrenoneAUCswas83%

relativetotheivroute.Ithasbeenshownthatfeedingsignificantlyincreasestheoral

bioavailabilityofallmeasuredmetabolitesresultingfromdosingdogswithspironolactone.

Aftermultipleoraldosesof2mgspironolactoneperkgfor5consecutivedays,steady-state

conditionsarereachedbyday3andonlyaslightaccumulationofcanrenoneisobserved.

Afteroraladministrationofspironolactoneindogsat2mg/kg,meanCmaxof41ng/mLare

achievedfort heprimarymetabolites,canrenoneand7α-thiomethyl-spironolactone,after4

hours,respectively.

Distribution

Themeanapparentvolumeofdistributionduringeliminationphaseafteroraldosingindogs

was41L/kgforcanrenone.

Themeanresidencetimeofthemetabolitesrangesfrom11hours.

Theproteinbindingisabout90%.

Metabolism

Spironolactoneisrapidlyandcompletelymetabolisedbytheliverintoitsactivemetabolites,

canrenone,7α-thiomethyl-spironolactoneand6β-hydroxy-7 

-thiomethyl-spironolactone,

whicharetheprimarymetabolitesinthedog.

Elimination

Spironolactoneismainlyexcretedviaitsmetabolites.Plasmaclearanceofcanrenoneis3

L/h/kgforcanrenone,indogs.Afteroraladministrationofradiolabelledspironolactonetothe

dog,66%ofthedoseisrecoveredinfaecesand12%intheurine.74%ofthedoseis

excretedwithin48hours

Environmentalproperties

Notapplicable

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Artificialchickenflavour

Yeast

CrospovidonetypeA

Sodiumlaurylsulfate

Maltodextrine

Magnesiumstearate

Silica,colloidalanhydrous

Silicifiedmicrocrystallinecellulose

Lactosemonohydrate

6.2Incompatibilities

None

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:36months

Shelf-lifeafterfirstopeningtheimmediatepackaging:72hours

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Storeinoriginalpackage

Anypart-usedtabletshouldbereturnedtotheopenedblisterandusedwithin72hours

6.5Natureandcompositionofimmediatepackaging

(PA-AL-PVC –aluminiumheatsealed)containing8 tabletsperblister

Cardboardboxof8tabletscontaining1blisterof8tablets

Cardboardboxof16tabletscontaining2blistersof8tablets

Cardboardboxof24tabletscontaining3blistersof8tablets

Cardboardboxof56tabletscontaining7blistersof8tablets

Cardboardboxof80tabletscontaining10blistersof8tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

SOGEVAL

200AVENUEDEMAYENNE

ZONEINDUSTRIELLEDESTOUCHES

53000LAVAL

FRANCE

Tel:33243495151

Fax:33243539700

E-mail: sogeval@sogeval.fr

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobecompletedinaccordancewithnationalrequirements

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FDA - U.S. Food and Drug Administration

20-7-2016

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Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

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Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

23-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of   recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to  Connector Separation Causing Potential for Loss of Pacing. Find out  more:  https://go.usa.gov/xPHxF  #FDA #MedicalDe

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDe

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDevice pic.twitter.com/negJ6HU4x2

FDA - U.S. Food and Drug Administration

19-9-2018

Targretin (Eisai GmbH)

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Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

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Europe -DG Health and Food Safety