Libromide

Main information

  • Trade name:
  • Libromide 325 mg Tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Libromide 325 mg Tablets for Dogs
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Bromides
  • Therapeutic area:
  • Dogs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0400/001
  • Authorization date:
  • 28-09-2011
  • EU code:
  • UK/V/0400/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:June2013

AN:01432/2012

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Libromide325mgTabletsforDogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Potassiumbromide 325mg

ForfulllistofexcipientsseeSection6.1

3. PHARMACEUTICALFORM

Tablet.

Plainwhitecircularbiconvex9.5mmtabletwithasinglescoredlineononeface.

Thetabletscanbedividedintoequalhalves.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Ananti-epilepticagentforuseasanadjuncttophenobarbitalinthecontrolof

refractorycasesofepilepsyindogs.

4.3 Contraindications

Donotuseincasesofknownhypersensitivitytobromide,ortoanyofthe

excipients.

Donotuseindogswithsevererenalinsufficiency.

4.4 Specialwarningsforeachtargetspecies

Itisadvisablenottochangethedog’sdietduringtherapyduetotheeffectof

chlorideintakeonserumbromideconcentrations,seesection4.8.

4.5 Specialprecautionsforuse

i Specialprecautionsforuseinanimals

Donotabruptlydiscontinuetherapyasthismayprecipitate

seizures.

Incasesofrenalinsufficiency,inordertopreventbromide

accumulation(seesection5.2),administerareduceddoseof

Libromideandmonitorthedogclosely.

Areductioninchlorideintakecouldcausebromideintoxication

(seesection4.8).

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Administrationonanemptystomachmayinducevomiting.

Dogsweighinglessthan11kgcannotbeaccuratelydosedwith

therecommendedinitialdoserateof15mg/kgtwicedailyas

theminimumdoseachievablebydivisionoftheLibromide

325mgtabletis162.5mg,seesection4.9.

Potentiallyseveresideeffectscanbeassociatedwiththeuse

ofpotassiumbromideincats.

iiSpecialprecautionsforthepersonadministeringtheveterinary

medicinalproducttoanimals

Donothandlethisproductifyouarepregnant,thinkyouare

pregnantorifyouarebreastfeeding.

Donotusethisproductifyouhaveaknownsensitivityto

bromide.

Washhandsthoroughlyimmediatelyafterbreakingorhandling

anytablets.

Discontinuehandlingthisproductifyoudevelopanysignsof

skinirritation,includingitchiness,rash,peelingorflakingofskin

orredness.Incaseofirritationoftheskinoreyes,orincaseof

accidentalself-administration,seekmedicaladviceimmediately

andshowthepackageleafletorthelabeltothephysician.

Tothephysician:

Bromideintoxicationcanbetreatedbyadministrationofsodium

chlorideorasuitablechlorureticagent.

4.6 Adversereactions(frequencyandseriousness)

Commonlyreportedadversereactionsincludepolyuria/polydipsia,polyphagia,

vomiting,somnolence,ataxia(hindendweaknessandlossofcoordination),nausea

anderythematousdermatitis(bromiderash).Inrarecasestransientdiarrhoeamay

occur.

Dogsreceivingpotassiumbromideincombinationwithphenobarbitalwillcommonly

exhibitelevatedserumpancreaticlipaseimmunoreactivityconcentrations(cPLI)

whichmayormaynotbeassociatedwithclinicalsignsofpancreatitis.

Incasesofpancreatitisordermatitis,symptomatictreatmentmayberequired.

Uncommonadversereactionsalsoincludebehaviouralchangessuchasirritability

orrestlessness.

Adverseclinicalsignswhichmayappearindogsonhigherdosesoftherapyusually

disappearfollowingareductionindose.Ifthedogistoosedated,assesstheserum

concentrationsofbothbromideandphenobarbitaltodeterminewhetherthedoseof

eithershouldbereduced.

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Ifthedoseisreduced,measuretheserumbromideconcentrationtoensureit

remainswithinthetherapeuticrange.

4.7 Useduringpregnancy,lactationorlay

Safetyhasnotbeenestablishedduringpregnancyorlactationindogs.Although

therewasnoevidenceofreproductivetoxicityinlaboratoryanimals,bromidecan

crosstheplacentaandcasesofneonatalbromidetoxicityhavebeenreportedin

humans.Intheabsenceofspecificdata,continueduseduringpregnancyshould

besubjecttoabenefit/riskassessmentbytheresponsibleveterinarian.

Sincebromidemaybeexcretedintomilk,monitornursingpuppiesfor

somnolescence/sedativeeffects;ifnecessary,considerearlyweaning,oran

artificialsucklingmethod.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Bromideandchloridecompeteforre-absorptionbythekidneys.Increasingdietary

chloride(salt)intakewilldecreaserenalre-absorptionofbromide,causing

decreasedserumbromideconcentrations,whichcouldleadtoseizures.

Conversely,changingtoadietlowinchloridewillincreaseserumbromide

concentrations,whichcouldcausebromideintoxication(seesection4.10).

Loopdiuretics(e.g.furosemide)canincreasebromideexcretion,loweringserum

bromideconcentrations.

Administrationoffluidsordrugformulationscontainingchloridecanlowerserum

bromideconcentrations.

BromideissynergisticwithotherGABA-ergicdrugssuchasphenobarbital.

4.9 Amount(s)tobeadministeredandadministrationroute

Fororaluse.Administerwithfood.

Administertodogswithrefractoryepilepsy,whereseizurecontrolisunsatisfactory

despiteappropriatephenobarbitaltherapy,whenserumphenobarbital

concentrationsareatasteady-statewithinthetherapeuticrange.

Thedoseshouldbetitratedtotheindividualdogastherequireddosagewilldepend

onthenatureandseverityoftheunderlyingdisease.

Administerwithfoodataninitialdoseof15mg/kgbodyweighttwicedaily

(equivalenttoatotaldailydoseof30mg/kg).Twicedailyadministrationisadvised

inordertoreducetheriskofgastrointestinaldisturbances.Duetothe24dayhalf-

lifeofbromide,itcantakeseveralweeksormonthstoachievesteady-stateserum

concentrations.

Foratleastthefirstthreemonthsfollowingcommencementoftherapy,measure

serumbromideconcentrationsevery4weeks.Theexpectedtherapeuticserum

bromideconcentration(whenusedinconjunctionwithphenobarbital)is800to2000

µg/ml.Adjustmentstothedoseshouldbemadewithregardtothefrequencyof

seizures,thehalf-lifeofbromideandtheserumbromideconcentration.

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Longtermmonitoringofserumbromide(andassociatedphenobarbital)

concentrationsshouldbeperformedasclinicallyjustifiedbytheindividualcase.

Closemonitoringforsideeffectsisadvisableathigherserumbromide

concentrations.

Useindogswithabodyweightoflessthan11kgshouldbesubjecttoarisk/benefit

assessment,seesection4.5.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Clinicalsignsofbromidetoxicity,suchasataxia,somnolence,nauseaand

pancreatitismayoccurindogswhenahighdoseisadministered.

Ifoverdoseissuspected,immediatelyreducethedosage.Closelymonitorthe

serumbromideconcentrationinordertoestablishanappropriatetherapeutic

concentration.

Incasesofoverdose,ifnecessaryandappropriate,administer0.9%sodium

chloridesolutionintravenouslytoreduceserumbromideconcentrations.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Psycholeptics:otherhypnoticsandsedatives:

bromides.

ATCVetCode:QN05CM11.

5.1 Pharmacodynamicproperties

Potassiumbromideisahalideanticonvulsant.Bromidereplaceschlorideinallbody

fluids.Itcompeteswithchloridetransportacrossnervecellmembranesandinhibits

sodiumtransportandsocausesmembranehyperpolarisation.This

hyperpolarisationraisestheseizurethresholdandpreventsthespreadofepileptic

discharges.Bromidehaseffectsonactivetransportacrossglialcellmembranes

andaffectspassivemovementsofionsbycompetitionwithchlorideforanion

channelsinpost-synapticmembranesthatareactivatedbyinhibitory

neurotransmitters.ThispotentiatestheeffectofGABAwhichresultsinasynergistic

activityofbromidewithotherdrugsthathaveGABA-ergicactivity.

5.2 Pharmacokineticproperties

Thepharmacokineticsofpotassiumbromidehasbeenstudiedindogs.Thehalf-life

isapproximately24days.Duetothisextremelylonghalflife,itcantakeseveral

weeks/monthstoachievesteadystateconcentrations.Potassiumbromideiswell

absorbedorallywithpeakabsorptioninabout1.5hours.Onceingested,the

potassiumbromidesaltdissociates,andthebromideionisrapidlyabsorbedbythe

gastrointestinaltract.

Afterabsorption,thebromideionrapidlydistributes,asdoeschloride,throughout

theextra-cellularspaceandintocells.Chlorideisdistributedpassivelyacrossmost

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cellmembranesaccordingtothetrans-membranepotential,anditislikelythat

bromidedistributesinthesamemanner.Asthebromideconcentrationisincreased

inthebody,theconcentrationofchlorideisdecreasedindirectproportiontothe

increaseinbromide.

Bromideisnotmetabolisedbythebody,itentersandleavesthebodyonlyasthe

monovalentanion.Excretionofbromideismainlyviathekidneys,whereit

competeswithchloridefortubularreabsorption.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Lactosemonohydrate

Microcrystallinecellulose

Magnesiumstearate

Stearicacid

Saccharinsodium

6.2 Incompatibilities

Notapplicable.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelflifeafterfirstopeningtheimmediatepackaging:3months.

Useanyhalvedtabletwithin12hours.

6.4 Specialprecautionsforstorage

Donotstoreabove25°C.

Keepthetabletcontainertightlyclosedinordertoprotectfrommoisture.

6.5 Natureandcompositionofimmediatepackaging

Packsizes:100and500tablets.

White,polypropylenecontainerwithpolypropylene,childresistantclosure.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

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7. MARKETINGAUTHORISATIONHOLDER

DechraLimited

DechraHouse

JamageIndustrialEstate

Stoke-on-Trent

Staffordshire

ST71XW

8. MARKETINGAUTHORISATIONNUMBER

Vm

10434/4073

9. DATEOFFIRSTAUTHORISATION

Date:4February2010

10. DATEOFREVISIONOFTHETEXT

Date:June2013

APPROVED 27/06/13