DOPAMINE 160 MG/ML STERILE CONCENTRATE

Main information

  • Trade name:
  • DOPAMINE 160 MG/ML STERILE CONCENTRATE
  • Dosage:
  • 160 Mg/Ml
  • Pharmaceutical form:
  • Concentrate for Soln for Inf
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOPAMINE 160 MG/ML STERILE CONCENTRATE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0437/003/003
  • Authorization date:
  • 21-05-1986
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dopamine160 mg/mlSterileConcentrate

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each mlofconcentratecontains160mg dopaminehydrochloride.

Each 5 mlofconcentratecontains800mg ofdopaminehydrochloride.

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Concentrateforsolution forinfusion.

Ampoulescontaining aclearcolourlessorpaleyellowsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Dopamineisindicatedforthecorrection ofhaemodynamicimbalancepresentin:-

Acutehypotension orshock associated with myocardialinfarction, endotoxicsepticaemia, traumaand renalfailure.

Asan adjunctafteropen heartsurgery, wherethereispersistenthypotension aftercorrection ofhypovolaemia.

In chroniccardiacdecompensation asin congestivefailure.

4.2Posologyandmethodofadminstration

Dopamineisapotentdrug;itmustbediluted beforeadministration.

ADULTS

Whereappropriate, thecirculating blood volumemustberestored with asuitableplasmaexpanderorwholeblood,

priorto administration ofdopaminehydrochloride.

Begin infusion ofdopaminehydrochloridesolution atdosesof2.5 mcg/kg/min in patientswho arelikely to respond to

modestincrementsofheartforceand renalperfusion.

In moreseverecases, administration may beinitiated atarateof5mcg/kg/min and increased gradually in 5 to

10mcg/kg/min incrementsup to 20 to 50mcg/kg/min asneeded.Ifdosesin excessof50mcg/kg/min arerequired, itis

advisableto check urineoutputfrequently.

Should urinary flowbegin to decreasein theabsenceofhypotension, reduction ofdopaminedosageshould be

considered.Ithasbeen found thatmorethan 50%ofpatientshavebeen satisfactorily maintained ondoseslessthan

20mcg/kg/min.

In patientswho do notrespond to thesedoses, additionalincrementsofdopaminemay begiven in an effortto achieve

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Treatmentofallpatientsrequiresconstantevaluation oftherapy in termsofblood volume, augmentation ofcardiac

contractility, and distribution ofperipheralperfusion and urinary output.

Dosageofdopamineshould beadjusted according to thepatient’sresponse, with particularattentionto diminution of

established urineflowrate, increasing tachycardiaordevelopmentofnewdysrhythmiasasindicationsfordecreasing or

temporarily suspending thedosage.

CHILDREN

Thesafety and efficacy ofdopaminein paediatricpatientshasnotbeen established.

GERIATRIC

No variation in dosageissuggested forgeriatricpatients.However, closemonitoring issuggested forblood pressure,

urineflowand peripheraltissueperfusion.

4.3Contraindications

Dopamineshould notbeused in patientswith phaeochromocytomaorhyperthyroidism.

Dopamineshould notbeused in thepresenceofuncorrected arterialorventriculartachyarrhythmiasorventricular

fibrillation.

Cyclopropaneand halogenated hydrocarbon anaestheticsshould beavoided.

4.4Special warningsandprecautionsforuse

Warnings:

Dopamineshould notbeused in thepresenceofuncorrected tachyarrhythmiasorventricularfibrillation.Norshould it

beused in patientswith phaeochromocytomaorhyperthyroidism.Cyclopropaneand halogenated hydrocarbon

anaestheticsshould beavoided.

Patientswhohavebeen treated with MAOinhibitorspriorto dopamineshouldbegiven reduced doses;thestarting

doseshould beonetenth (1/10th)oftheusualdose.

Excessadministration ofpotassium-freesolutionsmay resultin significanthypokalaemia.

Theintravenousadministration ofthesesolutionscan causefluid and/orsoluteoverloading resulting in dilution of

serumelectrolyteconcentrations, overhydration, congested statesorpulmonary oedema.

Precautions:

Hypovolaemiashould becorrected wherenecessary priorto dopamineinfusion.Lowdosesshould beused in shock

dueto acutemyocardialinfarction.

Ifadisproportionaterisein diastolicpressure(i.e. amarked decreasein pulsepressure)isobserved, theinfusion rate

should bedecreased and thepatientsobserved carefully forfurtherevidenceofpredominantvasoconstriction activity,

unlesssuch an effectisdesired.

Patientswith ahistory ofperipheralvasculardiseaseshould beclosely monitored forany changesin colouror

temperatureoftheskin oftheextremities.Ifachangeofskin colourortemperatureoccursand isthoughtto bethe

resultofcompromisedcirculation to theextremities, thebenefitsofcontinued dopamineinfusion should beweighed

againsttherisk ofpossiblenecrosis.Thesechangesmay bereversed by decreasingtherateordiscontinuing the

infusion.IVadministration ofphentolaminemesylate5-10 mg may reversetheischaemia.

Dopaminehydrochloridein 5%dextroseinjection should beinfused into alargevein wheneverpossibleto preventthe

possibility ofinfiltration ofperivasculartissueadjacenttotheinfusion site.Extravasation may causenecrosisand

sloughing ofthesurrounding tissue.Ischaemiacan bereversed by infiltration oftheaffected areawith 10-15mlof

salinecontaining 5 to 10mg phentolaminemesylate.Asyringewith afinehypodermicneedleshould beused to

liberally infiltratetheischaemicareaassoon asextravasation isnoted.

Dopamineshould beused with extremecaution in patientsinhaling cyclopropaneorhalogenated hydrocarbon

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Dextrosesolutionsshould beused with caution in patientswith known subclinicalorovertdiabetesmellitus.

Astheeffectofdopamineon impaired renaland hepaticfunction isnotknown, closemonitoring isadvised.

Dopamineinfusion should bewithdrawn gradually, to avoid unnecessary hypotension.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

i) Anaesthetics

Themyocardiumissensitised by theeffectofdopamine, cyclopropaneorhalogenated hydrocarbon anaesthetics, and

theseshould beavoided. Thisinteractionappliesboth to pressoractivity and cardiacbetaadrenergicstimulation.

ii) Alpha and Beta Blockers

Thecardiaceffectsofdopamineareantagonised byß-adrenergicblocking agentssuchaspropanololand metoprolol,

and theperipheralvasoconstriction caused by high dosesofdopamineisantagonised by-adrenergicblocking agents.

Dopamine-induced renalandmesentericvasodilation isnotantagonised by eitherorß-adrenergicblocking agents,

but, in animals, isantagonised by haloperidolorotherbutyrophenones, phenothiazines, and opiates.

iii) MonoamineOxidase(MAO)Inhibitors

MAOinhibitorspotentiatetheeffectofdopamineand itsduration ofaction. Patientswho havebeen treated with

monoamineoxidase(MAO)inhibitorspriorto dopamineshould begiven reduced doses;thestarting doseshould be

onetenth (1/10 th

)oftheusualdose.

iv) Phenytoin

Administration ofI.V. phenytoin to patientsreceiving dopaminehasresulted in hypotension and bradycardia;some

cliniciansrecommend thatPhenytoin beused with extremecaution, ifatall, in patientsreceiving dopamine.

4.6Pregnancyandlactation

Usein Pregnancy:

Animalstudieshaveshown noevidenceofteratogeniceffectswith dopamine. However, theeffectofdopamineonthe

human foetusisunknown thereforethedrug should beused in pregnantwomen only when theexpected benefits

outweigh thepotentialrisk to thefoetus.

Usein Lactation:

Itisnotknownifdopamineisexcreted in breastmilk, norifthereisany effecton theinfant.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Adversereactionsto dopaminearerelated to itspharmacologicalaction.

MoreCommon ReactionsInclude:

Cardiovascular:Ectopicbeats, tachycardia, anginalpain, palpitation, hypotension, vasoconstriction.

Gastrointestinal:Nausea, vomiting.

NervousSystem:Headache.

Respiratory:Dyspnoea.

LessCommon Reactionsinclude:

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Cardiovascular:Aberrantconduction, bradycardia, widened QRScomplex, hypertension, gangrene, cardiac

arrhythmiashavebeen reported on rareoccasions.

Eyedisorders:Mydriasis.

Nervoussystem:Piloerection.

SeriousorLife-threatening Reactions:

Gangreneoffeethasoccurred following dosesof10-14 mcg/kg/min and higherin afewpatientswith pre-existing

vasculardisease.

4.9Overdose

Excessiveelevation ofblood pressureand vasoconstriction can occurdueto thealphaadrenergicactionsofdopamine,

especially in patientswith ahistoryofocclusivevasculardisease.Ifdesired, thiscondition can berapidly reversed by

dosereduction ordiscontinuing theinfusion, sincedopaminehasahalf-lifeoflessthan 2 minutesin thebody.

Should thesemeasuresfail, an infusion ofan alphaadrenergicblocking agente.g., phentolaminemesylateshould be

considered.

Dopamineattheinfusion sitecan causelocalvasoconstriction, hencethedesirability ofinfusing into alargevein.The

resulting ischaemiacan bereversed by infiltration oftheaffected areawith 10-15mlofsalinecontaining 5mg to 10mg

phentolaminemesylate.Asyringewith afinehypodermicneedleshould beused to liberallyinfiltratetheischaemic

areaassoon asextravasation isnoted.

AccidentalOverdosage:

Accidentaloverdosageasevidenced by excessiveblood pressureelevation can becontrolled by dosereduction or

discontinuing thedopamineinfusion forashortperiod, sincetheduration ofaction ofdopamineisshort.

Should thesemeasuresfail, an infusion ofphentolaminemesylateshould beconsidered.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Dopaminestimulatesadrenergicreceptorsofthesympatheticnervoussystem. Thedrug hasprincipally adirect

stimulatory effectonß

-adrenergicreceptors, butalso appearsto havean indirecteffectby releasing norepinephrine

fromitsstoragesites.

Dopaminealso appearsto acton specificdopaminergicreceptorsin therenal, mesenteric, coronary, and intracerebral

vascularbedsto causevasodilation.Thedrug haslittleorno effectonß

-adrenergicreceptors.

In I.V. dosesof0.5-2µg/kg perminute, thedrugactspredominantly on dopaminergicreceptors;in I.V. dosesof2-

10µg/kg perminute, thedrugalso stimulatesß

-adrenergicreceptors.In highertherapeuticdoses,-adrenergic

receptorsarestimulated and theneteffectofthedrug istheresultof-adrenergic,ß

-adrenergic,and dopaminergic

stimulation.Themain effectsofdopaminedepend on thedoseadministered.In lowdoses, cardiacstimulation and

renalvasculardilation occurand in largerdosesvasoconstriction occurs.Itisbelieved that-adrenergiceffectsresult

frominhibition oftheproduction ofcyclicadenosine-3’5’-monophosphate(cAMP)by inhibition oftheenzymeadenyl

cyclase, whereasß-adrenergiceffectsresultfromstimulation ofadenylcyclaseactivity.

5.2Pharmacokineticproperties

Absorption:

Orally administered dopamineisrapidly metabolisedin theG.I. tract.Following I.V. administration, theonsetof

action ofdopamineoccurswithin 5 minutes, and thedrug hasaduration ofaction oflessthan 10 minutes.

Distribution:

Thedrug iswidely distributed in thebody butdoesnotcrosstheblood-brain barrierto asubstantialextent.Itisnot

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Elimination:

Dopaminehasaplasmahalf-lifeofabout2 minutes.Dopamineismetabolised in theliver, kidneys, and plasmaby

monoamineoxidase(MAO)and catechol-0-methyltransferaseto theinactivecompoundshomovanillicacid (HVA)and

3,4-dihydroxyphenylaceticacid.In patientsreceiving MAOinhibitors, theduration ofaction ofdopaminemay beas

long as1 hour.About25%ofadoseofdopamineismetabolised to norepinephrinewithin theadrenergicnerve

terminals.

Dopamineisexcreted in urineprincipally asHVAand itssulphateand glucuronideconjugatesand as3,4-

dihydroxyphenylaceticacid.Avery smallfraction ofadoseisexcreted unchanged.Following administration ofradio

labelled dopamine, approximately 80%oftheradioactivity reportedly isexcreted in urinewithin 24 hours.

5.3Preclinical safetydata

Thereisno pre-clinicaldataofrelevanceto theprescriberwhich areadditionalto thatalready included in other

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiummetabisulphite

WaterforInjections

6.2Incompatibilities

SterileDopamineConcentrateshould notbeadded to any alkalineintravenoussolutions, i.e. SodiumBicarbonate.Any

solution which exhibitsphysicalorchemicalincompatibility through acolourchangeorprecipitateshould notbe

administered.

Itissuggested thatadmixturescontaining Gentamicin Sulphate, Cephalothin Sodium, Cephalothin SodiumNeutralor

Oxacillin Sodiumshould beavoided unlessallotherviablealternativeshavebeen exhausted.

AdmixturesofAmpicillinand Dopaminein 5%GlucoseSolution arealkalineand incompatibleand resultin

decompositionofboth drugs.They should notbeadmixed.

AdmixturesofDopamine, Amphotericin Bin 5%GlucoseSolution areincompatibleasaprecipitateformsimmediately

on mixing.

6.3ShelfLife

Aspackaged forsale: 3 years.

In-use: Following dilution in therecommended diluents(seeSection 6.6), chemicaland physicalin-usestability has

been demonstrated for48 hoursatatemperaturenotabove25°C.

However, fromamicrobiologicalpointofview, theproductshould beused immediately.Ifnotused immediately, in-

usestoragetimesand conditionspriorto usearetheresponsibility oftheuserand would normally notbelongerthan 24

hoursat2-8°Cunlessdilution hastaken placein controlled and validated asepticconditions.

6.4Special precautionsforstorage

Aspackaged forsale:Do notstoreabove30°C.Keepcontainerin theoutercarton.

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6.5Natureandcontentsofcontainer

Clear, typeI, glassampoules.Pack Size:5’s.

6.6Special precautionsfordisposalofausedmedicinal productorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Forsingleuse. Discard any unused contents.

Do notuseifthesolution isdiscoloured.

Preparation ofInfusion Solutions

Suggested Dilution

Aseptically transferDopamineSterileConcentrateinto theIVsolution asshown in thefollowing table:

Dopaminehydrochloridecan bediluted with;

SodiumChloride(0.9%)IntravenousInfusion

Dextrose(5%), sodiumchloride(0.45%)solution

SodiumLactateIntravenousInfusion, Compound (Hartmann’sSolution forInjection)

7MARKETINGAUTHORISATIONHOLDER

MaynePharmaPlc

Queensway

RoyalLeamington Spa

Warwickshire

CV313RW

United Kingdom

8MARKETINGAUTHORISATIONNUMBER

PA437/3/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 21 May 1986

Dateoflastrenewal:21 May 2001

10DATEOFREVISIONOFTHETEXT

Strength of

Concentrate Volumeof

Concentrateml IVSolution Volumeml FinalConcentration

microgram/ml

200 mg/5 ml 5 500 400

200 mg/5 ml 5 250 800

200 mg/5 ml 10 250 1600

200 mg/5 ml 20 500 1600

800 mg/5 ml 5 500 1600

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