CITANEST 3% WITH OCTAPRESSIN SELF ASPIRATING

Main information

  • Trade name:
  • CITANEST 3% WITH OCTAPRESSIN SELF ASPIRATING
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CITANEST 3% WITH OCTAPRESSIN SELF ASPIRATING
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1045/001/002
  • Authorization date:
  • 01-04-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CitanestwithOctapressinDental,Prilocaine3%w/v,Felypressin0.03IU/mlSolutionforInjection,self-aspirating

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachmlcontainsPrilocaineHydrochloride30mg(66mg/2.2mlcartridge)andOctapressincorrespondingtofelypressin

0.03IU(0.066IU/2.2mlcartridge).

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Solutionforinjection

2.2mlself-aspiratingcartridgescontainingasterileaqueoussolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Indentalproceduresfortheproductionoflocalanalgesiabyinfiltrationandbynerveblock,whereavasoconstrictor

effectisdesirable.

4.2Posologyandmethodofadministration

Theusualdoseis1-2ml.Therecommendedmaximumdoseis600mg(10cartridges)inahealthyadult.

Childrenandelderlyordebilitatedpatientsrequiresmallerdoses.

4.3Contraindications

Hypersensitivitytotheactiveingredientsortoamideanaesthetics.

Useininfants.

Citanestshouldbeavoidedinpatientswithanaemiaorcongenitaloracquiredmethaemoglobinaemia.

4.4Specialwarningsandprecautionsforuse

Incommonwithotherlocalanaesthetics,Citanestshouldbeusedcautiouslyinpatientswithepilepsy,impairedcardiac

conduction,impairedrespiratoryfunction,andinpatientswithliverorkidneydamage,ifthedoseorsiteof

administrationislikelytoresultinhighbloodlevels.

Facilitiesforresuscitationshouldbeavailablewhenlocalanaestheticsareadministered.

Theeffectoflocalanaestheticsmaybereducedifaninjectionismadeintoaninflamedorinfectedarea.

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Patientsreceivingconcomitanttherapywithsulfonamidese.g.cotrimoxazoleareatincreasedriskofdeveloping

methaemoglobinaemia.

Prilocaineshouldbeusedwithcautioninpatientsreceivingotherlocalanaesthetics,oragentsstructurallyrelatedto

amide-typeanaesthetics,sincethetoxiceffectsareadditive.

4.6Pregnancyandlactation

Althoughthereisnoevidenceofharmtothefoetus,aswithalldrugsCitanestwithOctapressinshouldnotbegivenin

earlypregnancyunlessthebenefitsareconsideredtooutweightherisks.

Prilocaineentersthemother’smilk,butthereisgenerallynoriskofeffectontheinfantatrecommendeddoses.

4.7Effectsonabilitytodriveandusemachines

Noeffectsareforeseen.

4.8Undesirableeffects

Incommonwithotherlocalanaesthetics,adversereactionstoCitanestareextremelyrareindentalpracticeandare

usuallytheresultofexcessivelyhighbloodconcentrationsduetoinadvertentintravascularinjection,excessivedosage,

rapidabsorptionoroccasionallytohypersensitivity,idiosyncrasyordiminishedtoleranceonthepartofthepatient.

Insuchcircumstancessystemiceffectsoccurinvolvingthecentralnervoussystemand/orthecardiovascularsystem.

CNSreactionsareexcitatoryand/ordepressant,andmaybecharacterisedbynervousness,dizziness,blurredvisionand

tremors,followedbydrowsiness,convulsions,unconsciousnessandpossiblyrespiratoryarrest.Theexcitatory

reactionsmaybebrieformaynotoccuratall,inwhichcasethefirstmanifestationsoftoxicitymaybedrowsiness,

mergingintounconsciousnessandrespiratoryarrest.Cardiovascularreactionsaredepressant,andmaybecharacterised

byhypotension,myocardialdepression,bradycardiaandpossiblycardiacarrest.

Allergicreactionsareextremelyrare.Theymaybecharacterisedbycutaneouslesions,urticaria,oedemaor

anaphylactoidreactions.Detectionofsensitivitybyskintestingisofdoubtfulvalue.

Clinicallysignificantlevelsofmethaemoglobinmayoccurwithcyanosiswhendosesofprilocaineexceed600mg.

Methaemoglobinaemiamayoccuratlowerdosesofprilocaineinpatientssufferingfromanaemia,fromcongenitalor

acquiredhaemoglobinopathy(includingmethaemoglobinaemia),orinpatientsreceivingconcomitanttherapye.g.

sulfonamides,knowntocausesuchconditions.Infantsareparticularlysusceptible,duetoaloweractivityofthe

enzymewhichreducesmethaemoglobintohaemoglobin.

Methaemoglobinaemiamaybetreatedbytheintravenousadministrationofa1%solutionofmethyleneblueatadose

of1mg/kg.

4.9Overdose

Treatmentofapatientwithsystemictoxicityconsistsofarrestingconvulsionsandensuringadequateventilationwith

oxygen,ifnecessarybyassistedorcontrolledventilation(respiration).Ifconvulsionsoccurtheymustbetreated

promptlybyintravenousinjectionofthiopentone100to200mgordiazepam5to10mg.Alternativelysuccinylcholine

50to100mgi.v.maybeusedprovidingtheclinicianiscapableofperformingendotrachealintubationandmanaginga

fullyparalysedpatient.Ifcardiacarrestoccurseffectivecardiopulmonaryresuscitationmustbeinstituted.Thisshould

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:ATCcode:N01BB04.

CitanestwithOctapressinDentalcontainsthelocalanaestheticprilocaineandthevasoconstrictorfelypressin.

Prilocaineisalocalanaestheticoftheamidetype.Itstabilisestheneuronalmembraneandpreventstheinitiationand

transmissionofnerveimpulses,therebyeffectinglocalanaestheticaction.Itislesstoxicthanlidocaine.Thedoses

requiredtoproducetoxicsymptomsoftheCNSare,forexample,30-50%higherwithprilocainethanwithlidocaine.

Felypressinisasynthetichormoneoftheposteriorpituitarylobecharacterisedbyvasopressin-likeproperties.Itis

usedasavasoconstrictiveagentindentallocalanaestheticsolutionsasanalternativetosympathomimeticagents(e.g.

adrenaline).Felypressinhasalowtoxicityandiswelltoleratedbythetissues.

5.2Pharmacokineticproperties

CitanestwithOctapressinDentalhasarapidonsetofactionafterinfiltrationblockade,withanaverageof2-3minutes.

Mandibularblockaderequires5minutesormoreforfulleffect.Thedurationofeffectiveanaesthesiavariesin

individualsanddependsonthetypeofblockade.Theaveragedurationofusefulanaesthesiaafterinfiltrationis45

minutes.Aftersuccessfulregionalblockade,e.g.mandibularblockade,anaesthesiapersistsfor2hoursorlonger.

Thelocalischaemiceffectislesspronouncedwithfelypressinandisnotfollowedbytissuehypoxiaandcyanosisasis

thecasewithsolutionscontainingadrenaline.

FelypressininthedosesusedinCitanestwithOctapressinDentaldoesnotinteractwithtricyclicantidepressantdrugs.

Prilocaineismetabolisedintheliver,kidneysandlungs.Oneofthemetabolitesofprilocaineiso-toluidine,whichhas

beenfoundtoinduceanincreaseintheamountofmethaemoglobinintheblood.

Themeaneliminationhalf-lifeafterthei.v.injectionofprilocaineisabout1.5hours.Prilocainecrossestheblood-brain

andtheplacentabarriers.Hepaticorrenalinsufficiencymayaffecttheeliminationofprilocaineandleadtothe

accumulationofprilocaineand/oritsmetabolites.

5.3Preclinicalsafetydata

Prilocainehydrochlorideisawell-establishedactiveingredient.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumchloride

Hydrochloricacid

Waterforinjections

6.2Incompatibilities

Noneknown.

6.3ShelfLife

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6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

2.2mlself-aspiratingcartridgesofcolourlessPh.Eur.TypeIglassinboxesof100.Eachcartridgecontainsarubber

plungerandhasanaluminiumandrubbercombinationcap.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Useononepatientduringonetreatmentonly.Discardunusedcontents.

7MARKETINGAUTHORISATIONHOLDER

DentsplyLimited

HammMoorLane

Addlestone

Weybridge

SurreyKT152SE

UnitedKingdom

TradingasDentsplyPharmaceuticals

8MARKETINGAUTHORISATIONNUMBER

PA1045/1/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1980

Dateoflastrenewal:01April2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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