DEPONIT 5MG/ 24 HOURS TRANSDERMAL PATCH

Main information

  • Trade name:
  • DEPONIT 5MG/ 24 HOURS TRANSDERMAL PATCH
  • Dosage:
  • 5 Mg/ day
  • Pharmaceutical form:
  • Transdermal Patch
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DEPONIT 5MG/24 HOURS TRANSDERMAL PATCH
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0365/088/001
  • Authorization date:
  • 30-10-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0365/088/001

CaseNo:2072855

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

TransferredfromPA0271/007/001.

UCBPharmaLimited

208BathRoad,Slough,BerkshireSL13WE,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Deponit5mg/24hoursTransdermalPatch

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom30/10/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 30/10/2009 CRN 2072855 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Deponit5mg/24hoursTransdermalPatch

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtransdermalpatchcontains18.7mgofglyceryltrinitrateinapatchsizeof9cm 2

,releasinganominal5mg

ofglyceryltrinitrateper24hours.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

TransdermalPatch

White,translucentsquarepatchwithconvexroundcornerswith“deponit5”markedontheouterface.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Prophylaxisofanginapectorisaloneorincombinationwithotheranti-anginaltherapy.

4.2Posologyandmethodofadministration

Adults:

Treatmentshouldbeinitiatedwithonepatchdaily.Ifnecessarythedosagemaybeincreasedtotwopatches.

Itisrecommendedthatthepatchisappliedtohealthy,undamaged,relativelycreasefreeandhairlessskin.The

bestplacestoapplyDeponitpatchesaretheeasilyreached,fairlystaticareasatthefrontorsideofthechest;

however,Deponitpatchesmayalsobeappliedtotheupperarm,thigh,abdomenorshoulder.Skincareproducts

shouldnotbeusedbeforeapplyingthepatch.Thereplacementpatchshouldbeappliedtoanewareaofskin.

Allowseveraldaystoelapsebeforeapplyingafreshpatchtothesameareaofskin.

Tolerancemayoccurduringchronicnitratetherapy.Toleranceislikelytobeavoidedbyallowingapatch-free

periodof8-12hourseachday,usuallyatnight.Anadditionalanti-anginaltherapywithdrugsnotcontaining

nitrocompoundsshouldbeconsideredforthenitrate-freeintervalifrequired.

Aswithanynitratetherapy,treatmentwiththesepatchesshouldnotbestoppedabruptly.Ifthepatientisbeing

changedtoanothertypeoftreatment,thetwoshouldoverlap.

Elderly:

Nospecificinformationonuseintheelderlyisavailable,howeverthereisnotevidencetosuggestthatan

alterationindoseisrequired.

Children:

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4.3Contraindications

Knownhypersensitivitytonitratesortotheadhesivesusedinthepatch.

Acutecirculatoryfailure(shock,collapse).

Cardiogenicshock.

Raisedintracranialpressureincludingthatcausedbyheadtraumaorcerebralhaemorrhage.

Markedanaemia.

Closedangleglaucoma.

Hypotensiveconditionsandhypovolaemia.

Hypertrophicobstructivecardiomyopathy.

Aorticstenosisandmitralstenosis.

Constrictivepericarditis.

Cardiactamponade.

Concomitantuseofphosphodiesterasetype-5inhibitors.Phosphodiesterasetype-5inhibitors(e.g.sildenafil,

tadalafil,vardenafil)havebeenshowntopotentiatethehypotensiveeffectsofnitrates,andtheirco-

administrationwithnitratesornitricoxidedonorsisthereforecontra-indicated.

4.4Specialwarningsandprecautionsforuse

Thispatchshouldbeusedwithcautioninpatientswith:

Severehepaticorrenalimpairment.

Hypothyroidism.

Hypothermia.

Malnutrition.

Arecenthistoryofmyocardialinfarction.

Hypoxaemiaoraventilation/perfusionimbalanceduetolungdiseaseorischaemicheartfailure.

Thepatchisnotindicatedforuseinacuteanginaattacks.Intheeventofanacuteanginaattack,sublingual

treatmentsuchasasprayortabletshouldbeused.Aswithallnitratepreparationswithdrawaloflong-term

treatmentshouldbegradualbyreplacementwithdecreasingdosesoflongactingoralnitrates.

Ifthepatchesarenotusedasindicated(seesection4.2)tolerancetothemedicationcoulddevelop.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concomitanttreatmentwithothervasodilators,calciumantagonists,angiotensinconvertingenzyme(ACE)

inhibitors,beta-blockers,diuretics,antihypertensives,tricyclicantidepressantsandmajortranquillisers,aswell

astheconsumptionofalcohol,maypotentiatethehypotensiveeffectofthepreparation.

Thebloodpressureloweringeffectofthesepatcheswillbeincreasedifusedtogetherwithphosphodiesterase

inhibitors(e.g.sildenafil)whichareusedforerectiledysfunction(seecontraindications).Thismightleadtolife

threateningcardiovascularcomplications.Patientswhoareonnitratetherapymustnotusephosphodiesterase

inhibitors(e.g.sildenafil).

Ifadministeredconcurrently,thesepatchesmayincreasethebloodlevelofdihydroergotamineandleadto

coronaryvasoconstriction.

Thepossibilitythatingestionofacetylsalicylicacidandnon-steroidalanti-inflammatorydrugsmightdiminish

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4.6Pregnancyandlactation

Thesepatchesshouldnotbeusedduringpregnancyorlactationunlessconsideredabsolutelyessentialbythe

physician.

Itisnotknownwhethertheactivesubstancepassesintobreastmilk.Benefitstothemothermustbeweighed

againstrisktothechild.

4.7Effectsonabilitytodriveandusemachines

Thesepatchesmayaffectthereactivityofthepatient.Patientsshouldnotdriveoroperatemachineryiftheir

abilityisimpaired.

4.8Undesirableeffects

Averycommon(>10%ofpatients)adversereactiontothepatchisheadache.Theincidenceofheadache

diminishesgraduallywithtimeandcontinueduse.

Atstartoftherapyorwhenthedosageisincreased,hypotensionand/orlight-headednessonstandingare

observedcommonly(i.e.in1-10%ofpatients).Thesesymptomsmaybeassociatedwithdizziness,drowsiness,

reflextachycardia,andafeelingofweakness.

Infrequently(i.e.inlessthan1%ofpatients),nausea,vomiting,flushingandallergicskinreaction(e.g.rash),

whichmaybeseverecanoccur.Insinglecasesexfoliativedermatitismayoccur.

Severehypotensiveresponseshavebeenreportedfororganicnitratesandincludenausea,vomiting,restlessness,

pallorandexcessiveperspiration.

Uncommonlycollapsemayoccur(sometimesaccompaniedbybradyarrhythmiaandsyncope).Uncommonly

severehypotensionmayleadtoenhancedanginasymptoms.

Afewreportsofheartburn,mostlikelyduetoanitrate-inducedsphincterrelaxation,havebeenrecorded.

Allergicskinreactionstoglyceryltrinitrateandingredientscanoccur,buttheyareuncommon(i.e.>0.1%but

<1%).Patientsmaycommonlyexperienceslightitchingorburningatthesiteofapplication.Slightreddening

usuallydisappearswithouttherapeuticmeasuresafterthepatchhasbeenremoved.Allergiccontactdermatitisis

uncommon.

Duringthetreatmentwiththesepatches,atemporaryhypoxaemiamayoccurduetoarelativeredistributionof

thebloodflowinhypoventilatedalveolarareas.Particularlyinpatientswithcoronaryarterydiseasethismay

leadtoamyocardialhypoxia.

4.9Overdose

Inviewofthetransdermalmodeofdelivery,anoverdoseofglyceryltrinitrateisunlikelytooccur.However,in

theunlikelyeventofanoverdose,thesymptomscouldincludethefollowing:

Fallinbloodpressure 90mmHg.

Paleness.

Sweating.

Weakpulse.

Tachycardia.

Flushing.

Light-headednessonstanding.

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Weakness.

Dizziness.

Nausea.

Vomiting.

Methaemoglobinaemiahasbeenreportedinpatientsreceivingotherorganicnitrates.Duringglyceryl

trinitratebiotransformationnitriteionsarereleased,whichmayinducemethaemoglobinaemiaandcyanosis

withsubsequenttachypnoea,anxiety,lossofconsciousnessandcardiacarrest.Itcannotbeexcludedthatan

overdoseofglyceryltrinitratemaycausethisadversereaction.

Inveryhighdosestheintracranialpressuremaybeincreased.Thismightleadtocerebralsymptoms.

Generalprocedure:

Stopdeliveryofthedrug.

Sincethesepatchesareappliedtotheskin,removingthepatchimmediatelystopsdeliveryofthedrug.

Generalproceduresintheeventofnitrate-relatedhypotension:

Patientshouldbekepthorizontalwiththeheadloweredandlegsraised.

Supplyoxygen.

Expandplasmavolume.

Forspecificshocktreatmentadmitpatienttointensivecareunit.

Specialprocedure:

Raisingthebloodpressureifthebloodpressureisverylow.

Treatmentofmethaemoglobinaemia:

ReductiontherapyofchoicewithvitaminC,methylene-blue,ortoluidine-blue.

Administeroxygen(ifnecessary).

Initiateartificialventilation.

Redbloodcellorexchangetransfusion.

Resuscitationmeasures:

Incaseofsignsofrespiratoryandcirculatoryarrest,initiateresuscitationmeasuresimmediately.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:C01DA02,Vasodilatorsusedincardiacdiseases,organicnitrates.

Themainpharmacologicalactivityoforganicnitratesistherelaxationofsmoothvascularmuscles.The

systemicvasodilationinducesanincreaseofvenouscapacitance.Venousreturnisreduced.Ventricularvolume,

fillingpressuresanddiastolicwalltensionarediminished(preloadreduction).

Adiminishedventricularradiusandreducedwalltension,lowermyocardialenergyandoxygenconsumption,

respectively.

Thedilationofthelargearteriesneartheheartleadstoadecreaseinboththesystemic(reductionofafterload)

andthepulmonaryvascularresistance.Inaddition,thisrelievesthemyocardiumandlowersoxygendemands.

Bydilatingthelargeepicardialcoronaryarteries,glyceryltrinitrateenhancesbloodsupplytothemyocardium,

improvingitspumpfunctionandincreasingtheoxygensupply.

Atmolecularlevel,nitratesformnitricoxide(NO),whichcorrespondstothephysicalEDRF(endothelium

derivedrelaxingfactor).EDRFmediatedproductionofcyclicguanosinemonophosphate(CGMP)leadsto

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5.2Pharmacokineticproperties

(a)Generalcharacteristicsoftheactivesubstance:

Thetransdermalabsorptionofglyceryltrinitratecircumventstheextensivehepaticfirstpassmetabolismsothe

bio-availabilityisabout70%ofthatachievedafteri.v.administration.

Thesteady-stateconcentrationintheplasmadependsonthepatchdosageandthecorrespondingrateof

absorption.Atarateofabsorptionof0.4mg/h,thesteady-stateconcentrationisabout0.2micrograms/lon

average.Plasmaproteinbindingisabout60%.Glyceryltrinitrateismetabolizedto1,2-and1,3-dinitroglycerols.

Thedinitratesexertlessvasodilatoryactivitythanglyceryltrinitrate.Thecontributiontotheoveralleffectisnot

known.Thedinitratesarefurthermetabolizedtoinactivemononitrates,glycerylandcarbondioxide.

Theeliminationhalf-lifeofglyceryltrinitrateis2-4min.Themetabolismofglyceryltrinitrate,whichiseffected

intheliver,butalsoinmanyothercells,e.g.theredbloodcells,includestheseparationofoneormorenitrate

groups.Inadditiontothemetabolismofglyceryltrinitrate,thereisarenalexcretionofthecatabolites.

(b)Characteristicsinpatients:

Thereisnoevidencethatadosageadjustmentisrequiredintheelderlyorindiseasessuchasrenalfailureor

hepaticinsufficiency.

5.3Preclinicalsafetydata

Glyceryltrinitrateisawell-knownsubstance,establishedformorethanahundredyears.Thusnewpreclinical

studieshavenotbeencarriedoutwithDeponit5.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Acrylate/vinylacetateco-polymer

Polypropylenebackingfoil

Siliconisedpolyethylenereleaseliner

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

4years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

Multilaminatepaper/polyethylene/aluminium/surlynsachetcontainingasinglepatch.28transdermalpatchesin

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

UCBPharmaLimited

208BathRoad

Slough

BerkshireSL13WE

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0365/088/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:16February1996

Dateoflastrenewal:16February2006

10DATEOFREVISIONOFTHETEXT

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