ANDROPATCH

Main information

  • Trade name:
  • ANDROPATCH Transdermal Patch 2.5 Mg/ day
  • Dosage:
  • 2.5 Mg/ day
  • Pharmaceutical form:
  • Transdermal Patch
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ANDROPATCH Transdermal Patch 2.5 Mg/day
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1077/018/001
  • Authorization date:
  • 15-04-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Andropatch2.5mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachAndropatch2.5mgSystemcontains12.2mgtestosterone.

EachAndropatch2.5mgSystemdeliversin-vivoapproximately2.5mgoftestosteroneover24hoursacrossskinof

averagepermeability.Activesurfaceareais7.5cm 2

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Transdermalpatch.

Circular,self-adhesivepatchwith“TDPS-2”andthecompanylogoprintedonoppositesidesofacentraldrug

reservoir.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Andropatchisindicatedfortestosteronereplacementtherapyinuseforconditionsassociatedwithadeficiencyor

absenceofendogenoustestosterone,asseeninprimaryandsecondaryhypogonadism.

4.2Posologyandmethodofadministration

Adultsandelderly:Theusualdoseistwo2.5mgAndropatchSystemsappliednightly(approximately10pm)andworn

for24hours,providingapproximately5mgtestosteroneperday.Thedosecanbeadjustedupto7.5mgnightlyordown

toone2.5mgsystemnightlydependingontheserumtestosteronemeasuredinthemorningafterapplication.

Measurementofserumtestosteroneshouldberepeatedtakingcaretoensurepropersystemadhesionandcorrecttime

ofapplicationbeforethedoseisadjusted.Threesystemsperdaymayberequiredformenwithahigherbodyweight

(>130kg).Treatmentinnon-virilisedpatientsmaybeinitiatedwithonesystemappliednightly.Thedoseshouldbe

adjustedasappropriate.

Thedurationoftreatmentandfrequencyoftestosteronemeasurementsisdeterminedbythephysician.

TheadhesivesideoftheAndropatchSystemshouldbeappliedtoaclean,dryareaoftheskinontheback,abdomen,

upperarms,orthighs.Bonyprominences,suchastheshoulderandhipareasthatmaybesubjectedtoprolonged

pressureduringsleepingorsittingshouldbeavoided.Applicationtothesesiteshasbeenassociatedwithburn-like

blisterreactions(seesection4.8,Undesirableeffects).

Donotapplytobrokenordamagedskin.

Donotapplytothescrotum.Thesitesofapplicationshouldberotated,withanintervalofsevendaysbetween

applicationstothesamesite.Theareaselectedshouldnotbeoily,damagedorirritated.

Thesystemshouldbeappliedimmediatelyafteropeningthepouchandremovingtheprotectivereleaseline.The

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Children:

Andropatchisnotrecommendedforuseinchildren,asthereisnoclinicalexperienceofitsusebelowtheageof15

years.

4.3Contraindications

Androgensarecontra-indicatedinmenwithcarcinomaofthebreastorknownorsuspectedcarcinomaoftheprostate.

Knowhypersensitivitytotestosteroneorotherconstituentsofthepatch.

Andropatchhasnotbeenevaluatedinwomenandmustnotbeusedinwomen.

Testosteronemaybeharmfultothefoetus.

4.4Specialwarningsandprecautionsforuse

Initiationoftestosteronetreatmentanditsoveralldirectionshouldonlybecarriedoutbyspecialists.

Testosteronetherapyshouldonlybeusedinmalehypogondotrophisminwhichtestosteronelevelshavebeen

demonstratedtobelow.

Elderlymentreatedwithandrogensmaybeatanincreasedriskforthedevelopmentofprostatichyperplasiaand

prostaticcarcinoma.

Elderlymen,andotherswithanincreasedriskofdevelopingprostatecancer,shouldbeassessedbeforestarting

testosteronereplacementtherapybecausetestosteronemaypromotethegrowthofsubclinicalprostatecancer.

Asinmenwithouttestosteronedeficiency,patientsontestosteronereplacementtherapyshouldbeperiodically

evaluatedforprostatecancer.

Ifthepatientdevelopsanapplicationsitereaction,treatmentshouldbereviewedanddiscontinuedifnecessary.

Androgensmayreducethyroxine-bindingglobulinandPB1levelswithoutinducingclinicalhypothyroidism.

Thetreatmentregimenshouldavoidunduestimulationofeitherthephysicalormentalcapacityofthepatient.Evidence

ofexcessivesexualstimulationrequiresdiscontinuationoftherapy.

Careshouldbetakeninpatientswithskeletalmetastasesduetotheriskofhypercalcaemia/hypercalcuriadeveloping

fromandrogentherapy.

TestosteronemaycauseariseinbloodpressureandAndropatchshouldbeusedincautioninpatientswith

hypertension.

Oedema,withorwithoutcongestiveheartfailure,mayresultfromAndrogentreatmentinpatientswithpre-existing

cardiac,renal,orhepaticdisease.Inadditiontodiscontinuationoftherapy,diuretictreatmentmayberequired.

Andropatchshouldbeusedwithcautioninpatientswithischaemicheartdisease,epilepsyandmigraineasthese

conditionsmaybeaggravated.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Barbituratestakenconcurrentlymaystimulatetestosteronemetabolism,affectingdosagerequirements.

Whengivensimultaneouslywithanticoagulantstheanticoagulanteffectcanincrease.

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Concurrentadministrationofoxyphenbutazoneandandrogensmayresultinelevatedserumlevelsofoxyphenbutazone.

Indiabeticpatients,themetaboliceffectsofandrogensmayalterbloodglucoseandtherefore,insulinrequirements.

4.6Pregnancyandlactation

Andropatchtherapyhasnotbeenevaluatedinandmustnotbeusedinwomenunderanycircumstances.Testosterone

maybeharmfultothefoetus.(seesection4.3,Contraindications).

4.7Effectsonabilitytodriveandusemachines

ThereisnoevidencethatAndropatchwillaffecttheabilityofapatienttodriveortousemachines.

4.8Undesirableeffects

Inthemajorityofcases,transientmildtomoderateskinreactionshavebeenobservedatthesiteofapplicationatsome

timeduringtreatment.Theseincludepruritus,irritationwitherytherma,indurationorburning,rashandallergiccontact

dermatitis.Burn-likelesionscharacterisedbyblisters,skinnecrosis,andulcerationthathealedoverseveralweekswith

scarringinsomecaseshavealsobeenobserved.

Theburn-likelesionsoccurredsporadically,usuallyonlyatonesite,(mostcommonlyoverbonyprominencesorareas

thatmayhavebeensubjectedtoprolongedpressureduringsleepingorsitting).Suchlesionsshouldbetreatedasburns.

Asseenwithothertestosteronetreatments,prostateabnormalities,prostatecancer,headache,depressionand

gastrointestinalbleedingwerealsoobserved.

Otherknownundesirableeffectsassociatedwithtestosteronetreatmentsincludehirsuitism,malepatternbaldness,

seborrhoea,acne,excessivefrequencyanddurationofpenileerections,nausea,cholestaticjaundice,increasedor

decreasedlibido,anxiety,generalisedparasthesia,hypertrichosis,priapism,rashandfluidretention.Oligospermiamay

occurathighdoses.

Prolongedtestosteroneadministrationmaycauseelectrolytedisturbancese.g.retentionofsodium,chloride,potassium,

calcium,inorganicphosphatesandwater.

4.9Overdose

Thisismostunlikelyduetothemodeofadministration.Serumtestosteronehasahalf-lifeof70minutesandtherefore

fallsrapidlyonceAndropatchSystemsareremoved.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Andropatchdeliversphysiologicamountsoftestosteroneproducingcirculatingtestosteroneconcentrationsthatmimic

thenormalcircadianrhythmofhealthyyoungmen.

Testosterone,theprimaryandrogenichormoneisresponsibleforthenormalgrowthanddevelopmentofthemalesex

organsandforthemaintenanceofsecondarysexcharacteristics.Malehypogonadismresultsfrominsufficientsecretion

oftestosteroneandischaracterisedbylowserumconcentrations.Symptomsassociatedwithmalehypogonadism

includethefollowing:impotenceanddecreasedsexualdesire;fatigueandlossofenergy;mooddepression;regression

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Androgenspromoteretentionofnitrogen,sodium,potassiumandphosphorus,decreasedurinaryexcretionofcalcium,

increasedproteinanabolism,decreasedproteincatabolism,andarealsoresponsibleforthegrowthspurtofadolescence

andfortheeventualterminationofthelineargrowth.Theystimulatetheproductionofredbloodcellsbyenhancing

erythropoietinproduction.

Exogenousadministrationofandrogensinhibitsendogenoustestosteronerelease.Withlargedosesofexogenous

androgens,spermatogenesismaybesuppressed.

5.2Pharmacokineticproperties

FollowingAndropatchapplicationtonon-scrotalskin,testosteroneiscontinuouslyabsorbedduringthe24hourdosing

period.Dailyapplicationoftwo2.5mgAndropatchpatchesatapproximately10pmresultsinaserumtestosterone

concentrationprofilewhichmimicsthenormalcircadianvariationobservedinhealthyyoungmen.Maximum

concentrationsoccurintheearlymorninghourswithminimumconcentrationsintheevening.

Inhypogonadalmen,applicationoftwoAndropatch2.5mgSystemstotheback,abdomen,thighsorupperarms

resultedinaveragetestosteroneabsorptionof4to5mgover24hours.Applicationstothechestandshinsresultedina

greaterinter-individualvariabilityandaverage24hourabsorptionof3to4mg.Theserumtestosteroneconcentration

profilesduringapplicationweresimilarforallsites.

Normalrangemorningserumtestosteroneconcentrationsarereachedduringthefirstdayofdosing.Thereisno

accumulationoftestosteroneduringcontinuoustreatment.

UponremovaloftheAndropatchSystems,serumtestosteroneconcentrationsdecreasewithanapparenthalf-lifeof

approximately70minutes.Hypogonadalconcentrationsarereachedwithin24hoursfollowingsystemremoval.

5.3Preclinicalsafetydata

Noneclinicallyrelevant.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Purifiedwater

Glycerol(E422)

CarbomerCopolymerB

2NSodiumhydroxide(E524)

Ethanol95%

GlycerolMono-Oleate

Methyllaurate96%

CompositionofSystem:

Silicone-coatedPolyesterLiner

Acrylicadhesive/silicone-coatedPETLaminate

PeelableLDPE/aluminium/polyesterfilm

MicroporousHMWPE(highmolecularweightpolyethylene)film

Backingfilm:innerlayer:EVA,Surlyn®andmetallisedpolyethyleneandouterlayer:polyethylenelayerpigmented

withalcoholresistantbeigeinktoformabeigeplasticfilm.

6.2Incompatibilities

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6.3ShelfLife

2years

Applytoskinimmediatelyuponremovalfromaprotectivepouch.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

EachAndropatch2.5mgSystemisindividuallypackedintoapouchmadefromapaper/lowdensitypolyethylene

(LPDE)/Aluminiumfoil/LPDElaminate.Andropatch2.5mgSystemissuppliedincartonsof10,30and60pouches.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Andropatchmaybediscardedwithhouseholdwasteinamannerthatavoidsaccidentalcontactbyothers.

Damagedsystemsshouldnotbeused.

Thedrugreservoirmaybeburstbyexcessiveheatorpressure.

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKline(Ireland)Limited

StonemasonsWay

Rathfarnham

Dublin16

8MARKETINGAUTHORISATIONNUMBER

PA1077/018/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 03December1996

Dateoflastrenewal: 03December2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 24/11/2007 CRN 2043860 page number: 5