FELDENE TOPIGEL

Main information

  • Trade name:
  • FELDENE TOPIGEL
  • Dosage:
  • 5 mg/g
  • Pharmaceutical form:
  • Gel
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FELDENE TOPIGEL
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0822/022/001
  • Authorization date:
  • 16-03-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FeldeneTopigel5mg/gGel

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramofgelcontains5mgpiroxicam.

Excipients:Propyleneglycol200mg/g

Forfulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Clear,pale-yellowgel.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forlocalsymptomaticreliefofpainandinflammationinthetraumaofthetendons,ligaments,musclesandjointsand

inlocalisedformsofsofttissuerheumatism.

4.2Posologyandmethodofadministration

FeldeneTopigelisforexternaluseonly.Apply1gofthegel,correspondingto3cms,(approximately11/4inches)

andrubintotheaffectedsitethreetofourtimesdailyleavingnoresidualmaterialontheskin.Occlusivedressings

shouldnotbeused.

NSAIDsshouldbeusedwithparticularcautioninelderlypatientswhoaremorepronetoadverseevents.Thelowest

dosecompatiblewithadequatesafeclinicalcontrolshouldbeemployed.Seealsosection4.4

Intheabsenceofexperience,FeldeneTopigelshouldnotbeusedinchildren.

4.3Contraindications

FeldeneTopigelshouldnotbeusedinpatientswhohavepreviouslyshownahypersensitivitytothegelorpiroxicamin

anyofitsforms.Thepotentialexistsforcrosssensitivitytoaspirinandothernon-steroidalanti-inflammatoryagents.

Patientswithactivepepticulceration.

Patientswithahistoryofhypersensitivityreactions(e.g.bronchospasm,rhinitis,urticaria)inresponsetoFeldene

Topigel,aspirinornon-steroidalanti-inflammatorydrugs.

FeldeneTopigelshouldnotbegiventopatientsinwhomaspirinandothernon-steroidalanti-inflammatoryagents

inducethesymptomsofasthma,rhinitis,angioedemaorurticaria.

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4.4Specialwarningsandprecautionsforuse

Undesirableeffectsmaybereducedbyusingtheminimumeffectivedosefortheshortestpossibleduration.The

recommendedmaximumperiodoftreatmentis7days.PatientstreatedwithNSAIDslongtermshouldundergoregular

medicalsupervisiontomonitorforadverseevents.

Inpatientswithrenal,cardiacorhepaticimpairment,cautionisrequiredsincetheuseofNSAIDsmayresultin

deteriorationofrenalfunction.Assessmentofrenalfunctionshouldoccurpriortotheinitiationoftherapyand

regularlythereafter.

ElderlypatientsareparticularlysusceptibletotheadverseeffectsofNSAIDs.ProlongeduseofNSAIDsintheelderly

isnotrecommended.Whereprolongedtherapyisrequired,patientsshouldbereviewedregularly.

FeldeneTopigelshouldbeusedwithcautioninpatientswithahistoryofpepticulcerationorinflammatorybowel

disease.

AsNSAIDscaninterferewithplateletfunction,theyshouldbeusedwithcautioninpatientswithintracranial

haemorrhageandbleedingdiathesis.

Piroxicamshouldbeonlyusedwithcautioninpatientswithahistoryoforexistentpepticulceration,intestinal

inflammatorydiseaseorthosewithrenaldysfunctionorhepaticdisease.Theelderlyrequireparticularcarebecauseof

theirvulnerabilitytogastro-intestinalbleeding.

Patientsonprolongedtherapywithpiroxicamshouldbekeptunderregularsurveillance.

Piroxicammayprolongbleedingtimeanddecreaseplateletaggregation

Iflocalirritationoraggravationoftheconditionoccurs,useofthegelshouldbediscontinuedandappropriatetherapy

institutedasnecessary.

Keepawayfromtheeyesormucosa.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Careshouldbetakeninpatientstreatedwithanyofthefollowingdrugsasinteractionshavebeenreported:

Anti-hypertensives:reducedanti-hypertensiveeffect.

Diuretics:reduceddiureticeffect.DiureticscanincreasetheriskofnephrotoxicityofNSAIDs.

Cardiacglycosides:NSAIDsmayexacerbatecardiacfailure,reduceGFRandincreaseplasmacardiacglycosidelevels.

Lithium:decreasedeliminationoflithium.

Methotrexate:decreasedeliminationofmethotrexate.

Cyclosporin:increasedriskofnephrotoxicitywithNSAIDs.

OtherNSAIDs:avoidconcomitantuseoftwoormoreNSAIDs.

Corticosteroids:increasedriskofgastrointestinalbleeding.

Aminoglycosides:reductioninrenalfunctioninsusceptibleindividuals,decreasedeliminationofaminoglycosideand

increasedplasmaconcentrations.

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Oralhypoglycaemicagents:inhibitionofmetabolismofsulfonylureadrugs,prolongedhalf-lifeandincreasedriskof

hypoglycaemia.

Piroxicamishighlyprotein-bound.Thereisthereforeapossibilityofinteractionwithsuchdrugsascoumarintype

anticoagulants.Inaddition,somequantitativevariationinhandlingoforalFeldenehasbeennotedwhenaspirinisused

concurrently.Althoughinmindwhendesigningconcurrenttherapy,itisunlikelythatsignificantinteractionswill

occurwithFeldeneTopigel.

4.6Pregnancyandlactation

Useinpregnancy:Althoughnoteratogeniceffectswereseenwhenpiroxicamwasorallyadministeredinanimal

testing,thesafetyofthegelduringpregnancyorduringlactationhasnotyetbeenestablished.Piroxicaminhibits

prostaglandinsynthesisandreleasethroughareversibleinhibitionofthecyclo-oxygenaseenzyme.

Thiseffect,aswithothernon-steroidalanti-inflammatoryagents,hasbeenassociatedwithanincreasedincidenceof

dystociaanddelayedparturitioninpregnantanimalswhendrugadministrationwascontinuedintolatepregnancy.

Non-steroidalanti-inflammatoryagentsarealsoknowntoinduceclosureoftheductusarteriosusininfants.

Nursingmothers:Apreliminarystudyindicatesthatfollowingoraladministrationpiroxicamisfoundinmaternal

milkinaconcentrationofapproximately1%ofthatreachedinplasma.FeldeneTopigelisnotrecommendedforusein

nursingmothersasclinicalsafetyhasnotbeenestablished.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Treatment-relatedadverseeffectshavebeenreportedonlyrarely.

Inclinicalpiroxicamstudies,adverseeffectoccurredinonly2.6%ofstudysubjects

Ifthegelcauseslocalskinirritation,itsuseshouldbestoppedanditshouldbereplacedwithsomeothertreatment,if

needed.

4.9Overdose

OrganSystem Frequency AdverseEffect

Skinandsubcutaneoustissue Common( ≥1/100,<1/10) Pityroiddesquamation;

erythema;skinrash;localskin

irritation;pruritus;reactionsat

thesitesofapplication.

Rare( ≥1/10,000,<1/1000)

Contactdermatitis;eczema;

photosensitivityreaction;skin

discolorationandstainingof

clotheswhengelisnotrubbed

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Anti-inflammatorypreparations,non-steroidsfortopicaluse

ATCcode:M02AA07

Piroxicamisanon-steroidalanti-inflammatoryagentusefulinthetreatmentofinflammatoryconditions.Althoughthe

modeofactionforthisagentisnotpreciselyunderstood,piroxicaminhibitsprostaglandinsynthesisandrelease

throughareversibleinhibitionofthecyclo-oxygenaseenzyme.

5.2Pharmacokineticproperties

Onthebasisofvariouspharmacokineticandtissuedistributionstudiesinanimals,withpiroxicamgel0.5%,thehighest

concentrationsofpiroxicamwereachievedinthetissuesbelowthesiteofapplicationwithlowconcentrationsbeing

reachedintheplasma.Piroxicamgel0.5%wascontinuouslyandgraduallyreleasedfromtheskintounderlying

tissues,equilibriumbetweenskin,andmuscleorsynovialfluidappearedtobereachedrapidly,withinafewhoursof

application.

Fromapharmacokineticstudyinman,2goftheGelwasappliedtotheshouldersofnormalvolunteerstwicedaily

(correspondingto20mgpiroxicam/day)for14days,plasmalevelsofpiroxicamroseslowly,reachingsteadystateafter

about11days.Theplasmalevelsatthistimewerebetween300-400ng/ml,orone-twentiethofthoseobservedin

subjectsreceiving20mgorally.

Theserumhalf-lifeofpiroxicamisapproximately50hours.

5.3Preclinicalsafetydata

Notknown.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Propyleneglycol

Carbomer980

Ethanol

Benzylalcohol

Di-isopropanolamine

Hyetellose

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove30 °

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6.5Natureandcontentsofcontainer

Aluminium,blind-endedtubeincorporatingepoxy-phenolinternallacquerwithawhite,vinyl,pressure-sensitive

polyethyleneendseal,fittedwithapolypropylenecapcontaining30gFeldeneTopigel.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

PfizerHealthcareIreland,

9Riverwalk,

NationalDigitalPark,

CitywestBusinessCampus,

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA0822/022/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:29January1991

Dateoflastrenewal: 29January2006

10DATEOFREVISIONOFTHETEXT

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