DIDRONEL

Main information

  • Trade name:
  • DIDRONEL Tablets 200 mg Milligram
  • Dosage:
  • 200 mg Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIDRONEL Tablets 200 mg Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0170/014/001
  • Authorization date:
  • 23-12-1985
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Didronel200mgTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains200mgofEtidronateDisodium.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet

Whiterectangulartabletsmarkedwith‘P&G’ononefaceand‘402’ontheother.

4CLINICALPARTICULARS

4.1TherapeuticIndications

1. Paget'sdiseaseofbone:

InthemanagementofPaget’sdiseaseofbone,particularlythatofthepolyostotictypewithbonepainandsignificant

elevationsofurinaryhydroxyprolineandserumalkalinephosphatase,orinpatientsindangerofirreversible

neurologicaldamage,orwithinvolvementofweight-bearingbone.

2. HeterotopicBoneFormation:

Asacomplicationofhipreplacementorwhenduetospinalcordinjury.

4.2Posologyandmethodofadministration

5mg/kg/dayto20mg/kg/dayasdetailedbelow.

Didronelshouldbegivenonanemptystomach.Itisrecommendedthatpatientstakethetherapywithwater,atthemid

pointofafourhourfast(ie.twohoursbeforeandtwoafterfood).

DailyDosageGuide

*Courseoftherapy-6months

BodyWeight RequiredDailyRegimenof200mgTablets

Kilogrames Stones 5mg/kg* 10mg/kg* 20mg/kg+

12.5 2 4 8

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1. Paget'sdisease

AdultsandElderly:

TherecommendedinitialdoseofDidronelformostpatientsis5mg/kgbodyweight/day,foraperiodnotexceedingsix

months.Dosesabove10mg/kgshouldbereservedforusewhenthereisanoverridingrequirementforsuppressionof

increasedboneturnoverassociatedwithPaget'sdiseaseorwhenthepatientrequiresmorepromptreductionofelevated

cardiacoutput.Treatmentwithdosesabove10mg/kg/dayshouldbeapproachedcautiouslyandshouldnotexceedthree

monthsduration.Dosesinexcessof20mg/kg/dayarenotrecommended.

Retreatmentshouldbeundertakenonlyafteradrug-freeperiodofatleastthreemonthsandafteritisevidentthat

reactivationofthediseasehasoccurredandbiochemicalindicesofthediseasehavebecomesubstantiallyre-elevatedor

approachpre-treatmentvalues(approximatelytwicetheupperlimitofnormalor75%ofpre-treatmentvalue).Inno

caseshoulddurationoftreatmentexceedthemaximumdurationoftheinitialtreatment.

Prematureretreatmentshouldbeavoided.Inclinicaltrialsthebiochemicalimprovementsobtainedduringdrugtherapy

havegenerallypersistedforaperiodofthreemonthsto2yearsafterdrugwithdrawal.

Children:

Disordersofboneinchildren,referredtoasjuvenilePaget'sdisease,havebeenreportedrarely.Therelationshipto

adultPaget'sdiseasehasnotbeenestablished.DidronelhasnotbeenstudiedinchildrenforPaget'sdisease.

2. HeterotopicBoneFormation

Inheterotopicossificationcomplicatinghipreplacement,therecommendedadultdoseis20mg/kg/dayfor1monthpre-

operativelyfollowedby20mg/kg/dayfor3monthspost-operatively.Thetotaltreatmentperiodis4months.Thereis

noevidencethatDidroneltherapywillaffectmatureheterotopicbone.

InheterotopicossificationduetospinalcordinjurytherecommendedadultdoseofDidronelis20mg/kg/dayfor2

weeksfollowedby10mg/kg/dayfor10weeks.Thetotaltreatmentperiodis12weeks.Therecommendeddosage

shouldbeinstitutedassoonasismedicallyfeasiblefollowingtheinjury,preferablypriortoanyradiographicevidence

ofheterotopicossification.

4.3Contraindications

Useinpregnancyandlactation.Retreatmentwithin3monthsofapreviouscourse.Knownhypersensitivitytothedrug.

Clinicallyovertosteomalacia.

4.4Specialwarningsandprecautionsforuse

Didronelisnotmetabolisedbutexcretedunchangedviathekidney;therefore,areduceddoseshouldbeusedinpatients

withmildrenalimpairmentandtreatmentofpatientswithmoderatetosevererenalimpairmentshouldbeavoided.

Cautionshouldbetakeninpatientswithahistoryofrenalstoneformation.Inpatientswithimpairedrenalfunctionor

ahistoryofrenalstoneformation,serumandurinarycalciumshouldbemonitoredregularly.

Etidronatedisodiumsuppressesboneturnonerandmayretardmineralisationofosteoidlaiddownduringthebone

accretionprocess.Theseeffectsaredoseandtimedependent.Osteoid,whichmayaccumulatenoticeablyatdosesof

10-20mg/kg/day,mineralisesnormallypost-therapy.

Patientsinwhomserumphosphateelevationsarehighandreductionsofdiseaseactivityarelowmaybeparticularly

pronetoretardedmineralisationofnewosteoid.Inthosecaseswhere200mgperday(asingletablet)maybe

excessive,dosesmaybeadministeredlessfrequently.

Patientswithsignificantchronicdiarrhoealdiseasemayexperienceincreasedfrequencyofbowelmovementsand

diarrhoea,particularlyathigherdoses.

Theriskoffracturemayalsobegreaterinpatientswithextensiveandseveredisease,ahistoryofmultiplefractures,

and/orrapidlyadvancingosteolyticlesions.Itisthereforerecommendedthatthedrugisdiscontinuedwhenfractures

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Patientswithpredominantlylyticlesionsshouldbemonitoredradiographicallyandbiochemicallytopermittermination

ofetidronatedisodiuminthosepatientsunresponsivetotreatment.

Osteonecrosisofthejaw,generallyassociatedwithtoothextractionand/orlocalinfection(includingosteomyelitis)has

beenreportedinpatientswithcancerreceivingtreatmentregimensincludingprimarilyintravenouslyadministered

bisphosphonates.Manyofthesepatientswerealsoreceivingchemotherapyandcorticosteroids.Osteonecrosisofthe

jawhasalsobeenreportedinpatientswithosteoporosisreceivingoralbisphosphonates.

Adentalexaminationwithappropriatepreventivedentistryshouldbeconsideredpriortotreatmentwith

bisphosphonatesinpatientswithconcomitantriskfactors(e.g.cancer,chemotherapy,radiotherapy,cortiscosteroids,

poororalhygiene).

Whileontreatment,thesepatientsshouldavoidinvasivedentalproceduresifpossible.Forpatientswhodevelop

osteonecrosisofthejawwhileonbisphosphonatetherapy,dentalsurgerymayexacerbatethecondition.Forpatients

requiringdentalprocedures,therearenodataavailabletosuggestwhetherdiscontinuationofbisphosphonatetreament

reducesriskofosteonecrosisofthejaw.

Clinicaljudgementofthetreatingphysicianshouldguidethemanagementplanofeachpatientbasedonindividual

benefit/riskassessment.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Foodinthestomachorupperportionsofthesmallintestine,particularlymaterialswithahighcalciumcontentsuchas

milk,mayreduceabsorptionofetidronatedisodium.Vitaminswithmineralsupplementssuchasiron,calcium

supplements,laxativescontainingmagnesium,orantacidscontainingcalciumoraluminiumshouldnotbetakenwithin

twohoursofdosingetidronatedisodium.

Concurrentadministrationwithantacidsmayaffecttheactivityoftheetidronatedisodium,whilethelatterinturnmay

affectresponsestoantiarrhythmicsandcardiacglycosides.

Therehavebeenisolatedreportsofpatientsexperiencingchangesintheirprothrombintimeswhenetidronatewas

addedtowarfarintherapy.Themajorityofthesereportsconcernedvariableelevationsinprothrombintimeswithout

clinicallysignificantsequelae.Althoughtherelevanceofthesereportsandanymechanismofcoagulationalterationsis

unclear,patientsonwarfarinshouldhavetheirprothrombintimemonitored.

4.6Pregnancyandlactation

Useiscontraindicatedinpregnancyandlactation(Seesection4.3,Contraindications).

4.7Effectsonabilitytodriveandusemachines

Etidronatedisodiumdoesnotinterferewiththeabilitytodriveorusemachines.

4.8Undesirableeffects

Gastrointestinal

Themostcommoneffectsreportedarediarrhoeaandnausea.Reportsofexacerbationofpepticulcerwith

complicationsinfewpatients.

NervousSystem

Paresthesia,confusionhavebeenreportedrarely.

Haematological

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Other

Lesscommoneffectsbelievedtoberelatedtotherapyincludearthropathies(arthralgiaandarthritis),andrarelyburning

ofthetongue,alopecia,erythemamultiformeandexacerbationofasthma.

4.9Overdose

Overdosewouldmanifestasthesignsandsymptomsofhypocalcaemia.Treatmentshouldinvolvecessationoftherapy

andcorrectionofhypocalcaemiawithadministrationofCa intravenously.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Etidronateactsprimarilyonbone.Itcaninhibittheformation,growthanddissolutionofhydroxyapatitecrystalsand

amorphousprecursorsbychemisorptiontocalciumphosphatesurfaces.Inhibitionofcrystalresorptionoccursatlower

dosesthanarerequiredfortheinhibitionofcrystalgrowth.Botheffectsincreaseasboneincreases.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Starch

Magnesiumstearate

Microcrystallinecellulose

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

4years.

6.4Specialprecautionsforstorage

None.

6.5Natureandcontentsofcontainer

SuppliedinhighdensitypolyethylenebottleswithwhitepolypropyleneclosuresorinopaquePVDC/PE/PVC-

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Procter&GamblePharmaceuticalsUKLtd

RushamPark

WhitehallLane

Egham

TW209NW

Surrey

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0170/014/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:23December1985

Dateoflastrenewal:23December2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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