DIUMIDE-K

Main information

  • Trade name:
  • DIUMIDE-K Tablets 40mg, 600m %v/ v
  • Dosage:
  • 40mg, 600m %v/ v
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIUMIDE-K Tablets 40mg, 600m %v/v
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0913/004/001
  • Authorization date:
  • 04-01-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Diumide-KContinusprolonged release, film-coatedtablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Furosemide40 mg

PotassiumChloride600 mg (prolonged release).

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Prolonged release, film-coatedtablets.

Orange/white, filmcoated, bi-layered tabletswith theletters‘DK’on theorangecoloured layer.

4CLINICALPARTICULARS

4.1TherapeuticIndications

In themanagementoffluid retention in which potassiumsupplementation isrequired in supportofadiuretic

administered daily, in mild to moderatehypertension, andin oedemaofvariousaetiologies.

4.2Posologyandmethodofadminstration

RouteofAdministration

Oral.

Adultsonly

Theusualdosageisonetabletdaily.

4.3Contraindications

Useofthecombination in thepresenceofhyperkalaemia, precomaassociated with hepatic

cirrhosis, orAddison’sdisease.

Usein children.

Hypersensitivity to furosemide, potassiumchlorideorany otherconstituentofthetablets.

4. Patientswith rarehereditary problemsofgalactoseintolerance, theLapp lactasedeficiency or

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4.4Special warningsandspecialprecautionsforuse

Patientswhoarebeing treated with thispreparation requireregularsupervision with monitoring offluid and

electrolytestateto avoid inadequatepotassiumsupplementation orexcessivelossoffluid.

Thedosageofpotassiumsupplied with thisregimen isnotadjusted to therequirementsofany patientsand

thephysician mustensurecontinued suitabilityofdosageforeach patientparticularly ifheison

long-termtreatment.

Potassiumchloridemay produceoesophagealand smallbowelulceration in somepatientsparticularly ifthey

areon long-termtreatment.Thereisevidenceto suggestthatpatientswith systemiccardiovasculardisease

orlocaldisordersofgastrointestinalmotility areparticularly atrisk.

Thepreparation should only beused with particularcaution in elderly patients, orthosewith potential

obstruction oftheurinary tract, orwith disordersrendering theirelectrolytebalanceprecariousor

thosewith renalinsufficiency.

Furosemidemay inducehyperglycaemiaparticularly in patientswith latentdiabetes, and may necessitate

adjustmentofcontrolby hypoglycaemicagentsin casesofdiabetesmellitus.

Hyperuricaemiaand gout, may beinduced by furosemide.

Ototoxicity may occur.

FD+CYellow(E110)can causeallergic-typereactionssuch asasthma.Thisismorecommon in peoplewho

areallergicto aspirin.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theconcomitantadministration ofthispreparation with cardiacglycosidesorhypotensiveagents

may necessitateadjustmentofthedosageofthosedrugs.

Furosemidemay aggravatethenephrotoxicity ofcephaloridine.Furosemidemay potentiatethe

nephrotoxicity andototoxicity ofaminoglycosides.

Concurrentusewith lithiummay leadto increased serumlithiumlevelsrequiring adjustmentofdosage.

4.6Pregnancyandlactation

Animalstudiesdid notshowateratogeniceffect.Therehavebeen no adequatestudiesin human beings.The

preparation should only beused during pregnancyorlactation ifconsidered essentialby thephysician.The

drug/metaboliteisexcreted in breastmilk.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Sideeffectsincludegastrointestinaldisturbances, hypotension, rash, photosensitivity, allergicreactions, blood

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4.9Overdose

Overdosageischaracterised by excessivediuresis.Replacefluidsand correctelectrolyteimbalance.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

DIUMIDE-KCONTINUStabletscontain thediureticfurosemideand potassiumchloride.Furosemideisaloop

diuretic, inhibiting resorption fromtheascending Loop ofHenle.Itisused forthetreatmentofoedematousstatesof

variousaetiologies.Potassiumchlorideispresentin thetabletsto counteracttheurinary lossofpotassium.

5.2Pharmacokineticproperties

Thefurosemidelayerhasnormalreleasecharacteristics.Furosemideproducesadiuresiswithin onehourand itis

completewithin sixhours.Furosemidehasabiphasichalflifeintheplasmawith aterminalelimination phaseofup to

about1½hours.Thepotassiumchloridein DIUMIDE-KCONTINUStabletsisincorporated in themodified release

system.Thisensuresaprolonged releasegiving maximumabsorption, and avoiding‘flushing out’ofthepotassiumby

theaction ofthediuretic.

5.3Preclinical safetydata

Thereareno pre-clinicaldataofrelevanceto theprescriberwhich areadditionalto thatalready included in other

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

HydroxyethylCellulose

Gelatin

CetostearylAlcohol

Talc

MagnesiumStearate

FD&CYellow(E110)

LactoseMonohydrate

Povidone

Pregelatinised MaizeStarch

Filmcoat

Hypromellose

Macrogol400

6.2Incompatibilities

Notapplicable

6.3ShelfLife

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6.4Special precautionsforstorage

Do notstoreabove30°C.

6.5Natureandcontentsofcontainer

PVC/PVdCblisterwith aluminiumfoilbacking containing 30 tablets.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Napp PharmaceuticalsLtd

CambridgeSciencePark

Milton Road

Cambridge

CB4 0GW

8MARKETINGAUTHORISATIONNUMBER

PA913/4/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 4 th

January 1978

Dateoflastrenewal: 4 th

January 2003

10DATEOFREVISIONOFTHETEXT

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