DUPHALAC

Main information

  • Trade name:
  • DUPHALAC Oral Solution 3.335 MG/5ml
  • Dosage:
  • 3.335 MG/5ml
  • Pharmaceutical form:
  • Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DUPHALAC Oral Solution 3.335 MG/5ml
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0108/015/001
  • Authorization date:
  • 01-04-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Duphalac3.335g/5mlOralSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Lactulosesolutioncontaining3.335goflactuloseper5ml.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Oralsolution

Clear,colourlesstopalebrownish–yellowviscousliquid.

4CLINICALPARTICULARS

4.1TherapeuticIndications

(1)Inthetreatmentofconstipation.

(2)Inthetreatmentofhepaticencephalopathy.

4.2Posologyandmethodofadministration

HepaticEncephalopathy

Initially30to50mlthreetimesdaily;dosageshouldbesubsequentlyadjustedtoproduce2to3softstoolsdailyandan

acidicfaecalpH.

4.3Contraindications

1.Useinpatientswhorequireagalactose-freediet.

2.Useinpatientswithevidenceofgastrointestinalobstruction.

3.Hypersensitivitytoanyofthecomponentsoftheproduct.

4.4Specialwarningsandprecautionsforuse

1.Longtermuseofthisproductisinadvisableexceptundermedicalsupervision.

2.Adoseof30mlprovides116KJ(28kcals)andisunlikelytoadverselyaffectdiabetics.

3.Duphalacshouldbeadministeredwithcaretopatientswhoareintoleranttolactose.

Constipation

Adults: 15mltwicedaily.

Children5-10years: 10mltwicedaily.

Children2-5years: 5mltwicedaily.

Babies1-2years: 2.5ml-5mltwicedaily.

Irish Medicines Board

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Date Printed 10/05/2011 CRN 2099107 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theproductshouldnotbetakenwithentericcoatedmesalazine(5-ASA)asthelowerstoolpHmaypreventtherelease

ofmesalazine.

4.6Fertility,pregnancyandlactation

Theproductmaybeusedduringpregnancywhenconsiderednecessarybythephysician.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Gastrointestinaldisorders

Flatulencemayoccurduringthefirstfewdaysoftreatment.Asaruleitdisappearsafteracoupleofdays.

Whendosageshigherthaninstructedareusedstomachacheanddiarrhoeamayoccur.Insuchcasethedosage

shouldbedecreased.

Ifhighdoses(normallyonlyassociatedwithportosystemicencephalopathy,PSE)areusedforanextended

periodoftime,thepatientmayexperienceanelectrolyteimbalanceduetodiarrhoea.

4.9Overdose

Nodataoncasesofoverdosingareavailable.Ifdosedtoohigh,stomachacheanddiarrhoeacanoccur.Insuch

instance,cessationoftreatmentwillnormallysuffice.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Inthecolon,lactuloseisbrokendownbycolonicbacteriaintolowmolecularweightorganicacids.Theseacidsleadto

aloweringofpHinthecoloniclumenandviaanosmoticeffecttoanincreaseofthevolumeofthecolonic

contents.Theseeffectsstimulatetheperistalsisofthecolonandnormalisetheconsistencyofthestools.The

constipationisclearedandthephysiologicalrhythmofthecolonisreinstated.

Inhepaticencephalopathy(HE),theeffecthasbeenattributedtothesuppressionofproteolyticbacteriabyanincrease

ofacidophilicbacteria(e.g.lactobacillus),trappingofammoniaintheionicformbyacidificationofthecolonic

contents,catharsisduetothelowpHinthecolonaswellasanosmoticeffectandthealterationofthebacterial

nitrogenmetabolismbystimulatingthebacteriatoutiliseammoniaforbacterialproteinsynthesis.Withinthiscontext,

however,itshouldberealisedthathyperammoniaalonecannotexplaintheneuropsychiatricmanifestationsofHE.The

ammoniahowevermightserveasamodelcompoundforothernitrogenoussubstances.

5.2Pharmacokineticproperties

Lactuloseislargelyunabsorbedandreachesthecolonunchangedwhereitismetabolisedbythebacterialflora.

Metabolismiscompleteatdosesupto40-75ml;athigherdoses,somemaybeexcretedunchanged.

5.3Preclinicalsafetydata

Theresultsofacute,sub-chronicandchronictoxicitystudiesinvariousspeciesindicatethatthecompoundhasvery

lowtoxicity.Theeffectsobserved,appeartobemorerelatedtotheeffectofbulkingastrointestinaltractthantoamore

Irish Medicines Board

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Date Printed 10/05/2011 CRN 2099107 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Threeyears.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Donotrefrigerateorfreeze.

6.5Natureandcontentsofcontainer

OpaquewhitemultidosebottlesofHDPEwithapolypropylenescrewcapcontaining300mlor1litre.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

AbbottHealthcareProductsLimited

MansbridgeRoad

WestEnd

Southampton

SO183JD.

8MARKETINGAUTHORISATIONNUMBER

PA108/15/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1983

Dateoflastrenewal:01April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 10/05/2011 CRN 2099107 page number: 3