COLOMYCIN

Main information

  • Trade name:
  • COLOMYCIN Tablets 1,500,000 International Unit
  • Dosage:
  • 1,500,000 International Unit
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COLOMYCIN Tablets 1,500,000 International Unit
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0100/001/002
  • Authorization date:
  • 01-04-1977
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0100/001/002

CaseNo:2073635

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ForestLaboratoriesUKLtd

RiverbridgeHouse,AnchorBoulevard,CrosswaysBusinessPark,Dartford,KentDA26SL,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

ColomycinTablets1,500,000Units

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom10/02/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 11/02/2010 CRN 2073635 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ColomycinTablets1,500,000Units

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains1,500,000unitsofColistinSulphate.

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Tablet

Off-whitesmoothflattabletswiththePharmaxlogoembossedononesurfaceandaquarterbreaklineontheother.

Thetabletscanbedividedintoequalhalves.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ForthetreatmentofgastrointestinalinfectionscausedbysensitiveGramnegativeorganisms.Alsoforbowel

preparation.

Colistinsulphateisnotabsorbedfromthegastro-intestinaltractandmustnot,therefore,beusedforsystemic

infections.

4.2Posologyandmethodofadministration

Tobetakenorally.

Adultsandchildrenover30kgb.w.:

Theusualdoseis1.5to3.0millionunitsevery8hours.

Childrenupto15kg:

Theusualdoseis0.25to0.50millionunitsevery8hours.

Children15-30kg:

Theusualdoseis0.75-1.5millionunitsevery8hours.

Aminimumoffivedaystreatmentisrecommended.Dosagemaybeincreasedwhenclinicalorbacteriological

responseisslow.Forbowelpreparation,a24hourcourseatthenormaldosageaboveisgiven.Treatmentshould

preferablyfinish12hoursbeforesurgery.

4.3Contraindications

Irish Medicines Board

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4.4Specialwarningsandprecautionsforuse

Colistinshouldonlybeadministeredwithgreatcautioninpatientswithrenaldysfunctionordecreasedurinaryoutput

(asinshock)sincetheconsequentretentionofdrugwillincreasepotentialfortoxicity.Colistinissubjecttolimitedand

unpredictableabsorptionfromtheGItractininfantsundersixmonths.Studiesinolderchildrenandinadultshave

demonstratednosystemicabsorptionofcolistinfollowingoraladministration.

Nevertheless,cautionshouldbeemployedintheuseofthepreparationinpatientsreceivingcurariformmuscle

relaxants.Donotuseforsystemictherapy.

Prolongedadministrationofananti-infectivemayresultinthedevelopmentofsuperinfectionduetoorganisms

resistanttothatanti-infective.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Neurotoxicityhasbeenreportedinassociationwiththeconcomitantuseofeithercurariformagentsorantibioticswith

similarneurotoxiceffects.

Respiratoryarresthasbeenreported.

4.6Pregnancyandlactation

SafetyinhumanpregnancyhasnotbeenestablishedandColomycinisnotrecommendedforuseduringpregnancyand

lactation.Animalstudiesdonotindicateteratogenicproperties;however,parenteralsingledosestudiesinhuman

pregnancyshowthatColomycincrossestheplacentalbarrierandthereisariskoffoetaltoxicityifrepeateddosesare

giventopregnantpatients.Colomycinissecretedinbreastmilkandpatientstowhomthedrugisadministeredshould

notbreastfeedaninfant.

4.7Effectsonabilitytodriveandusemachines

Nospecificwarnings.

4.8Undesirableeffects

Nosignificantsystemicabsorptionhasbeenfoundtooccurinolderchildrenandadultsfollowingoraladministration

norhaveanysystemicsideeffectsbeenreported.

Theseadverseeffectsmayincludetransientsensorydisturbancessuchasperioralparaesthesiaandvertigo.

Neuro-toxicityandadverseeffectsonrenalfunctionhavebeenreportedinassociationwithsystemicover-dosage,

failuretoreducedosageinpatientswithrenalinsufficiencyandtheconcomitantuseofeithercurariformagentsor

antibioticswithsimilarneurotoxiceffects.Therapyneednotbediscontinuedandreductionofdosagemayalleviate

symptoms.Permanentnervedamagesuchasdeafnessorvestibulardamagehasnotbeenreported.

4.9Overdose

Nosymptomsofoverdosagehavebeenreportedfollowingoraluseofcolistin.However,followingsystemic

administrationoverdosagecanresultinrenalinsufficiency,muscleweaknessandapnoea.

Thereisnospecificantidote;managebysupportivetreatmentplusattemptstoincreasetherateofeliminationof

Irish Medicines Board

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ColistinisapolypeptideantibioticderivedfromBacilluspolymyxavar.colistinus.

ItpossessesarapidbactericidalactivityagainstanumberofGram-negativeorganisms,includingPseudomonas

aeruginosaandislargelyfreefromthedevelopmentortransferenceofresistance.

5.2Pharmacokineticproperties

Studiesonthegastrointestinalabsorptionofcolistinhaveshownnosignificantsystemicabsorptionfollowingoral

administrationinadultsandolderchildren.

Limitedandunpredictableabsorptionis,however,evidentininfantsunder6months.

5.3Preclinicalsafetydata

Therearenopreclinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Microcrystallinecellulose

Maizestarch

Colloidalsilicondioxide

Hydrogenatedcastoroil

6.2Incompatibilities

Notapplicable

6.3ShelfLife

Unopened:3years

6.4Specialprecautionsforstorage

Storebelow25ºC.Storeintheoriginalcontainer.

6.5Natureandcontentsofcontainer

Packof50tabletsinaplasticcontainerwithaplasticlid,inawhiteorgreypolypropylenebodyandwhitelowdensity

polyethyleneclosure.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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7MARKETINGAUTHORISATIONHOLDER

ForestLaboratoriesUKLimited

RiverbridgeHouse

AnchorBoulevard

CrosswaysBusinessPark

Dartford

Kent

DA26SL

8MARKETINGAUTHORISATIONNUMBER

PA100/1/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1977

Dateoflastrenewal:01April2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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