COLOMYCIN UNITS/ 5ML

Main information

  • Trade name:
  • COLOMYCIN UNITS/ 5ML
  • Dosage:
  • 250, 000 Units/ ml
  • Pharmaceutical form:
  • Syrup
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COLOMYCIN UNITS/5ML
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0100/001/003
  • 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)

PA0100/001/003

CaseNo:2071722

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ForestLaboratoriesUKLtd

RiverbridgeHouse,CrosswaysBusinessP,Kent,DA26SL,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

ColomycinSyrup250,000Units/5ml

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom25/09/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 25/09/2009 CRN 2071722 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ColomycinSyrup250,000Units/5ml

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each5mlofreconstitutedsyrupcontains250,000unitsofColistinSulphate.

Exipients:alsoincludessucrose2.187gper5mlandsodiummethylparahydroxybenzoate(E219)3.125mgper5ml

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Powderforsyrup

Amberglassbottlescontainingacream/whitepowderforsyrupwhichonreconstitutionwith58mlofwaterformsa

syrupofvolume80ml.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ForthetreatmentofgastrointestinalinfectionscausedbysensitiveGramnegativeorganisms.Alsoforbowel

preparation.

Colistinsulphateisnotabsorbedfromthegastro-intestinaltract,andmustnotbegivenorallyforthetreatmentof

systemicinfectionsinanyagegroup.

4.2Posologyandmethodofadministration

Adultsandchildrenover30kgb.w.:

Theusualdoseis1.5to3.0millionunitsevery8hours.

Childrenupto15kg:

Theusualdoseis0.25to0.50millionunitsevery8hours.

Children15–30kgb.w.:

Theusualdoseis0.75-1.5millionunitsevery8hours.

Ifsurgeryisintended,therapyshouldbecompleted12hourspre-operatively.Aminimumoffivedaystreatmentis

recommended.Dosagemaybeincreasedwhenclinicalorbacteriologicalresponseisslow.Forbowelpreparation,a24-

hourcourseatthenormaldosageaboveisgiven.Treatmentshouldpreferablyfinish12hoursbeforesurgery.

4.3Contraindications

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4.4Specialwarningsandprecautionsforuse

Colistinshouldonlybeadministeredwithgreatcautioninpatientswithrenaldysfunctionordecreasedurinaryoutput

(asinshock)sincetheconsequentretentionofdrugwillincreasepotentialfortoxicity.

Prolongedadministrationofananti-infectivemayresultinthedevelopmentofsuperinfectionduetoorganisms

resistanttothatanti-infective.

ColistinissubjecttolimitedandunpredictableabsorptionfromtheGItractininfantsundersixmonths.Studiesin

olderchildrenandinadultshavedemonstratednosystemicabsorptionofcolistinfollowingoraladministration.Itis

not,therefore,suitableforsystemictherapy.

Thesucrosecontentofthisformulationshouldbeborneinmindifthispreparationisintendedforuseindiabetics.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Neurotoxicityhasbeenreportedwithconcomitantuseofeithercurariformagentsorantibioticswithsimilarneurotoxic

effectsandsystemicadministrationofcolistin.

Respiratoryarresthasbeenreported.

4.6Pregnancyandlactation

SafetyinhumanpregnancyhasnotbeenestablishedandColomycinisnotrecommendedforuseduringpregnancyand

lactation.Animalstudiesdonotindicateteratogenicproperties;however,parenteralsingledosestudiesinhuman

pregnancyshowthatColomycincrossestheplacentalbarrierandthereisariskoffoetaltoxicityifrepeateddosesare

giventopregnantpatients.

Colomycinissecretedinbreastmilkandpatientstowhomthedrugisadministeredshouldnotbreast-feedaninfant.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Nosignificantsystemicabsorptionhasbeenfoundtooccurinolderchildrenandadultsfollowingoraladministration

norhaveanysystemicsideeffectsbeenreported.

Neurotoxicityandadverseeffectsonrenalfunctionhavebeenreportedinassociationwithsystemicover-dosage,

failuretoreducedosageinpatientswithrenalinsufficiencyandtheconcomitantuseofeithercurariformagentsor

antibioticswithsimilarneurotoxiceffects.

Therapyneednotbediscontinuedandreductionofdosagemayalleviatesymptoms.Permanentnervedamagesuchas

deafnessorvestibulardamagehasnotbeenreported.

4.9Overdose

Nosymptomsofoverdosagehavebeenreportedfollowingoraluseofcolistin.Followingsystemicadministration

overdosagecanresultinrenalinsufficiency,muscleweaknessandapnoea.

Thereisnospecificantidote.Managementissupportivetreatmentplusattemptstoincreasetherateofeliminationof

Irish Medicines Board

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ColistinisapolymyxinantibioticderivedfromBacilluspolymyxavar.colistinus.

IthasabactericidalactiononmostGram-negativebacilli,includingPseudomonasaeruginosaandislargelyfreefrom

thedevelopmentortransferenceofresistance.

ItisnotrecommendedforProteusspp.

5.2Pharmacokineticproperties

Inadultsandolderchildren:colistinsulphatetakenorallyisnotabsorbedfromtheG.I.tract.However,insmallinfants

lessthan6monthsold,someverylimitedandunpredictableabsorptionmayoccur.

Followingoraladministrationofcolistinsulphate,excretionisthroughfaecalmatterinbothchildrenandadults.

Assumingminimalabsorptionintheintestine,only1to10%ofcolistinisfoundinfaeces,tothatestimatedfromthe

doseadministeredandstoolvolume.Colistinfaecallevelsinmanaverage128microg/gwhendailyoraldosesof5-

20mg/kgareadministered(1mgColistinSulphatecontainsapprox.19,500units).

Controlstudieshaveindicatedthatcolistinisboundbythestool.Whengreaterconcentrationsofcolistinwereassayed,

significantlylessactivity,percentage-wise,waslost.Thissuggeststhatthe‘bindingsites’inthestoolweresaturated.

5.3Preclinicalsafetydata

Therearenopreclinicaldataofrelevancetotheprescriberthatmightaddtothesafetydataprovidedinothersections

ofthisSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sucrose

Sodiumcitrate(E331)

Benzoicacid(E210)

Sodiummethylparahydroxybenzoate(E219)

6.2Incompatibilities

Notapplicable

6.3ShelfLife

Unopened:3years

Reconstituted:14days

Discardanyusedsolution

6.4Specialprecautionsforstorage

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6.5Natureandcontentsofcontainer

ColomycinSyruppowderispresentedinanamberglassWinchesterbottlefittedwithawhitepolypropylenecap

containingpowderforreconstitutionwithwatertoproduce80mlofsyrup.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

ColomycinSyrupPowderisreconstitutedbyadding58mlofwater,andshakingthebottleuntilthepowderis

dissolvedtoproduceastrawinlightyellowcoloured,slightlyhazysolution.

7MARKETINGAUTHORISATIONHOLDER

ForestLaboratoriesUKLimited

RiverbridgeHouse

AnchorBoulevard

CrosswaysBusinessPark

Dartford

Kent

DA26SL

8MARKETINGAUTHORISATIONNUMBER

PA100/1/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1977

Dateoflastrenewal:01April2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 25/09/2009 CRN 2071722 page number: 5