CILOXAN 0.3 % W/ V EYE DROPS, SOLUTION.

Main information

  • Trade name:
  • CILOXAN 0.3 % W/ V EYE DROPS, SOLUTION.
  • Dosage:
  • 0.3 %w/ v
  • Pharmaceutical form:
  • Eye Drops Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CILOXAN 0.3 % W/V EYE DROPS, SOLUTION.
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0290/069/001
  • Authorization date:
  • 13-11-1995
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0290/069/001

CaseNo:2069252

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

AlconLaboratories(UK)Ltd

PentagonPark,BoundaryWay,HemelHempstead,HertfordshireHP27UD,England

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Ciloxan0.3%w/vEyeDropsSolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom24/02/2010until12/11/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 15/03/2010 CRN 2069252 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Ciloxan0.3%w/vEyeDropsSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Ciprofloxacin0.3%w/v(ashydrochloride)

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Eyedrops,solution

Aclear,colourlesstopaleyellowsterilesolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Adults,newborninfants(0-27days),infantsandtoddlers(28daysto23months),children(2-11years)and

adolescents(12–16years)

CILOXANisindicatedforthemanagementofcornealulcers,conjunctivitisandblepharitisduetomicroorganisms

resistanttootherantibiotics.

Considerationshouldbegiventoofficialguidanceontheappropriateuseofantibacterialagents.

4.2Posologyandmethodofadministration

Adults,newborninfants(0-27days),infantsandtoddlers(28daysto23months),children(2-11years)and

adolescents(12–16years)

CornealUlcers:

CILOXANmustbeadministeredinthefollowingintervals,evenduringnighttime:

Onthefirstday,instill2dropsintotheaffectedeyeevery15minutesforthefirstsixhoursandthen2

dropsintotheaffectedeyeevery30minutesfortheremainderoftheday.

Onthesecondday,instill2dropsintheaffectedeyehourly.

Onthethirdthroughthefourteenthday,placetwodropsintheaffectedeyeevery4hours.Ifthepatient

needstobetreatedlongerthan14days,thedosingregimenisatthediscretionoftheattendingphysician.

BacterialConjunctivitis/Blepharitis:

Forthefirst2daysintill1or2dropsintotheconjunctivalsac(s)oftheinfectedeye(s)every2hours

whileawake.Then1or2dropsevery4hourswhileawakeuntilthebacterialinfectionisresolved.

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4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Hypersensitivitytoquinolones.

4.4Specialwarningsandprecautionsforuse

Ciloxanshouldbeadministeredunderthesupervisionofaspecialistopthalmologyservice,havingthefacilitiesfor

regularmonitoringofclinicalandmicrobiologicaleffectsduringandafteradministration.

Prolongeduseofananti-infectiveincludingciprofloxacin,mayleadtosuperinfectionwithorganisms,includingfungi,

resistanttotheanti-infective.

Althoughtheextentofsystemicabsorptionistoolowtoinducesystemictoxicity,itissufficienttoprecipitateserious

allergicreactions,inparticularanaphylaxisandcardiovascularcollapse.Howeversuchreactionswerenotobservedin

opthalmaicciprofloxacinclinicaltrials.

LikewiseCiloxanshouldbesuspendedimmediatelyatthefirstappearanceofaskinrashoranyothersignof

hypersensitivityreactionandmedicaladviceshouldbesought.

Thisproductcontainsbenzalkoniumchloride,apreservativethatmaycauseeyeirritationandisknowntodiscolour

softcontactlenses.ContactlensesshouldnotbewornduringtreatmentwithCiloxan.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concentrationsofsystemicallycirculatingciprofloxacinareinsufficienttobeassociatedwith

interactionswithsystemicallyadministereddrugs.Howevernoinformationisavailableconcerning

interactionswithagentslocallyinstilledintheconjunctivalsac.

Ifsupplementaryeyepreparationsaretobeused,oneshouldwaitabout15minutesbetweenthetwo

applications.

4.6Pregnancyandlactation

ForCILOXAN0.3%EyeDropsnoclinicaldatafromwell-controlledstudiesinpregnantwomenare

available.

Animalsstudiesdonotindicatedirectorindirectharmfuleffectswithrespecttofertilityand

embryonic/foetaldevelopment.Studiesinrabbitshaveshownanincreasedriskofabortiondueto

maternalweightloss.Therelevanceofthesedataforhumansisunknown.

CILOXAN0.3%EyeOintmentshouldnotbeusedduringpregnancyunlessclearlynecessaryandonlyif

thepotentialbenefitjustifiesthepotentialrisktothefoetus.

ItisnotknownwhethertopicallyappliedCiprofloxacinisexcretedinhumanmilk.Itcrossesthe

placentaandisexcretedinbreastmilkandamnioticfluidinanimalstudies.

CautionshouldbeexercisedwhenCILOXAN0.3%EyeDropsisadministeredtoanursingmother.

Aswithotherquinolones,ciprofloxacinhasbeenshowntocausearthropathyinimmatureanimals.There

isnoevidencethattheophthalmicdosageformofciprofloxacinhasanyeffectonweightbearingjoints.

Plasmalevelsofdrugareverylowafteruseofophthalmicdrops.Neverthelesstheproductshouldonly

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4.7Effectsonabilitytodriveandusemachines

Temporarilyblurredvisionorothervisualdisturbancesmayeffecttheabilitytodriveorusemachines.If

blurredvisionorvisualdisturbancesoccur,thepatientmustwaituntilthevisionisclearbeforedriving

orusingmachinery.

4.8Undesirableeffects

ImmuneSystemDisorders

Veryrare(<0.01%):hypersensitivity(systemic).(SeeSection4.4)

NervousSystemDisorders

Common( ≥1%<10%):dysgeusia.

EyeDisorders

Common( ≥1%<10%):eyeirritation,oculardiscomfort,eyepruritus,foreignbodysensationineyes,

eyelidmargincrusting,ocularhyperaemia.

Uncommon( ≥0.1%<1%):keratopathy,keratitis,eyeallergy,eyelidoedema,lacrimationincreased,

photophobia,visualacuityreduced.

Investigations

Uncommon( ≥0.1%<1%):cornealstaining.

Injury,PoisoningandProceduralComplications

Uncommon( ≥0.1%<1%):medicationresidue.

Withlocallyappliedfluoroquinolones(generalized)rash,toxicepidermolysis,dermatitisexfoliative,Stevens-Johnson

syndromeandurticariaoccurveryrarely.

Inisolatedcasesblurredvision,decreasedvisualacuityandmedicationresiduehavebeenobservedwithophthalmic

ciprofloxacin.

Paediatricpopulation

SafetyandeffectivenessofCILOXAN3mg/mleyedropsweredeterminedin230childrenbetweentheagesof0and

12yearsofage.Noseriousadversedrugreactionwasreportedinthisgroupofpatients.

4.9Overdose

AtopicaloverdoseofCILOXANisunlikelytobeassociatedwithtoxicity.Atopicaloverdoseof

CILOXANmaybeflushedfromtheeyeswithlukewarmtapwater.AccidentalingestionofCILOXAN

isalsonotlikelytobeassociatedwithtoxicity.Treatmentofasuspectedingestionissymptomaticand

supportive.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Antiinfectives;OtherAntiinfectives

ATCCode:SO1AX13

Ciprofloxacinhascidalandinhibitoryactivitiesagainstbacteriawhichresultfromaninterferencewith

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informationfromthebacterialchromosomescannotbetranscribedanylongerwhichcausesabreakdown

ofthebacterialmetabolism.

5.2Pharmacokineticproperties

Aftertopicalocularadministration,ciprofloxacinisabsorbedsystemically.Plasmalevelsinvolunteers

rangedfromnonquantifiableto4.7ng/mL(some450-foldlessthanlevelsobservedfollowingsample

250mgoraladministration.

Therearenopharmacokineticdataavailableinrespectofuseinchildren.

5.3Preclinicalsafetydata

Ciprofloxacinandotherquinoloneshavebeenshowntocausearthropathyinimmatureanimalsofmostspeciestested

followingoraladministration.Thedegreeofcartilageinvolvementwasfoundtobedependentonage,speciesand

dosage.With30mg/kgciprofloxacintheeffectonthejointwasminimal.

Aonemonthtopicalocularstudywithciprofloxacin3mg/mleyedrops,solutioninimmaturebeagledogsdidnot

demonstrateanyarticularlesions.Likewisethereisnoevidencethattheophthalmicdosageformhasanyeffectonthe

weightbearingjoints.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzalkoniumchloride

Disodiumedetate

Mannitol

Aceticacid

Sodiumacetate

Hydrochloricacid/Sodiumhydroxide(toadjustpH)

Purifiedwater

6.2Incompatibilities

Incompatiblewithalkalinesolutions.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Discardanyremainingcontentsonemonthafterfirstopening.

6.5Natureandcontentsofcontainer

Lowdensitypolyethylenedroppercontainercontaining5ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

AlconLaboratories(UK)Limited

PentagonPark

BoundaryWay

HemelHempstead

HertsHP27UD

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0290/069/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorization:13November1995

Dateoflastrenewal:13November2005

10DATEOFREVISIONOFTHETEXT

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