CILOXAN 3 MG/ G EYE OINTMENT.

Main information

  • Trade name:
  • CILOXAN 3 MG/ G EYE OINTMENT.
  • Dosage:
  • 3 mg/ g
  • Pharmaceutical form:
  • Eye Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CILOXAN 3 MG/G EYE OINTMENT.
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0290/069/002
  • Authorization date:
  • 05-11-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0290/069/002

CaseNo:2069252

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

AlconLaboratories(UK)Ltd

PentagonPark,BoundaryWay,HemelHempstead,HertfordshireHP27UD,England

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Ciloxan3mg/gEyeOintment

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom24/02/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Ciloxan3mg/gEyeOintment

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Ciprofloxacinhydrochlorideequivalentto3mg/gciprofloxacin

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Eyeointment

Whitetooff-whiteeyeointment.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CILOXANEyeOintmentwillbeindicatedforadultsandchildrenafollows:

AdultsandChildren1yearandabove

Ciloxan3mg/gEyeOintmentisindicatedfortreatmentofbacterialconjunctivitisinpatients,whoareresistanttoother

antibiotics.

Considerationshouldbegiventoofficialguidanceontheappropriateuseofantibacterialagents.

4.2Posologyandmethodofadministration

AdultsandChildren1yearandabove

Therecommendeddosageregimensforadultsis:

Bacterialconjunctivitis:1.25cmribbonappliedintotheconjunctivalsacthreetimesdailyfortwodays,thentwice

dailyforafurtherfivedays.

Donottouchtubetiptoanysurface,asthismaycontaminatethecontents.

Useinhepaticandrenalimpairment

NostudieshavebeenperformedusingCILOXAN3mg/gEyeOintmentinpatientswithkidneyorliverproblems.

4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Hypersensitivitytoquinolones.

4.4Specialwarningsandprecautionsforuse

Thereisnoexperienceinchildrenlessthan1yearold.

CILOXAN3mg/gEyeOintmentshouldbeadministeredunderthesupervisionofaspecialistophthalmologyservice,

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WhenusingCILOXANeyeointmentoneshouldtakeintoaccounttheriskofarhinopharyngealpassagewhichcan

contributetotheoccurrenceandthediffusionofbacterialresistance.

Seriousandoccasionallyfatalhypersensitivity(anaphylactic)reactions,somefollowingthefirstdose,wereobservedin

patientsreceivingtreatmentbasedonsystematicallyadministeredquinolones.Somereactionswereaccompaniedby

cardiovascularcollapse,lossofconsciousness,tingling,pharyngealorfacialoedema,dyspnea,urticaria,anditching.

Onlyafewpatientshadahistoryofhypersensitivityreactions.

Aswithallantibacterialpreparationsprolongedusemayleadtoovergrowthofnon-susceptiblebacterialstrainsor

fungi.Ifsuperinfectionoccurs,appropriatetherapyshouldbeinitiated.

LikewiseCILOXAN3mg/gEyeOintmentshouldbesuspendedimmediatelyatthefirstappearanceofaskinrashor

anyothersignofhypersensitivityreactionandmedicaladviceshouldbesought.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

SpecificdruginteractionstudieshavenotbeenconductedwithophthalmicCiprofloxacin.However,thesystemic

administrationofsomequinoloneshasbeenshowntoelevateplasmaconcentrationsoftheophylline,interferewiththe

metabolismofcaffeine,enhancetheeffectsoftheoralanticoagulant,warfarin,anditsderivatives,andhasbeen

associatedwithtransientelevationsinserumcreatinineinpatientsreceivingcyclosporineconcomitantly.

4.6Pregnancyandlactation

Pregnancy

ForCILOXAN3mg/gEyeOintmentnoclinicaldatafromwell-controlledstudiesinpregnantwomenareavailable.

Animalstudiesdonotindicatedirectorindirectharmfuleffectswithrespecttofertilityandembryonic/foetal

development.Studiesinrabbitshaveshownanincreasedriskofabortionduetomaternalweightloss.Therelevance

ofthesedataforhumansisunknown(seesection5.3).

Inanimalstudies,systemicdosesofciprofloxacincausejointortendonconnectivetissuedisordersinimmatureanimal,

asdootherdrugsofthisseries.

CILOXAN3mg/gEyeOintmentshouldnotbeusedduringpregnancyunlessclearlynecessaryandonlyifthe

potentialbenefitjustifiesthepotentialrisktothefoetus.

Womenofchild-bearingpotential

Nospecialrecommendationsforwomenofchildbearingpotential.

Lactation

Itisnotknownwhethertopicallyappliedciprofloxacinisexcretedinhumanmilk.Itcrossestheplacentaandis

excretedinbreastmilkandamnioticfluidinanimalstudies.

CautionshouldbeexercisedwhenCILOXAN3mg/gEyeOintmentisadministeredtoanursingmother.

Fertility

Nospecialrecommendations(seesection5.3).

4.7Effectsonabilitytodriveandusemachines

Aswithanyocularmedication,iftransient,blurredvisionoccursatapplication,thepatientshouldwaituntilthevision

clearsbeforedrivingorusingmachinery.

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InclinicaltrialswithCILOXAN3mg/gEyeOintment,thefollowingtreatmentrelatedsignsandsymptomswere

reported:

Common

Ocular:Whiteprecipitate(3.0%)andoculardiscomfort(transientstingingandburninguponapplication)(1.4%).In

patientswithcornealulcerorfrequentadministrationofthedrug,whiteprecipitateshavebeenobservedwhichresolved

aftercontinuousapplicationofCILOXAN3mg/gEyeOintment.Theprecipitatedoesnotprecludecontinueduseof

CILOXAN3mg/gEyeOintmentnordoesitadverselyaffecttheclinicalcourseoftherecoveryprocess.

Uncommon

Oculareffects:Blurredvision(0.8%),hyperaemia(0.7%),pruritus(0.6%),decreasedvisualacuity(0.6%),pain(0.6%),

tearing(0.4%),andphotophobia(0.3%).

Specialsenseseffects:Tasteperversion(metallictaste)(0.5%).

SkinEffects:Dermatitis(0.2%).

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

syndromeandurticariaoccurveryrarely

SafetyandeffectivenessofCILOXAN3mg/geyeointmentweredeterminedin103childrenbetweentheagesofone

and12yearsofage.Noseriousadversedrugreactionwasreportedinthesepatients.

4.9Overdose

AtopicalocularoverdoseofCILOXAN3mg/gEyeOintmentmayberinsedfromtheeye(s)withlukewarmtapwater.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Anti-infectives;Otheranti-infectives.

ATCcode:S01AX13

CiprofloxacinhasinvitroactivityagainstarangeofGram-positiveandGram-negativeorganisms.Thebactericidal

actionofciprofloxacinresultsfrominterferencewiththeenzymeDNAgyrasethatisneededforthesynthesisof

bacterialDNA.

Susceptibility

Theprevalenceofacquiredresistancemayvarygeographicallyandwithtimeforselectedspeciesandlocalinformation

onresistanceisdesirable.Asnecessary,expertadviceshouldbesoughtwhenthelocalprevalenceofresistanceissuch

thattheutilityoftheagentinatleast

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Category1-Commonlysusceptiblespecies

Ciprofloxacinhasbeenshowntobeactiveagainstmoststrainsofthefollowingorganisms;anasteriskdenotesspecies

againstwhichitisconsideredthatciprofloxacinactivityhasbeensatisfactorilydemonstratedinclinicalstudies;no

asteriskindicatesthattheclinicalsignificanceofthesedatainophthalmicinfectionsisunknown:

SR>denotesEUCASTClinicalMICBreakpoints

Breakpointsapplytosystemicuseandmaynotbeapplicableduetothelocalconcentrationsandphysicochemical

conditionsthatapplytoactivityofciprofloxacinappliedtopicallyintheeye.

Category2-Speciesforwhichacquiredresistancemaybeaproblem

AerobicGram-PositiveMicroorganisms:

CiprofloxacinBreakpoint a,b

*Staphylococcusaureus 1/>1

*Staphylococcusepidermidis 1/>1

*Staphylococcusspp.,othercoagulase-

negativespp. 1/>1

*Corynebacteriumspp. 1

*Streptococcuspneumoniae 0.125/>2

*Streptococcus,Viridansgroup 1

Bacillusspecies 1

Staphylococcushaemolyticus 1/>1

Staphylococcushominis 1/>1

AerobicGram-NegativeMicroorganisms:

*Acinetobacterspp. 1/>1

*Haemophilusinfluenzae 0.5/>0.5

*Pseudomonasaeruginosa 0.5/>1

*Moraxellaspp.(includingM.[Branhamella]

catarrhalis) 0.5/>0.5

Acinetobactercalcoaceticus 1

Enterobacteraerogenes 1

Escherichiacoli 1

Haemophilusparainfluenzae 1

Klebsiellapneumoniae 1

Neisseriagonorrhoeae 1

Proteusmirabilis 1

Proteusvulgaris 1

Serratiamarcescens 1

AnaerobicMicroorganisms:

Peptococcusspp. 1

Peptostreptococcusspp. 1

Propionibacteriumacnes 1

Clostridiumpefringens 1

AerobicGram-PositiveMicroorganisms:

Staphylococcushaemolyticus

AerobicGram-NegativeMicroogramisms:

Burkholderia(Pseudomonas)cepacia

Stenotrophomonas(Pseudomonas)maltophilia

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OtherInformation:

Ciprofloxacindoesnotcross-reactwithotherantimicrobialagentssuchasbeta-lactamsoraminoglycosides;therefore,

organismsresistanttothesedrugsmaybesusceptibletociprofloxacin.

Bacterialsusceptibilitystudiesdemonstratethatmostmicroorganismsresistanttociprofloxacinareresistanttothe

otherophthalmicquinolonesaswell.

5.2Pharmacokineticproperties

Absorptionstudiesinhumanswiththeointmenthavenotbeenconducted.Twosystemicabsorptionstudieswere

performedwithCILOXAN3mg/mlEyeDropsusingtheconjunctivitisorcornealulcerdosingregimen.Inthestudy

involvingthemoreintensivedosingregimen(i.e.,cornealulcer/abscessindication),twodropswereadministeredin

oneeyeevery15minutesforsixhours,every30minutesfor18hours,thentwodropshourlyforoneday,followedby

twodropseveryfourhoursforfiveadditionaldays.Ineachstudy,themaximumreportedplasmaconcentrationof

ciprofloxacinwaslessthan5ng/ml.Themeanconcentrationsineachofthestudieswerelessthan2.5ng/ml.

Therearenopharmacokineticdataavailableinrespectofuseinchildren.

5.3Preclinicalsafetydata

Ciprofloxacinandotherquinoloneshavebeenshowntocausearthropathyinimmatureanimalsofmostspeciestested

followingoraladministration.Thedegreeofcartilageinvolvementwasfoundtobedependentonage,specieisand

dosage.With30mg/kgciprofloxacintheeffectonthejointwasminimal.

Aonemonthtopicalocularstudywithciprofloxacin3mg/mleyedrops,solutioninimmaturebeagledogsdidnot

demonstrateanyarticularlesions.Likewisethereisnoevidencethattheophthalmicdosageformhasanyeffectonthe

weightbearing j oints.

In634childrentreatedorallywithciprofloxacin,clinicalandradiologicalmonitoringdidnotrevealanyskeletal

toxicity.

Reproductionstudieshavebeenperformedinratsandmiceatdosesuptosixtimestheusualdailyhumanoraldoesand

haverevealednoevidenceofimpairedfertilityorharmtothefoetusduetociprofloxacin.Inrabbits,aswithmost

antimicrobialagents,ciprofloxacin(30and100mg/kgoral)producedgastrointestinaldisturbancesresultinginmaterial

weightlossandanincreasedincidenceorabortion.Noteratogenicitywasobservedateitherdose.Afterintravenous

administration,atdosesupto20mg/kg,nomaternaltoxicitywasproducedandnoembryotoxicityorteratogenicity

wasobserved.

Itisknownthatorallyadministeredciprofloxacinisexcretedinthemilkoflactatingrats,andoralciprofloxacinhas

beenreportedinhumanbreastmilkafterasingle500mgdose.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

LiquidParaffin

WhiteSoftParaffin

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

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4weeksafterfirstopening.

6.4Specialprecautionsforstorage

Donotstoreabove30ºC.

6.5Natureandcontentsofcontainer

Epoxy-phenoliclinedaluminiumtubewithpolyethylenenozzleandHDPEscrewcap.

Thetubecontains3.5gofeyeointment.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Notapplicable.

7MARKETINGAUTHORISATIONHOLDER

AlconLaboratories(UK)Limited,

PentagonPark,

BoundaryWay,

HemelHempstead,

Herts,HP27UD,

England.

8MARKETINGAUTHORISATIONNUMBER

PA0290/069/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffistauthorisation:05November2004

Dateofnextrenewal:05November2009

10DATEOFREVISIONOFTHETEXT

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