Ciloxan Eye Ointment

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Ciprofloxacin hydrochloride 3.5 mg/g equivalent to anhydrous ciprofloxacin base 3 mg/g
Available from:
Novartis New Zealand Ltd
INN (International Name):
Ciprofloxacin hydrochloride 3.5 mg/g (equivalent to anhydrous ciprofloxacin base 3 mg/g)
Dosage:
3 mg/g
Pharmaceutical form:
Eye ointment
Composition:
Active: Ciprofloxacin hydrochloride 3.5 mg/g equivalent to anhydrous ciprofloxacin base 3 mg/g Excipient: Liquid paraffin White soft paraffin
Units in package:
Tube, aluminium, Epoxy-phenolic lined with polyethylene nozzle and screw cap., 3.5 g
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Bayer AG
Product summary:
Package - Contents - Shelf Life: Tube, aluminium, Epoxy-phenolic lined with polyethylene nozzle and screw cap. - 3.5 g - 24 months from date of manufacture stored at or below 25°C. Do not freeze 4 weeks opened stored at or below 25°C. Do not freeze
Authorization number:
TT50-5209/1
Authorization date:
2006-09-01

CILOXAN ®

EyeOintment3mg/g

ciprofloxacinhydrochloride

CONSUMERMEDICINEINFORMATION

What IsIn ThisLeaflet

Readthisleafletcarefullybeforeyoustarttouse

CILOXAN ® EyeOintment.

Thisleaflethasbeen written to answersome common

questionsaboutCILOXAN ® EyeOintment.Itdoes

notcontainalloftheavailableinformationanddoes

nottaketheplaceoftalkingtoyourdoctoror

pharmacist.

Allmedicineshaverisksandbenefits.Indecidingto

prescribeCILOXAN ® EyeOintmentforyou,your

doctorhasweighedthepotentialrisksandthe

expectedbenefits ofusingthis medicine.

TheinformationinthisleafletappliestoCILOXAN ®

EyeOintmentonly.Thisinformationdoesnotapply

tosimilarproducts,eveniftheycontainthesame

ingredients.

IfyouhaveanyconcernsaboutusingCILOXAN ®

EyeOintmentaskyourdoctororpharmacist.

Keepthis leafletwith your medicine.

You mayneed toread itagain.

What CILOXAN ®

EyeOintmentIsUsed

For

CILOXAN ® EyeOintmentcontainsthe active

ingredientciprofloxacin hydrochloride. Ciprofloxacin

hydrochloride is a“fluoroquinolone”antibiotic.

CILOXAN ® EyeOintmentisusedtotreatcertain

typesofeyeinfectionscausedbybacteria.Your

doctorwillusuallyprescribeCILOXAN ®

Eye

Ointmentbecause you have either:

anulceronthesurfaceofyoureye(corneal

ulcer),

or

atypeofeyeinfectionscalledbacterial

conjunctivitisorblepharitis.

BeforeYou UseCILOXAN ®

EyeOIntment

When youmustnotuse it

Youareallergictociprofloxacin,anyother

“quinolone”antibiotic(e.g.nalidixicacid)ortoany

oftheotheringredientsinCILOXAN ® EyeOintment

(thesearelistedunder“ProductDescription”);

Someofthesymptomsofan allergicreactionmay

include shortnessofbreath,wheezingordifficulty

breathing;swellingoftheface,lips,tongueorother

parts ofthe body;rash,itchingorhiveson the skin.

Do not useCiloxan ®

EyeOintment if:

Theimprintedcartonsealshavebeendamagedor

removed;

the bottle/packagingshows signs oftampering

the expirydateon the bottle/carton has passed.

Ifyou usethis medicineafterthe expirydate has

passed, itmaynotwork.

DonotputCILOXAN ®

EyeOintmentintoyour

eye(s)whileyou are wearingsoftcontactlenses.

TheointmentbaseofCILOXAN ® EyeOintmentmay

be verydifficultto clean offyourlenses. CILOXAN ®

maycauseirritationordiscoloursoftcontactlenses.

Contactlenseswearisnotrecommendedduring

CILOXAN ®

treatment.

DonotuseCILOXAN ® EyeOintmentinchildren

under12 months ofage.

Ifyouarenotsurewhetheryoushouldstartusing

Ciloxan ® EyeOintment,talk toyour doctor.

Beforeyou startto useit

Tellyour doctorifyou have had anallergyto any

othermedicinesor anyother substances, such as

foods, preservativesor dyes.

Tellyour doctorifyou are pregnantorplanto

become pregnantor are breast-feeding.Your

doctorcan discusswith youtherisks and benefits

involved.

Ifyou have nottold yourdoctoraboutany ofthe

above, tellthembeforeyou useCiloxan ® Eye

Ointment.

Using othermedicines

Tellyourdoctororpharmacistifyou are takingany

othermedicines,includingothereye drops or

ointments,andanyothermedicines thatyou buy

withoutaprescriptionfroma pharmacy, supermarket

orhealth food shop.

Somemedicines and Ciloxan ® EyeOintmentmay

interfere with each otheroradd totheeffectsof

Ciloxan ®

EyeOintment.Theseinclude:

medicinestothin yourblood (e.g. warfarin)

medicinesto preventtissuerejection(e.g.

cyclosporin)

theophylline forasthma orbreathingproblems

caffeine forthetreatmentofmigraines.

Thesemedicines maybe affected byCiloxan ®

Eye

Ointment, ormayaffecthowwellitworks. You may

need differentamounts ofyourmedicines,oryou

mayneed totake differentmedicines.

Yourdoctororpharmacisthasmore information on

medicinesto be carefulwith oravoid while using

Ciloxan ®

EyeOintment.

Howto useCILOXAN ® EyeOintment

Carefullyfollowalldirections givento youby

your doctor andpharmacist.Theymaydifferfrom

theinformationcontainedin this leaflet.

Ifyou are beingchanged fromonemedicine to

another,followyourdoctor’s instructions carefullyas

to whento stopthe medicine and when tostartthe

neweye ointment.

Ifyou donot understandthe instructionson the

carton/bottle, ask yourdoctoror pharmacistfor

help.

Howmuchto use

TheusualdoseofCILOXAN ® EyeOintment

dependsonthetypeandseverityofeyeinfectionthat

is beingtreated.

Theusualdoseforcornealulcersis:

1.25cmribbonintheaffectedeye(s)every1-2hours

aroundtheclockfor2days,thenevery4hoursfora

further12 days.

Yourdoctormaycontinueyourtreatmentwith

CILOXAN ® EyeOintmentuntilthesurfaceofyour

eye (cornea)iscompletelyhealed.

Theusualdoseforbacterialconjunctivitis(and

blepharitis)is:

1.25cmribbonintheaffectedeye(s)3timesperday

for2days, then twiceperdayfor5 additionaldays.

Yourdoctormaycontinueyourtreatmentwith

CILOXAN ® EyeOintmentuntiltheinfectionis

completelycleared.

DonotuseCILOXAN ® EyeOintmentmoreoften

Howtouseit

Itis importanttouseCiloxan ®

exactlyasyourdoctor

orpharmacisthastold you.Ifapplytheointmentless

often than prescribed,theymaynotworkaswelland

the eye problemmaynotimprove. Applyingthe

ointmentmore often than prescribed maynot

improve the eye problemanyfasterand maycause

increased sideeffects.

Ifyou are wearingsoftcontactlenses,remove them

before applyingthe ointmentintoeye.

HowtouseCILOXAN ® EyeOintment

FollowthesestepstouseCILOXAN ® Eye

Ointment:

1.Washyour hands thoroughly.

2.Removethecapfromthetube.Usingyour

forefinger,gentlypullyourlowereyelid

down to form a pouch(seeDiagram 1).

3.Usingyourotherhand,carefullysqueezea

smallribbon(1.25cm)ofointmentintothe

pouch (seeDiagram 2).

4.Makingsurethattheointmentremains

withintheeye,slowlycloseyoureye

withoutblinking(seeDiagrams3and4).

Keepyoureyeclosed for1 to 2 minutes.

5.Ifnecessary,repeattheabovesteps1-5for

yourother eye.

6.Placethe cap on the tubeand close ittightly.

7.Washyour handsagain.

Youmayfeelaslightburningsensationintheeye

shortlyafterusingCILOXAN ® EyeOintment.Ifthis

persists,orisveryuncomfortable,contactyour

doctororpharmacist.

Donottouchthetipofthetubetoyoureyeorto

any other surface.

This willhelp topreventyoureyeointmentbecoming

dirtyorcontaminated.

Whentouseit

UseCILOXAN ®

EyeOintmenteveryday,atabout

thesametimeseachdayunlessyourdoctortellsyou

otherwise.Usingyoureyeointmentatthe sametimes

eachdaywillhavethebesteffectonyoureye

pressure.Itwillalsohelpyourememberwhentouse

the eyeointment.

Howlongto useit

AsCILOXAN ®

EyeOintmentstarttokillthe

bacteria thatare causingthe infection youreye(s)will

feelbetter.Itisveryimportant,however,thatyou

continuetouseCILOXAN ®

EyeOintmentforthe

fulltreatmentperiodasdirectedbyyourdoctorto

ensure thattheinfection doesnotreturn.

Ifyouareunsureaboutwhentostopusing

CILOXAN ® EyeOintmentyoushouldtalkto

your doctor or pharmacist.

Ifyouforgettouse CILOXAN ® EyeOintment

IfyouforgettouseCILOXAN ®

EyeOintmentyou

shouldapplythedosethatyoumissedassoonasyou

rememberandthengobacktousingthemnormally.

Ifitisalmosttimeforyournextdose,skipthedose

thatyouhavemissedandtakeyournextdosewhen

you are dueto.

Nevertakeadoubledosetomakeupfortheone

that you missed.

Ifyouarenotsurewhattodo,contactyourdoctoror

pharmacist.

In caseofoverdose

Ifyouaccidentallyputtoomuchointmentinyour

eye(s)immediatelyrinseyoureye(s)withwarm

water.

IfanyoneaccidentallyswallowsCILOXAN ®

Eye

Ointmentimmediatelytelephonethenearest

PoisonsInformationCentre(inAustraliacall13

1126;inNewZealandcall0800POISONor0800

764766foradvice,orgotoAccidentand

Emergencyatyournearesthospital.Dothiseven

ifthere are no signs ofdiscomfortor poisoning.

WhileYouAreUsing CILOXAN ® Eye

Ointment

Things youmustdo

Tellyourdoctorif,foranyreason,youhave

notusedCILOXAN ®

EyeOintmentexactlyas

thattheeyeointmentwerenoteffectiveand

changethe treatmentunnecessarily.

Tellyourdoctorifyoubecomepregnantwhile

you are usingCILOXAN ® EyeOintment.

Tellyourdoctorandpharmacistthatyouare

usingCILOXAN ® EyeOintmentbeforeyou

starttakinganyothermedicines.

Things youmustnotdo

DonotuseCILOXAN ® EyeOintmenttotreat

othercomplaintsunlessyourdoctortellsyou

to.

DonotletchildrenhandleCILOXAN ® Eye

Ointment.Ifachildaccidentallyswallowsany

oftheointmentreadtheinstructionsunder“In

case ofoverdose”.

DonotstopusingCILOXAN ®

EyeOintment

withoutfirstaskingyourdoctor.

Donotgivethismedicine toanyoneelse,even if

theyappearto have the same conditionasyou.

Thingsto becarefulof

Becarefuldrivingoroperatingmachineryuntil

youknowhowCILOXAN ® EyeOintmentaffects

youandyourvision.Aswithanyeyemedicine,

temporaryblurredvisionorothervisual

disturbancesmayaffecttheabilitytodriveoruse

machineryinsomepeople.Ifblurredvision

occurswhenyouuseyourointment,waituntil

yourvisionisclearbeforedrivingoroperating

machinery.

SideEffects

Allmedicinescanhavesideeffects.Sometimesthey

areserious,mostofthetimetheyarenot.Youmay

needmedicaltreatmentifyougetsomeoftheside

effects.

Tellyourdoctorassoon as possibleifyoudonotfeel

wellwhile you areusingCILOXAN ® EyeOintment.

Donotbealarmedbythefollowinglistofpossible

sideeffects. Youmaynotexperience anyofthem.

MostsideeffectsfromCILOXAN ® EyeOintment

occurin,oraround, the eye. Theseinclude:

Redness,itching,irritation,pain,swellingor

discomfortinoraroundtheeye(s)and/or

eyelids;

Localdiscomfort(transientstinging,burning,

itchingorpain);

Awhiteprecipitateintheeye(s)orcrustingon

the eyelids;

Excesstearproductionordischargefromthe

eye(s);

Dryeye(s);

Staining,swellingorirregularappearanceofthe

frontofthe eye(s)(cornea);

Flakingskin ofthe eyelids

Anumb sensationin oraround the eye(s);

Tiredeyes

Allergic reactions;

Afeelingthatsomethingisin youreye(s);

Decreasedorblurred vision;

Double vision

Sensitivityto light.

Thesearethemostcommonsideeffectsofyour

medicine.Theyare usuallymild and shortlived.

Occasionallysomepeoplenoticeunwantedeffectsin

therestoftheirbodyasaresultofusingCILOXAN ®

EyeOinment. Theseeffectsmayinclude:

Badtasteinthemouthfollowingtheuseof

CILOXAN ® EyeOintment;

Dermatitis.

Nausea;

Diarrhoea orabdominalpain

Headache;

Dizziness

Earpain

Increased drainage fromthe sinuses.

Ifyou are elderlyorifyouaretakinginflammation-

inhibitingproducts similarto cortisone, you have a

higherriskofgettingtendon problems during

treatmentwith CILOXAN ® EyeOintment. Ifthis

occurs, stoptreatmentand immediatelyconsultyour

doctor.

Ifany ofthefollowing happen, stopusing the

CILOXAN ®

EyeOintmentandtellyourdoctor

immediatelyor goto Accident&Emergency at

your nearesthospital:

skin rash

swellingofface, hands orfeet

wheezing, difficultyin breathing

shortness ofbreath (dyspnoea, heartfailure)

severeandsuddenonsetofpinkish,itchy

swellingsontheskin,alsocalledhivesor

Thesehypersensitivityreactionscanbeveryserious

sideeffects.Youmayneedurgentmedicalattention

orhospitalization.Theseside effectsareveryrare.

Letyourdoctorknowifyounoticeanyunwanted

effectswhileusingCILOXAN ® EyeOintment,even

iftheydo notappearinthelistsabove.

AfterUsing CILOXAN ®

EyeOintment

StoreCILOXAN ® EyeOintmentinacoolplace,

below25C.DonotfreezeCILOXAN ® Eye

Ointment.

DonotleaveCILOXAN ® EyeOintmentinthecar

anddonotleaveitinthebathroomorinother

warm, damp places.

KeepCILOXAN ® EyeOintment,andallother

medicines,inasafeplaceawayfromchildren.A

lockedcupboardatleastone-and-halfmetresabove

the groundisa good placeto store medicines.

Disposal

Writethe date onthetubewhen you open theeye

ointmentandthrowoutany remaining solution

afterfourweeks.

Ifyour doctortellsyou tostop usingCILOXAN ®

EyeOintmentorthey have passed theirexpiry

date, ask your pharmacistwhatto dowiththe

remaining solution.

Product Description

Whatitlooks like

CILOXAN ® EyeOintmentcomesina3.5gtubewith

screwcap.

Ingredients

Active ingredients(s):

Ciprofloxacinhydrochloride(equiv.to3mg/g

ciprofloxacin)

Inactive ingredients:

MineralOil

White petrolatum

FurtherInformation

Thisleafletdoesnotcontainalloftheinformation

availableaboutCILOXAN ® EyeOintment.Ifyou

haveanyquestions,orarenotsureaboutanything

regardingyourmedicine,youshouldaskyourdoctor

orpharmacist.

Supplied By

In Australia this productis supplied by:

Alcon Laboratories (Australia)PtyLtd

25 FrenchsForestRoad East

FRENCHS FOREST NSW 2086

In NewZealandthis productis distributed by:

Alcon NewZealand Limited

c/o Pharmaco NZLimited

4 FisherCresent

MtWellington, Auckland

Thisleafletwas prepared on12January2011

RegisteredTrademark

CILOXAN ® (ciprofloxacin hydrochloride)3mg/gEyeOintment

NAMEOF MEDICINE

CILOXAN ®

(ciprofloxacin hydrochloride)3mg/gEyeOintment

PRESENTATION

CILOXANEyeOintmentcontainstheequivalentof3mg/gciprofloxacinbase,andhave

beenformulatedas asterile,multiple-dose product,fortopicalophthalmicuse.

CILOXANEyeOintmentalso containsmineraloiland white petrolatum.

USES

Actions

Ciprofloxacinhasinvitroactivityagainstawiderangeofgram-negativeandgram-positive

organisms,possessingthegreatestantibacterialactivityofallquinolones.

ThebactericidalactionofciprofloxacinresultsfrominterferencewiththeenzymeDNA

gyrasewhich is neededforthesynthesisofbacterialDNA.

Ciprofloxacinhasbeenshowntobeactiveagainstmoststrainsofthefollowingorganisms

bothin vitroand inclinicalinfections (seeINDICATIONS):

Gram-Positive:

Staphylococcusaureus(includingmethicillin-susceptibleandmethicillin-resistant

strains)

Staphylococcus epidermidis

Streptococcus pneumoniae

Viridans group ofStreptococcus

Gram-Negative:

Pseudomonas aeruginosa

Serratiamarcescens

Haemophilus influenzae

OtherOrganisms:

MoststrainsofPseudomonascepaciaandsomestrainsofPseudomonas

maltophiliaareresistanttociprofloxacinasaremostanaerobicbacteria,including

BacteroidesfragilisandClostridiumdifficile.

Theminimalbactericidalconcentration(MBC)generallydoesnotexceedtheminimal

inhibitoryconcentration(MIC)bymorethanafactorof2.Resistancetociprofloxacininvitro

usuallydevelopsslowly(multiple-stepmutation).Aplasmid-mediatedbacterialresistance

doesnotappeartooccurwiththefluoroquinoloneclassofantibiotics,however,parallel

resistance is seen with thisgroup ofgyraseinhibitors.

Duetoitsspecialmodeofactionthereisnocross-overresistancebetweenciprofloxacin

andotherantibacterialcompoundswithdifferentchemicalstructures,suchas-lactam

antibiotics,aminoglycosides,tetracyclines,macrolideandpeptideantibioticsaswellas

sulfonamides,trimethoprimand nitrofuranderivatives.

Pharmacokinetics

Absorption studies inhumanswith theCILOXANEye Ointmenthave notbeenconducted.

TwosystemicabsorptionstudieswereperformedinwhichCILOXANEyeDropsusingthe

conjunctivitisorcornealulcerdosingregimen.Inthestudyinvolvingthemoreintensive

dosingregimen(iecornealulcerindication),twodropswereadministeredinoneeyeevery

15minutesforsixhours,every30minutesfor18hours,thentwodropshourlyforoneday,

followedbytwo dropsevery4 hoursfor5 additionaldays.

Ineachstudy,themaximumreportedplasmaconcentrationofciprofloxacinwaslessthan5

ng/mL(some450-foldlessthanlevelsobservedfollowingsimple250mgoral

administration).Themean concentrationin each ofthestudies wereless than 2.5ng/mL.

ToxicologicalProperties

Ciprofloxacinandrelateddrugshavebeenshowntocausearthropathyinimmatureanimals

ofmostspeciestestedfollowingoraladministration.However,aone-monthtopicalocular

studywithciprofloxacinophthalmicsolutioninimmatureBeagledogsdidnotdemonstrate

anyarticularlesions.

Acutetopicaloculartoxicologystudiesperformedinrabbitsemployinganexaggerated

topicalocularexposureto0.3%,0.75%,or1.5%ciprofloxacinophthalmicsolutionshowed

findingsthatwereminimalandtransientinnature,confinedtotheconjunctivaandgenerally

comparable to those effectsobservedin theuntreatedcontroland vehicle controlgroups.

Asubchronic,one-monthtopicalocularirritationstudyof0.3%to1.5%ciprofloxacin

ophthalmicsolution did notdemonstrateanyapparentsystemic oroculartoxicityin rabbits.

ClinicalStudies

Thedatageneratedinsevenmulticentre,controlled,clinicalstudiesdemonstratethat

ciprofloxaciniseffective,biothmicrobiologicallyandclinically,inthetreatmentofcorneal

ulcers,conjunctivitis,andblepharitisofbacterialaetiology.Ciprofloxacinwasfoundtobe

effective(at ≤2µm/mL)againstallthemajorgroupsoforganismsassociatedwiththe

aboveoculardiseases.Ofspecialnoteistheclinicalsuccessrateof93%against

Pseudomonasaeruginosaassociatedwithcornealulcers.Ciprofloxacinwaseffectivein

eradicatinginfectivebacteriaassociatedwithconjunctivitisinadults,andinchildren.

Ciprofloxacinalsoeradicatedorreducedthebacteriaintheeyesof97.6%ofblephartis

patientscomparedwith 11.8%ofpatientsonplacebo.

INDICATIONS

Treatmentofcornealulcers,conjunctivitisandblepharitiscausedbysusceptiblestrainsof

bacteriain adultsand children12months ofage orolder.

DOSAGEANDADMINISTRATION

CornealUlcers

Therecommendeddosageregimenforthetreatmentofcornealulcersis:1.25cmribbon

appliedintotheconjunctivalsacevery1-2hoursaroundtheclockfortwodays,thenevery4

hoursfora further12days.Thedosingmaybeextended atthediscretion ofthephysician.

BacterialConjunctivitis/Blepharitis

Therecommendeddosageregimenforthetreatmentofbacterialconjunctivitisis:1.25

cmribbonappliedintotheconjunctivalsac(oronthelidmargin)threetimesdailyfortwo

days,thentwicedailyforafurtherfivedays.Thedosingmaybeextendedatthediscretion

ofthephysician.

CONTRAINDICATIONS

Ahistoryofhypersensitivitytociprofloxacinoranyothercomponentofthemedication.A

historyofhypersensitivitytootherquinolones,includingnalidixicacid,mayalso

contraindicatetheuseofciprofloxacin.

WARNINGSANDPRECAUTIONS

FOR TOPICAL USEONLY-NOTFOR INJECTION

FOR OCULARUSEONLY

Seriousandoccasionallyfatalhypersensitivity(anaphylactic)reactions,somefollowingthe

firstdose,havebeenreportedinpatientsreceivingsystemicquinolonetherapy.Some

reactionswereaccompaniedbycardiovascularcollapse,lossofconsciousness,tingling,

pharyngealorfacialoedema,dyspnoea,urticaria,anditching.Onlyafewpatientshada

historyofhypersensitivityreactions.Seriousanaphylacticreactionsrequireimmediate

emergencytreatmentwithadrenalineandotherresuscitationmeasures,includingoxygen,

intravenousfluids,intravenousantihistamines,corticosteroids,pressoraminesandairway

management,as clinicallyindicated.

Moderatetoseverephototoxicitymanifestedbyanexaggeratedsunburnreactionhasbeen

observedinsomepatientswhowereexposedtodirectsunlightwhilereceivingsome

membersofthequinoloneclassofdrugs,includingoralciprofloxacin.Excessivesunlight

should beavoided.

General

Aswithotherantibacterialpreparations,prolongeduseofciprofloxacinmayresultin

overgrowthofnonsusceptibleorganisms,includingfungi.Ifsuperinfectionoccurs,

appropriatetherapyshouldbeinitiated.WhenusingCILOXANeyeointmentoneshould

takeintoaccounttheriskofarhinopharyngealpassagewhichcancontributetothe

occurrence and thediffusionofbacterialresistance.

Wheneverclinicaljudgmentdictates,thepatient’seye(s)shouldbeexaminedwiththeaidof

magnification,suchasslitlampbiomicroscopyand,whereappropriate,fluoresceinstaining.

Ciprofloxacinshouldbediscontinuedatthefirstappearanceofaskinrashoranyothersign

ofhypersensitivityreaction.

Tendon inflammation and rupturemayoccurwith systemic fluoroquinolone therapyincluding

ciprofloxacin,particularlyin elderlypatientsand inthose treatedconcurrentlywith

corticosteroids.Thereforetreatmentwith CILOXAN0.3%EyeOintmentshould be

discontinuedatthefirstsign oftendon inflammation.

Contactlenswearisnotrecommendedduringtreatmentofanocularinfection.Therefore,

patientsshouldbeadvisednottowearcontactlensesduringtreatmentwithCILOXANeye

ointment.

UseinPregnancy-CategoryB3

Reproductionstudieshavebeenperformedinratsandmiceatdosesuptosixtimesthe

usualdailyhumanoraldoseandhaverevealednoevidenceofimpairedfertilityorharmto

thefoetusduetociprofloxacin.Inrabbits,aswithmostantimicrobialagents,ciprofloxacin

(30and100mg/kgorally)producedgastrointestinaldisturbancesresultinginmaternal

weightlossandanincreasedincidenceofabortion.Noteratogenicitywasobservedat

eitherdose.Afterintravenousadministrationatdosesupto20mg/kg,nomaternaltoxicity

wasproducedandnoembryotoxicityorteratogenicitywasobserved.There are noadequate

andwellcontrolledstudiesinpregnantwomen.Asaprecautionarymeasure,itispreferable

toavoidtheuseofCILOXANduringpregnancy.Ciprofloxacinshouldbeusedduring

pregnancyonlyifthepotentialbenefitjustifies thepotentialriskto thefoetus.

Usein Lactation

Itisnotknownwhethertopicallyappliedciprofloxacinisexcretedinhumanmilk,however,it

isknownthatorallyadministeredciprofloxacinisexcretedinthemilkoflactatingrats,and

oralciprofloxacinhasbeenreportedinhumanbreastmilkafterasingle500mgdose.

Cautionshould beexercised when ciprofloxacin is administeredto anursingmother.

Usein Children

SafetyandeffectivenessofCILOXANEyeOintmentweredeterminedin192children

betweentheagesofoneto12years.Noseriousadverseeventwasreportedinthese

patients.Theseclinicalstudieshaveindicatedthatdosagemodificationsarenotrequired

forchildren.There is noexperience inchildrenless than 1yearold.

Althoughciprofloxacinandotherquinolonescausearthropathyinimmatureanimalsafter

oraladministration,topicalocularadministrationofciprofloxacintoimmatureanimalsdidnot

causeanyarthropathy,andthereisnoevidencethattheophthalmicdosageformhasany

effectontheweight-bearingjoints.

UseofCILOXANeyeointmentinneonateswithophthalmianeonatorumisnot

recommendedasithasnotbeenevaluatedinsuchpatients.Neonateswithophthalmia

neonatorumshould receive appropriate treatmentfortheircondition.

Usein Elderly

Clinicalstudies have indicateddosage modifications are notrequiredfortheelderly

Usein Hepatic andRenalImpairment

NostudieshavebeenperformedusingCILOXANEyeOintmentinpatientswithkidneyor

liverproblems.

Carcinogenesis,Mutagenesis,ImpairmentofFertility

Eightinvitromutagenicitytestshavebeenconductedwithciprofloxacinandthetestresults

arelistedbelow:

SalmonellaMicrosome Test(Negative)

E.coliDNARepairAssay(Negative)

Mouse LymphomaCellForwardMutationAssay(Positive)

Chinese HamsterV

CellHGPRTTest(Negative)

SyrianHamsterEmbryo CellTransformation Assay(Negative)

Saccharomyces cerevisiaePointMutationAssay(Negative)

SaccharomycescerevisiaeMitoticCrossoverandGeneConversionAssay

(Negative)

RatHepatocyte DNARepairAssay(Positive)

Thus,twooftheeighttestswerepositive,buttheresultsofthefollowingthreeinvivotest

systemsgave negative results:

RatHepatocyte DNARepairAssay

MicronucleusTest(Mice)

DominantLethalTest(Mice)

Carcinogenicitystudiesinmice(oraldosesupto1090mg/kg/dayand1455mg/kg/dayin

malesandfemales,respectively)andrats(oraldosesupto241mg/kg/dayand328

mg/kg/dayin males and females,respectively)showednoevidenceofcarcinogenicity.

OtherAnimalStudies

Specialstudiesincludedacataractogenicpotentialstudyofsystemicciprofloxacininrats.

Theresultsindicatedthatciprofloxacinwasnotco-cataractogenic.Anintravenousstudyof

ciprofloxacinatdoselevelsupto20mg/kgovera6-monthperiodinRhesusmonkeys

indicatedtherewerenosignsofchangesinlenstransparencyduetotheadministrationof

ciprofloxacin.

Thearthropathogenicpotentialofsomequinolonesinimmatureanimalsafteroral

administrationisrecognised.Topicalocularadministrationofciprofloxacintoimmature

animalsdidnotcauseanyarthropathyandthereisnoevidencethattheophthalmicdosage

formhasanyeffectontheweight-bearingjoints.

Effects on Abilityto Drive andUseMachines

Temporarilyblurredvisionorothervisualdisturbancesmayaffecttheabilitytodriveoruse

machines.Iftransientblurredvisionoccursuponinstillation,thepatientmustwaituntilthe

visionclearsbeforedrivingorusingmachinery.

ADVERSEEFFECTS

Themostfrequentlyreporteddrugrelatedadversereactionwaslocaldiscomfort(transient

stingingandburninguponapplication)(1.4%).Incornealulcerstudieswithfrequent

administrationofthedrug,whiteprecipitateswereseeninapproximately3%ofpatients.

TheprecipitatesresolvedaftercontinuousapplicationofCILOXANEyeOintment.The

precipitatedoesnotprecludecontinuesuseofCILOXANEyeOintmentnordoesit

adverselyaffectthe clinicalcourse oftherecoveryprocess.

Uncommonophthalmicevents(occurringinlessthan1%andgreaterthan0.1%ofpatients)

includedblurredvision(0.8%),hyperaemia(0.7%),pruritus(0.6%),pain(0.6%),vision

decrease(0.6%),tearing(0.4%)andphotophobia (0.3%).

Uncommonsystemicevents(occurringinlessthan1%andgreaterthan0.1%ofpatients)

includedtasteperversion (metallictaste)(0.5%)and dermatitis (0.2%).

Post-marketingExperience

Thefollowingadversereactionsareclassifiedaccordingtothefollowingconvention:very

common,common,uncommon,rare,veryrare,ornotknown(cannotbeestimatedfromthe

availabledata),accordingtosystemorganclasses.Withineachfrequency-grouping,

adversereactionsarepresentedinorderofdecreasingseriousness.Theadversereactions

have beenobservedduringclinicaltrialsand post-marketingexperience.

Infections andinfestations

Rare(>0.01%to ≤0.1%):hordeolum,rhinitis

Immune systemdisorders

Rare(>0.01%to ≤0.1%):hypersensitivity

Nervoussystemdisorders:

Common(>1%to <10%):dysgeusia

Uncommon(>0.1%to ≤1%):headache

Rare(>0.01%to ≤0.1%):dizziness

Eyedisorders

Common(>1%to <10%):cornealdeposits,oculardiscomfort,ocularhyperaemia

Uncommon(>0.1% to≤1%):keratopathy,cornealinfiltrates,cornealstaining,

photophobia,visualacuityreduced,eyelidoedema,blurredvision,eyepain,dryeye,eye

swelling,eyepruritus,foreignbodysensationineyes,lacrimationincreased,eyedischarge,

eyelid margin crusting,eyelid exfoliation,conjunctivaloedema,erythema ofeyelid

Rare(>0.01%to≤0.1%):oculartoxicity,punctatekeratitis,keratitis,conjunctivitis,corneal

disorder,cornealepitheliumdefect,diplopia,hypoaesthesiaeye,asthenopia,eyeirritation,

eye inflammation,conjunctivalhyperaemia

Earand labyrinthdisorders

Rare(>0.01%to ≤0.1%):earpain

Respiratory,thoracic andmediastinaldisorders:

Rare(>0.01%to ≤0.1%):paranasalsinushypersecretion

Gastrointestinaldisorders:

common(>0.1%to ≤1%):nausea

Rare(>0.01%to ≤0.1%):diarrhoea,abdominalpain

Skinand subcutaneoustissuedisorders:

Rare(>0.01%to ≤0.1%):dermatitis

Generaldisordersand administrationsite conditions:

Rare(>0.01%to ≤0.1%):drugintolerance

Investigations

Rare(>0.01%to ≤0.1%):laboratorytestabnormal

Withlocallyappliedfluoroquinolones(generalized)rash,toxicepidermolysis,dermatitis

exfoliative,Stevens-Johnson syndromeand urticariaoccurveryrarely.

Seriousandoccasionallyfatalhypersensitivity(anaphylactic)reactions,somefollowingthe

firstdose,havebeenreportedinpatientsreceivingsystemicquinolonetherapy.Some

reactionswereaccompaniedbycardiovascularcollapse,lossofconsciousness,tingling,

pharyngealorfacialoedema,dyspnoea,urticaria,and itching.

Rupturesoftheshoulder,hand,Achilles,orothertendonsthatrequiredsurgicalrepairor

resultedinprolongeddisabilityhavebeenreportedinpatientsreceivingsystemic

fluoroquinolones.Studiesandpostmarketingexperiencewithsystemicfluoroquinolones

indicatethattheriskoftheserupturesmaybeincreasedinpatientsreceiving

corticosteroids,especiallygeriatricpatientsandintendonsunderhighstress,includingthe

Achillestendon.Todate,clinicalandpostmarketingdatahavenotdemonstratedaclear

associationbetweenCILOXANandmusculoskeletalandconnectivetissueadverse

reactions.

InpatientswithcornealulcerandfrequentadministrationofCILOXAN,whitetopicalocular

precipitates(medicationresidue)havebeenobservedwhichresolvedaftercontinued

applicationofCILOXAN.TheprecipitatedoesnotprecludethecontinueduseofCILOXAN,

nordoes itadverselyaffecttheclinicalcourse oftherecoveryprocess.

INTERACTIONS

Specificdruginteractionstudieshavenotbeenconductedwithophthalmicciprofloxacin.

However,thesystemicadministrationofsomequinoloneshasbeenshowntoelevate

plasmaconcentrationsoftheophylline,interferewiththemetabolismofcaffeine,enhance

theeffectsoftheoralanticoagulantwarfarinanditsderivativesandhavebeenassociated

with transientelevations inserumcreatininein patientsreceivingcyclosporinconcomitantly.

Giventhelowsystemicconcentrationofciprofloxacinfollowingtopicalocularadministration,

druginteractions are unlikelyto occur.

OVERDOSAGE

AtopicaloverdoseofCILOXANEyeOintmentmaybeflushedfromtheeye(s)withwarm

tapwater.Accidentaloralingestion ofCILOXANisnotlikelyto beassociatedwith toxicity.

Treatmentofanyexposureissymptomatic and supportive.

PHARMACEUTICAL PRECAUTIONS

Storebelow25°C.Donotfreeze.Discardcontainer4weeksafteropening.Consumer

ProductInformation is suppliedwith thisproduct.

Incompatibilities

Notapplicable.

MEDICINECLASSIFICATION

PrescriptionOnlyMedicine.

PACKAGEQUANTITIES

Eye ointmenttube containing3.5gofsterile eye ointment.

FURTHERINFORMATION

Pharmaceutical

Ciprofloxacin,afainttolightyellowcrystallinepowderwhichissolubleinwater,isa

fluoroquinoloneantibacterial.Thechemicalstructureofciprofloxacinhydrochlorideis

representedas:

Empiricalformula: C

.HCl.H

0

Molecularweight: 385.8

COOH F

HCl

H

Chemicalname: Themonohydrochloridemonohydratesaltof1-cyclopropyl-6-fluoro-

1,4-dihydro-4-oxo-7-piperazin-1-ylquinoline-3-carboxylicacid.

CASNumber: 86393-32-0

SPONSORDETAILS

AlconNewZealand Limited

c/o PharmacoNZ Limited

4 FisherCrescent

MtWellington,Auckland

DATEOF PREPARATION

1July2010

RegisteredTrademark

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