ALOMIDE

Israel - English - Ministry of Health

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Active ingredient:
LODOXAMIDE AS TROMETAMOL 1 MG/ML
Available from:
LAPIDOT MEDICAL IMPORT AND MARKETING LTD
ATC code:
S01GX
Pharmaceutical form:
OPHTHALMIC SOLUTION
Administration route:
OCULAR
Manufactured by:
ALCON COUVREUR, BELGIUM
Therapeutic group:
OTHER ANTIALLERGICS
Therapeutic indications:
For the treatment of symptoms associated with ocular allergies.
Authorization number:
103972816500
Authorization date:
2012-01-01

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

16-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

16-01-2021

KAPVORM PMS ZWART

à 100% - 30%

44210-6

KAPVORM PMS ZWART

à 100% - 30%

44210-6 02-2012 © 2006, 2008, 2011, 2012 Novartis

SAALCON-COUVREURNV ALOMIDE

TheformatofthisleafletwasdeterminedbytheMinistryofHealthanditscontentwas

checkedandapprovedinMarch2012

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEMEDICINALPRODUCT

ALOMIDEeyedrops,ophthalmicsolution.

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Lodoxamidetrometamol1,78mg/ml.

Forexcipients,seesection6.1.

3.PHARMACEUTICALFORM

Eyedrops,ophthalmicsolution.

4.CLINICALPARTICULARS

4.1Therapeuticindications

Forthetreatmentofsymptomsassociatedwithocularallergies.

4.2Posologyandmethodofadministration

Childrenandadults:1or2dropsineacheyefourtimesadayatregularintervals.

PatientsshouldbeadvisedthattheeffectofALOMIDEtherapyisdependentuponits

administrationatregularintervals.ThesafetyandefficacyofALOMIDEinchildrenbelow

theageoffouryearshavenotbeenestablished.

SymptomaticresponsetoALOMIDEtherapy(decreaseditching,tearing,redness,and

discharge)isusuallyevidentwithinaweek,butlongertreatmentforuptofourweeksis

sometimesrequired.

Oncesymptomaticimprovementhasbeenestablished,therapyshouldbecontinuedfor

aslongasneededtosustainimprovement.

Ifrequired,corticosteroidsmaybeusedconcomitantlywithALOMIDE,ontheadviceof

theophthalmologist.

4.3Contra-indications

ALOMIDEiscontraindicatedinpatientswhohaveaknownhypersensitivitytolodoxamide

ortooneoftheexcipientsofthispreparation.

SAALCON-COUVREURNV ALOMIDE

4.4Specialwarningsandspecialprecautionsforuse

ALOMIDEisnotforinjection.Therecommendedfrequencyofadministrationshouldnot

beexceeded.

PatientsmustremovecontactlensespriortoapplicationofALOMIDEandbeinstructedto

wait15minutesafterinstillationbeforere-insertingcontactlenses.ALOMIDEcontains

benzalkoniumchloride,apreservativethatmaycauseeyeirritationandisknownto

discoloursoftcontactlenses.

Followingmeasuresare,afterapplicationoftheeyedrops,usefultoreducesystemic

resorption:

- Keeptheeyelidclosedfor2minutes.

- Closethelacrimalductwiththefingerfor2minutes.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

InteractionsofALOMIDEwithothermedicinalproductshavenotbeenspecifically

evaluated.

Ifmorethanoneeyepreparationistobeused,patientsshouldwait15minutesbetween

eachapplication.

4.6Pregnancyandlactation

Pregnancy

Therearenoadequate,well-controlledstudiesontheuseofALOMIDEEyeDropsin

pregnantwomen.Studiesinanimalshaveshownneitherreproductivenordevelopmental

toxicityoflodoxamidetrometamolatoraldosesofmorethan5000timestheproposed

humandose. ItisnotexpectedthatALOMIDEEyeDropswilldemonstrateanyeffecton

reproductionorembryofetaldevelopment.ALOMIDEEyeDropsshouldbeusedduring

pregnancyonlyifclearlyneeded.

Lactation

Itisnotknownwhetherlodoxamidepassesintohumanmilk.Becausemanydrugsare

excretedinhumanmilk,cautionshouldbeexercisedwhenALOMIDEisadministeredto

nursingmothers.

4.7Effectsonabilitytodriveandusemachines

Aswithanyeyedrop,temporarilyblurredvisionorothervisualdisturbancesmayaffectthe

abilitytodriveorusemachines.Ifblurredvisionoccursatinstillation,thepatientmustwait

untilthevisionclearsbeforedrivingorusingmachinery.

SAALCON-COUVREURNV ALOMIDE

4.8Undesirableeffects

DuringclinicalstudieswithALOMIDE,themostfrequentlyreportedundesirableeffects(in

about13%ofpatients)weretransienteyeirritation(burning),eyepain(stinging),orocular

discomfort.

ThefollowingundesirableeffectswerereportedduringclinicaltrialswithALOMIDE:

Nervoussystemdisorders

Uncommon(≥0.1%<1%):dizziness,headache,somnolence.

Eyedisorders

Verycommon(≥10%):eyeirritation,eyepain,oculardiscomfort.

Common(≥1%<10%):dryeye,eyepruritus,eyelidmargincrusting,increased

lacrimationincreased,ocularhyperemia,blurredvision.

Uncommon(≥0.1%<1%):abnormalsensationineye(ocularwarmingsensation,sticky

sensation),anteriorchambercell,asthenopia(ocularfatigue),blepharitis,conjunctival

oedema,cornealabrasion,cornealerosion,eyeallergy,eyedischarge,eyedisorder

(epitheliopathy),eyeoedema,eyelidoedema,foreignbodysensationineyes,keratitis,

keratopathy,visualdisturbance(dimvision).

Respiratory,thoracicandmediastinaldisorders

Uncommon(≥0.1%<1%):sneezing,nasaldryness.

Gastrointestinaldisorders

Uncommon(≥0.1%<1%):nausea,stomachdiscomfort.

SkinandSubcutaneousTissueDisorders

Uncommon(≥0.1%<1%):rash.

GeneralDisordersandAdministrationSiteConditions

Uncommon(≥0.1%<1%):feelinghot.

4.9Overdose

Intheeventofatopicaloverdose,flushtheeye(s)withrunningwater.Accidental

overdoseofanoralpreparationof120to180mgoflodoxamideresultedintemporary

sensationofwarmth,profusesweating,diarrhoea,light-headednessandafeelingof

stomachdistension;nopermanentadverseeffectswereobserved.

Treatmentofasuspectedingestionissymptomaticandsupportive.

5.PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:otheranti-allergics

ATCcode:S01GX05

SAALCON-COUVREURNV ALOMIDE

Lodoxamideisamastcellstabiliserwhich,followingextensiveinvivostudiesinanimals

andman,hasbeendemonstratedtoinhibittypeIimmediatehypersensitivityreactions.

Therefore,itisanticipatedthatlodoxamidewillbeusefulinthetreatmentofnon-infectious

oculardiseaseswheretypeIimmediatehypersensitivityplaysamajorroleinthe

pathogenesis.

Invitrostudieshavedemonstratedtheabilityoflodoxamidetostabilisemastcellsand

preventtheantigenspecificinducedreleaseofhistamine.Inaddition,lodoxamide

preventsthereleaseofothermastcellinflammatorymediators(i.e.SRS-a,slowreacting

substancesofanaphylaxis,alsoknownasthepeptido-leukotrienes).

Lodoxamideinhibitshistaminereleaseinvitrobypreventingthecalciuminfluxintothe

mastcellafterstimulation.

Inoneof3double-maskedclinicalstudies,lodoxamidewassignificantlymoreeffective

thansodiumcromoglycate2%.

Inadouble-maskedcomparativestudywithsodium-cromoglycate4%nodifferencewas

observed,exceptingiantpapillaryconjunctivitis,wherelodoxamidewasmoreeffectivefor

symptomsbutnotforothers,oncertaindays.

Lodoxamidehasnointrinsicvasoconstrictor,antihistaminic,cyclooxygenaseinhibitionor

otheranti-inflammatoryactivity.

5.2Pharmacokineticproperties

Nodataprovided.

5.3Preclinicalsafetydata

Nodataprovided.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzalkoniumchloride0,07mg–mannitol–disodiumedetate–hypromellose–sodium

citrate–citricacidmonohydrate–tyloxapol–sodiumhydroxideand/orhydrochloricacid

andpurifiedwaterto1ml.

6.2Incompatibilities

Noneknown.

6.3Shelflife

Unopened:24months.

Seeexpirydateonthepackageafterthesign"Exp."(month/year).

Discardfourweeksafterfirstopeningofthebottle.

SAALCON-COUVREURNV ALOMIDE

6.4Specialprecautionsforstorage

Storeupright,Donotstoreabove25 0

C.

6.5Natureandcontentsofcontainer

Droptainerof5and10ml.

Notallpacksizesmaybemarketed.

6.6Instructionsforuse[and][,]handling[anddisposal]

Nospecialrequirements.

7.MANUFACTURER

Alcon-CouvreurNV

Rijksweg14

2870Puurs

Belgium

8.LICENSENUMBER

103972816500

9.LICENSEHOLDER

LapidotMedicalImport&MarketingLtd.

8HashitaSt.CaesareaIndustrialPark38900

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