BLEPHAMIDE LIQUIFILM

Main information

  • Trade name:
  • BLEPHAMIDE LIQUIFILM
  • Dosage:
  • 0.22/10.3 %w/v
  • Pharmaceutical form:
  • Eye Drops Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BLEPHAMIDE LIQUIFILM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0148/021/001
  • Authorization date:
  • 01-04-1977
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA0148/021/001

CaseNo:2031031

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

AllerganPharmaceuticalsIreland

CastlebarRoad,Westport,Co.Mayo,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

BlephamideLiquifilmTopicalOpthalmicSuspension

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom21/12/2006until31/03/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/12/2006 CRN 2031031 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BlephamideLiquifilmTopicalOphthalmicSuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forexcipients,see6.1

3PHARMACEUTICALFORM

EyeDropsSuspension

Anoff-whitetoslightlyyellow,microfinesuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofnonpurulentblepharitisandblepharoconjunctivitis(seborrheal,staphylococcal,allergic),andnonpurulent

conjunctivitis(allergicandbacterial).

4.2Posologyandmethodofadministration

Onedroptwotofourtimesdaily,dependingupontheseverityofthecondition.

Ingeneral,duringearlyoracutestagesofblepharitis,Blephamideproducesresultsmostrapidlyandmostefficiently

withinstillationdirectlyintotheeye,withtheexcessspreadonthelid.

Whentheconditionisconfinedtothelid,however,Blephamidemaybeapplieddirectlytothesiteofthelesions.

4.3Contraindications

Contraindicatedinpatientshypersensitivetoanyingredientandinocularinfectionsduetomicro-organismsresistantto

sulphacetamide.Itisalsocontraindicatedinthepresenceofocularviralinfections,suchassuperficial(orepithelial)

herpessimplexkeratitis(dendritickeratitis),vacciniaorvaricella,fungalinfectionsoftheocularstructuresor

tuberculosisoftheeye.

4.4Specialwarningsandprecautionsforuse

Indiseasesduetomicroorganismsresistanttosulfacetamide,infectionmaybemasked,enhancedoractivatedbythe

steroid.Prolongedusemayresultintheovergrowthofnon-susceptibleorganisms,ormayaidintheestablishmentof

secondaryocularinfectionsfromfungiorvirusesfromoculartissue,ormaysuppressthehostimmuneresponsein

oculartissuesandthusincreasethepossibilityofsecondaryinfections.Iftheinfectiondoesnotrespondpromptly,

Blephamideshouldbediscontinueduntiltheinfectionhasbeencontrolledbyothermeans.

Variousoculardiseasesandlong-termuseoftopicalcorticosteroidshavebeenknowntocausecornealandscleral

ActiveIngredient Percent(w/v)

Sulfacetamidesodium 10.00

Prednisoloneacetate 0.20

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/12/2006 CRN 2031031 page number: 2

Fungalinfectionsofthecorneaareparticularlypronetodevelopcoincidentallywithlongtermsteroidapplication.

Whensignsofchronicocularinflammationpersistfollowingprolongedcorticosteroiddosing,thepossibilityoffungal

infectionsofthecorneashouldbeconsidered.Fungalcultureshouldbetakenwhenappropriate.

Prolongedorcontinueduseofcorticosteroidsmayincreaseintraocularpressure.Thereforeintraocularpressuremustbe

frequentlycontrolledparticularlyinpatientswithahistoryofpresenceofglaucoma.

Topicalcorticosteroidsshouldnotbeusedforlongerthanoneweekexceptunderophthalmicsupervisionwithregular

checksofintraocularpressure.

Prolongeduseofanti-infectivemayresultinthedevelopmentofsuperinfectionduetoorganisms,includingfungi,

resistanttothatanti-infective.Sulphonamidesareinactivatedbytheaminobenzoicacidpresentinpurulentexudates.

Theanti-infectivemaybetoxicifabsorbedfromopensurfaces.

Useofocularcorticosteroidmedicationinthetreatmentofpatientswithahistoryofherpessimplexrequiresgreat

caution;frequentslitlampmicroscopyisrecommended.

Useofocularsteroidsmayprolongthecourseandmayexacerbatetheseverityofmanyviralinfectionsoftheeye.As

withallsulphonamidepreparations,severesensitivityreactions,e.g.Stevens-Johnsonsyndrome,fever,skinrash,GI

disturbancesandbonemarrowdepressionhavebeenidentifiedinindividualswithnopriorhistoryofsulphonamide

hypersensitivity.Asignificantpercentageofstaphylococcalisolatesareresistanttosulphadrugs.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Blephamidesuspensionisincompatiblewithsilverpreparations.

4.6Pregnancyandlactation

Pregnancy:

Therearenoadequateandwellcontrolledstudiesinpregnantwomen,thereforethisproductshouldbeusedin

pregnancyonlyifthepotentialbenefitoutweighsthepotentialrisktothefoetus.

Nursingmothers:

Itisnotknownwhethertopicaladministrationcouldresultsinsufficientsystemicabsorptiontoproducedetectable

quantitiesinbreastmilk.Cautionshouldbeexercisedwhenthisproductisadministeredtoanursingwomantaking

intoconsiderationtheimportanceofthedrugtothemother.

Useinchildren:

Safetyandeffectivenessinpaediatricpatientsbelowtheageoftwoyearshasnotbeenestablished.

4.7Effectsonabilitytodriveandusemachines

Noneknown

4.8Undesirableeffects

Themostoftenfromthepresenceoftheanti-infectivecomponentareallergicsensitizations.

Thosereactionsassociatedwiththecorticosteroidcomponentincludeglaucomawithopticnervedamage,visualacuity

offielddefects,posteriorsubcapsularcataractformation,secondaryocularinfection,perforationoftheglobeand

delayedwoundhealing.

Occasionallykeratitis,conjunctivitis,cornealulcers,mydriasis,conjunctivalhyperaemia,alossofaccommodationand

ptosishavebeenreportedfollowinglocaluseofcorticosteroids,however,acasualrelationshipwasnotdetermined.

4.9Overdose

Forknownsymptomsofoverdosageandparticularsofitstreatment:

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/12/2006 CRN 2031031 page number: 3

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Sodiumsulphacetamideisapotentbacteriostaticagent(effectiveagainstavarietyofpathogens).Theprednisolone

contentintheformulationeffectivelycounterstheallergicandinflammatorymanifestationsofblepharitis.The

phenylephrinecomponentrapidlywhitenstheengorgedvesselsintheeyeandlid.

5.2Pharmacokineticproperties

Afterabsorption,prednisoloneacetatehydrolysesrapidlytotheactivemetaboliteprednisolone.

Afteruseof50µlofa1%suspensionofprednisoloneacetateinhumaneyes,thefollowingactivedrugconcentrations

werefoundinaqueous:

TherearenopharmacokineticorbioavailabilitydataconcerningsulfacetamidesodiuminBlephamideorother

comparablepreparations.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Polyvinylalcohol

Polysorbate80

Phenylmercuricnitrate

Sodiumphosphatemonobasicmonohydrate

Sodiumphosphatedibasicheptahydrate

Edetatedisodium

Phenazone(Antipyrine)

Sodiumthiosulfatepentahydrate

Hydrochloricacid

Purifiedwater

6.2Incompatibilities

Minutes ng/ml

0-30 49.6

31-60 171.4

61-90 301.9

91-120 669.6

121-180 659.9

181-240 453.0

241-360 251.5

361-720 132.9

721-1080 99.5

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/12/2006 CRN 2031031 page number: 4

6.3ShelfLife

Theshelf-lifeexpirydateforthisproductshallnotexceed1yearfromthedateofitsmanufacture.

Discard28daysafteropening.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Donotrefrigerateorfreeze.

Keepcontainerinoutercartontoprotectfromlight.

6.5Natureandcontentsofcontainer

5mland10mlplasticcontrolleddropperbottlescontaininganoff-whitetoslightlyyellowmicrofinesuspension.

Bottlesandtipsaremadefromlowdensitypolyethylene,capsaremadeofpolystyrene,andallcomponentscontaina

whitecolorant.Eachunitofthedrughasasafetysealaroundthebottlecaptoinsureintegrityoftheproduct.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Topreventcontamination,donottouchthedroppertiptoanysurface.

Storeinanuprightposition.

Keepbottletightlyclosedwhennotinuse.

7MARKETINGAUTHORISATIONHOLDER

AllerganPharmaceuticals(Ireland)Ltd,

CastlebarRoad,

Westport,

CountyMayo

8MARKETINGAUTHORISATIONNUMBER

PA148/21/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1 st

April1977

Dateoflastrenewal:1 st

April2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/12/2006 CRN 2031031 page number: 5