BETOPTIC 0.25% EYEDROPS

Main information

  • Trade name:
  • BETOPTIC 0.25% EYEDROPS
  • Dosage:
  • 0.25 %w/v
  • Pharmaceutical form:
  • Eye Drops Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BETOPTIC 0.25% EYEDROPS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0290/061/002
  • Authorization date:
  • 21-10-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0290/061/002

CaseNo:2064903

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

AlconLaboratories(UK)Ltd

PentagonPark,BoundaryWay,HemelHempstead,HertfordshireHP27UD,England

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Betoptic0.25%w/vEyeDrops,Suspension

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom16/06/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/06/2009 CRN 2064903 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Betoptic0.25%w/vEyeDrops,Suspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Betaxolol0.25%w/v(ashydrochloride).

Excipients:BenzalkoniumChloride0.01%w/v

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Eyedrops,suspension

Whitetooff-white,sterile,multidose,preservedsuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

BETOPTICSUSPENSIONisindicatedforthereductionofelevatedintra-ocularpressureinpatientswithocular

hypertensionandchronicopen-angleglaucoma.

4.2Posologyandmethodofadministration

Therecommendeddoseisonedropintheaffectedeye(s)twicedaily.Insomepatients,theintraocularpressure

loweringresponsestoBETOPTICSUSPENSIONmayrequireafewweekstostabilize.Aswithanynew

medication,carefulmonitoringofpatientsisadvised.

Iftheintraocularpressureofthepatientisnotadequatelycontrolledonthisregimen,concomitanttherapywith

pilocarpineandothermioticsand/orepinephrineand/orcarbonicanhydraseinhibitorscanbeinstituted.

Children

BetopticSuspensionisnotrecommendedforuseinchildren.

4.3Contraindications

Hypersensitivitytoanycomponentofthismedicationortobeta-adrenoceptorblockers.BETOPTIC

SUSPENSIONiscontraindicatedinpatientswithsinusbradycardia,anduncorrectedgreaterthanafirstdegree

atrioventricularblock,cardiogenicshock,orpatientswithovertcardiacfailure.

4.4Specialwarningsandprecautionsforuse

Ophthalmicbetaxololhasbeenshowntohaveaminoreffectonheartrateandbloodpressureinclinicalstudies.

Cautionshouldbeusedintreatingpatientswithahistoryofcardiacfailureorheartblock.Treatmentwith

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/06/2009 CRN 2064903 page number: 2

DiabetesMellitus:Beta-adrenergicblockingagentsshouldbeadministeredwithcautioninpatientssubjectto

spontaneoushypoglycaemiaortodiabeticpatients(especiallythosewithlabilediabetes)whoarereceivinginsulin

ororalhypoglycemicagents.Beta-adrenergicreceptorblockingagentsmaymaskthesignsandsymptomsofacute

hypoglycaemia.

Thyrotoxicosis:Beta-adrenergicblockingagentsmaymaskcertainclinicalsigns(e.g.,tachycardia)of

hyperthyroidism.Patientssuspectedofdevelopingthyrotoxicosisshouldbemanagedcarefullytoavoidabrupt

withdrawalofbeta-adrenergicblockingagents,whichmightprecipitateathyroidstorm.

MajorSurgery:Considerationshouldbegiventothegradualwithdrawalofbeta-adrenergicblockingagents

priortogeneralanesthesiabecauseofthereducedabilityofthehearttorespondtobeta-adrenergicallymedicated

sympatheticreflexstimuli.

Pulmonary:Althoughcardioselectivebeta-blockershavelesseffectonlungfunctionthannon-selectivebeta-

blockers,cautionshouldbeexercisedinthetreatmentofglaucomapatientswithobstructivepulmonarydisease.

TherehavebeenreportsofasthmaticattacksandpulmonarydistressduringBetoptictreatmentinsuchpatients.In

individualcases,therisktobenefitforeachpatientshouldbeconsidered.Anincreaseinairwayresistancecanbe

relievedbyinhaledbeta

-mimetics.

Incontrolledclinicalstudies,ophthalmicbetaxololhasshownminimaleffectonpulmonaryandcardiovascular

parameters.

Ocular:Inpatientswithangle-closureglaucoma,theimmediatetreatmentobjectiveistoreopentheangleby

constrictionofthepupilwithamioticagent.Betaxololhaslittleornoeffectonthepupil.WhenBETOPTIC

SUSPENSIONisusedtoreduceelevatedintraocularpressureinangle-closureglaucoma,itshouldbeusedwitha

mioticandnotalone.

Therehavebeenreportsofdryeyesassociatedwiththetopicalocularuseofbeta-blockingagents.Cautionshould

beexercisedintheuseofbeta-blockingagentsinpatientswithSiccaSyndromeorsimilartearfilmabnormalities.

Cautionshouldbeusedwhenprescribingforpatientswithdecreasedimmunoresponsiveness.

Safetyandeffectivenessinchildrenhavenotbeenestablished.

BETOPTICSUSPENSIONispreservedwithbenzalkoniumchloride,whichmaycauseeyeirritation.Itisalsoknown

todiscoloursoftcontactlensesandshouldnotbeusedwhilethepatientiswearingsoftcontactlenses.Contactlens

wearersmustremovetheirlensespriortoinstillationofBETOPTICSUSPENSIONandwaitfor15minutesafter

dosingbeforereinsertingthecontactlenses.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Patientswhoarereceivingabeta-adrenergicblockingagentorallyandBETOPTICSUSPENSIONshouldbe

observedforpotentialadditiveeffecteitherontheintraocularpressureorontheknownsystemiceffectsofbeta

blockade.

Closeobservationofthepatientisrecommendedwhenabeta-blockerisadministeredtopatientsreceiving

catecholamine-depletingdrugssuchasreserpine,becauseofpossibleadditiveeffectsandtheproductionof

hypotensionand/orbradycardia.

Betaxololisanadrenergicblockingagent;therefore,cautionshouldbeexercisedinpatientsusingconcomitant

adrenergicpsychotropicdrugs.

Althoughadruginteractionisunlikelybecauseofthelowsystemiclevelsattainedwithophthalmicdosesof

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/06/2009 CRN 2064903 page number: 3

4.6Pregnancyandlactation

ReproductionstudieshavebeenconductedwithorallyadministeredbetaxololHCIinratsandrabbits.Therewas

evidenceofdrugrelatedpostimplantationlossinrabbitsandratsatdoselevelsabove12mg/kgand128mg/kg

(1500and16,000timesthemaximumrecommendedhumanoculardose),respectively.BetaxololHCIwasnot

showntobeteratogenic,however,andtherewerenootheradverseeffectsonreproductionatsubtoxicdoselevels.

However,therearenoadequatewellcontrolledstudiesinpregnantwomen.

BETOPTICSUSPENSIONshouldbeusedduringpregnancyonlyifthepotentialbenefitjustifiesthepotential

risktothefoetus.

ItisnotknownwhetherbetaxololHCIisexcretedinhumanmilk.Becausemanydrugsareexcretedinhuman

milk,cautionshouldbeexercisedwhenBETOPTICSUSPENSIONisadministeredtonursingwomen.

4.7Effectsonabilitytodriveandusemachines

TheabilitytodriveandusemachinesisunlikelytobeaffectedfollowingtheuseofBETOPTICSUSPENSION.

4.8Undesirableeffects

Topicallyappliedbeta-adrenergicblockingagentsmaybeabsorbedsystemically.Adversereactionsfoundwith

systemicadministrationofbeta1-adrenergicblockingagentsmayoccurwithtopicaladministration(see4.4

SpecialWarnings).

Ocular:

Transientoculardiscomfort,suchasocularstingingandburning,blurredvision,cornealdisease,suchascorneal

punctatestaining,superficialpunctatekeratitis,foreignbodysensation,photophobia,tearing,itching,erythema,

mayoccuroccasionally.

Allergicreactions,decreasedcornealsensitivity,anddrynessofeyescannotbeexcluded.

Systemic:

Systemicreactionsfollowingtopicaladministrationofbetaxololhavebeenrarelyreported.Theseinclude:

Bradycardia,dyspnea,asthma,insomnia,headaches,depression,alopecia.

4.9Overdose

Noinformationisavailableonoverdosageofhumansafterocularapplication.TheoralLD

ofthedrugranged

from350-920mg/kginmiceand860-1050mg/kginrats.Thesymptomswhichmightbeexpectedwithan

overdoseofsystemicallyadministeredbeta-1-adrenergicreceptorblockingagentarehypotension,bradycardiaand

acutecardiacfailure.

Noinformationisavailableonoverdosageafterocularadministration.AtopicaloverdoseofBETOPTIC

SUSPENSIONmaybeflushedfromtheeye(s)withwarmtapwater.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Betaxolol,acardioselective(beta-1-adrenergic)receptorblockingagent,doesnothavesignificantmembrane-

stabilizing(localanaesthetic)activityandisdevoidofintrinsicsympathomimeticaction.Orallyadministeredbeta-

adrenergicblockingagentsmayreducecardiacoutputinhealthysubjectsandpatientswithheartdisease.In

patientswithsevereimpairmentofmyocardialfunction,beta-adrenergicreceptorantagonistsmayinhibitthe

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/06/2009 CRN 2064903 page number: 4

BetaxololhasnosignificanteffectonpulmonaryfunctionasmeasuredbyForcedExpiratoryVolume(FEV

ForcedVitalCapacity(FVC),FEV

/FVCandnoevidenceofcardiovascularbeta-adrenergic-blockadeduring

exercisewasobserved.

Wheninstilledintheeye,betaxololhastheactionofreducingelevatedaswellasnormalintraocularpressure

(IOP),whetherornotaccompaniedbyglaucoma.Itisthoughttoproducethiseffectbyreducingtherateof

productionofaqueoushumourasdemonstratedbytonographyandaqueousfluorophotometry.

BETOPTICSUSPENSIONprovidesIOPloweringactivityequivalenttothatdemonstratedbyBETOPTIC

OphthalmicSolution0.5%.ElevatedIOPpresentsamajorriskfactoringlaucomatousfieldloss.Thehigherthe

levelofIOP,thegreaterthelikelihoodofopticnervedamageandvisualfieldloss.Ophthalmicbetaxololhaslittle

ornoeffectontheconstrictionofthepupilandminimaleffectonpulmonaryandcardiovascularfunction.

5.2Pharmacokineticproperties

Theonsetofactionofbetaxololcangenerallybenotedwithin30minutesandthemaximaleffectcanusuallybe

detected2hoursaftertopicaladministration.Asingledoseprovidesa12-hourreductioninintraocularpressure.

Thepolarnatureofbetaxololcanproduceapparentoculardiscomfort.Inthisformulation,betaxololmoleculesare

ionicallyboundtotheamberliteresin.Uponinstillationthebetaxololmoleculesaredisplacedbyionsinthetear

film.Thisdisplacementprocessoccursoverseveralminutesandenhancestheocularcomfortobservedfor

BETOPTICSuspension.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzalkoniumchloride

Poly(styrenedivinylbenzene)sulphonicacid

Carbomer

Mannitol

N-Lauroylsarcosine

Boricacid

Disodiumedetate

Hydrochloricacidand/orsodiumhydroxide(forpHadjustment)

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Unopened:2years

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/06/2009 CRN 2064903 page number: 5

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

BETOPTICSUSPENSIONispackagedasa5mLlabelfillina5mLanda10mLlabelfillina10mLnatural

lowdensitypolyethylene(LDPE),DROP-TAINER withaLDPEdispensingpluganda15mmwhite

polypropyleneclosure.TheDROP-TAINER utilizesatamperevidentclosurewithabreakawayring.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Shakebeforeeachuse.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

AlconLaboratories(UK)Ltd.

PentagonPark

BoundaryWay

HemelHempstead

Hertfordshire,HP27UD

England

8MARKETINGAUTHORISATIONNUMBER

PA290/61/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:21October1993

Dateoflastrenewal:21October2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/06/2009 CRN 2064903 page number: 6