BETOPTIC

Main information

  • Trade name:
  • BETOPTIC Eye Drops Solution 0.5%w/v %w/v
  • Dosage:
  • 0.5%w/v %w/v
  • Pharmaceutical form:
  • Eye Drops Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BETOPTIC Eye Drops Solution 0.5%w/v %w/v
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA0465/143/001A
  • Authorization date:
  • 10-06-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Betoptic0.5%w/v,Eyedrops,solution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Betaxolol0.5%w/v(ashydrochloride)

Forexcipients,see6.1.

3PHARMACEUTICALFORM

EyeDrops,solution

Clear,colourlesstopaleyellowsterile,eyedropssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Betopticisindicatedforthereductionofelevatedintraocularpressureinpatientswithocularhypertensionandchronic

openangleglaucoma

4.2Posologyandmethodofadministration

Adults(includingtheelderly)

Theusualdoseisonedroptobeinstilledintotheaffectedeye(s)twicedaily.

Children

Betopticisnotrecommendedforuseinchildren.

4.3Contraindications

Betopticiscontraindicatedinpatientswithsinusbradycardiagreaterthanafirstdegreeblock,cardiogenicshockora

historyofovertcardiacfailureandinpatientswithhypersensitivitytoanycomponent.

4.4Specialwarningsandprecautionsforuse

Patientswhoarereceivingabeta-adrenergicblockingagentorallyandBetopticshouldbeobservedforpotential

additiveeffecteitheronintraocularpressureortheknownsystemiceffectsofbeta-blockade.

WhileBetoptichasdemonstratedalowpotentialforsystemiceffects,itshouldbeusedwithcautioninpatientswith

diabetes(especiallylabilediabetes)orinpatientssuspectedofdevelopingthyrotoxicosis.

Considerationshouldbegiventothegradualwithdrawalofbeta-adrenergicblockingagentspriortogeneral

anaesthesiabecauseofthereducedabilityofthehearttorespondtobeta-adrenergicallymediatedsympatheticreflex

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Betoptic,acardioselectivebeta-blocker,hasproducedonlyminimaleffectsinpatientswithreversibleairway

obstruction,however,cautionshouldbeexercisedinthetreatmentofpatientswithahistoryofobstructivepulmonary

disease.

Inpatientswithangle-closureglaucoma,theimmediatetreatmentobjectiveistore-opentheanglebyconstrictionof

thepupilwithamioticagent,betaxololhasnoeffectonthepupil,therefore,Betopticshouldbeusedwithamioticto

reduceelevatedintraocularpressureinangle-closureglaucoma.

Thisproductcontainsbenzalkoniumchlorideandisnotrecommendedforusewhensoftcontactlensesarebeingworn.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

AlthoughBetopticusedalonehaslittleornoeffectonpupilsize,mydriasisresultingfromconcomitanttherapywith

Betopticandadrenalinehasbeenreportedoccasionally.

Closeobservationofthepatientisrecommendedwhenabetablockerisadministeredtopatientsreceiving

catecholamine-depletingdrugssuchasreserpine,becauseofpossibleadditiveeffectsandtheproductionof

hypotensionand/orbradycardia.Cautionshouldbeexercisedinpatientsusingconcomitantadrenergicpsychotropic

drugs.

4.6Pregnancyandlactation

Althoughanimalstudieshavenotdemonstratedanyspecifichazardtherearenoadequateandwell-controlledstudiesin

pregnantwomen.Becauseanimalstudiesarenotalwayspredictiveofhumanresponsethisdrugshouldbeusedduring

pregnancyonlyifclearlyindicated.

ItisnotknownwhetherBetopticisexcretedinhumanmilk,cautionshouldthereforebeexercisedwhenBetopticis

administeredtonursingmothers

4.7Effectsonabilitytodriveandusemachines

Noeffectsonabilitytodriveandusemachineshavebeenreported.

4.8Undesirableeffects

AlthoughBetopticisgenerallywelltolerated,discomfortofshortdurationmaybeexperiencedbysomepatientsupon

instillationandoccasionaltearinghasbeenreported.

OcularEffects

Common:discomfort

Uncommon:tearing

Rare:decreasedcornealsensitivity,erythema,itching,cornealpunctatestaining,keratitis,anisocoriaandphotophobia.

Systemicreactionsfollowingtopicaladministrationofbetaxololhavebeenrarelyreported.

SystemicEffects:

Nervous:

Rare:insomnia,depression

BodyasaWhole:

Rare:headache

Cardiovascular:

Rare:bradycardia

Respiratory:

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SkinandAppendages:

Rare:alopecia

Sincetopicallyappliedbeta-adrenergicblockingagentsmaybeabsorbedsystemically,adversereactionsfoundwith

systemicadministrationofbeta

-adrenergicblockingagentsmayoccurwithtopicaladministration(see4.4Special

Warnings).

Thesemayincludebradycardia,aslowedAV-conductionorincreaseofanexistingAV-block,hypotension,heart

failure,coldandcyanoticextremities,Raynaudphenomenon,paraesthesiaoftheextremities,increaseofanexisting

intermittentclaudication,fatigue,headaches,impairedvision,hallucinations,psychoses,confusion,impotence,

dizziness,sleepdisturbances,depression,nightmares,gastro-intestinalproblems,nausea,vomiting,diarrhoea,

bronchospasminpatientswithbronchialasthmaorahistoryofasthmaticcomplaints,disorderoftheskin,especially

rash,anddryeyes.Betablockersmaymaskthesymptomsofthyrotoxicosisorhypoglycemia.AnincreaseinAnti

NuclearAntibodies(ANA)hasbeenseen;itsclinicalrelevanceisunclear.

4.9Overdose

AtopicaloverdoseofBetopticmaybeflushedfromtheeye(s)withwarmtapwater.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Ophthalmologicals:AntiglaucomaPreparation&Miotics.

ATCCode:S01ED02

BetaxololisacardioselectiveBeta

receptorblockerwhich,whenappliedtopicallytotheeye,lowersintraocular

pressure.Itisthoughttoproducethiseffectbyreducingtherateofproductionofaqueoushumour.

5.2Pharmacokineticproperties

Betaxololishighlylipophilicwhichresultsingoodpermeationofthecornea,allowinghighintraocularlevelsofthe

drug.Betaxololischaracterisedbyitsgoodoralabsorption,lowfirstpasslossandarelativelylonghalf-lifeofapprox

16-22hours.TheeliminationofBetaxololisprimarilybytherenalratherthanfaecalroute.Themajormetabolic

pathwaysyieldtwocarboxylicacidformsplusunchangedbetaxololintheurine(approx.16%oftheadministered

dose).

5.3Preclinicalsafetydata

Therearenopreclinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Disodiumedetate

Sodiumchloride

Benzalkoniumchloride

Sodiumhydroxide

Hydrochloricacid

Purifiedwater

6.2Incompatibilities

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6.3ShelfLife

Theshelf-lifeexpirydateofthisproductisthedateshownonthecontainerandouterpackageoftheproductonthe

marketinthecountryoforigin.

Shelflifeafteropening:onemonth.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Discardremainingcontentsonemonthafterfirstopening.

6.5Natureandcontentsofcontainer

LDPEbottleswithwhitedroppercap,containing5mlofsolution,packedinanoutercarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7ParallelProductAuthorisationHolder

PCOManufacturingLimited

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

8ParallelProductAuthorisationNumber

PPA0465/143/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:10June2005

10DATEOFREVISIONOFTHETEXT

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