BRICANYL RESPULES

Main information

  • Trade name:
  • BRICANYL RESPULES
  • Dosage:
  • 5mg/ 2 Millilitre
  • Pharmaceutical form:
  • Solution for Inhalation
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BRICANYL RESPULES
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0970/036/004
  • Authorization date:
  • 01-09-1997
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0970/036/004

CaseNo:2055163

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

AstraZenecaUKLimited

600CapabilityGreen,Luton,LU13LU,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

BricanylRespules5mg/2mlnebulisersolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom18/08/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 18/08/2009 CRN 2055163 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BricanylRespules5mg/2mlnebulisersolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Terbutalinesulphate2.5mg/ml.

EachsingledoseRespulecontains2ml(5mg).

Forafulllistofexcipientsseesection6.1.

3PHARMACEUTICALFORM

Nebulisersolution

Aclear,aqueous,isotonicsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Terbutalineisaselectivebeta

-adrenergicagonistrecommendedforthereliefofseverebronchospasminbronchial

asthmaandinchronicbronchitisandotherbronchopulmonarydisordersinwhichbronchospasmisacomplicating

factor.

4.2Posologyandmethodofadministration

Inmostpatients,theuseofterbutalinesulphate,basedonthedosesbelow,given2-4timesdailywillbesufficientto

relievebronchospasm.Inacute,severeasthma,additionaldosesmaybenecessary.

BricanylRespules:

ThepHofBricanylRespulesis3-4.5.

MultidoseBottles:

Adults:0.5to1ml(5to10mg)dilutedtorequirednebuliservolumewithsterilephysiologicalsaline.

Adults: 1or2Respules(5or10mg).

Children:(>25kg)1Respule(5mg).

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Tableillustratingmlundilutedsolutionfrommultidosebottlerequiredforadministrationtochildren

Elderly:Dosageasforadults.

4.3Contraindications

Bricanylpreparationsarecontra-indicatedinpatientswithahistoryofhypersensitivitytoanyoftheirconstituents.

4.4Specialwarningsandprecautionsforuse

Thepatient’sinhalationtechniqueshouldbecheckedregularly,andtheoptimaldoseofBricanylshouldbeadjustedfor

eachnebuliser.

Ifapreviouslyeffectivedosageregimennolongergivesthesamesymptomaticrelief,thepatientshouldurgentlyseek

furthermedicaladvice.Considerationshouldbegiventotherequirementsforadditionaltherapy(includingincreased

dosagesofanti-inflammatorymedication).Severeexacerbationsofasthmashouldbetreatedasanemergencyinthe

usualmanner.

Asforallbeta

-agonistscautionshouldbeobservedinpatientswiththyrotoxicosis.

Cardiovasculareffectsmaybeseenwithsympathomimeticdrugs,includingBricanyl.Thereissomeevidencefrom

post-marketingdataandpublishedliteratureofrareoccurrencesofmyocardialischaemiaassociatedwithbetaagonists.

Patientswithunderlyingsevereheartdisease(e.g.ischaemicheartdisease,arrhythmiaorsevereheartfailure)whoare

receivingBricanylshouldbewarnedtoseekmedicaladviceiftheyexperiencechestpainorothersymptomsof

worseningheartdisease.Attentionshouldbepaidtoassessmentofsymptomssuchasdyspnoeaandchestpain,asthey

maybeofeitherrespiratoryorcardiacorigin.

Duetothepositiveinotropiceffectofthebeta

-agonists,thesedrugsshouldnotbeusedinpatientswithhypertrophic

cardiomyopathy.

Duetothehyperglycaemiceffectsofbeta

-stimulants,additionalbloodglucosemeasurementsareinitially

recommendedwhenBricanyltherapyiscommencedindiabeticpatients.

Potentiallyserioushypokalaemiamayresultfrombeta

-agonisttherapy,mainlywithparenteralornebulised

administration.Particularcautionisadvisedinacutesevereasthma,asthiseffectmaybeaugmentedbyhypoxia.The

hypokalaemiceffectmaybepotentiatedbyconcomitanttreatmentwithxanthinederivatives,corticosteroidsand/or

diuretics.Itisrecommendedthatserumpotassiumlevelsaremonitoredinsuchsituations

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Beta-blockingagents(includingeyedrops),especiallythenon-selectiveonessuchaspropranolol,maypartiallyor

totallyinhibittheeffectofbeta-stimulants.Therefore,Bricanylpreparationsandnon-selectivebeta-blockersshouldnot

normallybeadministeredconcurrently.Bricanylshouldbeusedwithcautioninpatientsreceivingother

Age AverageWeight mg

Terbutaline mlundiluted

solution kg lb

<3 10 22 2.0 0.2

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Hypokalaemiamayresultfrombeta-agonisttherapyandmaybepotentiatedbyconcomitanttreatmentwithxanthine

derivatives,corticosteroidsanddiuretics(seesection4.4specialwarningsandprecautionsforuse).

4.6Pregnancyandlactation

Althoughnoteratogeniceffectshavebeenobservedinanimalsorinpatients,Bricanylshouldonlybeadministered

withcautionduringthefirsttrimesterofpregnancy.

Terbutalineissecretedviabreastmilk,butanyeffectontheinfantisunlikelyattherapeuticdoses.

Transienthypoglycaemiahasbeenreportedinnewbornpreterminfantsaftermaternalbeta

-agonisttreatment.

4.7Effectsonabilitytodriveandusemachines

Bricanyldoesnotaffecttheabilitytodriveorusemachines.

4.8Undesirableeffects

Thefrequencyofadversereactionsislowattherecommendeddose.Terbutalinegivenbyinhalationisunlikelyto

productsignificantsystemiceffectswhengiveninrecommendeddoses.Mostoftheadversereactionsare

characteristicofsympathomimeticamines.Themajorityoftheseeffectshavereversedspontaneouslywithinthefirst

1-2weeksoftreatment.

FrequencyClassification AdverseDrugReaction

SystemOrganClass(SOC) Preferredterm(PT)

VeryCommon( ≥1/10) NervousSystemDisorders Tremor

Headache

Common(<1/10and ≥

1/100) CardiacDisorders Tachycardia

Palpitations

Musculoskeletaland

ConnectiveTissueDisorders Musclespasms

MetabolismandNutrition

Disorders Hypokalaemia

Unknown* CardiacDisorders Arrhythmias,e.g.atrial

fibrillation,supraventricular

tachycardiaand

extrasystoles

Myocardialischaemia

GastrointestinalDisorders Nausea

PsychiatricDisorders Sleepdisorderand

Behaviouraldisturbances,

suchasagitationand

restlessness

NervousSystemDisorders

Respiratory,Thoracicand

MediastinalDisorders Psychomotorhyperactivity

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*Reportedspontaneouslyinpost-marketingdataandthereforefrequencyregardedasunknown

Pretermlabour

**Drugsforinhalationmaythroughunspecifiedmechanismscausebronchospasm.

4.9Overdose

Possiblesymptomsandsigns:

Headache,anxiety,tremor,nausea,toniccramp,palpitations,tachycardiaandarrhythmia.Afallinbloodpressure

sometimesoccurs.Laboratoryfindings;hypokalaemia,hyperglycaemiaandmetabolicacidosissometimesoccur.

Treatment:

Mildandmoderatecases:Reducethedose.

Severecases:Gastriclavage:activatedcharcoal(wheresuspectedthatsignificantamountshavebeenswallowed).

Determinationofacid-basebalance,bloodsugarandelectrolytes,particularlyserumpotassiumlevels.Monitoringof

heartrateandrhythmandbloodpressure.Metabolicchangesshouldbecorrected.Acardioselectivebeta-blocker(e.g.

metoprolol)isrecommendedforthetreatmentofarrhythmiascausinghaemodynamicdeterioration.Thebeta-blocker

shouldbeusedwithcarebecauseofthepossibilityofinducingbronchoconstriction:usewithcautioninpatientswitha

historyofbronchospasm.Ifthebeta-mediatedreductioninperipheralvascularresistancesignificantlycontributesto

thefallinbloodpressure,avolumeexpandershouldbegiven.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmaco–therapeuticgroup:selectivebeta

–agonist,terbutaline,ATCcode:R03AC03.

Terbutalineisaselectivebeta

-adrenergicstimulant,havingthefollowingpharmacologicaleffects:-

Inthelung:

Bronchodilation;increaseinmucociliaryclearance;suppressionofoedemaandanti-allergiceffects.

Inskeletalmuscle:

StimulatesNa +

transportandalsocausesdepressionofsubtetaniccontractionsinslow-contractingmuscle.

iii) Inuterinemuscle:

Inhibitionofuterinecontractions.

iv)IntheC.N.S:

Lowpenetrationintotheblood-brainbarrierattherapeuticdoses,duetothehighlyhydrophilicnatureofthemolecule.

IntheC.V.S:

Administrationofterbutalineresultsincardiovasculareffectsmediatedthroughbeta-receptorsintheperipheral

arteriesandinthehearte.g.inhealthysubjects,0.25-0.5mginjecteds.c.,isassociatedwithanincreaseincardiac

output(upto85%overcontrols)duetoanincreaseinheartrateandalargerstrokevolume.Theincreaseinheartrateis

probablyduetoacombinationofareflextachycardia,viaafallinperipheralresistance,andadirectpositive

SkinandSubcutaneous

TissueDisorders Urticaria

Rash

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5.2Pharmacokineticproperties

Basicparametershavebeenevaluatedinmanafteri.v.andoraladministrationoftherapeuticdoses,e.g.

I.V.singledose

Volumedistribution(VSS)-114L.

Totalbodyclearance(CL)-213ml/min.

Meanresidencetime(MRT)-9.0h.

Renalclearance(CLR)-149ml/min(males).

Oraldose

Renalclearance(CLR)-1.925ml/min(males).

Renalclearance(CLR)-2.32ml/min(females).

Theplasmaconcentration/timecurveafteri.v.administrationischaracterisedbyafastdistributionphase,an

intermediateeliminationphaseandalateeliminationphase.

Terminalhalf-lifet

hasbeendeterminedaftersingleandmultipledosing(meanvaluesvariedbetween16-20h.).

Bioavailability

Foodreducesbioavailabilityfollowingoraldosing(10%onaverage)fastingvaluesof14-15%havebeenobtained.

Metabolism

Themainmetaboliteafteroraldosingisthesulphateconjugateandalsosomeglucoronideconjugatecanbefoundin

theurine.

5.3Preclinicalsafetydata

Themajortoxiceffectofterbutaline,observedintoxicologicalstudies,isfocalmyocardialnecrosis.Thistypeof

cardiotoxicityisawell-knownclass-effect,andtheeffectofterbutalineissimilartoorlesspronouncedthanthatof

otherbeta-receptoragonists.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumchloride

Disodiumedetate

Hydrochloricacid

Waterforinjections

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Unopened:3years

Thepreparationisstablefor24hoursinthereservoirofthenebuliser.

Singledoesunitsinanopenedfoilenvelopeshouldbeusedwithin3months.

6.4Specialprecautionsforstorage

Donotstoreabove30 °

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6.5Natureandcontentsofcontainer

Singledose,plasticunits(Respules)incartonsof20Respules,as4stripsof5units,eachwrappedinafoilenvelope.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

BricanylRespuleswillnotnormallyrequiredilutionatrecommendeddoses.

Ifdilutionisrequiredusesterilenormalsaline.

7MARKETINGAUTHORISATIONHOLDER

AstraZenecaUKLtd.

600CapabilityGreen

Luton

LU13LU

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA970/36/4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1 st

September1982

Dateoflastrenewal:1 st

September2007

10DATEOFREVISIONOFTHETEXT

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