ALUPENT

Main information

  • Trade name:
  • ALUPENT Syrup 10 MG/5ml
  • Dosage:
  • 10 MG/5ml
  • Pharmaceutical form:
  • Syrup
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALUPENT Syrup 10 MG/5ml
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0007/015/004
  • Authorization date:
  • 01-04-1979
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0007/015/004

CaseNo:2066509

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

BoehringerIngelheimLimited

EllesfieldAvenue,Bracknell,BerkshireRG128YS,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AlupentSyrup10mg/5ml

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom29/10/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 29/10/2009 CRN 2066509 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AlupentSyrup10mg/5ml

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each5mlcontainsOrciprenalinesulphate10mg.

Excipients:Alsoincludessodiummetabisulphite(E223)500micrograms/5ml;methylparahydroxybenzoate(E218)

14mg/5ml;propylparahydroxybenzoate(E216)50micrograms/5mlandsorbitolsolution(70percent)(non-

crystallising)(E420)2.0g/5ml.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Syrup

Clear,colourlesstoslightlyyellow,brownsyrupwithafaintodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ALUPENTisindicatedasabronchodilatorinthereliefofbronchospasmsuchasoccursinasthma,bronchitisand

emphysema.

4.2Posologyandmethodofadministration

Adults:

Theusualdoseis2x5mlfourtimesdaily.Themaximumrecommendeddailydosageis8x5mlspoonfuls.

Children3-12years:

Theusualstartingdoseis1x5mlfourtimesdaily.Thismaybeincreasedto2x5mlthreetimesdailyasnecessary.

Themaximumrecommendeddailydosageis6x5mlspoonfuls.

Children1-3years:

Theusualstartingdoseis½x5mlfourtimesdaily.Thismaybeincreasedto1x5mlfourtimesdailyasnecessary.

Themaximumrecommendeddailydosageis4x5mlspoonfuls.

Children0-1year:

Theusualstartingdoseis½x5mlthreetimesdaily.Thismaybeincreasedto1x5mlthreetimesdailyasnecessary.

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Diluents:

ALUPENTSyrupmaybedilutedwitheitherSyrupBPorSorbitolSolutionBP.

Nospecificinformationontheuseofthisproductintheelderlyisavailable.

Clinicaltrialshaveincludedpatientsover65yearsandnoadversereactionsspecifictothisagegrouphavebeen

reported.

4.3Contraindications

Hypertrophicobstructivecardiomyopathy,andtachyarrhythmia.Hypersensitivitytoanyoftheingredientsin

ALUPENTSyrup

4.4Specialwarningsandprecautionsforuse

Ondemandtreatment(symptomorientated)maybepreferabletoregularuseinpatientsonlong-termtreatment.In

addition,thesepatientsshouldbere-evaluatedfortheadditionortheincreaseofanti-inflammatorytherapy(e.g.

inhaledcorticosteroids)tocontrolairwayinflammation,andtopreventlong-termdamage.

Patientsmustbewarnednottoexceedtheprescribeddose.

Inthecaseofacuterapidlyworseningdyspnoeaadoctorshouldbeconsultedimmediately.

OthersympathomimeticbronchodilatorsshouldonlybeusedwithALUPENTunderstrictmedicalsupervision.

Anticholinergicbronchodilatorsmay,however,beinhaledatthesametime.

InthefollowingconditionsALUPENTshouldonlybeusedaftercarefulrisk/benefitassessment,especiallywhendoses

higherthanthoserecommendedareused:insufficientlycontrolleddiabetesmellitus,recentmyocardialinfarction,

severeorganicheartorvasculardisorders,hyperthyroidism,pheochromocytoma,andinpatientswhoareunusually

responsivetosympathomimeticamines.

Cardiovasculareffectsmaybeseenwithsympathicomimeticdrugs,includingALUPENT®.Thereissomeevidence

frompost-marketingdataandpublishedliteratureofrareoccurrencesofmyocardialischaemiaassociatedwithbeta-

agonists.Patientswithunderlyingsevereheartdisease(e.g.ischaemicheartdisease,arrhythmiaorsevereheartfailure)

whoarereceivingALUPENT®,shouldbewarnedtoseekmedicaladviceiftheyexperiencechestpainorother

symptomsofworseningheartdisease.Attentionshouldbepaidtoassessmentofsymptomssuchasdyspnoeaandchest

pain,astheymaybeofeitherrespiratoryorcardiacorigin.

Ifbronchialobstructiondeteriorates,itisinappropriateandpotentiallyhazardoustosimplyincreasetheuseofbeta-

agonistssuchasALUPENTbeyondtherecommendeddoseoverextendedperiodsoftime.Theuseofhighamountsof

beta-agonistlikeALUPENTonaregularbasistocontrolsymptomsofbronchialobstruction,maysuggestdeclining

diseasecontrol.Inthissituationthepatient’stherapyplan,andinparticulartheadequacyofanti-inflammatorytherapy

shouldbereviewedtopreventpotentiallylife-threateningdeteriorationofdiseasecontrol.

Potentiallyserioushypokalaemiamayresultfromexcessivebeta-agonisttherapy.Particularcautionisadvisedin

severeasthma,asthiseffectmaybepotentiatedbyconcomitanttreatmentwithxanthinederivatives,

glucocorticosteroidsanddiuretics.Additionally,hypoxiamayaggravatetheeffectsofhypokalaemiaoncardiacrhythm.

Itisrecommendedthatserumpotassiumlevelsaremonitoredinsuchsituations.

Astheproductcontainssorbitol,patientswithrarehereditaryproblemsoffructoseintoleranceshouldnottakethis

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Inviewofthepossibleinteractionbetweenbeta-adrenergicsandmonoamineoxidaseinhibitorsortricyclicanti-

depressants,careshouldbeexercisedifitisproposedtoadministerthesecompoundsconcurrentlywithALUPENT.

Beta-adrenergics,anticholinergicsandxanthinederivatives(suchastheophylline)mayenhancethebronchodilatory

effectoforciprenaline.

Theconcurrentadministrationoftheotherbeta-adrenergics,systemicallyabsorbedanticholinergicsandxanthine

derivatives(e.g.theophylline)mayincreasethefrequencyandseverityofunwantedeffects.

Beta

-receptorblockerscounteracttheactionofALUPENT.Potentiallyseriousbronchospasmmayoccurduring

concurrentadministrationofbeta-blockerstopatientswithreversibleairwaysobstruction.

Inhalationofhalogenatedhydrocarbonanaestheticssuchashalothane,trichloroethyleneandenfluranemayincreasethe

susceptibilitytothecardiovasculareffectofbeta-agonists.

4.6Pregnancyandlactation

Insomepre-clinicalstudiesathighdoses,orciprenalinehasshownthepotentialtocausefoetalabnormalities.The

significancetohumansisnotknown.Therearenoadequateandwell-controlledstudiesinpregnantwomen.

ALUPENTshouldonlybeusedduringpregnancy,especiallythefirsttrimester,ifthepotentialbenefitoutweighsthe

potentialrisktothefoetus.Theinhibitoryeffectoforciprenalinesulphateonuterinecontractionshouldbetakeninto

account.

Safetyduringlactationhasnotyetbeenestablished.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

ThemostfrequentlyreportedundesirableeffectsobservedwithALUPENTaretremorandnervousness,headache,

dizziness,tachycardia,palpitations,gastro-intestinaldiscomfort,nauseaandvomiting.Somepatientshaveexperienced

afeelingoftightnessinthechest.

Potentiallyserioushypokalemiamayresultfrombeta

-agonisttherapy.

Aswithotherbeta-mimetics,sweating,weaknessandmyalgia/musclecrampsandmyocardialischaemiamayoccur.In

rarecasesdecreaseindiastolicbloodpressure,increaseinsystolicbloodpressure,arrhythmias,particularlyafterhigher

dosesmayoccur.

Inrarecases,localirritation,skinreactionsorallergicreactionshavebeenreported.Therehavebeenisolatedcasesof

anaphylacticoranaphylactoidreactions.Inindividualcasespsychologicalalterationshavebeenreportedunder

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4.9Overdose

Symptoms:

TheexpectedsymptomsofoverdosagewithALUPENTarethoseofexcessivebeta-stimulationsuchasflushing,

tremor,nausea,restlessness,tachycardia,palpitation,dizziness,headache,hypotension,hypertension,afeelingof

pressureinthechest,excitation,angina,increasedpulsepressureandarrhythmia.Hypokalaemiamayoccurfollowing

overdosewithorciprenaline.Serumpotassiumlevelsshouldbemonitored.

Therapy:

Treatmentofoverdosageshouldprimarilybesupportiveandsymptom-oriented.Ifspecifictherapyisconsidered

necessary,cardioselectivebeta-blockersaretobepreferred.Theseshouldbeadministeredwithextremecautionto

patientswithasthmabecauseoftheriskofprecipitatingseverebronchospasm.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ALUPENTisasyntheticsympathomimeticaminewithbeta-adrenergicstimulantproperties.Whenadministered

orallyorbyinhalation,orciprenalinesulphatedecreasesreversiblebronchospasm.Itisthoughtthatbeta-adrenergic

agonistsproducemanyoftheirpharmacologicaleffectsbyactivationofadenylcyclase,theenzymethatcatalysesthe

conversionofadenosinetriphosphatetoadenosinemonophosphate.

WithALUPENTithasbeenpossibletoinhibittheantigeninducedhistaminereleasebothinvitroinhumanlung

tissueandinisolatedmastcells.Inaddition,itisknownthatbeta-adrenergicagonistscauseanincreaseintherateof

ciliarymovementwhichenhancesmucociliaryclearance.

5.2Pharmacokineticproperties

Followingoraladministrationtheeffectisusuallynotedwithin30minutes.Thepeakeffectofbronchodilatoractivity

followingALUPENTgenerallyoccurswithin60to90minutesandvariesfrom1to5hours.Oraladministrationof

ALUPENTisfollowedbyrapidabsorptionwithamaximumplasmalevelbetween0.75–3hours,andahalf-lifeof2.1

hours.Approximately60%ofanorallyadministereddoseisabsorbedandissubjecttoextensivefirstpassmetabolism

bytheliver.Excretionoccursmainlyasthesulphuricacidconjugate,45%oftheoraldosebeingexcretedviathe

kidneys.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiummetabisulphite(E223)

Disodiumedetate

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

Hydroxyethylcellulose

Saccharin

Sorbitolsolution(70%)(Non-Crystallising)(E420)

Woodruffaroma

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Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Keepcontainerintheoutercarton.

6.5Natureandcontentsofcontainer

ALUPENTSyrupispresentedinamberglassTypeIIIbottleswithtamper-evident,child-resistantpolypropylenecaps

withexpandedpolyethyleneliners.

Registeredpacksizes:50ml,250ml,300mland2litres.Thecurrentmarketedpacksizeisanoriginalpackof300ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7MARKETINGAUTHORISATIONHOLDER

BoehringerIngelheimLimited

EllesfieldAvenue

Bracknell

BerkshireRG128YS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA7/15/4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1April1979

Dateoflastrenewal: 30June2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 29/10/2009 CRN 2066509 page number: 6