Airomir

Main information

  • Trade name:
  • Airomir 100 mcg/dose Aerosol inhaler, metered dose
  • Dosage:
  • 100 mcg/dose
  • Pharmaceutical form:
  • Aerosol inhaler, metered dose
  • Units in package:
  • Inhaler, metered, 200 dose units
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Sicor (Societa Italiana Corticosteroidi) Srl

Documents

Localization

  • Available in:
  • Airomir 100 mcg/dose Aerosol inhaler, metered dose
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 5087
  • Authorization date:
  • 31-08-1995
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

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DataSheet

AIROMIR™Inhaler

Salbutamolsulphate.120mcgperactuation(equivalentto100mcgexvalve

salbutamolbase)

Presentation

AIROMIRInhalercontainsmicrocrystallinesalbutamolsulphatesuspendedinnorflurane(HFA-134a)

propellantinapressurisedaluminiumcontainerclosedwithameteringvalvefittedtoaplasticoral

adaptor.Norfluranepropellantisnotachlorofluorocarbon(CFC).Excipientsincludeoleicacidand

ethanol.Eachactuationdeliverssalbutamolsulphateequivalentto100mcgex-valveofsalbutamolbase.

Uses

Actions

Salbutamolisarelativelyselectivebeta-2adrenoreceptorstimulant.Administrationbyinhalationresults

indirectstimulationofbeta-2receptorsinbronchialsmoothmuscle,andasaresultbronchodilation.

Thisisthoughttobeduetostimulationofadenylcyclasebysalbutamol,resultinginincreasedlevelsof

cyclic-AMPwithincells.Thisactionresultsinreductionoftheentryofcalciumionsintothecellsand

consequentinhibitionofsmoothmusclecontraction.Highlevelsofcyclic-AMPinmastcellsalsoinhibit

thereleaseofhistamineandSRS-A.ItisgenerallyconsideredthatthereleaseofhistamineandSRS-A,

inresponsetoaType1hypersensitivityreaction,isaprimarytriggerofallergicasthma.

Pharmacokinetics

FollowinginhalationofAIROMIRInhalerthemeantimetoonsetofa15%increaseinFEV

was

measuredat6minutes,withameandurationofeffect,asmeasuredbya15%increaseinFEV

,of3

hours.Withadministrationofsalbutamolbyaerosol,only10to20%ofthedosereachesthelungs,the

remainderstaysinthemouth,stomachorintheactuator.Theamountreachingthetargetareais

dependentonthepatient'sinhalertechnique.

Salbutamolreachingthelungsactsrapidlyanddirectlyonbronchialsmoothmuscle.Initiallysalbutamol

Salbutamolreachingthelungsactsrapidlyanddirectlyonbronchialsmoothmuscle.Initiallysalbutamol

isundetectableinblood,butafter2to3hourslowconcentrationsareseen,presumablyduetothe

portionofthedosewhichisswallowedandabsorbedfromthegastrointestinalsystem.

Theplasmahalf-lifeofsalbutamolfollowingaerosolororaladministrationisbetween2and7hours.

Foraerosolinhalationtheplasmahalf-lifeisusuallytowardsthehigherendofthisrange,possiblydue

totheslowremovalofactivedrugfromthelungs.

Themajormetaboliteofsalbutamol,recoveredfromtheurine,hasbeenidentifiedasthe4'-o-sulphate

esterandisfoundafteraerosol,oralorintravenousadministration.Salbutamolisnotmetabolisedinthe

lungandthepatternofmetabolismandexcretionsuggeststhatmostoftheaerosolisswallowed.

Salbutamolisexcretedintheurineeitherasfreesalbutamoloritsmetabolite,althoughasmallfractionis

excretedinthefaeces.Followinginhalationofsalbutamol77to97%ofthedoseisrecoveredinthe

urinewithin48hours,with45to60%presentasthe4'-o-sulphateesterandtherestasunchanged

salbutamol.

Asabout60%oforallyadministeredsalbutamolismetabolisedtoaninactiveform,impairmentofliver

functionmayresultinaccumulationofunchangedsalbutamol.Insuchpatientsthedosagemayneedto

bereduced.Itisnotknownwhethersalbutamolisremovedbydialysis.Impairmentofrenalfunction

mayalsorequireadosereductiontopreventexaggeratedorprolongedeffects.

Indications

AIROMIRInhalerisindicatedforthetreatmentofbronchialasthmaandforthetreatmentofreversible

airwaysobstructionassociatedwithbronchitisandemphysema.Itisalsosuitableforroutine

maintenancetherapyinchronicasthmaandchronicbronchitis.

AIROMIRInhalermaybeusedtorelieveattacksofacutedyspnoeaandmayalsobetakenbefore

exertiontopreventexercise-inducedasthma.

DosageandAdministration

TreatmentwithAIROMIRInhalershouldbeinadditiontomaintenancepreventivetherapyifthisis

required.

AIROMIRInhaleristherapeuticallyequivalenttoCFCsalbutamolpressurisedinhalers.Studieshave

shownthatpatientscanbeswitchedfromCFCsalbutamolinhalerstoAIROMIRInhaler,atthesame

dosage,withoutlossoftherapeuticeffect.

Adults

Forthereliefofacutebronchospasm,formanagingintermittentepisodesofasthma,formaintenanceof

therapyorforprophylactictherapy:oneortwoinhalationsmaybeadministeredasasingledose.The

maximumrecommendeddoseis16inhalationsaday.Forpreventionofexercise-induced

bronchospasm:oneortwoinhalationsbeforeexertion.

Children

Forthereliefofacutebronchospasm,managementofepisodicasthmaorbeforeexercise:oneinhalation

Forthereliefofacutebronchospasm,managementofepisodicasthmaorbeforeexercise:oneinhalation

increasingtotwoifnecessary.Themaximumrecommendeddoseis8inhalationsaday.

Elderly

Thedosageisthesameasforotheradults.

Impairedrenalorhepaticfunction

Initialdosesshouldbereducedtopreventexaggeratedorprolongedeffects.Thedosemaythenbe

graduallyincreasedifsufficientbronchodilationisnotachieved.

AIROMIRInhalershouldbeusedasdirectedtogainthefullbenefitfromtreatment.Patientsshouldbe

advisedtoincreasethedoseonlyonmedicaladviceandtoreportanyconcernsregardingthe

appearanceofadverseeffects.Primingoftheinhalerisrequiredforfirstusebyactuatingtheinhalerto

ensuredeliveryofthestatedsalbutamoldose.Thisdoesnotneedtoberepeatedduringusualuseunless

theinhalerisstoredandnotusedforaperiodlongerthantwoweeks.Patientsshouldbeinformedofthe

importanceofcorrectinhalertechnique.Ifnecessary,correcttechniqueshouldbedemonstratedto

patients,particularlyfirsttimeusersandthosewithpoorcoordination.Toensurecorrectuserefer

patientstotheConsumerMedicineInformationaccompanyingeachinhaler.

Spacers

Forpatientsrequiringaspacerdevice,theAerochamber™hasbeenshowntobecompatiblewith

AIROMIRInhaler.

Contraindications

Managementofprematurelabourandthreatenedabortion.

Hypersensitivitytosalbutamolorothersympathomimeticsoranyoftheinactiveingredientsin

AIROMIRInhaler.

WarningsandPrecautions

FailuretoobtainrelieffromAIROMIRInhalermaybeamedicalemergency.Thepatientshouldbe

advisedtoseekmedicaladvicewithoutdelay.Thepatientshouldbewarnedagainstexcessiveuseof

bronchodilatoraerosols.

Unwantedstimulationofcardiacadrenergicreceptorscanoccurinpatientstakingbeta-2agonist

therapy.Cautionisadvisedwhenconsideringsalbutamoltreatmentforpatientswithhyperthyroidismor

diabetes.Potentiallyserioushypokalaemiahasbeenreportedfollowingparenteralandnebulisedbeta-2

agonisttherapy.Cautionisthereforeadvisedwithinhaledsalbutamol,particularlyforacuteasthma

patients,andthosetakingconcomitanttreatmentwithxanthinederivatives,corticosteroids,diuretics

and/ordigitalisasthesemedicationscanfurtherincreasetheriskofhypokalaemia.Serumpotassium

levelsshouldbemonitoredinthesepatientsandinpatientswithhypoxia.

CardiacDiseases

Cautionisadvisedwhensalbutamolisadministeredtopatientswhoaresufferingfromcardiovascular

diseasessuchashypertension,coronaryarterydiseaseandmyocardialinsufficiency.

CardiacArrhythmias

Salbutamolmaypredisposetooraggravateexistingcardiacarrhythmiasbydirectchronotropiceffects

ontheheartorfromtheproductionofhypokalaemia.Salbutamolshouldthereforebeusedwithcaution

forpatientswithknownarrhythmiasandforpatientstakingdigitalisordiureticmedication.

Anaesthetics

Cautionshouldbeexercisedintheuseofanaestheticagentsthatsensitisethemyocardiumtocirculating

sympathomimeticamines.

Renalimpairment

Sinceapproximately50%ofsalbutamolisexcretedrenally,adjustmentofthedosewillbenecessaryif

renalfunctionismarkedlyimpaired.

Pregnancyandlactation

UseinPregnancy

Salbutamolisknowntocrosstheplacentalbarrierinhumans.Safetyforuseinpregnancyhasnotbeen

demonstrated.Inanimalstudies,therehasbeenevidenceofsomeharmfuleffectsonthefoetusatvery

highdoselevels.Studiesofthenorfluranepropellantadministeredtopregnantandlactatingratsand

rabbitshavenotrevealedanyspecialhazard.Incommonwithotherpotentselectivebeta-2agonists,

salbutamolhasbeenshowntobeteratogenicinmicewhengivensubcutaneously.

Salbutamolshouldthereforenotbeusedinpregnantwomen,orthoselikelytobecomepregnant,unless

theexpectedbenefitoutweighsanypotentialrisk.Salbutamolhas,however,beenusedclinicallyinthe

treatmentofprematurelabourwithoutadverseeffects.Salbutamolcausesariseinbloodglucosewhich

isusuallyofnoconsequenceexceptinthepregnantdiabetic.

UseinLactation

Itisnotknownwhethersalbutamolisexcretedinbreastmilkorhasaharmfuleffectonthenewborn.It

isthereforenotrecommendedfornursingmothersunlesstheexpectedbenefitsoutweighanypotential

risk.

AdverseEffects

Safetystudieswiththisproductshowedfewadverseeffects.Theseoccurredathighdosesandwere

consistentwiththeknowneffectsofsalbutamolwhenadministeredbyinhalation.Sincesalbutamolis

notentirelyspecificinitseffects,ithassomestimulanteffectsoncardiacsensitivity,onthecentral

nervoussystemandoncarbohydrateandfatmetabolism.Theseonlybecometroublesomewithrelative

overdosageorinparticularlysusceptiblesubjects.

overdosageorinparticularlysusceptiblesubjects.

Morecommonreactions

Cardiovascular

tachycardia,hypotension,superficialvasodilation,flushing.

Musculoskeletal

finemuscletremor,mostnoticeableinhands,musclecramps.

Nervoussystem

headache,dizziness,feelingsoftensionornervousnessandotheremotionalupsets.

Lesscommonreactions

Biochemicalabnormalities

increaseinplasmaconcentrationsofglucose,insulin,nonesterifiedfattyacids,decreaseinplasma

concentrationsofpotassium.

Gastrointestinal

nausea,vomiting.

Respiratory

reductionofPaO

hasbeenobservedinasmallnumberofpatientsfollowingadministrationof

bronchodilators,includingsalbutamol.

Hypersensitivity

aswithotherinhalationtherapy,paradoxicalbronchospasmmayoccur.Angioedema,urticaria,

bronchospasm,hypotensionandcollapsehavebeenreportedrarely.Hyperactivityhasbeenrarely

reportedinchildren.

Seriousorlifethreateningreactions

Overuseofsalbutamolpreparationsmayproducesignificanttachycardia,arrhythmiasandhypotension

(SeeOverdosage).

Interactions

Noreportedinteractionswithfoodoralcohol.

Adrenergicblockingagentsinhibitthebronchodilatoractionofsalbutamolandothersympathomimetic

Adrenergicblockingagentsinhibitthebronchodilatoractionofsalbutamolandothersympathomimetic

bronchodilators.Suchmedicationsshouldnotbeusedinasthmaticpatientsastheymayincreaseairway

resistance.

Theriskofhyperglycaemiaorhypokalaemiawillbeincreasediforalcorticosteroidsaregiven

simultaneously.Theriskofhypokalaemiamaybeenhancedduringconcomitantxanthineordiuretic

therapy.

Salbutamolhasadditiveeffectswithothersympathomimeticsandtheophylline.Salbutamolshouldnot

begiventopatientswhohavealreadyreceivedlargedosesofsympathomimetics.

Treatmentwithbendrofluazideaugmentsthehypokalaemicandcardiaceffectsofhigh-doseinhaled

salbutamol.Thearrhythmogenicpotentialofthisinteractionmaybeimportantinpatientswithacute

exacerbationsofchronicairflowobstruction,whohaveconcomitanthypoxaemiaandischaemicheart

disease.

Cautionisadvisedifsalbutamolisadministeredconcomitantlywithtricyclicanti-depressants,digitalis

preparationsormonoamineoxidaseinhibitors(MAOIs).

Highdosesofsalbutamolpriortoorshortlyafteradministrationofinhaledanaestheticagentssensitise

themyocardiumtotheeffectsofsympathomimeticagentsandmayincreasetheriskofsevere

ventriculararrhythmias.

Overdosage

Symptoms

Thesymptomsofoverdosagearethesameastheadverseeffectsofsalbutamol,themostsignificant

beingtachycardiaand/ormuscletremor.

Treatment

Insevereoverdosagetheuseofcardioselectivebeta-adrenergicantagonistmaybenecessary,although

theseagentsarelikelytodecreaseairwayscomplianceinasthmatics.Itshouldbenotedthatbeta-

blockersmayinducebronchospasminsomesensitivepatients.Serumpotassiumlevelsshouldalsobe

monitoredintheeventofoverdose.Inthecaseoforaloverdosage,gastriclavageshouldbeperformed.

PharmaceuticalPrecautions

AIROMIRInhalershouldbestoredbelow30ºCavoidingdirectsunlightorheatandprotectedfrom

frost.Asthecanisterispressurised,noattemptshouldbemadetopunctureordisposeofitbyburning.

MedicineClassification

PrescriptionMedicine

PackageQuantities

200doses

FurtherInformation

AIROMIRInhalerhasbeenspeciallyformulatedtoprovidefortheaerosoladministrationofsalbutamol

withaCFC-freepropellant.ThisinhalerhasadifferentfeelandtastetoCFCcontaininginhalersthat

patientsmaybeusingorhaveusedinthepasthowevertheclinicalefficacyandsafetyisequivalent.

AIROMIRInhalerisincludedontheListofInterchangeableMedicines.Thisformulationhasbeen

designedtocomplywiththeMontrealAgreement,thatrequiresthephasingoutofCFCbasedaerosol

inhalerswiththeminimumdisruptiontothedoseregimenofthepatient.Tothisend,thenewpropellant

hasundergoneextensivetoxicity,safetyandefficacytrialstoensurethatthetreatmentavailabletothe

patientisnotcompromised,andthatthedosageofactivemedicationdeliveredisequivalenttothatfrom

othersalbutamolaerosolinhalers.

Propellant

AIROMIRInhalercontainsnorfluranepropellant.Inanimalstudies,norfluranehasbeenshowntohave

nosignificantpharmacologicaleffectsotherthanatveryhighexposureconcentrations,wherenarcosis

andarelativelyweakcardiacsensitisingeffectwerefound.Thepotencyofcardiacsensitisationisless

thanthatofCFC-11(trichlorofluoromethane).Therearenoreasonstoconsidernorfluraneasapotential

mutagen,clastogenorcarcinogenjudgedfrominvitroandinvivostudiesincludinglong-term

administrationbyinhalationinrodents.

CleaningInstructions:

TheAIROMIRInhaleradaptorshouldbecleanedeveryweektoensurethatitfunctionscorrectly.

1.Removethecanisterfromtheadaptor.

2.Removethemouthpiececoverfromtheadaptor.

3.Rinsethemouthpiececoverandtheadaptorwithhotrunningwater.

4.Shakeoffthewaterandleavetodrycompletely,preferablyovernight.

5.Replacethecanisterensuringthatthevialstemisinthecorrectposition.

IftheInhalerisneededbeforetheadaptoriscompletelydry,replacethecanisterandspraytwopuffs

intotheair,taketherequireddose,thenwashtheadaptoragainandleavetodrycompletely.

NameandAddress

AIROMIRInhalerisdistributedinNewZealandby:

3MPharmaceuticals

adivisionof3MNewZealandLimited

P.O.Box2201ShortlandStreet

AUCKLAND

Telephone:(09)4445289

Facsimile:(09)4445770

AIROMIRInhalerisjointlymarketedinNewZealandwith:

HoechstMarionRoussel(NZ)Limited

P.O.Box12851Penrose

AUCKLAND

Telephone(09)5264102

Facsimile(09)5264109

TollFree0800467467

DateofPreparation

20January1999

AIROMIRInhalerisaproductoftechnologydevelopedby3MPharmaceuticals.

™AIROMIRisatrademarkof3M.

™AerochamberisatrademarkofTrudellMedicalLtd.

1N99