DOXAPRAM

Main information

  • Trade name:
  • DOXAPRAM Solution for Injection 20 Mg/Ml
  • Dosage:
  • 20 Mg/Ml
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOXAPRAM Solution for Injection 20 Mg/Ml
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1140/005/001
  • Authorization date:
  • 22-12-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA1140/005/001

CaseNo:2026068

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

TaroPharmaceuticals(Ireland)Limited

LourdesRoad,Roscrea,Co.Tipperary,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

DoxapramInjectionBP20mg/ml

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom17/12/2006until.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 26/04/2007 CRN 2026068 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DoxapramInjectionBP20mg/ml

SolutionforInjection

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each1mlofsterilesolutionforinjectioncontains20mgdoxapramhydrochloride

Each5mlofsterilesolutionforinjectioncontains100mgdoxapramhydrochloride.

Forexcipientssee6.1

3PHARMACEUTICALFORM

Solutionforinjection.

Clear,colourlesssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

DoxapramactsasaventilatorystimulantandDoxapramInjectionBP20mg/mlisusedfollowinganaesthesiato

stimulateventilationinthepost-operativeperiodasanaidtothereductionofpost-operativepulmonarycomplications,

andtopermittheuseofeffectivedosesofnarcoticanalgesicswithoutassociatedproblemsofventilatorydepression.

DoxapramInjectionBP20mg/mlisalsousedtoincreaseCNSarousalandspontaneousactivityfrominhalational

anaesthesiawhenthiswouldbebeneficial.

4.2Posologyandmethodofadministration

Routeofadministration:

Intravenousadministrationonly.

Adultsandolderpatients:

Therecommendeddosageis1.0to1.5mg/kgbodyweight,administeredoveraperiodof30secondsormore,which

mayberepeatedatone-hourintervals,ifnecessary.

Children:

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4.3Contraindications

Knownhypersensitivitytodoxapramortoanyoftheexcipients

Severehypertension

Statusasthmaticus

Coronaryarterydisease

Epilepsyorotherconvulsivedisorders

Cerebraloedema

Cerebrovascularaccident

Hyperthyroidism

Physicalobstructionofrespiratorytract,orconditionsresultinginrestrictionofchestwall,musclesofrespirationor

alveolarexpansion.

4.4Specialwarningsandprecautionsforuse

Doxapramshouldbeadministeredconcurrentlywithoxygentopatientswithsevereirreversibleairwaysobstructionor

severelydecreasedlungcompliance,duetotheincreasedworkofbreathinginthesepatients.

Inpatientspresentingwithbronchoconstriction,doxapramshouldalwaysbeusedinconjunctionwithbeta-

adrenoreceptorbronchodilatordrugsinordertoreducetheamountofrespiratoryeffort.

Asdoxapramismetabolisedprimarilybytheliver,usewithcareinpatientswithhepaticdysfunction.

Doxapramshouldbeadministeredcautiouslytopatientsreceivingsympathomimeticagentssinceanadditivepressor

effectmayoccur.

Doxapramshouldbeusedwithgreatcareinpatientswhoarebeingtreatedconcurrentlywithmonoamineoxidase

inhibitingdrugs.Animalstudieshaveshownthattheactionofdoxapramispotentiatedaftertreatmentwitha

MonoamineOxidaseInhibitor(MAOI).

Inpatientswhohavereceivedanaestheticsknowntosensitisethemyocardiumtocatecholamines,suchashalothane,

cyclopropane,andenflurane,initiationofdoxapramtherapyshouldbedelayedforatleast10minutesfollowing

discontinuanceofanaesthesia,sinceanincreaseinadrenalinereleasehasbeennotedwithdoxapramadministration.

Therespiratorystimulanteffectofdoxaprammaynotoutlasttheresidualeffectsofthedepressantdrugs.Since

respiratorydepressionmayrecurafterstimulationwithdoxapram,thepatientshouldbecloselymonitoreduntilfully

alertforonehalftoonehour.Doxaprammaytemporarilymasktheresidualeffectsofcurare-typemusclerelaxant

drugs.

Doxapramshouldbeadministeredwithcautioninpatientswithhypermetabolicstatesuchasphaeochromocytoma.

Theadministrationofdoxapramdoesnotdiminishtheneedforcontinuousmonitoringofallaspectsofpatient

response,includingfrequentanalysisofarterial-bloodgases.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Clinicaldatasuggestthatconcurrentuseofaminophyllineanddoxaprammaybeassociatedwithagitation,muscle

fasciculationandhyperactivity.Careshouldbetakenwhenthesetwodrugsareusedconcomitantly.

Doxapramshouldalsobeadministeredwithgreatcaretopatientsbeingtreatedconcurrentlywithmonoamineoxidase-

inhibitors(MAOIs).Animalstudieshaveshownthattheactionofdoxaprammaybepotentiatedafterpretreatmentwith

anMAOI.

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4.6Pregnancyandlactation

Animalstudiesareinsufficientwithrespecttoeffectsonpregnancyandembryonal/foetaldevelopment.Thepotential

riskforhumansisunknown.DoxapramInjectionBP20mg/mlshouldnotbeusedduringpregnancyunlessclearly

necessary

Itisnotknownwhetherthisdrugisexcretedinhumanmilk.Therefore,cautionshouldbeexercisedwhenprescribing

doxapramtoalactatingmother.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Doxaprammayproduceadverseeffectsduetogeneralstimulationofthecentral,peripheral,andautonomicnervous

systems.Pyrexia,sweating,flushing,headache,dizziness,hyperactivity,confusion,hallucinations,perinealwarmth,

musclefasciculation,andconvulsionshavebeenreported.

Respiratoryproblemssuchasdyspnoea,cough,bronchospasm,andlaryngospasmmayoccur.

Cardiovasculareffectshavebeenobservedandincludeamoderateincreaseinbloodpressure,arrhythmias,sinus

tachycardia,bradycardiaandextrasystoles,chestpain,orchesttightness.

Effectsonthegastrointestinaltractsuchasnauseaandvomitingmayalsooccur.

4.9Overdose

Overdosagemayresultinhypertension,tachycardiaandotherarrhythmias,skeletalmusclehyperactivityincluding

enhanceddeeptendonreflexes,anddyspnoea.Serioussymptomsofoverdosagemayincludechronicandgeneralised

seizures.Intravenousdiazepam,phenytoin,andshortactingbarbiturates,oxygenandresuscitativeequipmentshouldbe

readilyavailabletomanageoverdose.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Theprinciplepharmacologicalactionofdoxapramisanincreaseinminutevolumeproducedprimarilybyanincrease

intidalvolumeandtoalesserextentbychangesinrespiratoryrate.Neuropharmacologicalstudieshaveshownthatthe

primarysitesofactionofdoxapramaretheperipheralcarotidchemoreceptors.Itisconsideredthatthissiteofactionof

doxapramisresponsibleforitsrelativespecificityofaction;itisonlyfollowinglargedosesofdoxapramhydrochloride

thatnon-specificcentralnervoussystemstimulationoccurs.

5.2Pharmacokineticproperties

FollowinganIVbolusinjectionof1.5mg/kgdoxapram,theplasmaconcentrationofdoxapramdeclinedina

multiexponentialmanner.Themeanhalf-lifefrom4to12hourswas3.4hours(range2.4to4.1hours).Themean

apparentvolumeofdistributionwas1.5l/kgandthewholebodyclearancewas370ml/min.Renalclearancewasnot

relatedtourinefloworpH,butincreasedprogressivelywithtimeoverthefirst12hours.Themean0-24hourrenal

clearancevaluesforindividualvolunteersrangedfrom1.1to14.1ml/min.Therateofdeclineofplasmaconcentration

appearedtodecreaseafter12hours.Doxapramwasextensivelymetabolised,andlessthan5%ofanIVdosewas

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5.3Preclinicalsafetydata

Reproductionstudieshavebeenperformedinratsatdosesofupto1.6timesthehumandoseandhaverevealedno

evidenceofimpairedfertilityorharmtothefoetusassociatedwiththeuseofthedoxapram.Acutetoxicitystudiesin

severalanimalspeciessuggestimpairmentofthecentralnervoussystemathighdoses.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Waterforinjections

6.2Incompatibilities

Doxapramisincompatiblewithalkalinesolutionssuchasaminophylline,furosemideand

thiopentonesodium.

Donotmixwithanyothersolutionsforinfusion/injections

6.3ShelfLife

Unopened:3years.

Theproductshouldbeusedimmediatelyafteropening.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Donotrefrigerateorfreeze.

6.5Natureandcontentsofcontainer

ClearglassampoulestypeI,5ml.

Packsize:10x5mlampoules

6.6Specialprecautionsfordisposal

Forsingleuseonly.

Discardanyunusedcontents.

Donotmixand/orco-administerwithothersolutionsforinjectionorinfusion.

7MARKETINGAUTHORISATIONHOLDER

TaroPharmaceuticalsIrelandLimited,

LourdesRd.,

Roscrea,

CountyTipperary.

Ireland

Irish Medicines Board

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PA1140/5/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

22ndDecember2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 26/04/2007 CRN 2026068 page number: 6