AMIKIN

Main information

  • Trade name:
  • AMIKIN Solution for Injection 250 %v/v
  • Dosage:
  • 250 %v/v
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMIKIN Solution for Injection 250 %v/v
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0048/004/006
  • Authorization date:
  • 17-07-1976
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0048/004/006

CaseNo:2050682

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

Bristol-MyersSquibb(Holdings)

T/ABristol-MyersPharmaceuticals,Swords,Co.Dublin,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AmikinInjection500mg/2ml.

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom28/01/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2009 CRN 2050682 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AmikinInjection500mg/2ml.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each2mlvialcontainsamikacinsulphateequivalenttoamikacinactivity500mg(500,000internationalunits)in2ml

(250mg/ml).

Excipients:Eachvialcontains14.74mg(0.64mmol)sodium.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinjection.

Clearcolourlesssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthemanagementofinfectionsduetogramnegativeorganismssensitivetotheanti-infective.

4.2Posologyandmethodofadministration

Formostinfectionstheintramuscularrouteispreferred,butinlife-threateninginfections,orinpatientsinwhom

intramuscularinjectionisnotfeasibletheintravenousroutemaybeused.

Intramuscularandintravenousadministration

Attherecommendeddosagelevel,uncomplicatedinfectionsduetosensitiveorganismsshouldrespondtotherapy

within24to48hours.

Ifclinicalresponsedoesnotoccurwithinthreetofivedaysconsiderationshouldbegiventoalternativetherapy.

Adultsandchildren

15mg /

dayintwoequallydivideddoses(equivalentto500mgb.i.d.inadults):useofthe100mg /

2mlstrengthis

recommendedforchildrenfortheaccuratemeasurementoftheappropriatedose.

Neonatesandprematureinfants

Aninitialloadingdoseof10mg /

kgfollowedby15mg /

dayintwoequallydivideddoses.

Elderly

Amikacinisexcretedbytherenalroute,renalfunctionshouldbeassessedwheneverpossibleanddosageadjustedas

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Life-threateninginfectionsand /

orthosecausedbyPseudomonas

Theadultdosemaybeincreasedto500mgeveryeighthoursbutshouldneitherexceed1.5g /

daynorbeadministered

foraperiodlongerthan10days.Amaximumtotaladultdoseof15gshouldnotbeexceeded.

Urinarytractinfections(otherthanpseudomonalinfections)

7.5mg /

dayintwoequallydivideddoses(equivalentto250mgb.i.d.inadults).Astheactivityofamikacinis

enhancedbyincreasingthepH,aurinaryalkalisingagentmaybeadministeredconcurrently.

Impairedrenalfunction

Inpatientswithimpairedrenalfunction,thedailydoseshouldbereducedand /

ortheintervalsbetweendosesincreased

toavoidaccumulationofthedrug.Thecriticalserumcreatinineconcentrationis1.5mg/100ml.

Otherroutesofadministration

Amikininconcentrationsof0.25%maybeusedsatisfactorilyasanirrigatingsolutioninabscesscavities,thepleural

spaceandtheperitoneum.

4.3Contraindications

Hypersensitivitytoanyofthecomponentsoftheproduct.

Useofamikacinintraperitoneallyinyoungchildrenorinpatientsunderanaesthesiaormusclerelaxingdrugs.

Myastheniagravis.

4.4Specialwarningsandprecautionsforuse

Patientsshouldbewellhydratedduringamikacintherapy.

Inpatientswithimpairedrenalfunctionordiminishedglomerularfiltration,amikacinshouldbeusedcautiously.In

suchpatients,renalfunctionshouldbeassessedbytheusualmethodspriortotherapyandperiodicallyduringtherapy.

Dailydosesshouldbereducedand /

ortheintervalbetweendoseslengthenedinaccordancewithserumcreatinine

concentrationstoavoidaccumulationofabnormallyhighbloodlevelsandtominimisetheriskofototoxicity.

Monitoringofdruglevelsshouldalsobeperformedandtroughconcentrations>4µg/mlshouldbeavoided.

Aswithotheraminoglycosides,ototoxicityand /

ornephrotoxicitycanresultfromtheuseofamikacinandaredirectly

relatedtototaldosageofdrug,durationoftherapyanddegreeofdehydration.

Monitoringofvestibularandauditoryfunctionshouldbecarriedoutduringandaftertreatment.

Theuseofamikacininpatientswithahistoryofallergytoaminoglycosidesorinpatientswhomayhavesubclinical

renaloreighthnervedamageinducedbyprioradministrationofnephrotoxicand /

orototoxicagentssuchas

streptomycin,dihydrostreptomycin,gentamicin,tobramycin,kanamycin,bekanamycin,neomycin,polymyxinB,

colistin,cephaloridine,orviomycinshouldbeconsideredwithcaution,astoxicitymaybeadditive.

Inthesepatientsamikacinshouldbeusedonlyif,intheopinionofthephysician,therapeuticadvantagesoutweighthe

potentialrisks.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theriskofototoxicityisincreasedwhenamikacinisusedinconjunctionwithrapidlyactingdiureticdrugs,

particularlywhenthediureticisadministeredintravenously.Suchagentsincludefrusemideandethacrynicacid.

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Theintraperitonealuseofamikacinisnotrecommendedinpatientsundertheinfluenceofanaestheticsormuscle-

relaxingdrugs(includingether,halothane,d-tubocurarine,succinylcholineanddecamethonium)asneuromuscular

blockadeandconsequentrespiratorydepressionmayoccur.

Indomethacinmayincreasetheplasmaconcentrationofamikacininneonates.

Inpatientswithseverelyimpairedrenalfunction,areductioninactivityofaminoglycosidesmayoccurwith

concomitantuseofpenicillin-typedrugs.

4.6Pregnancyandlactation

ThesafetyofAmikininpregnancyhasnotyetbeenestablished.Amikacinshouldonlybeusedinpregnancyor

lactationifconsideredessentialbythephysician.Thedrugcrossestheplacentabutdoesnotreachsignificantlevelsin

breastmilk.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Sideeffectsincludeallergicreactions,tinnitus,headache,anaemia,purpuraandincreasedlevelsofbilirubin

occasionally.Ototoxicityandnephrotoxicityarethemostsignificantproblems.Urinarysignsofrenalirritation

(albumin,castsandredorwhitebloodcells),azotaemiaandoliguriahavebeenreported.Therehavebeenreportsof

retinaltoxicityfollowingintravitrealinjectionofamikacin.

Thesodiumbisulphitecontentoftheproductmayrarelycauseseverehypersensitivityreactionsandbronchospasm.

4.9Overdose

Intheeventofoverdosageortoxicreaction,peritonealdialysisorhaemodialysiswillaidintheremovalofamikacin

fromtheblood.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Amikacinsulphateisanaminoglycosideantibioticwhichisactiveagainstabroadspectrumofgram-negative

organisms,includingPseudomonasspp,Escherichiacoli,indole-positiveandindole-negativeProteusspp.,Klebsiella-

Enterobacter-Serratiaspp.,Salmonella,Shigella,Minea-Herellae,CitrobacterfreundiiandProvidenciaspp..

Manystrainsofthesegram-negativeorganismsresistanttogentamicinandtobramycinmayshowsensitivityto

amikacininvitro.Theprincipalgram-positiveorganismsensitivetoamikacinisStaphylococcusaureus,including

methicillin-resistantstrains.Amikacinhassomeactivityagainstothergram-positiveorganismsincludingcertain

strainsofStreptococcuspyogenes,EnterococciandDiplococcuspneumoniae.

5.2Pharmacokineticproperties

Amikinisrapidlyabsorbedafterintramuscularinjection.Peakserumlevelsofapproximately11mg /

land23mg /

lare

reachedonehourafterIMdosesof250mgand500mgrespectively.Levels10hoursafterinjectionareoftheorderof

0.3mg /

land2.1mg /

lrespectively.

Twentypercentorlessisboundtoserumproteinandserumconcentrationsremaininthebactericidalrangefor

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Amikindiffusesreadilythroughextracellularfluidsandisexcretedintheurineunchanged,primarilybyglomerular

filtration.Half-lifeinindividualswithnormalrenalfunctionsistwotothreehours.

Followingintramuscularadministrationofa250mgdose,about65%isexcretedinsixhoursand91%within24hours.

Theurinaryconcentrationsaverage563mg /

linthefirst6hoursand163mg /

lover6to12hours.Meanurine

concentrationsaftera500mgIMdoseaverage832mg /

linthefirstsixhours.

Singledosesof500mgadministeredtonormaladultsasanintravenousinfusionoveraperiodof30minutesproducea

meanpeakserumconcentrationof38mg /

lattheendoftheinfusion.Repeatedinfusionsdonotproducedrug

accumulation.

Amikinhasbeenfoundincerebrospinalfluid,pleuralfluid,amnioticfluidandintheperitonealcavityfollowing

parenteraladministration.

5.3Preclinicalsafetydata

Nofurtherrelevantinformation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumcitrate

Sodiumbisulphite(E222)

Sulphuricacid(forpH-adjustment)

Waterforinjection

6.2Incompatibilities

Thismedicinalproductmustnotbemixedwithothermedicinalproducts.

6.3ShelfLife

Unopened:3years.

Tobeusedimmediatelyafteropening.Anyremainingcontentsmustbediscarded.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

2mlflintglassType1vialwithbutylrubberstopperandaluminiumseal.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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7MARKETINGAUTHORISATIONHOLDER

Bristol-MyersSquibbHoldingsLtd

t/aBristol-MyersPharmaceuticals

Swords

Co.Dublin

8MARKETINGAUTHORISATIONNUMBER

PA0048 /

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:15 th

July1976

Dateoflastrenewal:15 th

July2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 28/01/2009 CRN 2050682 page number: 6