CIDOMYCIN ADULT

Main information

  • Trade name:
  • CIDOMYCIN ADULT
  • Dosage:
  • 40 Mg/Ml
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CIDOMYCIN ADULT
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0540/036/001
  • Authorization date:
  • 09-03-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CidomycinAdult80mg/2mlSolutionforInjection

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachampoule(2ml)containsGentamicinSulphateequivalentto80mgGentamicinbase(40mg/ml).

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Solutionforinjection

Clearcolourlesssolutionineasyopenampoules.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Gentamicininjectionisindicatedforthetreatmentofserioussystemicinfectionsincludingthoseofthecentralnervous

systemduetoorganismssensitivetothisanti-infective.

4.2Posologyandmethodofadministration

ADULTS:

Seriousinfections:Ifrenalfunctionisnotimpaired,5mg/kg/dailyindivideddosesatsixoreighthourlyintervals.The

totaldailydosemaybesubsequentlyincreasedordecreasedasclinicallyindicated.

Systemicinfections:Ifrenalfunctionisnotimpaired,3-5mg/kg/dayindivideddosesaccordingtoseverityofinfection,

adjustingaccordingtoclinicalresponseandbodyweight.

Urinarytractinfections:As“Systemicinfections”.Or,ifrenalfunctionisnotimpaired,160mgoncedailymaybe

used.

RenalImpairment:Gentamicinisexcretedbysimpleglomerularfiltrationandthereforereduceddosageisnecessary

whererenalfunctionisimpaired.Nomogramsareavailableforthecalculationofdose,whichdependsonthepatient’s

age,weightandrenalfunction.Thefollowingtablemaybeusefulwhentreatingadults.

Therecommendeddoseandprecautionsforintramuscularandintravenousadministrationareidentical.Gentamicin

whengivenintravenouslyshouldbeinjecteddirectlyintoaveinorintothedripsettubingovernolessthanthree

minutes.Ifadministeredbyinfusion,thisshouldbeovernolongerthan20minutesandinnogreatervolumeoffluid

than100ml.

Bloodureamg/100ml

(mmol/l) Creatinineclearance

(GRF)(ml/min) Doseandfrequencyof

administration

<40(6-7) >70 80mg*8hourly

40-100(6-17) 30-70 80mg*12hourly

100-200(17-34) 10-30 80mg*daily

>200(>34) 5-10 80mg*every48hours

Twiceweeklyintermittent

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 03/11/2006 CRN 2029632 page number: 1

*60mgifbodyweight>60kg.Frequencyofdosageinhoursmayalsobeapproximatedasserumcreatinine(mg%)x

eightorinSIunits,asserumcreatinine(micromol/l)dividedby11.Ifthesedosageguidesareused,peakserumlevels

mustbemeasured.Peaklevelsofgentamicinoccurapproximatelyonehourafterintramuscularandintravenous

injection.Troughlevelsaremeasuredjustpriortothenextinjection.Assayingpeakserumlevelsgiveconfirmationof

adequacyofdosageandalsoservestodetectlevelsabove10mg/l,atwhichthepossibilityofototoxicityshouldbe

considered.Onehourconcentrationsofgentamicinshouldnotexceed10mg/l(butshouldreach4mg/l),whilethepre-

dosetroughconcentrationshouldbelessthan2mg/l.

ELDERLY:

Dosageisdependantonrenalfunctionstatus.

CHILDREN:

2weeksto12years:Theusualtotaldailydoseis6mg/kginthreedivideddoses.

Undertwoweeksofage:Theusualdailydoseis6mg/kgintwodivideddoses.

4.3Contraindications

Useinpatientshypersensitivetogentamicinortootheraminoglycosides.

Useinearlypregnancyunlessthephysicianconsiderstheinfectionlife-threatening.

Useconcurrentlywithothernephrotoxicorototoxicdrugsubstances.

Gentamicinshouldnotbemixedwithanyotherdrugpriortoadministration.

4.4Specialwarningsandprecautionsforuse

Inthepresenceofimpairedrenalfunction,frequencyandthetotaldosageofgentamicinmustbereducedtoensurethe

toxicitydoesnotderivefrompeakserumlevelsover10mg/landtroughsabove2ml.

Renal,auditoryandvestibularfunctionshouldbemonitoredinthesepatients.Regularmonitoringofdruglevelsand

renalfunctionarenecessary.

Gentamicinshouldbeusedwithcautionintheelderly,thosewithahistoryof,orexistenteardisease,orthose

previouslyonaminoglycosides.

Gentamicinshouldonlybeusedduringpregnancyifconsideredessentialbythephysician.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Useofgentamicinconcurrentlywithcephalosporinsorloopdiureticsmaypotentiatenephrotoxicityorototoxicity

respectively.Kidneyfunctionshouldbecarefullymonitored.

Aminoglycosides,includinggentamicinmayinduceneuromuscularblockageandrespiratoryparalysisandshould

thereforeonlybeusedwithgreatcautioninpatientsreceivingcuraremusclerelaxantsorgeneralanaesthetics.

Cross-sensitivitywithneomycinandkanamycinmayoccur.Synergisticactionhasbeendemonstratedwithpenicillins.

Concurrentusewithamphotericinorcyclosporinemayincreasetheriskofnephrotoxicityandototoxicity.Concurrent

usewithoralanticoagulantsmayincreasethehypoprothrombinaemiceffect.

4.6Pregnancyandlactation

Gentamicinshouldonlybeusedduringpregnancyifconsideredessentialbythephysician.Therearenoprovencases

ofintrauterinedamagecausedbygentamicin.However,incommonwithmostdrugsknowntocrosstheplacenta,usage

inpregnancyshouldonlybeconsideredinlifethreateningsituationswhereexpectedbenefitsoutweighpossiblerisks.

Intheabsenceofgastro-intestinalinflammation,theamountofgentamiciningestedfromthemilkisunlikelytoresult

insignificantbloodlevelsinbreast-fedinfants.

4.7Effectsonabilitytodriveandusemachines

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 03/11/2006 CRN 2029632 page number: 2

4.8Undesirableeffects

Sideeffectsincludevestibulardamageorhearingloss,particularlyafterexposuretoototoxicdrugsorinthepresence

ofrenaldysfunction.Nephrotoxicity(usuallyreversible)andoccasionallyacuterenalfailure,hypersensitivity,anaemia,

purpura,convulsionsandeffectsonliverfunctionoccuroccasionally.

4.9Overdose

Haemodialysisandperitonealdialysiswillaidtheremovalfrombloodbuttheformerisprobablymoreefficient.

Calciumsaltsgivenintravenouslyhavebeenusedtocountertheneuromuscularblockadecausedbygentamicin.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Gentamicinisamixtureofantibioticsubstancesproducedbythegrowthofmicromonosporapurpurea.Itisbactericidal

withgreaterantibacterialactivitythanstreptomycin,neomycinorkanamycin.

Gentamicinexertsanumberofeffectsoncellsofsusceptiblebacteria.Itaffectstheintegrityoftheplasmamembrane

andthemetabolismofrna,butitsmostimportanteffectsisinhibitionofproteinsynthesisatthelevelofthe30s

ribosomalsubunit.

5.2Pharmacokineticproperties

Gentamicinisnotreadilyabsorbedfromthegastro-intestinaltract.Gentamicinis70-85%boundtoplasmaalbumin

followingadministrationandisexcreted90%unchangedinurine.

Thehalf-lifeforitseliminationinnormalpatientsis2to3hours.

Effectiveplasmaconcentrationis4-8micrograms/ml.

Thevolumeofdistribution(vd)is0.3l/kg.

Theeliminationrateconstantis:

0.02hr foranuricpatients*

0.30hr normal.

*Thereforeinthosewithanuriacaremustbeexercisedfollowingtheusualinitialdose,anysubsequentadministration

beingreducedin-linewithplasmaconcentrationsofgentamicin.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Disodiumedetate

Waterforinjections

6.2Incompatibilities

Ingeneral,gentamicininjectionshouldnotbemixed.Inparticularthefollowingareincompatibleinmixedsolution

withgentamicininjection:penicillins,cephalosporins,erythromycin,heparins,sodiumbicarbonate.*Dilutioninthe

bodywillobviatethedangerofphysicalandchemicalincompatibilityandenablegentamicintobegivenconcurrently

withthedrugslistedaboveeitherasabolusinjectionintothedriptubing,withadequateflushing,oratseparatesites.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 03/11/2006 CRN 2029632 page number: 3

*Carbondioxidemaybeliberatedonadditionofthetwosolutions.Normallythiswilldissolveinthesolution,but

undersomecircumstancessmallbubblesmayform.

6.3ShelfLife

Unopened:3years.

Opened:useimmediatelyafteropening.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Donotrefrigerateorfreeze.

6.5Natureandcontentsofcontainer

CidomycinAdultInjectableissuppliedinampoules.TheampoulescompriseofTypeIPh.Eur.clearglass.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Forsingleuseonly.

Discardanyremainingsolutionafteruse.

7MARKETINGAUTHORISATIONHOLDER

Sanofi-aventisIrelandLtd.

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA540/36/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:09March1977

Dateoflastrenewal:09March2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 03/11/2006 CRN 2029632 page number: 4