CIDOMYCIN INTRATHECAL

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0006/003/001
  • Authorization date:
  • 10-06-1976
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CidomycinIntrathecalInjectable5mg/ml

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachampoule(1ml)containsGentamicinSulphateequivalentto5mg(5000internationalunits)ofgentamicin.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

SolutionforInjection

Sterile,clear,colourlessaqueoussolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Gentamicinintrathecalinjectableisindicatedforthetreatmentofmeningitisandventriculitisduetobacteriasensitive

tothisanti-infective.

4.2Posologyandmethodofadminstration

Theusualdailydosebytheintraventricularorintrathecalrouteis1mggentamicinbase.Thedosecanbecontrolledby

thephysicianonthebasisofCSFlevelsofdrug.Durationoftreatmentisdependentonmicrobiologicalclearingofthe

CSF.IftheMICoftheinfectingorganismssorequires,anintrathecal/ventriculardoseupto5mgdailycanbegivenin

additiontotheabovetreatment.Gentamicinshouldbegivenintramuscularlyaccordingtothefollowingsuggested

schedules:

Adults:2to4mg/kgevery24hoursindivideddosesat8hourintervals.

Children-(infantsover2weeksuptochildrenaged12years):6.0mg/kginthreeequaldivideddoses.

Infantsupto2weeks:6.0mg/kg/dayintwoequaldivideddoses.

Patientswithrenalimpairment:

creatinineclearance

ml/min dose

frequencyofadministration

>70 80 8hourly

30–70 80 12hourly

10–30 80 24hourly

5–10 80 48hourly

Irish Medicines Board

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Date Printed 27/06/2006 CRN 2024886 page number: 1

4.3Contraindications

1.Useinpatientshypersensitivetogentamicinorotherrelatedaminoglycosides.

2.Concurrentusewithotherpotentiallynephrotoxicorototoxicagents.

4.4Specialwarningsandprecautionsforuse

1.Inadditiontonephrotoxicityandototoxicity,anaemia,purpura,convulsions,increasedliverfunctiontestsand

anaphylaxismayoccur.

2.Inpatientswithrenaldysfunctionthefrequencyandquantityofdosingmayrequirereductiontoavoidtoxicity

fromserumconcentrations,inexcessof10µg/ml.

3.Inviewoftheconcentrationofgentamicinpermlinthisformulationitisessentialtoensurethatthecorrect

volumeanddosageisnotinadvertentlyexceeded.

4.Renalandauditoryfunctionshouldbecarefullyandregularlymonitoredduringgentamicintherapy.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

1.Concurrentusewithcephalosporinsorloopdiureticsmaypotentiatenephrotoxicity.

2.Gentamicin,asdootheraminoglycosidesmayinduceneuromuscularblockageandrespiratoryparalysis.It

shouldthereforeonlybeusedwithgreatcautioninpatientsreceivingcurare-typemusclerelaxants.

3.Gentamicinandcarbenicillinexertasynergisticeffectoncombination.

4.6Pregnancyandlactation

Gentamicinshouldonlybeusedduringpregnancyandlactationifconsideredessentialbythephysician.Thedrug

crossestheplacentabutdoesnotreachbreastmilkinmeasurablelevels.Thereisapossibilityofdamagetothe

auditorynerveofthefoetus.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

See“specialwarnings&precautionsforuse”.

4.9Overdose

Haemodialysisandperitonealdialysiswillaidtheremovalfrombloodbuttheformerisprobablymore

efficient.Calciumsaltsgivenintravenouslyhavebeenusedtocountertheneuromuscularblockadecausedby

gentamicin.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Abroadspectrumbactericidalantibioticwhichbytheusualsystemicroutedoesnotcrossthebloodbrainbarriertoany

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5.2Pharmacokineticproperties

Intrathecallyadministeredthedrugiseliminatedintosystemiccirculationtokidneyforexcretionbyglomerular

filtrationwithat

ofabout4hours.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumchloride

Waterforinjections

6.2Incompatibilities

Ingeneral,GentamicinInjectionshouldnotbemixedwithotherdrugspriortoadministration.Inparticularthe

followingareincompatibleinmixedsolutionwithgentamicininjection:penicillins,cephalosporins,erythromycin,

heparins,sodiumbicarbonate*.Dilutioninthebodywillobviatethedangerofphysicalandchemicalincompatibility

andenablegentamicintobegivenconcurrentlywiththedrugslistedaboveeitherasabolusinjectionintothedrip

tubing,withadequateflushing,oratseparatesites.Inthecaseofcarbenicillin,administrationshouldonlybeata

separatesite.

*Carbondioxidemaybeliberatedonadditionofthetwosolutions.Normallythiswilldissolve

inthesolutionbutundersomecircumstancessmallbubblesmayform.

6.3ShelfLife

Unopened:36months.

Opened:Onceopened,thecontentsoftheampouleshouldbeusedimmediately.Anyunusedcontentsshouldbe

disposedofappropriately.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

CidomycinIntrathecalInjectableissuppliedin1mlneutralclearcolourlesstypeIglassampoulesinpacksof5.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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Date Printed 27/06/2006 CRN 2024886 page number: 3

7MARKETINGAUTHORISATIONHOLDER

RousselLaboratoriesLtd

BroadwaterPark

Denham

Uxbridge

MiddlesexUB95HP

England

8MARKETINGAUTHORISATIONNUMBER

PA6/3/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:10June1976

Dateoflastrenewal:10June2001

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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