Cefazolin Package Leaflet: Usage, Dosage, and Warnings for Antibiotic Injections | Slides Medicine

Package leaflet: Information for the patient

Cefazolin 1 g Powder for solution for injection/infusion

Cefazolin 2 g Powder for solution for injection/infusion

Cefazolin (as Cefazolin sodium)

Read all of this leaflet carefully before you start using this

medicine because it contains important information for you.

- Keepthisleaflet.Youmayneedtoreaditagain.

- Ifyouhaveanyfurtherquestions,askyourdoctoror

pharmacist.

- Thismedicinehasbeenprescribedforyouonly.Donot passit

ontoothers.Itmayharmthem,eveniftheirsignsofillnessare

thesameasyours.

- Ifyougetanysideeffects,talktoyourdoctororpharmacist.This

includesanypossiblesideeffectsnotlistedinthisleaflet.See

section4.

ThenameofyourmedicineisCefazolin 1 g Powder for solution

for injection/infusion and Cefazolin 2 g Powder for solution

for injection/infusion.Intherestofthisleafletthenameofthe

medicineshallbe Cefazolin.

What is in this leaflet

1. WhatCefazolinisandwhatitisusedfor

2. WhatyouneedtoknowbeforeyouaregivenCefazolin

3. HowCefazolinisgiven

4. Possiblesideeffects

5. HowtostoreCefazolin

6. Contentsofthepackandotherinformation

1. What Cefazolin is and what it is used for

Thismedicinecontainstheactivesubstancecefazolin,whichisan

antibiotic.Cefazolinisusedtotreatbacterialinfectionscausedby

cefazolin-susceptiblebacteria,e.g:

• Infectionsofskinandsofttissue

• Infectionsofbonesandjoints

Cefazolincanalsobeusedbefore,duringandaftersurgeryto

preventpossibleinfections.

2. What you need to know before you are given Cefazolin

Do not use Cefazolin:

- ifyouareallergictocefazolinoranyoftheotheringredientsof

thismedicine(listedinsection6).

- ifyouareallergic(hypersensitive)toanycephalosporin

antibiotics.

- haveeverhadasevereallergic(hypersensitive)reactiontoany

othertypeofbetalactamantibiotic(penicillins,monobactamsand

carbapenems).

Warnings and precautions

TalktoyourdoctororpharmacistbeforeusingCefazolinifyou:

• Arepronetoallergicreactions(e.g.hayfeverorbronchial

asthma),sincethentheriskofsevereallergicreactionsto

Cefazolinisincreased.

• Havehadpreviouslyanallergicreactiontootherbeta-lactam

antibiotics(e.g.penicillins),sincethenthereisanincreasedrisk

ofbeingallergictoCefazolinaswell.

• Sufferfromanimpairedkidneyorliverfunction.

• Sufferfromdisordersofbloodclotting(e.g.haemophilia)oryour

presentconditioncanleadtosuchdefects(parenteralfeeding,

malnutrition,liverorkidneydiseases,reductioninbloodplatelets

whichincreasesriskofbleedingorbruising[thrombocytopenia],

administrationofmedicinesthatpreventbloodclotting

[anticoagulantslikeheparin]).

• Sufferfromdiseaseswhichcancausebleedings(e.g.

gastrointestinalulcers).

• Sufferfromseverepersistentdiarrhoeaduringoraftertreatment

withCefazolin.Inthiscasecontactyourdoctorimmediately.

Donottakeanyanti-diarrhoeamedicinewithoutconsultingyour

doctor.

Children

• Cefazolinmaynotbeusedinnewborninfantsandinfants

belowtheageof1monthasthesafetyofusehasnotyetbeen

establishedinthisgroup

Other medicines and Cefazolin

Tellyourdoctororpharmacistifyouaretaking,haverecentlytaken

ormighttakeanyothermedicines,includingmedicinesavailable

withoutprescription.

Yourdoctorwilltakespecialcareifyouareusinganyofthefollowing

medicines:

• Anticoagulants (medicines that prevent blood clotting):

Cefazolinmayveryrarelyleadtodisordersofbloodclotting.

Therefore,ifyousimultaneouslyreceivecefazolinandmedicines

thatpreventbloodclotting(e.g.heparin),acarefulandregular

controlofthecoagulationfactorsisnecessary.

• Probenecid (medicineforthetreatmentofjointdiseaseand

gout).

• Medicines potentially harmful to kidney: Cefazolinmay

intensifytheharmfuleffectofcertainantibiotics(aminoglycosides)

andofmedicinesthatcauseincreaseinurination(diuretics,e.g.

furosemide)onthekidney.UsingCefazolinandoneofthese

medicinesatthesametimerequiresregularmonitoringofthe

kidneyfunction,especiallyinpatientswithkidneydisease.

Pregnancy and breast-feeding

Ifyouarepregnantorbreast-feeding,thinkyoumaybepregnantor

areplanningtohaveababy,askyourdoctororpharmacistforadvice

beforetakingthismedicine.

Pregnancy

Cefazolincrossestheplacentaandcanaffecttheunbornchild.

Therefore,ifyouarepregnant,yourdoctorshouldonlygiveyou

cefazolinifclearlynecessaryandaftercarefulconsiderationof

benefitsandrisks.

Breast-feeding

Cefazolinpassesinsmallamountsintobreastmilk.Therefore,

breastfeedingshouldbediscontinuedduringtreatmentwith

Cefazolin.

Driving and using machines

Cefazolinhasnoornegligibleinfluenceontheabilitytodriveand

usemachines.

Cefazolin contains sodium

1gvial:Thismedicinecontains50.6mgsodium(maincomponent

ofcooking/tablesalt)ineachvial.Thisisequivalentto2.5%ofthe

recommendedmaximumdailydietaryintakeofsodiumforanadult.

2gvial:Thismedicinecontains101.2mgsodium(maincomponent

ofcooking/tablesalt)ineachvial.Thisisequivalentto5%ofthe

recommendedmaximumdailydietaryintakeofsodiumforanadult.

3. How Cefazolin is given

Administration:

Cefazolinisalwaysadministeredbyhealthcarepersonnel.Itwillbe

givenasaninjectionorinfusion(intoavein)afterbeingdissolved,

orintoamuscle(intramuscularly)asadeepIMinjection.Your

doctorwillinformyouaboutthenecessarydurationandfrequencyof

administrationofCefazolin.

The recommended doses are:

Adult patients with normal kidney function

• Infectionscausedbybacteriasusceptibletothismedicine:

 1–2gdaily,dividedinto2–3doses.

• Infectionscausedbybacterialesssusceptibletothismedicine:

3–4gdaily,dividedinto3–4doses.

Anincreaseofthedailydoseupto6ginthreeorfourequaldosesis

possible.

Use in children and adolescents

Prematures and infants below the age of one month:

Thesafetyininfantsbelowtheageofonemonthhasnotbeen

determined.

Children over the age of one month:

• Infectionscausedbybacteriasusceptibletothismedicine:

 25–50mg/kgbodyweight/daydividedin2–4singledoses,

every6,8or12hours.

• Infectionscausedbybacterialesssusceptibletothismedicine:

 Upto100mg/kgbodyweight/daydividedin3–4singledoses,

every6–8hours.

Thisproductisnotrecommendedforchildrenunder1monthoflife.

Elderly patients

Nodosageadjustmentisrequiredforelderlypatientswithnormal

renalfunction.

Special dosage recommendations

Preventionofinfectionsduringsurgicalprocedures

1gcefazolin30-60minutesbeforesurgery.

Incaseoflongsurgicalprocedures(2hoursormore),additional

0.5g-1gcefazolinduringtheoperation.

Patientswithimpairedkidneyfunction

Inpatientswithimpairmentofthekidneyfunction,theeliminationof

cefazolinisslower.Forthisreason,yourdoctorwilladjustthedosage

accordingtotheseverityofthekidneyimpairmentbyreducingthe

maintenancedoseorprolongationofthedosageintervals.

Duration of treatment

Thetreatmentdurationdependsontheseverityoftheinfectionas

wellasonyourrecoveryfromyourillness.

If you are given more Cefazolin than you should

Sincethemedicinewillbegiventoyoubyadoctorornurse,itis

unlikelythatyouwillbegiventoomuch.

Symptomsofoverdoseareheadache,dizziness(vertigo),sensation

ofprickingortinglingontheskin(paraesthesia),restlessness

(agitation),involuntarytwitchingofamuscleoragroupofmuscles

(myoclonia)andcramps(convulsions).Ifthesesymptomsoccurtalk

toyourdoctorimmediately.

Inemergencies,yourphysicianmusttakethenecessarymeasures

forthetreatmentofsymptomsofoverdose.

If you miss a dose of Cefazolin

Adoubledosemustnotbegiventomakeupforaforgottendose.A

forgottendoseshouldonlybegivenbeforethenextregulardoseif

thetimeuntilthenextregulardoseislongenough.

If the treatment with Cefazolin is interrupted or discontinued too

early

Lowdosage,irregularadministrationorstoppingthetreatment

tooearlycancompromisetheoutcomeofthetherapyorleadtoa

relapse,thatismoredifficulttotreat.Pleasefollowtheinstructionsof

yourdoctor.

200 x 650 mm ARIAL 9 pt

Preparation and handling

Preparation of the solution

Foreachrouteofadministrationseethetableforaddition

volumesandsolutionconcentrations,whichmaybeuseful

whenfractionaldosesarerequired.

Guidelines for adult dosage

Intramuscularinjection

Cefazolin1g:

ReconstituteCefazolinwithoneofthefollowingcompatible

diluentsaccordingtothedilutiontablethatfollows:

• waterforinjection

• 10%glucosesolution

• 0.9%sodiumchloridesolution

• 0.5%lidocaineHClsolution

Shakewelluntilcontentsofthevialarefullydissolvedand

injectasdeepIMinjection.

Reconstitutiontableforintramuscularinjection

Content per vial Amount of diluent to

be added

Approximate

concentration

1 g 2.5 mL 330 mg / mL

Fortheamountofdiluenttobeaddedforpaediatricpopulation

pleaserefertosectionGuidelinesforpaediatricdosage.

Useoflidocaine:

Incasealidocainesolutionisusedasasolvent,cefazolin

solutionsmustonlybeusedforintramuscularinjection.

Contraindicationstolidocaine,warningsandotherrelevant

informationasdetailedintheSummaryofProduct

Characteristicsoflidocainemustbeconsideredbeforeuse.

Thelidocainesolutionshouldneverbeadministered

intravenously.

IMinjectionwithlidocaineassolventisindicatedforchildren

over30monthsold.

Cefazolin2g:Shouldnotbeusedforintramuscular

administration.

Intravenousinjection

ReconstituteCefazolinwithofoneofthefollowingcompatible

diluentsaccordingtothedilutiontablethatfollows:

• waterforinjections

• 0.9%sodiumchloridesolution

• 5%glucosesolution

• 10%glucosesolution

Reconstitutiontableforintravenousinjection

Content per vial Minimum amount of

diluent to be added

Approximate

concentration

1 g 4 mL 220 mg / mL

Cefazolinistobeinjectedslowlyoverthreetofiveminutes.In

nocaseshouldthesolutionbeinjectedinlessthan3minutes.

Thisshouldbedonedirectlyintotheveinorintothetubefrom

whichthepatientreceivesintravenoussolution.

Singledosesexceeding1gshouldbegivenasintravenous

infusionover30to60minutes.

Guidelines for paediatric dosage:

1gvial:Thecontentof1vial(1000mgcefazolin)isdissolved

in4mLofacompatiblesolvent(i.e.concentrationapprox.

220mg/mL).Therespectivevolumeofthissolutiontobeused

isindicatedintable1inadditiontothedoseinmg.

2gvial:Thecontentof1vial(2000mgcefazolin)isdissolved

in10mlofacompatiblesolvent(i.e.concentrationapprox.

180mg/mL).Therespectivevolumeofthissolutiontobeused

isindicatedintable2inadditiontothedoseinmg.

Fortheamountofdiluenttobeaddedforpaediatricpopulation

pleaserefertosectionGuidelinesforpaediatricdosage.For

volumesinferiorof1mL,pleaseusea0.5mLsyringeforbetter

accuracyofdosing.

Intravenousinfusion

Cefazolinshouldfirstbereconstitutedwithoneofthediluents

detailedascompatibleforintravenousinjection.

Furtherdilutionshouldtakeplacewithoneofthefollowing

compatiblediluentsaccordingtothedilutiontablethatfollows:

- sodiumchloride0.9%solution

- glucose5%

- Ringer’ssolution

- lactatedRinger’ssolution

- waterforinjections

Dilutiontableforintravenousinfusion

Content

per vial Reconstitution Dilution Approximate

concentration

Minimum amount of

diluent to be added

Amount of diluent

to be added

1 g 4 mL 50 mL - 100 mL 20 mg / mL -

10 mg / mL

2 g 8 mL 50 mL - 100 mL 40 mg / mL -

20 mg / mL

ForCefazolin2g,ifsmallerdosesareneeded,itis

recommendedtousehalfofthereconstitutedsolution(about

4mLwith1gcefazolin;i.e.halfofthevialcontent)andtoadd

acompatiblediluenttoafinalvolumeof100mL(resulting

concentrationabout10mg/mL).Therequiredamountofthis

dilutedsolutioncanthenbeadministeredtothepatientoverthe

prescribedtime.Cefazolinsolutionscontaininglidocaineshould

neverbeadministeredintravenously.Asforallparenteral

medicinalproducts,inspectthereconstitutedsolutionvisually

forparticulatematteranddiscolorationpriortoadministration.

Thesolutionshouldonlybeusedifthesolutionisclearand

practicallyfreefromparticles.Thereconstitutedproductis

forsingleuseonly.Anyunusedmedicinalproductorwaste

materialshouldbedisposedofinaccordancewithlocal

requirements.

Incompatibilities

Cefazolinisincompatiblewithamikacindisulfate,amobarbital-

sodium,ascorbicacid,bleomycinsulphate,calciumgluceptate,

calciumgluconate,cimetidinehydrochloride,colistinmethat-

sodium,erythromycingluceptate,kanamycinsulphate,

oxytetracyclinhydrochloride,pentobarbital-sodium,polymyxin-

B-sulphateandtetracyclinehydrochloride.

Posology and method of administration

Thedosageaswellasthemethodofadministrationare

dependentonthelocationandseverityoftheinfectionand

ontheclinicalandbacteriologicalprogress.Localtherapeutic

guidanceshouldbetakenintoconsideration.

Adults and adolescents (above 12 years of age and ≥ 40 kg

bodyweight)

• Infectionscausedbysensitivemicro-organisms:

 1g–2gcefazolinperdaydividedinto2–3equaldoses.

• Infectionscausedbymoderatelysensitivemicro-organisms:

 3g–4gcefazolinperdaydividedinto3–4equaldoses.

Insevereinfections,dosesofupto6gperdaycanbe

administeredinthreeorfourequaldoses(onedoseevery6or

8hours).

Special dosage recommendations

Peri-operativeprophylaxis

• Topreventpostoperativeinfectionincontaminatedor

potentiallycontaminatedsurgery,recommendeddosesare:

1gcefazolin30–60minutesbeforesurgery

• Incaseoflongsurgicalinterventions(2hoursormore)

additional0.5–1gcefazolinduringtheintervention.

• Prolongedcontinuationofadministrationbeyondthe

surgicalinterventionshouldbesupportedbynationalofficial

guidance.

Itisimportantthat(1)thepreoperativedosebegivenjust

(30minto1hour)priortothestartofsurgerysothatadequate

antibioticlevelsarepresentintheserumandtissuesatthetime

ofinitialsurgicalincision;and(2)cefazolinbeadministered,if

necessary,atappropriateintervalsduringsurgerytoprovide

sufficientlevelsoftheantibioticattheanticipatedmomentsof

greatestexposuretoinfectiveorganisms.

Adult patients with renal impairment

Adultswithrenalimpairmentmayneedalowerdosetoavoid

overlapping.

Thislowerdosemaybeguidedbydeterminingbloodlevels.

Ifnotpossible,thedosagecanbeestablishedbasedon

creatinineclearance.

Cefazolin maintenance therapy in patients with renal

impairment

Creatinine clearance

(ml/min)

Serum

creatinine

(mg/dl)

Dosage

≥ 55 ≤ 1.5 Normal dose and normal

dosage interval

35 - 54 1.6 - 3.0 Normal dose, every 8 hours

11 - 34 3.1 - 4.5 Half of the normal dose every

12 hours

≤ 10 ≥ 4.6 Half of the normal dose every

18-24 hours

Inhaemodialysispatients,thetreatmentscheduledependson

thedialysisconditions.

Guidelines for adult dosage

Reconstitutiontableforintramuscularinjection

Content per vial Amount of diluent to

be added

Approximate

concentration

1 g 2.5 mL 330 mg / mL

Reconstitutiontableforintravenousinjection

Content per vial Minimum amount of

diluent to be added

Approximate

concentration

1 g 4 mL 220 mg / mL

Paediatric population:

Infections caused by sensitive microorganisms

Adoseof25–50mg/kgbodyweightdividedintotwotofour

equaldosesperdayisrecommended(onedoseevery6,8or

12hours).

Infections caused by moderately sensitive microorganisms

Adoseofupto100mg/kgbodyweightdividedinthreeorfour

equaldosesisrecommended(onedoseevery6or8hours).

Thefollowinginformationisintendedforhealthcareprofessionalsonly:

Cefazolin Package Leaflet: Usage, Dosage, and Warnings for Antibiotic Injections, Slides of Medicine

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