21/4/2016 Fluconazole:Druginformation

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Fluconazole:Druginformation

Copyright19782016Lexicomp,Inc.Allrightsreserved.

(Foradditionalinformationsee"Fluconazole:Patientdruginformation"andsee"Fluconazole:Pediatricdrug
information")

ForabbreviationsandsymbolsthatmaybeusedinLexicomp(showtable)

BrandNames:US Diflucan
BrandNames:Canada ACTFluconazoleApoFluconazoleCanesOralCOFluconazoleDiflucan
DiflucaninjectionDiflucanOneDiflucanPWSDomFluconazoleFluconazoleInjectionFluconazole
InjectionSDZFluconazoleOmegaMonicureMylanFluconazoleNovoFluconazolePHLFluconazolePMS
FluconazolePROFluconazoleRivaFluconazoleTaroFluconazole

PharmacologicCategory AntifungalAgent,AzoleDerivativeAntifungalAgent,OralAntifungal
Agent,Parenteral

Dosing:Adult ThedailydoseoffluconazoleisthesameforbothoralandIVadministration
Usualdosagerange:Oral,IV:150mgonceorLoadingdose:200to800mgmaintenance:200to800mg
oncedailydurationanddosagedependonlocationandseverityofinfection

Indicationspecificdosing:

Blastomycosis(offlabeluse):Oral:CNSdisease:Consolidation:800mgdailyfor12monthsanduntil
resolutionofCSFabnormalities(Chapman2008)

Candidiasis:Oral,IV:

Candidemia(neutropenicandnonneutropenic):Loadingdose:800mg(12mg/kg)onday1,then400
mgdaily(6mg/kg/day)for14daysafterfirstnegativebloodcultureandresolutionof
signs/symptoms.Note:Notrecommendedforpatientswithrecentazoleexposure,critical
illness,orifC.kruseiorC.glabrataaresuspected(Pappas2009).

Chronic,disseminated:400mgdaily(6mg/kg/day)untilcalcificationorlesionresolution(Pappas
2009)

CNScandidiasis(alternativetherapy):400to800mgdaily(6to12mg/kg/day)untilCSF/radiological
abnormalitiesresolved.Note:Recommendedasalternativetherapyinpatientsintolerantof
amphotericinB(Pappas2009).

Endocarditis,prostheticvalve(offlabeluse):400to800mgdaily(6to12mg/kg/day)for6weeks
aftervalvereplacement(asstepdowninstable,culturenegativepatients)longtermsuppression
inabsenceofvalvereplacement:400to800mgdaily(Pappas2009)

Endophthalmitis(offlabeluse):400to800mgdaily(6to12mg/kg/day)for4to6weeksuntil
examinationindicatesresolution(Pappas2009)

Esophageal:

Manufacturer'slabeling:Loadingdose:200mgonday1,thenmaintenancedoseof100to400
mgdailyfor21daysandforatleast2weeksfollowingresolutionofsymptoms

Alternativedosing:200to400mgdailyfor14to21dayssuppressivetherapyof100to200mg
3timesweeklymaybeusedforrecurrentinfections(Pappas2009)

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Intertrigo(offlabeluse):50mgdailyor150mgonceweekly(Coldiron1991Nozickova1998Stengel
1994)

Oropharyngeal:

Manufacturer'slabeling:Loadingdose:200mgonday1maintenancedose100mgdailyfor2
weeks.Note:Therapywith100mgdailyisassociatedwithresistancedevelopment(Rex
1995).

Alternativedosing:100to200mgdailyfor7to14daysforuncomplicated,moderatetosevere
diseasechronictherapyof100mg3timesweeklyisrecommendedinimmunocompromised
patientswithhistoryoforopharyngealcandidiasis(OPC)(Pappas2009)

Osteoarticular:400mgdailyfor6to12months(osteomyelitis)or6weeks(septicarthritis)(Pappas
2009)

Pacemaker(orICD,VAD)infection(offlabeluse):400to800mgdaily(6to12mg/kg/day)for4to6
weeksafterdeviceremoval(asstepdowninstable,culturenegativepatients)longterm
suppressionwhenVADcannotberemoved:400to800mgdaily(Pappas2009)

Pericarditisormyocarditis:400to800mgdailyforseveralmonths(Pappas2009)

Peritonitis:50to200mgdaily.Note:Somecliniciansdonotrecommendusing<200mgdaily(Chen
2004).

Prophylaxis:

Bonemarrowtransplant:400mgoncedaily.Patientsanticipatedtohavesevere
granulocytopeniashouldstarttherapyseveraldayspriortotheanticipatedonsetof
neutropeniaandcontinuefor7daysaftertheneutrophilcountis>1000mm3.

HighriskICUpatientsinunitswithhighincidenceofinvasivecandidiasis:400mgoncedaily
(Pappas2009)

Neutropenicpatients:400mgoncedailyfordurationofneutropenia(Pappas2009)

Peritonealdialysisassociatedinfection(concurrentlytreatedwithantibiotics),preventionof
secondaryfungalinfection:200mgevery48hours(Restrepo2010)

Solidorgantransplant:200to400mgoncedailyforatleast7to14days(Pappas2009)

Surgical(perioperative)prophylaxisinhighriskpatientsundergoingliver,pancreas,kidney,or
pancreaskidneytransplantation(offlabeluse):IV:400mggivenintheperioperativeperiod
andcontinuedinthepostoperativeperiodfor28days.Timeofinitiationanddurationvaries
withtransplanttypeandoperativeprotocol(Bratzler2013).

Thrombophlebitis,suppurative(offlabeluse):400to800mgdaily(6to12mg/kg/day)andasstep
downinstablepatientsfor2weeks(Pappas2009)

Urinarytract:

Cystitis:

Manufacturer'slabeling:UTI:50to200mgoncedaily

Asymptomatic,patientundergoingurologicprocedure:200to400mgoncedailyseveral
daysbeforeandaftertheprocedure(Pappas2009)

Symptomatic:200mgoncedailyfor2weeks(Pappas2009)

Fungusballs:200to400mgoncedaily(Pappas2009)

Pyelonephritis:200to400mgoncedailyfor2weeks(Pappas2009)

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Vaginal/Vulvovaginal:Oral:

Uncomplicated:Manufacturer'slabeling:150mgasasingledose

Complicatedorsevere:150mgevery72hoursfor3doses(Pappas2009)or150mgevery72
hoursfor2doses(CDC[Workowski2015])

Recurrent:150mgoncedailyfor10to14days,followedby150mgonceweeklyfor6months
(Pappas2009)orfluconazole100mg,150mg,or200mgevery72hours(day1,4,and7)
foratotalof3doses,then100mg,150mg,or200mgonceweeklyfor6months(CDC
[Workowski2015])

Coccidioidomycosis,treatment(offlabeluse):

HIVinfected(HHS[OIadult2015]):

Meningealinfections(consultationwithspecialistisadvised):IV,Oral:400to800mgoncedaily
patientswhocompleteinitialtherapyshouldbeconsideredforlifelongsuppressivetherapy
usingfluconazole400mgoncedailyifCD4countsremain<250cells/mm3.

Mildinfections(eg,focalpneumonia):Oral:400mgoncedailypatientswhocompleteinitial
therapyshouldbeconsideredforlifelongsuppressivetherapyusingfluconazole400mg
oncedailyifCD4countsremain<250cells/mm3.

NonHIVinfected(offlabeluse):Oral,IV:

Disseminated,extrapulmonary:400mgoncedaily(someexpertsuse2000mgdaily[Galgiani
2005])

Meningitis:400mgoncedaily(someexpertsuseinitialdosesof800to1000mgdaily),lifelong
duration(Galgiani2005)

Pneumonia,acute,uncomplicated:200to400mgdailyfor3to6months(Catanzaro1995
Galgiani2000)

Pneumonia,chronicprogressive,fibrocavitary:200to400mgdailyfor12months(Catanzaro
1995Galgiani2000)

Pneumonia,diffuse:ConsolidationafteramphotericinBinduction:400mgdailyfor12months
(lifelonginchronicallyimmunosuppressed)(Galgiani2005)

Coccidioidomycosis,prophylaxis(offlabeluse):Oral:

HIVinfectedpatients(HHS[OIadult2015]):

PrimaryprophylaxisinpatientswithanewpositiveIgMorIgGserologictestwholiveindisease
endemicareasandhaveCD4counts<250cells/mm3:400mgoncedaily

Chronicsuppressivetherapy(secondaryprophylaxis):400mgoncedaily

Solidorgantransplant(offlabeluse):Note:Prophylaxisregimensinthissettinghavenotbeen
establishedthefollowingregimenhasbeenproposedfortransplantrecipientswhomaintain
residenceinaCoccidioidessppendemicarea.

Previoushistory>12monthspriortotransplant:200mgoncedailyfor6to12months(Vikram
2009Vucicevic2011)

Previoushistory12monthspriortotransplant:400mgoncedaily,lifelongtreatment(Vikram
2009Vucicevic2011)

Positiveserologybeforeorattransplant:400mgoncedaily,lifelongtreatmentifserologyis
negativeat12months,consideradosereductionto200mgdaily(Vikram2009Vucicevic
2011)

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Nohistory(atriskfordenovoposttransplantdisease):someclinicianstreatwith200mgdaily
for6to12months(Vucicevic2011)

Cryptococcosis:

Meningitis:

Manufacturer'slabeling:Oral,IV:400mgfor1dose,then200to400mgoncedailyfor10to12
weeksfollowingnegativeCSFculture

Alternatedosing:HIVinfected:

Induction(alternativetopreferredtherapy):Oral,IV:800to1,200mgoncedailywith
concomitantflucytosinefor6weeks(Perfect2010)or400to800mgoncedailywith
concomitantflucytosineforatleast2weeks(HHS[OIadult2015])or1,200mgonce
dailyasmonotherapyforatleast2weeks(HHS[OIadult2015])

Consolidation(preferredtherapy):Oral,IV:400mgoncedailyforatleast8weeks(HHS[OI
adult2015])

Maintenance(suppression)(preferredtherapy):Oral:200mgoncedailyforatleast12
monthsmaintenancetherapymaybestoppedifthefollowingcriteriaarefulfilled:
induction,consolidation,andatleast12monthsofmaintenancetherapyhasbeen
completed,patientremainsasymptomaticfromcryptococcalinfection,andCD4count
100cells/mm3for3monthsandHIVRNAsuppressedinresponsetoeffectiveART
(HHS[OIadult2015])

Pulmonary(immunocompetent)(offlabeluse):400mgoncedailyfor6to12months(Perfect
2010)

Dosing:Pediatric
(Foradditionalinformationsee"Fluconazole:Pediatricdruginformation")

ThedailydoseoffluconazoleisthesamefororalandIVadministration

Usualdosagerange:Oral,IV:Loadingdose:6to12mg/kg/dosemaintenance:3to12mg/kg/doseonce
dailydurationanddosagedependonlocationandseverityofinfection

Indicationspecificdosing:

Candidiasis:Oral,IV:

Esophageal:

Manufacturersrecommendation:Loadingdose:6mg/kg/dosemaintenance:312mg/kg/doseonce
dailyfor21daysandforatleast2weeksfollowingresolutionofsymptoms(maximum:600
mg/day)

HIVexposed/infected:Loadingdose:6mg/kg/doseonceonday1maintenance:3to6mg/kg/dose
oncedailyfor4to21days(maximum:400mg/day)(CDC2009)

Relapsesuppression(HIVexposed/infected):3to6mg/kg/doseoncedaily(maximum:200
mg/day)(CDC2009)

Invasivedisease(alternativetherapy):5to6mg/kg/doseevery12hoursfor28days
(maximum:600mg/day)(CDC2009)

Oropharyngeal:

Manufacturersrecommendation:Loadingdose:6mg/kg/dosemaintenance:3mg/kg/doseoncedaily
for2weeks(maximum:600mg/day)
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HIVexposed/infected:3to6mg/kg/doseoncedailyfor7to14days(maximum:400mg/day)(CDC
2009)

Surgical(perioperative)prophylaxisinhighriskpatientsundergoingliver,pancreas,kidney,orpancreas
kidneytransplantation(offlabeluse):IV:6mg/kggivenintheperioperativeperiodandcontinuedin
thepostoperativeperiodfor28days(maximumdose400mg).Timeofinitiationanddurationvaries
withtransplanttypeandoperativeprotocol(Bratzler2013).

Coccidioidomycosis:Oral,IV:

Children:Meningealinfection,orinastablepatientwithdiffusepulmonaryordisseminateddisease(HIV
exposed/infected):

Treatment:5to6mg/kg/dosetwicedaily(maximumdailydose:800mg/day)(CDC2009)followedby
chronicsuppressivetherapy(seebelow)

Relapsesuppression:6mg/kg/doseoncedaily(maximumdailydose:400mg/day)(CDC2009)

Adolescents:Treatment,primaryprophylaxis,orchronicsuppressivetherapy(secondaryprophylaxis):
Refertoadultdosing.

Cryptococcosis:Oral,IV:

Meningitis:Manufacturer'slabeling:12mg/kg/dosefor1dose,then6to12mg/kg/dayfor1012weeks
followingnegativeCSFculture

HIVexposed/infected:

CNSdisease(alternativetherapyinpatientsintolerantofamphotericinB):

Children:

Induction:12mg/kg/dosefor1dose,then6to12mg/kg/day(maximum:800mg/day)for2
weeks(incombinationwithflucytosine)(CDC2009)

Consolidation:10to12mg/kg/dayfor8weeks(Perfect2010)or12mg/kg/dosefor1dose,
then6to12mg/kg/day(maximum:800mg/day)for8weeks(CDC2009)

Maintenance(suppression):6mg/kg/day(maximum:200mg/day)(CDC2009Perfect2010)

Adolescents:Refertoadultdosing.

NonCNSdisease,disseminated(includingseverepulmonarydisease)(alternativetherapyofflabel
use):Induction:12mg/kg/dosefor1dose,then6to12mg/kg/day(maximum:600mg/day)
(CDC2009)

NonCNSdisease,localized(includingisolatedpulmonarydisease)(offlabeluse):12mg/kg/dosefor
1dose,then6to12mg/kg/day(maximum:600mg/day).Note:Durationdependsuponinfection
siteandseverity(CDC2009).Forpatientswithpulmonarydisease(notdelineatedbyseverity),
theIDSArecommendsadurationof6to12months(Perfect2010).

Primaryantifungalprophylaxisinpediatriconcologypatients(guidelinerecommendationsScience
2014):Oral,IV:

Allogeneichematopoieticstemcelltransplant(HSCT):Infants1month,Children,andAdolescents<19
years:6to12mg/kg/day(maximum:400mg/day),beginatthestartofconditioningcontinueuntil
engraftment

AllogeneicHSCTwithgrades2to4acutegraftversushostdisease(GVHD)orchronicextensiveGVHD:
BeginwithGVHDdiagnosis,continueuntilGVHDresolves:

Infants1monthandChildren<13years:6to12mg/kg/day(maximum:400mg/day)

Adolescents13years(whereposaconazoleiscontraindicated):6to12mg/kg/day(maximum:400
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mg/day)

AutologousHSCTwithneutropeniaanticipated>7days:Infants1month,Children,andAdolescents<19
years:6to12mg/kg/day(maximum:400mg/day),beginatthestartofconditioningcontinueuntil
engraftment

Acutemyeloidleukemia(AML)ormyelodysplasticsyndromes(MDS):Infants1month,Children,and
Adolescents<19years:6to12mg/kg/day(maximum:400mg/day)duringchemotherapyassociated
neutropeniaalternativeantifungalsmaybesuggestedforchildren13yearsincenterswithahigh
localincidenceofmoldinfectionsoriffluconazoleisnotavailable

Dosing:Geriatric Refertoadultdosing.
Dosing:RenalImpairment
Manufacturer'slabeling:Note:RenalfunctionestimatedusingtheCockcroftGaultformula

Noadjustmentforvaginalcandidiasissingledosetherapy

For multiple dosing in adults, administer loading dose of 50 to 400 mg, then adjust daily doses as follows
(dosagereductioninchildrenshouldparalleladultrecommendations):

CrCl>50mL/minute:Nodosageadjustmentnecessary

CrCl50mL/minute(nodialysis):Reducedoseby50%

Endstagerenaldiseaseonintermittenthemodialysis(IHD):

Manufacturer's labeling: 100% of daily dose (according to indication) after each dialysis session on
nondialysisdays,patientshouldreceiveareduceddoseaccordingtotheirCrCl.

Alternaterecommendations: Doses of 200 to 400 mg every 48 to 72 hours or 100 to 200 mg every 24

hours have been recommended. Note: Dosing dependent on the assumption of 3 times/week,
completeIHDsessions(Heintz2009).

Continuous renal replacement therapy (CRRT) (Heintz 2009 Trotman 2005): Drug clearance is highly
dependent on the method of renal replacement, filter type, and flow rate. Appropriate dosing requires close
monitoring of pharmacologic response, signs of adverse reactions due to drug accumulation, as well as drug
concentrations in relation to target trough (if appropriate). The following are general recommendations only
(basedondialysateflow/ultrafiltrationratesof1to2L/hourandminimalresidualrenalfunction)andshouldnot
supersedeclinicaljudgment:

CVVH:Loadingdoseof400to800mgfollowedby200to400mgevery24hours

CVVHD/CVVHDF: Loading dose of 400 to 800 mg followed by 400 to 800 mg every 24 hours (CVVHD or
CVVHDF)or800mgevery24hours(CVVHDF)

Note: Higher maintenance doses of 400 mg every 24 hours (CVVH), 800 mg every 24 hours (CVVHD), and
500 to 600 mg every 12 hours (CVVHDF) may be considered when treating resistant organisms and/or
whenemployingcombinedultrafiltrationanddialysisflowratesof2L/hourforCVVHD/CVVHDF(Heintz
2009Trotman2005).

Dosing:HepaticImpairment Therearenodosageadjustmentsprovidedinthemanufacturer's
labelingusewithcaution.

DosageForms:US Excipientinformationpresentedwhenavailable(limited,particularlyforgenerics)
consultspecificproductlabeling.

Solution,Intravenous:

Generic:100mg(50mL)200mg(100mL)400mg(200mL)

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Solution,Intravenous[preservativefree]:

Generic:200mg(100mL)400mg(200mL)

SuspensionReconstituted,Oral:

Diflucan:10mg/mL(35mL)40mg/mL(35mL)[orangeflavor]

Generic:10mg/mL(35mL)40mg/mL(35mL)

Tablet,Oral:

Diflucan:50mg,100mg,150mg,200mg

Generic:50mg,100mg,150mg,200mg

GenericEquivalentAvailable:US Yes
Administration
IV:Donotuseifcloudyorprecipitated.Infuseover~1to2hoursdonotexceed200mg/hour.

Oral:Maybeadministeredwithoutregardtomeals.

Hazardousagentuseappropriateprecautionsforhandlinganddisposal(NIOSH2014[group3]).

Compatibility StableinD5W,LR,NS.
Ysiteadministration:

Compatible: Acyclovir, aldesleukin, allopurinol, amifostine, amikacin, aminophylline, amiodarone,

ampicillin/sulbactam, anidulafungin, aztreonam, benztropine, bivalirudin, caspofungin, cefazolin,
cefepime, cefotetan, cefoxitin, chlorpromazine, cimetidine, cisatracurium, daptomycin,
dexamethasone sodium phosphate, dexmedetomidine, diltiazem, dimenhydrinate, diphenhydramine,
dobutamine,docetaxel,dopamine,doripenem,doxorubicinliposome,droperidol,etoposidephosphate,
famotidine, fenoldopam, filgrastim, fludarabine, foscarnet, gallium nitrate, ganciclovir, gemcitabine,
gentamicin,granisetron,heparin,hetastarchinlactateelectrolyteinjection(Hextend),hydrocortisone
sodiumphosphate,immuneglobulinintravenous,leucovorincalcium,linezolid,lorazepam,melphalan,
meperidine, meropenem, metoclopramide, metronidazole, midazolam, morphine, nafcillin,
nitroglycerin, ondansetron, oxacillin, paclitaxel, pancuronium, pemetrexed, penicillin G potassium,
phenytoin, piperacillin/tazobactam, prochlorperazine edisylate, promethazine, propofol,
quinupristin/dalfopristin, ranitidine, remifentanil, sargramostim, tacrolimus, telavancin, teniposide,
theophylline, thiotepa, ticarcillin/clavulanate, tigecycline, tobramycin, vancomycin, vasopressin,
vecuronium,vinorelbine,zidovudine.

Incompatible: Amphotericin B cholesteryl sulfate complex, ampicillin, calcium gluconate, cefotaxime,

ceftriaxone, cefuroxime, chloramphenicol, diazepam, digoxin, erythromycin lactobionate, furosemide,
haloperidol, hydroxyzine, imipenem/cilastatin, pantoprazole, pentamidine,
sulfamethoxazole/trimethoprim. Variable (consult detailed reference): Amphotericin B, anakinra,
ceftazidime,clindamycin,piperacillin.

Use Treatmentofcandidiasis(esophageal,oropharyngeal,peritoneal,urinarytract,vaginal)systemic
candidainfections(eg,candidemia,disseminatedcandidiasis,andpneumonia)cryptococcalmeningitis
antifungalprophylaxisinallogeneicbonemarrowtransplantrecipients

Use:OffLabel
CandidaintertrigoCoccidioidomycosis(prophylaxis/treatment/chronicsuppressivetherapy)inHIVinfected
patients(adolescentsandadults)CryptococcalpneumoniaPrimaryantifungalprophylaxisinpediatric

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oncologypatientsSurgicalprophylaxis(perioperative)

MedicationSafetyIssues

Soundalike/lookalikeissues:
Fluconazolemaybeconfusedwithflecainide,FLUoxetine,furosemide,itraconazole,voriconazole

Diflucanmaybeconfusedwithdiclofenac,Diprivan,disulfiram

Internationalissues:
Canesten (oral capsules) [Great Britain] may be confused with Canesten brand name for clotrimazole
(various dosage forms) [multiple international markets] Cenestin brand name estrogens (conjugated
A/synthetic)[US,Canada]

AdverseReactionsSignificant Frequencynotalwaysdefined.
Cardiovascular:Angioedema(rare)

Centralnervoussystem:Headache(2%to13%),dizziness(1%)

Dermatologic:Rash(2%)

Gastrointestinal:Nausea(2%to7%),abdominalpain(2%to6%),vomiting(2%to5%),diarrhea(2%to3%),
dysgeusia(1%),dyspepsia(1%)

Hepatic: Alkaline phosphatase increased, ALT increased, AST increased, hepatic failure (rare), hepatitis,
jaundice

Miscellaneous:Anaphylacticreactions(rare)

Postmarketing and/or case reports: Agranulocytosis, alopecia, cholestasis, diaphoresis, drug eruption,
exanthematous pustulosis, fatigue, fever, hypercholesterolemia, hypertriglyceridemia, hypokalemia,
insomnia,leukopenia,malaise,myalgia,neutropenia,paresthesia,QTprolongation,seizure,somnolence,
StevensJohnson syndrome, thrombocytopenia, torsade de pointes, toxic epidermal necrolysis, tremor,
vertigo,weakness,xerostomia

Contraindications Hypersensitivitytofluconazoleoranycomponentoftheformulation(crossreaction
withotherazoleantifungalagentsmayoccur,buthasnotbeenestablishedusecaution)coadministrationof
terfenadineinadultpatientsreceivingmultipledosesof400mgorhigherorwithCYP3A4substrateswhich
mayleadtoQTcprolongation(eg,astemizole,cisapride,erythromycin,pimozide,orquinidine)

Warnings/Precautions
Concernsrelatedtoadverseeffects:

Arrhythmias: Cases of QTc prolongation and torsade de pointes associated with fluconazole use have
beenreported(usuallyhighdoseorincombinationwithagentsknowntoprolongtheQTinterval)use
cautioninpatientswithconcomitantmedicationsorconditionswhicharearrhythmogenic.

CNSeffects:Mayoccasionallycausedizzinessorseizuresusecautiondrivingoroperatingmachinery.

Hepatotoxicity: Serious (and sometimes fatal) hepatic toxicity (eg, hepatitis, cholestasis, fulminant
hepaticfailure)hasbeenobserved.Monitorpatientswhodevelopabnormalliverfunctiontestsforthe
developmentofmoreseverehepaticinjurydiscontinuefluconazoleifsignsandsymptomsconsistent
withliverdiseasedevelop.

Hypersensitivity reactions: Anaphylaxis has been reported rarely use with caution in patients with
hypersensitivitytootherazoles.
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Skinreactions:Rareexfoliativeskindisordershavebeenobservedfataloutcomeshavebeenreported
in patients with serious concomitant diseases. Monitor patients with deep seated fungal infections
closely for rash development and discontinue if lesions progress. In patients with superficial fungal
infectionswhodeveloparashattributabletofluconazole,treatmentshouldalsobediscontinued.

Diseaserelatedconcerns:

Hepatic impairment: Use with caution in patients with preexisting hepatic impairment monitor liver
functioncloselyanddiscontinueifsymptomsconsistentwithliverdiseasedevelop.

Renal impairment: Use with caution in patients with renal impairment dosage adjustment may be
necessary.

Concurrentdrugtherapyissues:

Drugdrug interactions: Potentially significant interactions may exist, requiring dose or frequency
adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions
databaseformoredetailedinformation.

Dosageformspecificissues:

Benzylalcoholandderivatives:Somedosageformsmaycontainsodiumbenzoate/benzoicacidbenzoic
acid (benzoate) is a metabolite of benzyl alcohol large amounts of benzyl alcohol (99 mg/kg/day)
havebeenassociatedwithapotentiallyfataltoxicity(gaspingsyndrome)inneonatesthegasping
syndromeconsistsofmetabolicacidosis,respiratorydistress,gaspingrespirations,CNSdysfunction
(including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP
1997 CDC 1982) some data suggests that benzoate displaces bilirubin from protein binding sites
(Ahlfors 2001) avoid or use dosage forms containing benzyl alcohol derivative with caution in
neonates.Seemanufacturerslabeling.

Sucrose: Oral suspension contains sucrose avoid use in patients with fructose intolerance, glucose
galactosemalabsorption,orsucraseisomaltaseinsufficiency.

Specialhandling:

Hazardousagent:Useappropriateprecautionsforhandlinganddisposal(NIOSH2014[group3]).

Metabolism/TransportEffects InhibitsCYP1A2(weak),CYP2C19(strong),CYP2C9(moderate),
CYP3A4(moderate)

DrugInteractions
(Foradditionalinformation:LaunchLexiInteractDrugInteractionsProgram)

Alfentanil:FluconazolemayincreasetheserumconcentrationofAlfentanil.Management:Monitorforincreased
anestheticandrespiratorydepressanteffectsifalfentaniliscombinedwithfluconazole.Considerusing
lowerinitialdosesofalfentaniloranalternativeanesthetic.RiskD:Considertherapymodification

Amitriptyline:MayenhancetheQTcprolongingeffectofFluconazole.Fluconazolemayincreasetheserum
concentrationofAmitriptyline.RiskC:Monitortherapy

AmphotericinB:AntifungalAgents(AzoleDerivatives,Systemic)maydiminishthetherapeuticeffectof
AmphotericinB.RiskC:Monitortherapy

Apixaban:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofApixaban.RiskC:Monitor
therapy

Aprepitant:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofAprepitant.RiskX:Avoid
combination

ARIPiprazole:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofARIPiprazole.

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Management:Monitorforincreasedaripiprazolepharmacologiceffects.Aripiprazoledoseadjustmentsmay
ormaynotberequiredbasedonconcomitanttherapyand/orindication.Consultfullinteractionmonograph
forspecificrecommendations.RiskC:Monitortherapy

Asunaprevir:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofAsunaprevir.RiskX:
Avoidcombination

AtorvaSTATin:FluconazolemayincreasetheserumconcentrationofAtorvaSTATin.RiskC:Monitortherapy

Avanafil:FluconazolemayincreasetheserumconcentrationofAvanafil.Management:Limitavanafiltoa
maximumdoseof50mgper24hourperiodinanypatientwhoisalsoreceivingamoderateinhibitorof
CYP3A4suchasfluconazole.RiskD:Considertherapymodification

Blonanserin:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofBlonanserin.RiskC:
Monitortherapy

Bosentan:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofBosentan.Management:
ConcomitantuseofbothaCYP2C9inhibitorandaCYP3Ainhibitororasingleagentthatinhibitsboth
enzymeswithbosentanislikelytocausealargeincreaseinserumconcentrationsofbosentanandisnot
recommended.Seemonographfordetails.RiskC:Monitortherapy

Bosentan:CYP2C9Inhibitors(Moderate)mayincreasetheserumconcentrationofBosentan.Management:
ConcomitantuseofbothaCYP2C9inhibitorandaCYP3Ainhibitororasingleagentthatinhibitsboth
enzymeswithbosentanislikelytocausealargeincreaseinserumconcentrationsofbosentanandisnot
recommended.Seemonographfordetails.RiskC:Monitortherapy

Bosutinib:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofBosutinib.RiskX:Avoid
combination

Brexpiprazole:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofBrexpiprazole.
Management:Thebrexpiprazoledoseshouldbereducedto25%ofusualifusedtogetherwithbotha
moderateCYP3A4inhibitorandastrongormoderateCYP2D6inhibitor,orifamoderateCYP3A4inhibitor
isusedinaCYP2D6poormetabolizer.RiskC:Monitortherapy

Bromocriptine:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofBromocriptine.
Management:Thebromocriptinedoseshouldnotexceed1.6mgdailywithuseofamoderateCYP3A4
inhibitor.TheCyclosetbrandspecificallyrecommendsthisdoselimitation,butotherbromocriptine
productsdonotmakesuchspecificrecommendations.RiskD:Considertherapymodification

Budesonide(Systemic):CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofBudesonide
(Systemic).Management:Considerreducingtheoralbudesonidedosewhenusedtogetherwitha
CYP3A4inhibitorortemporarilystoppingbudesonidetherapyduringCYP3A4inhibitoruse.Monitor
patientscloselyforsigns/symptomsofcorticosteroidexcess.RiskD:Considertherapymodification

Budesonide(Topical):CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofBudesonide
(Topical).Management:PerUSprescribinginformation,avoidthiscombination.Canadianproductlabeling
doesnotrecommendstrictavoidance.Ifcombined,monitorforexcessiveglucocorticoideffectsas
budesonideexposuremaybeincreased.RiskD:Considertherapymodification

BusPIRone:AntifungalAgents(AzoleDerivatives,Systemic)maydecreasethemetabolismofBusPIRone.
Isavuconazoniumconsiderationsareaddressedinseparatemonographs.RiskD:Considertherapy
modification

Busulfan:AntifungalAgents(AzoleDerivatives,Systemic)mayincreasetheserumconcentrationofBusulfan.
Isavuconazoniumconsiderationsareaddressedinseparatemonographs.RiskC:Monitortherapy

CalciumChannelBlockers:FluconazolemayincreasetheserumconcentrationofCalciumChannelBlockers.
Exceptions:Clevidipine.RiskC:Monitortherapy

Cannabis:CYP2C9Inhibitors(Moderate)mayincreasetheserumconcentrationofCannabis.More
specifically,tetrahydrocannabinolserumconcentrationsmaybeincreased.RiskC:Monitortherapy
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Cannabis:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofCannabis.Morespecifically,
tetrahydrocannabinolandcannabidiolserumconcentrationsmaybeincreased.RiskC:Monitortherapy

CarBAMazepine:FluconazolemayincreasetheserumconcentrationofCarBAMazepine.RiskC:Monitor
therapy

Carvedilol:CYP2C9Inhibitors(Moderate)mayincreasetheserumconcentrationofCarvedilol.Specifically,
concentrationsoftheScarvedilolenantiomermaybeincreased.RiskC:Monitortherapy

Cilostazol:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofCilostazol.Management:
Considerreducingthecilostazoldoseto50mgtwicedailyinadultpatientswhoarealsoreceiving
moderateinhibitorsofCYP3A4.RiskD:Considertherapymodification

Cilostazol:CYP2C19InhibitorsmayincreasetheserumconcentrationofCilostazol.Management:Consider
reducingthecilostazoldoseto50mgtwicedailyinpatientswhoarealsoreceivinginhibitorsofCYP2C19.
RiskD:Considertherapymodification

Cisapride:AntifungalAgents(AzoleDerivatives,Systemic)mayincreasetheserumconcentrationof
Cisapride.Isavuconazoniumconsiderationsareaddressedinseparatemonographs.RiskX:Avoid
combination

Citalopram:FluconazolemayenhancetheQTcprolongingeffectofCitalopram.Fluconazolemayincreasethe
serumconcentrationofCitalopram.Management:Ifthiscombinationcannotbeavoided,consideralower
doseofcitalopramandmonitorcloselyforQTcprolongationandarrhythmias.RiskX:Avoidcombination

Clopidogrel:CYP2C19Inhibitors(Strong)maydecreaseserumconcentrationsoftheactivemetabolite(s)of
Clopidogrel.Management:Duetoariskforimpairedclopidogreleffectivenesswithsuchacombination,
carefullyconsidertheneedforastrongCYP2C19inhibitorinpatientsreceivingclopidogrel.Monitor
patientscloselyforevidenceofadiminishedresponsetoclopidogrel.RiskD:Considertherapy
modification

Cobimetinib:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofCobimetinib.
Management:AvoidtheconcomitantuseofcobimetinibandmoderateCYP3A4inhibitors.Ifconcurrent
shortterm(14daysorless)usecannotbeavoided,reducethecobimetinibdoseto20mgdaily.RiskX:
Avoidcombination

Colchicine:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofColchicine.Management:
ReducecolchicinedoseasdirectedwhenusingwithamoderateCYP3A4inhibitor,andincrease
monitoringforcolchicinerelatedtoxicity.Useextracautioninpatientswithimpairedrenaland/orhepatic
function.RiskD:Considertherapymodification

CycloSPORINE(Systemic):FluconazolemayincreasetheserumconcentrationofCycloSPORINE
(Systemic).RiskC:Monitortherapy

CYP2C19Substrates:CYP2C19Inhibitors(Strong)maydecreasethemetabolismofCYP2C19Substrates.
RiskD:Considertherapymodification

CYP2C9Substrates:CYP2C9Inhibitors(Moderate)maydecreasethemetabolismofCYP2C9Substrates.
RiskC:Monitortherapy

CYP3A4Substrates:CYP3A4Inhibitors(Moderate)maydecreasethemetabolismofCYP3A4Substrates.
RiskC:Monitortherapy

Dapoxetine:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofDapoxetine.Management:
Thedoseofdapoxetineshouldbelimitedto30mg/daywhenusedtogetherwithamoderateinhibitorof
CYP3A4.RiskD:Considertherapymodification

Didanosine:MaydecreasetheabsorptionofAntifungalAgents(AzoleDerivatives,Systemic).Entericcoated
didanosinecapsulesarenotexpectedtoaffecttheseantifungals.RiskD:Considertherapymodification

Domperidone:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofDomperidone.RiskX:

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Avoidcombination

DOXOrubicin(Conventional):CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationof
DOXOrubicin(Conventional).Management:SeekalternativestomoderateCYP3A4inhibitorsinpatients
treatedwithdoxorubicinwheneverpossible.OneU.S.manufacturer(PfizerInc.)recommendsthatthese
combinationsbeavoided.RiskD:Considertherapymodification

Dronabinol:CYP2C9Inhibitors(Moderate)mayincreasetheserumconcentrationofDronabinol.RiskC:
Monitortherapy

Dronabinol:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofDronabinol.RiskC:
Monitortherapy

Eletriptan:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofEletriptan.Management:
Theuseofeletriptanwithin72hoursofamoderateCYP3A4inhibitorshouldbeavoided.RiskD:Consider
therapymodification

Eliglustat:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofEliglustat.Management:
Useshouldbeavoidedundersomecircumstances.Seefulldruginteractionmonographfordetails.Risk
D:Considertherapymodification

Eplerenone:FluconazolemayincreasetheserumconcentrationofEplerenone.Management:Reducethe
startingdoseofeplerenoneto25mg/daymonitorpatientscloselyforincreasedeplerenoneeffects.Risk
D:Considertherapymodification

Erythromycin(Systemic):FluconazolemayenhancetheQTcprolongingeffectofErythromycin(Systemic).
FluconazolemayincreasetheserumconcentrationofErythromycin(Systemic).RiskX:Avoid
combination

Etravirine:AntifungalAgents(AzoleDerivatives,Systemic)mayincreasetheserumconcentrationof
Etravirine.ApplicableIsavuconazoniumconsiderationsareaddressedinseparatemonographs.Etravirine
maydecreasetheserumconcentrationofAntifungalAgents(AzoleDerivatives,Systemic).Thiswouldbe
anticipatedwithitraconazoleorketoconazole.Etravirinemayincreasetheserumconcentrationof
AntifungalAgents(AzoleDerivatives,Systemic).Thiswouldbeanticipatedwithvoriconazole.
Management:Monitorforincreasedeffects/toxicityofetravirine.Antifungaldoseadjustmentmaybe
neededforketoconazole,itraconazole,orposaconazolebutspecificdosingguidelinesarelacking.RiskD:
Considertherapymodification

Everolimus:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofEverolimus.Management:
Everolimusdosereductionsarerequiredforpatientsbeingtreatedforsubependymalgiantcell
astrocytomaorrenalcellcarcinoma.Seeprescribinginformationforspecificdoseadjustmentand
monitoringrecommendations.RiskD:Considertherapymodification

FentaNYL:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofFentaNYL.Management:
Monitorpatientscloselyforseveraldaysfollowinginitiationofthiscombination,andadjustfentanyldose
asnecessary.RiskD:Considertherapymodification

Flibanserin:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofFlibanserin.RiskX:Avoid
combination

Fluvastatin:FluconazolemayincreasetheserumconcentrationofFluvastatin.Management:Limitfluvastatin
maximumadultdoseto20mgtwicedaily,andmonitorfortoxiceffectsoffluvastatin(e.g.,myalgia,
rhabdomyolysis,liverfunctiontestabnormalities),duringconcomitanttreatment.RiskD:Considertherapy
modification

Fosphenytoin:FluconazolemayincreasetheserumconcentrationofFosphenytoin.RiskD:Considertherapy
modification

GuanFACINE:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofGuanFACINE.
Management:Canadianlabelingrecommendsaninitial50%reductioninguanfacinedosewithfurtherdose

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titrationasneeded.However,USlabelingdoesnotcallforanyspecificguanfacinedosereductionwith
thiscombination.RiskC:Monitortherapy

Halofantrine:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofHalofantrine.RiskD:
Considertherapymodification

HighestRiskQTcProlongingAgents:QTcProlongingAgents(IndeterminateRiskandRiskModifying)may
enhancetheQTcprolongingeffectofHighestRiskQTcProlongingAgents.Management:Avoidsuch
combinationswhenpossible.UseshouldbeaccompaniedbyclosemonitoringforevidenceofQT
prolongationorotheralterationsofcardiacrhythm.RiskD:Considertherapymodification

Hydrocodone:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofHydrocodone.RiskC:
Monitortherapy

Ibrutinib:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofIbrutinib.Management:Ifa
moderateCYP3Ainhibitormustbeused,considerreducingthedoseofibrutinibto140mgdailyand
monitorcloselyforsignsoftoxicity.RiskX:Avoidcombination

Ifosfamide:CYP3A4Inhibitors(Moderate)maydecreaseserumconcentrationsoftheactivemetabolite(s)of
Ifosfamide.RiskC:Monitortherapy

Imatinib:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofImatinib.RiskC:Monitor
therapy

Ivabradine:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofIvabradine.RiskX:Avoid
combination

Ivacaftor:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofIvacaftor.Management:
Ivacaftordosereductionsarerequiredconsultprescribinginformationforspecificageandweightbased
recommendations.RiskD:Considertherapymodification

Lomitapide:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofLomitapide.RiskX:Avoid
combination

Losartan:FluconazolemaydecreasetheserumconcentrationofLosartan.Specifically,fluconazolemay
decreasetheserumconcentrationofE3174,themorepotentactivemetaboliteoflosartan.RiskC:
Monitortherapy

Lovastatin:FluconazolemayincreasetheserumconcentrationofLovastatin.RiskC:Monitortherapy

Lurasidone:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofLurasidone.Management:
U.S.labeling:startat20mg/dayandlimittomaxof80mg/daywithmoderateCYP3A4inhibitor.Canadian
labeling:limittomaxof40mg/daywithmoderateCYP3A4inhibitoravoidconcomitantuseofgrapefruit
products.RiskD:Considertherapymodification

Methadone:FluconazolemayenhancetheQTcprolongingeffectofMethadone.Fluconazolemayincreasethe
serumconcentrationofMethadone.Management:Monitorpatientscloselyforevidenceofmethadone
toxicities,includingbutnotlimitedtorespiratorydepressionandQTprolongation/torsadesdepointes,if
combinedwithfluconazole.Methadonedosereductionsmayberequired.RiskD:Considertherapy
modification

Mifepristone:MayenhancetheQTcprolongingeffectofQTcProlongingAgents(IndeterminateRiskandRisk
Modifying).Management:ThoughthedrugslistedherehaveuncertainQTprolongingeffects,theyallhave
somepossibleassociationwithQTprolongationandshouldgenerallybeavoidedwhenpossible.RiskD:
Considertherapymodification

ModerateRiskQTcProlongingAgents:QTcProlongingAgents(IndeterminateRiskandRiskModifying)may
enhancetheQTcprolongingeffectofModerateRiskQTcProlongingAgents.RiskC:Monitortherapy

Naloxegol:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofNaloxegol.RiskX:Avoid
combination

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Nateglinide:FluconazolemayincreasetheserumconcentrationofNateglinide.RiskC:Monitortherapy

Nevirapine:FluconazolemayincreasetheserumconcentrationofNevirapine.RiskC:Monitortherapy

NiMODipine:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofNiMODipine.RiskC:
Monitortherapy

Olaparib:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofOlaparib.Management:
AvoiduseofmoderateCYP3A4inhibitorsinpatientsbeingtreatedwitholaparib.Ifsuchconcurrentuse
cannotbeavoided,thedoseofolaparibshouldbereducedto200mgtwicedaily.RiskX:Avoid
combination

Ospemifene:FluconazolemayincreasetheserumconcentrationofOspemifene.RiskX:Avoidcombination

OxyCODONE:CYP3A4Inhibitors(Moderate)mayenhancetheadverse/toxiceffectofOxyCODONE.
CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofOxyCODONE.Serum
concentrationsoftheactivemetaboliteOxymorphonemayalsobeincreased.RiskD:Considertherapy
modification

Parecoxib:FluconazolemayincreasetheserumconcentrationofParecoxib.Management:Usethelowest
possibledoseofparecoxibinpatientswhoaretakingfluconazole.RiskD:Considertherapymodification

Phenytoin:FluconazolemayincreasetheserumconcentrationofPhenytoin.RiskD:Considertherapy
modification

Pimecrolimus:CYP3A4Inhibitors(Moderate)maydecreasethemetabolismofPimecrolimus.RiskC:Monitor
therapy

Pimozide:AntifungalAgents(AzoleDerivatives,Systemic)mayenhancethearrhythmogeniceffectof
Pimozide.AntifungalAgents(AzoleDerivatives,Systemic)mayincreasetheserumconcentrationof
Pimozide.ThisincreaseinserumconcentrationsmayleadtoQTcintervalprolongationandventricular
arrhythmias.ApplicableIsavuconazoniumconsiderationsareaddressedinseparatemonographs.RiskX:
Avoidcombination

Pimozide:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofPimozide.RiskX:Avoid
combination

PredniSONE:FluconazolemayincreasetheserumconcentrationofPredniSONE.RiskC:Monitortherapy

Propafenone:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofPropafenone.RiskC:
Monitortherapy

ProtonPumpInhibitors:FluconazolemayincreasetheserumconcentrationofProtonPumpInhibitors.RiskC:
Monitortherapy

QuiNIDine:AntifungalAgents(AzoleDerivatives,Systemic)maydecreasethemetabolismofQuiNIDine.
ApplicableIsavuconazoniumconsiderationsareaddressedinseparatemonographs.RiskX:Avoid
combination

Ramelteon:FluconazolemayincreasetheserumconcentrationofRamelteon.RiskC:Monitortherapy

Ranolazine:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofRanolazine.Management:
Limittheranolazineadultdosetoamaximumof500mgtwicedailyinpatientsconcurrentlyreceiving
moderateCYP3A4inhibitors(e.g.,diltiazem,verapamil,erythromycin,etc.).RiskD:Considertherapy
modification

RedYeastRice:FluconazolemayincreasetheserumconcentrationofRedYeastRice.Specifically,
concentrationsoflovastatinandrelatedcompoundsfoundinRedYeastRicemaybeincreased.RiskC:
Monitortherapy

RifamycinDerivatives:AntifungalAgents(AzoleDerivatives,Systemic)mayincreasetheserumconcentration
ofRifamycinDerivatives.Onlyrifabutinappearstobeaffected.RifamycinDerivativesmaydecreasethe

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serumconcentrationofAntifungalAgents(AzoleDerivatives,Systemic).Management:Avoidthese
combinationswhenpossible.Voriconazoleandisavuconazoniumareconsideredcontraindicated.RiskD:
Considertherapymodification

Ruxolitinib:FluconazolemayincreasetheserumconcentrationofRuxolitinib.Management:Thiscombination
shouldbeavoidedundersomecircumstances.Seemonographfordetails.RiskD:Considertherapy
modification

Saccharomycesboulardii:AntifungalAgents(Systemic,Oral)maydiminishthetherapeuticeffectof
Saccharomycesboulardii.RiskX:Avoidcombination

Salmeterol:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofSalmeterol.RiskC:
Monitortherapy

Saxagliptin:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofSaxagliptin.RiskC:
Monitortherapy

Sildenafil:FluconazolemayincreasetheserumconcentrationofSildenafil.RiskC:Monitortherapy

Simeprevir:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofSimeprevir.RiskX:Avoid
combination

Simvastatin:FluconazolemayincreasetheserumconcentrationofSimvastatin.RiskC:Monitortherapy

Sirolimus:FluconazolemayincreasetheserumconcentrationofSirolimus.Management:Sirolimusdose
adjustmentswilllikelybeneededwhenstarting/stoppinganyazoleantifungal.Clinicaldatasuggest
sirolimus(adult)dosereductionsof5090%willbeneededwhenstartinganazoleantifungal,butspecific
guidelinesarelacking.RiskD:Considertherapymodification

Solifenacin:AntifungalAgents(AzoleDerivatives,Systemic)maydecreasethemetabolismofSolifenacin.
ApplicableIsavuconazoniumconsiderationsareaddressedinseparatemonographs.RiskD:Consider
therapymodification

Sonidegib:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofSonidegib.Management:
AvoidconcomitantuseofsonidegibandmoderateCYP3A4inhibitorswhenpossible.Whenconcomitant
usecannotbeavoided,limitCYP3A4inhibitorusetolessthan14daysandmonitorforsonidegibtoxicity
(particularlymusculoskeletaladversereactions).RiskD:Considertherapymodification

Sulfonylureas:FluconazolemayincreasetheserumconcentrationofSulfonylureas.Management:Seek
alternativeswhenpossible.Ifusedtogether,monitorcloselyforincreasedeffectsofsulfonylureasif
fluconazoleisinitiated/doseincreased,ordecreasedeffectsiffluconazoleisdiscontinued/dose
decreased.RiskD:Considertherapymodification

SUNItinib:AntifungalAgents(AzoleDerivatives,Systemic)maydecreasethemetabolismofSUNItinib.
ApplicableIsavuconazoniumconsiderationsareaddressedinseparatemonographs.RiskD:Consider
therapymodification

Suvorexant:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofSuvorexant.RiskD:
Considertherapymodification

Tacrolimus(Systemic):FluconazolemayincreasetheserumconcentrationofTacrolimus(Systemic).
Management:Monitortacrolimusconcentrationscloselyandadjustoraltacrolimusdoseasnecessary
whenconcomitantlyadministeredwithfluconazole.Reduceddosesoftacrolimuswilllikelyberequired.
RiskD:Considertherapymodification

Tadalafil:FluconazolemayincreasetheserumconcentrationofTadalafil.RiskC:Monitortherapy

Temsirolimus:Fluconazolemayincreaseserumconcentrationsoftheactivemetabolite(s)ofTemsirolimus.
Management:Considertemsirolimusdosereductionsoralternativestofluconazole.Monitorsirolimus
concentrationsinallpatientsreceivingfluconazoleoranysystemicazoleantifungal.RiskD:Consider
therapymodification

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Tetrahydrocannabinol:CYP2C9Inhibitors(Moderate)mayincreasetheserumconcentrationof
Tetrahydrocannabinol.RiskC:Monitortherapy

Tetrahydrocannabinol:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationof
Tetrahydrocannabinol.RiskC:Monitortherapy

Tipranavir:FluconazolemayincreasetheserumconcentrationofTipranavir.Management:Limitfluconazole
adultmaximumdoseto200mg/dayinpatientstreatedwithtipranavir.RiskD:Considertherapy
modification

TiZANidine:CYP1A2Inhibitors(Weak)mayincreasetheserumconcentrationofTiZANidine.Management:
Avoidthesecombinationswhenpossible.Ifcombinedusecannotbeavoided,initiatetizanidineatanadult
doseof2mgandincreasein24mgincrementsbasedonpatientresponse.Monitorforincreasedeffects
oftizanidine,includingadversereactions.RiskD:Considertherapymodification

Tofacitinib:FluconazolemayincreasetheserumconcentrationofTofacitinib.Management:Reducetheadult
doseoftofacitinibto5mgdailyinpatientsreceivingmoderateCYP3A4inhibitorsthatstronglyinhibit
CYP2C19(e.g.,fluconazole,sitaxentan).RiskD:Considertherapymodification

Tolvaptan:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofTolvaptan.RiskX:Avoid
combination

Trabectedin:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofTrabectedin.RiskX:
Avoidcombination

Ulipristal:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofUlipristal.Management:This
isspecificforwhenulipristalisbeingusedforsigns/symptomsofuterinefibroids(Canadianindication).
Whenulipristalisusedasanemergencycontraceptive,patientsreceivingthiscombinationshouldbe
monitoredforulipristaltoxicity.RiskX:Avoidcombination

Vardenafil:FluconazolemayincreasetheserumconcentrationofVardenafil.Management:Limitvardenafil
dosestoamaximumof5mgper24hourperiodinpatientsreceivingconcurrenttherapywithamoderate
CYP3A4inhibitorsuchasfluconazole.RiskD:Considertherapymodification

Vilazodone:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofVilazodone.RiskC:
Monitortherapy

Vindesine:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofVindesine.RiskC:Monitor
therapy

VitaminKAntagonists(eg,warfarin):FluconazolemayincreasetheserumconcentrationofVitaminK
Antagonists.RiskD:Considertherapymodification

Voriconazole:FluconazolemayincreasetheserumconcentrationofVoriconazole.RiskX:Avoidcombination

Zidovudine:FluconazolemaydecreasethemetabolismofZidovudine.RiskC:Monitortherapy

Zolpidem:AntifungalAgents(AzoleDerivatives,Systemic)mayincreasetheserumconcentrationofZolpidem.
ApplicableIsavuconazoniumconsiderationsareaddressedinseparatemonographs.RiskC:Monitor
therapy

Zopiclone:CYP3A4Inhibitors(Moderate)mayincreasetheserumconcentrationofZopiclone.Management:
Thestartingadultdoseofzopicloneshouldnotexceed3.75mgifcombinedwithamoderateCYP3A4
inhibitor.Monitorpatientsforsignsandsymptomsofzopiclonetoxicityiftheseagentsarecombined.Risk
D:Considertherapymodification

PregnancyRiskFactor C(singledoseforvaginalcandidiasis)/D(allotherindications)(showtable)
PregnancyImplications Adverseeventshavebeenobservedinsomeanimalreproductionstudies.
Whenusedinhighdoses,fluconazoleisteratogenicinanimalstudies.Followingexposureduringthefirst
trimester,casereportshavenotedsimilarmalformationsinhumanswhenusedinhigherdoses(400mg/day)
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overextendedperiodsoftime(Aleck1997).Abnormalitiesreportedincludeabnormalfacies,abnormalcalvarial
development,arthrogryposis,brachycephaly,cleftpalate,congenitalheartdisease,femoralbowing,thinribs
andlongbones.Useoflowerdoses(150mgasasingledose)doesnotsuggestanincreaserisktothefetus.
Mostazoleantifungals,includingfluconazole,arerecommendedtobeavoidedduringpregnancy(Pappas
2009).Onlytopicalazoleantifungalsarerecommendedforthetreatmentofvulvovaginalcandidiasisin
pregnantwomen(CDC[Workowski2015]).

BreastFeedingConsiderations Fluconazoleisexcretedinbreastmilk.Themanufacturer
recommendsthatcautionbeexercisedwhenadministeringfluconazoletonursingwomen.Fluconazoleisfound
inbreastmilkatconcentrationssimilartomaternalplasma.

Pricing:US
Solution(FluconazoleinDextroseIntravenous)

200mg/100mL(100mL):$13.56

400mg/200mL(200mL):$15.13

Solution(FluconazoleinSodiumChlorideIntravenous)

100mg/50mL0.9%(50mL):$12.00

200mg/100mL0.9%(100mL):$11.00

400mg/200mL0.9%(200mL):$7.15

Suspension(reconstituted)(DiflucanOral)

10mg/mL(35mL):$131.96

40mg/mL(35mL):$456.49

Suspension(reconstituted)(FluconazoleOral)

10mg/mL(35mL):$35.90

40mg/mL(35mL):$130.40

Tablets(DiflucanOral)

50mg(30):$588.10

100mg(30):$924.02

150mg(12):$588.29

200mg(30):$1512.13

Tablets(FluconazoleOral)

50mg(30):$167.13

100mg(30):$262.62

150mg(12):$167.20

200mg(30):$429.75

Disclaimer:ThepricingdataprovidearepresentativeAWPand/orAAWPpricefromasinglemanufacturerof
thebrandand/orgenericproduct,respectively.Thepricingdatashouldbeusedforbenchmarkingpurposes
only,andassuchshouldnotbeusedtosetoradjudicateanypricesforreimbursementorpurchasing
functions.Pricingdataisupdatedmonthly.

MonitoringParameters Periodicliverfunctiontests(AST,ALT,alkalinephosphatase)andrenal
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21/4/2016 Fluconazole:Druginformation

functiontests,potassium

InternationalBrandNames Afungil(MX)Avezol(MY)Baten(DO,EC,GT,HN,PA,SV)Biozole
(MY)Burnax(EC)Candeur(LI)Candifix(ES)Candizole(BE)Canesoral(AU)Cryptal(ID)Diaflu(UA)
Diflazon(VN)Diflucan(AE,AT,AU,BB,BE,BF,BG,BH,BJ,BM,BS,BZ,CH,CI,CL,CN,CR,CZ,DE,
DK,DO,EE,ES,ET,FI,GB,GH,GM,GN,GT,GY,HK,HN,HR,HU,ID,IE,IS,IT,JM,JO,JP,KE,KR,
KW,LB,LI,LR,LT,LU,LV,MA,ML,MR,MT,MU,MW,MX,MY,NE,NG,NI,NL,NO,NZ,PA,PE,PH,PL,
PT,QA,RO,RU,SA,SC,SD,SE,SI,SK,SL,SN,SR,SV,TH,TN,TR,TT,TW,TZ,UG,VN,ZA,ZM,
ZW)DiflucanOne(AU)Difluvid(LK,MY)Difluzole(KR)Difnazol(KR)Dimycon(HR)DizoleOne(AU)
Dyflyuzol(UA)Dyzolor(PH)Eapacon(ET)Exomax(HK)FCZInfusion(ID)Flocan(KR)FLUD(TW)
Flucand(AE,BH,CY,EG,IQ,IR,JO,KW,LB,LY,OM,QA,SA,SY,YE)Flucanol(IL)Flucazol(AE,BH,
BR,CY,EG,IQ,IR,JO,KW,LB,LY,OM,QA,SA,SY,YE)Flucazole(NZ)Flucogus(TW)Flucon(KR)
Flucona(KR)FluconaDenk(TZ)Fluconaz(PH)Flucoral(ID)Flucoran(NZ)Flucoxan(MX)Flucozal(BR,
LK,MT,PK)Fludicon(HK)Fludizol(TH)Fluken(ZW)Flumax(KR)Flumyc(ZW)Flunazol(CY)Flunazole
(TW)Flunco(TH)Fluxar(ID)Fluzin(KR)Fluzole(AU)Fluzoral(TH)Forcan(IN,LV,VN)Fukole(MY,PH)
Fumay(TW)Funa(TH)Funazol(KR)Funex(CO)Fungata(AT,DE)Fungicon(ZW)Fungostatin(GR)
Fungoz(ID)Funzela(PH)Funzol(AE,HR,JO,LB,QA,SA)Fuzolan(ID)Kyrin(TH)Lucon(HK)
Medoflucon(CN,SG)Mikosyst(UA)Mutum(AR,PE,VE)Mycocyst(BB,BM,BS,BZ,GY,JM,SR,TT)
Mycomox(LV)Mycorest(SG)Mycosyst(HU)Neoconal(KR)Nobzol1(CO)Nobzol2(CO)Nuforce(LK)
Odaft(MY,PH)Omastin(SG)Onecan(LK)Oneflu(KR)Oramax(AE,ET,KW,LB,QA,SA)Oxifungol
(MX)Oxole(AU)Sixanol(PY,UY)Spirolac(PY)Stabilanol(ET,IL)Stalene(TH)Syscan(ET,IN)Tavor
(EC)Tinazole(KR)Treflucan(AE,BH,CY,EG,IQ,IR,JO,KW,LB,LY,OM,QA,SA,SY,YE)Triflucan
(FR,IL,TR)Uzol(TW)Zelix(LI)Zemyc(ID)Zoldicam(MX)Zoleshot(PH)Zolmed(VN)

MechanismofAction InterfereswithfungalcytochromeP450activity(lanosterol14demethylase),
decreasingergosterolsynthesis(principalsterolinfungalcellmembrane)andinhibitingcellmembrane
formation

PharmacodynamicsandPharmacokinetics
Absorption:Oral:Wellabsorbedfooddoesnotaffectextentofabsorption

Distribution: Vd: ~0.6 L/kg widely throughout body with good penetration into CSF, eye, peritoneal fluid,
sputum,skin,andurine

RelativediffusionbloodintoCSF:Adequatewithorwithoutinflammation(exceedsusualMICs)

CSF:bloodlevelratio:Normalmeninges:50%to90%Inflamedmeninges:~80%

Proteinbinding,plasma:11%to12%

Bioavailability:Oral:>90%

Halflife elimination: Normal renal function: ~30 hours (range: 20 to 50 hours) Elderly: 46.2 hours Neonates
(gestationalage26to29weeks):73.6to46.6hours(decreaseswithincreasingpostnatalage)Pediatric
patients9monthsto15years:19.5to25hours

Timetopeak,serum:Oral:1to2hours

Excretion:Urine(80%asunchangeddrug)

UseofUpToDateissubjecttotheSubscriptionandLicenseAgreement.

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