It is advised these patients only if it is determined that the potential benefit outweighs the potential risks. place oftalking toyourdoctororpharmacist. Itraconazole is excreted mainly as inactive metabolites in urine (35%) and in feces (54%) within one week of an oral solution dose. Contact a certified poison control center for the most up to date information on the management of SporanoxThe solution should be vigorously swished in the mouth (10 mL at a time) for several seconds and swallowed.For patients with oropharyngeal candidiasis unresponsive/refractory to treatment with fluconazole tablets, the recommended dose is 100 mg (10 mL) b.i.d. )Overallexposuretoitraconazole,basedonAUC,wasdecreasedinpatientswithmoderateandsevererenalimpairmentbyapproximately30%and40%,respectively,as comparedwithsubjects withnormal renal function.Dataarenotavailableinrenallyimpairedpatientsduringlong-termuseofitraconazole.Dialysishasnoeffectonthehalf-lifeorclearanceofitraconazoleorhydroxy-itraconazole(seealsoLimitedpharmacokineticdataareavailableontheuseofitraconazoleinthepediatricpopulation.Clinicalpharmacokineticstudiesinchildrenandadolescentsagedbetween5monthsand17yearswereperformedwithitraconazolecapsules,oralsolutionorintravenousformulationIndividualdoseswiththecapsuleandoralsolutionformulationrangedfrom1.5to12.5mg/kg/day,givenasonce-dailyortwice-dailyadministration.Theintravenousformulationwasgiveneitherasa2.5mg/kgsingleinfusion,ora2.5mg/kginfusiongivenoncedailyortwicedaily.Forthesamedailydose,twicedailydosingcomparedtosingledailydosingyieldedpeakandtroughconcentrationscomparabletoadultsingledailydosing.NosignificantagedependencewasobservedforitraconazoleAUCandtotalbodyclearance,whileweakassociationsbetweenageanditraconazoledistributionvolume,Cratewerenoted.ItraconazoleapparentclearanceanddistributionvolumeseemedtoberelatedtoTheoralbioavailabilityofhydroxypropyl-β-cyclodextringivenasasolubilizerofitraconazoleinoralsolutionisonaveragelowerthan0.5%andissimilartothatofhydroxypropyl-β-cyclodextrinalone.Thisloworalbioavailabilityofhydroxypropyl-β-cyclodextrinisnotmodifiedbythepresenceoffoodandis similar aftersingle andrepeatedadministrations.Itraconazolehasbeentestedinastandardbatteryofnon-clinical safetystudies.Acutetoxicitystudieswithitraconazole inmice,rats,guineapigsand dogsindicateawidesafetymargin.Sub(chronic)oraltoxicitystudiesinratsanddogsrevealedseveraltargetorgansortissues:adrenalcortex,liverandmononuclearphagocytesystemaswellasdisordersofthelipidmetabolismpresentingasxanthomacells invarious organs.Athighdoses,histologicalinvestigationsofadrenalcortexshowedareversibleswellingwithcellularhypertrophyofthezonareticularis andfasciculata, whichwas sometimesassociatedwithathinningofthezonaglomerulosa.Reversiblehepaticchangeswerefoundathighdoses.Slightchangeswereobservedinthesinusoidalcellsandvacuolationofthehepatocytes,thelatterindicatingcellulardysfunction,butwithoutvisiblehepatitisorhepatocellularnecrosis.macrophages withincreasedproteinaceous material invariousparenchymal tissues.AgloballowerbonemineraldensitywasobservedinjuveniledogsafterchronicitraconazoleInthreetoxicologystudiesusingrats,itraconazoleinducedbonedefects.Theinduceddefectsincludedreducedboneplateactivity,thinningofthezonacompactaofthelargebones,andItraconazoleisnotaprimarycarcinogeninratsormice.Inmalerats,however,therewasahigherincidenceofsoft-tissuesarcoma,whichisattributedtotheincreaseinnon-neoplastic,chronicinflammatoryreactionsoftheconnectivetissueasaconsequenceofraisedcholesterolTherearenoindicationsofamutagenic potentialofitraconazole.Itraconazolewasfoundtocauseadose-relatedincreaseinmaternaltoxicity,embryotoxicity,andteratogenicityinratsandmiceathighdoses.Inrats,theteratogenicityconsistedofmajorskeletal defects;inmice,itconsistedofencephaloceles andmacroglossia.Thereis noevidenceofaprimaryinfluenceonfertilityunder treatment withitraconazole.Singleandrepeateddosetoxicitystudiesinmice,ratsanddogsindicateawidesafetymargin(histologicalchangesintheurinarytract,softeningoffecesrelatedtotheosmoticwaterretentioninthelargeintestine,activationofthemononuclearphagocytesystem)andshowedgoodSlightliver changes occurredat dosesofabout30times theproposedhumandoseofHP- OraltreatmentofjuvenileBeagledogswithHP-β-CDat1200mg/kgforaperiodofupto13weekswitha4-weekrecoveryperiodwasclinicallywelltoleratedwithnoeffectsnotedwhencomparedtocontrol animals at laboratoryor histopathologyexamination.Noprimarycarcinogenicityactivitywasevidencedinthemousecarcinogenicitystudy.Intheratcarcinogenicitystudy,anincreasedincidenceofneoplasmsinthelargeintestine(at5000mg/kg/day)andintheexocrinepancreas(from500mg/kg/day)wereseen.Basedonahumanequivalentdosecalculationnormalizedforbodysurfacearea,therecommendedclinicaldoseofSPORANOX ® oralsolutioncontainsapproximately1.7timestheamountofHP-β-CDaswasinthe500mg/kg/daydoseadministeredinrats inthis carcinogenicitystudy.Theslightlyhigherincidenceofadenocarcinomasinthelargeintestineswaslinkedtothehypertrophic/hyperplasticandinflammatorychangesinthecolonicmucosabroughtaboutbyHP-β-CD-inducedincreasedosmoticforcesandisconsideredtobeoflowclinicalrelevance.Developmentofthepancreatictumorsisrelatedtothemitogenicactionofcholecystokinininrats.Thisfindingwasnotobservedinthemousecarcinogenicitystudy,norina12-monthtoxicitystudyindogsorina2-yeartoxicitystudyinfemalecynomolgusmonkeys.Thereisnoevidencethat cholecystokininhas a mitogenic actioninman.-CDisnotmutagenic.ThechemicalstructureofHP-β-CDdoesnotraisesuspicionforgenotoxicactivity.TestsonDNA-damage,genemutationsandchromosomeaberrations-CDhas nodirect embryotoxic andnoteratogenic effect, andisnot mutagenic.Caramel,cherryflavor1,cherryflavor2,hydrochloricacid,hydroxypropyl- propyleneglycol,purifiedwater, sodiumhydroxide,sodiumsaccharinandsorbitol.Storeat 25°Corbelow.Keepoutofthesight and reachofchildren.150ml amber glassbottle, withchild-resistantpolypropylenescrewcapandLDPE liner ring.SPORANOX ® oralsolutionissuppliedinbottleswithachildproofcap,andshouldbeopenedasfollows:pushtheplasticscrewcapdownwhileturningitcounterclockwise.itsitsonthebottle.Makesurethatthesidewiththegraduations(thesidethatholdsless)isuppermost;that is thesideyouhavetofill.

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