2/4/2016 Albendazole:Druginformation

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Albendazole:Druginformation

Copyright19782016Lexicomp,Inc.Allrightsreserved.

(Foradditionalinformationsee"Albendazole:Patientdruginformation"andsee"Albendazole:Pediatricdruginformation")

ForabbreviationsandsymbolsthatmaybeusedinLexicomp(showtable)

BrandNames:US Albenza
PharmacologicCategory Anthelmintic
Dosing:Adult
Neurocysticercosis:Oral:

<60kg:15mg/kg/dayin2divideddoses(maximum:800mg/day)for830days

60kg:800mg/dayin2divideddosesfor830days

Note:Giveconcurrentanticonvulsantandcorticosteroid(eg,dexamethasoneorprednisolone)therapyduringfirstweek.

Hydatid:Oral:

<60kg:15mg/kg/dayin2divideddoses(maximum:800mg/day)

60kg:800mg/dayin2divideddoses

Note:Administerdoseforthree28daycycleswitha14daydrugfreeintervalinbetweeneachcycle.

Ancylostomacaninum,Ascaris lumbricoides (roundworm), Ancylostoma duodenale (hookworm), and Necator americanus (hookworm) (offlabel use):
Oral:400mgasasingledose

Clonorchissinensis(Chineseliverfluke)(offlabeluse):Oral:10mg/kg/dayfor7days

Cutaneouslarvamigrans(offlabeluse):Oral:400mgoncedailyfor3days

Enterobiusvermicularis(pinworm)(offlabeluse):Oral:400mgasasingledoserepeatin2weeks

Giardiaduodenalis(giardiasis)(offlabeluse):Oral:400mgoncedailyfor5days

Gnathostomaspinigerum(offlabeluse):Oral:800mg/dayin2divideddosesfor21days
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Gongylonemiasis(offlabeluse):Oral:400mgoncedailyfor3days

Mansonellaperstans(offlabeluse):Oral:800mg/dayin2divideddosesfor10days

Oesophagostomumbifurcum(offlabeluse):Oral:400mgasasingledose(Ziem,2004)

Trichinellaspiralis(Trichinellosis)(offlabeluse):Oral:800mg/dayin2divideddosesfor814dayspluscorticosteroidsforseveresymptoms

Viscerallarvamigrans(toxocariasis)(offlabeluse):Oral:800mg/dayin2divideddosesfor5days

Cysticercuscellulosae(offlabeluse):Oral:800mg/dayin2divideddosesfor830daysmayberepeatedasnecessary

Echinococcusgranulosus(tapeworm)(offlabeluse):Oral:800mg/dayin2divideddosesfor16months

Microsporidiosis(notlimitedtotheHIVinfectedpatient)(offlabeluseAnon2007):Oral:

Disseminatedmicrosporidiosis:800mg/dayin2divideddoses

Intestinalmicrosporidiosis(E.intestinalis):800mg/dayin2divideddosesfor21days

Ocularmicrosporidiosis:800mg/dayin2divideddoses,incombinationwithfumagillin

MicrosporidiosisinHIVinfectedpatients(offlabeluseHHS[OIadult2015]):Oral:

Disseminatedmicrosporidiosis(causedbyTrachipleistophoraorAnncaliia):800mg/dayin2divideddosesincombinationwithitraconazole

Disseminatedorintestinalmicrosporidiosis(causedbymicrosporidiosisotherthanE.bieneusiandV.corneae):800mg/dayin2divideddosescontinueuntil
CD4count>200cells/mm3for>6monthsafterARTinitiation

Ocularmicrosporidiosis:800mg/dayin2divideddoses,incombinationwithfumagillindiscontinuetherapyafterocularinfectionresolutionifCD4count>200
cells/mm3continuetherapyuntilocularinfectionresolutionandincreaseinCD4countto>200cells/mm3foratleast6monthsinresponsetoARTifCD4
count200cells/mm3

Dosing:Pediatric
(Foradditionalinformationsee"Albendazole:Pediatricdruginformation")

Neurocysticercosis:Oral:Refertoadultdosing.

Hydatid:Oral:Refertoadultdosing.

Cysticercuscellulosae(offlabeluse):Oral:15mg/kg/day(maximum:800mg/day)in2divideddosesfor830daysmayberepeatedasnecessary

Echinococcusgranulosus(tapeworm)(offlabeluse):Oral:15mg/kg/day(maximum:800mg)dividedtwicedailyfor16months

Giardiaduodenalis(giardiasis)(offlabeluse):Oral:10mg/kg/dayfor5days(Yereli,2004)
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MicrosporidiosisinHIVexposed/infectedpatients(offlabeluse):Oral:

Disseminatedorintestinalinfection(causedbymicrosporidiosisotherthanE.bieneusiorV.corneae):

InfantsandChildren:15mg/kg/day(maximum:800mg/day)in2divideddosescontinueduntilimmunereconstitutionafterHAARTinitiation(CDC,2009)

Adolescents:Refertoadultdosing.

Disseminatedmicrosporidiosis(causedbyTrachipleistophoraorAnncaliia):Adolescents:Refertoadultdosing.

Ocularmicrosporidiosis:Adolescents:Refertoadultdosing.

For the following offlabel uses, refer to adult dosing: Ancylostoma caninum, Ascaris lumbricoides (roundworm), Ancylostoma duodenale (hookworm),
Clonorchissinensis,(Chineseliverfluke),cutaneouslarvamigrans,Enterobiusvermicularis(pinworm),Gnathostomaspinigerum,gongylonemiasis,Mansonella
perstans,Necatoramericanus(hookworm),Oesophagostomumbifurcum,Trichinellaspiralis(Trichinellosis),viscerallarvamigrans(toxocariasis)

Dosing:Geriatric Refertoadultdosing.
Dosing:RenalImpairment Nodosageadjustmentprovidedinthemanufacturer'slabeling(hasnotbeenstudied).However,theneedforadjustmentnot
likelysincealbendazoleisprimarilyeliminatedbyhepaticmetabolism.

Dosing:HepaticImpairment Nodosageadjustmentprovidedinmanufacturer'slabeling.However,patientswithunderlyingliverdiseasemaybemoreat
riskforadverseeffects.

DosageForms:US Excipientinformationpresentedwhenavailable(limited,particularlyforgenerics)consultspecificproductlabeling.
Tablet,Oral:

Albenza:200mg[containssaccharinsodium]

GenericEquivalentAvailable:US No
Administration Shouldbeadministeredwithahighfatmeal.Administeranticonvulsantandcorticosteroidtherapyduringfirstweekofneurocysticercosis
therapy.Ifpatientshavedifficultyswallowing,tabletsmaybecrushedorchewed,thenswallowedwithadrinkofwater.

Use TreatmentofparenchymalneurocysticercosiscausedbyTaeniasoliumandcystichydatiddiseaseoftheliver,lung,andperitoneumcausedby
Echinococcusgranulosus

Use:OffLabel
MicrosporidiosisinHIVinfectedpatients(adolescentsandadults)

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MedicationSafetyIssues

Soundalike/lookalikeissues:
AlbenzamaybeconfusedwithAplenzin,Relenza

Internationalissues:
Albenza[US]maybeconfusedwithAvanzabrandnameformirtazapine[Australia]

AdverseReactionsSignificant
>10%:

Centralnervoussystem:Headache(neurocysticercosis:11%hydatid:1%)

Hepatic:Increasedliverenzymes(hydatid:16%neurocysticercosis:<1%)

1%to10%:

Centralnervoussystem:Increasedintracranialpressure(2%),dizziness(1%),vertigo(1%),meningism(1%)

Dermatologic:Alopecia(<1%to2%)

Gastrointestinal:Abdominalpain(6%),nauseaandvomiting(4%to6%)

Miscellaneous:Fever(1%)

<1% (Limited to important or lifethreatening):Acute hepatic failure, acute renal failure, agranulocytosis, aplastic anemia, erythema multiforme, granulocytopenia,
hepatitis,hypersensitivityreaction,leukopenia,neutropenia,pancytopenia,skinrash,StevensJohnsonsyndrome,thrombocytopenia,urticaria

Contraindications Hypersensitivitytoalbendazole,benzimidazoles,oranycomponentoftheformulation
Warnings/Precautions
Concernsrelatedtoadverseeffects:

Bone marrow suppression:Agranulocytosis, aplastic anemia, granulocytopenia, leukopenia, and pancytopenia have occurred leading to fatalities (rare) use
with caution in patients with hepatic impairment (more susceptible to hematologic toxicity). Discontinue therapy in all patients who develop clinically
significantdecreasesinbloodcellcounts.

Transaminaseelevations:Reversibleelevationsinhepaticenzymeshavebeenreported.PatientswithabnormalLFTsandhepaticechinococcosisareatan
increased risk of hepatotoxicity. Discontinue therapy if LFT elevations are >2 times the upper limit of normal may consider restarting treatment (with
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frequentmonitoringofLFTs)whenhepaticenzymesreturntopretreatmentvalues.

Diseaserelatedconcerns:

Neurocysticercosis:Appropriate use: Corticosteroids (eg, dexamethasone or prednisolone) should be administered before or upon initiation of albendazole
therapytominimizeinflammatoryreactionsandpreventcerebralhypertension.Anticonvulsanttherapyshouldbeusedconcurrentlyduringthefirstweekof
therapy to prevent seizures. These measures are important to minimize neurological symptoms which may result from uncovering of preexisting
neurocysticercosiswhenusingalbendazoletotreatotherconditions.Ifretinallesionsexist,weighriskoffurtherretinaldamageduetoalbendazoleinduced
changestotheretinallesionvsbenefitofdiseasetreatment.

Metabolism/TransportEffects SubstrateofCYP1A2(minor),CYP3A4(minor)Note:AssignmentofMajor/Minorsubstratestatusbasedonclinically
relevantdruginteractionpotential

DrugInteractions
(Foradditionalinformation:LaunchLexiInteractDrugInteractionsProgram)

Aminoquinolines(Antimalarial):MaydecreasetheserumconcentrationofAnthelmintics.RiskC:Monitortherapy

CarBAMazepine:Maydecreaseserumconcentrationsoftheactivemetabolite(s)ofAlbendazole.RiskC:Monitortherapy

GrapefruitJuice:Mayincreaseserumconcentrationsoftheactivemetabolite(s)ofAlbendazole.RiskC:Monitortherapy

PHENobarbital:Maydecreaseserumconcentrationsoftheactivemetabolite(s)ofAlbendazole.RiskC:Monitortherapy

Phenytoin:Maydecreaseserumconcentrationsoftheactivemetabolite(s)ofAlbendazole.RiskC:Monitortherapy

FoodInteractions Albendazoleserumlevelsmaybeincreasediftakenwithafattymeal(increasestheoralbioavailabilitybyupto5times).Management:
Shouldbeadministeredwithahighfatmeal(peanutsoricecream).

PregnancyRiskFactor C(showtable)
PregnancyImplications Adverseeventswereobservedinanimalreproductionstudies.Albendazoleshouldnotbeusedduringpregnancy,ifatall
possible.Themanufacturerrecommendsapregnancytestpriortotherapyinwomenofreproductivepotential.Womenshouldbeadvisedtoavoidpregnancyforat
least1monthfollowingtherapy.Discontinueifpregnancyoccursduringtreatment.

BreastFeedingConsiderations Albendazoleexcretionintobreastmilkwasstudiedfollowingasingleoral400mgdoseinbreastfeedingwomen2
weeksto6monthspostpartum(n=33).Meanalbendazoleconcentrations6hoursafterthedosewere63.711.9ng/mL(maternalserum)and31.99.2ng/mL
(milk).Anactiveandinactivemetabolitewasalsodetectedinbreastmilk(Abdeltawab,2009).Themanufacturerrecommendsthatcautionbeexercisedwhen
administeringalbendazoletonursingwomen.

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DietaryConsiderations Shouldbetakenwithahighfatmeal.
Pricing:US
Tablets(AlbenzaOral)

200mg(2):$402.54

Disclaimer:ThepricingdataprovidearepresentativeAWPand/orAAWPpricefromasinglemanufacturerofthebrandand/orgenericproduct,respectively.The
pricingdatashouldbeusedforbenchmarkingpurposesonly,andassuchshouldnotbeusedtosetoradjudicateanypricesforreimbursementorpurchasing
functions.Pricingdataisupdatedmonthly.

MonitoringParameters Monitorfecalspecimensforovaandparasitesfor3weeksaftertreatmentifpositive,retreatLFTsandCBCwithdifferentialat
startofeach28daycycleandevery2weeksduringtherapy(morefrequentmonitoringforpatientswithliverdisease)ophthalmicexam(patientswith
neurocysticercosis)pregnancytest

InternationalBrandNames Abentel(CN,LI)ABZ(IN,ZW)Acure(PK)Adazol(EC)Albatel(TH)Alben(BR)AlbenVC(TH)Albenda(AE,BH,KW,
LB,QA,SA)Albentel(PE)Albenzol(EC)Albex(AE,BH,CY,EG,IQ,IR,JO,KW,LB,LY,OM,QA,SA,SY,VN,YE)Albezole(IN)Aldazol(PH)Alfuca(TH)
Allbacom(KR)Almex(MY)Alminth(IN)Alzental(AE,BH,CY,EG,ET,IQ,IR,JO,KW,LB,LI,LY,OM,QA,SA,SG,SY,YE)Alzol(TH)Andazol(TR)
Anhelmin(UA)Ascarol(EC)Bendex(ET)Bendex400(ZA)Benzol(PH)Bruzol(MX)CB400(TH)Ceprazol(CL)Ciclopar(CO)Cystazole(JO)Dalben(HR)
DaxolPlus(PY)Digezanol(MX)Emanthal(IN)Eskasole(MX)Eskazole(AT,AU,DE,ES,GB,IL,JP,NL,NZ)Fintel(PE)Frantel(VN)Gascop(MX)
Helmiben(UY)Helmidazole(AE,BH,CY,EG,IL,IQ,IR,JO,KW,LB,LY,OM,QA,SA,SY,YE)Hyemex(PH)Labenda(TH)Lomsin(MX)Lurdex(MX)
Mebenix(BR)Nemozole(IN,ZW)Ovis(ET)Oxal(LI)Oxarmin(CR,DO,GT,HN,NI,PA,SV)Pantex(PY)Paranthil(ZA)Parhel(CR,DO,GT,HN,NI,PA,
SV)Rotopar(EC)Sioban(IN)Temizol(PY)Thelban(MY)ValbazenVet(NO)Vastus(AR)Vemizol(MY)VerminPlus(MX)Vetoben(TH)Vormil(UA)
Wormed(ZW)Zeben(TH)Zela(TH)Zendal(MY)Zental(RO)Zentel(AE,AU,BB,BF,BG,BH,BJ,BM,BR,BS,BZ,CH,CI,CL,CN,CO,CR,CY,CZ,EC,
EG,ET,FR,GH,GM,GN,GR,GT,GY,HN,IQ,IR,IT,JM,JO,KE,KR,KW,LB,LI,LR,LY,MA,ML,MR,MU,MW,MX,MY,NE,NG,NI,OM,PA,PE,PL,PR,
PT,QA,SA,SC,SD,SG,SI,SK,SL,SN,SR,SV,SY,TH,TN,TT,TZ,UA,UG,VE,VN,YE,ZA,ZM,ZW)Zestaval(TR,ZW)

MechanismofAction Activemetabolite,albendazolesulfoxide,causesselectivedegenerationofcytoplasmicmicrotubulesinintestinalandtegmentalcells
ofintestinalhelminthsandlarvaeglycogenisdepleted,glucoseuptakeandcholinesterasesecretionareimpaired,anddesecratorysubstancesaccumulate
intracellulary.ATPproductiondecreasescausingenergydepletion,immobilization,andwormdeath.

PharmacodynamicsandPharmacokinetics
Absorption:PoorfromtheGItractmayincreaseupto5timeswhenadministeredwithafattymeal

Distribution:Widelydistributedthroughoutthebodyincludingurine,bile,liver,cystwall,cystfluid,andCSF

Proteinbinding:70%

Metabolism:Hepaticextensivefirstpasseffectpathwaysincluderapidsulfoxidationtoactivemetabolite(albendazolesulfoxide[major]),hydrolysis,andoxidation

Halflifeelimination:8to12hours(albendazolesulfoxide)
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Timetopeak,serum:2to5hoursforthemetabolite

Excretion:Urine(<1%asactivemetabolite)feces

UseofUpToDateissubjecttotheSubscriptionandLicenseAgreement.

REFERENCES

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16818928]
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9. GarciaHH,PretellEJ,GilmanRH,ATrialofAntiparasiticTreatmenttoReducetheRateofSeizuresDuetoCerebralCysticercosis,NEnglJMed,2004,350(3):24958.[PubMed
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infectionsinHIVinfectedadultsandadolescents:recommendationsfromtheCentersforDiseaseControlandPrevention,theNationalInstitutesofHealth,andtheHIVMedicine
AssociationoftheInfectiousDiseasesSocietyofAmerica.http://aidsinfo.nih.gov/contentfiles/lvguidelines/adult_oi.pdf.UpdatedSeptember24,2015.AccessedSeptember25,2015.
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Topic9371Version100.0

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