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Albendazole: Drug information

Access Lexicomp Online here.


Copyright 1978-2013 Lexicomp, Inc. All rights reserved.

(For additional information see "Albendazole: Patient drug information" and see
"Albendazole: Pediatric drug information")

For abbreviations and symbols that may be used in Lexicomp (show table)

Brand Names: U.S. Albenza

Pharmacologic Category Anthelmintic

Dosing: Adult
Neurocysticercosis: Oral:

<60 kg: 15 mg/kg/day in 2 divided doses (maximum: 800 mg/day) for 8-30 days

≥60 kg: 800 mg/day in 2 divided doses for 8-30 days

Note: Give concurrent anticonvulsant and corticosteroid (eg, dexamethasone or


prednisolone) therapy during first week.

Hydatid: Oral:

<60 kg: 15 mg/kg/day in 2 divided doses (maximum: 800 mg/day)

≥60 kg: 800 mg/day in 2 divided doses

Note: Administer dose for three 28-day cycles with a 14-day drug-free interval
in between each cycle.

Ancylostoma caninum, Ascaris lumbricoides (roundworm), Ancylostoma


duodenale (hookworm), and Necator americanus (hookworm) (unlabeled
use): Oral: 400 mg as a single dose

Clonorchis sinensis (Chinese liver fluke) (unlabeled use): Oral: 10 mg/kg/day


for 7 days

Cutaneous larva migrans (unlabeled use): Oral: 400 mg once daily for 3 days

Enterobius vermicularis (pinworm) (unlabeled use): Oral: 400 mg as a single


dose; repeat in 2 weeks

Giardia duodenalis (giardiasis) (unlabeled use): Oral: 400 mg once daily for 5
days

Gnathostoma spinigerum (unlabeled use): Oral: 800 mg/day in 2 divided doses


for 21 days

Gongylonemiasis (unlabeled use): Oral: 400 mg once daily for 3 days

Mansonella perstans (unlabeled use): Oral: 800 mg/day in 2 divided doses for 10
days

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Oesophagostomum bifurcum (unlabeled use): Oral: 400 mg as a single dose


(Ziem, 2004)

Trichinella spiralis (Trichinellosis) (unlabeled use): Oral: 800 mg/day in 2


divided doses for 8-14 days plus corticosteroids for severe symptoms

Visceral larva migrans (toxocariasis) (unlabeled use): Oral: 800 mg/day in 2


divided doses for 5 days

Cysticercus cellulosae (unlabeled use): Oral: 800 mg/day in 2 divided doses for 8-
30 days; may be repeated as necessary

Disseminated microsporidiosis (unlabeled use): Oral: 800 mg/day in 2 divided


doses

Echinococcus granulosus (tapeworm) (unlabeled use): Oral: 800 mg/day in 2


divided doses for 1-6 months

Intestinal microsporidiosis (E. intestinalis) (unlabeled use): Oral: 800 mg/day in


2 divided doses for 21 days

Ocular microsporidiosis (unlabeled use): Oral: 800 mg/day in 2 divided doses, in


combination with fumagillin

Dosing: Pediatric
(For additional information see "Albendazole: Pediatric drug information")

Neurocysticercosis: Oral: Refer to adult dosing.

Hydatid: Oral: Refer to adult dosing.

Cysticercus cellulosae (unlabeled use): Oral: 15 mg/kg/day (maximum: 800


mg/day) in 2 divided doses for 8-30 days; may be repeated as necessary

Echinococcus granulosus (tapeworm) (unlabeled use): Oral: 15 mg/kg/day


(maximum: 800 mg) divided twice daily for 1-6 months

Giardia duodenalis (giardiasis) (unlabeled use): Oral: 10 mg/kg/day for 5 days


(Yereli, 2004)

Microsporidiosis (other than Enterocytozoon bienuesi or or V. corneae),


disseminated or intestinal infection (HIV-positive, unlabeled use): Oral:
Infants and Children: 15 mg/kg/day (maximum: 800 mg/day) in 2 divided doses
continued until immune reconstitution after HAART initiation (CDC, 2009)

For the following unlabeled uses, refer to adult dosing: Ancylostoma caninum,
Ascaris lumbricoides (roundworm), Ancylostoma duodenale (hookworm),
Related Searches: Clonorchis sinensis, (Chinese liver fluke), cutaneous larva migrans, Enterobius
vermicularis (pinworm), Gnathostoma spinigerum, gongylonemiasis,
Mansonella perstans, Necator americanus (hookworm), Oesophagostomum
bifurcum, Trichinella spiralis (Trichinellosis), visceral larva migrans
(toxocariasis)
?

Map Of Indonesia Dosing: Geriatric Refer to adult dosing.

Dosing: Renal Impairment No dosage adjustment provided in the


Hotel Bandung manufacturer's labeling (has not been studied). However, the need for adjustment
not likely since albendazole is primarily eliminated by hepatic metabolism.
Bandung
Dosing: Hepatic Impairment No dosage adjustment provided in

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Conference manufacturer's labeling. However, patients with underlying liver disease may be
more at risk for adverse effects.
Bandung Hotels Dosage Forms: U.S. Excipient information presented when available
(limited, particularly for generics); consult specific product labeling.
Travel Indonesia
Tablet, Oral:

Abdul Halim Albenza: 200 mg [contains saccharin sodium]

Malaysian Music Generic Equivalent Available: U.S. No

Administration Should be administered with a high-fat meal. Administer


Malaysian Ringgit
anticonvulsant and corticosteroid therapy during first week of neurocysticercosis
therapy. If patients have difficulty swallowing, tablets may be crushed or chewed,
Jakarta Hotels then swallowed with a drink of water.

Indonesia Travel Use Treatment of parenchymal neurocysticercosis caused by Taenia solium and
cystic hydatid disease of the liver, lung, and peritoneum caused by Echinococcus
granulosus

Use - Unlabeled Albendazole has activity against Ascaris lumbricoides


(roundworm); Ancylostoma caninum; Ancylostoma duodenale and Necator
americanus (hookworms); cutaneous larva migrans; Enterobius vermicularis
(pinworm); Giardia duodenalis (giardiasis); Gnathostoma spinigerum; Gongylonema
sp; Mansonella perstans (filariasis); Oesophagostomum bifurcum; Opisthorchis
sinensis (liver fluke); Trichinella spiralis (Trichinellosis); visceral larva migrans
(toxocariasis); activity has also been shown against the liver fluke Clonorchis
sinensis, Giardia lamblia, Cysticercus cellulosae, and Echinococcus multilocularis.
Albendazole has also been used for the treatment of intestinal microsporidiosis
(Encephalitozoon intestinalis), disseminated microsporidiosis (E. hellem, E.
cuniculi, E. intestinalis, Pleistophora sp, Trachipleistophora sp, Brachiola
vesicularum), and ocular microsporidiosis (E. hellem, E. cuniculi, Vittaforma
corneae).

Medication Safety Issues

Sound-alike/look-alike issues:

Albenza® may be confused with Aplenzin™, Relenza®

International issues:
The use
Albenza [U.S.] of UpToDate
may is subject
be confused to the brand
with Avanza Subscription Close
name for mirtazapine
and License Agreement.
[Australia]
Lexicomp drug information & Lexi-Interact are subject to the Lexicomp License A

Adverse Reactions Significant


>10%:

Central nervous system: Headache (11% neurocysticercosis; 1% hydatid)

Hepatic: LFTs increased (16% hydatid; <1% neurocysticercosis)

1% to 10%:

Central nervous system: Intracranial pressure increased (≤2%), dizziness


(≤1%), fever (≤1%), vertigo (≤1%), meningeal signs (1%)

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Dermatologic: Alopecia (<1% to 2%)

Gastrointestinal: Abdominal pain (≤6%), nausea/vomiting (4% to 6%)

<1% (Limited to important or life-threatening symptoms): Acute liver failure, acute


renal failure, aplastic anemia, agranulocytosis, erythema multiforme,
granulocytopenia, hepatitis, hypersensitivity reaction, leukopenia, neutropenia,
pancytopenia, rash, Stevens-Johnson syndrome, thrombocytopenia, urticaria

Contraindications Hypersensitivity to albendazole, benzimidazoles, or any


component of the formulation

Warnings/Precautions
Concerns related to adverse effects:

• 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 significant decreases in blood cell counts.

• Transaminase elevations: Reversible elevations in hepatic enzymes have been


reported. Patients with abnormal LFTs and hepatic echinococcosis are at
an increased risk of hepatotoxicity. Discontinue therapy if LFT elevations
are >2 times the upper limit of normal; may consider restarting treatment
(with frequent monitoring of LFTs) when hepatic enzymes return to
pretreatment values.

Disease-related concerns:

• Neurocysticercosis: Appropriate use: Corticosteroids (eg, dexamethasone or


prednisolone) should be administered before or upon initiation of
albendazole therapy to minimize inflammatory reactions and prevent
cerebral hypertension. Anticonvulsant therapy should be used concurrently
during the first week of therapy to prevent seizures. These measures are
important to minimize neurological symptoms which may result from
uncovering of pre-existing neurocysticercosis when using albendazole to
treat other conditions. If retinal lesions exist, weigh risk of further retinal
damage due to albendazole-induced changes to the retinal lesion vs
benefit of disease treatment.

Metabolism/Transport Effects Substrate of CYP1A2 (minor), CYP3A4


(minor); Note: Assignment of Major/Minor substrate status based on clinically
relevant drug interaction potential

Drug Interactions
(For additional information: Launch Lexi-Interact™ Drug Interactions Program)

Aminoquinolines (Antimalarial): May decrease the serum concentration of


Anthelmintics. Risk C: Monitor therapy

Grapefruit Juice: May increase serum concentrations of the active metabolite(s) of


Albendazole. Risk C: Monitor therapy

Ethanol/Nutrition/Herb Interactions Food: Albendazole serum levels

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may be increased if taken with a fatty meal (increases the oral bioavailability by up
to 5 times). Management: Should be administered with a high-fat meal (peanuts or
ice cream).

Pregnancy Risk Factor C (show table)

Pregnancy Implications Adverse events were observed in animal


reproduction studies. Albendazole should not be used during pregnancy, if at all
possible. The manufacturer recommends a pregnancy test prior to therapy in women
of reproductive potential. Women should be advised to avoid pregnancy for at least 1
month following therapy. Discontinue if pregnancy occurs during treatment.

Lactation Excreted in breast milk/use caution

Breast-Feeding Considerations Albendazole excretion into breast milk


was studied following a single oral 400 mg dose in breast-feeding women 2 weeks to
6 months postpartum (n=33). Mean albendazole concentrations 6 hours after the
dose were 63.7 ± 11.9 ng/mL (maternal serum) and 31.9 ± 9.2 ng/mL (milk). An
active and inactive metabolite was also detected in breast milk (Abdel-tawab, 2009).
The manufacturer recommends that caution be exercised when administering
albendazole to nursing women.

Dietary Considerations Should be taken with a high-fat meal.

Pricing: U.S. (Medi-Span®)


Tablets (Albenza Oral)

200 mg (2): $119.40

Disclaimer: The pricing data provided represent a median AWP and/or AAWP price
for the brand and/or generic product, respectively. The pricing data should be used
for benchmarking purposes only, and as such should not be used to set or
adjudicate any prices for charging or reimbursement functions. Pricing data is
updated monthly.

Monitoring Parameters Monitor fecal specimens for ova and parasites for 3
weeks after treatment; if positive, retreat; LFTs and CBC with differential at start of
each 28-day cycle and every 2 weeks during therapy (more frequent monitoring for
patients with liver disease); ophthalmic exam (patients with neurocysticercosis);
pregnancy test

International Brand Names ABZ (IN); Acure (PK); Adazol (EC); Albatel
(TH); Alben (BR); Alben-VC (TH); Albentel (PE); Albenzol (EC); Albex (AE, BH, CY,
EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Albezole (IN); Alfuca (TH);
Almex (MY); Alminth (IN); Alzental (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM,
QA, SA, SG, SY, YE); Alzol (TH); Andazol (TR); Ascarol (EC); Bendex-400 (ZA);
Benzol (PH); Bruzol (MX); CB-400 (TH); Ceprazol (CN); Ciclopar (CO); Dalben (HR);
Digezanol (MX); Emanthal (IN); Eskasole (MX); Eskazole (AT, AU, DE, ES, GB, IL,
JP, NL, NZ); Fintel (PE); 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); Mesin-C (MY); Nemozole (IN);
Pantex (PY); Paranthil (ZA); Rotopar (EC); Sioban (IN); Thelban (MY); Tilminth (PH);
Valbazen Vet (NO); Vastus (AR); Vemizol (MY); Vermin Plus (MX); Vetoben (TH);
Zeben (TH); Zela (TH); Zendal (MY); Zentel (AE, AU, BB, BF, BG, BH, BJ, BM, BR,
BS, BZ, CH, CI, CL, CN, CO, CR, CY, CZ, DO, EC, EG, ET, FR, GH, GM, GN, GR,
GT, GY, HN, IQ, IR, IT, JM, JO, KE, KP, KW, LB, LR, LY, MA, ML, MR, MU, MW,
MX, MY, NE, NG, NI, OM, PA, PE, PL, PR, PT, QA, SA, SC, SD, SG, SL, SN, SR,
SV, SY, TH, TN, TT, TZ, UG, VE, YE, ZA, ZM, ZW)

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Mechanism of Action Active metabolite, albendazole sulfoxide, causes


selective degeneration of cytoplasmic microtubules in intestinal and tegmental cells
of intestinal helminths and larvae; glycogen is depleted, glucose uptake and
cholinesterase secretion are impaired, and desecratory substances accumulate
intracellulary. ATP production decreases causing energy depletion, immobilization,
and worm death.

Pharmacodynamics/Kinetics
Absorption: Poor; may increase up to 5 times when administered with a fatty meal

Distribution: Well inside hydatid cysts and CSF

Protein binding: 70%

Metabolism: Hepatic; extensive first-pass effect; pathways include rapid


sulfoxidation to active metabolite (albendazole sulfoxide [major]), hydrolysis,
and oxidation

Half-life elimination: 8-12 hours

Time to peak, serum: 2-5 hours

Excretion: Urine (<1% as active metabolite); feces

Use of UpToDate is subject to the Subscription and License Agreement.

REFERENCES

1. Abdel-tawab AM, Bradley M, Ghazaly EA, et al, "Albendazole and its


Metabolites in the Breast Milk of Lactating Women Following a Single Oral
Dose of Albendazole," Br J Clin Pharmacol, 2009, 68(5):737-42. [PubMed
19916998]
2. Baird RA, Wiebe S, Zunt JR, et al, “Evidence-Based Guideline: Treatment of
Parenchymal Neurocysticercosis: Report of the Guideline Development
Subcommittee of the American Academy of Neurology,” Neurology, 2013,
80(15):1424-9. [PubMed 23568997]
3. Bethony J, Brooker S, Albonico M, et al, “Soil-Transmitted Helminth
Infections: Ascariasis, Trichuriasis, and Hookworm,” Lancet, 2006,
367(9521):1521-32. [PubMed 16679166]
4. Del Brutto OH, Roos KL, Coffey CS, et al, “Meta-Analysis: Cysticidal Drugs
for Neurocysticercosis: Albendazole and Praziquantel,” Ann Intern Med, 2006,
145(1):43-51. [PubMed 16818928]
5. de Silva N, Guyatt H, and Bundy D, “Anthelmintics. A Comparative Review of
Their Clinical Pharmacology,” Drugs, 1997, 53(5):769-88. [PubMed 9129865]
6. DHHS. Guidelines for the Prevention and Treatment of Opportunistic Infections
Among HIV-Exposed and HIV-Infected Children: Recommendations From the
National Institutes of Health, Centers for Disease Control and Prevention, the
HIV Medicine Association of the Infectious Diseases Society of America, the
Pediatric Infectious Diseases Society, and the American Academy of
Pediatrics. Available at: http://aidsinfo.nih.gov. November 2013.

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7. DHHS Panel on Opportunistic Infections (OI) in HIV-Infected Adults and


Adolescents, "Guidelines for Prevention and Treatment of Opportunistic
Infections in HIV-Infected Adults and Adolescents: Recommendations from
the Centers for Disease Control and Prevention (CDC), the National Institutes
of Health (NIH), and the HIV Medicine Association (HIVMA) of the Infectious
Diseases Society of America (IDSA)," May 7, 2013. Available at
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8. “Drugs for Parasitic Infections,” Med Lett Drugs Ther, 2007, 5(suppl):e1-14.
9. Garcia HH, Gilman RH, Horton J, et al, “Albendazole therapy for
neurocysticercosis: A Prospective Double-Blind Trial Comparing 7 Versus 14
Days of Treatment,” Neurology, 1997, 48(5):1421-7. [PubMed 9153484]
10. Garcia HH, Pretell EJ, Gilman RH, “A Trial of Antiparasitic Treatment to
Reduce the Rate of Seizures Due to Cerebral Cysticercosis,” N Engl J Med,
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12. Liu LX and Weller PF, “Antiparasitic Drugs,” N Engl J Med, 1996,
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13. Smego, RA, Bhatti S, Khaliq AA, et al, “Percutaneous Aspiration-Injection-
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15228719]

Topic 9371 Version 50.0

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