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Medication Safety Issues
Sound-alike/look-alike issues:
Albenza® may be confused with Aplenzin™, Relenza®
International issues:
Albenza® may be confused with Avanza® which is a brand name for mirtazapine in Australia
Pronunciation
(al BEN da zole)
U.S. Brand Names
Generic Available
No
Pharmacologic Category
Use: Labeled Indications
Treatment of parenchymal neurocysticercosis caused by Taenia solium and cystic hydatid disease of the liver, lung, and peritoneum caused by Echinococcus granulosus
Use: Unlabeled/Investigational
Albendazole has activity against Ascaris lumbricoides (roundworm); Ancylostoma caninum; Ancylostoma duodenale and Necator americanus (hookworms); cutaneous larva migrans; Enterobius vermicularis (pinworm); Gnathostoma spinigerum; Gongylonema sp; Mansonella perstans (filariasis); Opisthorchis sinensis (liver fluke); 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).
Pregnancy Risk Factor
C
Pregnancy Considerations
Albendazole has been shown to be teratogenic in laboratory animals and should not be used during pregnancy, if at all possible. Women should be advised to avoid pregnancy for at least 1 month following therapy. Discontinue if pregnancy occurs during treatment.
Lactation
Excretion in breast milk unknown/not recommended
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 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. If retinal lesions exist, weigh risk of further retinal damage due to albendazole-induced changes to the retinal lesion vs benefit of disease treatment.
Adverse Reactions
>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 (up to 2%), dizziness (?1%), fever (?1%), vertigo (?1%), meningeal signs (1%)
Dermatologic: Alopecia (<1% to 2%)
Gastrointestinal: Abdominal pain (up to 6%), nausea/vomiting (4% to 6%)
<1%, postmarketing, and/or case reports (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
Metabolism/Transport Effects
Substrate (minor) of CYP1A2, 3A4; Inhibits CYP1A2 (weak)
Drug Interactions
Aminoquinolines (Antimalarial): May decrease the serum concentration of Anthelmintics. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Food: Albendazole serum levels may be increased if taken with a fatty meal (increases the oral bioavailability by up to 5 times).
Storage
Store between 20°C and 25°C (68°F to 77°F)
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
Dosage
Oral:
Children:
Cysticercus cellulosae (unlabeled use): 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): 15 mg/kg/day (maximum: 800 mg) divided twice daily for 1-6 months
Children and Adults:
Neurocysticercosis:
<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 steroid therapy during first week.
Hydatid:
<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. The manufacturer recommends a total of 3 cycles.
Ancylostoma caninum, Ascaris lumbricoides (roundworm), Ancylostoma duodenale (hookworm), and Necator americanus (hookworm) (unlabeled use): 400 mg as a single dose
Clonorchis sinensis (Chinese liver fluke) (unlabeled use): 10 mg/kg for 7 days
Cutaneous larva migrans (unlabeled use): 400 mg once daily for 3 days
Enterobius vermicularis (pinworm) (unlabeled use): 400 mg as a single dose; may repeat in 2 weeks
Gnathostoma spinigerum (unlabeled use): 800 mg/day in 2 divided doses for 21 days
Gongylonemiasis (unlabeled use): 10 mg/kg/day for 3 days
Mansonella perstans (unlabeled use): 800 mg/day in 2 divided doses for 10 days
Visceral larva migrans (toxocariasis) (unlabeled use): 800 mg/day in 2 divided doses for 5 days
Adults:
Cysticercus cellulosae (unlabeled use): 800 mg/day in 2 divided doses for 8-30 days; may be repeated as necessary
Disseminated microsporidiosis (unlabeled use): 800 mg/day in 2 divided doses
Echinococcus granulosus (tapeworm) (unlabeled use): 800 mg/day in 2 divided doses for 1-6 months
Intestinal microsporidiosis (unlabeled use): 800 mg/day in 2 divided doses for 21 days
Ocular microsporidiosis (unlabeled use): 800 mg/day in 2 divided doses, in combination with fumagillin
Administration: Oral
Should be administered with a high-fat meal. Administer anticonvulsant and steroid therapy during first week of neurocysticercosis therapy. If patients have difficulty swallowing, tablets may be crushed or chewed, then swallowed with a drink of water.
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); pregnancy test
Dietary Considerations
Should be taken with a high-fat meal.
Patient Education
You may be prescribed other medications to take during first week of therapy. Do not take any other new medication during therapy unless approved by prescriber. Laboratory tests may be required; maintain recommended schedule. Take as directed, with a high-fat meal. Follow prescriber's suggestions to prevent reinfection. May cause loss of hair (reversible); nausea or vomiting (small, frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); or dizziness or headaches (use caution when driving or engaging in tasks that require alertness until response to drug is known). Report unusual fever, persistent or unresolved abdominal pain, vomiting, yellowing of skin or eyes, darkening of urine, or light colored stools. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Breast-feeding is not recommended. Becoming pregnant within 1 month following therapy is not advised.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
May rarely cause bone marrow suppression; use caution with clozapine and carbamazepine. Carbamazepine may increase the metabolism of albendazole.
Nursing: Physical Assessment/Monitoring
Dosing based on identification of parasite. Note pretreatment suggestions. Assess laboratory results for therapeutic effectiveness (reduction or elimination of ova and parasites) and adverse reactions (eg, elevated LFTs, leukopenia). Teach patient appropriate use, possible side effects/appropriate interventions, and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet:
Albenza®: 200 mg
Pricing: U.S. (www.drugstore.com)
Tablets (Albenza)
200 mg (12): $26.99
References
Bethony J, Brooker S, Albonico M, et al, “Soil-Transmitted Helminth Infections: Ascariasis, Trichuriasis, and Hookworm,” Lancet, 2006, 367(9521):1521-32.
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.
de Silva N, Guyatt H, and Bundy D, “Anthelmintics. A Comparative Review of Their Clinical Pharmacology,” Drugs, 1997, 53(5):769-88.
“Drugs for Parasitic Infections,” Med Lett Drugs Ther, 2004, 46(1189):e1-12.
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.
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, 2004, 350(3):249-58.
Hawk MW, Shahlaie K, Kim KD, and Theis JH, “Neurocysticercosis: A Review,” Surg Neurol, 2005, 63(2):123-32.
Liu LX and Weller PF, “Antiparasitic Drugs,” N Engl J Med, 1996, 334(18):1178-84.
Smego, RA, Bhatti S, Khaliq AA, et al, “Percutaneous Aspiration-Injection-Reaspiration Drainage Plus Albendazole or Mebendazole for Hepatic Cystic Echinococcosis: A Meta-Analysis,” Clin Infect Dis, 2003, 37(8):1073-83.
Wilson ME, Lorente CA, Allen JE, et al, “Gongylonema Infection of the Mouth in a Resident of Cambridge, Massachusetts,” Clin Infect Dis, 2001, 32(9):1378-80.
International Brand Names
Lexi-Comp.com
Last full review/revision May 2009
Content last modified May 2009
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