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Albendazole

Pronunciation

Pronunciation

(al BEN da zole)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Albenza: 200 mg [contains saccharin sodium]

Brand Names: U.S.

  • Albenza

Pharmacologic Category

  • Anthelmintic

Pharmacology

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.

Absorption

Poor from the GI tract; may increase up to 5 times when administered with a fatty meal

Distribution

Widely distributed throughout the body including urine, bile, liver, cyst wall, cyst fluid, and CSF

Metabolism

Hepatic; extensive first-pass effect; pathways include rapid sulfoxidation to active metabolite (albendazole sulfoxide [major]), hydrolysis, and oxidation

Excretion

Urine (<1% as active metabolite); feces

Time to Peak

Serum: 2 to 5 hours for the metabolite

Half-Life Elimination

8 to 12 hours (albendazole sulfoxide)

Protein Binding

70%

Special Populations: Hepatic Function Impairment

Systemic availability, rate of absorption, and the elimination half-life of albendazole sulfoxide are increased in patients with extrahepatic obstruction.

Use: Labeled Indications

Hydatid disease: Treatment of cystic hydatid disease of the liver, lung, and peritoneum caused by the larval form of the dog tapeworm, Echinococcus granulosus.

Neurocysticercosis: Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium.

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).

Contraindications

Hypersensitivity to albendazole, benzimidazoles, or any component of the formulation

Dosing: Adult

Neurocysticercosis: Oral:

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

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

Note: Give concurrent anticonvulsant and corticosteroid therapy.

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) (off-label use): Oral: 400 mg as a single dose (Parasitic Infections 2013)

Clonorchis sinensis (Chinese liver fluke) or Opisthorchis viverrini (Southeast Asian liver fluke) (off-label use): Oral: 10 mg/kg/day for 7 days (Parasitic Infections 2013)

Cutaneous larva migrans (off-label use): Oral: 400 mg once daily for 3 days (Parasitic Infections 2013)

Cysticercus (off-label use): Oral: 15 mg/kg/day (maximum: 800 mg/day) in 2 divided doses for 8 to 30 days; may be repeated as necessary (Parasitic Infections 2013)

Echinococcus granulosus (tapeworm) (off-label use): Oral: 15 mg/kg/day (maximum: 800 mg/day) in 2 divided doses for 1 to 6 months (Parasitic Infections 2013)

Enterobius vermicularis (pinworm) (off-label use): Oral: 400 mg as a single dose; repeat in 2 weeks (Parasitic Infections 2013)

Giardia duodenalis (giardiasis) (off-label use): Oral: 400 mg once daily for 5 days (Parasitic Infections 2013)

Gnathostoma spinigerum (off-label use): Oral: 800 mg/day in 2 divided doses for 21 days (Parasitic Infections 2013)

Gongylonemiasis (off-label use): Oral: 400 mg once daily for 3 days (Parasitic Infections 2013)

Microsporidiosis:

Immunocompetent patients:

Disseminated (off-label use): 800 mg/day in 2 divided doses (Parasitic Infections 2013)

Intestinal (E. intestinalis) (off-label use): 800 mg/day in 2 divided doses for 21 days (Parasitic Infections 2013)

Ocular (off-label use): 800 mg/day in 2 divided doses, in combination with topical fumagillin (Parasitic Infections 2013)

Immunocompromised (HIV-positive) patients

Disseminated or intestinal infection (other than Enterocytozoon bieneusi or V. corneae) (off-label use): 800 mg/day in 2 divided doses; continue until CD4 count >200 cells/mm3 for >6 months after initiation of antiretroviral therapy (DHHS [OI Adults 2015])

Ocular (off-label use): 800 mg/day in 2 divided doses, in combination with topical fumagillin; continue until resolution of ocular symptoms and until CD4 count >200 cells/mm3 for >6 months after initiation of antiretroviral therapy (DHHS [OI Adults 2015])

Oesophagostomum bifurcum (off-label use): Oral: 400 mg as a single dose (Ziem 2004)

Trichinella spiralis (Trichinellosis) (off-label use): Oral: 800 mg/day in 2 divided doses for 8 to 14 days plus corticosteroids for severe symptoms (Parasitic Infections 2013)

Visceral larva migrans (toxocariasis) (off-label use): Oral: 800 mg/day in 2 divided doses for 5 days (Parasitic Infections 2013)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Neurocysticercosis: Children and Adolescents: Oral: Refer to adult dosing.

Hydatid: Children and Adolescents: Oral: Refer to adult dosing.

Off-label uses:

Cysticercus (off-label use): Pediatric: Oral: 15 mg/kg/day (maximum: 800 mg/day) in 2 divided doses for 8 to 30 days; may be repeated as necessary (Parasitic Infections 2013)

Giardia duodenalis (giardiasis) (off-label use): Children and Adolescents: Oral: 10 mg/kg/day for 5 days (Yereli 2004)

Microsporidiosis (other than Enterocytozoon bieneuesi or V. corneae), disseminated or intestinal infection, HIV-positive (off-label use): Infants, Children, and Adolescents: 15 mg/kg/day (maximum: 800 mg/day) in 2 divided doses continued until immune reconstitution after cART initiation (DHHS [OI Children] 2013)

Microsporidiosis, intestinal infection (immunocompetent) (off-label use): Infants ≥6 months and Children: 15 mg/kg/day in 2 divided doses for 7 days (Tremoulet 2004)

Additional pediatric off-label uses: Refer to adult dosing: Ancylostoma caninum, Ascaris lumbricoides (roundworm), Ancylostoma duodenale (hookworm), Clonorchis sinensis (Chinese liver fluke), cutaneous larva migrans, Echinococcus granulosus (tapeworm), Enterobius vermicularis (pinworm), Gnathostoma spinigerum, gongylonemiasis, Necator americanus (hookworm), Oesophagostomum bifurcum, Opisthorchis viverrini (Southeast Asian liver fluke), Trichinella spiralis (Trichinellosis), visceral larva migrans (toxocariasis)

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). However, the need for adjustment not likely since albendazole is primarily eliminated by hepatic metabolism.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in manufacturer's labeling. However, patients with underlying liver disease may be more at risk for adverse effects.

Administration

Administer with a high-fat meal if treating a systemic infection. Administer on an empty stomach if treating an intraluminal infection (Lange 1988). If patients have difficulty swallowing, tablets may be crushed or chewed, then swallowed with a drink of water; chewable tablets are available for patients with difficulty swallowing.

Storage

Store between 20°C and 25°C (68°F to 77°F)

Drug Interactions

Aminoquinolines (Antimalarial): May decrease the serum concentration of Anthelmintics. Monitor therapy

CarBAMazepine: May decrease serum concentrations of the active metabolite(s) of Albendazole. Monitor therapy

Grapefruit Juice: May increase serum concentrations of the active metabolite(s) of Albendazole. Monitor therapy

PHENobarbital: May decrease serum concentrations of the active metabolite(s) of Albendazole. Monitor therapy

Phenytoin: May decrease serum concentrations of the active metabolite(s) of Albendazole. Monitor therapy

Adverse Reactions

>10%:

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

Hepatic: Increased liver enzymes (hydatid: 16%; neurocysticercosis: <1%)

1% to 10%:

Central nervous system: Increased intracranial pressure (≤2%), dizziness (≤1%), vertigo (≤1%), meningism (1%)

Dermatologic: Alopecia (<1% to 2%)

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

Miscellaneous: Fever (≤1%)

<1% (Limited to important or life-threatening): Acute hepatic failure, acute renal failure, agranulocytosis, aplastic anemia, erythema multiforme, granulocytopenia, hepatitis, hypersensitivity reaction, leukopenia, neutropenia, pancytopenia, skin rash, Stevens-Johnson syndrome, thrombocytopenia, urticaria

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. Discontinue therapy if hepatic enzymes are significantly increased.

Disease-related concerns:

• Neurocysticercosis: Appropriate use: Corticosteroids should be administered before or upon initiation of albendazole therapy to minimize inflammatory reactions and prevent increased intracranial pressure. Anticonvulsant therapy should be used concurrently to prevent seizures. If retinal lesions exist, weigh risk of further retinal damage due to albendazole-induced inflammatory changes to the retinal lesion vs benefit of disease treatment.

Monitoring Parameters

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 for retinal lesions (patients with neurocysticercosis); pregnancy test

Pregnancy Risk Factor

C

Pregnancy Considerations

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 during and for at least 1 month following therapy. Discontinue if pregnancy occurs during treatment.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, abdominal pain, vomiting, or nausea. Have patient report immediately to prescriber signs of infection, signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), or severe loss of strength and energy (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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