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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 of albendazole sulfoxide is increased in patients with extrahepatic obstruction.

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

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 8-30 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) (off-label use): Oral: 400 mg as a single dose

Clonorchis sinensis (Chinese liver fluke) (off-label use): Oral: 10 mg/kg/day for 7 days

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

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

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

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

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

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

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 8-14 days plus corticosteroids for severe symptoms

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

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

Echinococcus granulosus (tapeworm) (off-label use): Oral: 800 mg/day in 2 divided doses for 1-6 months

Microsporidiosis (not limited to the HIV-infected patient) (off-label use; Anon 2007): Oral:

Disseminated microsporidiosis: 800 mg/day in 2 divided doses

Intestinal microsporidiosis (E. intestinalis): 800 mg/day in 2 divided doses for 21 days

Ocular microsporidiosis: 800 mg/day in 2 divided doses, in combination with fumagillin

Microsporidiosis in HIV-infected patients (off-label use; HHS [OI adult 2015]): Oral:

Disseminated microsporidiosis (caused by Trachipleistophora or Anncaliia): 800 mg/day in 2 divided doses in combination with itraconazole

Disseminated or intestinal microsporidiosis (caused by microsporidiosis other than E. bieneusi and V. corneae): 800 mg/day in 2 divided doses; continue until CD4 count >200 cells/mm3 for >6 months after ART initiation

Ocular microsporidiosis: 800 mg/day in 2 divided doses, in combination with fumagillin; discontinue therapy after ocular infection resolution if CD4 count >200 cells/mm3; continue therapy until ocular infection resolution and increase in CD4 count to >200 cells/mm3 for at least 6 months in response to ART if CD4 count ≤200 cells/mm3

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Neurocysticercosis: Oral: Refer to adult dosing.

Hydatid: Oral: Refer to adult dosing.

Cysticercus cellulosae (off-label 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) (off-label use): Oral: 15 mg/kg/day (maximum: 800 mg) divided twice daily for 1-6 months

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

Microsporidiosis in HIV-exposed/-infected patients (off-label use): Oral:

Disseminated or intestinal infection (caused by microsporidiosis other than E. bieneusi or V. corneae):

Infants and Children: 15 mg/kg/day (maximum: 800 mg/day) in 2 divided doses continued until immune reconstitution after HAART initiation (CDC, 2009)

Adolescents: Refer to adult dosing.

Disseminated microsporidiosis (caused by Trachipleistophora or Anncaliia): Adolescents: Refer to adult dosing.

Ocular microsporidiosis: Adolescents: Refer to adult dosing.

For the following off-label uses, refer to adult dosing: Ancylostoma caninum, Ascaris lumbricoides (roundworm), Ancylostoma duodenale (hookworm), 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)

Dosing: Renal Impairment

No dosage adjustment 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

No dosage adjustment provided in manufacturer's labeling. However, patients with underlying liver disease may be more at risk for adverse effects.

Administration

Should be administered with a high-fat meal. Administer anticonvulsant and corticosteroid 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.

Dietary Considerations

Should be taken with a high-fat meal.

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.

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 preexisting 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.

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

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 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, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, bruises without a reason or that get bigger, or any bleeding that is very bad or that will not stop), signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), 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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