(al BEN da zole)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Albenza: 200 mg [contains saccharin sodium]
Brand Names: U.S.
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.
Poor from the GI tract; may increase up to 5 times when administered with a fatty meal
Widely distributed throughout the body including urine, bile, liver, cyst wall, cyst fluid, and CSF
Hepatic; extensive first-pass effect; pathways include rapid sulfoxidation to active metabolite (albendazole sulfoxide [major]), hydrolysis, and oxidation
Urine (<1% as active metabolite); feces
Time to Peak
Serum: 2 to 5 hours for the metabolite
8 to 12 hours (albendazole sulfoxide)
Special Populations: Hepatic Function Impairment
Systemic availability of albendazole sulfoxide is increased in patients with extrahepatic obstruction.
Special Populations: Children
Albendazole sulfoxide pharmacokinetics are similar to those observed in adults.
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
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).
Hypersensitivity to albendazole, benzimidazoles, or any component of the formulation
Infants and Children: Microsporidiosis, disseminated or intestinal (caused by microsporidiosis other than E. bieneusi or V. corneae) in HIV-exposed/-infected patients (off-label use): 15 mg/kg/day (maximum: 800 mg/day) in 2 divided doses continued until immune reconstitution after HAART initiation (CDC, 2009)
Cysticercus cellulosae (off-label use): 15 mg/kg/day (maximum: 800 mg/day) in 2 divided doses for 8 to 30 days; may be repeated as necessary
Echinococcus granulosus (tapeworm) (off-label use): 15 mg/kg/day (maximum: 800 mg) divided twice daily for 1-6 months
Giardia duodenalis (giardiasis) (off-label use): 10 mg/kg/day for 5 days (Yereli, 2004)
Children and Adults:
<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 to 30 days
Note: Give concurrent anticonvulsant and corticosteroid (eg, dexamethasone or prednisolone) therapy during first week.
<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): 400 mg as a single dose
Clonorchis sinensis (Chinese liver fluke) (off-label use): 10 mg/kg/day for 7 days
Cutaneous larva migrans (off-label use): 400 mg once daily for 3 days
Enterobius vermicularis (pinworm) (off-label use): 400 mg as a single dose; repeat in 2 weeks
Gnathostoma spinigerum (off-label use): 800 mg/day in 2 divided doses for 21 days
Gongylonemiasis (off-label use): 400 mg once daily for 3 days
Mansonella perstans (off-label use): 800 mg/day in 2 divided doses for 10 days
Oesophagostomum bifurcum (off-label use): 400 mg as a single dose (Ziem, 2004)
Trichinella spiralis (Trichinellosis) (off-label use): 800 mg/day in 2 divided doses for 8-14 days plus corticosteroids for severe symptoms
Visceral larva migrans (toxocariasis) (off-label use): 800 mg/day in 2 divided doses for 5 days
Adolescents and Adults:
Microsporidiosis in HIV-infected patients (off-label use; HHS [OI adult 2015]):
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
Cysticercus cellulosae (off-label use): 800 mg/day in 2 divided doses for 8 to 30 days; may be repeated as necessary
Echinococcus granulosus (tapeworm) (off-label use): 800 mg/day in 2 divided doses for 1 to 6 months
Giardia duodenalis (giardiasis) (off-label use): 400 mg once daily for 5 days
Microsporidiosis (not limited to the HIV-infected patient) (off-label use; Anon, 2007):
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
Dosage adjustment in 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.
Dosage adjustment in hepatic impairment: No dosage adjustment provided in manufacturer's labeling. However, patients with underlying liver disease may be more at risk for adverse effects.
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.
Should be taken with a high-fat meal.
Store between 20°C and 25°C (68°F to 77°F)
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
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%)
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
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.
• 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.
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
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.
• 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 dyspepsia or nausea. Have patient report immediately to prescriber signs of infection, signs of hemorrhaging, signs of hepatic impairment, severe asthenia, considerable headache, or vision changes (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.
More about albendazole
- Other brands: Albenza