Albendazole (Monograph)
Brand name: Albenza
Drug class: Anthelmintics
VA class: AP200
Chemical name: [5-(Propylthio)-1H-benzimidazol-2-yl]-carbamic acid methyl ester
Molecular formula: C12H15N3O2S
CAS number: 54965-21-8
Introduction
Anthelmintic agent; benzimidazole derivative.1 4
Uses for Albendazole
Neurocysticercosis
Treatment of parenchymal neurocysticercosis resulting from active lesions caused by Cysticercus cellulosae, the larval form of Taenia solium (pork tapeworm).1 5 7 25 26 27 28 29 105 134
Recommended antiparasitic treatment usually is albendazole, but a regimen of albendazole and praziquantel may be recommended depending on the number of viable parenchymal cysticerci.25
Corticosteroids and anticonvulsant therapy may be indicated prior to and/or during albendazole treatment.1 5 6 25 26 28 29 105 134 (See Precautions Related to Neurocysticercosis under Cautions.)
Diagnosis and management of neurocysticercosis is complex; consult specialized references and experts.25 28 29 134
Hydatid Disease
Treatment of cystic hydatid disease (unilocular hydatid disease) of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm (Echinococcus granulosus).1 3 5 7 134
Surgery often is treatment of choice when medically feasible;3 5 7 11 12 134 perioperative use of an anthelmintic may be indicated to minimize risk of intraoperative dissemination of daughter cysts.7 11 134 Albendazole is drug of choice when an anthelmintic indicated.7 11 12 134
Has been used for treatment of alveolar hydatid disease† [off-label] caused by Echinococcus multilocularis.3 5 7 12 134 Surgical excision of the larval mass is the recommended and only reliable treatment.105 134 Long-term (months to years) albendazole treatment has been associated with clinical stability in some nonresectable cases and may rarely cure the infection.134
Ascariasis
Treatment of ascariasis† [off-label] caused by Ascaris lumbricoides (roundworm).105 134 Albendazole, mebendazole, and ivermectin are drugs of choice.105 134
Baylisascariasis
Treatment of baylisascariasis† [off-label] caused by Baylisascaris procyonis (raccoon roundworm);18 30 31 32 105 134 used with or without a corticosteroid.30 31 32 105 134
CNS damage can occur before patient exhibits symptoms of baylisascariasis;18 30 32 105 anthelmintic started within 1–3 days of possible infection might prevent clinical disease by killing larvae before they enter CNS.18 134
CDC and others recommend that albendazole (with or without a corticosteroid) be initiated as soon as possible in all probable or suspected cases of baylisascariasis (e.g., CNS disease with CSF eosinophilia and likely exposure).30 32 105 134 These experts also recommend immediate preemptive treatment with albendazole following known or suspected exposure to B. procyonis (e.g., ingestion of raccoon feces, oral exposure to soil or objects contaminated with raccoon feces, playing or working near raccoon latrines) while further diagnostic investigations are being conducted.30 32 105 134 Concomitant use of a corticosteroid usually recommended.30 31 32 105 134
Information on prevention, diagnosis, and treatment of baylisascariasis is available from CDC at [Web].
Capillariasis
Treatment of capillariasis† [off-label] caused by Capillaria philippinensis (Philippine threadworm).134 Mebendazole is drug of choice; albendazole is an alternative.134
Enterobiasis
Treatment of enterobiasis† [off-label] caused by Enterobius vermicularis (pinworm).105 134 Albendazole, mebendazole, and pyrantel pamoate are drugs of choice.105 134
Filariasis
Treatment of filariasis caused by Wuchereria bancrofti or Brugia malayi† (roundworms).20 21 22 23 105 134 Diethylcarbamazine (available in the US from CDC) is the drug of choice.105 134 Ivermectin (with or without albendazole) has been used.20 21 22 23 105 134 A single dose of albendazole used in conjunction with either a single dose of diethylcarbamazine or ivermectin may be more effective than any one drug alone for suppression of microfilaremia caused by these organisms.20 21 22 105 134
Has been used to reduce microfilaremia in the treatment of loiasis† caused by Loa loa (roundworm).134 Diethylcarbamazine (available in the US from the CDC) is the drug of choice;134 albendazole may be useful when diethylcarbamazine is ineffective or cannot be used, but repeated courses may be necessary.134
Gnathostomiasis
Treatment of gnathostomiasis† caused by Gnathostoma spinigerum.134 Albendazole or ivermectin (with or without surgical removal) is recommended.134
Gongylonemiasis
Treatment of gongylonemiasis† caused by Gongylonema.134 Albendazole or surgical removal is recommended.134
Hookworm Infections
Treatment of cutaneous larva migrans† (creeping eruption) caused by dog or cat hookworms.105 134 Usually self-limited with spontaneous cure after several weeks or months; albendazole or ivermectin are drugs of choice when treatment is indicated.105 134
Treatment of intestinal hookworm infections† caused by Ancylostoma duodenale or Necator americanus.105 134 Albendazole, mebendazole, and pyrantel pamoate are drugs of choice.105 134
Treatment of eosinophilic enterocolitis† caused by Ancylostoma caninum (dog hookworm).134 Treatment of choice is albendazole, mebendazole, or endoscopic removal of worms.134
Oesophagostomiasis
Treatment of oesophagostomiasis† caused by Oesophagostomum bifurcum.19 134 Albendazole or pyrantel pamoate may be effective.19 134
Strongyloidiasis
Treatment of strongyloidiasis† caused by Strongyloides stercoralis (threadworm).105 134 Drug of choice is ivermectin; albendazole is an alternative.105 134 Prolonged or repeated treatment may be necessary in people with hyperinfection and disseminated strongyloidiasis, and relapse can occur.105
Toxocariasis (Visceral Larva Migrans)
Treatment of toxocariasis† (visceral larva migrans) caused by Toxocara canis or T. cati (dog or cat roundworm).105 134 Albendazole and mebendazole are drugs of choice.105 134 Concomitant corticosteroids may be indicated in severe cases with cardiac, ocular, or CNS involvement.105 134 Antiparasitic treatment may not be effective for ocular larva migrans; inflammation may be reduced by corticosteroid injections; surgery may be necessary for secondary damage.105
Trichinellosis
Treatment of trichinellosis† (trichinosis) caused by Trichinella spiralis (pork worm).105 134 Drug of choice is albendazole; mebendazole is an alternative.134 Concomitant corticosteroids usually recommended, especially for severe disease.105 134 Corticosteroids alleviate symptoms of the inflammatory reaction and can be lifesaving when cardiac or CNS systems are involved.105
Trichostrongyliasis
Treatment of trichostrongyliasis† caused by Trichostrongylus.134 Pyrantel pamoate is drug of choice; albendazole and mebendazole are alternatives.134
Trichuriasis
Treatment of trichuriasis† caused by Trichuris trichiura (whipworm).105 134 Albendazole is drug of choice; mebendazole and ivermectin are alternatives.105 134
Trematode (Fluke) Infections
Treatment of infections caused by Clonorchis sinensis† (Chinese liver fluke) or Opisthorchis viverrini† (Southeast Asian liver fluke).134 Albendazole and praziquantel are drugs of choice.134 Other anthelmintics (usually praziquantel) recommended for all other fluke infections.134
Giardiasis
Treatment of giardiasis† caused by Giardia duodenalis (also known as G. lamblia or G. intestinalis).105 134 Metronidazole, tinidazole, and nitazoxanide are drugs of choice.105 134 Albendazole is an alternative.134
Microsporidiosis
Treatment of intestinal microsporidiosis† caused by Encephalitozoon intestinalis.14 15 16 17 105 134 155 156 Albendazole is drug of choice.105 134 155 156
Treatment of ocular microsporidiosis†.14 15 16 17 134 Albendazole in conjunction with topical ophthalmic fumagillin (not commercially available in US) recommended.134 155 156 While topical fumagillin may clear susceptible microsporidia from the eye, albendazole is used to clear microsporidia that persist systemically.155 156 Topical fumagillin generally not effective for ocular lesions caused by Vittaforma corneae and keratoplasty may be necessary.134
Treatment of disseminated microsporidiosis† caused by microsporidia other than Enterocytozoon bieneusi and V. corneae.14 15 16 17 134 155 156 Albendazole is drug of choice.134 155 156 Used in conjunction with itraconazole for treatment of disseminated disease caused by Trachipleistophora or Anncaliia.155
Ineffective for infections caused by E. bieneusi15 17 105 155 and V. corneae.155
Related/similar drugs
doxycycline, metronidazole, vancomycin, Flagyl, ivermectin, itraconazole, Vibramycin
Albendazole Dosage and Administration
General
-
Evaluate blood cell counts prior to and during albendazole treatment.1 (See Hematologic Effects under Cautions.)
-
Evaluate hepatic enzymes (aminotransferases) prior to and during albendazole treatment.1 (See Hepatic Effects under Cautions.)
-
Perform pregnancy test prior to initiating albendazole in women of reproductive potential.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Administration
Oral Administration
Administer orally with food.1 Food, especially fatty food, increases bioavailability.1 3 7
In patients who have difficulty swallowing tablets whole (particularly children), tablets may be crushed or chewed and swallowed with a drink of water.1
Dosage
Pediatric Patients
Neurocysticercosis
Oral
Children weighing <60 kg: 15 mg/kg daily (up to 800 mg daily), administered as 2 equally divided doses with meals, for 8–30 days.1 134 Repeat as necessary.134
Children weighing ≥60 kg: 400 mg twice daily with meals for 8–30 days.1 134 Repeat as necessary.134
Use corticosteroids and appropriate anticonvulsant therapy concomitantly as indicated.1 (See Precautions Related to Neurocysticercosis under Cautions.)
Hydatid Disease
Oral
Children weighing <60 kg: 15 mg/kg daily (up to 800 mg daily), administered in 2 equally divided doses with meals for 28 days, followed by a 14-day albendazole-free interval.1 Repeat for a total of 3 dosage cycles.1
Children weighing ≥60 kg: 400 mg twice daily with meals for 28 days, followed by a 14-day albendazole-free interval.1 Repeat for a total of 3 dosage cycles.1
Alternatively, 15 mg/kg daily (up to 800 mg daily) for 1–6 months has been recommended by some clinicians.134
Ascariasis (Roundworm)†
Oral
Single 400-mg dose.134
Baylisascariasis (Raccoon Roundworm)†
Oral
20–50 mg/kg daily with or without a corticosteroid is recommended by CDC and others for treatment, including preemptive treatment (see Baylisascariasis under Uses).18 30 32 134
Initiate treatment immediately if baylisascariasis is probable;18 32 105 do not delay treatment until patient is symptomatic or diagnosis confirmed.18 Continue treatment for at least 10 days;32 usually has been continued for 3–6 weeks.31 32
Initiate preemptive treatment immediately following suspected or confirmed exposure to B. procyonis.30 32 Continue for 10–20 days while conducting further diagnostic investigations.30
Capillariasis (Philippine Threadworm)†
Oral
400 mg once daily for 10 days.134
Enterobiasis (Pinworm)†
Oral
400-mg initial dose followed by a second 400-mg dose given 2 weeks later.134
Some clinicians state consider treating all household contacts, especially when multiple or repeated symptomatic infections are occurring in the household.105 134
Gnathostomiasis†
Oral
400 mg twice daily for 21 days.134
Gongylonemiasis†
Oral
400 mg daily for 3 days.134
Hookworm Infections†
Cutaneous Larva Migrans (Creeping Eruption)†
Oral400 mg once daily for 3 days.134
Intestinal Hookworm Infections†
OralSingle 400-mg dose.134
Perform a repeat stool examination (using a concentration technique) for eggs of A. duodenale or N. americanus 2 weeks after treatment; repeat dose if results are positive.105
Eosinophilic Enterocolitis Caused by Ancylostoma caninum (Dog Hookworm)†
OralSingle 400-mg dose.134
Strongyloidiasis†
Oral
400 mg twice daily for 7 days.134
Repeated or prolonged treatment or use of other agents may be necessary in immunocompromised individuals or those with disseminated disease.105 134
Toxocariasis (Visceral Larva Migrans Caused by Dog or Cat Roundworm)†
Oral
400 mg twice daily for 5 days has been recommended.134
Optimum duration of treatment not known; some clinicians recommend up to 20 days of treatment.134 For severe symptoms or eye involvement, some clinicians state treatment may be extended to 2–4 weeks.134
Trichinellosis (Pork Worm)†
Oral
400 mg twice daily for 8–14 days.134
Trichostrongyliasis†
Oral
Single 400-mg dose.134
Trichuriasis (Whipworm)†
Oral
400 mg once daily for 3 days.134
Trematode (Fluke) Infections Caused by C. sinensis or O. viverrini†
Oral
10 mg/kg daily for 7 days.134
Giardiasis†
Oral
10 mg/kg daily for 5 days.134
Microsporidiosis†
Intestinal Microsporidiosis†
Oral7.5 mg/kg (up to 400 mg) twice daily.134 156
Some clinicians recommend treatment duration of 21 days.134 In HIV-infected patients, experts recommend continuing treatment until symptoms resolve and sustained immune response to antiretroviral therapy attained (CDC immunologic category 1 or 2 for >6 months).156
Ocular Microsporidiosis†
Oral7.5 mg/kg (up to 400 mg) twice daily.134 156
In HIV-infected patients, experts recommend continuing treatment until ocular symptoms resolve and sustained immune response to antiretroviral therapy attained (CDC immunologic category 1 or 2 for >6 months).156
Disseminated Microsporidiosis†
Oral7.5 mg/kg (up to 400 mg) twice daily.134 156
In HIV-infected patients, experts recommend continuing treatment until symptoms resolve and sustained immune response to antiretroviral therapy attained (CDC immunologic category 1 or 2 for >6 months).156
Adults
Neurocysticercosis
Oral
Adults <60 kg: 15 mg/kg daily (up to 800 mg daily), administered in 2 equally divided doses with meals, for 8–30 days.1 134 Repeat as necessary.134
Adults ≥60 kg: 400 mg twice daily with meals for 8–30 days.1 5 134 Repeat as necessary.134
Use corticosteroids and appropriate anticonvulsant therapy concomitantly as indicated.1 (See Precautions Related to Neurocysticercosis under Cautions.)
Hydatid Disease
Oral
Adults <60 kg: 15 mg/kg daily (up to 800 mg daily), administered in 2 equally divided doses with meals for 28 days, followed by a 14-day albendazole-free interval.1 Repeat for a total of 3 dosage cycles.1
Adults ≥60 kg: 400 mg twice daily with meals for 28 days, followed by a 14-day albendazole-free interval.1 Repeat for a total of 3 dosage cycles.1
Alternatively, 15 mg/kg daily (not to exceed 800 mg daily) for 1–6 months has been recommended by some clinicians.134
Ascariasis (Roundworm)†
Oral
Single 400-mg dose.134
Baylisascariasis (Raccoon Roundworm)†
Oral
20–50 mg/kg daily with or without a corticosteroid is recommended by CDC and others for treatment, including preemptive treatment (see Baylisascariasis under Uses).18 30 32 134
Initiate treatment immediately if baylisascariasis is probable;18 32 105 do not delay treatment until patient is symptomatic or diagnosis confirmed.18 Continue treatment for at least 10 days;32 usually has been continued for 3–6 weeks.31 32
Initiate preemptive treatment immediately following suspected or confirmed exposure to B. procyonis.30 32 Continue for 10–20 days while conducting further diagnostic investigations.30
Capillariasis (Philippine Threadworm)†
Oral
400 mg once daily for 10 days.134
Enterobiasis (Pinworm)†
Oral
400-mg initial dose followed by a second 400-mg dose given 2 weeks later.134
Some clinicians state consider treating all household contacts, especially when multiple or repeated symptomatic infections are occurring in the household.105 134
Gnathostomiasis†
Oral
400 mg twice daily for 21 days.134
Gongylonemiasis†
Oral
400 mg daily for 3 days.134
Hookworm Infections†
Cutaneous Larva Migrans (Creeping Eruption)†
Oral400 mg once daily for 3 days.134
Intestinal Hookworm Infections†
OralSingle 400-mg dose.134
Perform a repeat stool examination (using a concentration technique) for eggs of A. duodenale or N. americanus 2 weeks after treatment; repeat dose if results are positive.105
Eosinophilic Enterocolitis Caused by Ancylostoma caninum (Dog Hookworm)†
OralSingle 400-mg dose.134
Strongyloidiasis†
Oral
400 mg twice daily for 7 days.134
Repeated or prolonged treatment or use of other agents may be necessary in immunocompromised individuals or those with disseminated disease.105 134
Toxocariasis (Visceral Larva Migrans Caused by Dog or Cat Roundworm)†
Oral
400 mg twice daily for 5 days has been recommended.134
Optimum duration of treatment not known; some clinicians recommend up to 20 days of treatment.134 For severe symptoms or eye involvement, some clinicians state treatment may be extended to 2–4 weeks.134
Trichinellosis (Pork Worm)†
Oral
400 mg twice daily for 8–14 days.134
Trichostrongyliasis†
Oral
Single 400-mg dose.134
Trichuriasis (Whipworm)†
Oral
400 mg once daily for 3 days.134
Trematode (Fluke) Infections Caused by C. sinensis or O. viverrini†
Oral
10 mg/kg daily for 7 days.134
Giardiasis†
Oral
400 mg daily for 5 days.134
Microsporidiosis†
Intestinal Microsporidiosis†
Oral400 mg twice daily.134
Some clinicians recommend a treatment duration of 21 days.134 In HIV-infected patients, experts recommend continuing treatment until symptoms resolve and sustained immune response to antiretroviral therapy attained (CD4+ T-cell count >200 cells/mm3 for at least 6 months).155
Ocular Microsporidiosis†
Oral400 mg twice daily.134
In HIV-infected patients, experts recommend continuing treatment until ocular symptoms resolve and sustained immune response to antiretroviral therapy attained (CD4+ T-cell count >200 cells/mm3 for at least 6 months).155
Disseminated Microsporidiosis†
Oral400 mg twice daily.134
In HIV-infected patients, experts recommend continuing treatment until symptoms resolve and sustained immune response to antiretroviral therapy attained (CD4+ T-cell count >200 cells/mm3 for at least 6 months).155
Prescribing Limits
Pediatric Patients
Neurocysticercosis
Oral
Children weighing <60 kg: Maximum 800 mg daily.1 134
Hydatid Disease
Oral
Children weighing <60 kg: Maximum 800 mg daily.1 134
Microsporidiosis†
Oral
Maximum dose 400 mg.134
Adults
Neurocysticercosis
Oral
Adults weighing <60 kg: Maximum 800 mg daily.1 134
Hydatid Disease
Oral
Adults weighing <60 kg: Maximum 800 mg daily.1 134
Special Populations
No special population dosage recommendations.
Cautions for Albendazole
Contraindications
-
Hypersensitivity to benzimidazole derivatives or any component in the formulation.1
Warnings/Precautions
Sensitivity Reactions
Hypersensitivity Reactions
Hypersensitivity reactions, including rash and urticaria, reported rarely.1 Erythema multiforme and Stevens-Johnson syndrome reported during postmarketing experience.1
Hematologic Effects
May cause bone marrow suppression, aplastic anemia, and agranulocytosis.1 Leukopenia, granulocytopenia, pancytopenia, agranulocytosis, and thrombocytopenia reported in <1% of patients receiving the drug.1 Fatalities related to granulocytopenia or pancytopenia reported.1
Monitor blood cell counts at the beginning of each 28-day cycle of albendazole treatment and every 2 weeks during treatment.1 Patients with liver disease and those with hepatic echinococcosis are at increased risk for bone marrow suppression; monitor blood cell counts more frequently in such patients.1
Discontinue albendazole if clinically important decreases in blood cell counts occur.1
Fetal/Neonatal Morbidity and Mortality
May cause fetal harm.1 Teratogenic effects (embryotoxicity, skeletal malformations) reported in rats and rabbits.1
Exclude pregnancy before initiating albendazole in women of reproductive potential.1 Avoid pregnancy during and for at least 1 month after final dose.1
If patient becomes pregnant, immediately discontinue the drug and apprise patient of the potential hazard to the fetus.1 (See Pregnancy under Cautions.)
Hepatic Effects
Mild to moderate increases of hepatic enzymes reported in about 16% of patients in clinical trials.1 Hepatic enzymes generally returned to normal when the drug discontinued, but acute liver failure of uncertain casualty and hepatitis have been reported.1
Patients with elevated hepatic enzymes are at increased risk for hepatotoxicity.1 Discontinue albendazole if clinically important increases in hepatic enzymes occur.1
Evaluate hepatic aminotransferase concentrations at the beginning of each cycle of albendazole treatment and at least every 2 weeks during treatment.1 If hepatic enzymes exceed twice the ULN, consider discontinuing the drug based on the individual patient circumstance.1 Decisions to re-institute albendazole when hepatic enzymes return to pretreatment levels should be individualized taking into account the risks and benefits of further albendazole treatment.1 If the drug is re-instituted, perform laboratory tests frequently.1
Precautions Related to Neurocysticercosis
In patients with neurocysticercosis, adverse CNS effects (e.g., seizures, increased intracranial pressure and focal signs, hydrocephalus) may occur resulting from inflammatory reactions caused by albendazole-induced death of parasites within the brain.1 5 7 Use appropriate corticosteroid and anticonvulsant treatment as required.1 5 7 134 Consider oral or IV corticosteroid therapy during first week of treatment to prevent cerebral hypertensive episodes.1
Patients with neurocysticercosis may have retinal lesions, and destruction of cysticercal lesions by albendazole may cause retinal damage.1 5 134 Prior to treatment of neurocysticercosis, examine patient for retinal lesions.1 In those with such lesions, weigh need for treatment against possibility of irreparable retinal damage resulting from inflammatory reactions caused by albendazole-induced death of parasites in the eye.1 5 134
Undiagnosed neurocysticercosis may be uncovered in patients receiving albendazole treatment for other conditions.1 Before initiating albendazole, evaluate patients with epidemiologic factors that increase risk for neurocysticercosis.1
Specific Populations
Pregnancy
May cause fetal harm.1 Use during pregnancy only if potential benefits justify risks to the fetus and only when no alternative management is appropriate.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Use in women of childbearing age only after a negative pregnancy test.1 Advise women of childbearing age to use effective contraceptive measures during and for 1 month after albendazole treatment.1
Discontinue immediately if patient becomes pregnant;1 advise the woman of the potential hazard to the fetus.1
Lactation
Distributed into milk in animals;1 distribution into human milk also reported.24
Use with caution in nursing women.1
Pediatric Use
Has been used for treatment of neurocysticercosis in pediatric patients; efficacy appears similar to that in adults and no unusual problems were reported.1
Hydatid disease is uncommon in infants and young children.1
Geriatric Use
Data insufficient to determine whether safety and efficacy of albendazole in patients ≥65 years of age differ from that in younger patients.1
Hepatic Impairment
Individuals with hepatic impairment are at increased risk for hepatotoxicity and bone marrow suppression during albendazole treatment.1
Discontinue albendazole if hepatic enzymes exceed twice the ULN or if clinically important decreases in blood counts occur.1
Renal Impairment
Not studied.1
Common Adverse Effects
Treatment of neurocysticercosis: Headache, nausea, vomiting, increased intracranial pressure, meningeal signs.1
Treatment of hydatid disease: Elevated hepatic enzymes, abdominal pain, nausea, vomiting, reversible alopecia, fever, headache, vertigo, dizziness.1
Drug Interactions
Induces CYP1A isoenzyme.1
Specific Drugs
Drug |
Interaction |
Comments |
---|---|---|
Cimetidine |
Increased concentrations of albendazole sulfoxide (active metabolite) in bile and cystic fluid in hydatid cyst patients receiving cimetidine; plasma concentrations of albendazole sulfoxide unchanged 4 hours after dosing1 |
|
Dexamethasone |
Increased albendazole sulfoxide trough concentrations1 |
|
Praziquantel |
Increased plasma concentrations and AUC of albendazole sulfoxide; time to peak concentrations and plasma elimination half-life of albendazole sulfoxide unchanged1 |
|
Theophylline |
Single albendazole dose does not affect theophylline metabolism; potential for interaction exists since albendazole induces CYP1A1 |
Monitor theophylline concentrations during and after albendazole therapy1 |
Albendazole Pharmacokinetics
Absorption
Bioavailability
Poorly absorbed from GI tract because of low aqueous solubility.1
Rapidly converted to active metabolite (albendazole sulfoxide) before reaching systemic circulation.1 Peak plasma concentrations of albendazole sulfoxide attained 2–5 hours after a dose.1
Food
Oral bioavailability enhanced by coadministration with fatty meal (estimated fat content 40 g); plasma concentrations up to fivefold higher compared with administration in fasted state.1
Distribution
Extent
Widely distributed throughout body.1 Detected in urine, bile, liver, cyst wall, cyst fluid, and CSF.1
Plasma Protein Binding
70%.1
Elimination
Metabolism
Rapidly converted in liver to active metabolite (albendazole sulfoxide) which is responsible for anthelmintic activity.1 Further metabolized to albendazole sulfone and other primary oxidative metabolites.1
Elimination Route
Albendazole is undetectable in urine; <1% of albendazole sulfoxide detectable in urine.1 Albendazole sulfoxide partially eliminated in bile.1
Half-life
Albendazole sulfoxide: 8–12 hours.1
Special Populations
Extrahepatic obstruction: Increased albendazole sulfoxide serum concentrations and prolonged half-life.1 Elimination half-life of albendazole sulfoxide may be 31.7 hours.1
Renal impairment: Pharmacokinetics not studied to date.1
Pediatric patients: Pharmacokinetics in patients 6–13 years of age similar to that in adults.1
Geriatric patients: Pharmacokinetics not fully evaluated; data from patients up to 79 years of age with hydatid cysts suggest pharmacokinetics similar to healthy young adults.1
Stability
Storage
Oral
Tablets
20–25°C.1
Actions and Spectrum
-
Benzimidazole derivative anthelmintic agent;1 4 structurally related to mebendazole.4
-
Principal anthelmintic effect of benzimidazoles appears to be specific, high-affinity binding to free β-tubulin in parasite cells,1 3 4 resulting in selective inhibition of parasite microtubule polymerization,1 3 4 and inhibition of microtubule-dependent uptake of glucose,2 3 6 which leads to parasitic death.1
-
Benzimidazole derivatives bind to the β-tubulin of parasites at much lower concentrations than to mammalian β-tubulin protein;4 the drugs do not inhibit glucose uptake in mammals, and do not appear to have any effect on blood glucose concentrations in humans.2 6
-
Active against the larval forms of Echinococcus granulosus and Taenia solium.1
-
Resistance to albendazole can occur when amino acid changes cause changes in parasite β-tubulin protein resulting in reduced binding of the drug.1
Advice to Patients
-
Advise patients of the importance of taking albendazole with food to increase oral bioavailability.1
-
Advise patients who experience difficulty swallowing the tablets whole (particularly children) that the tablets may be crushed or chewed and swallowed with a drink of water.1
-
Advise patients that albendazole has been associated with adverse hematologic and hepatic effects and that routine (every 2 weeks) monitoring of blood cell counts and liver function tests is important.1
-
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1
-
Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.1
-
Advise women of reproductive potential to use effective contraceptive measures to avoid becoming pregnant during and for 1 month after completion of albendazole treatment.1
-
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Oral |
Tablets, film-coated |
200 mg |
Albenza |
Amedra |
AHFS DI Essentials™. © Copyright 2024, Selected Revisions June 11, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
1. Amedra Pharmaceuticals LLS. Albenza (albendazole) film-coated tablets prescribing information. Horsham, PA; 2017 Dec.
2. Keystone JS. Mebendazole. Ann Intern Med. 1979; 91:582-6. http://www.ncbi.nlm.nih.gov/pubmed/484964?dopt=AbstractPlus
3. Liu LX. Antiparasitic drugs. N Engl J Med. 1996; 334:1178-84. http://www.ncbi.nlm.nih.gov/pubmed/8602186?dopt=AbstractPlus
4. Tracy JW, Webster LT Jr. Drugs used in the chemotherapy of helminthiasis. In: Hardman JG, Limbird LE, Molinoff PB et al, eds. Goodman and Gilman’s the pharmacological Basis of Therapeutics. 9th ed. New York: McGraw-Hill; 1996:1009-26.
5. SmithKline Beecham Pharmaceuticals, Philadelphia, PA: Personal communication.
6. Wolfe MS. Mebendazole: treatment of trichuriasis and ascariasis in Bahamian children. JAMA. 1974; 230:1408-11. http://www.ncbi.nlm.nih.gov/pubmed/4479643?dopt=AbstractPlus
7. Jernigan JA, Pearson RD. Antiparasitic agents. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas and Bennett’s principles and practice of infectious diseases. 4th ed. New York: Churchill Livingstone; 1995:458-92.
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; 48:1421-7. http://www.ncbi.nlm.nih.gov/pubmed/9153484?dopt=AbstractPlus
10. Gil-Grande LA, Rodriguez-Caabeiro F, Prieto JG et al. Randomised controlled trial of efficacy of albendazole in intra-abdominal hydatid disease. Lancet. 1993; 342:1269-72. http://www.ncbi.nlm.nih.gov/pubmed/7901585?dopt=AbstractPlus
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