VA Class:AP200
Albendazole, a benzimidazole derivative, is an anthelmintic agent.1, 4
Albendazole is used in the treatment of tissue infections caused by the larval forms of certain cestodes (tapeworms) including neurocysticercosis caused by Cysticercus cellulosae , the larval form of Taenia solium (pork tapeworm).1, 5, 25, 26, 27, 28, 29, 105 Albendazole also is used for the treatment of hydatid disease caused by the larval form of Echinococcus granulosus (dog tapeworm).1, 3, 5, 7, 134 Other anthelmintics (usually praziquantel or nitazoxanide) are used for the treatment of intestinal infections caused by adult forms of cestodes.105, 134
Albendazole is used for the 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 Symptoms commonly associated with neurocysticercosis include headaches, seizures, or other CNS effects thought to result from expanding active cysticercal lesions or edema surrounding individual degenerating cysts in brain parenchyma.5, 12, 134 Therefore, important measures of response to antineurocysticercal therapy include resolution of CNS symptoms and radiologic response.5
Safety and efficacy of albendazole in patients with neurocysticercosis caused by T. solium initially were demonstrated by analysis of 3 sets of data, including a compilation of data from published reports of albendazole use in neurocysticercosis, data from US compassionate use patients, and data from a limited clinical study.5 Analysis of 2 of the data sets combined (the report compilation and the US compassionate use data) indicated that about 41% of patients experienced a cure (no symptoms of neurocysticercosis), about 50% were considered to be improved, and 9% experienced no change.5 Only limited data are available from well-designed, placebo-controlled studies regarding the long-term effects of albendazole on resolution of neurocysticercosis-associated seizures.25, 26, 27 Corticosteroid and anticonvulsant therapy may be indicated prior to and/or during albendazole treatment.1, 5, 7, 25, 26, 28, 29, 105, 134 Concomitant corticosteroids may alleviate some adverse CNS effects resulting from albendazole-induced death of parasites within the brain.1, 5, 7, 25, 26, 29 (See Precautions Related to Neurocysticercosis under Cautions: Warnings/Precautions.)
Initial treatment of parenchymal disease with seizures focuses on symptomatic treatment with anticonvulsants.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 Obstructive hydrocephalus is treated with surgical removal of the obstructing cyst or CSF diversion and prednisone; arachnoiditis, vasculitis, or cerebral edema is treated with corticosteroids (prednisone or dexamethasone) used in conjunction with albendazole or praziquantel.105, 134 Even when corticosteroids are used, any cysticercocidal drug may cause irreparable damage when used to treat ocular or spinal cysts; therefore, ophthalmic exams should be performed before treatment to rule out intraocular cysts.105, 134
Diagnosis and management of neurocysticercosis is complex and specialized references and experts should be consulted.25, 28, 29, 134
Albendazole is used for the 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 considered the treatment of choice for hydatid disease, when medically feasible,3, 5, 7, 11, 12, 134 but perioperative administration of an anthelmintic drug (e.g., albendazole, mebendazole, praziquantel) may be indicated in patients undergoing surgical removal of cysts to minimize the risk of intraoperative dissemination of daughter cysts.7, 11, 134 Percutaneous drainage with ultrasound guidance plus albendazole treatment has been effective for the management of hepatic hydatid cyst disease.134
Albendazole is absorbed to a greater extent, and achieves higher plasma concentrations (as its active metabolite) than mebendazole,7, 10, 11, 12 and some clinicians consider albendazole to be a drug of choice for treatment of hydatid cyst disease caused by E. granulosus .7, 11, 12, 134 Risks associated with surgery include operative morbidity, cyst recurrence, and anaphylaxis or dissemination of infection resulting from spillage of fluid from the cysts.3, 5, 7 Preoperative administration of albendazole may inactivate protoscolices and minimize the possibility of recurring cysts,3, 5, 7, 10 and postoperative treatment with the drug may prevent secondary dissemination of the cestode that can occur after spontaneous or operative rupture and spillage of cyst contents.3, 7 Optimal cysticidal effect of albendazole is achieved preoperatively or postoperatively when the drug is administered in three 28-day courses of therapy.3, 5, 7 Also, some clinicians have recommended administration of albendazole in patients with inoperable, widespread, or numerous E. granulosus cysts and in patients with complex medical problems who are not eligible for surgery.3, 5, 7
Because of the low incidence of hydatid disease, safety and efficacy of albendazole in patients with hydatid disease caused by E. granulosus were demonstrated by combining data from accumulated clinical reports in small series of patients.5 Four sets of data were considered, including data from European compassionate use patients, an analysis of data from published studies, data from Australian compassionate use patients (not evaluable), and data from US compassionate use patients.5 About 30-31% of evaluable patients with hydatid disease receiving albendazole experienced a clinical cure (i.e., disappearance of cysts), and improvement (i.e., a reduction in cyst diameter of at least 25%) was observed in about 40-42% of evaluable patients.5, 7 About 24% of patients receiving albendazole experienced no change or were considered to be worse.5
Although albendazole has been used to treat alveolar hydatid disease†, another form of hydatid cyst disease caused by Echinococcus multilocularis ,3, 5, 7, 12, 134 surgical excision of the larval mass is the recommended and only reliable treatment for this infection.134 Long-term (months to years) albendazole treatment reportedly has been associated with clinical stability in some nonresectable cases and may rarely cure the infection.134
Nematode (Roundworm) Infections
Albendazole is used for the treatment of ascariasis† caused by Ascaris lumbricoides .105, 134 Albendazole, ivermectin, and mebendazole are considered the drugs of choice for the treatment of ascariasis.105, 134
Albendazole has been used with or without corticosteroids for the treatment of baylisascariasis† caused by Baylisascaris procyonis and is considered the drug of choice for the treatment of such infections.18, 30, 31, 32, 105, 134 B. procyonis , a common roundworm found in the small intestine of raccoons, can cause severe or fatal encephalitis (neural larva migrans) in birds and mammals (including humans) and also can cause ocular and visceral larva migrans in humans.18, 30, 105 Humans become infected by ingesting B. procyonis eggs after contact with infected raccoon feces;18, 30, 32 young children are at particular risk for infection if they place fecally contaminated objects or fingers into their mouths.30, 32 From 1973-2010, there were 22 documented cases of baylisascariasis in the US.18, 30 Between May 2013 and December 2015, 6 cases of Baylisascaris neural larva migrans and 1 case of Baylisascaris ocular larva migrans were reported in the US (California, Massachusetts, Minnesota, Ohio, Oklahoma, Virginia).30
Because CNS damage can occur before the patient exhibits symptoms of baylisascariasis, treatment with anthelmintic or anti-inflammatory agents initiated after symptom onset may not improve outcome.18, 30, 32, 105 Use of an anthelmintic agent started within 1-3 days of possible infection might prevent clinical disease by killing larvae before they enter the CNS.18, 134 Therefore, CDC and other clinicians recommend that albendazole treatment (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) and that preemptive treatment with albendazole be initiated immediately following a 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 corticosteroid therapy usually is recommended and has been used in most reported cases of baylisascariasis.30, 31, 32, 105, 134 If albendazole is unavailable, some clinicians suggest that mebendazole, levamisole (not commercially available in the US), or ivermectin could be tried.134 Ocular baylisascariasis has been treated successfully using laser photocoagulation therapy to destroy the intraretinal larvae.32, 134
Information on prevention, diagnosis, and treatment of baylisascariasis is available from the CDC at [Web].
Albendazole has been used in the treatment of capillariasis† caused by Capillaria philippinensis (Philippine threadworm).134 Mebendazole is considered the drug of choice for the treatment of capillariasis and albendazole is an alternative.134
Albendazole is used for the treatment of enterobiasis† caused by Enterobius vermicularis (pinworm).105, 134 Albendazole, mebendazole, and pyrantel pamoate are considered the drugs of choice for the treatment of enterobiasis.105, 134
Wuchereria and Brugia Infections
Although diethylcarbamazine (available in the US from the CDC) is considered the drug of choice for the treatment of filariasis caused by Wuchereria bancrofti † or Brugia malayi †, 105, 134 ivermectin has been used (with or without albendazole) for the treatment of these infections.20, 21, 22, 23, 105, 134 There is some evidence that a combined regimen of a single dose of albendazole with a single dose of diethylcarbamazine or ivermectin is more effective than any one drug alone for suppression of microfilaremia caused by W. bancrofti or B. malayi .20, 21, 22, 105, 134 A regimen of albendazole and ivermectin has been used effectively in patients coinfected with W. bancrofti and O. volvulus .22
Albendazole has been used to reduce microfilaremia in the treatment of loiasis caused by Loa loa †.134 Diethylcarbamazine (available in the US from the CDC) usually is considered the drug of choice for Loa loa infections.134 Albendazole may be useful for treatment of loiasis when diethylcarbamazine is ineffective or cannot be used, but repeated courses may be necessary.134 Because rapid killing of microfilariae may provoke encephalopathy, albendazole may be the preferred alternative (rather than ivermectin) because of its slower onset of action and decreased risk of encephalopathy.134
For the treatment of gnathostomiasis† caused by Gnathostoma spinigerum , use of albendazole or ivermectin (with or without surgical removal) is recommended.134
For the treatment of gongylonemiasis† caused by Gongylonema , surgical removal or use of albendazole is recommended.134
Albendazole is used for the treatment of cutaneous larva migrans† (creeping eruption) caused by dog and cat hookworms.105, 134 Although cutaneous larva migrans usually is self-limited with spontaneous cure after several weeks or months, albendazole or ivermectin are considered the drugs of choice when treatment is indicated.105, 134
Intestinal Hookworm Infections
Albendazole is used for the treatment of intestinal hookworm infections† caused by Ancylostoma duodenale or Necator americanus , and albendazole, mebendazole, or pyrantel pamoate are considered the drugs of choice for intestinal hookworm infections.105, 134
Albendazole, mebendazole, or endoscopic removal of worms is recommended for the treatment of eosinophilic enterocolitis† caused by Ancylostoma caninum (dog hookworm).134
Albendazole or pyrantel pamoate may be effective for the treatment of oesophagostomiasis† caused by Oesophagostomum bifurcum .19, 134
Albendazole is used for the treatment of strongyloidiasis† caused by Strongyloides stercoralis (threadworm).105, 134 Some clinicians consider ivermectin the drug of choice and albendazole an alternative for the treatment of strongyloidiasis.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)
Albendazole is used for the treatment of toxocariasis† (visceral larva migrans) caused by Toxocara canis or T. cati (dog or cat roundworms), and albendazole or mebendazole are considered the drugs of choice for these infections.105, 134 In severe cases with cardiac, ocular, or CNS involvement, corticosteroids also may be indicated.105, 134 Treatment may not be effective in ocular larva migrans; inflammation may be reduced by corticosteroid injections and surgery may be necessary for secondary damage.105
Albendazole is used for the treatment of trichinellosis† (trichinosis) caused by Trichinella spiralis (pork worm) .105, 134 Although some clinicians state that albendazole and mebendazole are equally effective for the treatment of trichinellosis,105 other clinicians consider albendazole the drug of choice and mebendazole the alternative agent.134 Use of corticosteroids in addition to the anthelmintic usually is recommended, especially when symptoms are severe.105, 134 Corticosteroids alleviate symptoms of the inflammatory reaction and can be lifesaving when cardiac or CNS systems are involved.105
Albendazole is used in the treatment of trichostrongyliasis†.134 Pyrantel pamoate is considered the drug of choice for the treatment of Trichostrongylus infections and albendazole and mebendazole are alternatives.134
Albendazole is used in the treatment of trichuriasis† caused by Trichuris trichiura (whipworm).105, 134 Albendazole is considered the drug of choice and mebendazole and ivermectin are alternatives for the treatment of trichuriasis.105, 134
For the treatment of infections caused by Clonorchis sinensis † (Chinese liver fluke) or Opisthorchis viverrini † (Southeast Asian liver fluke), albendazole and praziquantel are recommended as the drugs of choice.134 Other anthelmintics (usually praziquantel) are recommended for all other fluke infections.134
Although metronidazole, tinidazole, or nitazoxanide generally are considered the drugs of choice for the treatment of giardiasis caused by Giardia duodenalis (also known as G. lamblia or G. intestinalis ), albendazole may be an alternative for the treatment of giardiasis†.134
Albendazole has been used in the treatment of microsporidiosis†.14, 15, 16, 17, 105, 134, 155, 156 Microsporidia can cause ocular infections (e.g., Encephalitozoon hellem , E. cuniculi , Vittaforma corneae ), intestinal infections (e.g., Enterocytozoon bieneusi , E. intestinalis ), and disseminated infections (e.g., E. hellem , E. cuniculi , E. intestinalis , Pleistophora , Trachipleistophora , Brachiola vesicularum ).134, 155, 156 Intestinal infections are most common in immunocompromised patients,105 including patients with human immunodeficiency virus (HIV) infection (especially those with CD4+ T-cell counts less than 100 cells/mm3) and organ transplant recipients.14, 15, 17, 105, 155, 156
Ocular infections caused by microsporidia usually are treated with albendazole in conjunction with topical ophthalmic fumagillin (not commercially available in the US).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 therapy generally is not effective for ocular lesions caused by V. corneae , and keratoplasty may be necessary.134
For the treatment of intestinal infections caused by E. intestinalis and disseminated infections caused by microsporidia other than E. bieneusi and V. corneae , albendazole usually is the drug of choice.134, 155, 156 Some clinicians recommend that albendazole be used in conjunction with itraconazole for the treatment of disseminated disease caused by Trachipleistophora or Anncaliia .155
Albendazole is ineffective in infections caused by E. bieneusi 15, 17, 105, 155 and V. corneae ,155 and generally is recommended for initial treatment of intestinal and disseminated microsporidiosis only when the infection is caused by microsporidia other than E. bieneusi and V. corneae .155
Blood cell counts should be evaluated prior to and during albendazole treatment.1 (See Hematologic Effects under Cautions: Warnings/Precautions.)
Hepatic enzymes (aminotransferases) should be evaluated prior to and during albendazole treatment.1 (See Hepatic Effects under Cautions: Warnings/Precautions.)
A pregnancy test should be performed prior to initiating albendazole in women of reproductive potential.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions: Warnings/Precautions.)
Albendazole film-coated tablets are administered orally with food.1
Oral bioavailability of albendazole appears to be increased when the drug is administered with a fatty meal.1, 3, 7 When the drug is administered with a fatty meal containing about 40 g of fat, plasma concentrations of albendazole sulfoxide (active metabolite of albendazole) are up to 5 times higher than those observed when the drug is administered to fasting patients.1
In patients who have difficulty swallowing tablets whole (particularly children), albendazole tablets may be crushed or chewed and swallowed with a drink of water.1
For the treatment of neurocysticercosis caused by the larval form of the pork tapeworm ( Taenia solium ) in adults and children weighing 60 kg or more,1 the usual dosage of albendazole is 400 mg given twice daily with meals for 8-30 days.1, 134 For the treatment of neurocysticercosis in patients weighing less than 60 kg, the usual daily dosage of albendazole is 15 mg/kg daily (not to exceed 800 mg daily), administered as 2 equally divided doses with meals, for 8-30 days.1, 134 Courses of albendazole treatment may be repeated as necessary.134
Concomitant corticosteroid therapy should be considered to prevent cerebral hypertensive episodes during the first week of treatment, and appropriate anticonvulsant therapy should be used if indicated.1 (See Precautions Related to Neurocysticercosis under Cautions: Warnings/Precautions.)
For the treatment of cystic hydatid disease of the liver, lung, or peritoneum caused by the larval form of the dog tapeworm ( Echinococcus granulosus ) in adults or children weighing 60 kg or more, the usual dosage of albendazole is 400 mg twice daily given with meals for 28 days, followed by a 14-day albendazole-free interval, and this regimen is repeated for a total of 3 dosage cycles.1 For patients weighing less than 60 kg, the usual dosage is 15 mg/kg daily (not to exceed 800 mg daily), administered in 2 equally divided doses with meals for 28 days, followed by a 14-day albendazole-free interval, and this regimen is repeated for a total of 3 dosage cycles.1
Some clinicians recommend that adults and pediatric patients receive 15 mg/kg daily (not to exceed 800 mg daily) administered in 2 equally divided doses for 1-6 months for the treatment of hydatid cyst disease.134
Nematode (Roundworm) Infections
For the treatment of ascariasis† caused by Ascaris lumbricoides , some clinicians recommend that adult and pediatric patients receive a single 400-mg dose of albendazole.134
For the treatment of baylisascariasis† caused by Baylisascaris procyonis or preemptive treatment following a suspected or confirmed exposure to B. procyonis (see Baylisascariasis under Uses: Nematode [Roundworm] Infections), the US Centers for Disease Control and Prevention (CDC) and other clinicians recommend that albendazole be given in a dosage of 20-50 mg/kg daily with or without a corticosteroid.18, 30, 32, 134
Treatment should be initiated immediately if baylisascariasis is probable and should not be delayed until symptoms emerge or the diagnosis is confirmed.18, 32, 105 Treatment should be continued for at least 10 days,32 and usually has been continued for 3-6 weeks.30, 31, 32
Preemptive treatment should be initiated immediately following a suspected or confirmed exposure to B. procyonis ,30, 32 and should be continued for 10-20 days while further diagnostic investigations are conducted.30
For the treatment of capillariasis† caused by Capillaria philippinensis (Philippine threadworm), some clinicians recommend that adults and pediatric patients receive albendazole in a dosage of 400 mg once daily for 10 days.134
For the treatment of enterobiasis† caused by Enterobius vermicularis (pinworm), some clinicians recommend that adult and pediatric patients receive an initial 400-mg dose of albendazole and a second 400-mg dose given 2 weeks later.134
Because other family members often are infected, some clinicians recommend that all household contacts of patients with enterobiasis receive treatment, especially when multiple or repeated symptomatic infections are occurring in the household.105, 134
Some clinicians recommend that adults and pediatric patients with gnathostomiasis† caused by Gnathostoma spinigerum receive albendazole in a dosage of 400 mg twice daily for 21 days.134
For the treatment of gongylonemiasis† caused by Gongylonema , some clinicians recommend that adults and pediatric patients receive albendazole in a dosage of 400 mg daily for 3 days.134
For the treatment of cutaneous larva migrans† (creeping eruption) caused by dog or cat hookworms, some clinicians recommend that adults and pediatric patients receive albendazole in a dosage of 400 mg once daily for 3 days.134
For the treatment of intestinal hookworm infections† caused by Ancylostoma duodenale or Necator americanus , some clinicians recommend that adult and pediatric patients receive a single 400-mg dose of albendazole.134 A repeat stool examination (using a concentration technique) for eggs of A. duodenale or N. americanus should be performed 2 weeks after treatment and the regimen should be repeated if results are positive.105
For the treatment of eosinophilic enterocolitis† caused by Ancylostoma caninum (dog hookworm), some clinicians recommend that adult and pediatric patients receive a single 400-mg dose of albendazole.134
For the treatment of strongyloidiasis† caused by Strongyloides stercoralis (threadworm), some clinicians recommend that adults and pediatric patients receive albendazole in a dosage of 400 mg twice daily for 7 days.134 It may be necessary to repeat or prolong treatment or use other agents in immunocompromised individuals or those with disseminated disease.134
Toxocariasis (Visceral Larva Migrans)
For the treatment of toxocariasis† (visceral larva migrans) caused by dog or cat roundworms, some clinicians recommend that adults and pediatric patients receive albendazole in a dosage of 400 mg twice daily for 5 days.134 However, optimum duration of treatment is not known and some clinicians recommend that treatment be continued for up to 20 days.134
For the treatment of trichinellosis† (trichinosis) caused by Trichinella spiralis (pork worm), some clinicians recommend that adults and pediatric patients receive albendazole in a dosage of 400 mg twice daily for 8-14 days.134
For the treatment of infections caused by Trichostrongylus †, some clinicians recommend that adults and pediatric patients receive a single 400-mg dose of albendazole.134
Some clinicians recommend that adults and pediatric patients with trichuriasis† caused by Trichuris trichiura (whipworm) receive albendazole in a dosage of 400 mg once daily for 3 days.134
For the treatment of infections caused by Clonorchis sinensis † (Chinese liver fluke) or Opisthorchis viverrini † (Southeast Asian liver fluke), some clinicians recommend that adults and pediatric patients receive albendazole in a dosage of 10 mg/kg daily given for 7 days.134
For the treatment of giardiasis† caused by Giardia duodenalis (also known as G. lamblia or G. intestinalis ), some clinicians recommend that adults receive albendazole in a dosage of 400 mg daily for 5 days and that pediatric patients receive a dosage of 10 mg/kg daily for 5 days.134
For the treatment of ocular microsporidiosis†, some clinicians recommend that adults receive albendazole in a dosage of 400 mg twice daily134, 155 and that pediatric patients receive 7.5 mg/kg (up to 400 mg) twice daily134, 156 in conjunction with topical ophthalmic fumagillin (not commercially available in the US).134, 155, 156 In patients with human immunodeficiency virus (HIV) infection, some experts recommend that treatment of ocular microsporidiosis be continued until ocular symptoms resolve and there has been a sustained immune response to antiretroviral therapy (CD4+ T-cell count greater than 200 cells/mm3 for at least 6 months in adults or CDC immunologic category 1 or 2 for longer than 6 months in children).155, 156
For the treatment of intestinal or disseminated microsporidiosis† caused by microsporidia other than Enterocytozoon bieneusi or Vittaforma corneae , some clinicians recommend that adults receive albendazole in a dosage of 400 mg twice daily134, 155 and that pediatric patients receive 7.5 mg/kg (up to 400 mg) twice daily.134, 156 Some clinicians recommend a treatment duration of 21 days in patients with intestinal infections.134 In HIV-infected patients with intestinal or disseminated microsporidiosis, some experts recommend that treatment be continued until symptoms resolve and there has been a sustained immune response to antiretroviral therapy (CD4+ T-cell count greater than 200 cells/mm3 for at least 6 months in adults or CDC immunologic category 1 or 2 for longer than 6 months in children).155, 156
If albendazole is used in conjunction with itraconazole for the treatment of disseminated disease caused by Trachipleistophora or Anncaliia , some clinicians recommend that adults receive albendazole in a dosage of 400 mg twice daily.134, 155
No special population dosage recommendations.1
Albendazole is contraindicated in patients hypersensitive to benzimidazole derivatives or any component in the formulation.1
Hypersensitivity reactions, including rash and urticaria, have been reported rarely in patients receiving albendazole.1 Erythema multiforme and Stevens-Johnson syndrome have been reported during postmarketing experience.1
Albendazole may cause bone marrow suppression, aplastic anemia, and agranulocytosis.1 Leukopenia, granulocytopenia, pancytopenia, agranulocytosis, and thrombocytopenia have been reported in less than 1% of patients receiving albendazole.1 Fatalities related to granulocytopenia or pancytopenia have been reported.1
Blood cell counts should be evaluated at the beginning of each 28-day treatment cycle of albendazole and every 2 weeks during treatment with the drug.1 Patients with liver disease and those with hepatic echinococcosis are at increased risk for bone marrow suppression, and more frequent monitoring of blood cell counts is warranted in such patients.1
Albendazole should be discontinued if clinically important decreases in blood cell counts occur.1
Fetal/Neonatal Morbidity and Mortality
Albendazole may cause fetal harm.1 Teratogenic effects (embryotoxicity, skeletal malformations) have been reported in rats and rabbits.1
Pregnancy should be excluded before initiating albendazole in women of reproductive potential.1 Women of reproductive potential should be advised to use effective birth control to avoid pregnancy during and for 1 month after completion of albendazole treatment.1 (See Pregnancy under Warnings/Precautions: Specific Populations, in Cautions.)
Mild to moderate increases in hepatic enzymes have been reported in approximately 16% of patients receiving albendazole in clinical trials.1 Increased hepatic enzymes generally returned to normal when the drug was discontinued; however, acute liver failure of uncertain causality and hepatitis have been reported.1 Patients with elevated hepatic enzymes are at increased risk for hepatotoxicity.1 Albendazole should be discontinued if clinically important increases in hepatic enzymes occur.1
Hepatic enzymes (aminotransferases) should be evaluated at the beginning of each 28-day treatment cycle of albendazole and at least every 2 weeks during treatment with the drug.1 If hepatic enzyme concentrations exceed twice the upper limit of normal, consideration should be given to discontinuance of the drug based on the individual patient circumstance.1 Decisions to reinstitute 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 reinstituted, laboratory tests should be performed frequently.1
Precautions Related to Neurocysticercosis
Because of its activity against the pork tapeworm ( Taenia solium ), use of albendazole for the treatment of neurocysticercosis resulting from active lesions caused by Cysticercus cellulosae (the larval form of T. solium ) has been associated with adverse CNS effects (e.g., seizures, increased intracranial pressure and focal signs, hydrocephalus) resulting from inflammatory reactions caused by albendazole-induced death of parasites within the brain.1, 5, 7
Patients receiving albendazole for the treatment of neurocysticercosis should receive appropriate corticosteroid and anticonvulsant therapy as required.1, 5, 7, 134 Oral or IV corticosteroid therapy should be considered during the first week of albendazole 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 Therefore, patients should be examined for the presence of retinal lesions and, if such lesions are present, the need for treatment of neurocysticercosis should be weighed against the possibility of 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, patients with epidemiologic factors that increase the risk for neurocysticercosis should be evaluated.1
Albendazole may cause harm to the fetus.1 The drug should be used during pregnancy only if potential benefits justify the risks to the fetus and only when no alternative management is appropriate.1
Albendazole should be initiated in women of childbearing age only after a negative pregnancy test.1 Women of childbearing potential should be advised to use effective contraceptive measures during albendazole treatment and for 1 month after treatment with the drug is discontinued.1 If a patient becomes pregnant while receiving albendazole, the drug should be immediately discontinued and the woman should be apprised of the potential hazard to the fetus.1
Teratogenic effects (embryotoxicity, skeletal malformations) have been reported in rats and rabbits.1 In rats, albendazole was teratogenic at oral dosages of 10 and 30 mg/kg daily (approximately 0.1 and 0.3 times the recommended human dosage, respectively) given during gestation days 6-15.1 In rabbits, teratogenic effects were reported at oral dosages of 30 mg/kg daily (0.6 times the recommended human dosage) given during gestation days 7-19.1 Maternal toxicity (33% mortality) was reported in rabbits receiving an albendazole dosage of 30 mg/kg daily.1
Albendazole is distributed into milk in animals;1 distribution into human milk also has been reported.24
Albendazole should be used with caution in nursing women.1
Efficacy of albendazole for the treatment of neurocysticercosis in pediatric patients appears to be similar to that in adults.1 Hydatid disease is uncommon in infants and young children.1
Albendazole pharmacokinetics in pediatric patients 6-13 years of age are similar to pharmacokinetics in adults.1
Data are insufficient to determine whether safety and efficacy of albendazole for the treatment of neurocysticercosis or hydatid disease in patients 65 years of age and older differ from that in younger patients.1
Albendazole pharmacokinetics in geriatric patients have not been fully evaluated, but data from adults up to 79 years of age with hydatid cysts suggest that pharmacokinetics in these patients are similar to that in younger patients.1
Individuals with hepatic impairment are at increased risk for hepatotoxicity and bone marrow suppression during albendazole treatment.1 Albendazole should be discontinued if hepatic enzymes exceed twice the upper normal limit or if clinically important decreases in blood cell counts occur.1
In patients with extrahepatic obstruction, systemic availability of albendazole sulfoxide (active metabolite of albendazole) was increased (i.e., twofold increase in peak serum concentration and sevenfold increase in area under the plasma concentration-time curve [AUC]).1 The rate of absorption and elimination of albendazole sulfoxide in these patients appeared to be prolonged with a mean time to peak serum concentrations of 10 hours and mean serum elimination half-life of 31.7 hours.1
Pharmacokinetics of albendazole have not been evaluated to date in patients with impaired renal function.1
Treatment of neurocysticercosis: Adverse effects reported in 1% or more of patients include headache, nausea, vomiting, increased intracranial pressure, and meningeal signs.1
Treatment of hydatid disease: Adverse effects reported in 1% or more of patients include elevated hepatic enzymes, abdominal pain, nausea, vomiting, reversible alopecia, fever, headache, dizziness, and vertigo.1
Albendazole induces cytochrome P-450 (CYP) isoenzyme 1A in human hepatoma cells.1
Concomitant use of albendazole (20 mg/kg daily) and cimetidine (10 mg/kg daily) in hydatid cyst patients resulted in a twofold increase in concentrations of albendazole sulfoxide (active metabolite of albendazole) in bile and cystic fluid compared with use of albendazole alone.1 Albendazole plasma concentrations were unchanged 4 hours after dosing.1
Concomitant use of dexamethasone (8 mg) with each dose of albendazole (15 mg/kg daily) in patients with neurocysticercosis resulted in a 56% increase in steady-state trough concentrations of albendazole sulfoxide.1
When praziquantel (40 mg/kg) was administered concomitantly with albendazole (400 mg) in healthy individuals in the fed state, mean peak plasma concentrations and area under the plasma concentration-time curve (AUC) of albendazole sulfoxide were increased by about 50% compared with individuals who received albendazole alone; however, the mean time to peak plasma concentrations and mean plasma elimination half-life of albendazole sulfoxide were not affected.1 In addition, praziquantel pharmacokinetics were not affected.1
Concomitant administration of a single dose of albendazole (400 mg) did not affect the pharmacokinetics of theophylline (aminophylline 5.8 mg/kg infused over 20 minutes).1 However, because albendazole induces CYP1A in human hepatoma cells, plasma concentrations of theophylline should be monitored during and after albendazole treatment.1
Albendazole is a synthetic, benzimidazole-derivative anthelmintic agent.1, 4 The drug is structurally related to mebendazole and thiabendazole (not commercially available in the US).4 Like mebendazole, albendazole is a benzimidazole carbamate derivative.4
Although the exact mechanism of action of albendazole has not been fully elucidated, the principal anthelmintic effect of benzimidazoles, including albendazole, appears to be the specific, high-affinity binding of the drug 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 Benzimidazole drugs 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
Albendazole is 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 to β-tubulin.1
Albendazole is poorly absorbed from the GI tract; however, oral bioavailability appears to be enhanced when the drug is administered with a fatty meal.1 Albendazole is metabolized in the liver to an active metabolite, albendazole sulfoxide,1, 7, 11 and systemic anthelmintic activity of the drug has been attributed to this metabolite.1, 3, 7, 11 Peak plasma concentrations of albendazole sulfoxide are achieved 2-5 hours after an oral dose.1 Because albendazole is rapidly converted to albendazole sulfoxide, plasma concentrations of the parent drug are negligible or undetectable.1 Albendazole sulfoxide is widely distributed throughout the body and has been detected in urine, bile, liver, cyst wall, cyst fluid, and CSF.1 The drug is 70% bound to plasma proteins.1 The mean apparent terminal elimination half-life of albendazole sulfoxide in healthy individuals is 8-12 hours.1 Albendazole sulfoxide is partially eliminated in bile; less than 1% is eliminated in urine.1
Advise patients of the importance of taking albendazole with food to increase oral bioavailability.1
Patients who experience difficulty swallowing the tablets whole (particularly children) should be advised that the tablets may be crushed or chewed and swallowed with 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 enzymes is needed during treatment with the drug.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 advising patients of other important precautionary information.1 (See Cautions.)
Additional Information
Overview® (see Users Guide). For additional information on this drug until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.
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.
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