Albendazole
Albendazole Prescribing Information
Albendazole Tablets is an anthelmintic drug indicated for:
- Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. ()
1 INDICATIONS & USAGEAlbendazole Tablets is an anthelmintic drug indicated for:
- Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm,Taenia solium.
- Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm,Echinococcus granulosus.
1.1 NeurocysticercosisAlbendazole Tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm,
Taenia solium.1.2 Hydatid DiseaseAlbendazole Tablets are indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm,
Echinococcus granulosus. - Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm,
- Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus. ()
1 INDICATIONS & USAGEAlbendazole Tablets is an anthelmintic drug indicated for:
- Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm,Taenia solium.
- Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm,Echinococcus granulosus.
1.1 NeurocysticercosisAlbendazole Tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm,
Taenia solium.1.2 Hydatid DiseaseAlbendazole Tablets are indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm,
Echinococcus granulosus. - Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm,
Patients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg, 15 mg/kg/day in divided doses twice daily (maximum total daily dose 800 mg). Albendazole Tablets should be taken with food. (
Patients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg, 15 mg/kg/day in divided doses twice daily (maximum total daily dose 800 mg). Albendazole Tablets should be taken with food.
- Hydatid disease: 28‑day cycle followed by 14‑day albendazole‑free interval for a total of 3 cycles.
- Neurocysticercosis: 8 to 30 days.
See additional important information in the Full Prescribing Information.
Dosing of Albendazole Tablets will vary depending upon the indication. Albendazole Tablets may be crushed or chewed and swallowed with a drink of water. Albendazole Tablets should be taken with food [
Table 1: Albendazole Tablets Dosage | |||
Indication | Patient Weight | Dose | Duration |
| Hydatid Disease | 60 kg or greater | 400 mg twice daily, with meals | 28‑day cycle followed by a 14‑day albendazole‑free interval, for a total of 3 cycles |
| Less than 60 kg | 15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg) | ||
| Neurocysticercosis | 60 kg or greater | 400 mg twice daily, with meals | 8 to 30 days |
| Less than 60 kg | 15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg) | ||
Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of treatment [
- Monitor blood counts at the beginning of each 28‑day cycle of therapy, and every 2 weeks while on therapy with Albendazole Tablets in all patients [seeWarnings and Precautions ( 5.1 )].
- Monitor liver enzymes (transaminases) at the beginning of each 28‑day cycle of therapy, and at least every 2 weeks during treatment with Albendazole Tablets in all patients [seeWarnings and Precautions ( 5.5 )].
- Obtain a pregnancy test in females of reproductive potential prior to therapy
[seeWarnings and Precautions ( 5.2 )].
- Hydatid disease: 28‑day cycle followed by 14‑day albendazole‑free interval for a total of 3 cycles. ()
2 DOSAGE & ADMINISTRATIONPatients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg, 15 mg/kg/day in divided doses twice daily (maximum total daily dose 800 mg). Albendazole Tablets should be taken with food.
- Hydatid disease: 28‑day cycle followed by 14‑day albendazole‑free interval for a total of 3 cycles.
- Neurocysticercosis: 8 to 30 days.
See additional important information in the Full Prescribing Information.
2.1 DosageDosing of Albendazole Tablets will vary depending upon the indication. Albendazole Tablets may be crushed or chewed and swallowed with a drink of water. Albendazole Tablets should be taken with food [
seeClinicalPharmacology(12.3)].Table 1: Albendazole Tablets DosageIndicationPatient WeightDoseDurationHydatid Disease 60 kg or greater 400 mg twice daily, with meals 28‑day cycle followed by a 14‑day albendazole‑free interval, for a total of 3 cycles Less than 60 kg 15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg) Neurocysticercosis 60 kg or greater 400 mg twice daily, with meals 8 to 30 days Less than 60 kg 15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg) 2.2 Concomitant Medication to Avoid Adverse ReactionsPatients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of treatment [
seeWarnings and Precautions ( 5.3 )].2.3 Monitoring for Safety Before and During Treatment- Monitor blood counts at the beginning of each 28‑day cycle of therapy, and every 2 weeks while on therapy with Albendazole Tablets in all patients [seeWarnings and Precautions ( 5.1 )].
- Monitor liver enzymes (transaminases) at the beginning of each 28‑day cycle of therapy, and at least every 2 weeks during treatment with Albendazole Tablets in all patients [seeWarnings and Precautions ( 5.5 )].
- Obtain a pregnancy test in females of reproductive potential prior to therapy
[seeWarnings and Precautions ( 5.2 )].
- Neurocysticercosis: 8 to 30 days. ()
2 DOSAGE & ADMINISTRATIONPatients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg, 15 mg/kg/day in divided doses twice daily (maximum total daily dose 800 mg). Albendazole Tablets should be taken with food.
- Hydatid disease: 28‑day cycle followed by 14‑day albendazole‑free interval for a total of 3 cycles.
- Neurocysticercosis: 8 to 30 days.
See additional important information in the Full Prescribing Information.
2.1 DosageDosing of Albendazole Tablets will vary depending upon the indication. Albendazole Tablets may be crushed or chewed and swallowed with a drink of water. Albendazole Tablets should be taken with food [
seeClinicalPharmacology(12.3)].Table 1: Albendazole Tablets DosageIndicationPatient WeightDoseDurationHydatid Disease 60 kg or greater 400 mg twice daily, with meals 28‑day cycle followed by a 14‑day albendazole‑free interval, for a total of 3 cycles Less than 60 kg 15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg) Neurocysticercosis 60 kg or greater 400 mg twice daily, with meals 8 to 30 days Less than 60 kg 15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg) 2.2 Concomitant Medication to Avoid Adverse ReactionsPatients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of treatment [
seeWarnings and Precautions ( 5.3 )].2.3 Monitoring for Safety Before and During Treatment- Monitor blood counts at the beginning of each 28‑day cycle of therapy, and every 2 weeks while on therapy with Albendazole Tablets in all patients [seeWarnings and Precautions ( 5.1 )].
- Monitor liver enzymes (transaminases) at the beginning of each 28‑day cycle of therapy, and at least every 2 weeks during treatment with Albendazole Tablets in all patients [seeWarnings and Precautions ( 5.5 )].
- Obtain a pregnancy test in females of reproductive potential prior to therapy
[seeWarnings and Precautions ( 5.2 )].
See additional important information in the Full Prescribing Information. (
Patients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg, 15 mg/kg/day in divided doses twice daily (maximum total daily dose 800 mg). Albendazole Tablets should be taken with food.
- Hydatid disease: 28‑day cycle followed by 14‑day albendazole‑free interval for a total of 3 cycles.
- Neurocysticercosis: 8 to 30 days.
See additional important information in the Full Prescribing Information.
Dosing of Albendazole Tablets will vary depending upon the indication. Albendazole Tablets may be crushed or chewed and swallowed with a drink of water. Albendazole Tablets should be taken with food [
Table 1: Albendazole Tablets Dosage | |||
Indication | Patient Weight | Dose | Duration |
| Hydatid Disease | 60 kg or greater | 400 mg twice daily, with meals | 28‑day cycle followed by a 14‑day albendazole‑free interval, for a total of 3 cycles |
| Less than 60 kg | 15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg) | ||
| Neurocysticercosis | 60 kg or greater | 400 mg twice daily, with meals | 8 to 30 days |
| Less than 60 kg | 15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg) | ||
Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of treatment [
- Monitor blood counts at the beginning of each 28‑day cycle of therapy, and every 2 weeks while on therapy with Albendazole Tablets in all patients [seeWarnings and Precautions ( 5.1 )].
- Monitor liver enzymes (transaminases) at the beginning of each 28‑day cycle of therapy, and at least every 2 weeks during treatment with Albendazole Tablets in all patients [seeWarnings and Precautions ( 5.5 )].
- Obtain a pregnancy test in females of reproductive potential prior to therapy
[seeWarnings and Precautions ( 5.2 )].
- Tablet: 200 mg
Based on findings from animal reproduction studies, Albendazole Tablets may cause fetal harm when administered to a pregnant woman. However, available human data from a small number of published case series and reports on the use of multiple-dose albendazole in the 1st trimester of pregnancy, and several published studies on single-dose albendazole use later in pregnancy, have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproductive studies, oral administration of albendazole during the period of organogenesis caused embryotoxicity and skeletal malformations in pregnant rats (at doses of 0.10 times and 0.32 times the maximum recommended human dose based on body surface area in mg/m2) and pregnant rabbits (at doses of 0.60 times the maximum recommended human dose based on body surface area in mg/m2). Albendazole was also associated with maternal toxicity in rabbits (at doses of 0.60 times the recommended human dose based on body surface area in mg/m2) (see Data). Advise a pregnant woman of the potential risk to the fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Albendazole has been shown to be teratogenic (to cause embryotoxicity and skeletal malformations) in pregnant rats and rabbits. The teratogenic response in the rat was shown at oral doses of 10 and 30 mg/kg/day (0.10 times and 0.32 times the maximum recommended human dose based on body surface area in mg/m2, respectively) during organogenesis (gestation days 6 to 15) and in pregnant rabbits at oral doses of 30 mg/kg/day (0.60 times the maximum recommended human dose based on body surface area in mg/m2) administered during organogenesis (gestation days 7 to 19). In the rabbit study, maternal toxicity (33% mortality) was noted at 30 mg/kg/day. In mice, no teratogenic effects were observed at oral doses up to 30 mg/kg/day (0.16 times the recommended human dose based on body surface area in mg/m2), administered during gestation days 6 to 15.
Albendazole Tablets are contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of Albendazole Tablets.
- Bone Marrow Suppression: Fatalities have been reported due to bone marrow suppression; monitor blood counts in all patients at the beginning of each 28‑day cycle of therapy, and every 2 weeks while on therapy. Discontinue Albendazole Tablets if clinically significant changes in blood counts occur. (,
5.1 Bone Marrow SuppressionFatalities associated with the use of Albendazole Tablets have been reported due to granulocytopenia or pancytopenia. Albendazole Tablets may cause bone marrow suppression, aplastic anemia, and agranulocytosis. Monitor blood counts at the beginning of each 28‑day cycle of therapy, and every 2 weeks while on therapy with Albendazole Tablets in all patients. Patients with liver disease and patients with hepatic echinococcosis are at increased risk for bone marrow suppression and warrant more frequent monitoring of blood counts. Discontinue Albendazole Tablets if clinically significant decreases in blood cell counts occur.
)5.4 Risk of Retinal Damage in Patients with Retinal NeurocysticercosisCysticercosis may involve the retina. Before initiating therapy for neurocysticercosis, examine the patient for the presence of retinal lesions. If such lesions are visualized, weigh the need for anticysticeral therapy against the possibility of retinal damage resulting from inflammatory damage caused by albendazole‑induced death of the parasite.
- Embryo-Fetal Toxicity: May cause fetal harm. Pregnancy testing is recommended for females of reproductive potential prior to therapy. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception. (,
2.3 Monitoring for Safety Before and During Treatment- Monitor blood counts at the beginning of each 28‑day cycle of therapy, and every 2 weeks while on therapy with Albendazole Tablets in all patients [seeWarnings and Precautions ( 5.1 )].
- Monitor liver enzymes (transaminases) at the beginning of each 28‑day cycle of therapy, and at least every 2 weeks during treatment with Albendazole Tablets in all patients [seeWarnings and Precautions ( 5.5 )].
- Obtain a pregnancy test in females of reproductive potential prior to therapy
[seeWarnings and Precautions ( 5.2 )].
,5.2 Embryo-Fetal ToxicityBased on findings from animal reproduction studies, Albendazole Tablets may cause fetal harm when administered to a pregnant woman. Embryotoxicity and skeletal malformations were reported in rats and rabbits when treated during the period of organogenesis (at oral doses approximately 0.1 to 0.6 times the recommended human dose normalized for total body surface area). Advise pregnant women of the potential risk to a fetus. Pregnancy testing is recommended for females of reproductive potential prior to initiating Albendazole Tablets [
see Dosage and Administration]. Advise females of reproductive potential to use an effective method of contraception during treatment with Albendazole Tablets and for 3 days after the final dose [see Use in Specific Populations and Clinical Pharmacology].,8.1 PregnancyRisk SummaryBased on findings from animal reproduction studies, Albendazole Tablets may cause fetal harm when administered to a pregnant woman. However, available human data from a small number of published case series and reports on the use of multiple-dose albendazole in the 1sttrimester of pregnancy, and several published studies on single-dose albendazole use later in pregnancy, have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproductive studies, oral administration of albendazole during the period of organogenesis caused embryotoxicity and skeletal malformations in pregnant rats (at doses of 0.10 times and 0.32 times the maximum recommended human dose based on body surface area in mg/m2) and pregnant rabbits (at doses of 0.60 times the maximum recommended human dose based on body surface area in mg/m2). Albendazole was also associated with maternal toxicity in rabbits (at doses of 0.60 times the recommended human dose based on body surface area in mg/m2) (see Data). Advise a pregnant woman of the potential risk to the fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
DataAnimal DataAlbendazole has been shown to be teratogenic (to cause embryotoxicity and skeletal malformations) in pregnant rats and rabbits. The teratogenic response in the rat was shown at oral doses of 10 and 30 mg/kg/day (0.10 times and 0.32 times the maximum recommended human dose based on body surface area in mg/m2, respectively) during organogenesis (gestation days 6 to 15) and in pregnant rabbits at oral doses of 30 mg/kg/day (0.60 times the maximum recommended human dose based on body surface area in mg/m2) administered during organogenesis (gestation days 7 to 19). In the rabbit study, maternal toxicity (33% mortality) was noted at 30 mg/kg/day. In mice, no teratogenic effects were observed at oral doses up to 30 mg/kg/day (0.16 times the recommended human dose based on body surface area in mg/m2), administered during gestation days 6 to 15.
)8.3 Females and Males of Reproductive PotentialPregnancy TestingPregnancy testing is recommended for females of reproductive potential prior to initiating Albendazole Tablets.
ContraceptionFemalesAlbendazole Tablets may cause fetal harm when administered to a pregnant woman
[see Use in Specific Populations (8.1)].Advise females of reproductive potential to use effective contraception during treatment with Albendazole Tablets and for 3 days after the final dose. - Monitor blood counts at the beginning of each 28‑day cycle of therapy, and every 2 weeks while on therapy with Albendazole Tablets in all patients [
- Risk of Neurologic Symptoms: Neurocysticercosis patients may experience cerebral hypertensive episodes, seizures or focal neurologic deficits after initiation of therapy; begin appropriate steroid and anticonvulsant therapy. ()
5.3 Risk of Neurologic Symptoms in NeurocysticercosisPatients being treated for neurocysticercosis should receive steroid and anticonvulsant therapy to prevent neurological symptoms (e.g. seizures, increased intracranial pressure and focal signs) as a result of an inflammatory reaction caused by death of the parasite within the brain.
- Risk of Retinal Damage in Retinal Cysticercosis: Cases of retinal involvement have been reported; examine the patient for the presence of retinal lesions before initiating therapy for neurocysticercosis. ()
5.4 Risk of Retinal Damage in Patients with Retinal NeurocysticercosisCysticercosis may involve the retina. Before initiating therapy for neurocysticercosis, examine the patient for the presence of retinal lesions. If such lesions are visualized, weigh the need for anticysticeral therapy against the possibility of retinal damage resulting from inflammatory damage caused by albendazole‑induced death of the parasite.
- Hepatic Effects. Elevations of liver enzymes may occur. Monitor liver enzymes before the start of each treatment cycle and at least every 2 weeks while on Albendazole Tablets therapy and discontinue if clinically significant elevations occur. ()
5.5 Hepatic EffectsIn clinical trials, treatment with Albendazole Tablets has been associated with mild to moderate elevations of hepatic enzymes in approximately 16% of patients. These elevations have generally returned to normal upon discontinuation of therapy. There have also been case reports of acute liver failure of uncertain causality and hepatitis [
seeAdverse Reactions ( 6 )].Monitor liver enzymes (transaminases) before the start of each treatment cycle and at least every 2 weeks during treatment. If hepatic enzymes exceed twice the upper limit of normal, consideration should be given to discontinuing Albendazole Tablets therapy based on individual patient circumstances. Restarting Albendazole Tablets treatment in patients whose hepatic enzymes have normalized off treatment is an individual decision that should take into account the risk/benefit of further Albendazole Tablets usage. Perform laboratory tests frequently if Albendazole Tablets treatment is restarted.
Patients with elevated liver enzyme test results are at increased risk for hepatotoxicity and bone marrow suppression [
seeWarnings and Precautions ( 5.1 )]. Discontinue therapy if liver enzymes are significantly increased or if clinically significant decreases in blood cell counts occur.