Albendazole

U.S. BRAND NAMES — Albenza®
PHARMACOLOGIC CATEGORY Anthelmintic
DOSING: ADULTS Neurocysticercosis: Oral: <60 kg: 15 mg/kg/day in 2 divided doses (maximum: 800 mg/day) for 8-30 days 60 kg: 400 mg twice daily for 8-30 days Note: Give concurrent anticonvulsant and steroid therapy during first week.
Hydatid: Oral: <60 kg: 15 mg/kg/day in 2 divided doses (maximum: 800 mg/day) 60 kg: 400 mg twice daily Note: Administer dose for three 28-day cycles with a 14-day drug-free interval in between.
Ancylostoma caninum, Ascaris lumbricoides(roundworm), Ancylostoma duodenale, and Necator americanus(hookworms) (unlabeled use): Oral: 400 mg as a single dose
Clonorchis sinensis(Chinese liver fluke) (unlabeled use): Oral: 10 mg/kg for 7 days
Cutaneous larva migrans (unlabeled use): Oral: 400 mg once daily for 3 days
Enterobius vermicularis(pinworm) (unlabeled use): Oral: 400 mg as a single dose; may repeat in 2 weeks
Gnathostoma spinigerum (unlabeled use): Oral: 400 mg twice daily for 21 days
Gongylonemiasis (unlabeled use): Oral: 10 mg/kg/day for 3 days
Mansonella perstans(unlabeled use): Oral: 400 mg twice daily for 10 days
Visceral larva migrans (toxocariasis) (unlabeled use): Oral: 400 mg twice daily for 5 days
Cysticercus cellulosae(unlabeled use): Oral: 400 mg twice daily for 8-30 days; may be repeated as necessary
Disseminated microsporidiosis (unlabeled use): Oral: 400 mg twice daily
Echinococcus granulosus(tapeworm) (unlabeled use): Oral: 400 mg twice daily for 1-6 months
Intestinal microsporidiosis (unlabeled use): Oral: 400 mg twice daily for 21 days
Ocular microsporidiosis (unlabeled use): Oral: 400 mg twice daily, in combination with fumagillin
DOSING: PEDIATRIC
(For additional information see "Albendazole: Pediatric drug information")Neurocysticercosis: Oral: Refer to adult dosing.
Hydatid: Oral: Refer to adult dosing.
Cysticercus cellulosae(unlabeled use): Oral: 15 mg/kg/day (maximum: 800 mg/day) in 2 divided doses for 8-30 days; may be repeated as necessary
Echinococcus granulosus(tapeworm) (unlabeled use): Oral: 15 mg/kg/day (maximum: 800 mg) divided twice daily for 1-6 months
For the following unlabeled uses, refer to adult dosing: Ancylostoma caninum, Ascaris lumbricoides (roundworm), Ancylostoma duodenale, Clonorchis sinensis, (Chinese liver fluke), cutaneous larva migrans, Enterobius vermicularis (pinworm), Gnathostoma spinigerum, gongylonemiasis, Mansonella perstans, Necator americanus (hookworms), visceral larva migrans (toxocariasis)
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet: 200 mg
DOSAGE FORMS: CONCISE Tablet: Albenza®: 200 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Administer with meals. Administer anticonvulsant and steroid therapy during first week of neurocysticercosis therapy.
USE — Treatment of parenchymal neurocysticercosis caused by Taenia solium and cystic hydatid disease of the liver, lung, and peritoneum caused by Echinococcus granulosus
USE - UNLABELED / INVESTIGATIONAL — Albendazole has activity against Ascaris lumbricoides (roundworm); Ancylostoma caninum; Ancylostoma duodenale and Necator americanus (hookworms); cutaneous larva migrans; Enterobius vermicularis (pinworm); Gnathostoma spinigerum; Gongylonema sp; Hymenolepis nana sp (tapeworms); Mansonella perstans (filariasis); Opisthorchis sinensis and Opisthorchis viverrini (liver flukes); Strongyloides stercoralis and Trichuris trichiura (whipworm); 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).
ADVERSE REACTIONS SIGNIFICANT N = Neurocysticercosis; H = Hydatid disease
>10%: Central nervous system: Headache (11% - N; 1% - H) Hepatic: LFTs increased (~15% - H; <1% - N)
1% to 10%: Central nervous system: Dizziness, vertigo, fever (1%), intracranial pressure increased (1% - N), meningeal signs (1% - N) Dermatologic: Alopecia (2% - H; <1% - N) Gastrointestinal: Abdominal pain (6% - H; 0% - N), nausea/vomiting (3% to 6%) Hematologic: Leukopenia (reversible) (<1%) Miscellaneous: Allergic reactions (<1%)
<1% (Limited to important or life-threatening): Acute renal failure, agranulocytopenia, allergic reaction, granulocytopenia, pancytopenia, rash, thrombocytopenia, urticaria
CONTRAINDICATIONS — Hypersensitivity to albendazole or any component of the formulation
WARNINGS / PRECAUTIONS — Discontinue therapy if LFT elevations are significant; may restart treatment when decreased to pretreatment values. Becoming pregnant within 1 month following therapy is not advised.
Neurocysticercosis: Corticosteroids should be administered 1-2 days before albendazole therapy to minimize inflammatory reactions. Steroid and anticonvulsant therapy should be used concurrently during the first week of therapy to prevent cerebral hypertension. If retinal lesions exist, weigh risk of further retinal damage due to albendazole-induced changes to the retinal lesion vs benefit of disease treatment.
DRUG INTERACTIONS — Substrate (minor) of CYP1A2, 3A4; Inhibits CYP1A2 (weak)
ETHANOL / NUTRITION / HERB INTERACTIONS — Food: Albendazole serum levels may be increased if taken with a fatty meal (increases the oral bioavailability by 4-5 times).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Albendazole has been shown to be teratogenic in laboratory animals and should not be used during pregnancy, if at all possible. Women should be advised to avoid pregnancy for at least 1 month following therapy. Discontinue if pregnancy occurs during treatment.
LACTATION — Excretion in breast milk unknown/not recommended
DIETARY CONSIDERATIONS — Should be taken with a high-fat meal.
PRICING — (data from drugstore.com)Tablets (Albenza) 200 mg (12): $23.59
MONITORING PARAMETERS — Monitor fecal specimens for ova and parasites for 3 weeks after treatment; if positive, retreat; monitor LFTs and clinical signs of hepatotoxicity; CBC at start of each 28-day cycle and every 2 weeks during therapy
INTERNATIONAL BRAND NAMES — Abentel (CN); ABZ (IN); Acure (PK); Adazol (EC); Albatel (TH); Alben (BR); Albendol (MY); Albenzol (EC); Albex (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Albezole (IN); Alfuca (TH); Alminth (IN); Alzental (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SG, SY, YE); Alzol (TH); Bendapar (MX); Bendex-400 (ZA); Borotel (PE); Ceprazol (CL, PE); Champs D-Worm 6 (MY); Ciclopar (CO); Dalben (HR); Emanthal (IN); Eskazole (AT, AU, DE, GB, IL, JP, MX, NL); Fintel (PE); Gascop (MX); Getzol (CO); Helmiben (UY); Labenda (TH); Loveral (MX); Mebenix (BR); Monodox (CO); Mycotel (TH); Nemozole (IN); Pantex (PY); Paranthil (ZA); Rotopar (EC); Sioban (IN); Vastus (AR); Vemizol (MY); Vermin Plus (MX); Xadem (CO); Zeben (TH); Zela (TH); Zentab (TH); Zentel (AE, AN, AU, BB, BF, BG, BH, BJ, BM, BR, BS, BZ, CI, CL, CO, CR, CY, CZ, DO, EC, EG, ET, FR, GH, GM, GN, GR, GT, GY, HN, IQ, IR, IT, JM, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, MX, MY, NE, NG, NI, OM, PA, PE, PH, PL, QA, SA, SC, SD, SL, SN, SR, SV, SY, TH, TT, TZ, UG, VE, YE, ZA, ZM, ZW)
MECHANISM OF ACTION — Active metabolite, albendazole, 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.
PHARMACODYNAMICS / KINETICS Absorption: <5%; may increase up to 4-5 times when administered with a fatty meal
Distribution: Well inside hydatid cysts and CSF
Protein binding: 70%
Metabolism: Hepatic; extensive first-pass effect; pathways include rapid sulfoxidation (major), hydrolysis, and oxidation
Half-life elimination: 8-12 hours
Time to peak, serum: 2-2.4 hours
Excretion: Urine (<1% as active metabolite); feces