Each tablet contains 200 mg.
Pharmacology: Pharmacokinetics: Tab: Absorption: Poor; may increase up to 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 to active metabolite [albendazole sulfoxide (major)], hydrolysis, & oxidation.
Half-life elimination: 8-12 hours.
Time to peak, serum: 2-5 hours
Excretion: Urine (<1% as active metabolite); feces.
Alben-VC for treatment of parenchymal neurocystercosis caused by Taenia solium and cystic hydatid disease of the liver, lung and peritoneum caused by Echinococcus granulosus.
Tab: Roundworm (Ancylostoma caninum, Ascaris lumbricoides), Hookworm (Ancylostoma duodenale, Necator americanus); Children and Adults: 400 mg single dose.
Pinworm (Enterobius granulosus): Children and Adults: 400 mg single dose and repeat in 2 weeks.
Tapeworm (Echinococcus granulosus): Adults: 800 mg per day in 2 divided doses for 1-6 months.
Giardiasis (Giardia duodenalis): Adults: 400 mg once daily for 5 days.
Mode of Administration: Should be administered with a high fat meal. Administer anticonvulsant and steroid therapy during first week of neurocysticercosis therapy. If patients have difficulty swallowing, tablet may be crushed or chewed, then swallowed with a drink of water.
Suspension: Adult and children >2 years: Roundworm, hookworm, pinworm, whipworm, threadworm: 10 mL single dose.
Tapeworm: 10 mL single dose or 10 mL 1 dose/day for 3 days.
Opisthorchiasis clonorchiasis: 10 mL 2 doses/day for 3 days.
Treatment: Symptomatic therapy and general supportive measures are recommended.
Hypersensitivity to Albendazole, benzimidazole class of compounds, or any component of the product.
Bone marrow suppression, aplastic anemia, and agranulocytosis may occur, including fatalities; monitoring recommended.
Cerebral hyperetensive episodes may occur during the first week of neurocysticercosis therapy; pretreatment recommended.
Elevations of hepatic enzymes may occur; increase risk of hepatotoxicity and bone marrow suppression; monitoring recommended; discontinuation of therapy may be warranted.
Hepatic disease, preexisting; increase risk of bone marrow suppression leading to pancytopenia, aplastic anemia, agranulocytosis, and leukopenia; monitoring recommended; discontinuation of therapy may be warranted.
Preexisting neurocysticercosis, previously undiagnosed; may experience neurological symptoms (eg. Seizures, increased intracranial pressure, and focal signs) which may occur soon after treatment and require medical management.
Retinal lesions; increase risk of retinal damage in patients with cysticercosis; weigh the risks versus benefits of therapy.
Use in Pregnancy: 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.
Use in Lactation: Excretion in breastmilk unknown/use caution.
Tab: Common: Gastrointestinal:
Abdominal pain, nausea, vomiting.
Erythema multiforme, Stevens-Johnson syndrome.
Agranulocytosis (less than 1%), aplastic anemia, granulocytopenic disorder (less than 1%), leukopenia (less than 1%), pancytopenia (less than 1%), thrombocytopenia (less than 1%).
Hepatotoxicity, with elevated liver enzymes.
Acute renal failure (rare).
Gastrointestinal disturbance, headache, dizziness.
Tab: Increased Effect/Toxicity: The level/effects of Albendazole may be increased by grapefruit juice.
Decreased effect: The level/effects of Albendazole may be decreased by Aminoquinolines (antimalarial).
Susp: Increased serum levels with dexamethasone, praziquantel. Metabolism may be increased by cimetidine.
Protect from light and temperature not exceeding 30°C.
P02CA03 - albendazole ; Belongs to the class of benzimidazole derivative agents. Used as antinematodal.
FC tablet 200 mg (white round biconvex with break line on one side & the other is plain) x 2's, 100's. Susp 200 mg/5 mL x 10 mL.