Active substanceAlbendazoleAlbendazole
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  • Dosage form: & nbspTablets are chewable.
    Composition:Each tablet contains -
    Active ingredient: albendazole 400 mg;
    Excipients: sucrose, lactose, sodium benzoate, dye sunset yellow (dye yellow), purified water, magnesium stearate, talc, peppermint flavor (peppermint essence), menthol (levomenthol).
    Description:Round, flat tablets, with a risk applied on one side, light orange color with impregnations of a darker and lighter color.
    Pharmacotherapeutic group:Anthelminthic and protozoal.
    ATX: & nbsp

    P.02.C.A.03   Albendazole

    P.02.C.A   Benzimidazole derivatives

    Pharmacodynamics:An anthelminthic agent selectively suppresses the polymerization of beta-tubulin, which leads to the destruction of cytoplasmic microtubules of intestinal tract cells of helminths; changes the course of biochemical processes (suppresses the utilization of glucose), blocks the movement of secretory granules and other organelles in the muscle cells of roundworms, causing their death.The most effective for larval forms of cestodes is Echinococcus granulosus and Taenia solium; nematodes - Strongyloides stercolatis.
    Pharmacokinetics:Suction: after oral administration is poorly absorbed in the gastrointestinal tract, due to poor solubility in water. The drug is rapidly metabolized at the "first passage" through the liver, so the plasma concentrations of albendazole in an unchanged form are negligible and are not determined. Bioavailability when ingestion is low. However, the simultaneous intake of fatty foods significantly increases the absorption and concentration of albendazole in blood plasma (5 times).
    The maximum concentration of albendazole sulfoxide is reached after 2 -5 l.
    Distribution: the degree of binding to plasma proteins is 70%. Albendazole is well distributed throughout the body, revealing high concentrations in the urine, bile, liver, wall and fluid of parasitic cysts, cerebrospinal fluid.
    Metabolism: Albendazole is rapidly metabolized in the liver to the formation of the primary metabolite, albendazole sulfoxide, also having anthelmintic activity. Albendazole sulfoxide, in turn, is converted to albendazole sulfone (secondary metabolite) and other oxidized products devoid of pharmacological activity.Albendazole is the inducer of the microsomal enzymes CYP1A2 of the cytochrome P450 system in human liver cells.
    Excretion: the half-life of albendazole sulfoxide is 8-12 hours. The drug is excreted in the form of various metabolites with urine and bile, with renal excretion insignificant (less than 1%).
    Pharmacokinetics in special clinical cases: against the background of liver damage, the bioavailability of albendazole increases. The maximum concentration of albendazole sulfoxide increases by a factor of 2, and the half-life is prolonged. In patients with impaired renal function, the clearance of albendazole and its metabolites does not change.
    Indications:Neurocysticercosis caused by the larval form of pork tapeworm (Taenia solium); echinococcosis of the liver, lungs, peritoneum, caused by the larval form of the canine tapeworm (Echinococcus granulosus); Nematodosis: ascariasis, trichocephalus, ankylostomiasis, enterobiasis, strongyloidiasis; trematodes: opisthorchiasis; Some protozoal infections: giardiasis, microsporidiosis, mixed
    helminthiases; as an auxiliary in the surgical treatment of echinococcus cysts.
    Contraindications:Individual intolerance (incl.to other benzimidazole derivatives), children's age (up to 3 years).
    Carefully:Inhibition of bone marrow hematopoiesis, hepatic insufficiency, cirrhosis of the liver, cysticercosis with involvement of the retina of the eye.
    Pregnancy and lactation:The drug is not used during pregnancy, except when alternative treatment is not possible. Thus, before the start of treatment in women of childbearing age, a pregnancy test is conducted. During and during the month after the end of treatment, reliable contraception is required. With special care, the drug is prescribed to women breastfeeding.
    Dosing and Administration:Is taken internally. Tablets can be chewed or swallowed entirely. The dose is set individually, depending on the type of helminth and body weight of the patient.
    The following dosing regimen is recommended:
    with neurocysticercosis and echinococcosis:
    patients with a body weight of 60 kg and more - 400 mg twice a day;
    less than 60 kg - 15 mg / kg per day in 2 divided doses.
    The maximum daily dose is 800 mg. Course of treatment: with neurocysticercosis - 8-30 days; with echinococcosis - 3 cycles of 28 days with a 14 day break between cycles.With surgical treatment, the duration of drug treatment is 3 courses.
    with ascariasis, trichocephalosis, enterobiasis, ankylostomiasis:
    adults and children over 3 years - 400 mg once, if necessary, repeat after 3 weeks; with giardiasis:
    adults and children over 3 years - 400 mg once a day for 3 days;
    with strongyloidiasis and cestodosis:
    adults and children over 3 years - 400 mg once a day for 3 days, if necessary, repeat after 3 weeks.
    Side effects:Dysfunction of the liver with changes in functional liver tests (slight or moderate increase in the level of transaminases), suppression of bone marrow hematopoiesis (leukopenia, granulocytopenia, agranulocytosis, thrombocytopenia, pancytopenia), fever, abdominal pain, nausea, vomiting, headache, dizziness, meningeal symptoms, increased blood pressure, acute renal failure, reversible alopecia, skin rash, itching and other allergic reactions.
    Overdose:Symptomatic therapy, gastric lavage, Activated carbon.
    Interaction:When combined with dexamethasone, cimetidine, praziquantel, the latter increase the concentration of albendazole sulfoxide in the blood.
    Special instructions:Patients with neurocysticercosis should receive appropriate therapy with glucocorticosteroids and anticonvulsant drugs. Oral or intravenous glucocorticosteroids are used to prevent a sharp increase in blood pressure in the first week of anti-cystic therapy. It is recommended to control the cellular composition of the blood; blood tests should be performed at the beginning of each 28 day cycle and every 2 weeks during the treatment with albendazole. When leukopenia occurs, treatment is suspended. Continuation of treatment with albendazole is possible if a decrease in the total content of leukocytes and neurotrophilic leukocytes is moderate and does not progress.
    If there is a violation of the liver before and during treatment is necessary. regular laboratory monitoring (every two weeks). In case of a significant increase in the level of hepatic transaminases, treatment should be discontinued. However, if the level of liver enzymes returned to the original, albendazole can be re-assigned, provided that the laboratory parameters are constantly monitored.
    With neurocysticercosis with eye damage before the beginning of treatment, retinal examination is necessary in connection with the risk of aggravation of its pathology.
    Be wary appoint children under 6 years.
    Form release / dosage:Tablets chewing on 400 mg.
    Packaging:1, 2 or 3 tablets in a planar cell package (PVC / aluminum blister); 1 contour pack in a pack of cardboard, complete with instructions for medical use in Russian.
    Storage conditions:List B. Store in a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:3 years.
    Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-008052/08
    Date of registration:10.10.2008 / 17.12.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:Oxford Laboratories Pvt. Ltd.Oxford Laboratories Pvt. Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspOXFORD LABORATORY Pvt. Ltd. OXFORD LABORATORY Pvt. Ltd. India
    Information update date: & nbsp2016-12-17
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