Active substanceAlbendazoleAlbendazole
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  • Gelmodol-BM
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  • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet, film-coated, contains:

    active substance: albendazole (micronized) - 200.0 mg;

    Excipients: lactose monohydrate 164.5 mg, corn starch 70.0 mg, magnesium stearate 5.5 mg, sodium carboxymethyl starch 10.0 mg, crospovidone 80.0 mg, povidone 17.0 mg, sodium lauryl sulfate 1 , 0 mg;

    shell: hypromellose - 7.5 mg, macrogol - 3.75 mg, titanium dioxide - 3.0 mg, talc purified - 30.0 mg.

    Description:

    Round, biconvex tablets, covered with a film coat of white or almost white, with a characteristic odor. On the cross-section the nucleus is white.

    Pharmacotherapeutic group:Anthelminthic and antiprotozoal drug
    ATX: & nbsp

    P.02.C.A.03   Albendazole

    P.02.C.A   Benzimidazole derivatives

    Pharmacodynamics:

    Gelmodol-BM is an anthelmintic drug whose pharmacological properties are due to the action of the active substance - albendazole. Albendazole belongs to the group of carbamate benzimidazoles.The mechanism of action of albendazole is its ability to disrupt the activity of the microtubule system of the cells of the intestinal canal of helminths, thus causing damage to the tubulin protein. The consequence of this is biochemical disorders in the cell - the suppression of glucose transport and fumarate reductase, which underlies the suppression of cell division at the stage of metaphase and which is associated with oppression of oviposition and development of helminth larvae.

    Albendazole blocks the movement of secretory granules and other organelles in the muscle cells of roundworms, causing their death.

    Albendazole is effective against most intestinal nematodes, as well as larval (larval forms) cestodes.

    Albendazole as an antiparasitic drug has a fairly broad spectrum of action.

    Pharmacokinetics:

    Suction. After ingestion, the drug is poorly absorbed in the gastrointestinal tract, unchanged is not detected in the blood plasma. Bioavailability when ingestion is low. The intake of fatty foods increases absorption and maximum concentration by 5 times.

    Metabolism. Albendazole rapidly converts into the liver into the primary metabolite of albendazole sulfoxide, which also has anthelmintic activity.

    Distribution. The maximum concentration in the blood plasma of albendazole sulfoxide is reached in 2-5 hours after administration. The metabolite is associated with plasma proteins by 70% and is completely distributed throughout the body: it is found in urine, bile, liver, in the wall and liquid of helminth cysts, cerebrospinal fluid.

    Excretion. Albendazole sulfoxide in the liver is converted into albendazole sulfone (secondary metabolite) and other oxidized products. The half-life of albendazole sulfoxide is 8-12 hours. It is excreted in the urine in the form of various metabolites. The excretion of albendazole and albendazole sulfoxide through the kidneys is insignificant. In patients with impaired renal function, the clearance does not change.

    In patients with liver damage, bioavailability is increased, the maximum concentration of albendazole sulfoxide in blood plasma is increased 2-fold, and the half-life is prolonged.

    Albendazole induces cytochrome CYP1A2 in human liver cells; accelerates the metabolism of many drugs.

    Indications:

    Gelmodol-BM - highly effective anthelmintic and antiprotozoal drug of multivalent action, intended for therapy of the majority of existing helminthiases:

    - nematode:

    • ascariasis, causative agent - round helminth Ascaris lumbricoides;
    • trichocephalosis (withered head), causative agent - round helminth Trichocephalus trichiurus;
    • enterobiosis (pinworm), causative agent - round helminth Enterobius vermicularis;
    • ankylostomidosis (crooked head), pathogens - Ancylostoma duodenale and Necator americanus;
    • trichinosis, causative agent - Trichinella spiralis;
    • toxocarosis, pathogen - Toxocara canis;
    • strongyloidiasis (intestinal uger), causative agent - round helminth Strongiloides strcoralis, as well as mixed invasions;

    - tissue cestodiasis:

    • neurocysticercosis Cysticercus cellulosus, larval stage of the ribbon parasite of the pork chain);
    • hydatidic echinococcosis of the liver, lungs, peritoneum, caused by the larval form of the canine tapeworm (Echinococcus granulosus),

    also the drug is used as an auxiliary in the surgical treatment of alveolar echinococcosis, the causative agent - Echinococcus multilocularis.

    Contraindications:

    - Hypersensitivity to albendazole, other components of the drug, other benzimidazole derivatives;

    - deficiency of lactase, lactose intolerance, glucose-galactose malabsorption;

    - pathology of the retina;

    - Children under 3 years old (for this dosage form);

    - pregnancy, the period of breastfeeding.

    Carefully:

    A drug Gelmodol-BM with caution used for violations of liver function (it is necessary before and during treatment to regularly monitor liver function), oppression of bone marrow hematopoiesis, liver cirrhosis.

    Pregnancy and lactation:

    A drug Gelmodol-BM is contraindicated for use during pregnancy and lactation (breast-feeding).

    Dosing and Administration:The drug is taken orally, during or after a meal. Special training and diet is not required.

    The dosage form is chosen individually, depending on the convenience of taking the drug and the tolerability of the substances involved.

    The dose of the drug is set individually, depending on the type of infestation, the body weight of the patient.

    The maximum daily dose is 800 mg.

    With nematoses (including ascariasis, trichocephalosis, non-catarosis) Gelmodol-BM is prescribed to patients with a body weight of 60 kg and more - 400 mg per day once or in 2 divided doses; patients with a body weight of less than 60 kg - 15 mg / kg body weight once or in 2 divided doses.

    With enterobiasis adults and children over 3 years old take the drug at a dose of 400 mg once. After 14 days, the course of treatment should be repeated in the same dose and in the same regimen.

    With strongyloidiasis, ankylostomiasis adults and children over 3 years old take the drug at a dose of 400 mg once for 3 days. After a week, it is recommended to repeat the treatment cycle in the same doses.

    With trichinosis the drug is taken at a dose of 400 mg 2 times a day for 10-14 days. In cases of severe invasion and organ damage (myocarditis, pneumonitis, meningoencephalitis), glucocorticosteroid and symptomatic agents are also prescribed.

    With toxocarose adults and children over 14 years of age and weighing more than 60 kg the drug is taken 400 mg twice a day for 10 days, with a body weight of less than 60 kg 200 mg. It is required to conduct repeated courses of treatment with an interval of 2 weeks / month. In the process of treatment, peripheral blood control (once every 5-7 days) and aminotransferases at the same time is necessary.

    With neurocysticercosis and hydatidid echinococcosis patients with a body weight of 60 kg or more take 400 mg twice a day, with a body weight of less than 60 kg - at a rate of 15 mg / kg of body weight per day in two divided doses; the maximum daily dose of 800 mg. The course of treatment for neurocysticercosis 28-30 days (2 days before the drug and in the first week of taking glucocorticosteroid drugs), with echinococcosis - 3 cycles of 28 days with a 14 day break between cycles.

    When giardiasis: 400 mg once a day for 3 days.Children with body weight less than 10 kg - 200 mg once a day, once for 5 days. With mixed invasions, the drug is taken 400 mg twice a day, for 3 days.

    If necessary, the course of treatment can be repeated after 1 month.

    Before using the drug, you need a clinical blood test and a biochemical blood test. Treatment is carried out at normal laboratory parameters. In the process of treatment, a blood and aminotransferase assay is performed every 5-7 days. With a decrease in leukocytes below 3.0x109 and a 2-fold increase in the activity of aminotransferases, it is necessary to suspend treatment until the parameters are normalized. The drug therapy can be resumed after the laboratory indicators return to the level that was before the beginning of the therapy, nevertheless during the therapy laboratory tests should be carried out regularly. The appointment of hepatoprotectors during treatment and in cases of toxic manifestations is ineffective, it is necessary to cancel the drug.

    Pediatric Use

    The drug is intended for use in children aged 3 years. Clinical data on the use of albendazole up to 3 years are limited.Children should avoid high doses of albendazole whenever possible for a long time.

    Side effects:

    From the digestive system: impaired liver function with changes in functional liver tests (mild or moderate increase in the activity of "liver" transaminases), abdominal pain, nausea, vomiting, hepatitis, acute liver failure, epigastric pain, anorexia, constipation, diarrhea, dry mouth.

    On the part of the hematopoiesis system: oppression of bone marrow hematopoiesis (leukopenia, granulocytopenia, agranulocytosis, thrombocytopenia, pancytopenia), aplastic anemia, suppression of bone marrow activity, neutropenia.

    From the cardiovascular system: increase in blood pressure.

    From the central nervous system: headache and dizziness, meningeal symptoms, increased intracranial pressure.

    From the urinary system: changes in renal function (acute renal failure).

    From the skin: itching, skin rash, erythema multiforme, Stephen-Johnson syndrome.

    Allergic reactions: angioedema, immediate-type hypersensitivity reactions.

    Other: hyperthermia, alopecia.

    Overdose:

    Symptoms: increased dose-dependent side effects.

    Treatment: gastric lavage, the appointment of activated charcoal, symptomatic therapy.

    Interaction:

    Praziquantel, dexamethasone and cimetidine increase the concentration of albendazole sulfoxide in the blood.

    Simultaneous application with carbamazepine, phenytoin, phenobarbital and ginseng ordinary may lead to a decrease in drug concentration albendazole in the intestine.

    Special instructions:

    It is recommended to monitor the cellular composition of the blood; When leukopenia occurs, the drug is stopped.

    At women of childbearing age before the beginning of treatment spend the test for absence of pregnancy. During therapy, reliable contraception is necessary.

    It should be remembered that before appointment Gelmodol-VM, like any other anthelminthic drug, you should carefully clean the room, wash children's toys, before going to bed and after a shower and change your underwear.Bed linen is advisable during the days of treatment and a few days after taking the drug iron it with a hot iron.

    With neurocysticercosis with eye damage before the start of treatment, retinal studies are necessary in connection with the risk of aggravation of its pathology.

    Simultaneous use of albendazole and theophylline (nausea, vomiting, palpitations, convulsive seizures). In this regard, it is recommended to monitor plasma concentrations of theophylline during treatment with albendazole.

    Patients should avoid eating foods with grapefruit during treatment with albendazole (the risk of side effects increases).

    Effect on the ability to drive transp. cf. and fur:A drug can cause dizziness, so you need to avoid transport management or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:

    Tablets, film-coated, 200 mg.

    Packaging:

    2 Tablets in a blister of PVC-aluminum foil.

    One blister, along with instructions for use, is placed in a cardboard box.
    Storage conditions:

    Store at a temperature of 15 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 of the year.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000938
    Date of registration:18.10.2011 / 19.10.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:World Medical Co., Ltd.World Medical Co., Ltd. Egypt
    Manufacturer: & nbsp
    Representation: & nbspTROKAS PHARMA LLCTROKAS PHARMA LLCRussia
    Information update date: & nbsp20.03.2017
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