Active substanceAlbendazoleAlbendazole
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  • Dosage form: & nbsporal suspension
    Composition:

    Each 5 ml of the suspension contains:

    Active substance: albendazole - 100.00 mg

    Excipients: cellulose microcrystalline and carmellose sodium (cellulose microcrystalline - 84%, carmellose sodium 11% water - 5%) - 25.00 mg, carmellose sodium - 45.00 mg, glycerol 750.00 mg, benzoic acid 10.00 mg, potassium 10.50 mg, sorbic acid 10.00 mg, polysorbate 80-5.00 mg, sorbitol 2750.00 mg, fruit flavor 0.01 ml, flavor ice cream 0,0025 ml, purified water up to 5 ml.

    Description:

    Suspension from white to almost white with a characteristic fruity odor.

    Pharmacotherapeutic group:Anthelminthic and antiprotozoal drug
    ATX: & nbsp

    P.02.C.A.03   Albendazole

    P.02.C.A   Benzimidazole derivatives

    Pharmacodynamics:

    Nemozol® is an anthelmintic preparation 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 stages) cestodes, as well as lamblia. 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 quickly turns into a liver in 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. At 70 % metabolite is bound to plasma proteins 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 through the kidneys in the form of various metabolites. The excretion of albendazole and albendazole sulfoxide through the kidneys is insignificant. In patients with impaired renal function, clearance does not change.

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

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

    Indications:

    - nematodes:

    ascariasis, causative agent - round helminth Ascaris lumbricoidesl;

    trichocephalosis (withered head), causative agent - round helminth Trichocephalus trichiurus;

    enterobiosis (pinworm), causative agent - round helminth Enterobius vermicularis;

    ankylostomidosis (crooked head), pathogens - Ancylostoma duodenalc and Necator americanus;

    trichinosis, pathogens - Trichinella spiralis;

    toxocarosis, pathogen - Toxocara canis;

    giardiasis, causative agent - Giardia intestinalis;

    Strogyloidosis (intestinal ugly), causative agent - round helminth Strongiloides strcoralis, as well as mixed invasions.


    - tissue cestodiasis:

    Neurocysticercosis, the causative agent - Cysticercus cellulosus (larval stage of the pork chain);

    hydatidic echinococcosis of the liver, lungs, peritoneum, pathogen - Echinococcus granulosus (larval stage of the canine tapeworm);

    as an aid in the surgical treatment of alveolar echinococcosis, the causative agent - Echinococcus multilocularis.

    Contraindications:

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

    - intolerance to fructose;

    - pathology of the retina:

    - children's age up to 1 g ode;

    - pregnancy and the period of breastfeeding

    Carefully:

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

    Pregnancy and lactation:

    Albendazole is contraindicated in pregnancy and during breastfeeding.

    Dosing and Administration:

    Inside, during or after a meal. Special training and diet is not required.

    The drug is intended for use in adults and children aged 1 year.

    The dose of the drug is set individually, depending on the type of infestation and body weight of the patient. The need to reduce the dose from 400 mg to 200 mg may occur if the child's body weight is less than 10 kg. However, in general, there are no grounds for reducing the dose in children.

    The maximum daily dose is 800 mg.

    Children should, if possible, avoid using high doses of albendazole for a long time.

    It is recommended to use a syringe for accuracy and convenience of dosing.

    With nematodes (including ascaridosis, trichocephalosis, non-caranose)

    The standard dose for the treatment of invasion by roundworms for adults and children with weight body 60 kg and more - 400 mg (20 ml of suspension) per day once;

    for adults and children weighing less than 60 kg -15 mg / kg body weight once;

    For children aged 1 to 2 years, a dose of 200 mg (10 ml of suspension) should be used.

    With enterobiasis adults and children older than 2 years take 400 mg (20 ml suspension) once; for children aged 1 to 2 years, a dose of 200 mg (10 ml suspension) once.

    If necessary, after 14 days, repeat the course of treatment in the same dose and in the same regime.

    With strongyloidiasis. ankylostomidosis adults and children older than 2 years take 400 mg (20 ml of suspension) once for 3 days. For children from 1 year to 2 years, the dose is 200 mg (10 ml suspension). After a week, it is recommended to repeat the treatment cycle in the same doses.

    With trichinosis the drug is taken 400 mg (20 ml suspension) 2 times a day for 10-14 days. In case of severe invasion and organ damage (myocarditis, pneumonitis, meningoencephalitis), glucocorticosteroid and symptomatic agents are also taken.

    With toxocarose adults and children older than 14 years with a body weight of 60 kg or more: take 400 mg (20 ml of suspension) 2 times a day for 10 days; adult patients with a body weight of less than 60 kg 200 mg (10 ml suspension) 2 times a day for 10 days; children 2-14 years: take 10 mg / kg 2 times a day for 10 days. 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 giardiasis: 400 mg I 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.

    With neurocysticercosis and hydatidid echinococcosis patients with a body weight of 60 kg or more take 400 mg (20 ml of suspension) twice a day, with a body weight of less than 60 kg - at a rate of 15 mg / kg body weight per day in 2 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.

    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 white blood cells lower 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 start of therapy, however, 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.

    Treatment albendazole alveolar echinococcosis is an additional remedy.

    Doses and the mode of prescribing the drug are the same as for hydatidid echinococcosis. The duration and course of treatment is determined by the patient's condition and tolerability of the drug.

    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), hepatitis, acute liver failure, epigastric pain, anorexia, constipation, diarrhea and dry mouth, nausea, vomiting.

    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 part of the 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, Stevens-Johnson syndrome.

    Allergic reactions: angioedema, immediate-type hypersensitivity reactions.

    Other: hyperthermia, alopecia.

    If any of the side effects listed in the manual are aggravated, or any other side effects not indicated in the instructions appear, you should notify the doctor.

    Overdose:

    Symptoms: increased dose-related side effects.

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

    Interaction:

    The simultaneous use of albendazole with praziquantel, dexamethasone and cimetidine may increase the concentration of albendazole sulfoxide in the blood. Simultaneous use with carbamazepine, phenytoin, phenobarbital and ginseng can lead to a decrease in the concentration of the drug albendazole in the intestine.

    Special instructions:

    It is recommended that all members of the family be treated at the same time.

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

    With neurocysticercosis with eye damage before the beginning of treatment, retinal examination is necessary in connection with the risk of aggravation of its pathology.

    At women of childbearing age before the beginning of treatment spend the test for pregnancy. During therapy and within 1 month after the end of this period, reliable contraception is necessary.

    It should be remembered that before using albendazole. as well as any other anthelmintic preparation, you should carefully clean the room, wash children's toys, daily (morning and evening) hygiene procedures, change of underwear. During treatment and several days after taking the drug, it is more convenient to change the bed linen more frequently or to iron it with a hot iron.

    The simultaneous use of albendazole and theophylline may lead to an increased risk of toxic effects of theophylline (nausea, vomiting, palpitations, convulsive seizures). Although single doses of albendazole do not inhibit theophylline metabolism. albendazole all the same induces cytochrome P4501A in hepatocytes.In this regard, it is recommended to monitor plasma concentrations of theophylline during treatment with albendazole.

    Patients should avoid eating foods with grapefruit while taking albendazole, because the plasma concentrations of albendazole may increase. which increases the risk of adverse adverse reactions.

    Effect on the ability to drive transp. cf. and fur:

    It is necessary to avoid driving and other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions, as the drug may cause dizziness and other side effects that may affect these abilities.

    Form release / dosage:

    Suspension for oral administration.

    Packaging:

    For 20 ml of the drug in a plastic bottle with an aluminum screw cap with a PVC liner and with a ring of the first opening.

    One bottle together with the instruction is placed in a cardboard box.

    Storage conditions:

    Store in a dry, dark place at a temperature below 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N014471 / 03
    Date of registration:25.11.2008
    The owner of the registration certificate:Ipka Laboratories Ltd.Ipka Laboratories Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspIPKA LABORATORIES LTD. IPKA LABORATORIES LTD. India
    Information update date: & nbsp15.08.2015
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