Nemozole, pills 400mg, 5pcs

Composition

Each film coated tablet contains: Active ingredient: albendazole-400.00 mg Excipients: corn starch – 83.00 mg, dried corn starch – 10.00 mg, sodium lauryl sulfate – 5.00 mg, povidone (polyvinylpyrrolidone K 30) – 5.00 mg, methyl parahydroxybenzoate – 0.360 mg, propyl parahydroxybenzoate – 0.040 mg, gelatin – 5.50 mg, purified talc – 10.00 mg, sodium carboxymethyl starch – 5.20 mg, colloidal silicon dioxide – 3.00 mg, magnesium stearate – 3.00 mg. Shell: hypromellose – 5.32 mg, titanium dioxide-3.20 mg, purified talc-1.60 mg, sodium lauryl sulfate-0 mg, macrogol 400-0 mg, propylene glycol-1.60 mg

Pharmacological action

Pharmacotherapy group:

anthelmintic and antiprotozoal agent.

ATX Code: P 02 CA 03

Pharmacological properties

Pharmacodynamics

Albendazole is an anthelmintic drug, the pharmacological properties of which are due to the action of the Active ingredient – albendazole. Albendazole belongs to the carbamatbenzimidazole group. The mechanism of action of albendazole is its ability to disrupt the activity of the microtubular system of helminth intestinal canal cells, while causing damage to the tubulin protein. The consequence of this is biochemical disturbances in the cell – inhibition of glucose and fumarate reductose transport, which underlies the suppression of cell division at the metaphase stage and is associated with inhibition of egg laying 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 giardia. Albendazole as an antiparasitic drug has a fairly wide spectrum of action.

Pharmacokinetics

Suction. After oral use, the drug is poorly absorbed in the gastrointestinal tract, and is not detected unchanged in blood plasma. Oral bioavailability is low. Intake of fatty foods increases absorption and maximum concentration by 5 times.

Metabolism. Albendazole is rapidly converted in the liver to its primary metabolite, albendazole sulfoxide, which also has anthelmintic activity.

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

Output. Albendazole sulfoxide is converted in the liver to albendazole sulfone (a 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. Renal excretion of albendazole and albendazole sulfoxide is negligible. In patients with impaired renal function, clearance does not change.

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

Albendazole induces cytochrome SUR1 A 2 in human liver cells, accelerates the metabolism of many drugs.

Indications

-Nematodoses: ascariasis, pathogen – round helminth Ascaris lumbricoidesl; trichocephalosis (whipworm), pathogen – round helminth Trichocephalus trichiurus; enterobiosis (pinworms), pathogen – round helminth Enterobius vermicularis; hookworm (hookworm), pathogens – Ancylostoma duodenale and Necator americanus;trichinosis, pathogen —Trichinella spiralis;toxocariasis, pathogen – Toxocara canis;giardiasis, pathogen – Giardia intestinalis;strogiloidosis (intestinal acne), pathogen – round helminth Strongiloides strcoralis, as well as mixed infestations. – tissue cestodoses: Neurocysticercosis, pathogen-Cysticercus cellulosus (larval stage of pork tapeworm); hydatid echinococcosis of the liver, lungs, peritoneum, pathogen-Echinococcus granulosus (larval stage of canine tapeworm); as an auxiliary agent in the surgical treatment of alveolar echinococcosis, pathogen – Echinococcus multilocularis.

Contraindications

-Hypersensitivity to albendazole, other components of the drug and other benzimidazole derivatives; – retinal pathology; – children under 3 years of age (for this dosage form);- Pregnancy and lactation with caution Albendazole is used with caution in cases of liver function disorders (it is necessary to regularly monitor liver function before and during treatment), bone marrow hematopoiesis depression, and cirrhosis of the liver.

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. From the hematopoietic system: suppression of bone marrow hematopoiesis (leukopenia, granulocytopenia, agranulocytosis. thrombocytopenia, pancytopenia, aplastic anemia, bone marrow suppression, neutropenia). From the cardiovascular system: increased blood pressure. From the central nervous system: headache and dizziness, meningeal symptoms, increased intracranial pressure. From the urinary system: changes in renal function indicators (acute renal failure). Skin disorders: pruritus, skin rash, erythema multiforme, Stevens-Johnson syndrome. Allergic reactions: angioedema, immediate hypersensitivity reactions. Other: hyperthermia, alopecia. If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Concomitant use of albendazole with iraziquantel, dexamethasone and cimetidine may increase the concentration of albendazole sulfoxide in the blood. Concomitant use with carbamazepine, phenytoin, phenobarbital and common ginseng may lead to a decrease in the concentration of albendazole in the intestine.

How to take, course of use and dosage

Inside, during or after a meal. No special training or diet is required. The dosage form is selected individually, depending on the convenience of taking the drug and the tolerance of the substances included in it. The dose of the drug is set individually, depending on the type of invasion and the patient’s body weight. The maximum daily dose is 800 mg. In children, if possible, avoid using high doses of albendazole for a long time. With nematodoses (including ascariasis, trichocephalosis, necatorosis)The standard dose for the treatment of roundworm infestations for adults and children with a body weight of 60 kg or more is 400 mg per day once;for adults and children with a body weight of less than 60 kg-15 mg/kg of body weight once or in 2 doses. With enterobiosis, adults and children over 3 years of age take the drug at a dose of 400 mg once. If necessary, after 14 days, repeat the course of treatment in the same dose and in the same mode. With strongyloidosis, hookworm disease, adults and children over 3 years of age take the drug at a dose of 400 mg once for 3 days. If necessary, repeat the course of treatment in the same doses after 7 days. With trichinosis, the drug is taken 400 mg 2 times a day for 10-14 days. With severe invasion and organ damage (myocarditis, pneumonitis, meningoencephalitis), glucocorticosteroids and symptomatic agents are also taken. With toxocarosis, adults and children over 14 years of age and with a body weight of more than 60 kg take the drug 400 mg 2 times a day for 10 days, with a body weight of less than 60 kg 200 mg. Repeated courses of treatment are required at intervals of 2 weeks / month. During treatment, it is necessary to monitor peripheral blood (once every 5-7 days)and aminotransferases at the same time. For giardiasis: 400 mg once a day for 3 days. Children with a body weight of less than 10 kg-200 mg once a day once for 5 days. For mixed infestations, the drug is taken 400 mg 2 times a day, for 3 days. If necessary, the course of treatment can be repeated after 1 month. With neurocysticercosis and hydatid echinococcosis, patients with a body weight of 60 kg or more should take 400 mg 2 times a day, with a body weight of less than 60 kg-at the rate of 15 mg /kg of body weight per day in 2 doses; the maximum daily dose is 800 mg. The course of treatment for neurocysticercosis is 28-30 days (2 days before taking 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, a clinical blood test and a biochemical blood test are required. Treatment is performed at normal laboratory parameters. During treatment, blood and aminotransferase tests are performed every 5-7 days. With a decrease in white blood cells below 3.0 x 109 and a 2-fold increase in aminotransferase activity, treatment should be suspended until the parameters normalize. Therapy with the drug can be resumed after the laboratory parameters return to the level that was before the start of therapy, however, during therapy, laboratory tests should be carried out regularly. The use of hepatoprotectors during treatment and in cases of toxic manifestations is ineffective, it is necessary to cancel the drug. Albendazole treatment for alveolar echinococcosis is an additional treatment option. The dosage and mode of use of the drug are the same as for hydatid echinococcosis. The duration and course of treatment is determined by the patient’s condition and tolerability of the drug.

Overdose

Symptoms: increased dose-dependent side effects. Treatment: gastric lavage, use of activated charcoal, symptomatic therapy.

Special instructions

Simultaneous treatment of all family members is recommended. Monitoring of blood cell composition is recommended; if leukopenia occurs, drug therapy is suspended. In case of neurocysticercosis with eye damage, retinal examination is necessary before starting treatment due to the risk of aggravation of its pathology. In women of childbearing age, a pregnancy test is performed before starting treatment. Reliable contraception is necessary during therapy and for 1 month after it ends. It should be remembered that before using Nemozole, as well as any other anthelmintic drug, you should thoroughly clean the room, wash children’s toys, conduct hygiene procedures daily (morning and evening), change underwear. During treatment and several days after taking the drug, it is advisable to change bed linen more often or iron it with a hot iron. Concomitant use of albendazole and theophylline may increase the risk of toxic effects of theophylline (nausea, vomiting, rapid heartbeat, seizures). Although single doses of albendazole do not inhibit theophylline metabolism, albendazole still induces cytochrome P 4501 A in hepatocytes. In this regard, it is recommended to monitor plasma concentrations of theophylline during treatment with albendazole. Patients should avoid consuming grapefruit products while taking albendazole, as albendazole plasma concentrations may increase, which increases the risk of adverse side effects. Effects on the ability to drive vehicles, mechanisms You should avoid driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions, as the drug can cause dizziness and other side effects that may affect these abilities.

Form of production

Film-coated tablets

Storage conditions

Store in a dry place protected from light at temperatures below 25° C. Keep out of the reach of children.

Shelf

life is 3 years.

Active ingredient

Albendazole

Conditions of release from pharmacies

By prescription

Dosage form

Tablets