Nemozol tablets p/o 400mg №1×1

Name:
Nemozol. Release form Tablets. ProducerIpka laboratoryiz ltd. INNAlbendazole. FTGAntihelminthic and antiprotozoal agent. Composition 1 film-coated tablet contains: active substance: albendazole 400 mg excipients: corn starch, gelatin, sodium lauryl sulfate, povidone (PVPK-30), purified water, purified talc, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate , hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol. Suspension for oral administration contains: active substance: albendazole 100 mg in 5 ml excipients: microcrystalline cellulose and carboxymethylcellulose sodium salt, carboxymethylcellulose sodium salt, glycerin, benzoic acid, potassium hydroxide, sorbic acid, polysorbate-80, sorbitol solution, mixed fruit essence , flavoring essence of ice cream, purified water.
Description:
Pills, film-coated Tablets white or almost white, round, biconvex, film-coated. Suspension for oral administration Suspension from white to almost white. Separation is allowed, which is eliminated by shaking. Pharmacotherapeutic group Anthelmintics. Means for the treatment of nematodes. ATX code: P02CA03. Pharmacological action The main mechanism of action of albendazole is its inhibitory effect on beta-tubulin polymerization, which leads to the destruction of cytoplasmic microtubules of helminth intestinal tract cells; 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 intestinal and tissue parasites. Albendazole has larvicidal, ovocidal and anthelmintic effects, causing energy depletion of helminths, which leads to their immobilization and destruction. Pharmacokinetics Poorly absorbed (less than 5%) in the gastrointestinal tract, unchanged is not determined in the blood plasma, tk. quickly turns in the liver into the primary metabolite of albendazole sulfoxide, which also has anthelmintic activity. The systemic pharmacological effect of albendazole is enhanced when taken with fatty foods, which increase absorption by about 5 times. The smah of albendazole sulfoxide is achieved in 2-5 hours. It is 70% bound to plasma proteins and is widely distributed throughout the body; found in urine, bile, liver, cyst wall and cystic fluid, cerebrospinal fluid. Albendazole sulfoxide is converted in the liver to albendazole sulfone (secondary metabolite) and other oxidized products. T1 / 2 albendazole sulfoxide 8-12 hours. Excreted in the urine. Renal excretion of albendazole and its main metabolite, albendazole sulfoxide, is insignificant, clearance does not change in patients with impaired renal function. Against the background of liver damage, bioavailability increases and Cmax of albendazole sulfoxide increases by 2 times, T1 / 2 lengthens. Albendazole is an inducer of microsomal enzymes of the cytochrome P-450 system; accelerates the metabolism of many drugs. Pharmacokinetics in special groups of patients – Extrahepatic cholestasis: Since the excretion of albendazole sulfoxide is reduced, the patient should be monitored closely. – Elderly patients: Clinical pharmacokinetic studies of albendazole sulfoxide in elderly patients have not been conducted, but data obtained in the treatment of 26 patients (up to 79 years of age) with echinococcal cysts suggest that the pharmacokinetics in this age group of patients is similar to that in young healthy volunteers. – Use in renal insufficiency: The pharmacokinetics of albendazole in patients with renal insufficiency have not been studied. – Use in hepatic impairment: The pharmacokinetics of albendazole in patients with hepatic impairment have not been studied. – Features of pharmacokinetics in children: clinical studies have been conducted on the safety of albendazole in children 6-13 years of age. Albendazole was administered once to patients with echinococcosis (three children on an empty stomach and two after meals) at doses of 200 to 300 mg (based on about 10 mg/kg). At the same time, there were no features in the pharmacokinetics of albendazole compared with adult patients. Clinical experience with albendazole in children under 6 years of age is limited. At the same time, no data were found indicating the presence of features in the tolerability of the drug in patients of this age group suffering from echinococcosis. Data are available from five clinical studies involving 1-year-old children with neurocysticercosis. No significant adverse effects of albendazole were noted. At the same time, the efficacy of albendazole was similar to that in adult patients. Intestinal helminthiases, including mixed helminthic infestations, caused by the following helminths and parasites: Nematodes: Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm), Enterobius vermicularis (pinworm), Ankylostoma duodenale (hookworm), Necator americanus (nematode) , Strongyloides stercoralis (intestinal acne), hookworms that cause larval (larval) helminthiasis (skin form). Trematodes: Clonorchis sinensis (Chinese fluke), Opisthorchis viverrini (squirrel fluke). Cestodes: Taenia solium (pork tapeworm), Taenia saginata (bovine tapeworm), Hymenolepis papa (pygmy tapeworm), if they occur in combination with nematodes. If there is a lesion exclusively with tapeworms or other cestodes, then Nemozol should not be used. Protozoa: Giardia lamblia (intestinal or duodenal). Systemic helminthiases: Albendazole shows the greatest efficacy in the treatment of cysts of the liver, lungs and peritoneum. Experience with cysts of the bones, heart and central nervous system is limited. cystic echinococcosis (caused by Echinococcus granulosus). Albendazole is used to treat patients with cystic echinococcosis. if surgery is unacceptable; before surgery; after surgery, if the preoperative treatment was too short, if there was leakage of the contents of the cyst, or if a viable material was found during the surgical intervention; after percutaneous drainage of cysts for diagnostic or therapeutic purposes. alveolar echinococcosis (caused by Echinococcus multilocularis) Albendazole is used to treat patients with alveolar echinococcosis: in case of inoperable disease, especially in cases of local or distant metastases; after palliative surgery; after radical surgery or liver transplantation. neurocystecircosis caused by the larval form of the pork tapeworm (Taenia solium). Albendazole is used to treat patients with the following conditions: solitary or multiple cysts or granulomatous lesions of the brain parenchyma; arachnoid or intraventricular cysts; villous cysts. capillariasis caused by Capillaria philippinensis. Gnathostomiasis caused by Gnathostoma spinigerum. trichinosis (caused by Trichinella spiralis and T. pseudospiralis). toxocariasis (caused by Toxocara canis and other related species) Contraindications Hypersensitivity to the active substance or any of the excipients, other benzimidazole derivatives. Albendazole should not be used during pregnancy or in women who are expected to be pregnant. Women of childbearing potential should be advised to use effective contraceptive measures, including non-hormonal contraceptives, during treatment and for one month after completion of treatment. Dosage and administration The drug is taken orally, during a meal. It is recommended that all family members be treated simultaneously. The usual dosage for adults and children over 2 years of age (> 10 kg) in the treatment of the following helminthic invasions: Nematodosis, including ascariasis, trichuriasis, enterobiasis, hookworm, necatoriasis, – 400 mg of albendazole (1 tablet or 20 ml of suspension) orally once. Strongyloidiasis – 400 mg of albendazole (1 tablet or 20 ml of suspension) orally for 3 days. Note: The recommended dosage applies only to intestinal parasites and strongyloidiasis. The dosage may not be suitable for the treatment of immunocompromised patients with severe organ damage. See “Special Dosage Instructions”. Mixed helminthiases (intestinal nematodes in combination with flat tapeworms) Taenia solium (pork tapeworm), Taenia saginata (bovine tapeworm) – 400 mg albendazole (1 tablet or 20 ml suspension) orally for 3 days Hymenolepis papa (pygmy tapeworm) – 400 mg albendazole (1 tablet or 20 ml suspension) orally for 3 days, repeat the course after 2-3 weeks Trematodose caused by Clonorchis sinensis (Chinese fluke), Opisthorchis viverrini (squirrel fluke) orally 400 mg albendazole (1 tablet or 20 ml suspension ) 2 times a day for 3 days. Giardiasis (in children 2-12 years old): 400 mg of albendazole (1 tablet or 20 ml of suspension) orally for 5 days. Dosage for children 1-2 years old: half the standard dose. Use only suspension. Dosage for children over 2 years old but weighing less than 10 kg: half the standard dose. Use only suspension. Duration of treatment See “Usual dosage”. If after 3 weeks there is no improvement: repeat the treatment. Systemic helminthiases: To date, there is limited experience with the use of albendazole at high doses in children under the age of six years, so use in children under six years of age is not recommended for treatment. The dosage depends on the parasite, the patient’s body weight, and the severity of the infection: Infection Patient’s body weight Dose Duration of treatment and frequency of administration per day Cystic echinococcosis > 60 kg 800 mg in two separate doses of 400 mg Daily for 28 days. The 28-day course of therapy can be repeated after 14 days, during which the drug is not prescribed; a total of three such cycles of treatment < 60 kg 15 mg/kg in two separate equal doses (maximum dose 800 mg/day) can be carried out. - inoperable and multiple cysts When treating cysts of the liver, lungs and peritoneal cysts, up to three 28-day cycles of treatment with albendazole can be carried out. Longer treatment may be required for cysts in the bones and brain. - before surgery Before surgery, if possible, two 28-day treatment cycles should be carried out. If surgery is required before the completion of two cycles of treatment, albendazole should be used as long as possible. after surgery after percutaneous drainage of a cyst If there is only a short course of treatment (less than 14 days) before surgery, and in cases where urgent surgery is required, albendazole should be used after surgery for two 28-day cycles, with a 14-day interval without application drug. In addition, if viable cysts are identified after preoperative treatment or if cyst contents leak, two complete cycles of treatment should be performed. Alveolar echinococcosis 1 > 60 kg < 60 kg 800 mg as two equal divided doses. 15 mg/kg as two equal divided doses (maximum dose 800 mg/day). Daily for 28 days. The 28-day course of therapy can be repeated after 14 days during which the drug is not prescribed). Treatment may be needed for several months or years. Continuous treatment using a constant dose was carried out for a period of up to 20 months. Neurocysticercosis 2 > 60 kg < 60 kg 800 mg as two equal divided doses 15 mg/kg as two equal separate doses (maximum dose 800 mg/day). Daily for 7-30 days, depending on response to therapy. The second course of treatment can be carried out in two weeks. - parenchymal cysts and granulomas > 60 kg 800 mg as two equal divided doses Treatment is usually carried out from seven (minimum) to 28 days <60 kg 15 mg/kg as two equal divided doses (maximum dose 800 mg/day). - Arachnoid or intraventricular cysts > 60 kg < 60 kg 800 mg as two equal divided doses 15 mg/kg as two equal separate doses (maximum dose 800 mg/day). Non-parenchymal cysts usually require treatment for 28 days - Vaginal cysts > 60 kg < 60 kg 800 mg as two equal divided doses 15 mg/kg as two equal divided doses (maximum dose 800 mg/day). Treatment is usually required for at least 28 days. Continuous treatment was carried out, the duration of which was determined taking into account the clinical and radiographic response Notes: 1 - alveolar echinococcosis: in cystic echinococcosis, treatment is usually carried out in 18-day cycles. You may need treatment for months or even years. Current follow-up data suggest that survival times improve significantly after long-term treatment. Continuous treatment resulted in an apparent cure in a small number of patients. 2-Neurocysticercosis: Patients treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as needed. The use of oral or intravenous corticosteroids is recommended to prevent hypertensive cerebral events during the first week of treatment. Infection Dose for adults and children Duration of treatment Capillariasis 400 mg Daily for 10 days.3 Gnathostomiasis 400 mg Daily for 10-20 days. 3 Trichinosis 400 mg Twice a day for 5-10 days. 3 Toxocariasis 400 mg Twice a day for 5-10 days. 3 3 - usually only one course of treatment is required, but further courses can be carried out if there are positive clinical and parasitological data. Special Dosage Instructions Elderly: Data on the use of the drug in patients over 65 years of age are insufficient. Anecdotal reports indicate that dosage restrictions are not required. However, elderly patients with impaired liver function should use Nemozol with caution. Use in Renal Insufficiency: Since excretion of albendazole and the original metabolite albendazole sulfoxide via the kidneys is not significant, there is no need to adjust the dosage. However, patients with renal insufficiency require monitoring. Use in hepatic insufficiency: Since albendazole is rapidly metabolized in the liver to the pharmacologically important metabolite albendazole sulfoxide, reduced liver function affects the pharmacokinetics of albendazole sulfoxide. Patients with elevated levels of transaminases before starting treatment need to control the level of liver enzymes. Treatment with albendazole should be discontinued as soon as liver enzyme levels begin to deteriorate, or if there is a clinically significant decrease in blood cells (see "Warnings and Precautions" and "Side Effects"). Proper way of taking Tablets should be swallowed whole. Some patients find it difficult to swallow the tablet whole. In these cases, tablets with a small amount of water can be chewed or crushed, mixed with food. Small children should be treated with the suspension. Suspension (with fruit flavor) is taken undiluted or mixed with a drink. Shake the bottle well before use. If you accidentally skip the time of taking the drug, the next dose should be taken as soon as possible. In the event that the time of the next dose of the drug is approaching, the next dose should be taken according to the schedule, without increasing the total dose. Side effects Data from large clinical trials and post-marketing experience were used to determine the frequency of side effects. Frequency determination: very often: ≥ 10%; often: ≥ 1% and < 10%; infrequently: ≥ 0.1% and < 1%; rarely: ≥ 0.01% and < 0.1%; very rarely: <0.01%. From the immune system: Rarely: hypersensitivity reactions, including rash, pruritus and urticaria. From the nervous system: Infrequently: headaches and dizziness. Neurological symptoms (convulsions, increased intracranial pressure, focal symptoms) caused by previous neurocysticercosis (see "Precautions"). From the gastrointestinal tract: infrequently - dyspepsia (for example, pain in the epigastric region or in the abdomen, nausea and vomiting), as well as diarrhea. From the side of the liver and gallbladder: Rarely: increased levels of liver enzymes. On the part of the skin: Very rarely: polymorphic erythema, Stevens-Johnson syndrome. Additional cases of increased intracranial pressure, neck stiffness, acute renal failure, leukopenia, pancytopenia, aplastic anemia, agranulocytosis, very often elevated liver enzymes, hepatitis, reversible alopecia and fever. Patients with liver disease, including those with hepatic echinococcosis, are more susceptible to bone marrow depression (see Dosage/Method of Use and Precautions). In the event of the occurrence of these adverse reactions, as well as the appearance of other adverse reactions not described in this leaflet, you should consult a doctor. Interaction with other drugs With the simultaneous use of praziquantel, cimetidine or dexamethasone in the blood plasma, the concentration of the active metabolite of albendazole (sulfoxide) may increase several times, which may contribute to an increase in the frequency of side effects. Grapefruit juice also helps to increase the level of albendazole sulfoxide in the blood. Ritonavir, phenytoin, carbamazepine, phenobarbital, levamisole, ritonavir can reduce the concentration of active metabolites of albendazole in blood plasma. The clinical significance of this effect is unknown; but it is possible to reduce the effectiveness of Nemozol, in particular, with systemic helminthic invasions. In this case, the effectiveness of treatment should be monitored. Under certain circumstances, alternative dosages or treatments are necessary. Due to possible changes in the activity of cytochrome P-450, there is a theoretical risk of interaction with oral contraceptives, anticoagulants, hypoglycemic agents, theophylline. In all cases, caution should be exercised. PrecautionsSuspension Nemozol contains: benzoic acid, which can irritate the skin, eyes and mucous membranes. Benzoic acid may increase the risk of jaundice in newborns. In this age group (< 1 year), treatment is not recommended; sorbitol, so it should not be used in patients with rare hereditary fructose intolerance; sodium salts: 1 dose (20 ml suspension) contains no more than 26.6 mg of sodium, it must be taken into account in patients on a salt-free diet. Use in intestinal infections and larval (larval) helminthiasis (skin form) (shorter duration of treatment using a lower dose) In order to avoid taking albendazole in early pregnancy, women of childbearing age should begin treatment during the first week of menstruation or after receiving a negative test pregnancy. Pre-existing neurocysticercosis may be detected during treatment with albendazole, especially in areas with a high prevalence of taeniasis. Patients may experience seizures, increased intracranial pressure, and focal symptoms as a result of the inflammatory response caused by parasite death in the brain. Symptoms may occur shortly after treatment and appropriate steroid and anticonvulsant therapy should be started immediately. Use in systemic helminthiases (longer treatment with higher doses) Treatment with albendazole was associated with mild to moderate elevations in liver enzymes, which returned to normal after treatment was discontinued. Cases of hepatitis have been reported (see "Side Effects"). Before the start of each treatment cycle, and at least every two weeks during treatment, liver function tests should be performed. With an increase in liver enzyme levels (twice the upper limit of normal), treatment with albendazole should be discontinued. It is possible to resume treatment after normalization of liver enzyme levels with careful monitoring of the patient for relapse. Albendazole causes bone marrow depression. Patients with liver disease, including those with hepatic echinococcosis, are more susceptible to bone marrow depression, which can lead to pancytopenia, aplastic anemia, agranulocytosis, and leukopenia, so more frequent CBC monitoring is indicated in these cases. Blood tests should be performed at the beginning of every 28 day cycle and every 2 weeks during albendazole therapy. It is possible to continue treatment with albendazole if the decrease in the total content of leukocytes and neutrophilic leukocytes is moderate and does not progress. Albendazole should be discontinued if a clinically significant reduction in blood cells is noted (see "Dosage and Administration" and "Side Effects"). In order to avoid taking albendazole in early pregnancy, women of childbearing age should: start treatment after receiving a negative pregnancy test. The test should be repeated at least once before the start of the next cycle; during therapy and within one month after its completion, reliable contraception is required. Patients treated with albendazole for neurocysticercosis may experience symptoms associated with an inflammatory response after parasite death (eg, convulsions, increased intracranial pressure, focal symptoms). Treatment should include appropriate steroids and anticonvulsants. The use of corticosteroids during the first week of therapy is recommended to prevent hypertensive cerebral events. Pre-existing neurocysticercosis may be detected during treatment with albendazole, especially in areas with a high prevalence of taeniasis. Patients may experience seizures, increased intracranial pressure, and focal symptoms as a result of the inflammatory response caused by parasite death in the brain. Symptoms may occur shortly after treatment and appropriate steroid and anticonvulsant therapy should be started immediately. Risk of retinal damage in patients with retinal neurocysticercosis Cysticercosis can affect the retina. Before starting therapy for neurocysticercosis, it is necessary to examine the patient for retinal damage. If such lesions are visualized, weigh the need for anticysticercosis therapy against the possibility of retinal damage resulting from the inflammatory process caused by albendazole-induced parasite death. Detection of neurocysticercosis in echinococcosis patients Undiagnosed neurocysticercosis may be detected in patients treated with albendazole for other indications. Patients with epidemiological risk factors for neurocysticercosis should be evaluated prior to initiating therapy. Pregnancy and lactation Animal studies have shown adverse effects on the fetus. Currently, there are no sufficient data on the use of Nemozol in pregnant women. The drug is contraindicated in pregnant women (see "Contraindications"). If necessary, the use of the drug, women of reproductive age should use effective methods of contraception (see "Precautions"). Breastfeeding: No studies have been conducted in breastfeeding women. There are no data on whether albendazole or its metabolites are excreted in breast milk. Therefore, Nemozol can be used during breastfeeding only if the intended benefit to the mother outweighs the potential risk to the child. Influence on the ability to drive vehicles and work with mechanisms When taking albendazole, dizziness is possible. Patients should be warned about the need to take special care when driving vehicles and while working with potentially dangerous mechanisms. Overdose Treatment: symptomatic, gastric lavage, activated charcoal. Packing: 1 film-coated tablet, 400 mg in PVC/Al blister. Suspension for oral administration 100 mg / 5 ml, 20 ml each in a white plastic bottle with an aluminum screw cap with a seal and a first opening control. Shelf life Tablets, film-coated - 3 years. Suspension for oral administration - 3 years. Storage conditionsKeep in a place protected from moisture and light at a temperature below 25°C. Keep away from children. Conditions of release According to a doctor's prescription. Buy Nemozol tablets p/o 400mg No. 1x1