Pharmacological properties of the drug Nemozol™
Pharmacodynamics. Albendazole is a broad-spectrum anthelmintic agent that is also active against pathogenic protozoa. Acts on intestinal and tissue forms of parasites; active against eggs, larvae and adult helminths. The antihelminthic effect of the drug is due to inhibition of tubulin polymerization, which leads to metabolic disturbances and death of the helminth. Albendazole is active against intestinal parasites, including nematodes (Ascaris lumbricoides, Triсhiurus triсhiura, Enterobius vermicularis, Ancylostoma duodenale, Necator americanus, Strongiloides stercoralis, Cutaneous Larva Migrans) , cestodes (Hymenolepsis nana, Taenia solium, Taenia saginata) , trematodes ( Opisthorhis viverrini, Clonorchis sinensis) , protozoa ( Giardia lamblia (intestinalis and duodenalis) . Albendazole is effective against tissue parasites, including cystic echinococcosis and alveolar echinococcosis, caused by invasion of Echinococcus granulosus and Echinococcus multilocularis , respectively. The drug is also effective in the treatment of neurocysticercosis, caused by nogo invasion larvae of the pork tapeworm T. solium, capillariasis caused by invasion of Gnatostoma spinigerum . Albendazole destroys cysts or significantly reduces their size in patients with cysts of granular echinococcus. Pharmacokinetics. After oral administration, the drug is poorly absorbed (up to 5%) in the gastrointestinal tract. Simultaneous use of fatty foods approx. increases drug absorption 5 times. Albendazole is 70% bound to blood plasma proteins and is freely distributed in the body; determined in urine, bile, liver, cyst wall and cyst fluid, CSF. Albendazole sulfoxide is rapidly converted in the liver to albendazole sulfone (a secondary metabolite) and other oxidized products. The half-life of albendazole sulfoxide from blood plasma lasts 8–12 hours. Albendazole sulfoxide and other metabolites are excreted primarily in the bile, and only a small amount is excreted in the urine. Since the renal excretion of albendazole and its primary metabolite, albendazole sulfoxide, is insignificant, clearance in patients with impaired renal function does not change. In patients with biliary obstruction, systemic bioavailability may be increased and the half-life of albendazole sulfoxide may be prolonged.
Nemozol's analogs
Level 4 ATC code matches:
Medamin
Vermakar
Vermox
Aldazole
Zentel
Wormil
Vormin
Sanoxal
Mebendazole
Structural analogues of Nemozol: Gelmodol-VM , Sanoxal , Albendazole .
Nemozol or Vermox - which is better?
Vermox is a broad-spectrum antiparasitic agent. The basis of the drug is the substance mebendazole , its concentration in one tablet is 100 mg.
Vermox is most effective against trichuriasis and enterobiasis . Nemozol exhibits the greatest activity against the larvae of pork tapeworm and echinococcus , as well as against intestinal acne .
Vermox can be used from the age of two, while the Nemozol suspension is prescribed to children from the age of one.
Which is better: Dekaris or Nemozol?
Decaris tablets levamisole (50 or 150 mg/tablet) as an active substance Levamisole is effective against infections with the following parasites:
- Ancylostoma duodenale;
- Ascaris lumbrocoides;
- Necator Americanus.
The drug is approved for use in patients over three years of age.
Use of the drug Nemozol™
Use internally during meals. The oral bioavailability of albendazole is increased if the drug is taken with a fatty meal. Adults and children over 2 years of age are prescribed:
- for enterobiasis, hookworm, necatoriasis, ascariasis, trichinosis, 400 mg (1 tablet) or 20 ml of suspension once. When treating enterobiasis, it is recommended to carry out simultaneous treatment of all persons living together;
- for strongyloidiasis and taeniasis - 400 mg (1 tablet) or 20 ml suspension 1 time per day for 3 days;
- for toxocariasis - 400 mg (1 tablet) or 20 ml suspension 1 time per day for 10 days;
- for mixed infestations caused by Opisthorchis viverrini and Clonorchis sinensis - 400 mg (1 tablet) 2 times a day for 3 days.
Children aged 2–12 years with giardiasis are prescribed 400 mg (1 tablet) or 20 ml of suspension once a day for 5 days. For cystic echinococcosis, patients weighing more than 60 kg are prescribed Nemozol at a dose of 400 mg (1 tablet) or 20 ml of suspension 2 times a day for 28 days. For patients weighing less than 60 kg, albendazole preparations are used in a daily dose of 15 mg/kg, divided equally, in 2 doses. The maximum daily dose is 800 mg. The course of treatment can be repeated after a 14-day break; if necessary, 3 courses of treatment can be carried out. For alveolar echinococcosis, patients weighing more than 60 kg are prescribed Nemozol at a dose of 400 mg (1 tablet) or 20 ml of suspension 2 times a day for 3 courses of 28 days with 14-day breaks between courses. For patients weighing less than 60 kg, albendazole preparations are used in a daily dose of 15 mg/kg, divided equally, in 2 doses. The maximum daily dose is 800 mg. For neurocysticercosis, patients weighing more than 60 kg Nemozol are prescribed at a dose of 400 mg (1 tablet) or 20 ml of suspension 2 times a day for 7–30 days, depending on the clinical effect. For patients weighing less than 60 kg, albendazole preparations are used in a daily dose of 15 mg/kg, divided equally, in 2 doses. The maximum daily dose is 800 mg. The course of treatment is 7–30 days, a second course can be carried out after a 14-day break. For cutaneous larva migrans syndrome, 400 mg (1 tablet) or 20 ml of suspension is prescribed once a day for 1–3 days.
Nemozol 400 mg No. 1 tablet p.o.
Instructions for medical use of the drug Nemozol Trade name of the drug Nemozol International nonproprietary name Albendazole Dosage form Film-coated tablets, 400 mg Composition 1 tablet contains the active substance - albendazole 400 mg, excipients: corn starch, sodium lauryl sulfate, purified water, povidone ( PVPR-30), methyl parahydroxybenzoate, propyl parahydroxybenzoate, gelatin, purified talc, sodium starch glycolate, colloidal silicon dioxide, dried corn starch, magnesium stearate. tablet shell: 2-propanol, hypromellose, titanium dioxide (E171), purified talc, propylene glycol, methylene chloride. Description Tablets are round, biconvex, film-coated, white or almost white. Pharmacotherapeutic group: Anthelmintic drugs. Preparations for the treatment of nematodes. Benzimidazole derivatives. Albendazole ATC code P02CA03 Pharmacological properties Pharmacokinetics After oral administration, albendazole is poorly absorbed from the gastrointestinal tract (less than 5%), unchanged in the plasma, bioavailability is low. The systemic pharmacological effect is increased if the dose is taken with a fatty meal, which increases absorption and maximum plasma concentration (Cmax) by 5 times. Plasma protein binding -70%, penetrates in significant quantities into bile, liver, cerebrospinal fluid, urine, wall and fluid of helminth cysts. Metabolized in the liver to form the primary metabolite albendazole sulfoxide, which has anthelmintic activity. The time to reach Cmax of albendazole sulfoxide is 2-5 hours. Albendazole sulfoxide is metabolized to albendazole sulfone (secondary metabolite) and other oxidized products. After taking a single dose of 400 mg, the pharmacologically active metabolite, albendazole sulfoxide, reaches plasma concentrations from 1.6 to 6.0 µmol/l. The half-life of albendazole is 8.5 hours. It is excreted in the bile through the intestines in the form of albendazole sulfoxide and only a small part of its amount is excreted in the urine. With liver damage, bioavailability increases, while the Cmax of albendazole sulfoxide increases by 2 times, and the half-life is extended. Induces cytochrome P450 1A2 in human liver cells. Pharmacodynamics Nemozol is a broad-spectrum antiprotozoal and anthelmintic drug, a benzimidazole carbamate derivative. Nemozol disrupts the processes of glucose transport, suppresses the polymerization of beta-tubulin, causes a disorder in the function of the microtubular apparatus in the body of the helminth, which leads to its death and elimination from the human body. The drug is active against intestinal parasites that cause the skin syndrome Larva Migrans (wandering larvae syndrome); — Nematodae (roundworms): Ascaris lumbricoides (roundworm), Enterobius vermicularis (pinworm), Ancylostoma duodenale (hookworm), Necator americanus, Strongyloides stercoralis; — Cestoidea (tapeworms): Hymenolepsis nana (dwarf tapeworm), Taenia solium (pork tapeworm), Taenia saginata (bovine tapeworm); — Trematodae (flukes): Opisthorchis viverrini, Clonorchis sinensis; — Pretosae (protozoa): Giardia lamblia (intestinal or duodenal). Nemozol is active against tissue parasites, Echinococcus granulosus and Echinococcus multilocularis, which cause cystic and alveolar echinococcosis. Nemozol is effective in the treatment of neurocysticircosis caused by larval infestation of Taenia solium, hepaticolosis caused by Capilaria philippinensis and gnathostomiasis caused by infestation of Gnathostoma spinigerum. Most drugs used to treat ascariasis are effective only against the intestinal stage of this helminthiasis. Nemozol is effective against all stages of development of roundworm and trichinella. Efficiency is 95–100%. Indications for use - intestinal nematodes: ascariasis, enterobiasis, trichuriasis, hookworm disease, strongyloidiasis - tissue nematodes: trichinosis, toxocariasis - tissue cestodiasis: taeniasis, cysticercosis (including neurocysticircosis), hymenolipidosis, echinococcosis (cystic, alveococcosis ) - opistarchosis, clonorchiasis - giardiasis Method of administration and dosage The drug is taken orally, during or after meals, the tablets are not chewed, washed down with water. The use of laxatives and a special diet are not required. It is recommended to treat all family members simultaneously. The dose is set individually, depending on the type of helminth and the patient’s body weight. Treatment of intestinal nematodes Ascariasis, trichocephalosis Nemozol is prescribed to adults and children over 12 years of age at a dose of 400 mg per day once, if necessary, repeat after 3 weeks. No special preparation or diet is required. Enterobiasis It is sufficient to prescribe the drug in a dose of 1 tablet (400 mg) for adults and children over 12 years of age. Strongyloidiasis The drug is prescribed to adults and children over 12 years of age: 1 tablet (400 mg), once for 3 days. Ankylostomiasis Doses of the drug are the same as for the treatment of strongyloidiasis. Treatment of tissue nematodes Trichinosis There are no standard treatment regimens for trichinosis. Treatment is carried out individually, taking into account the timing of the invasion, its clinical manifestations, as well as the severity of the patient’s condition. Nemozol is prescribed to children over 12 years of age (weighing more than 60 kg), the average dosage is 1 tablet (400 mg) 2 times a day after meals for 5 to 10 days. In case of severe invasion and organ damage (myocarditis, pneumonitis, meningoencephalitis), glucocorticosteroids and symptomatic drugs are also prescribed. The effectiveness of treatment is assessed by clinical, laboratory and instrumental indicators (normalization of temperature, cessation of muscle pain, disappearance of edema, normalization of the electrocardiogram, disappearance of physical and radiological signs of lung damage, regression of neurological symptoms, decrease in blood eosinophilia, etc.). Toxocarosis Nemozol is prescribed to adults and children over 12 years of age (weighing more than 60 kg) with an average dosage of 800 mg (2 tablets) per day in 2 divided doses after meals for 5-10 days. May require repeated courses of treatment at intervals of 2 weeks to a month. Adverse reactions are rare and manifest as mild dyspeptic disorders. An increase in aminotransferase levels is extremely rare. Treatment of tissue cestodoses Cystic echinococcosis Treatment of echinococcosis is usually surgical. Chemotherapy is carried out in cases of rupture of cysts and contamination of the body, in the postoperative period, when there is a danger of contamination if the integrity of the cyst is violated during surgery, as well as in cases of multiple lesions of small cysts (no more than 3–5 cm). Anti-relapse treatment is recommended after surgery, when the presence of other small localizations of the parasite cannot be ruled out. It is inappropriate to treat large cysts due to ineffectiveness and the possibility of complications due to the violation of the integrity of the cyst under the influence of the drug. Before prescribing the drug, a clinical blood test and biochemical blood test (liver, kidney tests) are required. Treatment is carried out with normal laboratory values. Nemozol is prescribed in a dose for adults and children over 12 years of age (weighing more than 60 kg) 400 mg 2 times a day, for those weighing less than 60 kg 15 mg/kg/day of body weight in 2 divided doses after meals. The duration of treatment is 4 weeks. During treatment, blood and aminotransferase tests are performed every 5–7 days. If leukocytes decrease below 3.0x109/l and aminotransferase levels increase 5-6 times, it is necessary to suspend treatment until the parameters normalize or significantly improve. In cases of progressive leukopenia and elevated liver enzymes, discontinuation of the drug is required. The prescription of hepatoprotectors during treatment and in cases of toxic manifestations is ineffective; discontinuation of the drug is necessary. Treatment of echinococcosis is multi-course. Nemazol is prescribed in courses with an interval of 2 weeks to 1 month. The duration of treatment for clinically pronounced forms of invasion (presence of cysts) is 28 days. The effectiveness of treatment is assessed by instrumental monitoring and monitoring the dynamics of the titer of specific antibodies. If the indications for prescribing the drug are correctly defined and the dosage and course of treatment are followed, recovery is observed. Alveolar echinococcosis Treatment of alveolar echinococcosis is surgical. Chemotherapy is an additional treatment. The doses of Nemozol and its regimen are the same as for cystic echinococcosis. The duration of the course of treatment is determined by the patient’s condition and tolerability of the drug. A complete cure does not occur when using Nemozol alone. Cysticercosis Nemozol is prescribed to adults and children over 12 years of age (weighing more than 60 kg) 400 mg 2 times a day. Course duration is 7–30 days. 2 days before taking the drug and in the first week (sometimes longer if indicated) of taking the drug, glucocorticosteroids (40–50 mg prednisolone) are prescribed. Before treatment, while taking the drug and at the end, the same monitoring is carried out as in the treatment of echinococcosis. The effectiveness of treatment for cerebral cysticercosis is monitored by clinical parameters and the results of X-ray computed tomography of the brain and nuclear magnetic resonance. With effective treatment, disappearance and/or calcification of the lesions is observed. Repeated courses of treatment are often required. It should be remembered that even in cases of good treatment effect, complete regression of clinical symptoms may not occur due to persistent structural changes in the brain tissue. Giardiasis Adults and children over 12 years of age weighing more than 60 kg, 400 mg 1 time per day for 5 days. Opisthorchiasis The maximum daily dose is 800 mg (2 tablets) 3 times a day. Side effects According to the frequency of manifestation, adverse reactions are defined as very frequent (>1/10), frequent (>1/100, <1/10), sometimes (>1/1000, <1/100), rare (≥1 /10,000 and <1/1000), very rare (<1/10,000). Short-term therapy with low doses Sometimes - headache and dizziness - epigastric or abdominal pain, nausea, vomiting and diarrhea Rarely - hypersensitivity reactions, including rash, itching and urticaria - increased levels of liver enzymes Very rarely - erythema multiforme, Stevenson-Johnson syndrome Long-term high dose therapy Very common - headache - slight or moderate increase in liver enzymes Common - dizziness - abdominal pain, nausea, vomiting and diarrhea (in the treatment of echinococcosis) - reversible alopecia (thinning and moderate hair loss) - fever Sometimes - hypersensitivity reactions , including rash, itching and urticaria - leukopenia - hepatitis Very rarely - pancytopenia, aplastic anemia, agranulocytosis Patients with liver pathologies, including hepatic echinococcosis, are more predisposed to suppressed bone marrow function. - erythema multiforme, Stevenson-Johnson syndrome Contraindications - hypersensitivity to albendazole and other components of the drug - retinal pathology - pregnancy and lactation - children under 12 years of age Drug interactions Cimetedine, praziquantel and dexamethasone increase plasma levels of the albendazole metabolite responsible for systemic effectiveness product. Ritonavir, phenytoin, carbamazepine and phenobarbital may potentially reduce the plasma concentrations of albendazole's active metabolite, albendazole sulfoxide. The clinical significance of this fact is unknown, but it may affect the effectiveness of Nemozol, especially in the treatment of systemic helminthiases. Patients should be monitored by a physician for the effectiveness of treatment, which may require an alternative dosing regimen or a review of therapy. Special instructions There may be a slight or moderate increase in the level of liver enzymes, which normalize after stopping Nemozol. Liver function tests should be performed before each treatment cycle and every two weeks during treatment. If transaminase levels double or more, Nemozol should be discontinued. Treatment is repeated when liver function tests return to normal. Nemozol can cause a reversible moderate decrease in the total number of leukocytes. Blood tests should be performed at the beginning and every two weeks during each 28-day cycle. If leukopenia develops, the drug should be discontinued. During short courses of treatment, it is necessary to monitor peripheral blood (once every 5–7 days) and aminotransferases at the same time. If necessary, patients with neurocysticercosis should receive complex therapy, including steroids and anticonvulsants. For eye diseases, a retinal examination is necessary before starting treatment. In case of ocular cysticercosis, antiparasitic treatment is contraindicated due to the possibility of severe complications (retinal detachment) and the development of blindness. To avoid taking Nemozol in early pregnancy, women of childbearing potential should undergo treatment in the first week after menstruation or after a negative pregnancy test. Contraception should be taken during treatment and for one month after completion of the drug for systemic helminthiasis. Peculiarities of the drug's influence on the ability to drive a vehicle or operate potentially dangerous mechanisms. No effect. Overdose No symptoms described. Release form and packaging 1 tablet is placed in a blister pack made of aluminum foil. 1 blister pack together with instructions for use in the state and Russian languages are placed in a cardboard box. 10 packs are placed in a group cardboard box. Storage conditions Store in a dry place, protected from light, at a temperature not exceeding 250C. Keep out of the reach of children! Shelf life: 3 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription, India 48, Kandivili Ind. Estate, Mumbai 400067, India Owner of the registration certificate “Ipca laboratories Limited”, India Address of the organization accepting claims on the territory of the Republic of Kazakhstan from consumers regarding product quality Almaty, st. Kurmangazy, 48 a, office 10 tel.: 261-51-41 fax: 261-44-66 [email protected]
Side effects of the drug Nemozol™
from the gastrointestinal tract: stomatitis, dry mouth, heartburn, nausea, vomiting, abdominal pain, flatulence, diarrhea, constipation; from the cardiovascular system: arterial hypertension; from the central and peripheral nervous system: insomnia or drowsiness, headache, dizziness, confusion, disorientation, hallucinations, convulsions, decreased visual acuity; from the hematopoietic system: leukopenia, thrombocytopenia, pancytopenia; from the skin and its appendages: alopecia; from the urinary system: impaired renal function, acute renal failure; allergic reactions: itching, urticaria, pemphigus, dermatitis, chills; laboratory indicators: increased activity of liver enzymes.
Special instructions for the use of Nemozol™
During use of the drug, it is necessary to monitor the activity of liver enzymes before the start of each treatment cycle. If the indicators exceed the upper limit of normal by more than 2 times, the use of Nemozol must be stopped until the indicators are completely normalized. It is necessary to monitor the number of leukocytes at the beginning and every 2 weeks of the 28-day cycle of drug use. The use of Nemozol for leukopenia can be continued if the degree of reduction is insignificant and the leukopenia does not progress. Patients with neurocysticercosis should receive appropriate therapy with steroids and anticonvulsants. Special security measures. In order to prevent the use of Nemozol in the early stages of an unknown pregnancy, women of childbearing age can begin taking the drug only after receiving a negative pregnancy test result or at the beginning of menstruation. During the treatment period, with breaks between courses inclusive, it is necessary to ensure reliable contraception. Use during pregnancy or breastfeeding. Taking Nemozol during pregnancy is contraindicated. During treatment, breastfeeding should be stopped (the safety of the drug has not been established). Children. The drug is used in children over 2 years of age. Influence on reaction speed when driving vehicles or working with other mechanisms. During the treatment period, you should refrain from driving vehicles and performing work that requires increased attention and quick reaction.
