Albendazole tablets p/o 400mg №1×1

Name:
Albendazole. Forms of release Tablets. INNAlbendazole. FTGAntihelminthic and antiprotozoal agent. Composition One tablet contains: active ingredient – albendazole – 400 mg; excipients – microcrystalline cellulose, corn starch, sodium croscarmellose, crospovidone, povidone K 30, sodium lauryl sulfate, magnesium stearate, Opadry II (including macrogol 4000, lactose monohydrate, hypromellose, titanium dioxide E 171).
Description:
: Film-coated tablets, white, biconvex, round. Pharmacotherapeutic group Anthelmintic agent. ATX code: P02CA03. Pharmacological properties Pharmacodynamics Albendazole is a benzimidazole derivative with anthelmintic and antiprotozoal activity against intestinal and tissue parasites. Albendazole exerts larvicidal, ovocidal, and anthelmintic effects, presumably by inhibiting tubulin polymerization. This causes metabolic disturbances in helminths, including energy depletion (suppression of glucose uptake), which leads to immobilization and then destruction of susceptible helminths. Pharmacokinetics After oral administration, albendazole is poorly absorbed from the gastrointestinal tract (GIT) – less than 5%, unchanged is not determined in plasma, bioavailability is low. Systemic pharmacological action is enhanced when the drug is taken with fatty foods, while absorption increases and Cmax in blood plasma increases by 5 times. The time to reach Cmax of albendazole sulfoxide is 2–5 hours. Plasma protein binding is 70%. Albendazole is found in bile, liver, cyst wall and cystic fluid, cerebrospinal fluid. Albendazole rapidly undergoes a first-pass effect in the liver and is usually not detected in the blood. The main metabolite with anthelmintic activity and providing efficacy in systemic tissue infections is albendazole sulfoxide. After taking the drug in a single dose of 400 mg, the pharmacologically active metabolite, albendazole sulfoxide, reaches plasma concentrations of 1.6 to 6.0 µmol/l. T1 / 2 albendazole sulfoxide 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. Clearance from cysts has been observed for several weeks following long-term high doses. With extrahepatic cholestasis, hepatic clearance is significantly reduced, which leads to an increase in AUC and an increase in plasma albendazole sulfoxide. Special categories of patients: Children: The pharmacokinetics of albendazole sulfoxide when taken in single doses of 200-300 mg (approximately 10 mg / kg) of albendazole is comparable to the pharmacokinetics observed in adults after a meal. Clinical experience with children under 6 years of age is limited. Elderly patients: The pharmacokinetics of albendazole sulfoxide is comparable to that in healthy young patients. Patients with impaired renal function: The pharmacokinetics of albendazole when used in patients with impaired renal function has not been studied. Patients with hepatic impairment: The pharmacokinetics of albendazole when used in patients with hepatic impairment has not been studied. Indications for use Intestinal infections and larval (larval) helminthiasis (including mixed helminthic infestations) – Nematodosis: ascariasis, enterobiasis, trichuriasis, hookworm, necatoriasis, strongyloidiasis. – Trematodosis: opisthorchiasis and clonorchiasis. – Giardiasis in children aged 2–12 years. – Cestodoses: taeniasis (Taenia solium, Taenia saginata), hymenolepiasis. Systemic helminthiases – Echinococcosis. 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: 1. if surgery is unacceptable. 2. before surgery. 3. after surgery, if the preoperative treatment was too short, or the contents of the cyst leaked, or viable material was found during the surgery. 4. after percutaneous drainage of cysts for diagnostic or therapeutic purposes. – Alveolar echinococcosis (caused by Echinococcus multilocularis). Albendazole is used to treat patients: 1. with inoperable disease, especially in cases of local or distant metastases. 2. after palliative surgery. 3. after radical surgery or liver transplantation. – Neurocysticercosis. Albendazole is used to treat patients with the following conditions: 1. solitary or multiple cysts or granulomatous lesions of the brain parenchyma. 2. arachnoid or intraventricular cysts. 3. grape-shaped cysts. Dosage and administration The drug is taken orally during a meal. It is preferable to take at the same time of day. If after 3 weeks there is no recovery, then a second course of treatment should be prescribed. For patients who are unable to swallow the tablet whole, it is recommended to crush it and drink it with a small amount of water. Infection Age Duration of administration Enterobiosis, hookworm, necatoriasis, ascariasis, trichuriasis Adults and children over 2 years (>10 kg) 400 mg once a day once a day Children from 1 to 2 years old (>10 kg) 200 mg once a day once a day Strongyloidiasis , taeniasis, hymenolepiasis Adults and children over 2 years (>10 kg) 400 mg once a day for 3 days. For hymenolepidosis, a second course of treatment is recommended after 2-3 weeks Clonorchiasis, opisthorchiasis Adults and children over 2 years (>10 kg) 400 mg 2 times a day for 3 days Larva Migrans skin syndrome Adults and children over 2 years (>10 kg) 400 mg 1 time per day. Duration of administration from 1 day to 3 days Giardiasis Only children from 2 (>10 kg) to 12 years 400 mg 1 time per day for 5 days Special categories of patients Children. In children under 4 years of age, or who have difficulty swallowing, it is recommended to use the drug in the form of a suspension. Elderly patients. Experience in patients aged 65 years or older is limited. According to reports, dose adjustment is not required, but albendazole should be used with caution in patients with signs of hepatic impairment (see section “Patients with hepatic impairment”). Patients with impaired renal function. Since the renal excretion of albendazole and its main metabolite albendazole sulfoxide is insignificant, the likelihood of a change in the clearance of these compounds in such patients is low. Patients with impaired renal function do not require dose adjustment, but such patients should be closely monitored. Patients with impaired liver function. Since albendazole is rapidly metabolized in the liver to form the main pharmacologically active metabolite of albendazole sulfoxide, a significant effect on the pharmacokinetics of albendazole sulfoxide can be expected in case of impaired liver function. Patients with abnormal liver function tests (transaminases) should be closely monitored before initiating albendazole therapy. Systemic helminth infections (long-term treatment with higher doses). There is limited experience with the use of albendazole in children under the age of six years, therefore it is not recommended to use albendazole in this age period. The recommended dose for children over 6 years of age is 12 mg/kg/day in divided doses. For patients weighing more than 60 kg, the dose of the drug is 400 mg 2 times a day. For patients weighing less than 60 kg, the drug is prescribed at the rate of 15 mg / kg / day in 2 divided doses. The maximum daily dose is 800 mg. It is recommended that all family members be treated simultaneously. Infection Duration of administration Cystic echinococcosis 28 days. For the inoperable form, three 28-day treatment cycles separated by a 14-day drug break are recommended. Before surgery, two 28-day cycles are recommended, separated by a 14-day drug break. If the preoperative course is less than 14 days or viable cysts are found, then after the operation two cycles of 28 days are performed, separated by a 14-day break in taking the drug. Alveolar echinococcosis 28 days. The second 28-day course is repeated after a two-week break in taking the drug. Treatment may be continued for several months or years. Neurocysticercosis Duration of administration 7–31 days. The second course can be repeated after a two-week break in taking the drug. Special categories of patients Dosing features in elderly patients and patients with impaired renal function – see intestinal infections and skin syndrome Larva migrans. Side effect The undesirable reactions presented below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is defined as follows: very often (≥ 1/10), often (≥ 1/100 and ˂ 1/10), infrequently (≥ 1/1000 and ˂ 1/100), rarely (≥ 1/10000 and ˂ 1 /1000), very rarely (˂ 1/10000, including isolated cases). Frequency categories were formed on the basis of post-registration observation. Frequency of occurrence of adverse reactions Use in intestinal infections and larval (larval) helminthiasis (skin form) (shorter duration with a lower dose) Immune system disorders: rarely: hypersensitivity reactions, including rash, itching and urticaria. Nervous system disorders: Uncommon: headache and dizziness. Gastrointestinal disorders: Uncommon: Upper gastrointestinal symptoms (eg, epigastric or abdominal pain, nausea, vomiting) and diarrhea. Liver and biliary tract disorders: rare: increased levels of liver enzymes. Skin and subcutaneous tissue disorders: very rare: erythema multiforme, Stevens-Johnson syndrome. Use in systemic helminthiases (longer treatment with high doses) Blood and lymphatic system disorders: infrequently: leukopenia; very rarely: pancytopenia, aplastic anemia, agranulocytosis. In patients with liver diseases, such as liver echinococcosis, bone marrow suppression is more often observed (see sections “Method of application and doses”, “Precautions”). Immune system disorders: infrequently: hypersensitivity reactions, including rash, itching and urticaria. Nervous system disorders: very common: headache; often: dizziness. Gastrointestinal disorders: Common: Gastrointestinal disorders (abdominal pain, nausea, vomiting). In the treatment of patients with echinococcosis, gastrointestinal disorders associated with albendazole have been observed. Liver and biliary tract disorders: very common: slight or moderate increase in liver enzymes, hepatitis. Skin and subcutaneous tissue disorders: often: reversible alopecia (hair thinning and moderate hair loss); very rarely: erythema multiforme, Stevens-Johnson syndrome. General disorders and disorders at the injection site: often: fever. Contraindications – hypersensitivity to albendazole or any other component that is part of the drug; – Albendazole should not be used during pregnancy or in women who are expected to be pregnant. For women of childbearing age, pregnancy must first be excluded (see also “Use during pregnancy and lactation”). Reporting Suspected Adverse Reactions Health professionals are encouraged to send information about any suspected adverse reactions and drug inefficacy to: Republican Unitary Enterprise “Center for Expertise of Tests in Healthcare”, www.rceth.by. Precautions Possible mild or moderate increase in liver enzymes with prolonged use of the drug, which is normalized after discontinuation. Determination of indicators of liver function should be carried out before the start of each cycle of treatment and every 2 weeks during treatment. If the activity of hepatic transaminases increases by 2 times or more, albendazole should be discontinued. Treatment is repeated when liver function tests return to normal. Albendazole can cause bone marrow suppression, therefore, the patient’s blood should be analyzed both at the beginning of treatment and every 2 weeks during the 28-day treatment cycle. Patients with liver disease, including hepatic echinococcosis, are more prone to bone marrow suppression, resulting in pancytopenia, aplastic anemia, agranulocytosis, and leukopenia, which necessitates careful monitoring of blood counts. In the event of a significant decrease in blood counts, treatment should be discontinued. Treatment with albendazole can detect the presence of pre-existing neurocysticercosis, especially in areas with high infection rates with strains of Taenia solium. Patients may experience neurological symptoms such as seizures, increased intracranial pressure, and focal symptoms due to an inflammatory response caused by parasite death in the brain. Symptoms may occur immediately after treatment, so appropriate therapy with corticosteroids and anticonvulsants should be started immediately. Cysticercosis can, in rare cases, affect the retina. If such lesions are visualized, the need for therapy for cysticercosis should be weighed against the possibility of retinal damage caused by albendazole-induced retinal changes. Oral or intravenous corticosteroids are recommended to prevent an increase in cerebral pressure during the first week of treatment. Treatment with the drug does not require the use of enemas, laxatives or a special diet. Albendazole contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency and glucose-galactose malabsorption should not take this medicinal product. Use during pregnancy and breastfeeding The drug is contraindicated during pregnancy. To avoid taking albendazole during early pregnancy, women of childbearing age should be treated after receiving a negative pregnancy test; this test should be repeated at least once before starting the next cycle. Contraceptive measures should be taken during and within one month after the end of treatment for systemic infection. It is not known whether albendazole or its metabolites are secreted into human breast milk. Therefore, albendazole should not be used during breastfeeding, unless it is believed that the potential benefit outweighs the possible risks associated with treatment. Use in children Use with caution in children. Influence on the ability to drive vehicles and control mechanisms Given the possibility of developing dizziness, it is necessary to be careful when driving vehicles and servicing mechanical equipment on the move. Interactions with other drugs It has been established that albendazole induces hepatic enzymes of the cytochrome P450 system responsible for its metabolism. Medicinal products that may reduce the effectiveness of albendazole and which require monitoring of effects, as it may be necessary to use other dosing regimens or therapy: – anticonvulsants (for example, phenytoin: fospheniton, carbamazepine, phenobarbital, primidone); – levamisole; – ritonavir. Drugs that can increase the levels of active metabolites of albendazole, and when using which it is necessary to monitor for a possible increase in the side effects of albendazole: – cimetidine; – dexamethasone (continuous use increases the levels of albendazole metabolites by 50%); – praziquantel. Grapefruit juice also increases plasma levels of albendazole sulfoxide. Other possible interactions In connection with a possible change in the activity of cytochrome P450, there is a theoretical risk of interaction with the following drugs: – oral contraceptives; – anticoagulants; – hypoglycemic agents for oral administration; – theophylline. Caution must be exercised when using Albendazole in patients taking the above drugs. Overdose Symptoms of overdose are not described. Treatment: gastric lavage, symptomatic treatment and general supportive measures. Packing: 1 or 5 tablets in a blister pack made of PVC film and aluminum foil. 1 blister pack of 10 tablets, together with the leaflet, is placed in a cardboard box (No. 10×1). 1, 2 or 3 blister packs of 2 tablets, together with the leaflet, are placed in a cardboard box (No. 2×1, No. 2×2, No. 2×3). Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25 ° C. Keep out of the reach of children. Terms of dispensing from pharmacies By prescription. Shelf life 2 years. Do not use the medicine after the expiration date. Buy Albendazole tablets p/o 400mg №1×1 Price for Albendazole tablets p/o 400mg №1×1