Mebendazole Grindeks pills 100mg №6×1

NameMebendazole Grindeks tabl. 1 blister, together with instructions for the medical use of the drug in a pack of cardboard. text Main active ingredient Mebendazole Release form Tablets. Dosage 100 mg in blister pack No. 6×1 Pharmacodynamics Mebendazole is an anthelmintic agent of the benzimidazole group with a wide spectrum of action. It shows the greatest activity against intestinal nematodes, it is also effective in the case of other helminths, their larvae and eggs. The greatest antihelminthic activity of mebendazole is observed with the invasion of the following helminths: Ascaris lumbricoides (98%), Ancylostoma duodenale (96%), Necator americanus (96%), Enterobius vermicularis (95%), Trichuris trichiura (68%). Mebendazole is also effective against Mansonella, Trichinella and the primary animal parasites Angiostrongylus cantonensis and Grathostoma spinigerum. Mebendazole is ineffective in case of Echinococcus invasion by Finns. The ability of mebendazole to inhibit the activity of helminths depends on many factors, including the duration of treatment, the degree of helminth invasion, etc. The mechanism of the anthelminthic action of mebendazole is based on its ability to influence the energy processes of helminths, reducing the glucose reserve, depleting glycogen stores in the tissues of helminths, preventing the synthesis of cellular tubulin, as well as inhibiting the synthesis of ATP. PharmacokineticsAbsorption After oral administration, about 20% of the administered dose reaches the systemic circulation due to incomplete absorption and extensive first pass metabolism (first pass effect). The maximum plasma concentration, as a rule, is observed 2-4 hours after taking mebendazole. The simultaneous use of mebendazole with food containing fats leads to a slight increase in its bioavailability. Distribution Plasma protein binding is 90-95%. The volume of distribution is 1-2 l / kg, which indicates the distribution of mebendazole outside the vessels. This is supported by data obtained from patients who used mebendazole for a long time (for example, 40 mg / kg / day for 3-21 months) and in which the level of mebendazole was determined in the tissues. Metabolism After oral administration, mebendazole is metabolized primarily in the liver. Plasma concentrations of its main metabolites (in the form of amines and hydroxylated amine derivatives of mebendazole) are significantly higher than those of mebendazole. Impaired liver function, metabolic disorders or biliary disorders can lead to an increase in plasma concentrations of mebendazole. Withdrawal Mebendazole, its conjugated forms and metabolites are partially subjected to enterohepatic recirculation and excreted in the urine and bile. The elimination half-life after oral administration in most patients is 3-6 hours. Impaired renal function does not significantly affect the excretion of mebendazole from the body. Steady state pharmacokinetics Long-term use (eg, 40 mg/kg/day for 3–21 months) increases plasma concentrations of mebendazole and its major metabolites, resulting in an approximately 3-fold increase in total systemic exposure compared to a single dose. Pharmacokinetics in children under the age of 2 years has not been studied, at the age of 2 years it is similar to the pharmacokinetics in adults. Pharmacokinetics in elderly patients has no features. Indications Mebendazole-Grindeks tablets are used to treat single or mixed gastrointestinal infestations of cestodes and nematodes such as Enterobius vermicularis (pinworms), Trichuris trichiura (whipworm), Ascaris lumbricoides (ascaris), Ancylostoma duodenale and Necator americanus (nematodes). Dosage and administrationFor oral administration with a small amount of water. The tablet can be swallowed whole, chewed or crushed and added to food. During treatment with mebendazole, there is no need to follow a diet and use laxatives. For adults and children over the age of 2 years, the doses are the same. In case of invasion with pinworms, 100 mg (1 tablet) is prescribed once. Due to the short life cycle of pinworms and the high risk of re-infestation, especially in closed groups, the course of treatment should be repeated after 2 weeks. When infected with other helminths and mixed helmitosis – 100 mg in the morning and evening for 3 days in a row. The treatment is repeated if signs of helminthiasis are found again after 3 weeks. The drug should not be prescribed to children under the age of 2 years, since its safety in young children has not been confirmed by clinical data. If you forgot to take the next dose of the medicine on time, wait and do it at the usual time. Do not use a double dose to replace a forgotten dose. If you have any questions about the use of this medicine, ask your doctor or pharmacist. Use during pregnancy and lactation In animal experiments, mebendazole revealed an embryotoxic and teratogenic effect. The potential risk to humans is not known, so use during pregnancy is not recommended. Use during breastfeeding is not recommended, as it is not known whether mebendazole is excreted in mother’s milk. Precautions To avoid re-invasion and recurrence of the disease, patients should strictly observe the rules of personal hygiene. With prolonged use, it is necessary to monitor the picture of peripheral blood, liver and kidney function. During the day after the intake, the use of ethanol, fatty foods, laxatives is prohibited. Be sure to periodically examine the smears of the anal area and feces after the end of treatment: therapy is considered effective in the absence of helminths or their eggs for 7 consecutive days. In rare cases, mebendazole can cause seizures in children under 2 years of age, so the use of mebendazole in children in this age group is not recommended. The use of mebendazole in very young children should only be considered if pinworm infection has a clear impact on the nutritional status and physical development of the child. The results of clinical studies indicate a possible relationship between the simultaneous use of mebendazole and metronidazole and the development of Stevens-Johnson syndrome / toxic epidermal necrolysis. Therefore, the simultaneous use of mebendazole and metronidazole should be avoided. The tablets contain lactose, therefore, in patients with rare congenital galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, the use of the drug is contraindicated. Dye yellow “sunset” (E110), contained in the composition of the tablets, can cause allergic reactions. Interaction with other drugs In therapeutic doses without exceeding the duration of treatment, mebendazole practically does not interact with other drugs. With prolonged simultaneous use with cimetidine, the inactivation of mebendazole in the liver can be slowed down, as a result of which mebendazole accumulates in the body. In this case, it is recommended to determine the concentration of mebendazole in blood plasma in order to correctly adjust the dose. The simultaneous use of mebendazole and metronidazole should be avoided (see section “Precautions”). Contraindications Hypersensitivity to mebendazole and / or to any excipient of the drug. Composition One tablet contains: active substance – mebendazole 100 mg; excipients: lactose monohydrate, corn starch, povidone, sodium starch glycolate (type A), magnesium stearate, sunset yellow (E 110). OverdoseSymptoms: in case of acute overdose, disorders of the gastrointestinal tract were observed – abdominal pain, nausea, vomiting, diarrhea, accompanied by a feeling of dizziness and headaches. When using doses significantly higher than recommended or long-term use, the following side effects have been reported in rare cases: alopecia, reversible liver dysfunction, hepatitis, agranulocytosis, neutropenia and glomerulonephritis. Treatment is symptomatic, there is no specific antidote. It is necessary to remove the drug from the stomach by inducing vomiting or by doing a gastric lavage, as well as by taking activated charcoal. Side effects Due to the fact that at recommended doses mebendazole acts mainly locally on the gastrointestinal tract, side effects are rare and are usually associated with disorders of the gastrointestinal tract. The side effects mentioned below are aligned with the classification of MedDRA organ systems and the frequency of occurrence: very often: (?1/10), often: (?1/100 to <1/10), infrequently (?1/1000 to <1 /100), rare (?1/10,000 to <1/1000), very rare (<1/10,000), frequency not known (cannot be determined from the available data). Blood and lymphatic system disorders Very rarely - neutropenia (with prolonged use, doses are much higher than recommended). Immune system disorders Very rarely - hypersensitivity reactions, including anaphylactic and anaphylactoid reactions. Nervous system disorders Rarely - dizziness, very rarely - convulsions in infants. Gastrointestinal disorders Very rare - abdominal pain, diarrhea (these symptoms may also be the result of helminth infestation). Liver and / or biliary tract disorders: Very rarely - increased activity of hepatic transaminases, abnormal liver function, hepatitis (with prolonged use, doses are much higher than recommended). Skin and subcutaneous tissue disorders: Very rare: rash, Stevens-Johnson syndrome and toxic epidermal necrolysis, urticaria, angioedema. On the part of the kidneys and urinary tract Very rarely - glomerulonephritis (when using doses much higher than recommended). Reporting adverse reactions It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are encouraged to report any suspected adverse drug reactions through national adverse drug reaction and drug failure reporting systems. The patient, if he experiences any adverse reactions, is advised to consult a doctor. consult a doctor. This recommendation applies to any possible adverse reactions, including those not listed in the instructions for use of the drug. You can also report adverse reactions to the adverse drug reactions (actions) information database, including reports of drug failures. By reporting adverse reactions, you help to get more information about the safety of the drug. Storage conditionsStore at a temperature not exceeding 25 °C. Keep out of the reach of children! Do not use after the expiry date stated on the packaging. Shelf life - 5 years. Buy Mebendazole Grindeks tablets 100mg No. 6x1