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Prevention of cardiovascular diseases. For adult patients without clinically expressed coronary heart disease, but with several risk factors for developing coronary heart disease, such as age, Smoking, hypertension, low HDL (high-density lipoproteins), or having an early family history of coronary heart disease, Limistin is indicated for: reducing the risk of myocardial infarction; reducing the risk of stroke; reducing the risk of revascularization and angina. For patients with type II diabetes and without clinically expressed coronary heart disease, but with several risk factors for coronary heart disease, such as retinopathy, albuminuria, tyutyunopalinnya or hypertension, the drug is indicated for Limistin: reducing the risk of myocardial infarction; reducing the risk of stroke. For patients with clinically expressed coronary heart disease Limitin shown for: reducing the risk of non-lethal myocardial infarction; reducing the risk of fatal and non-lethal stroke; reducing the risk of revascularization procedures; reducing the risk of hospitalization for congestive heart failure; reducing the risk of angina. Lipidemia. As a Supplement to the diet to reduce elevated levels of total cholesterol, LDL cholesterol (low-density lipoproteins), apolipoprotein B and triglycerides, as well as to increase HDL cholesterol in patients with primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (types IIA and IIB according to the Fredrickson classification). As a Supplement to the diet for the treatment of patients with elevated serum triglyceride levels (type IV according to the Fredrickson classification). For the treatment of patients with primary dysbetalipoproteinemia (type i according to the Fredrickson classification) in cases where dieting is not effective enough. To reduce total and LDL cholesterol in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (for example, LDL apheresis) or if such treatments are not available. As an adjunct to the diet to reduce total cholesterol, LDL cholesterol, and apolipoprotein B levels in boys and girls after the onset of menstruation at the age of 10 to 17 years with heterozygous familial hypercholesterolemia, if after appropriate dietary therapy, the test results are as follows: a) LDL cholesterol remains 3,190 mg/DL or b) LDL cholesterol 3 160 mg/DL and: family history of early cardiovascular disease or two or more other risk factors for cardiovascular disease are present in a child patient.
Description
Limistin 20 coated tablets 20 mg Composition
active substance: atorvastatin;
1 tablet contains atorvastatin calcium in terms of atorvastatin 10 mg or 20 mg or 40 mg;
excipients: calcium carbonate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium; polysorbate 80, hydroxypropyl cellulose, magnesium stearate, propylene glycol, hydroxypropyl ethylcellulose, polyethylene glycol-6000, talc, titanium dioxide E 171 (tablets of 10 mg and 20 mg); calcium carbonate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium; polysorbate 80, hydroxypropyl cellulose, magnesium stearate; crospovidone, sodium lauryl sulfate, hypromellose, poly ethylene glycol, talc, titanium dioxide E 171 (tablets of 40 mg).
Limistin 20 coated tablets 20 mg Release form
10 tablets in blisters, 3 blisters in a box.
Dosage form
Film-coated tablets.
white or almost white, capsule-shaped, film-coated tablets, scored on one side (10 mg and 20 mg tablets);
white or almost white, round, biconvex film-coated tablets (40 mg tablets).
Limistin 20 coated tablets 20 mg Active substance
ATORVASTATIN
Pharmacodynamics
A selective competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A-reductase enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonic acid, which is a precursor of sterols, including cholesterol. Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting 3-hydroxy-3-methylglutaryl coenzyme A-reductase and hepatic cholesterol synthesis, as well as increasing the number of low-density lipoprotein receptors on the surface of hepatocytes, which leads to increased density. Atorvastatin lowers total cholesterol, low-density lipoprotein, apoli protein B, and three glycerides, causes an increase in high-density lipoprotein cholesterol, and apolipoprotein A.
Pharmacokinetics
Atorvastatin is rapidly absorbed after oral administration; the maximum concentration in blood plasma is reached in 1-2 hours. The degree of absorption increases in proportion to the dose of atorvastatin. The bioavailability of the drug is 95-99%. The absolute bioavailability of atorvastatin is approximately 12% and the systemic availability of 3-hydroxy-3-methylglutaryl coenzyme A-reductase inhibitory activity is almost 30%. Low systemic bioavailability is due to pre-systemic clearance in the gastrointestinal mucosa and / or biotransformation during primary passage through the liver. The average volume of distribution of atorvastatin is approximately 565 liters. Atorvastatin binds to plasma proteins by more than 98%, is biotransformed by cytochrome P 450 3 A 4 with the formation of ortho- and parahydroxylated derivatives and various beta-oxidation products. The effect of atorvastatin on 3-hydroxy-3-methylglutarylcoenzyme A-reductase is approximately 70% determined by the activity of circulating metabolites. The drug is excreted in bile after hepatic and / or extrahepatic biotransformation. The drug is not subject to severe intestinal and hepatic recirculation. The mean elimination half-life of atorvastatin is almost 14 hours. Inhibitory activity against 3-hydroxy-3-methylglutarylcoenzyme A-reductase lasts about 20-30 hours due to the presence of active metabolites. There are no data on the pharmacokinetics of the drug in children.
Indications
In addition to the diet for the treatment of patients with elevated levels of total cholesterol, low-density lipoprotein cholesterol (L-LDL), apolipoprotein B, three glycerides to increase high-density lipoprotein cholesterol (L-LVH) in hyperterosperic patients and non-hereditary hypercholesterolemia), combined (mixed) hyperlipidemia (Fredrickson type IV) and patients with dysbetalipoproteinemia (Fredrickson type III) in cases where the diet does not provide the desired effect. To reduce the level of total cholesterol and LDL in patients with homozygous familial hypercholesterolemia, when diet and other non-drugs do not provide the proper effect. Patients without clinical manifestations of cardiovascular disease, with or without dyslipidemia, but who have several risk factors for cardiovascular disease, such as smoking, hypertension, diabetes, low HDL, or a family history of cardiovascular disease -vascular diseases at a young age in order to:
• reducing the risk of fatal manifestations of coronary heart disease and non-fatal myocardial infarction;
• reducing the risk of stroke;
• reducing the risk of angina and the need for myocardial revascularization procedures.
Children (10-17 years). Limistin is prescribed as an adjunct to the diet to lower total cholesterol, LDL and apolipoprotein
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