Simvastatin tab p / 10 mg film about 30 pieces of ozone

Description

Composition
Active substance:
1 tablet contains: Simvastatin – 10, 20 or 40 mg.
Product form:
Tablets, film-coated 10 mg, 20 mg and 40 mg. At 7, 10, 14, 20, 30, 50 tablets in blisters of PVC film and aluminum foil printed patent. 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets in polyethylene jars for pharmaceuticals or polymer cans for medicines. One jar or 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 contour of cellular packaging together with instructions for use placed in a cardboard box (pack).
Contraindications
• Hypersensitivity to simvastatin or other components of the drug as well as other drugs of a number of statin (HMG-CoA reductase) in history; • liver disease in active phase or persistent increase in “liver” enzymes in the blood plasma of unknown etiology; • age of 18 years (except for children and teenagers of 10-17 years with heterozygous familial hypercholesterolemia (see “Indications») • pregnancy, breast-feeding;.. • simultaneous application of potent inhibitors isoenzyme CYP3A4 (itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone and preparations containing kobitsistat); • the simultaneous application of gemfibrozil, cyclosporin or danazol; • neper enosimost lactose, lactase deficiency and syndrome of glucose-galactose malabsorption.
Dosage
10 mg
Indications
Patients with coronary heart disease (CHD) or at high risk of coronary artery disease: • Coronary heart disease (secondary prevention) formulation indicated for patients to reduce total mortality; to reduce coronary mortality risk and prevention of myocardial infarction; in order to reduce the risk of stroke and transient ischemic attacks; to slow the progression of coronary atherosclerosis. • reduce the risk of the need for restoration of coronary blood flow operations (such as coronary artery bypass graft and percutaneous transluminal coronary angioplasty). • reduce the risk of the need for recovery operations in peripheral blood flow and other non-coronary revascularization. • Reducing the risk of hospitalization due to angina. Hypercholesterolemia and hyperlipidemia: • Primary Hypercholesterolemia (type IIa and IIb Fredrickson for) the poor diet low in cholesterol and other non-drug interventions (exercise and weight reduction) in patients with an increased risk of coronary atherosclerosis; • reduction of elevated concentrations of total cholesterol (TC), low density lipoprotein cholesterol (LDL), triglycerides (TG), apolipoprotein B (apo B). • raising high density lipoprotein cholesterol (HDL-C). • reduction ratio LDL / HDL cholesterol and total cholesterol / HDL cholesterol. • hypertriglyceridemia (type IV hyperlipidemia Fredrickson classification). • an adjunct to diet and other methods for treating patients with homozygous familial hypercholesterolemia to reduce elevated concentrations of total cholesterol, LDL cholesterol and apo B. • disbetalipoproteinemiya primary (type III hyperlipidemia Fredrickson classification). • combined hypercholesterolemia and hypertriglyceridemia, not correctable special diet and exercise. Use in children and adolescents with heterozygous familial hypercholesterolemia: simvastatin simultaneously with the diet is indicated for the reduction of elevated concentrations of total cholesterol, LDL cholesterol, triglycerides, apo B in young men 10-17 years and women 10-17 years of not less than 1 year after menarche (first menstrual bleeding) with heterozygous familial hypercholesterolemia.
pharmachologic effect
Pharmacological group:
Lipid-lowering drugs – HMG-CoA reductase inhibitor.
Pharmacological properties:
The hypolipidemic drug derived synthetically from a fermentation product of Aspergillus terreus. The simvastatin body being inactive lactone, is hydrolyzed in the liver to form the corresponding beta-hydroxyacid form simvastatin – main metabolite, has an inhibitory effect on the W-Z- hydroxy-methylglutaryl-coenzyme A (HMG-CoA) – reductase, the enzyme catalyzing the initial and the most significant step of cholesterol biosynthesis. As a result of simvastatin reduced total cholesterol content in blood plasma of low density lipoproteins (LDL) and very low density lipoproteins (VLDL). Simvastatin content causes a decrease in plasma triglycerides and moderate elevation of high density lipoprotein (HDL), and thus, reduces the ratio of LDL / HDL and total cholesterol / HDL. The active metabolite of simvastatin is a specific inhibitor of HMG-CoA reductase, the enzyme catalyzing the reaction for the formation of mevalonate HMG-CoA. Despite this, simvastatin in dosage does not lead to complete inhibition of HMG-CoA reductase, which allows to keep the production of the biologically required amount of mevalonate. Since the conversion of HMG-CoA to mevalonate is an early step in cholesterol biosynthesis, it is believed that the use of simvastatin should not cause accumulation in the body is potentially toxic sterols. In addition, GMG CoA is rapidly metabolized to acetyl-CoA, which participates in many biosynthetic processes in the body. Reduces total cholesterol and LDL levels in cases of familial and non-familial heterozygotic hypercholesterolaemia forms, in mixed hyperlipidemia where the high content of cholesterol is a risk factor. The drug reduces the total cholesterol and LDL cholesterol in patients with coronary heart disease, reducing the risk of myocardial infarction and death in these patients. Simvastatin significantly reduces the content in polipoproteina moderately increases HDL cholesterol concentration and reduced plasma triglycerides (TG). As a result of these effects, simvastatin reduced total cholesterol ratio (TC) to HDL cholesterol (TC / HDL) cholesterol and LDL cholesterol to LPVN (LDL / HDL). Notable therapeutic effects observed during 2 weeks of treatment, the maximum therapeutic effect after 4-6 weeks after initiation of treatment. The effect is maintained with continued therapy. When a reception simvastatin concentration of cholesterol is returned to the initial concentration observed before treatment.
Conditions of supply of pharmacies
Prescription.
Dosing and Administration
Prior to treatment with simvastatin, patients should assign a standard hypolipidemic diet, which must be maintained throughout the course of treatment. Simvastatin should be taken orally once a day 1 night, drinking plenty of water. Time of administration of the drug should not be associated with food intake. Hypercholesterolemia recommended dose of simvastatin varied from 5 to 80 mg 1 time per day in the evening. The recommended starting dose for patients with hypercholesterolemia is 10 mg. The maximum daily dose – 80 mg. Change (selection) the dose should be made at intervals of 4 weeks. In most patients, the optimal effect is obtained by taking the drug at doses up to 20 mg per day. Cardiovascular prevention in patients with coronary heart disease (CHD) or at high risk for coronary heart disease (in combination with hyperlipidemia or without – patients with diabetes, patients with stroke or cerebrovascular disease in history, patients with peripheral vascular disease), standard simvastatin initial dose is 40 mg once a day in the evening. Drug therapy should be started simultaneously with diet and exercise therapy. Patients with hyperlipidemia who do not have the above risk factors. Typically, the initial dose is 20 mg per day, which is assigned only once in the evening. For patients who need a considerable (over 45%) decrease in the concentration of LDL cholesterol, the initial dose may be 40 mg once a day in the evening. Patients with mild to moderate hypercholesterolemia can be administered at an initial dose of simvastatin 10 mg. If necessary, the selection of doses to be carried out in accordance with the above scheme. Patients with homozygous familial hypercholesterolemia patients with homozygous familial hypercholesterolemia recommended daily dose of simvastatin 40 mg 1 time per day in the evening or 80 mg in 3 doses (20 mg in the morning, afternoon, and 20 mg to 40 mg in the evening). Dose of 80 mg per day is recommended to be prescribed only for patients at high risk for cardiovascular complications if treatment with lower doses is not possible to achieve target lipid levels, and the anticipated benefits of therapy outweighs the potential risk. In such patients, simvastatin drug is used as an adjunct to other lipid-lowering therapy (e.g. plasmapheresis LDL) or without such treatment, if it is available. If the kidney function Because simvastatin is excreted by kidneys in small amounts, there is no need to change the dosage in patients with mild renal impairment. In severe renal failure (less than 30 ml / min creatinine clearance) should carefully weigh the desirability destination of the drug in doses exceeding 10 mg per day. If such dosages are necessary, they should be administered with caution.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist