$4.90
Manufacturer: Macedonia
Lipid-lowering drugs, monocomponent. HMG-CoA reductase inhibitors. ATX code C10A A01.
Hypercholesterolemia
Treatment of primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet when response to diet and other non-drug treatments (eg, exercise, weight loss) is inadequate. Treatment of homozygous familial hypercholesterolemia as an adjunct to diet and other lipid-lowering treatment (eg, low-density lipid apheresis) or when such treatments are not required.
Cardiovascular Prevention
Reducing the risk of mortality in patients with cardiovascular disease and morbidity in patients with overt atherosclerotic cardiovascular disease or diabetes mellitus with normal or elevated cholesterol levels as adjunctive therapy to correct other risk factors and other cardioprotective.
Description
Composition
active ingredient: simvastatin;
1 film-coated tablet contains simvastatin 10 mg or 20 mg or 40 mg;
excipients: microcrystalline cellulose; lactose, monohydrate; citric acid, monohydrate; ascorbic acid; magnesium stearate; butylhydroxytoluene (E 321); pregelatinized starch; povidone; opadra II pink.
Pharmaco-therapeutic group
Lipid-lowering drugs, monocomponent. HMG-CoA reductase inhibitors. ATX code C10A A01.
Pharmacodynamics
After oral administration, simvastatin, which is an inactive lactone, is hydrolyzed in the liver to form the corresponding beta-hydroxy acid derivative, which has a high inhibitory activity against HMG-CoA reductase (3-hydroxy-3-methylglutaryl-CoA reductase), an enzyme that converts HMG-CoA into mevalonate, the initial and most important step in cholesterol biosynthesis. Simvastatin has been shown to lower normal levels of low-density lipoprotein cholesterol (LDL-C). Low-density lipoproteins (LDL) are formed from very-low-density lipoproteins (VLDL) and are catabolized primarily by receptors with high affinity for LDL. The mechanism of the LDL-lowering effect of simvastatin may consist of both a decrease in the concentration of VLDL-C and stimulation of LDL receptors, leading to reduced production and increased catabolism of LDL cholesterol. Apolipoprotein B levels are also significantly reduced during treatment with simvastatin. In addition, simvastatin significantly increases high-density lipoprotein cholesterol (HDL-C) and reduces plasma triglyceride levels. As a result of these changes, the ratio of total cholesterol to HDL-C and LDL-C to HDL-C decreases.
Indications
Hypercholesterolemia
Treatment of primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet when response to diet and other non-drug treatments (eg, exercise, weight loss) is inadequate. Treatment of homozygous familial hypercholesterolemia as an adjunct to diet and other lipid-lowering treatment (eg, low-density lipid apheresis) or when such treatments are not required.
Cardiovascular Prevention
Reducing the risk of mortality in patients with cardiovascular disease and morbidity in patients with overt atherosclerotic cardiovascular disease or diabetes mellitus with normal or elevated cholesterol levels as adjunctive therapy to correct other risk factors and other cardioprotective.
Allesta’s contraindications
- Hypersensitivity to simvastatin or any component of this drug;
- Liver disease in the acute stage or incomprehensible persistent increase in serum transaminases.
- Pregnancy and lactation ;
- Concomitant use of strong CYP3A4 inhibitors (drugs that increase AUC by about 5 times or more), such as itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors (eg, nelfinavir), boceprevir, telaprevir, erythromycin, and medicines containing cobicistat.
- Concomitant use of gemfibrozil, cyclosporine or danazol;
- In the case of homozygous familial hypercholesterolemia in patients receiving lomitapide, the use of simvastatin in doses greater than 40 mg is contraindicated.
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