Simvastatin tablets 20mg, No. 30 Ozone

primary hypercholesterolemia (type IIa and IIb) with ineffectiveness of diet therapy with low cholesterol and other non-drug measures (exercise and weight loss) in patients with an increased risk of coronary atherosclerosis;

combined hypercholesterolemia and hypertriglyceridemia, not corrected by a special diet and physical activity.

Coronary heart disease:

for the prevention of myocardial infarction, to reduce the risk of death, reduce the risk of cardiovascular disorders (stroke or transient ischemic attacks), slow the progression of coronary atherosclerosis, reduce the risk of revascularization procedures.

Before starting treatment with Simvastatin, the patient should be prescribed a standard cholesterol cholesterol diet, which should be followed throughout the course of treatment.

Simvastatin should be taken orally 1 time / day in the evening with plenty of water. The time of taking the drug should not be associated with food intake.

The recommended dose of Simvastatin for the treatment of hypercholesterolemia varies from 10 to 80 mg 1 time / day in the evening.

The recommended starting dose for patients with hypercholesterolemia is 10 mg. The maximum daily dose is 80 mg.

Changes (selection) of the dose should be carried out at intervals of 4 weeks. In most patients, the optimal effect is achieved when taking the drug in doses up to 20 mg / day.

In patients with homozygous hereditary hypercholesterolemia, the recommended daily dose of Simvastatin is 40 mg 1 time / day in the evening or 80 mg in three divided doses (20 mg in the morning, 20 mg in the afternoon and 40 mg in the evening).

In the treatment of patients with coronary artery disease (IHD) or a high risk of developing IHD, the effective doses of Simvastatin are 20-40 mg / day. Therefore, the recommended starting dose for such patients is 20 mg / day. Changes (selection) of the dose should be carried out at intervals of 4 weeks, if necessary, the dose can be increased to 40 mg / day. If the LDL content is less than 75 mg / dL (1.94 mmol / L), the total cholesterol content is less than 140 mg / dL (3.6 mmol / L), the dose of the drug must be reduced.

In elderly patients and in patients with mild or moderate renal failure, changes in the dosage of the drug are not required.

In patients with chronic renal failure (creatinine clearance less than 30 ml / min) or receiving cyclosporine, danazol, gemfibrozil or other fibrates (except fenofibrate), niacin in lipid-lowering doses (1 g / day) in combination with simvastatin, the maximum recommended dose of simvastatin is not should exceed 10 mg / day.

For patients taking amiodarone or verapamil at the same time as simvastatin, the daily dose should not exceed 20 mg.

Active ingredient: simvastatin - 20 mg

Excipients : lactose monohydrate (milk sugar) - 112.96 mg, microcrystalline cellulose - 29 mg, corn starch - 20 mg, povidone K25 - 6 mg, butylhydroxyanisole - 0.04 mg, magnesium stearate - 2 mg.

The composition of the film shell: hypromellose - 3.3 mg, macrogol-4000 - 0.9 mg, titanium dioxide - 1.8 mg.

liver disease in the active phase, a persistent increase in the activity of liver enzymes of unknown etiology;

diseases of skeletal muscles (myopathy);

age up to 18 years (efficacy and safety have not been established);

hypersensitivity to simvastatin or to other components of the drug (including hereditary lactose intolerance), as well as to other statin drugs (MMC-CoA reductase inhibitors) in history.

It is prescribed with caution to patients who abuse alcohol, patients after organ transplantation, who are undergoing immunosuppressive therapy (due to the increased risk of rhabdomyolysis and renal failure); in conditions that can lead to the development of severe renal insufficiency, such as arterial hypotension, acute infectious diseases of a severe course, severe metabolic and endocrine disorders, disturbances in water and electrolyte balance, surgical interventions (including dental) or trauma; patients with decreased or increased tone of skeletal muscles of unclear etiology; epilepsy.

Active ingredient: simvastatin - 10 mg

Excipients : lactose monohydrate (milk sugar) - 56.48 mg, microcrystalline cellulose - 14.5 mg, corn starch - 10 mg, povidone K25 - 3 mg, butylhydroxyanisole - 0.02 mg, magnesium stearate - 1 mg.

The composition of the film shell: hypromellose - 1.65 mg, macrogol-4000 - 0.45 mg, titanium dioxide - 0.90 mg.

Composition:

Active ingredient: simvastatin - 20 mg

Excipients : lactose monohydrate (milk sugar) - 112.96 mg, microcrystalline cellulose - 29 mg, corn starch - 20 mg, povidone K25 - 6 mg, butylhydroxyanisole - 0.04 mg, magnesium stearate - 2 mg.

The composition of the film shell: hypromellose - 3.3 mg, macrogol-4000 - 0.9 mg, titanium dioxide - 1.8 mg.

Clinical and pharmacological group: Lipid-lowering drug

Pharmaco-therapeutic group: Lipid-lowering agent - HMG-CoA reductase inhibitor

pharmachologic effect

A lipid-lowering agent, obtained synthetically from the fermentation product of Aspergillus terreus, is an inactive lactone; it undergoes hydrolysis in the body to form a hydroxy acid derivative. The active metabolite inhibits 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase), an enzyme that catalyzes the initial reaction for the formation of mevalonate from HMG-CoA. Since the conversion of HMG-CoA to mevalonate is an early stage in cholesterol synthesis, the use of simvastatin does not cause the accumulation of potentially toxic sterols in the body. HMG-CoA is readily metabolized to acetyl-CoA, which is involved in many synthesis processes in the body.

Causes a decrease in blood plasma triglycerides (TG), low density lipoprotein (LDL), very low density lipoprotein (VLDL) and total cholesterol (in cases of heterozygous familial and nonfamilial forms of hypercholesterolemia, with mixed hyperlipidemia, when high cholesterol is a risk factor) ... Increases high-density lipoprotein (HDL) and decreases the LDL / HDL ratio and total cholesterol / HDL.

The beginning of the manifestation of the effect - after 2 weeks from the start of admission, the maximum therapeutic effect is achieved after 4-6 weeks. The effect persists with continued treatment, with discontinuation of therapy, the cholesterol content gradually returns to the initial level.

Pharmacokinetics

The absorption of simvastatin is high. After oral administration, Cmax in blood plasma is reached after about 1.3-2.4 hours and decreases by 90% after 12 hours. Plasma protein binding is about 95%.

It is metabolized in the liver, has a 'first pass' effect through the liver (it is hydrolyzed to form an active derivative: beta-hydroxy acids, other active as well as inactive metabolites have been found). T1 / 2 of active metabolites is 1.9 hours. It is excreted mainly with feces (60%) in the form of metabolites. About 10-15% is excreted by the kidneys in an inactive form.

Indications

Hypercholesterolemia:

primary hypercholesterolemia (type IIa and IIb) with ineffectiveness of diet therapy with low cholesterol and other non-drug measures (exercise and weight loss) in patients with an increased risk of coronary atherosclerosis;

combined hypercholesterolemia and hypertriglyceridemia, not corrected by a special diet and physical activity.

Coronary heart disease:

for the prevention of myocardial infarction, to reduce the risk of death, reduce the risk of cardiovascular disorders (stroke or transient ischemic attacks), slow the progression of coronary atherosclerosis, reduce the risk of revascularization procedures.

Dosage regimen