Vasilip tablets 10mg, No. 28

hypercholesterolemia:

- primary hypercholesterolemia of types IIa and IIb, including polygenic hypercholesterolemia, heterozygous hereditary hypercholesterolemia and mixed hyperlipidemia. The drug is used as monotherapy in cases where adherence to diet and other methods of treatment was insufficient.

cardiovascular prevention:

- reduction of cardiovascular mortality and morbidity in patients with clinical manifestations of atherosclerotic cardiovascular diseases or diabetes mellitus; with normal or high cholesterol levels and as an additional measure to the correction of other risk factors and cardioprotective therapy.

Inside, once, in the evening.

The recommended dose of simvastatin varies from 5 to 80 mg once a day in the evening. Most often, the initial dose of VasilipЃ is 10 mg. Changes (selection) of the dose should be carried out at intervals of at least 4 weeks. The maximum daily dose is 80 mg. This dose is only recommended for patients with severe hypercholesterolemia or a high risk of cardiovascular complications. The duration of the use of the drug is determined by the attending physician individually.

Hypercholesterolemia

The patient should follow a standard hypocholesterol diet throughout the entire period of treatment with VasilipЃ. The recommended starting dose is 10 mg. For a more pronounced decrease in LDL cholesterol (more than 45%), treatment can be started with 20-40 mg / day (once in the evening).

In patients with homozygous hereditary hypercholesterolemia, the recommended daily dose is 40 mg in the evening or 80 mg in 3 divided doses (20 mg in the morning, 20 mg in the afternoon and 40 mg in the evening); these patients are recommended to use VasilipЃ in combination with other lipid-lowering therapy (for example, LDL apheresis).

Cardiovascular prophylaxis

In patients with a high risk of coronary artery disease, hyperlipidemia or without it, the effective dose of VasilipЃ is 20Ц40 mg per day. Therefore, the recommended starting dose for these patients is 20 mg per 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 per day. If the content of LDL is less than 75 mg / dL (1.94 mmol / L), total cholesterol is less than 140 mg / dL (3.6 mmol / L), the dose of the drug must be reduced.

Concomitant therapy

VasilipЃ is effective in monotherapy or in combination with bile acid sequestrants (for example, cholestyramine and colestipol). In patients receiving treatment with cyclosporine, gemfibrozil, other fibrates or nicotinic acid (more than 1 g / day), the recommended initial dose is 5 mg, the maximum daily dose is 10 mg. Further dose increases in such situations are not recommended. In patients simultaneously receiving amiodarone or verapamil, the daily dose of VasilipЃ should not exceed 20 mg.

Elderly patients and patients with moderate renal failure do not need to change the dosage of the drug. In patients with severe renal insufficiency (Cl creatinine <30 ml / min), the recommended dose of VasilipЃ should not exceed 10 mg per day. If it is necessary to increase the dose, careful monitoring of such patients is necessary.

hypersensitivity to simvastatin and other components of the drug;

liver disease in the active phase or a persistent increase in the activity of hepatic transaminases of unclear etiology;

concomitant use of cytochrome P450 3A4 (CYP3A4) inhibitors (for example, itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone);

pregnancy;

lactation period;

age up to 18 years (efficacy and safety of use have not been studied).

With care: alcohol abuse before starting therapy, a history of liver disease, severe electrolyte imbalance, severe endocrine and metabolic disorders, arterial hypotension, severe acute infections (sepsis), myopathy, uncontrolled epilepsy, major surgical interventions, trauma, lactase deficiency, galactosemia or glucose-galactose malabsorption syndrome (since the drug contains lactose), simultaneous administration with gemfibrozil, cyclosporine, nicotinic acid (more than 1 g / day), amiodarone, verapamil, diltiazem, fenofibrate, grapefruit juice.