Mertenil tablets 10mg, No. 30

hypercholesterolemia and combined (mixed) dyslipidemic conditions to reduce the increased concentration of total cholesterol, LDL cholesterol, ApoB and TG in serum as an adjunct to diet therapy, when diet and other non-drug methods (for example, exercise, weight loss) are insufficient;

familial homozygous hypercholesterolemia as an adjunct to diet therapy and other methods of lipid-lowering therapy (for example, LDL apheresis) or in cases where such therapy is not effective enough;

hypertriglyceridemia (Fredrickson type IV) as an adjunct to diet;

to slow the progression of atherosclerosis as an addition to the diet in patients who are indicated for therapy to reduce the concentration of total cholesterol and LDL cholesterol;

primary prevention of major cardiovascular complications (cardiovascular death, stroke, heart attack, unstable angina pectoris and arterial revascularization) in adult patients without clinical signs of coronary heart disease, but with an increased risk of its development (age over 50 years for men and 60 years for women, an increased concentration of C-reactive protein -? 2 mg / l - in the presence of at least one of the additional risk factors, such as arterial hypertension, low concentration of HDL cholesterol, smoking, family history of early onset of coronary heart disease).

Inside, at any time of the day, regardless of food intake, without chewing or crushing, swallowing whole, drinking water.

Before starting treatment, the patient should follow a standard diet with low cholesterol content, which should be continued throughout the treatment period. Doses of the drug should be selected individually, in accordance with the goal of the treatment and the patient's therapeutic response to the therapy, taking into account the current generally accepted recommendations for target lipid levels.

The recommended initial dose of the drug is 5 or 10 mg 1 time per day both for patients who have not previously taken statins and for patients who have been transferred to this drug after therapy with other HMG-CoA reductase inhibitors.

When choosing the initial dose of the drug, one should take into account the level of cholesterol in each individual patient, as well as the possible risk of developing cardiovascular complications and the potential risk of side effects. If necessary, the dose can be adjusted after 4 weeks.

Due to the possible development of side effects when taking a dose of 40 mg compared with lower doses of the drug (see 'Side Effects'), final titration to a maximum dose of 40 mg should be performed only in patients with severe hypercholesterolemia and a high risk of cardiovascular complications (especially patients with hereditary hypercholesterolemia), in whom the target cholesterol level was not reached when taking a dose of 20 mg and who will be under medical supervision. When prescribing a dose of 40 mg, close medical supervision is recommended. It is not recommended to prescribe a dose of 40 mg to patients who have not previously consulted a doctor.

Elderly patients

No dose adjustment due to age is required.

Patients with renal impairment

No dose adjustment is required in patients with mild to moderate renal impairment. The recommended initial dose of the drug is 5 mg for patients with moderate renal insufficiency (Cl creatinine less than 60 ml / min). Appointment of the drug MertenilЃ in any dose is contraindicated in patients with severe renal failure (see 'Contraindications'). For patients with moderate renal insufficiency, the administration of the drug at a dose of 40 mg is contraindicated.

Patients with hepatic impairment

An increase in the systemic concentration of rosuvastatin in patients with a Child-Pugh score of 7 or less was not detected. However, an increase in the systemic concentration of the drug was observed in patients with Child-Pugh scores of 8 and 9. In such patients, liver function should be monitored during therapy. There are no data on the use of the drug by patients with a Child-Pugh score above 9. MertenilЃ is contraindicated in patients with active liver disease.

Ethnic groups

In patients of the Asian race, an increase in the systemic concentration of rosuvastatin is possible. When prescribing doses of 10 and 20 mg, the recommended starting dose for patients of Asian origin is 5 mg. The use of the drug at a dose of 40 mg in such patients is contraindicated (see 'Contraindications').

Patients predisposed to myopathy

When prescribing doses of 10 and 20 mg, the recommended initial dose of the drug for patients with a predisposition to myopathy is 5 mg. The use of the drug at a dose of 40 mg in such patients is contraindicated.

5, 10 and 20 mg tablets

hypersensitivity to rosuvastatin or any of the components of the drug;

liver disease in the active phase, including a persistent increase in the activity of hepatic transaminases, as well as any increase in the activity of transaminases in the blood serum by more than 3 times compared with VGN;

severe renal dysfunction (Cl creatinine less than 30 ml / min);

myopathy;

concomitant use of cyclosporine;

patients prone to the development of myotoxic complications;

patients with liver failure with a score above 9 on the Child-Pugh scale;

lactose intolerance, lactase deficiency or glucose-galactose malabsorption;

pregnancy;

lactation period;

women of childbearing age who do not use reliable contraception;

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

Tablets 40 mg:

hypersensitivity to rosuvastatin or any of the components of the drug;

liver disease in the active phase, including a persistent increase in the activity of hepatic transaminases, as well as any increase in the activity of transaminases in the blood serum by more than 3 times compared with VGN;

renal failure of moderate severity (Cl creatinine less than 60 ml / min);

myopathy;

concomitant use of cyclosporine;

patients prone to the development of myotoxic complications;

hypothyroidism;

a personal or family history of muscle disease;

myotoxicity while taking other inhibitors of HMG-CoA reductase or fibrates in history;

excessive alcohol consumption;

conditions that can lead to an increase in the concentration of rosuvastatin in the blood plasma;

patients of the Asian race;

simultaneous reception of fibrates;

patients with liver failure with a score above 9 on the Child-Pugh scale;

lactose intolerance, lactase deficiency or glucose-galactose malabsorption;

pregnancy;

lactation period;

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

Carefully

Tablets 5, 10 and 20 mg - the presence of a risk of developing myopathy / rhabdomyolysis - renal failure; hypothyroidism; a personal or family history of hereditary muscle disease and a previous history of muscle toxicity with other HMG-CoA reductase inhibitors or fibrates; excessive alcohol consumption; conditions in which an increase in the plasma concentration of rosuvastatin is noted; age over 65; history of liver disease; sepsis; arterial hypotension; extensive surgical interventions; trauma; severe metabolic, endocrine or electrolyte disturbances; uncontrolled epilepsy; race (Asian race); simultaneous reception of fibrates.

Tablets 40 mg - risk of myopathy / rhabdomyolysis - mild renal failure (Cl creatinine> 60 ml / min); age over 65; history of liver disease; sepsis; arterial hypotension; extensive surgical interventions; trauma; severe metabolic, endocrine or electrolyte disturbances; uncontrolled epilepsy.